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Neuroscience Building
National Institutes of Health
Conference Rooms C & D
6001 Executive Boulevard
Bethesda, Maryland
Thursday, December 6, 2001 - Afternoon Session
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Thursday, December 6th, 2001
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Morning Session
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Friday, December 7th, 2001
Contents
Morning Session
Afternoon Session
P R O C E E D I N G S
[Lunch recess taken at 12:34 p.m.]
A F T E R N O O N S E S S I O N
[1:00 p.m.]
DR. GROFT: You may or may not want to do this, but I wanted to at least propose it to see if it was a feasible way. Maybe this is not the final answer, whether it would be a feasible way of grouping the recommendations. So that, if we end up with 85, we don't have 85, but we may have 15 or 18.
I just wanted to offer it as a possibility, something we have thought of and we may not even be able to discuss it today, but perhaps tomorrow, or at some other point in the very near future, to think about it.
DR. GORDON: Let me make another point along with that, is this should not exempt us from cutting down or compressing recommendations, that wherever we can do that, if there are half a dozen recommendations around the same issue, let's try to compress them.
What this effort that Steve and the rest of the staff have been doing is really, what is the best way for us to present what we have been doing in a way that is concise enough and directed enough so that people will get what we are up to and will understand what we think is most important.
Now, there are going to be a number of ways to do it, this is one way, but I think while we are doing -- and please look at what they have done, but while we are working today, please also be thinking of how to compress and condense, and we have done a little bit of that, and I think that is great, but not repeating something in two different or three different sections where it doesn't need to be there.
DR. FINS: What do you do with the text?
DR. GROFT: The text continues to grow. The text will continue, it will be expanded, and all the recommendations map back to one of these major concepts, so we can trail them. The text will change as we would normally do it, as we prepare the final report.
DR. FINS: I like this very much. What I don't understand is, there is a chapter on Education that we just did. That chapter will still be there.
DR. GROFT: Yes.
DR. FINS: This recommendation, Action Item 1.1, so this is just clustering?
DR. GROFT: Clustering the recommendations into action items.
DR. FINS: This could also be the executive summary.
DR. GROFT: It would be the start of an executive summary, right.
Tom.
MR. CHAPPELL: What I have been looking for, because we need to anticipate that we are going to have readers of these documents, and this rationalizes the work into some categories of thought that I think will be very persuasive and powerful.
I definitely have been looking for something like this and I want to encourage it.
DR. GROFT: We were listening, and I was trying to figure out what we could do. Linnea sent us a document, and then it hit me, gee, we can combine several of these things into a workable document that will make sense. Tom is right, we have so many different audiences we have to play towards and get the message to that we do have to simplify somehow.
I am not saying that these concepts and these recommendations that we provided are absolutely 100 percent correct, but I think just the idea if this is a way that you would like to go, we would then consider this for the final report.
There may be a need for more recommendations, but I think we heard all along that people would like to reduce the number of recommendations down, but I want to make sure that we are capturing your thoughts and concerns with this idea and these concepts that were put forth as recommendations.
DR. GORDON: But I think what is crucial right now is just keep this as one possible schema. We very much have our task in front of us and understand that we may present different ways of organizing the material. We don't really want to focus on this, just Steve wanted to make sure that everybody had this available to them.
DR. FINS: Did some things move? There were some action items that might have been with Education and Coverage and Reimbursement, that we created a new category. Or, are they pretty much still where they were?
DR. GROFT: They did not migrate at this time, but they may migrate later on as we refine the report and the recommendations even more, like we talked about some that really should have been in Access, so they are going to migrate out where they were and into the Access section.
DR. FINS: The real beauty of this really is that everybody -- I mean, I haven't read through it -- but everybody can probably agree on what is in the bold print.
DR. GROFT: Hopefully, so, yes, that is the idea. We do have the opportunity to expand the number of recommendations by several more if they are the major concept that we want to convey.
DR. GORDON: The problem is the same. The problem is that the recommendations may not be strong enough if we try to reduce them to these general categories.
We are just presenting the pros and cons, and we really need to come back to this later because everybody needs to take a look at it and see how it serves. Then, we can come back and have a much fuller discussion.
DR. FINS: When we go back and write the final version of the thing other than the introductory chapter and the Principle and the History chapter, this could be like the executive summary, and then for each of the action items we just have a bullet of justification or rationale.
In other words, I think one of the problems that I think we have to determine is the big wind up on the Background section, and then the recommendations which may or may not make sense to the reader versus having the reader get the action item and then the rationale right there, so they can see how it links up.
DR. GROFT: We are wrestling with that, too. It may be a peculiar problem to Access and Delivery where so much is presented before you get to the recommendation as opposed to the other sections, that things are stated and then recommendations follow it, but it is something we want to talk about a little bit more.
DR. GORDON: What I would like to do is talk more about -- we are going to talk more about where we are headed tomorrow -- I want to just mention a couple of other things. This is really in the spirit of mentioning coming attractions.
There are two sections that we haven't organized, and again, we will come back to this tomorrow because we really need to start momentarily, one is there is a vision section at the end that will sort of be what is the vision that comes out of this whole report, and that is not going to be a very long section, but it will be a section.
One of my thoughts was if there is a group of people who are interested in that section, I could do a first draft and then work with people on that section. So that is just something to think about, we will come back to that tomorrow and then people can critique the section and we can go through it.
It will come out of what we have here, what we come up with on recommendations and text, and then it will go out after the group has massaged it, it will go out to everybody, and then it will come back and we will work on it again.
The other piece that I want to ask people about tomorrow is whether or not you saw there are two recommendations which are not fixed in stone obviously in any way about the response to 9/11, and I want to have a discussion tomorrow about whether we should be addressing issues related to 9/11 at all, and go from there. We will do that at lunchtime tomorrow.
Anything else, Steve, that we have to give a preview about?
DR. GROFT: No, I think that is it.
One last thing, we are going to change the afternoon sessions today. Dean has to go tomorrow over to HCFA, and so we will move the Coordination of CAM Research, which was Session VI, to the first session this afternoon, and we will move Access and Delivery that was scheduled this afternoon until tomorrow morning at 10:00.
The section on Wellness and Prevention scheduled at 1:00 tomorrow will be moved to 3:15 today, and then we will flip the Coverage and Reimbursement until tomorrow afternoon.
So, we are moving Session VI, Coordination of CAM Research, to the next session, that will follow lunch, and we will move Session VII, which is CAM in Wellness and Prevention, that was scheduled for tomorrow at 1:00, into the session for today at 3:15, and then those two sessions, III and IV, that were to be held this afternoon, will be moved to 10:00 tomorrow morning and 1:00 tomorrow afternoon.
DR. GORDON: We really need to begin because we need to give the sections adequate time.
DR. GROFT: Everybody tonight, for dinner, is pretty much on their own. I think the feeling was that people are pretty well worn out. I don't know about you guys, we are tired, too. We just said just go ahead and enjoy the evening on your own and relax, and we will get together in February.
DR. GORDON: Is everybody with us on this? We are going to be meeting in February, and either the second or third week, is that our plan?
DR. GROFT: Somewhere around the 20th or 21st.
DR. GORDON: Everybody has got to check their schedule for third and fourth week.
DR. GROFT: Yes, about the third or fourth week.
DR. GORDON: Let's begin now with Research. We will be discussing this tomorrow. This is just time to go back and check your calendars between now and tomorrow, and then we will come to a decision.
Dean, do you want to begin?
Session III: Coordination of CAM Research
DR. ORNISH: First, let me say I want to thank Jim and everyone involved in switching the order. I have had some unexpected issues come up with Medicare that I am having to deal with that are really consuming me, so the irony is not lost, believe me, on all this, so I really, really appreciate and apologize for any inconvenience that this may have caused anyone, but thank you.
So, why don't we just get right to it. If you all can open your bibles to Chapter 7. We are talking about the coordination of research. I think Wayne is supposed to join us. Also, we have the resolutions which begin at the very beginning under the first section.
I think that probably the easiest say to do this, we can go through the text, but it might be easier to just focus on the recommendations and then use the text as a backup to any clarification or issues that people might have.
I have to say that some of the recommendations, Wayne and I, were new to us, so we may have comments on these, as well as you all do, but let's start with the first one.
DR. GORDON: Dean, excuse me, the question is are there any other recommendations, gap recommendations or new recommendations. I have one that may be answered as we go through this, but if not, I want some time at the end.
Does anybody else have any recommendations, gap recommendations?
[No response.]
DR. GORDON: Okay.
DR. ORNISH: Just speak up and make sure we know that, so we don't leave it out.
The first recommendation is that the Commission recommends strengthening the emerging dialogue between conventional medicine and CAM by continuing to develop ways to enhance communication, cooperation, and collaboration among conventional and CAM research and clinical professionals, research centers, and accredited institutions, professional organizations, and federal and state research and health agencies, the profit and nonprofit sectors, and the general public, and the whole wide world.
Any comments of questions about this particular point? Bill.
DR. FAIR: I like the suggestion. My basic philosophy is that the fewer number of recommendations, as Jim said, and the shorter the recommendations, the more likely they will be read, so I was wondering what you would think about just having: "The Commission recommends strengthening the emerging dialogue between conventional medicine and CAM," period, and then put the rest of the stuff in the discussion.
DR. ORNISH: I like that. All in favor, aye; all opposed. No. 2.
DR. JONAS: Since this is in the Research section, this should be about collaboration around researchers and investigators, so we should have words to that extent, and I don't mind what you just said, however, what I would suggest is we just add "conventional and CAM researchers" or "investigators," period.
DR. ORNISH: Good. That is a nice one to start with in that way, because it sets a tone of dialogue that we are trying to build bridges.
DR. FINS: How about researchers?
DR. ORNISH: Well, researchers generally have come from someplace.
DR. JONAS: Investigators and institutions.
DR. ORNISH: Researchers and research institutions.
MS. POLLEN: May I say something?
DR. ORNISH: Yes, you may.
MS. POLLEN: Then, you are really limiting it to just researchers or clinical professionals. All researchers will be clinical and basic.
DR. ORNISH: I mean, in a way we are also talking about strengthening the emerging dialogue between clinicians, and so on, but that is a different section. So, if we want to say to the topic here.
MS. POLLEN: You are leaving out the federal and state agencies.
DR. ORNISH: We are leaving out everything.
MS. POLLEN: Everything else, so you want all of that just in the text.
DR. ORNISH: Yes, it's implicit, and if somebody really wants to read the rest of it, they can.
DR. GORDON: Are you leaving in "clinicians"?
DR. ORNISH: No.
DR. GORDON: I think that is important, the reason being that many clinicians are kind of wondering how to do research, especially CAM clinicians, but also conventional clinicians who want to do research on CAM.
DR. JONAS: We are not leaving out anybody in this first recommendation. We are actually shortening it, so that we can include everybody. Later on, in later recommendations, we specifically address the issue of clinicians.
DR. GORDON: Fair enough.
DR. JONAS: Just for this first recommendation, it is just in the spirit of --
DR. ORNISH: It sets a nice tone for everything that follows.
DR. FINS: We might simply say, "conducting basic science and clinical research" as a phrase to be put in there to show that it's a comprehensive approach.
DR. ORNISH: I think once you start getting more specific, then, it becomes more glaring what you are omitting. I think if you just make it a general thing, and then the other recommendations, we do get pretty specific about that.
If you find that we haven't covered that in the later recommendations, then, we can come back to this. But there is something nice and short, people can read this and it is not overwhelming, and it is not a long run-on sentence like it is now.
DR. PIZZORNO: Could you read the final version?
DR. ORNISH: Wayne.
DR. JONAS: "The Commission recommends strengthening the emerging dialogue between conventional medicine and CAM, investigators, and institutions."
DR. ORNISH: Issue No. 2. "The Commission recommends that standards of quality for all aspects of research and related activities be the same for CAM as for conventional medicine."
This is a particular pet issue of mine, as you all know, because I think it really levels the playing field, it appeals to the fairness of the American people, and it forces critics to say, oh, no, we think that it should be held to different standards, which is much harder position to defend.
Any problems with that? Joe.
DR. FINS: Scientific standards?
DR. ORNISH: It's not just scientific standards. It's everything. Again, we are going to get into that more later. We are trying to kind of set a tone early on and then get into the details later, but again, it is a good thought. Keep the thoughts of it. If we don't address it adequately later, you can raise it again.
Any opposition to this?
[No response.]
DR. ORNISH: No. 3. "The Commission recommends that research journal, regulatory and health insurance advisory and review committees in both the public and private sectors include, as needed, trained and qualified CAM and conventional professionals, and recommends adopting, as appropriate, any regulations that might impede such representation."
Comments?
DR. FAIR: I think it is a good recommendation. I was trying to figure out, since journals are private, generally privately run, does anybody have any ideas about how one would increase the input of CAM providers on journal editorial boards or anything like that? Is there any way to go about that?
DR. JONAS: Are you just asking for some general thoughts about how that could occur?
DR. FAIR: Yes. How could we actuate that suggestion?
DR. JONAS: We could recommend to them.
DR. ORNISH: Actually, the sentence is not really saying what it is intending to say. It really actually should say "and recommends adopting, as appropriate, any regulations to avoid impeding such representations."
I am not entirely comfortable myself with that last part of it, about the regulation part, because I think that gets into an area where people say we don't want the federal government dictating to private journals who should be on their boards, and I would support that actually, so my recommendation would be to end the sentence after, "and conventional professions," period.
Are you all comfortable with that? Okay.
Number 4. "The Commission recommends independent or collaborative support by the public, private, and nonprofit sectors to organize multidisciplinary conferences on CAM research, to increase opportunities for CAM and conventional medical practitioners, clinicians, researchers, and others to exchange ideas on approaches to setting and supporting CAM research."
MS. SCOTT: I just thought you read it differently than what it said.
DR. ORNISH: I did? Julia, talk into the microphone.
MS. SCOTT: Did you end with "research"?
DR. ORNISH: I thought I did.
MS. SCOTT: Mine ends with "questions."
DR. ORNISH: What is the date of yours?
MS. SCOTT: Oh, I have no idea. It was in the book.
DR. JONAS: You are looking at the text. It is not exactly the same.
DR. ORNISH: Oh, how about that. So, what is the more current one? 11-16. They both say 11-16 on them.
MS. SCOTT: I was on page 5. Recommendation No. 4.
DR. ORNISH: Number 4 is different from the one that is in the summary at the beginning. If you look under Tab 7, page 5, there are recommendations there, but if you look in the very front of the book, under Tab 1, it has the summary of all the recommendations throughout the binder.
MS. SCOTT: Is that what you are on?
DR. ORNISH: I was using the one in the front just because they are all in one place, but I didn't realize there was any discrepancy.
MS. SCOTT: Okay. They are not the same.
DR. ORNISH: So, what is the more current version? They both have the same date on them.
MS. SCOTT: I think you just have to decide which one you are going to use. We will just all go to the one in the front.
DR. GORDON: Which one did you work off of?
DR. ORNISH: Well, the one I was working off today, I have been looking at the summary at the beginning. I presumed they were the same since the dates are the same.
DR. GORDON: I would like to suggest whichever one you and Wayne have been working with most consistently. Have you been working with the same one?
DR. ORNISH: Gerri is saying we should use the ones under Tab 7 because those were probably brought forward to the summary.
So, No. 4, "The Commission recommends independent or collaborative support by the public, private, and nonprofit sectors for organizing multidisciplinary conferences on CAM research and related activities to increase opportunities for CAM and conventional medical practitioners, clinicians, researchers, and others to exchange ideas on program policy and research planning and methodological approaches to setting CAM questions."
I think there is an overarching issue. We shouldn't have any sentences that require you to take three breaths when you read them.
DR. JONAS: Let's truncate it at "related activities." "Multidisciplinary conferences on CAM research and related activities."
DR. GORDON: Fine.
DR. ORNISH: Good. Do we want to say "on CAM research that has been shown to be safe and effective," or --
DR. GORDON: No, because the research can show it is not safe and effective, too, that is good research, as well.
DR. JONAS: The point of this is that we think there should be more multidisciplinary conferences on CAM research and related activities.
DR. ORNISH: Good. Perfect.
DR. JONAS: How about "and research methodology," we add in here? "And research methodology"?
DR. ORNISH: Well, if you start talking about, again, research methodology, then, you are getting specific, and then you say, well, why not be specific about other areas of research.
DR. JONAS: That is a large overarching issue.
DR. GORDON: To me, "research" covers --
DR. ORNISH: Research methodology, certainly is a subset of research, but so are lots of other issues.
DR. JONAS: Actually, not, very infrequently do they really focus on research methodology. They are usually focusing on a particular topic they are researching.
DR. ORNISH: Okay. I don't have strong feelings about it, if it is important to you, let's include it. Is everybody okay with that?
DR. GORDON: Which are we going to do?
DR. ORNISH: It is going to say: "The Commission recommends independent or collaborative support by the public, private, and nonprofit sectors for organizing multidisciplinary conferences on CAM research, research methodology, and related activities."
DR. GORDON: Is that okay with everyone?
DR. ORNISH: All in favor?
[No response.]
DR. GORDON: Okay.
DR. ORNISH: Number 5. "The Commission encourages the creation of novel funding partnerships or consortia within the nonprofit sector and the private sector to augment collaboratively with federal agencies or separately support for CAM research, research infrastructure, and training, research conferences, and information dissemination."
DR. FINS: I thought it was kind of vague, "novel," you know, I didn't know what that meant. I know what we mean, but I didn't like the word "novel."
DR. ORNISH: How about "innovative"?
DR. FINS: Better, but --
DR. ORNISH: How about just funding, "creation of funding"?
DR. FINS: Yes.
DR. ORNISH: Take out "novel."
"The Commission encourages the creation of funding partnerships or consortia within the nonprofit sector and the private sector" -- we could just make it simple and just say, "to augment support for CAM research, research infrastructure, and training," and then leave out the part about "collaboratively with federal agencies or separately," or at least put that at the end of the sentence, so it doesn't sound like such a long run-on sentence.
DR. PIZZORNO: In the interest of brevity, et cetera, do we need this? It seems self-evident. Does this commission have to actually say this?
DR. ORNISH: We don't have to say anything, but we are trying to use a bully pulpit to encourage people to do these things. I think as anyone who has ever tried to raise money to do research, I would say, yes, that is a pretty good one to have in there, but I think we can shorten it.
DR. JONAS: Also, as you recall, there were many more recommendations in this one section even before this, and we went through and said, well, which ones do we want to highlight, and this was one we felt like was important to highlight, is that there should be more activity in which there is kind of joint and collaborative funding mechanisms.
DR. ORNISH: So, how do you want to shorten it?
DR. JONAS: I don't want to shorten it. I like it like it is.
DR. ORNISH: Like it is.
Okay. All in favor? All opposed?
DR. FAIR: May I make one comment?
DR. ORNISH: Sure.
DR. FAIR: I like it, short or long, because the business about the private sector. I just spent this weekend at a meeting in Palm Beach, a workshop and conference on Cox-2's and specific inhibition in cancer treatment and prevention, and it is really an exciting area.
It turns out Cox-2 is induced in the neovascularity of tumor vessels, so that Cox-2 inhibition is a strategy which is really virtually nontoxic for the inhibition of tumor growth.
The interesting thing to this meeting is that if one looks back -- and many of you know more about herbs than I do -- but in the ancient traditional Chinese medicine, and also in Hindu medicine, things like curcumin and turmeric play a major role in the multiple prescriptions for preventing cancer.
It turns out that coumarin and curcumin have high levels of Cox-2 inhibition. Of course, up until 10 years ago, we didn't know what Cox-2 was, so people would say, oh, well, there is no evidence that those herbs work.
So, I think that something like this would make an ideal collaboration between an industrial firm, which this happened to be Pharmacia, and complementary medicine to explore some of these interactions between the two, and I think it is another area where we could link the ancient healing arts with modern and molecular biology.
DR. ORNISH: Thank you. That is very good.
DR. FAIR: I would like to see something in there about the private sector.
DR. ORNISH: It's in there. You mean you like what is in there, you are not suggesting we revise it?
DR. FAIR: No, I just thought, I don't whether it is possible to put industrial pharmaceutical industry or something like that in there.
DR. ORNISH: Well, that is included in the private sector. Do you want to make it more explicit? We could say in the private sector (including the pharma and industrial), but that is going to make it even longer. We could put something in the text on it, Gerri, so we can clarify it that way.
But just to digress, I like what you are saying, and I think that so often we can do studies showing that there is an effect before we understand the mechanisms by which that effect is occurring.
Certainly, in our studies 25 years ago, when we found heart disease is reversible, people don't know about, you know, endothelial function and vasomotor tongue changes, prostacyclins, and all the different mechanisms and inflammation that we now understand.
So, thank you for bringing that up.
Can we move on? Other comments?
MS. POLLEN: Just read that quickly.
DR. ORNISH: "The Commission encourages the creation of novel funding partnerships or consortia" --
DR. JONAS: We struck "novel."
DR. ORNISH: I'm sorry, thank you.
It is basically the same, what is in there.
MS. POLLEN: Are we taking out "collaboratively with federal agencies" --
DR. ORNISH: We thought about putting that at the end of the sentence, but we can leave it where it is, or do you want to take it out?
DR. JONAS: No, I think the point is exactly that.
DR. ORNISH: So, you can either leave it there or move it to the end of the sentence, whichever looks better.
A friend of mine has three kids, and the whole family talks incessantly, and they have this thing embroidered on their pillow that says, "Lose your breath, lose your turn." So, I want to make sure that I keep going here.
No. 6. "The Commission recommends supporting research on why people use CAM, how they determine its effectiveness, and what they find satisfying about CAM itself and in comparison with conventional medicine, and parallel this research with the public impact on the emerging integrated health care system."
My recommendation is to delete this one, but I am open to any suggestions anyone has.
DR. JONAS: I would like to suggest we reword it. Do you have a wording?
DR. FINS: Recommend supporting health services research on the demographics of CAM utilization and outcomes, just basically, there is a whole other kind of research as health services research.
DR. JONAS: That is actually not how I was going to suggest rewording it. We do have health services research later. This is not exactly that. This is actually sociological research looking at reasons for CAM use.
DR. FINS: You could say sociological use.
SISTER KERR: But it includes anthropological, too, so you have got to keep it broader.
DR. JONAS: And anthropological, yes. I think we ought to use lay terms in this area, I mean, to get at the same thing.
DR. FINS: Social science.
DR. JONAS: Social science research. I think that would be okay, "supporting social science research."
DR. FINS: Exploring why people use CAM, et cetera.
DR. JONAS: Exploring why people use CAM.
SISTER KERR: Wayne, my opinion is if you say more than just why, you are predicting what the reasons are. It could be cosmic, who knows. That is not sociological or anthropological. We don't know why.
DR. FINS: If you just simply say "sociological research exploring CAM utilization," period, that would capture it, and then each of the investigators would come up with their study design.
DR. JONAS: I think "why" is a very important word in this recommendation, because it focuses on really trying to work with patients and the public to say, you know, what is it do you want. Now, that is what sociological and anthropological in qualitative research does, but I think if you say those and you leave out why, people won't know that.
I would like to truncate it, however, and we could say, "supporting sociological research on why people use CAM, how they determine its effectiveness" -- which I think is very important -- "and what they find satisfying and unsatisfying about CAM" -- period. That would end the sentence.
DR. FINS: Or their degree of satisfaction.
DR. JONAS: Or their degree of satisfaction. It is different, though. I mean, the degree of satisfaction and what it is that produces the satisfaction are different or unsatisfaction.
DR. ORNISH: I like the fact that you are putting satisfying and unsatisfying, because it sets a tone that we are not advocates of CAM, that we are trying to find out what is true.
DR. JONAS: And then a period after "CAM."
DR. ORNISH: But I would take out the word "sociological" because why limit it, because there are many forms of research, not just that.
So, you could just say basically, "The Commission recommends supporting research on why people use CAM, how they determine its effectiveness, and what they find satisfying and unsatisfying about CAM" -- period. Is that okay? Tom.
MR. CHAPPELL: I agree. When you begin to qualify it, it just starts sending it in different directions of research.
DR. ORNISH: Anything else?
[No response.]
DR. ORNISH: Number 7. "The Commission recommends that federal agencies supporting biomedical and health services research develop training programs for public representatives to help them provide input to the agencies in the most effective way with respect to biomedical and health services research agendas and budget policy and the dissemination of information."
Definitely shorten that one.
DR. GORDON: I am not sure what the connection is here with CAM, and I think that has to be made explicit why this has anything to do with CAM.
DR. JONAS: I thought we dealt with this later on. I thought we had a specific recommendation later on when we talked about public input that dealt with this. That doesn't really clearly capture that.
This got back to, Julia, what you were mentioning, and we had talked about before, about simply having people sitting on boards as public representatives is inadequate, that we need to develop ways in which they are particularly trained to do that properly.
So, this recommendation is saying this needs to be done in research also.
DR. LOW DOG: Maybe we could just be more specific. You could say, "public representatives that are sitting on boards that have to do with complementary and alternative medicine research," but then you could also say, comma, "and conventional," I mean, for both, but it does leave you wondering, and I think it needs to be shortened. I think we need to shorten it.
DR. JONAS: I think we could cut out the last part of it where we don't have to necessarily list all the different things they would sit on.
DR. GORDON: The other question I would raise about this, Wayne, is that there may be people who are CAM professionals sitting on these boards, who also don't understand research. You can see this is as part of the effort to provide kind of conventional research training for CAM practitioners and others who may be involved in this process.
DR. JONAS: Okay. You could utilize it for that, right. I would hesitate to insert that in here and then isolate CAM practitioners as opposed to other practitioners who also don't know how to do research.
DR. ORNISH: What if we just put a period after the "in the most effective way" -- period. Can we all agree on that?
DR. GORDON: After what, Dean? I'm sorry.
DR. ORNISH: In the sentence, "to provide input to the agencies in the most effective way" -- period, and delete everything that follows. I mean, not for the whole book, but just for that paragraph.
DR. GORDON: Somehow this has to relate to CAM. The word isn't even in the recommendation.
MR. CHAPPELL: What is the result of this? Are we training the power brokers or what?
DR. JONAS: No, we are training the unpower brokers.
MR. CHAPPELL: Who are lucky enough to get into the power systems.
DR. JONAS: Right, empowering public and consumer representatives to be more effective in terms of guiding research in these areas.
DR. ORNISH: So, why don't we just say, "The Commission recommends that federal agencies supporting biomedical and health services research in CAM develop training programs for public representatives" -- blah, blah, blah -- "in the most effective way."
"In CAM and conventional health care"?
Can we all live with that?
It would say, "The Commission recommends that federal agencies supporting biomedical and health services research in CAM and conventional health care develop training programs" -- blah, blah, blah -- "in the most effective way."
DR. JONAS: I would way, "to ensure more effective input."
DR. CHOW: It goes back to the other issue that we took up earlier, to have informed and empowered representatives from the public.
DR. JONAS: I like that. I would like to use those words in there.
DR. CHOW: To inform and empower the representatives.
DR. JONAS: I would like to use those words in here because it is not simply training. I mean, what you really want is you want a program that empowers and informs, informs and empowers, so that they can better participate, and part of that would be training, but there also may be other methods.
DR. ORNISH: So, how about if we say, "The Commission recommends that federal agencies supporting biomedical and health services research in CAM and conventional health care develop training programs to help empower and inform public representatives" -- oh, I see -- "inform public representatives, to help empower and inform them to provide input" -- blah, blah, blah.
DR. JONAS: That's fine. It is in our Guiding Principles.
DR. ORNISH: So, we have got that. You can work out the details on that.
DR. JONAS: We will reword that, but try to include the empowerment and training issues.
Before we go on to the next recommendations, are there any comments on the text part that goes with each recommendation?
[No response.]
DR. ORNISH: If not, moving on to Recommendation No. 8.
DR. JONAS: Just a minute. I have several comments, but I wanted to give the Commission actually the opportunity to make a comment.
DR. GORDON: Are you going to make comments about the previous text?
DR. JONAS: About the text that just preceded these four recommendations.
DR. GORDON: Go ahead.
DR. JONAS: In applying the same standards, under No. 1, I think I like this as is written. I would like to add -- page 2, line 9 -- I think we ought to add also that the Commission recognizes that the interaction of orthodox and unorthodox research may help in evolving new and innovative research methods.
It has been demonstrated historically that by having this creative tension between those that are outside the mainstream and inside the mainstream, that new methodologies, not simply the same standard methodologies are evolved.
So, it is a statement about evolving methodologies, that research methodologies are not static, that just because we think they should be the same, it doesn't mean it should always be the same.
DR. ORNISH: I want to comment on that because I think that is an important point, but I wouldn't put it here, because the thing that I am trying to avoid is the land mine of having people say, well, CAM has its own methodologies that are really different than conventional methodologies, and that leaves it open to the fact that they are not as rigorous.
My preference would be to put it under some other place where we talk about research methodologies, which I think is further along here, because I think it's an important point, I just wouldn't put it there.
DR. JONAS: I am not sure I like that. This actually brings me back to a concern I have about the word "same," because what I am really interested in is high standards.
If the standards in conventional medicine are low, and there are some areas where they are very low, I don't think we should necessarily apply the same standards.
DR. ORNISH: But, Wayne, it makes it pretty clear in this paragraph. I love this paragraph myself, because what it says is that, you know, that, on the one hand, people think that CAM is held to a higher standard, on the other hand, the conventional journals often say CAM research doesn't even come to the same standards, and here we are saying it should be a level playing field, they should be the same standards of high standards of excellence applying to both.
I think that is really important.
DR. JONAS: We are saying applying high quality standards there.
DR. ORNISH: Well, it says, "meet the same high standards."
DR. JONAS: It doesn't say meet the same standards.
DR. ORNISH: No, it says, "Meet the same high standards of quality and rigor."
DR. GORDON: Isn't the wording, "same high standards"?
MS. POLLEN: Yes, it is.
DR. JONAS: I would put that up in the title then also.
DR. ORNISH: That's okay.
DR. JONAS: Well, whatever. I mean, I think the thing about evolving, how methodology is evolving, and that research in -- that is one of the contributions of doing research in complementary medicine is that it can help you evolve your standards properly.
DR. LOW DOG: Is that what we were trying to get at on page 9, when you get to 18, we were talking about the methodology?
DR. ORNISH: Exactly, precisely, that is exactly where it is.
DR. LOW DOG: And then we moved down and we talked about the controlled trial is the gold standard, but then we went into the complexity.
DR. ORNISH: Exactly.
DR. LOW DOG: Did that not cover it?
DR. JONAS: Page 10, you mean?
DR. ORNISH: Page 9 and 10.
DR. LOW DOG: Yes, 9 and 10. It starts on like No. 18 and then moves down, but I thought that is what we were trying to get at.
DR. ORNISH: It was.
Joe.
DR. FINS: In this umbrella section, and maybe also going back into Recommendation No. 2, we should say something about -- you know, we talk about standards, but I think it is important to say, you know, the ethical standards, the conduct of research.
We do get to it later, but in a more sort of particularistic way, but I think it is an over-reaching concern.
DR. ORNISH: I don't object to putting this in the paragraph on page 2, "the same high standards of quality, rigor, and ethics."
DR. FINS: Right.
DR. ORNISH: I don't think that is a problem. I think it just makes it sound even that much better.
On page 2, No. 9, line 9, just add, "meet the same high standards of quality, rigor, and ethics."
Tieraona.
DR. LOW DOG: I guess my question was just, Wayne, was there something more you were looking for?
DR. JONAS: Yes, actually, this does not address it, however, I do think this is a place it could be addressed. We could put it down there.
DR. ORNISH: Perfect. Okay. What other issues do you have?
DR. JONAS: I am not sure what the relevance of the first paragraph under Public Use and Input is. It seems like a recitation of what we had in the beginning. It doesn't deal with research.
DR. ORNISH: I agree with you.
DR. GORDON: We have a lot more recommendations to go through, so I just want to urge us to -- if everyone agrees that this issue should be dealt with, then, I think we can leave it to the text writers to deal with it either on page 9 or page 2, or page 3.
DR. ORNISH: I think you are right, Jim, Wayne, if you are comfortable, let's go through all the recommendations, see if we can get consensus, and if there is any time left over, we can go back to the text and fix that.
DR. JONAS: I don't want to do that. I want to deal with the text under each recommendation, so that we at least have it in our mind what the recommendation is, but I am finished with any of my comments about this first section.
DR. ORNISH: Okay.
MS. POLLEN: Wayne said he had a problem with the first part of the second paragraph on page 2, but we could start with "the growing influence" and delete everything above that, if you wanted to.
DR. ORNISH: That sounds good.
DR. JONAS: I think this paragraph, since it is background and support for our recommendation the public be empowered and educated and trained, we ought to say something about the fact that doesn't exist very well or inadequately, and actually there is a number of reports, including the IOM report, that specifically addressed this.
We heard testimony in our first session about this from Leon Eisenberg, in which he said -- you know, and there is an IOM report saying that the public should be more involved. So, something along those lines would be --
MS. POLLEN: Something rather than that.
DR. JONAS: Yes, right.
MS. POLLEN: Got it.
DR. GORDON: Wayne, I just think that some of it is kind of a little clunky, those first couple paragraphs, in the way that point is presented.
DR. JONAS: I think Gerri knows what I am talking about.
MS. POLLEN: I know exactly what he says.
DR. ORNISH: So, you will fix it, right?
MS. POLLEN: Yes, I fixed it.
DR. ORNISH: Any other comments, so we can move on?
[No response.]
DR. ORNISH: Page 12, paragraph 9. "The Commission recommends that state professional regulatory boards develop processes that will allow practitioners who have developed scientifically acceptable preliminary data" -- am I in the right place?
DR. JONAS: Eight.
DR. ORNISH: Oh, did I leave 8? Sorry, I stand corrected. Thank you.
DR. JONAS: Watch him, he will slip it under.
[Laughter.]
DR. ORNISH: "The Commission recommends that all federal agencies with research or related health care responsibilities increase CAM activities relevant to their biomedical or health services missions in a more proactive manner including the consideration of special initiatives to ensure that CAM is properly integrated into the health care system."
DR. JONAS: I think the point of this recommendation was that we wanted to say that there needs to be proactive efforts in all the federal agencies. What we currently have is one federal agency that has a proactive effort in that area.
DR. ORNISH: Do we need to have "The Commission recommends" in each of these sentences. Can we just say -- I mean, start with, for example, "All federal agencies"? It doesn't matter, it just shortens it a little bit.
DR. JONAS: I think we could truncate at "special initiatives" if we wanted to shorten it. I would keep that "special initiatives," however.
DR. ORNISH: Except I would add again "increase CAM activities shown to be safe and effective."
DR. JONAS: This is about establishing safe and effective.
DR. GORDON: I think that is appropriate.
DR. JONAS: Not shown to be safe and effective. This is about doing research.
DR. GORDON: The point is doing research to find out.
DR. ORNISH: I guess it is a question about CAM activities as opposed to -- because this paragraph is talking about ensuring that CAM is properly integrated into the health care system, which is not a research issue.
DR. GORDON: Right, I agree with you about that.
DR. ORNISH: But you are presuming in here that the research is going to show something positive when, in fact, it may not.
DR. GORDON: Let me suggest that last part be omitted because I think that is not appropriate to have here about the inclusion.
DR. ORNISH: Okay.
MS. POLLEN: To ensure.
DR. ORNISH: No, actually, you would end the sentence after "in a more proactive manner" -- period, and then everything else that follows is out.
DR. GORDON: That is fine.
DR. JONAS: I want to keep "special initiatives."
DR. ORNISH: I don't know what a special initiative is.
DR. GORDON: What is a special initiative?
DR. JONAS: A special initiative is an RFA where they set aside money and say we are going to fund this.
DR. GORDON: Okay. So, maybe that has got to be made clearer.
DR. JONAS: That is about the only way it actually gets done, frankly.
DR. GORDON: Including federally initiated funding.
DR. ORNISH: -- "including the consideration of special initiatives, such as RFAs or RFPs." How about that?
DR. FINS: Or "including special funding initiatives."
DR. JONAS: Yes, I think it could be a lot more than that in this, for example, developing an office at the CDC, that specifically addresses facilitation of CAM research and prevention would be an example of a special initiative. So, it is no limited to RFAs.
MS. POLLEN: I am suggesting that we take the ideas on RFAs, RFPs, and move it to the text, make sure it is in the text.
DR. ORNISH: So, the sentence would end, "including the consideration of special initiatives" -- period, and you can define what that is in the text.
DR. ORNISH: Okay? Anyone object?
DR. PIZZORNO: I am not objection, however, I think this whole section has the wrong title. It says, "Research Support," and I looked through the various topics we are looking at, and I see apples and oranges and bananas, so I think there is some different language that needs to be done here.
When I think of research support, I am thinking about things like funding where here we are talking about research scope and the kinds of research that should be considered, so some different terminology is necessary here.
DR. ORNISH: Charlotte?
SISTER KERR: This is just a clarification. Wayne, when you mentioned the CDC, I just don't know where we have done it in the report, do we have it somewhere under here in terms of funding, because I think that is something that they need money, they have got a department, but where would we do that, or have we done it?
DR. JONAS: Well, in the text, under No. 4, Expanding -- I think this is maybe what you are asking, Charlotte, but correct me if I am wrong -- under Expanding Areas of Scientific, we actually list a number of mechanisms, as well as agencies that could have special initiatives including the CDC, but there is a number of others in there, so as long as this recommendation gets linked back to that in a specific way, then, I think it is okay, as long as it doesn't get lost.
One could say perhaps, "as described in Section 4." It is right under the same recommendation, Special Initiatives as described in Part 4, which starts on page 8, line 21, and then goes all through the top of page 9, and especially page 9 starting at line 11, in addition to NCCAM. Well, there is only a few of them listed, and actually the CDC isn't in there.
SISTER KERR: This will go back to Jim's request that we will get to 9/11, but if we didn't have 9/11, I would still really want us to be looking at CDC here.
DR. JONAS: I know that it is in here.
SISTER KERR: Really need to be getting big bucks.
DR. ORNISH: We need something on acupuncture and anthrax in here. That would do it.
DR. JONAS: I think we haven't moved off of 8 yet.
DR. ORNISH: So, what are you trying to see, if there is any reference to the CDC in here?
DR. JONAS: That is what I think Charlotte was asking.
DR. ORNISH: Why don't we just make a note that we will check on that, and come back to it, and if there is not, we can add it to the text later, but it wouldn't be a recommendation, so just to keep things moving.
DR. GORDON: Can we have the final reading on No. 8 then?
DR. ORNISH: "The Commission recommends that all federal agencies with research or related health care responsibilities increase CAM activities relevant to their biomedical or health services missions in a more proactive manner including the consideration of special initiatives" -- period.
In the text, we will define what special initiatives mean.
DR. JONAS: I think we ought to specify this actually under No. 9, where we did talk a little bit about some of the other NIH agencies and National Science Foundation -- page 9, starting at line 11 to 16, we talk about Department of Defense, Department of Energy, National Science Foundation are examples of federal organizations that might consider contributing in these areas.
DR. ORNISH: Just add CDC there.
DR. GORDON: It also seems to me you need to define "special initiatives" in there, in the text, so that people will understand.
DR. ORNISH: We talked about that.
DR. JONAS: The question is what kind of special initiatives do we want to recommend because one of them we mentioned is RFAs, RFPs, this type of thing, but another one would be the development of offices, and I am not sure if that is what you want to say, and, if so, then, we ought to have a paragraph saying we recommend proactive and special initiatives in federal agencies and, to me, that would then elevate that to a level of a recommendation.
DR. ORNISH: I am not sure that adding special offices at this late date is the way to go, but if it's important to you, we can include it. It is unlikely that they are going to create a special office just from reading this recommendation anyway.
DR. JONAS: Well, the NCI created one. The CDC, as a number of you know, CDC has the strategic plan around complementary and alternative medicine. I don't know, does it include an office?
DR. GORDON: I don't think there is.
DR. JONAS: Probably not, because there is not resources, but if they had resources and a mandate to do an office, they could, and it would be something that could then coordinate all those activities.
DR. GORDON: What about, Wayne, making a recommendation about special -- I mean, I think you may be right -- that we may need a separate recommendation about special offices, either that, or we have to include it here and make it explicit along with RFAs, RFPs, et cetera.
DR. ORNISH: The easiest way to do it would just be to refer back in the text to what special initiatives include.
DR. JONAS: We could have a paragraph describing special initiatives and examples of what those are like.
DR. ORNISH: Such as a special office in the CDC.
DR. JONAS: And an example of that is the OAM and NCCOM, and Office of Dietary Supplements perhaps in NCI's office.
DR. ORNISH: That's good. Is that okay?
DR. JONAS: Okay, if we did that on page 9 at the end of that.
DR. GORDON: Is everybody following this discussion? Okay.
DR. JONAS: I would then recommend that in this recommendation, that we say "as described in the text, Section blah-blah-blah," or whatever, so that people can see examples of what we are talking about by special initiatives, because apparently that is not clear.
DR. ORNISH: Joe.
DR. PIZZORNO: I would like to have one sentence and it could easily be in the text, and that would be part of the recommendation, but I think that as we are asking federal agencies to increase their research in this area, that they should try to do so in collaboration with CAM, public health professionals, institutions to help them think through the agenda, should not be doing it independently of that input.
So, again, it would part of the recommendation or part of the supporting language.
DR. ORNISH: Recommendation No. 9. The Commission recommends that --
DR. GORDON: I'm sorry, Joe. What happened to Joe's suggestion?
DR. JONAS: We can add that into the text.
DR. GORDON: In the text, okay.
DR. JONAS: We can put that in the text, I agree. I made a note of that.
DR. GORDON: Thank you.
DR. ORNISH: Everybody ready to move on?
Number 9. "The Commission recommends that state professional regulatory boards develop processes that will allow practitioners who have developed scientifically acceptable preliminary data to move successfully to clinical investigation of a non-approved treatment while maintaining their ethical and professional responsibilities toward their patients and the public."
Joe.
DR. FINS: Yes, a couple problems here. First, this is a hodge-podge of things that have been said. To call something a treatment implies that it works, so I have rewritten this just briefly to something that basically wanted to give protection to the CAM practitioner to pursue research without getting sanctioned by the state medical board.
The suggestion is, "The Commission recommends that state professional regulatory bodies develop processes to allow CAM practitioners to pursue clinical research if their protocols receive IRB approval."
DR. ORNISH: I was going to suggest the same thing.
DR. GORDON: I would not say just CAM practitioners. I would also say conventional practitioners using CAM modalities.
DR. FINS: Okay. So, CAM practitioners and conventional practitioners using CAM modalities.
DR. ORNISH: Right.
DR. JONAS: Is that substituted then for --
DR. FINS: "The Commission recommends that state professional regulatory boards develop processes to allow CAM practitioners and conventional practitioners using CAM modalities to pursue clinical research if their protocols receive IRB approval."
DR. WARREN: Doesn't that imply that you are part of an institution?
DR. FINS: There are free-standing IRBs, but IRBs have to meet certain federal standards, so this is a way of ensuring buy-in to the human subjects research protections concerns.
DR. JONAS: Go ahead.
DR. LOW DOG: I guess my question is if you got IRB approval, then, why do you need this statement? My understanding of what this -- I am not saying I agree with it -- what I am saying my understanding of this is, is that for people that think they have got promising data, that haven't gone to get an IRB, but they think they have got some promising finding, that there is trying to be some mechanism for them to go then and present that data without fear of persecution to go get research.
What we are saying here is that, you know, you should not be impeded from doing your research if you have received IRB approval, and if you have already done that, why would you be impeded? I think that they are saying two different things.
DR. FINS: It's a quid pro quo. I want a condition of their not being impeded, that they have actually gone through an IRB, because the only way you can protect the human subject is go through an IRB, not a state medical board.
DR. LOW DOG: I think that if you read the text, that is not what this says, and I am not saying I disagree with you at all, I am just saying that that is not what this says, and that is not what I believe the intent was, and I think part of it was trying to get some practitioners in the field, who may feel that they have come across something, to come forward to get the research done. I thought that is where this was driving.
DR. ORNISH: The text actually makes reference on line 20 to the need to follow IRB guidelines. This isn't something new. I think what Joe is trying to do is just to make it clear in the recommendation itself, and I agree with that.
DR. FINS: Tieraona, if somebody has already done the research without IRB approval, then, they have violated ethical norms.
DR. LOW DOG: Right. That is what actually is occurring right now, is that a lot of what is going on, because it has not been shown to be therapeutic or effective, much of this is a large experimentation on the population.
Much of what we do in CAM is experimenting upon the public because we don't know if it works or not. I understand what you are saying. I am saying if you take it to its logical conclusion, though, much of what we are doing is a grand experiment without people's consent or permission.
DR. ORNISH: That is what we are trying to change here. I mean, I think it is really important that we take a balanced approach, otherwise, you can end up with things like, you know, Tuskegee, or, you know, horrible things in the name of CAM.
An IRB, if it's a good IRB, doesn't say you have to prove that something works in order to get IRB approval, because, by definition, how would you know until you do the study.
DR. FINS: Not that it has to work.
DR. ORNISH: It just has to be it is not going to hurt people.
DR. FINS: There has to be adequate informed consent, there has to be adequate safeguards. The person who is providing the intervention has to be appropriately trained, et cetera. I just want to say a CAM training program or a school can have their own IRB. It doesn't have to be in the allopathic arena. But it is the only way to ensure human subject protection.
DR. ORNISH: Joe.
DR. PIZZORNO: I need to better understand what is trying to be accomplished with No. 9, because if you are going to require they go through a standard IRB process, this is not necessary.
If you are looking for a CAM practitioners is doing something out in the field that they think may have value, expecting them to go through an IRB process is unrealistic. They don't have the training or funding to do something of that nature.
So, what are we trying accomplish in No. 9?
DR. ORNISH: I agree with both what you and Tieraona are saying, that that is not what most CAM practitioners are doing, but that doesn't make a right. They need to do it, and to say they don't have the funding or it's too hard or they are not trained to do it is nonsense.
They need to be held to the same standard, that we all need to be held to. Just because it's CAM doesn't mean it's okay to be unethical.
DR. GORDON: Let me say what I think we are trying to accomplish here. What we have heard in the Commission is a number of people who are interested, who believe they have promising treatments, who have been afraid of prosecution from state medical boards, and who have been prosecuted by state medical boards.
We are trying to provide a mechanism by which those people who do responsible research can have a shield as they do that research. That is the purpose of this recommendation.
DR. ORNISH: Maybe we should say that more explicitly.
Gerri.
MS. POLLEN: The first step, as I understand it, when we were discussing this during meetings on research, is to be able to take data that you think is good data and that meets the requirements or the standards of good data, and somehow or other have a mechanism for submitting that data to a program like the NCI program or even NCCAM looks at preliminary data, so that the data can be evaluated.
DR. JONAS: That is not what the goal of this was.
DR. ORNISH: That is one aspect of it, but that is not the whole thing. They may or may not want to present it to NCCAM or NCI, who may or may not be interested.
MS. POLLEN: I am not saying those are the only places. That would just be an example.
DR. FINS: The Best Case Series that Jeff White was talking about.
MS. POLLEN: Jeff White, and there were others, as well, right.
DR. LOW DOG: I am still confused. Dean, I think maybe you misinterpreted me. I agree with going to the IRB, I believe that you should have all the appropriate protocols in place.
I am hearing what Joe is also saying, though, it is not explicitly clear, and, Jim, when you say that they have got promising treatments that they don't want to be prosecuted, well, if you went and got an IRB, you wouldn't.
DR. ORNISH: That was a question actually. Are they cases we have heard from where people had IRB approval and still got prosecuted?
DR. GORDON: No. There have been cases that were presented to us where people were not able to get IRB approval for a study -- I think it was a study on qigong, I don't remember which university it was, maybe it was the University of Washington perhaps, it was one of the major universities where they would not give IRB approval to a study, so the study couldn't go forward.
Let me just add something.
DR. JONAS: It has nothing to do with state regulatory boards.
DR. GORDON: You are asking me different issues. Let me try to explain the variety of different issues.
DR. JONAS: I am all mixed up in this one.
DR. GORDON: I have a question that is embedded in here. I don't know what the obstacles have been to getting IRB approval, and that is something I actually would like to know before we make the recommendation.
I mean, we, for example, have had IRB approval completely, not for work at Georgetown, but outside of Georgetown, just doing research on our own, so it is not impossible to get it.
But the issue that we are really dealing with is those people who believe they have promising data, I do not know -- and it's a good question -- have they tried to get IRBs or not.
If they have tried to get an IRB and they have been unable to, or somehow been denied it, then, we need to know that, and we need to have another criteria. If they haven't tried, or if it's possible to get an IRB, and that is what relates to Don's question, then, maybe the IRB isn't an appropriate criteria.
DR. FINS: We had this discussion at the very, very beginning, in the very first meeting, I think I mentioned this, and everybody said, you know, there are not differences in the ethics.
Now, I pointed out maybe -- if I recall correctly -- maybe the IRBs needed some education on this issue, so maybe we want to have another recommendation here that IRBs that are in the process of reviewing CAM practitioners' work and conventional practitioners doing CAM studies, should be appropriately constituted to reflect that review process.
So, that would be a parallel recommendation, but I want to just say that if an allopathic practitioner who is out there in the community is doing research, and can't get an IRB approval, they must get an IRB approval.
So, the point is if we are talking about a single standard or research, and a single standard of ethical adherence, then, what is true for me is true for the CAM practitioner.
DR. ORNISH: So, why don't we just say something like, at the very beginning, the first sentence could read, "CAM and allopathic" -- or CAM and whatever we are calling conventional medicine -- "should be held to the same ethical standard" -- period.
Then, we go into the second part of it. "As part of that, both traditional and CAM researchers need to get IRB approval before investigating new modalities."
The third part could be, "If they get this approval, then, they should be protected from sanction in the same way that conventional medical practitioners are," in other words, it doesn't give you blanket protection, you can still get IRB approval and do something really stupid and hurt people, but it provides you the same level.
Again, it goes into the overarching thing of let's hold things to the same standard.
DR. JONAS: I would like to suggest some wording changes here. I think it would be a good idea if we did have a separate one that addressed IRB, because that is a different thing than state regulatory boards, and actually, they have very little to do with each other.
The IRB issues are there and that we should make some recommendation encouraging appropriate education, training, representation on IRBs, and then we could leave in here the issue about IRB as being kind of the bottom line standard for everyone, but in that case, then, I would suggest we change "allow" to "encourage," make it positive rather than negative.
So, this recommendation would read -- there would be an additional one on IRBs -- but this recommendation would read: "The Commission recommends that state professional and regulatory boards develop processes that encourage practitioners who have obtained IRB approval for collecting data to move successfully into clinical investigation of non-approved treatments."
DR. FINS: But it's not treatment because it is not a treatment until it has been proven.
DR. JONAS: Okay, just CAM interventions or whatever.
DR. ORNISH: But, Wayne, if somebody has encouraging data and IRB approval, is the same regulatory board giving them a hard time?
DR. JONAS: As I understood your recommendation, you were going to substitute "obtained IRB approval for this, who have developed scientifically acceptable preliminary data."
DR. FINS: That is not what I said.
DR. JONAS: Okay. I would like to suggest that because I think the issue here is not that you have already preliminary data, because most of these practitioners don't have preliminary data, and they want to do research in order to collect the preliminary data, that requires IRB approval in order to do that.
If it was a requirement that the regulatory boards encourage practitioners who have IRB approval to collect data, if we are to say that practitioners who have developed scientifically acceptable preliminary data, you will have that many who fit into this criteria.
The point of this recommendation was to address the testimony, as Jim said, that we heard that there were claims that the regulatory boards were preventing people from collecting preliminary data.
Now, whether that is accurate or not, I don't know, but that is what we heard.
DR. GORDON: That is their perception.
DR. JONAS: Perception.
DR. ORNISH: Wayne, you are saying that if anybody has data already, that they collected, that they didn't get through an IRB, that they should still be able to present --
DR. JONAS: No, I am suggesting we totally throw out the whole issue of preliminary data, because most all of these people are going to be attempting to collect preliminary data, and they should do that through IRB approval. Then, they can collect the data, and we should encourage the state regulatory boards to develop ways to encourage that and facilitate that process.
DR. PIZZORNO: I really like the direction you are going because I think the word "allow" is wrong. I like using the stronger word "facilitate," and in many ways we are at the pre-IRB process.
I think we need to facilitate the people, if they have an idea, to provide training and funding, so they can go through an IRB process, informally do their own preliminary gathering of data.
I think really it's the pre-IRB process. People have an idea, they want to do something with it, let's provide them a pathway and assistance for doing it.
DR. JONAS: Maybe we could say, "The Commission recommends that state professional regulatory boards develop processes that encourage practitioners to move successfully into clinical investigation including IRB approval, collection of preliminary data," et cetera.
DR. FINS: State medical boards, those boards don't foster research.
DR. ORNISH: That is not their job.
DR. FINS: They are disciplinary bodies, so it's a different role, and as far as the education is concerned --
DR. JONAS: Do they impede research?
DR. FINS: I think what this is meant to do here is to say that if a CAM practitioner or a conventional practitioner is doing CAM research, and they have got an IRB approval, and they have punched all those tickets, and part of getting IRB approval is having taken a training course and passed an exam before you can qualify to do an IRB-sanctioned protocol, if you have done all that, and you are collecting research, they can't say that that is an unapproved or it's unprofessional conduct because you have gone through this other regulatory -- that you have opened it up to peer review, you have ensured the adequacy of informed consent, safety, you have demonstrated your own competency to do the study, so there would not be a basis for them to sanction that person.
DR. JONAS: Right. So, eliminate then anything about state professional medical boards.
DR. LOW DOG: I am a little confused still about this recommendation. One, I support that you get IRBs before you do research. The reality is that the preliminary data, scientific data may or may not be there. People just make claims that what they are already doing treats the disease.
I mean, we keep skirting around this issue that we are not treating disease, we are promoting health and wellness, but that is not the reality of much of what is going on in CAM. Much of what is going on is people saying that what they are doing treats this disease or treats that disease, and is effective at it, and if it has not been shown clinically to be effective, if there is no evidence that it has been effective, then, basically, you are still experimenting with people, and you never got an IRB. So, the reality is much of what is out there is not falling under this.
So, I think it is one thing to say we want to facilitate the process, but the other is to say -- I think this is not strong enough in saying actually this does not exist, and that there needs to be stronger sanctions against people that are claiming to have cures for things that they haven't done research on.
DR. ORNISH: I like that.
DR. GORDON: That is a somewhat different issue. I think that either we have to come to a decision right now -- we have 13 more items, we have 25 minutes, and we need to either refer this back to the group, which is my sense, that there is a lot going on, on many different sides. There are now two recommendations that are possible. I think we don't have much information about what is actually happening with IRBs at the present time.
DR. JONAS: I think that that would be fine to put it back and have us work on this again, realizing there may be two recommendations, but I would like some feedback from you in order to help do that about state medical boards, should that be part of these recommendations at all, or should we eliminate any statements about the state medical boards being involved in this process or any recommendations directed towards them.
MR. CHAPPELL: I am just not seeing why the state medical boards needs to be part of this, because the issue is much broader, so I need an explanation of why they need to be part of it.
DR. FINS: I think we heard from people like Nicholas Gonzalez and others, and other people as well, that they were fearful of even trying to do research because they would be sanctioned for unprofessional conduct.
DR. ORNISH: Even if they had an IRB, you mean?
DR. FINS: No, the idea of linking it to the IRB was an idea that I came up with to somehow shield -- in other words, it was a quid pro quo, if you did this, you would get protection on the other end, because we just wanted to have them buy into some of the safeguards, so as not only to safeguard themselves, but --
MR. CHAPPELL: Could I make a suggestion that this be limited to regulatory boards, because if I am doing preliminary research, it is not the state that I am concerned about?
DR. JONAS: Do we need a statement then about regulatory boards? Take out professional, take out state?
MR. CHAPPELL: I am saying you drop "state," and just say "professional regulatory boards" or "appropriate regulatory boards," because the state is not the one that is governing my work.
DR. ORNISH: Again, the regulatory boards don't encourage research, they regulate, discipline. That is not their job. It is the wrong organization to do it.
MR. CHAPPELL: That is not true. I just have to say that is not true.
DR. GORDON: Regulatory boards have been discouraging research.
DR. ORNISH: They can discourage it, but they don't encourage it. You can ask them not to discourage it, but you can't ask a regulatory board to facilitate research. That is not what they do.
MR. CHAPPELL: No matter what I do, I am regulated by the FDA, period, whether I am working on new ground, unknown ground, or known ground.
DR. ORNISH: The FDA may say you can't make a claim on a certain toothpaste, but they are not going to facilitate doing research on what is the best toothpaste to use.
DR. GORDON: I want to ask you guys, what you need to go back and cogitate on this. Do you still need anything, because we need to move on.
DR. JONAS: All I need is whether state regulatory boards should be part of any of these recommendations at all.
DR. PIZZORNO: This is a fascinating discussion because there is this gray area here that seems to be significant in CAM. On the one hand, you have the Textbook of Medicine, or Textbook of Natural Medicine where it says this is how you do it.
Over here you have got this data, which means I am ready to go for an IRB. In between, there is this gray area that practitioners see by doing something different, they might do a little bit different in one patient, do it a little different in another patient. They start seeing some experiences building up to the point they get to doing an IRB.
Well, those people are seeing things somewhat differently, in particular, we are seeing them do it in CAM, then get nailed by the state disciplinary boards.
So, how do we deal with this gray area in between? I think that is what we are talking about, between standards of practice, Textbook of Medicine, and we are ready for an IRB proposal.
DR. FINS: I think that's a very good point, and it's like when does clinical innovation, when does therapeutic innovation become experimentation, and I think most people would say when you generate a hypothesis, and if you are going to publish it as data.
So, if you are still in the practice of your therapeutic intervention, and you decide, well maybe, you know, two pills are better than one pill, and you are just sort of fiddling around with an established dose or something, at a certain point you say, well, let me study it formally, when you start wanting to study it formally.
But in the CAM arena, what we might have to say is we have to actually move that line back, and that all practices that are involved in any kind of risk to a human subject, should be construed as should be on protocol.
We do that with chemotherapy. There are things that are historically efficacious, so we don't do a protocol on Didge [ph] anymore, you know, because there is 10 years of history, and maybe we should.
DR. ORNISH: Part of the problem is some of the people who testified said oh, we don't even see how CAM could ever hurt anybody, so there is this presumption that everything is safe, so therefore, it is okay to try anything without having to have a protocol.
DR. FINS: I think this is getting overly complicated.
DR. JONAS: Let's finish with Effie and then we will move back and redo these ourselves, and we will bring them back.
Effie.
DR. CHOW: I think it is complicated, but I think the key issue here is that if the regulatory boards don't understand about research, and is not sympathetic to research, and doesn't support the individual who is practicing and experimenting, to do research and protect them when they come out to do research on a particular methodology, that does add to the problem.
I think that somehow the regulatory boards need to be stated in here, because we are talking about the future, not just immediate.
I just have one general concept, is that a lot of our discussion is now edited by what is happening and what isn't happening, and I would like to bring our vision back that we are envisioning for the future, not just what is possible right now.
I don't know whether I am clear or not, but a lot of discussion is saying what is happening and what isn't, and then we are adjusting our recommendations to what we see as possible right now.
I would like to just expand our vision a bit more.
DR. JONAS: Thank you, Effie.
DR. ORNISH: Let's move on. So, just to be clear, we are going to just go back to our committee and address all of these issues, the issues including are people experimenting on the general public now without IRB approval as part of the norm, the issues about applying the same ethical standards to both conventional and CAM approaches, that both need IRB approval, both need the same protection from sanctions if they have IRB approvals, those issues.
DR. GORDON: And third is are there obstacles to obtaining creating an IRB for some of the CAM research, because that is the crucial factor.
DR. ORNISH: Obstacles unique to CAM.
DR. GORDON: Understood.
DR. FAIR: I don't know the answer to this, maybe somebody does. When you are doing multi-institutional trials, many pharmaceutical firms will have a CRO, a research organization, clinical research organization, and I know in some of those, some institutions, if you get approval by the CRO, which may apply to 10 institutions, you don't need to an IRB.
Does anyone have any more information on that?
DR. GROFT: There is an IRB approval, it's just that it's a common IRB that it goes through one -- it may go through one, but many of the universities will require that it go through theirs also.
DR. FINS: It depends on if there are consortia agreements.
DR. GORDON: We have 13 more recommendations in this section, so can we move ahead. Anyone who would like to participate in this discussion can be in touch with Gerri, right, to get on the participation? So, please do that.
DR. ORNISH: Number 10. "The Commission recommends that the agencies, as appropriate, develop programs to evaluate practice-based data for potential research support, communicate the availability of such initiatives in a proactive manner to CAM and to conventionally-trained practitioners who believe that they have promising data on non-approved treatments and provide training and data collection, protocol development, and ethical guidelines on human subject protection."
Comments?
DR. GORDON: Seems like a good idea.
DR. JONAS: I think I would phrase this much differently. I think that the most effective effort in this area would not necessarily be to develop training programs for practitioners who are too busy actually to collect practice-based data in any case, but to target resources, since this is in Resources section, for research institutions to do that, so that then they could use practice-based research networks and other types of mechanisms that are in place to look at CAM practices in practices.
So, I think the recommendation is slightly off the group that it should be targeted towards. It should be for research institutions that could collect practice-based research data blah-blah-blah.
DR. ORNISH: We won't even talk about whether that practice-based data was generated under an IRB or not.
DR. JONAS: Well, IRB, I mean, if you target it towards those who professionally do research, and that is part of their business, then, they have IRBs as part of the process.
DR. ORNISH: Okay.
Can we live with that? Any comments, questions, concerns?
[No response.]
DR. ORNISH: All right.
Number 11. "The Commission recommends continuing adequate public funding for research on promising and/or frequently used CAM products that would be unlikely to receive a patent, and therefore not likely to attract private research dollars."
My own bias here, of course, would be to say research on -- I mean, it would have to be more than promising really, but I am open to any suggestions.
MR. CHAPPELL: This is where you want the safety and efficacy qualification.
DR. LOW DOG: This may be where you are trying to establish safety for some of these, because of the way DSHEA is written. You don't have to prove safety before they are entered into the marketplace, and so what you may want to do research on is to determine its safety if taken in pregnancy, et cetera.
DR. ORNISH: Yes, I like this the way it is.
DR. JONAS: I actually again think we are missing the boat here in terms of our role as someone that can target things towards federal policy. I think it is highly unlikely, nor is it even probably advisable to suggest that the government be funding safety and efficacy research on non-patentable products, because that is infinite, it's huge, we will never be able to do that. Just look at all the herbs.
DR. GORDON: But that is not in the recommendation, Wayne, we are not talking about safety and efficacy research specifically.
DR. ORNISH: Well, in a way we are, though, I think. That is exactly where we need it.
DR. JONAS: What we are currently doing now, and this is a explicit policy of NCCAM, is that they fund research on publicly used supplements, for example, and herbs, because there is no private money going into it, because you can't get a patent that is going to guarantee your intellectual property on that.
I am suggesting we are missing the boat by suggesting that, because that is a drop in the bucket as to what needs to happen in these areas, and instead, what we should be doing is addressing the intellectual property and patent laws to facilitate the private sector moving into these areas, and not simply saying the government should be providing more money to do that.
DR. GORDON: Wayne, doesn't that come under the next recommendation?
DR. JONAS: I didn't see patents address in that.
DR. GORDON: The question here -- and I want to try to simplify things because again, we have 10 or 11 recommendations in 10 or 11 minutes --
DR. ORNISH: I know what you are going to say, so let's just --
DR. GORDON: What I would like to do is to go ahead with this recommendation and then amend No. 12 to reflect your concerns.
DR. ORNISH: Can we live with No. 11 as it is written?
DR. PIZZORNO: Why the word "continuing" --
DR. ORNISH: We can say "continuing" or you can say "increasing," because, as Wayne said, there is research that is being done through NCCAM on this very issue.
DR. GORDON: But it's not adequate.
DR. ORNISH: Why don't we just say "increasing public funding," or just say, "recommend providing adequate public funding," how about that? All right, so "providing adequate public funding."
Number 12. "The Commission recommends that the federal government provide incentives to stimulate private sector investment and research on CAM products and NDA development, and on developing analytical methods for producing better quality CAM products."
If you want, Wayne, we could say, "private sector investment" -- da, da, da -- "such as changes in patent laws" without specifying what those are.
Would you be comfortable with that?
DR. GROFT: Changes in patent law are very difficult, Dean, I don't see that happening.
DR. ORNISH: How about if we leave it the way it is? Wayne, are you comfortable with that the way it is?
DR. JONAS: No, I think that we should say something about patents.
MR. CHAPPELL: I would like to hear, Wayne, what you have in mind, because --
DR. JONAS: I don't know.
MR. CHAPPELL: Then, let me just say that we are dealing with public health when there are 15 herbs being used commonly in this country right now. This is a matter of public risk. I see no point to privatizing the opportunity side of that use.
In fact, I think it is the government's responsibility to weigh in where small companies do not have the dollars to demonstrate safety of these very complicated interactions, and it is precisely the government that should bear the burden of establishing safety of these most commonly used, because it is a matter of already public risk.
DR. ORNISH: So, Tom, what I hear, an unintended consequence I hear you saying is that the large multinational corporations could end up with patents on these products because smaller companies couldn't afford to do those kinds of things.
MR. CHAPPELL: That is one of the implications.
DR. ORNISH: Okay.
DR. LOW DOG: The other side of that, though, is that because of the way that the laws currently are written under DSHEA, it is not just the 15 herbs. I take Wayne's point seriously, that it becomes this endless, I mean, endless, so every new compound that comes out, not just the 20 tops herbs, but every new compound, we are going to have to do research on, and it puts the onus on the government while the companies make the money, so they can put whatever they want out there, and the FDA has to prove it is unsafe.
Now what we are saying is the government has to then do all the research to show -- it's a public health issue, I agree, I think we need more research on it, but I think there needs to be some tweaking of the language here a bit, because I am not sure all the responsibility should fall under the government to do all the research.
DR. ORNISH: What you are really saying is you should look under DSHEA and say that DSHEA should be modified, so that the burden of proof is on the person who is selling the supplement to show it is safe as opposed to the government to show it is no safe.
DR. GORDON: I would like to return to the recommendation, what do we want to do with this recommendation? Do we need extensive discussion?
MR. CHAPPELL: No, I think other than changing the word "providing," we are there. I think we ought to keep -- I did not want to amend it to include some adjustment to the patent laws, as Wayne was suggesting. I think it is fine the way it is.
There might be incentives that could be made available, the smaller companies, very legitimate --
DR. ORNISH: Just in the interests of time, can we leave it the way it is, or did you want to change it?
MR. CHAPPELL: Yes.
DR. JONAS: I just want to just make a statement, that we are missing. There is an entire section that is completely absent from incentivizing research in the private sector, and that is, what do we do about intellectual property, the problems with intellectual property other than say dump more government money into it.
We currently say to be established as safe and effective, you have to meet certain criteria, and those criteria are set up for drug law, for drug production, and the current laws, intellectual property laws, allow a huge investment in that.
So, if we are going to hold herbs to the same standard, then, we should something to try to encourage the private sector to do that, or say that they are different and we shouldn't be treated as --
DR. GORDON: Is this an area where we need another recommendation?
MR. CHAPPELL: This is a gap recommendation.
DR. JONAS: And it not be just patent, and I am not saying we know the answers, but I am saying intellectual property issues around these areas need to be address in some way.
MR. CHAPPELL: I am fine with that.
DR. ORNISH: Let me just get some closure on this because we have to move on. Everything that you are saying, Wayne, is a subset of what is here. If you think it needs to be more explicit than what is here, then, we need to go back to our subcommittee and talk about it, but everything you have said is really contained within this, it just doesn't explain it explicitly.
DR. PIZZORNO: I have one solution to recommend. Back in October, 14 months ago, there was a representative here from a drug company who discussed the methodology they have for protecting the research they were doing on an herbal product.
I don't recall, I didn't fully understand how they were doing it. It might be worthwhile to go back to that October notes and see what the methodology was, because maybe we can facilitate that.
DR. ORNISH: Okay. Why don't we just table this for now, and we will send it back to our committee.
DR. GORDON: Excuse me. You want to table the recommendation or approve this recommendation and make another --
DR. ORNISH: My suggestion is that we approve the recommendation and that we make more explicit in the text the ideas that Wayne is talking about, because they are subsumed within this, unless you prefer to do it a different way.
DR. JONAS: Well, I think we could accept this recommendation as long as it is part of our charge is to develop a recommendation that addresses intellectual property rights and how we can use that to incentivize private sector investment.
DR. GORDON: Let's move on then. Good.
DR. FINS: There is a law called the Bayh-Dahl Act, which is meant to bring basic science innovation to the marketplace. One of the problems is, is that it is predicated on patents and it is predicated on disclosure of patent methods and dissemination, so I think whatever gets said here has to refer back to Bayh-Dahl.
Also, things could be patented, I mean, to answer Joe's question --
DR. GORDON: Joe, I am going to ask you if you would help them with this. Okay?
DR. ORNISH: Okay. Moving on, No. 13. "The Commission recommends that the federal and private sectors provide support for workshops to discuss research needs for regulatory review and approval of CAM products and devices, as well as for other purposes."
Comments or questions?
[No response.]
DR. ORNISH: Sold.
DR. WARREN: This statement here pretty well correlates with No. 4, that you had earlier in this section, and you are dealing with supporting conferences or workshops.
DR. ORNISH: You are right, it does, so maybe it's redundant. Why don't we just delete it.
DR. GORDON: It is regarded as redundant?
DR. ORNISH: This is a conference on regulatory review. I think we can delete this myself, but I don't feel strongly about it.
DR. GORDON: So, we can either delete or compress.
DR. ORNISH: Maybe we could cover that in the text.
DR. GORDON: Okay.
DR. ORNISH: Any objections?
[No response.]
DR. ORNISH: Number 14. "The Commission recommends federal and nonprofit support for research on practices that build on lifestyle and self-care, and support for new, innovative and sometimes controversial CAM research in emerging areas of scientific study that might expand our understanding of health and disease, and encourage support for basic research on core question described in many CAM systems, such as bioenergy."
DR. GORDON: This speaks to my gap recommendation, because I think there are at least two separate thoughts in No. 14. My gap recommendation that relates to it is, "The Commission recommends that a high priority be given to research on complex, multimodality CAM and integrative therapeutic interventions and to research on the individualization of therapeutic interventions."
That seems to me to go with the first half of No. 14, and then there is the second thought, which was separate, I think before on the sort of emerging areas in No. 14.
DR. JONAS: I agree that they are separate ideas. I actually think what you just read is even separate than self-care, and self-care is important enough that we ought to have it --
DR. ORNISH: I agree with Wayne that those can be two separate things, but I kind of like the way they are, just separate them, that's all.
DR. GORDON: You like them together?
DR. ORNISH: No. I mean, we can separate them, but there is two different things, because I mean, they are separate things. I mean, personally, I like the first part up to the semicolon. When you start talking about support for new, innovative and sometimes controversial, I think that is just a big land mine you want to stay away from, because I mean, either it has got some innovation or it has not, and whether it's controversial, that can be something that's equally whether it's allopathic or not.
DR. JONAS: That is very important. That's where the money is. Well, that's where the excitement is. I mean, that is what the paradigm issue is all about. The ones that are controversial often ignore data, and people argue simply over beliefs.
DR. ORNISH: Well, I am not any stranger to controversy, but I don't think we have to make it explicit in here that just because is something controversial, that it should have a higher priority.
DR. JONAS: Yours isn't nearly controversial enough.
DR. FINS: Simply by saying it is not going to make it happen. It is really establishing a structure that can review it. This is like a throwaway recommendation.
DR. ORNISH: It is.
DR. GORDON: Which is, Joe?
DR. FINS: The second part of 14.
DR. ORNISH: The second part of it especially.
DR. GORDON: The second part or the first part?
DR. FINS: The second part. If you have an entity that has a funding opportunity, and they are in a process to review new proposals, that is productive, but to say we should fund as an idea, you know, bioenergy, decontextualized from an NCCAM or some substantive thing, it is not going to play.
DR. ORNISH: It raises questions about our bias, that's all. That is what I mean, because it raises those questions.
DR. GORDON: Is there a later recommendation on frontier science here, or that is it?
MS. POLLEN: The text at the bottom of page 8 and 9, the first half of the first paragraph on 9, the text, I think gets to this issue.
DR. GORDON: But not the recommendation. Joe, I would argue the other way. I think it is important to emphasize. We may have made it too specific here, but I think it is important to emphasize frontier science and some of those core questions.
This is one of the areas that, you know, we can really make a difference by making that kind of statement. We are saying research on it, we are not saying you should believe in it. We are saying this is an important area to study, and this is an area also that is implicit, if not explicit, in virtually every traditional system of healing.
So, I think it is important for us to approach it. I am not sure the wording here is actually really strong enough or comprehensive enough, Wayne, to really say what we are talking about.
DR. JONAS: Right, I agree. I think the issue is frontier sciences and the emphasis, that we encourage that or we would like to see more -- not encourage frontier medicine, but we encourage research in the area of frontier sciences, and focusing it just on bioenergy is probably too narrow, and that needs to be expanded.
I do think that should be -- we essentially have within this one, this could be split up if we include what you mentioned, what you read, three potential recommendations.
DR. GORDON: What do you want to do with that, how do you want to handle it?
DR. ORNISH: Why don't we just say Recommendation 14 would be until the semicolon, Recommendation 15 could be, "The Commission recommends support for new and innovative" -- I would leave out "sometimes controversial" -- "The Commission recommends support for new and innovative CAM research and emerging frontier areas of scientific study that might expand our understanding of health and disease, and encourage support for basic research on core questions in these areas."
DR. GORDON: I think we have to give some examples because otherwise people won't know what we are talking about.
DR. ORNISH: It's in the text, so we are just referring back to the text. There are lots of examples in the text.
DR. GORDON: Okay. Do you want me to read my recommendation now, since it goes with these, or do you want to wait until the end?
DR. ORNISH: Go ahead.
DR. GORDON: The recommendation that I made again is, "The Commission recommends that a high priority be given to research on complex, multimodality CAM and integrative therapeutic interventions, and to research on the individualization of therapeutic interventions."
DR. ORNISH: I don't know what that means, but it sounds good.
DR. GORDON: Do you want me to explain? It means like the Ornish program, for whom it works and for whom, those few for whom it doesn't work.
DR. JONAS: Except for the complex side.
DR. ORNISH: I am just a simple guy.
DR. PIZZORNO: I really like Jim's recommendation because this is what we are actually doing. We are using complex multiple therapies that we individualize to particular patients, and nobody studies what we actually do. Let's state what we actually do.
DR. GORDON: Gerri, I can hand you this.
DR. ORNISH: As chair, you get the prerogative. I might as well agree with you.
DR. FINS: It's just very high on jargon, the way it reads. One man's jargon is another man's idiom, you know.
DR. GORDON: I will accept any de-jargonifying.
DR. JONAS: Examples would help, and we can put some of those in.
DR. ORNISH: When you combine five-syllable words with seven-line sentences, it is dangerous.
DR. GORDON: If we have consensus, can we move on to No. 15, the actual No. 15 in the text?
DR. ORNISH: Which will be No. 16 now.
DR. GORDON: It will be No. 17.
DR. JONAS: "The Commission recommends that NCCAM conduct a review assisted by the National Science Foundation, the Institute of Medicine, the World Health Organization, or other federal and non-federal bodies on methods to study, in a credible manner, emerging areas of scientific investigation associated with CAM."
DR. PIZZORNO: Isn't this the same as No. 4?
DR. GORDON: Is it the same as No. 4 or the same as the second part of 14? To me, this seems like the frontier science recommendation, just worded slightly differently, or do you mean something else?
DR. JONAS: It depends what you mean by "emerging."
DR. ORNISH: My short recommendation here is just accept it as it is, because it is going to provide a lot of credibility for mainstream readers who read that. The fact that we have just mentioned these organizations will make them feel better. So, I think it is worth putting it in there.
[Laughter.]
DR. ORNISH: You think I am joking, but I am not.
DR. JONAS: Well, in that case, we should just fill the whole thing full of that. What confused me on this was the term "emerging." I mean, if we need frontier medicine in these areas, then, do away with the above, merge it with the below, but define what "emerging" means.
DR. ORNISH: We will accept the recommendation to do away with the above and merge with the below.
DR. JONAS: I mean, is that what this is focused on? It is also focused more on methodology, right? Is it on methods of frontier areas?
DR. ORNISH: What they are trying to say here is that there are new, emerging areas of scientific investigation like energy medicine, and they may require the very thing that you are talking about, which is new methodologies, and as a way of trying to ground this, so it doesn't sound so airy fairy to say let's have some conventional organizations help us develop these new methodologies to avoid the criticism that I hear all the time, that people say oh, CAM wants to develop its own methodologies that are inferior, because they can't stand up to the scrutiny of -- you know, there is good science and bad science, and it doesn't matter what you are studying.
DR. JONAS: Thank you, Dean, I understand it. No, I do, I am serious. That was very clear. I actually recommended this, but now that you have explained it to me, I understand it. I agree.
DR. FAIR: I like the term "emerging" because it also applies to new applications.
DR. JONAS: Excuse me?
DR. FAIR: I like the term "emerging" because it also applies to new applications of old drugs. Joe mentioned we are not studying things like digitalis, but there are a number of studies now on Coumadin, warfarin, it has been around for years, and now it turns out it has some anti-metastatic properties, so it is being used in patients with cancer to try to stop the tumor from metastasizing, and no one would have thought of that in the 25 years it has been used.
DR. GORDON: We have six minutes and six recommendations.
Are we okay with this? Yes? Okay.
DR. ORNISH: All opposed say no or forever hold your peace.
Number 16, please.
DR. JONAS: Number 16. "The Commission recommends providing increased public and private resources to strengthen the CAM research infrastructure at strategically located conventional, medical, and CAM sites, to expand the corps of researchers knowledgeable about CAM who have received rigorous research training in basic clinical and health services research."
I think we could probably reword that and still get the essence of it.
DR. ORNISH: Is everybody okay with it? Anybody opposed?
[No response.]
DR. ORNISH: Great, No. 17.
DR. JONAS: "The Commission recommends strong support for enhanced research training by all federal agencies with research and training program and responsibilities that encompass CAM-related questions."
DR. GORDON: So, these two we may be able to condense, as well, as we move ahead.
DR. ORNISH: It is hard to argue with those.
Number 18.
DR. JONAS: "The Commission recommends utilizing existing resources, such as NCCAM-supported centers and the National Center for Research Resources, general clinical research centers to increase opportunities to conduct clinical research and training on CAM and examine the integration of CAM into the clinical setting."
DR. ORNISH: Okay? Okay.
Number 19.
DR. JONAS: "The Commission recommends continued strong support for career development awards that enable investigators focusing on CAM to develop into independent investigators and faculty members, and mid-career awards to provide the time required to mentor new CAM investigators."
DR. ORNISH: The only thing I would add is something to even just highlight what may seem redundant, which is so that they can be strong scientific researchers, something like that.
DR. JONAS: There is support, it is debatable how strong it is.
DR. ORNISH: Let's just delete the word "continued."
DR. JONAS: Maybe not strong, just continued support. It is ongoing.
DR. ORNISH: All right.
DR. JONAS: Bill.
DR. FAIR: What happened to the SPORE?
MS. POLLEN: It's in there. It is in the text. It's on page 10, first paragraph. On Methodology and Design, the Commission notes. It starts obviously the page before, but if you get down to the specialized awards, it isn't the only one, exploratory grants and center core grants, they all encourage interdisciplinary research approaches, including SPORE.
DR. ORNISH: Number 20 is too long to read, but does anybody have any recommendations on it?
DR. WARREN: I have a question as to what you really meant there. I want an explanation of 20.
DR. ORNISH: Of which one, 19 or 20?
DR. WARREN: Twenty. That is the one we are on, isn't it?
DR. ORNISH: Then, you are going to make me read it.
DR. WARREN: I thought you said it was too long to read.
DR. ORNISH: That's the problem.
DR. WARREN: Go for it.
DR. ORNISH: Well, they are basically saying that somebody should create an evidence-based database, so that people can access and get to see what is the level of evidence for any particular CAM modality, preferably be available on the Internet.
DR. GORDON: I feel we have to recommend strongly that it be public funding. I don't think we should wait for somebody to do it. We can say this should be publicly funded.
DR. ORNISH: If you put public and private, that doesn't take anything away from it.
DR. GORDON: I understand, but we are in no position to do anything with private. We are in a position to recommend either legislation or administrative change.
I think this is one of those areas where we can make a fairly pointed recommendation. If we talk about private resources, it becomes more diffuse.
DR. ORNISH: We could do that although we have talked about private things throughout this whole document.
DR. GORDON: I'm sorry?
DR. ORNISH: We have talked about private support throughout this whole document.
DR. GORDON: I understand.
DR. LOW DOG: You have got already people doing this. You have got Cochrane, and you have got AHRQ, I mean, so you already have people doing systematic reviews and some doing actually a lot.
I think that you want to do public and private, because there is already a lot of this being done.
DR. GORDON: I am saying there should be public funds made available to do this is what I am suggesting.
DR. LOW DOG: Doesn't it say public and private resources?
DR. ORNISH: It does.
DR. GORDON: I think the tendency is to say we will let -- what we have heard from people in the private sector is it is happening, it is happening somewhat slowly and very incompletely, and what they are saying is we don't have the money to do it.
DR. JONAS: It is also not authoritative if it's generally done by private --
DR. GORDON: Unless there is significant government effort to do this, it is not going to happen. That is my concern.
MR. CHAPPELL: The consumers will tell you their primary concerns are that they need an education on what these modalities are for, and then they need to know they are safe.
I would say right now safety is the even greater of the two questions, and since that is the prevailing number one concern among probably the 20 percent of the population that are using these, I would agree with Jim that it does bear a burden, you know, we ought to put the burden of support of research on the government, because it's a matter of great public safety.
DR. WARREN: Can we leave off the second sentence in that recommendation? That is just an explanatory sentence anyway.
DR. JONAS: Put it in the text.
DR. ORNISH: That's a good idea.
DR. GORDON: I didn't understand that.
DR. ORNISH: Take the second sentence and put it in the text.
DR. GORDON: Okay.
DR. ORNISH: So we delete the word "private"?
MR. CHAPPELL: I am not sure you need to delete the word "private," you need to make the case for the public first, and no need to delete the private. I don't think you need to delete the private, do you, Jim?
DR. GORDON: I just think that the federal government, either itself or through contracting with private entities, however you want to say it, do this. All I am saying is we need to focus on federal money being used to do this, not necessarily the government is doing it itself, but contracting out.
DR. ORNISH: So, in summary, you want to take the words "and private" out, and leave the first sentence the way it is?
DR. GORDON: Yes.
DR. ORNISH: I don't have any strong objection to that.
DR. PIZZORNO: Can we wipe out the second sentence just for brevity?
DR. ORNISH: We are going to put it in the text. You weren't listening.
[Laughter.]
DR. ORNISH: Twenty-one. Any comments or questions? You hurt our feelings so badly, you are going to have to read it yourself.
In a way, 21 is really a subset of 20, isn't it?
DR. GORDON: Right, exactly.
DR. ORNISH: I think we could just put that in the text.
DR. JONAS: Actually, they are all a subset of 22.
DR. ORNISH: Yes. Let's combine --
DR. GORDON: Combine 21, 22, and 23?
DR. ORNISH: There is no 23.
DR. GORDON: Oh, 20, 21, and 22, sorry.
DR. JONAS: Charlotte, there is a book sitting on the corner of the desk there, would you hold it up, please? This is what I think we should try to get done. I think if there is one thing that we get done out of this entire section here, if the federal government -- and I agree the federal government should be doing this because actually the federal government is supporting that one in England -- were to produce an ongoing publication like this one is, it is periodically updated, it is current state-of-the-art evidence for safety and efficacy from the clinical research in CAM, this would go a long way towards facilitating the whole process of CAM use, regulation, research, et cetera.
They do include CAM someplace, the criteria are there, the methods to do it are there.
DR. GORDON: Wayne, can you and Dean come back to us with something that summarizes those three, with Gerri, those three?
DR. JONAS: We can. I mean, these aren't all completely redundant, for example, because what AHRQ is doing is much more expanded than that book or even than what Cochrane does, so they are different, and they cost a lot more.
DR. GORDON: Understood.
DR. JONAS: So, they are not all exactly redundant, but they are all subsections basically of ongoing summaries.
DR. GORDON: Why don't we leave them and then let you all, if you feel they can be condensed and reordered, please do them. Is that okay with everyone? Basically, we are leaving these, and we are allowing some condensation and reordering with the clear notion that these three recommendations, as they are, are the ones we want.
DR. ORNISH: Thank you. I couldn't have said it better myself.
DR. TIAN: The Commission recommends who should do the summary report?
DR. ORNISH: You mean?
DR. TIAN: Number 22.
DR. JONAS: Number 22? The federal government.
DR. ORNISH: The federal government is what they are advocating.
DR. TIAN: Can we put the federal government --
DR. ORNISH: We are going to consolidate.
DR. GORDON: The federal government fund the summary report.
DR. JONAS: Right.
DR. ORNISH: Thank you all. This has been a real pleasure.
DR. GORDON: Thank you, guys. You did great.
[Applause.]
Session III Summary
DR. GORDON: I am sure everybody remembers everything that transpired in the last two hours, so I hardly need to go over it.
For the most part, the recommendations were accepted as amended. There is a Recommendation No. 9 regarding IRBs, protection for clinicians who want to do research, and professional regulatory boards was referred back to the committee to work on, so anyone who wants to work on that with them, please do so.
Also, the discussion of intellectual property is one that the committee is going to take up again.
Recommendation No. 23 is very much related to Recommendation No. 4, and is either going to be folded in or deleted. Gap Recommendation Nos. 14 and 15 were split, and the gap recommendation was relating to complex interventions and individualization was also put in there.
The last series of recommendations, it is clear that there needs to be federal funding for some of these efforts to bring together research and make that research available to the public.
Thank you again. Let's break until 3:20. Well, to be fair, 3:23, and then we will come back and are going to be moving into Wellness.
[Recess.]
Session IV: CAM in Wellness and Prevention
DR. ORNISH: You all know how much I hate being late, so let's get started.
[Laughter.]
DR. ORNISH: Why don't we take the same format that we did with our last one, which is we will go through the recommendations, and if anyone has any questions or comments about the recommendations or the text that elaborates on them, speak now or forever hold your peace.
The first recommendation is on page 4 in Tab 8. "The Commission recommends" -- you will notice these recommendations are shorter, that is the first thing -- "The Commission recommends that DHHS review the 10 leading health indicators and, where appropriate, develop strategies to encourage the use of safe and effective CAM principles and practices in these areas."
Comments, questions? Bill.
DR. FAIR: Two comments. First, I couldn't believe that hypertension wasn't among the 10 leading health indicators. The second thing was, as I mentioned, I was very disappointed not to see --
DR. ORNISH: I think hypertension was No. 11.
DR. FAIR: You mean it is better than environment quality? I don't know.
At any rate, I was very disappointed not to see as our No. 1 recommendation, actually the lifestyle modifications as part of an educational program from grades K through 12.
Certainly, we talked about lifestyle modifications in the elderly and the dying, which is a very short-term problem, and I think there is little better we could do for children than to start teaching them as soon as they got to school the lifestyle changes that would be beneficial for them.
They are not getting it from their peers, they are not getting it from their families, attested to by these figures.
MS. AXELROD: Bill, can I just interrupt you just for a point of clarification? One of the things that we changed in this go-around was we switched what was previously No. 1 and No. 2, so you will find the recommendations that address children under the second issue.
We put this one first because it is kind of even broader than that. It is really, you know, the recommendation that applied to the whole country, to all populations. So I think some of your concerns may be addressed in the second one.
DR. FAIR: I have read all of them, I can't find it.
DR. GORDON: There is no specific recommendation on schoolchildren.
MS. AXELROD: There is a reason for that and perhaps when we get to No. 2, we can elaborate on that because we had quite a bit of discussion on that.
DR. FAIR: You mean Recommendation No. 2?
MS. AXELROD: I mean, Issue No. 2.
DR. FAIR: Are you going to wait for that? I mean, you do say "where appropriate, CAM practices." I guess I would ask the question, where is it not appropriate?
DR. LOW DOG: When you look at Healthy People 2010, reducing vehicular deaths, that is not a lot to do with CAM. So, I think "where appropriate," is appropriate when you are referring to the top leading health indicators, and also where you are talking about the preventive strategies for different things that are listed in 2010. I think "where appropriate" is okay.
DR. GORDON: Can we stay focused on one recommendation at a time?
DR. LOW DOG: That is where we are. We are on Recommendation 1.
DR. GORDON: You're are on Recommendation --
DR. ORNISH: No. 1.
DR. GORDON: I'm sorry. I thought you were on Recommendation 3.
DR. LOW DOG: No. I am right where I am supposed to be.
I am glad that we added the specifics, Corinne, in the text, but my comment still remains what it was, that I think we want to be careful not to co-opt a lot of the preventive strategies that have been done through the CDC community prevention, the prevention guidelines.
There has been an awful lot of work that really has not come out of complementary and alternative medicine practice. We have a lot to offer, but a lot of this has not come through the work that we have done.
DR. ORNISH: But, Tieraona, don't you think that by saying "where appropriate," this is an augmentation to that?
DR. LOW DOG: I am talking about the text, the supporting text for that. It is the tone, the general tone still, and I think it is better than it was, I think it is not there yet.
DR. ORNISH: So, would you like it to make more reference to Healthy People 2010, and so on?
DR. LOW DOG: I just think that we have had a tendency to neglect the down sides of CAM and to then co-opt everything that is good, even in conventional medicine, and then use it under the rubric of CAM.
DR. GORDON: Where in the text, Tieraona?
DR. LOW DOG: It's all throughout.
DR. GORDON: But is it there under Issue 1?
DR. LOW DOG: It's under the introduction including. We still talk about that preventing heart disease, cancer, stroke, others, yet, there has only been limited success in reducing the occurrence of these conditions.
DR. GORDON: Where are you reading from?
DR. LOW DOG: Page 1.
DR. ORNISH: Look at page 3, line 75, because the intention there is to acknowledge Healthy People 2010 and to say, in line 87, how CAM principles and practices are consistent with two of their overarching goals, and then it goes on to talk about that.
The intention of these was to not co-opt it, but to augment it, to say that CAM can add something to the important work that they have already done. Now, if that didn't come through, we need to change it, but that was the intention.
DR. GORDON: I would also like to offer another general perspective here. My own work in working in schools is that in spite of everything, certainly in the D.C. schools, in spite of everything that the Healthy People 2000, 2010, the Surgeon General has said, none of these things are happening or virtually none are happening in the schools here where I live.
From my point of view, one of the opportunities we have is precisely because we are coming at it from another place with a fresh kind of energy and a fresh crew of people who are available, that we may be able to have an influence in a kind of synergistic way.
The Surgeon General has been saying many, many things, the President's Council on Physical Fitness, Healthy People, but it is just not happening most places.
So, I think we can contribute and we can help to move things ahead without saying that we are the only people who are talking about it.
DR. ORNISH: Okay? Can we move on or you seem like you are still not satisfied?
DR. LOW DOG: I sent you comments, and I am glad that we beefed it up with some of the examples, I mean, I came up with a lot of the examples, because I do think CAM has a role to play here.
It is just that there is still this feeling, one, that CAM can prevent illness, and I think you have to be specific, what are you talking about. When we talk about CAM nutrition, that is also one for me. It is like, well, is that the Atkins Diet, or is it the Right for your Blood Type, I mean, what is CAM nutrition? I don't even know what that is.
MS. AXELROD: It might be helpful if we just add an introduction, you know, to introduce the whole concept of some balance in this subject.
DR. ORNISH: Why don't we just use what we were talking about before -- Bill, could you turn your mike off -- is to talk about in the case of nutrition or CAM modalities that are proven to be safe and effective. We don't have to get into identifying which ones are and which ones aren't, but certainly that is the overarching theme.
I have had a problem all along with the whole idea of this chapter, you know, that, to me, what is wise wellness part of CAM, you know, some of these things are to me not really CAM anyway, and yet here we are with this section, so now having made the decision that we are going to talk about wellness, self-care, and prevention, I think it does a reasonably good job of that, but we can always make it better.
DR. FAIR: Now, can I put my light on, Dean?
DR. ORNISH: I'm sorry, Bill. Yes, now you can turn your light on.
DR. FAIR: I think we are being a bunch of wimps if we don't come out and make that comment that we need to have education. In schools, fire drills are mandatory. Even some schools had to put condoms on are mandatory. This is just so reduced here.
I know you said you were going to add something, but I 8-fold increase in incidence of diabetes in 30-year-old among minorities, is an absolutely staggering statistic, and it just means that we are not doing anything --
DR. ORNISH: Bill, look at Recommendations 3 and 4. I think part of the confusion is that they flipped those two, and so they are under that. Now, we will get to those in a moment, and we may want to expand them in the ways that you are talking about it, but that is where those ended up.
DR. FAIR: "Where appropriate," I mean, to me means where the school board is not getting money from McDonald's to put McDonald's in the cafeteria.
DR. ORNISH: What I am just suggesting is, can we stay with Recommendation No. 1, and then defer your comments until we get to Recommendation 3, which is really where they are.
DR. FAIR: I think it will be one, that is what I am saying. I think we ought to come right out and take a strong stand on it.
DR. ORNISH: It is not a question of priority, it is just a question of what is in that section, that's all.
DR. GORDON: Although let me say that if there are strong feeling about priorities, it is fine to put those out there now, and we will sort of take them into account as we look at prioritizing.
I am not trying to interrupt with your order, Dean.
DR. ORNISH: I am just saying, just so we can get through, let's do No. 1, then No. 2, and then we will do No. 3. If we decide that No. 3 should be put up at the very beginning, we can do that, but let's just, for the sake of discussion, let's try to focus on one issue at a time.
With Recommendation 1, Tom?
MR. CHAPPELL: I think we are missing an opportunity by not being more explicit about CAM principles and practices in No. 1. We have been very explicit about the 10 health indicators, and we are being very general about the usefulness of CAM.
So, I actually think this should be built up quite a bit to be more specific if we can. I mean, I know we can.
DR. ORNISH: Here again, in the text, we do give specific examples, and we want the recommendations to be broad, they are under the overarching theme, the things that are safe and effective, and we do give some specific examples.
MR. CHAPPELL: I have seen those in the text. Is that as far as we want to go?
DR. ORNISH: They are just examples, they are not the only places that CAM has been found to be useful, but again, in the interests of space, we are just trying to give a general principle here.
MR. CHAPPELL: I guess I don't, and this is one case where I don't think reducing it is helpful. I think it ought to be built up with more --
DR. ORNISH: What would you like to include in here, specifically? What is missing here?
MR. CHAPPELL: Well, specifically, I would like to see those items mentioned in the text brought into the recommendation, and I would like to see CAM practices that are relevant beyond what is mentioned in the text enumerated.
DR. ORNISH: With the first part, we have made a decision not to put the specific things in there because once you start giving specific examples, then, by exclusion, you are eliminating many, many more. We already made the decision even before this section, to put the principle as the recommendation, and give the specific examples in the text.
So, I am not really interested in deviating from that unless there is a really compelling reason to do so.
MR. CHAPPELL: If you read the recommendation, do you get a full sense of what is being said, Dean?
DR. ORNISH: Well, I don't think you get a full sense in any recommendation, otherwise, we wouldn't have text, but the principle that --
MR. CHAPPELL: I don't agree with that, Dean, not everyone is going to read the text, they are going to read the recommendations, and especially when we reorient this to the kind of rationalization that has been suggested by Steve earlier, this is going to be showing just as a separate bullet point, and I think it needs to be built up with specifics and action steps.
DR. ORNISH: Why this and not the other examples?
MR. CHAPPELL: I can't answer that, I am focused on the topic at hand right now.
DR. GORDON: Tom, there are two questions. One is what would you like to say, and then if this recommendation doesn't lend itself to that kind of strength, we may want, as Bill is suggesting, to move it back down in the order.
I am hearing from both of you that you want stronger and more specific recommendations, but we need to hear what they are.
MR. CHAPPELL: I guess I need to ask for help from the committee who has done the work. We could lift out the specific references to massage therapy, meditation, Tai Chi, of nutrition. I am just trying to direct us to have more influence, to be more helpful when we come up with a recommendation than this does.
I think we use CAM practices and principles often, and I think this is one case, because you have enumerated the 10 leading health indicators.
DR. ORNISH: The 10 leading health indicators are in text, they are in the footnote. In the last two hours we spent the whole time going through and shortening recommendations by eliminating the specific examples and referring people back to the text, so it is just puzzling to me why this has suddenly become such an important issue.
MR. CHAPPELL: Because I think this is so dilute. I think this is going to be glossed over as it is presently written. I am just trying to be helpful, gentlemen, I am not trying to be difficult.
DR. ORNISH: Nobody has a greater interest in lifestyle and health than I do, it is very dear to my heart.
MR. CHAPPELL: Okay. Then, let's put some punch into it, let's say what we want to say.
DR. ORNISH: I think it does say what I want it to say.
MR. CHAPPELL: But it's euphemistically described as effective CAM principles and practices.
DR. ORNISH: It talks about safe and effective CAM principles and practices. We have spent earlier in this thing --
MR. CHAPPELL: Then, let's be specific about what they are as they relate to the 10 health indicators.
DR. ORNISH: We could broaden the text.
DR. GORDON: You mean give examples?
MR. CHAPPELL: Yes.
DR. ORNISH: We can give examples in the text and broaden that, and I am certainly very familiar with that literature.
MR. CHAPPELL: I am sure you are.
DR. ORNISH: But I don't think it belongs in the recommendations.
DR. GORDON: I would say, Tom, that the 10 -- and this relates to Bill's point -- I don't think the 10 health indicators are the best place to get more specific. If I were getting more specific, I would talk in terms of wellness programs, whether in the school or for the elderly, or in the federal government, this is so diffuse because as Tieraona is saying, what does it have to do with car accidents, it just gets to be too complex.
I think that we should get -- what I am hearing is that we need to get more specific. I think we need to find the right place to get specific, and then not get specific every place, because if we do, it will be boring and overwhelming.
Does that make sense, Dean?
DR. ORNISH: I agree with you, Tom, that we could flesh out in the text more of the evidence. My work, for example, is a good example of this, and it is not in there. I mean, we could lots of things that we could be citing that we haven't done in the text.
So, I agree with you completely that have more substance and impact and specifics in the text, and I actually share your belief, but I do think that there is some benefit in keeping the recommendations concise because once you start to get specific about one thing, it raises the question why did you pick that one, and leave out all the other ones. It also just makes it long and unwieldy as we have seen before.
DR. FAIR: But you can be concise in one sentence. Your 10 leading health indicators here, if they are given in order, are physical activity or lack of, and overweight and obesity. I mean, I can't believe that environmental quality ranks anywhere near those two in terms of health care indicators.
With all due respect to Dean, you know, it is one thing to put a man through your excellent program at age 50, but we are talking about kids that are 10 years ago have a much longer time to go, and the best time to indoctrinate them into a healthy lifestyle is when they are young.
DR. ORNISH: Do you think I disagree with that?
DR. FAIR: Can you disagree with it?
DR. ORNISH: No, I said do you think that I would disagree with that?
DR. FAIR: I would hope not.
DR. ORNISH: Well, I don't, so I am not sure what the point is.
DR. FAIR: The point is that you have another 40 or 50 years when you approach children as opposed --
DR. ORNISH: We are coming to the issue, Bill, just hang on just for a minute, we are almost there. We are talking about Recommendation 1, the children comes in Recommendation 3 and 4, and I hope we will get to that, I thought we would already be there actually, so I understand your impatience because I am a little impatient myself.
Tom?
MR. CHAPPELL: The issue that we are talking about is the utilization of CAM to help achieve nation's health promotion and disease prevention goals.
I think my concern was really lifted out a little bit more specifically by Jim's comment that there are going to be areas -- this is an opportunity section to be specific about our goals, about health promotion goals.
I would hope somewhere in a recommendation we actually have those more specifically.
DR. ORNISH: Tieraona.
DR. LOW DOG: I would like to make -- we don't really have it under Research, and it may appropriately go there, but perhaps part of what is needed is also research into more of these. When we are talking about obesity, I think there is an assumption that with CAM, you can help people to lose weight and actually there is no really good evidence that that is the case.
Many people are chasing a lot of products to lose weight, some with deleterious effects, but I think there needs to be more exploration of the research to see what the outcomes actually are for more of these CAM modalities and practice to see actually do they prevent illness, to what extent, and at what cost, and how much do they actually promote health or change behaviors because I hear what you are saying, Jim, but behaviors are very difficult to change and systems, and, you know, that is why tobacco cessation, the things that really changed it was banning them in public places and increasing the cost of cigarettes, but I mean, those were systems changes.
Safety belts, nobody wore them just because they thought it was going to prevent them from getting in a car accident, it was because you got fined if you didn't wear your seat belt, so I mean, a lot of public health and preventive strategies have been through public policy and through systems changes, and I think at this point some of these CAM practices and principles that we think may be beneficial for that, it is premature to say that they are actually going to change behavior, they are going to prevent illness, or they are going to promote health.
I think that some of this data is available, but not to the extent that it comes through in this document.
DR. ORNISH: I want to distinguish between the recommendations and the text. The recommendations talk about safe and effective CAM, so that to me covers what you are saying. I do think that we could expand the text more to include both the need for more research, the evidence of things that do work, and equally important, the evidence of things that don't work or the importance, at the very least, of using research to help sort out what works, what doesn't work, for whom, and under what circumstances. I completely agree with that, and I think that could be more beefed up -- it is probably the wrong term.
DR. GORDON: Tieraona, I would say that there are certain fundamental approaches for which there is a fair amount of evidence for many of these conditions and for psychological conditions, as well, physical exercise, dietary change, and stress management.
DR. LOW DOG: I don't consider physical exercise as CAM.
DR. GORDON: I understand, but for our purposes, at this point, it is CAM, as well as conventional. It is one of those overlapping circles. It is not CAM. For example, we don't need to go into this at great length, but, for example, not much is taught in conventional medical education about using physical exercise therapeutically.
DR. LOW DOG: How much is taught in massage school, acupuncture school, I mean, how much really in exercise?
DR. GORDON: Listen to what I am saying. It is not -- that is one of the problems of those schools, as well.
DR. LOW DOG: [Off mike.]
DR. GORDON: Let me just continue. I am trying to make the case for what we are doing. I am not saying that there aren't gaps in all of these educational programs. I think Chinese medicine programs that don't teach qigong and Tai Chi are ridiculous. That should be part of the curriculum, working with those techniques of movement.
But the point is these are approaches that are part of CAM approaches, whether or not they are also part of conventional, which is they are not emphasized. We have done surveys of what is taught in nutrition in most medical schools, and as you know, it is not very much.
DR. ORNISH: Okay. Let's move on.
DR. GORDON: Stress management, not very much. Those are aspects of CAM for which there is good evidence they are safe, they are effective, they can have a significant effect on a variety of different conditions.
I think we ought to enumerate those.
DR. ORNISH: I need to point out, Jim, that we are still on the first point here, and we have been doing this for 25 minutes, so I would like to move on. I didn't really think that No 1 was going to be this controversial frankly, but I do think that No. 1 covers everything that has been said as long as we expand in the text all of the other things that have been very helpfully pointed out.
Can we all live with that?
MS. AXELROD: Can I just add that in previous meetings, we have asked for people to send in any examples of information, and some of you have done that, it has been very helpful, so I just want to make a plug again, if you have examples that you think would be helpful, please send them to me ASAP.
DR. FAIR: On the conference call, I thought there was total unanimity that we would make this discussion, I mean, we would recommend education in the schools starting early.
DR. ORNISH: We are almost there, Bill, we are almost there. That is the third point. We are still on the first point.
Charlotte.
SISTER KERR: I just want to comment on what I am observing. There is a lot of passion by some people that something is not just quite right, and rather than maybe -- at least this is how I feel about it, maybe everyone else doesn't -- rather than resisting that, I am wondering what is that, what is so important that is not here, that we need a listening for, so we get it right, so we meet our mandate.
I just wanted us to kind of take a minute to think about is there something that is it so important that these people are so passionate about that we haven't gotten, and we want to do that.
DR. ORNISH: I want to clarify. I appreciate what you are trying to say, that it is just a question of where you put it, it is not a question of whether it is included, and I completely agree the points that everyone has made should be included in here, but I think they should be included in the text because if you start making the recommendations three or four paragraphs, it doesn't work, and I thought that was something that we had all agreed to in our previous discussions, and so it puzzles me why suddenly we are changing that now.
I think that everything that has been said has been incredibly useful and constructive and helpful, and will be included in the text, but I do think that all of those things are subsumed in the recommendation as it currently exists, and when we start to make it more broad or specific than that in the recommendation, it becomes unwieldy.
I am open to sort of reconsidering that and to changing it in whatever ways you all want to, but that is where I am coming from.
MR. CHAPPELL: Dean, I appreciate your patience with me on this. I think the recommendation responds to a world view without helping to present our world view, and the opportunity that I see missed in this section, both in the text and in the recommendation, is that we don't have the promotion here of a list of CAM modalities that can, in fact, contribute to the nation's health promotion and disease prevention.
DR. ORNISH: Tom, I just want to interrupt you in the interests of time. All we are talking about is where you put it, okay. I agree with you that those should be broadened and expanded upon in the text.
The only place I think that we might disagree is how much of that should go in the recommendation itself.
MR. CHAPPELL: Then, I would like to see it more coherent in the text as something that is as euphemistic as the 10 leading health indicators juxtaposed with the 10 leading CAM modalities to deal with that. The opportunity is not being fulfilled here of our world view.
DR. ORNISH: I am not aware that you can actually come up with a CAM modality to match it for each of these indicators.
MR. CHAPPELL: I am not sure we can, but I am sure that this is not enough as a way to promote our point of view of health promotion and disease prevention.
DR. ORNISH: I am going to just end this discussion now by saying I would welcome any comments that you or anyone else has in how we can broaden the text. Since several people have seemed to feel very passionately about this, it would be really helpful to channel some of that passion into actually giving us the text, giving us the specific examples that you would like to have included in the text, and we will do that. That would be very helpful.
DR. GORDON: There are issues that people want changes in the language in the recommendations.
DR. ORNISH: Well, if you have any suggested change in the language of the recommendations, we would certainly -- I mean, if you have them now or if you have them later, we would welcome them.
Does anyone have any specific changes in the recommendation language that they would like to see other than just listing CAM modalities in there?
DR. FAIR: I will send you one because I don't see it in the text either, Dean, and we are missing a golden opportunity. Rumor has it that Ted Cooper is going to be the next Surgeon General, and if that is the case, we would have support there. I think it is a golden opportunity for this committee to take a strong stance.
DR. ORNISH: Specifically, Bill, what would you like it to say in that first recommendation?
DR. FAIR: I would like to say that education relative to proper nutrition and exercise should be incorporated in the school programs from K through 12, and I think there are enough data. I mean, I wouldn't argue with you on these things, but I think there are some data --
DR. GORDON: I would say stress management, too. I have that, too. I have that in there as very strong language.
DR. FAIR: There are data that those things work.
DR. ORNISH: Again, we are talking --
DR. GORDON: We are talking number.
DR. ORNISH: Let's talk about Recommendation No. 3, because I am a little frustrated here, because I keep saying that we are about to get to it, and I am not feeling like I am being heard.
DR. GORDON: I think, Dean, the issue is that you are not feeling like you are being heard, and they are not feeling like they are being heard, and I think it's wise to go to No. 3. I think once we get this language down in one place, the other recommendations will go easier.
DR. ORNISH: Let's talk about Recommendation No. 3. Bill.
DR. FAIR: I have this question about where appropriate, what is it appropriate, where is it not appropriate.
DR. GORDON: Bill, why don't you just make the language that you would like to have and just start with a clean slate on No. 3, what language would you like there and let's see how everybody feels about it.
DR. FAIR: Well, words to the effect that we would strongly recommend that proper dietary habits and exercise should be incorporated in the school program starting at Grade K through 12.
DR. ORNISH: I think that is a really important distinction to make when we can say things like diet, exercise, and maybe even stress management. When we talk about CAM in general, it raises a lot of fears particularly in the right wing and the different ends of the different ends of the political spectrum that you are going to be teaching my kid, you are going to be forcing my kid to be chanting in Sanskrit in public school and the devil is going to take over their brain while they are doing that.
I mean, I actually hear this a lot even from the people that we teach meditation to as adults, so people get very sensitized to what they feel like -- if you stay with diet and nutrition and exercise and maybe stress management as opposed to CAM in general, I completely agree with you.
DR. GORDON: Why don't we say that, if we agreed on that, let's make that the recommendation.
DR. FAIR: I was just thinking of even diet and exercise, I agree with you about the chanting and Sanskrit and stuff, that is a land mine, but certainly it is hard to imagine that diet and exercise would get anybody too upset.
DR. GORDON: I would say diet, exercise, and stress management, and I think stress management is accepted, chanting and Sanskrit has a mixed review.
DR. ORNISH: You can use stress management, but if you use the word "meditation," then you are hitting a land mine. If we could all agree that the Commission strongly agrees that diet, stress management, and exercise should be part of education K through 12, and an important part of the education K through 12, and in the text we can make reference to the fact that physical education programs are being cut back now, which I think is ridiculous at a time when childhood obesity is epidemic and childhood diabetes is epidemic, so I think we are all in agreement about that.
DR. GORDON: Can we have that as a recommendation and a consensus>? Joe.
DR. PIZZORNO: It is not clear how you are doing that. Could I suggest on the second line it say, "Where appropriate, CAM practices such as diet, exercise, stress relaxation" comma --
DR. ORNISH: I think if you do that, you are really opening the door to some real resistance. Instead of saying, "Where appropriate, CAM practices such as," I would just say, "Diet, exercise, stress management" -- blah-blah.
I just want to point out the land mine when you say "for example," then you are saying you are including this and other CAM modalities, then, it is a very small stretch from there for a critic to say, oh, you know, the recommendation is that --
DR. GORDON: Let me think of one way to accommodate this, if we make a very clear statement, "Diet, exercise, and stress management should be included in all school programs K through 12," and then we can make a later recommendation in the area of wellness or maybe it comes under research, "research needs to be done on the appropriate use of a variety of CAM therapies to promote wellness," something like that.
DR. ORNISH: That's good.
DR. GORDON: Bill, are you with me on this, are you beginning to understand?
DR. FAIR: Thank you. I mean, I don't view anything esoteric. I think diet and exercise, and if you want to add stress reduction, that is fine.
DR. ORNISH: Does that fully address your concern?
DR. FAIR: Yes.
DR. GORDON: I agree with you. I think it is going to be a very important item for us to talk with Ted Cooper and to talk with Congress about.
DR. ORNISH: Ken Cooper.
DR. WARREN: Are you planning on eliminating the last sentence about the media campaign? Are you going to keep the media campaign in it?
DR. ORNISH: Yes, I think that's good.
Now, can we go back to Recommendation No. 2, which we skipped? "The Commission recommends that questions on specific CAM uses be included in the national surveys that are the sources of the HP-2010 data including the National Health Interview Survey" -- blah, blah, blah.
I mean, you are right, these are kind of boring, but they are important.
DR. PIZZORNO: I would like to see one minor change, and that is, after CAM, put "provider and practice usage," so we are looking at CAM provider usage, not just CAM practice usage.
DR. JONAS: I just want to mention that not only is it boring, it is already ongoing. They are already included, these questions are already included in the National Health Interview Survey.
DR. ORNISH: So, do you want to just eliminate it? All of these surveys are? Some of them are, I don't think they all are.
DR. JONAS: The major ones, the ones that are ongoing data collection nationally that are run by CDC and National Center for Health Statistics are.
DR. ORNISH: Wayne, are you recommending that we delete the Recommendation No. 2 as being redundant?
DR. JONAS: National Health Interview Survey, National Health Nutrition Examine Survey, I am not sure about that one, but the first and the third one, they are in.
DR. ORNISH: So, what is your recommendation?
DR. JONAS: I would suggest that rather than just say we ought to collect data about this in these surveys, is that what we should do is that we should incorporate CAM practices that have been proven to be safe and effective into recommendations for how to implement Healthy People 2020.
DR. ORNISH: That sounds good.
SISTER KERR: Just a point of clarification. Is there actually a Healthy People 2020 already in process?
DR. ORNISH: I don't know.
SISTER KERR: The people from Candace or the lady -- that report that was sent to us, they talk about 2020 report.
DR. ORNISH: According to Corinne, there is.
MS. AXELROD: The Healthy People, actually there is an ongoing process, and it is a very organized process. They have working groups, consortia, so it is an ongoing thing, and they are working on HP-2020.
DR. JONAS: Yes, and that is the exact opportunity then that we have to make recommendations that complementary and alternative medicine discussion or representation or however you want to phrase it, be included in that process.
DR. ORNISH: Okay. Now, Bill, how strongly do you feel about Issue No. 3, should we go back to the way things were originally and have Issue No. 2 first, which would then make Recommendation No. 3 first? The thinking was that -- Recommendation No. 2, we did.
Is everyone familiar with Wayne's recommendation?
DR. WARREN: What is it?
DR. ORNISH: Wayne, do you want to say it again?
DR. JONAS: The Commission recommends that there be input on the role of complementary and alternative medicine in achieving health goals of Healthy People 2020. I will have to think about a smoother way of writing that, but essentially, that is the recommendation.
MS. AXELROD: I am still not clear, though, if you all want to delete the data collection part, I am not as convinced that all this data is actually being collected, but even if it is, I don't think it does us any harm to advocate that that data is included, and there may be other surveys, as well, that we might want to add.
DR. ORNISH: I would include that plus expand to what Wayne is advocating. Can we all live with that?
DR. GORDON: How is it going to read now, please?
MS. AXELROD: We will keep the first part about the data collection and then we will incorporate the data from these surveys into achieving the goals of HP-2020 or something to that effect.
DR. GROFT: I think what we will do, too, we will find out exactly what surveys are ongoing and especially NCCAM, I think would probably be the primary group that would provide some support to do the study or to put questions in. Usually, that is the way you get questions in, several hundred thousand to do it, so we will check into that.
DR. PIZZORNO: One of the needs we have is data on CAM providers. Are any of these doing things like measuring the number of naturopathic doctors, acupuncturists, chiropractors, massage therapists in the country. I mean, there is no exact numbers for these things.
Are those part of these kinds of surveys being done?
DR. ORNISH: I would defer to Wayne on that.
Do you know, Wayne?
DR. JONAS: Most of these that I have seen in these ongoing national surveys have not addressed issues of the Cam practitioners of CAM use, following kind of the David Eisenberg survey, although many of them have included have you visited non-conventional practitioners, some of them then leave the question open like that, and some of them give some examples, but very few of them give a complete list.
MS. AXELROD: I have some information on that. Actually I have given this to Joe who sent it out to the Education and Training workgroup, but I guess that group decided not to act on it, and perhaps has something that can go on Access, but there are several things like the resource file, the U.S. Health Work Force Personnel Fact Book.
I have a list of about eight different major data collection of practitioner types of information, everything from the census to stuff in HCFA, stuff in the National Center for Education Statistics, so I think many of you already have copies of this, but it might be more appropriate to have that in Access since it doesn't just apply to Wellness.
DR. ORNISH: So, getting back to the question of whether we should move the Issue 2 section back to where it was, as Issue 1, Bill would you be more comfortable if we do that? In that way, Recommendation 3 will become recommendation No. 1
DR. FAIR: What happened to the K through 12? That is eliminated?
DR. ORNISH: No. We are talking about Recommendation No 3.
DR. GORDON: Bill, what Dean is saying is that the recommendation about K through 12 would become the first recommendation in the section.
DR. ORNISH: In the last draft of this, Issue 2 was where Issue 1 is, and vice versa. Issue 1 is now where it is because it's the more general idea, and then the others have become subsets, but it doesn't have to be that way.
Since you feel as strongly as you do about Recommendation No. 3, if we move Issue No. 2 to Issue No. 1, that will make it the first recommendation. Does that make sense?
DR. FAIR: I guess I don't understand it. I thought that our best chance to make a really strong recommendation is that one about, not CAM, but diet and exercise, and maybe stress reduction is No. 1.
DR. ORNISH: Let's just switch these. Let's just switch the positions of Issue 1.
DR. ORNISH: Corinne, can you read Recommendation No. 3 as it stands, just we are all perfectly clear/
The Commission recommends that CAM become part of a national focus to improve the health behaviors of children. Where appropriate, diet, exercise, and stress management should be incorporated into educational programs from Kindergarten to 12th grade is all school programs as part of the National Guidelines on Wellness and Prevention Practice for Children, and a media campaign be conducted that includes public service and involvement of public figures to teach and encourage Health Behaviors among children.
DR. GORDON: I would just say that I think we struck out the "where appropriate."
DR. ORNISH: You might just make a second sentence, also a media campaign shall be conducted just so it is not such a long sentence.
DR. FAIR: I won't beat a tired horse, but why can't we just make the one recommendation K to 12, with diet and exercise and stress reduction. I mean, if you did something like that, that would be picked up by somebody like Jane Brody or something, and one of these give national attention to it.
I think if it's lost, then a three-sentence recommendation, never likely to miss that opportunity, but that is a personal opinion.
DR. ORNISH: We can delete the first sentence and just go into the second sentence, which will make it now the first sentence,
SISTER KERR: I kind of agree with that. I think we need to think that all the way through with these run-on sentences. In this case, this could be three short sentences.
DR. ORNISH: Why don't we just make it, I mean, we can delete the first sentence, and how would it start then?
DR. GORDON: I think the first sentence is important in tying these things in.
DR. ORNISH: Well we will have three sentences. We will have the first sentence, we will have the second sentence, about K through 12, and we will have the third sentence about media.
Can we all live with that?
SISTER KERR: The last thing I want to say about it is are we, as a group, clear that the only three things we want to say are diet, exercises and stress management.
DR. ORNISH: And energy medicine, too.
SISTER KERR: How about low fat?
DR. ORNISH: No. 4. Do you want to read it?
DR. GORDON: Do you want to read it, or do you want it ready for comments?
DR. ORNISH: Why don't you give us your comments?
DR. GORDON: I think it has to be stronger, and I would day, "The Commission recommends that, in partnership with the business community and school boards, that schools develop healthier school lunches and snacks, and eliminate the sale and advertising of high fat snacks." I wouldn't mince around with that one.
DR. ORNISH: Well, I would disagree with that, even though you might find that puzzling, given what I do, but I think that we don't want to be the food police, and I don't think that high fat snacks should be eliminated, I just think that -- I mean, kids don't necessarily have to eat such a low fat diet.
They eat way too much fat, they eat way too much sugar. They should be limited, clearly, but to eliminate them, there is kind of a fascist quality that people tend to associate --
DR. GORDON: I'm interested in eliminating the sale and advertising of any of that stuff.
DR. ORNISH: You are not saying "limit"? We are agreeing about limiting. You are talking about eliminating.
DR. GORDON: Yes, that's right.
DR. ORNISH: I don't agree with that. I am a believer in freedom of choice. I think we are going to really hit a major land mine if we talk about eliminating those. We are going to be the food police.
DR. GORDON: Actually, the Center for Science in the Public Interest has recommended it.
DR. ORNISH: I know that, I work with them.
DR. GORDON: I know. Other consumer groups, many parents groups. All I am saying is it is not as if we are completely out of the spectrum.
DR. ORNISH: The Center for Science in the Public Interest is the perfect example of someone who has been considered the food police. That is what people call them.
DR. GORDON: Understood.
DR. ORNISH: And I work closely with them, I know, but I don't think that is advisable here.
Effie.
DR. CHOW: I agree with Jim. I think we should use strong language. If they want to bring Twinkies in, that's their business, but not to have it for sale in the schools, et cetera. I bet there could be in collaboration with parent groups and with groups that we know support that.
I think we are pussyfooting around different things too much.
DR. ORNISH: We are hypocrites if we do that.
DR. CHOW: Excuse me, I haven't finished, Dean.
DR. ORNISH: Okay.
DR. CHOW: Thank you. I think we shouldn't worry about land mines all the time and that we need to put out some strong wording, and this is not like promoting, well, I don't know, Sanskrit you mentioned, but there is nothing wrong with that either.
But anyway, I go back to thinking that we are here to represent the people, not just our thoughts and not just out own experience. We have heard a lot about these, and we need to really put out our vision and be strong about a lot of these factors.
MS. AXELROD: Just a little history. The reason that we put this in this context of incentives is because we have discussed how schools derive so much money from having these in their schools that even if they, in principle, agreed with this, that they need incentives to address the issue of the funding that they get from them.
SISTER KERR: I really only want to make comments, and I have to say, we have to give thought, in my opinion, to what Dean is saying.
To me, particularly since we haven't done it anywhere else, this is such a dramatic statement given the tone of the whole report, that we are into situational ethics, we are into huge philosophical decisions and discussion here about freedom of choice.
If anything, my radical statement would be the fact that we trade a computer for a child's mind to advertise to them. So I would be into something really dramatic, like every school better rewrite its ethical codes and relook at its moral statements. So I don't think we can put those in there.
This is a big deal when we eliminate choice. I think an educational, philosophical position could be that you teach a child how to make a choice, and there is plenty of data, which is what disturbs me, that in advertising, you almost start to get into whether or not we lose the mind's ability to make a choice.
So, these are humongous, and I have the passion of feeling that Jim and Effie have about this, but I don't know if it's the right thing to do in this case.
DR. ORNISH: Again, no one is more committed to people eating healthier than I am. At the same time, I can just tell you, from 25 years of doing this how easy it is to get painted into a corner and say, "Oh, the Commission is going to take away the Girl Scout cookies, they're going to take away the bake sales, they're going to be the food police, they're going to say you can't have a cookie or you're going to die.
I'm not going to raise my son not to ever eat cookies. I mean, I don't think that is a big deal to have an occasional treat. The problem comes when that is all you eat. It is one thing if you have got heart, it is another thing if you are a little kid.
Clearly, we need to limit things. If we talk about eliminating them, I think we are really in an area that I am not comfortable, and I know a lot of other people aren't either.
DR. GORDON: Can we get some wording, having heard the differing opinions? Does somebody want to offer some wording that all of us can live with? Don, do you want to offer something? Were you offering something? Or, Tom?
MR. CHAPPELL: I just need clarification from Dean.
Would you rather not have this in there at all?
DR. ORNISH: I like the idea of limiting the sale and advertising. I was actually working with the Assistant Secretary of Agriculture to reduce the amount of fat in the school lunch programs about five years ago, and we went around and we were hearing testimony from various people saying they would go to McDonald's because the food was so much healthier than what they serving in the schools.
Look, there is a lot of room for improvement, and I would be the first to say that we need to do it. I am only saying what I consider an extreme position, of saying I don't think we should legislate that only healthy food can be served there, but I do think we need to change it, improve it, and incentivize it in a better direction. There is a lot of room for improvement.
MR. CHAPPELL: Don't you have the latitude for that, the way it is written now?
DR. ORNISH: I like the way it is written now.
DR. LOW DOG: I do, too.
DR. ORNISH: I don't have any problem with it at all.
DR. GORDON: So does that mean that you can live with this, Tom?
MR. CHAPPELL: I can live with this.
DR. ORNISH: Can you live with this?
DR. GORDON: I can live with it. I will make one final comment, however, that I don't think any food should be advertised in schools, frankly. I went to a school where they advertised any food, and it was fine. We had the school lunches. Some of it was healthy, some of it wasn't healthy.
DR. LOW DOG: You're still alive.
MR. CHAPPELL: Where do fishsticks come from?
DR. GORDON: If you wanted to buy unhealthy things, you could go off, buy unhealthy things at lunchtime. You could buy unhealthy things anytime during the day. You go off campus.
I am not saying you shouldn't have cookies. I'm not a cookie fascist. I like cookies, but schools should set an example so that you have a little bit of sweet, a little bit of fat, but you don't push the stuff. That's my problem with it, that when there are companies coming in that are making a lot of money off these kids and getting them habituated to eating this stuff, it should not be the function of the school to say it's okay.
DR. ORNISH: I think that is pretty well covered here by saying "limiting the sale and advertising of high fat snacks."
Can we all agree to that and move on?
DR. CHOW: Yes. I can live with that, too.
DR. ORNISH: Great.
DR. CHOW: But idealistically, I like the other, but I will live with it.
DR. ORNISH: I mean, clearly, we live in an imperfect world.
Would that cover your suggested changes? All right.
SISTER KERR: My last comment is, it is so painful to me, Jim. It is a painful thing, and it's complicated, and I wish we could get to a way of making recommendations that would get to some of these true dilemmas in the whole nutrition issue. It is so complicated.
DR. GORDON: Just one more try. What about limiting the sale, and eliminating the advertising? I don't know, it's just the advertising, it seems to me, there is something so pernicious about it all. But if everybody else can live with it.
DR. ORNISH: Yes, I would go with that. I would go with that.
DR. LOW DOG: I could eliminate the advertising.
DR. ORNISH: We could say "limit the sale and eliminate the advertising of high fat snacks." Yes, I could live with that.
DR. CHOW: But that's what we said in the first place, was to eliminate the sale and --
DR. ORNISH: No, no. It was "eliminate the sale and --
DR. GORDON: Eliminate both.
DR. ORNISH: I mean, even Coca-Cola or Pepsi took their soft drink machines out of schools recently because they were feeling the heat.
Can we all agree with that? All right.
No. 5. God, I thought we were just going to breeze through these. Little did I know. "The Commission recommends that CAM wellness and prevention activities be included in all federal worksite wellness in health and prevention programs, and federal health coverage plans.
How about if we say scientifically proven and effective CAM wellness and prevention activities? Is that okay? Or, just safe and effective. Safe and effective is easier to say. Is that okay with everybody?
DR. WARREN: Read it again.
DR. ORNISH: It would say, "The Commission recommends that safe and effective CAM wellness and prevention activities," blah-blah-blah.
DR. GORDON: Dean, let's think through a little bit. Say what you are thinking of when you say that.
DR. ORNISH: Well, it is deliberately vague so that we don't have to get into specifics, but it protects the Commission from any charge that we are saying that everybody should sit under a pyramid and do crystals and have oral chelation in all federal worksite wellness and health promotion programs, that's all.
When mandating something in federal agencies, you have to be careful. Is that okay?
DR. GORDON: Everyone? Do we have consensus on that?
[No response.]
DR. GORDON: Okay, good.
DR. ORNISH: No, wait. Do you have a comment? Turn your mic on.
DR. BERNIER: With the term "federal worksite wellness and health promotion programs," is that going to be interpreted as endorsing anything in particular?
DR. ORNISH: Hopefully not. That's why it is so vague.
DR. GORDON: I think the modifier is the "safe and effective."
DR. ORNISH: Yes, endorsing anything that is safe and effective. Then again, you marginalize people. You say, well, why wouldn't you want things that are safe and effective on the worksite, unless it is because of an economic issue. We could even say "safe, effective, and cost effective," but that may be going too far.
No. 6, "The Commission recommends that in consultation with the business community, incentives be developed for employers to include CAM wellness and prevention in worksite wellness programs and health coverage and decrease premiums."
I think I would put "safe and effective CAM wellness and prevention."
DR. FAIR: What does "in consultation with the business community"? To me, that means you go in and you say, "We would like to do this program," and the business leader would say, "How much," and that would be the end of the conversation. Why don't we just eliminate "in consultation."
DR. ORNISH: Well, you can't force them to. You can't mandate that --
DR. FAIR: We're just making a recommendation. We're not saying we're forcing it, we're just making a recommendation.
DR. ORNISH: Well, it just has a tone of inclusivity, as opposed to Big Brother.
DR. GORDON: Are there other thoughts about this one?
DR. LOW DOG: I think it is important --
DR. ORNISH: Hang on, Tieraona.
Are you comfortable with that?
DR. FAIR: I just realized how much more mellow you have gotten than I have over the years, with the food police and the consultation with business community.
DR. ORNISH: Are you saying I have sold out. Those are fighting words.
DR. FAIR: No, I don't think you have sold out. I just think that if we are going to attract any attention, that we have to be stronger in what we come up with.
DR. ORNISH: So, what would you like this to say?
DR. FAIR: I would just cut out "in consultation with the business community." Because we are recommending that. That doesn't mean they have to do it.
DR. ORNISH: Okay, Tieraona.
DR. LOW DOG: I just think that it's important to build bridges, and not all of these businesses are GMs or Fords. Some of them have three and four employees. I think that you have to do it in consultation with the people that you're trying to bring on board.
DR. ORNISH: Yes. We can learn from them.
DR. LOW DOG: They may have better ideas. They may have good ideas for what would work that somebody might not think about, or there may be limits or obstacles. I don't know how you could make the recommendation without being in consultation with them.
DR. FAIR: [Inaudible] -- talk to them.
DR. ORNISH: Well, if you talk to them, then that is what it means. Is the word "consultation" the problem? Have a discussion, would that be better?
DR. TIEN: I think "discussion" is better. I feel comfortable.
DR. ORNISH: Okay. Bill, would you be more comfortable?
DR. FAIR: Yes, I agree.
DR. ORNISH: Because "consultation" to you has an approval quality, that we would have to get their approval for it?
DR. FAIR: Well, you would have to get the approval anyhow.
DR. ORNISH: Well, that's the point.
DR. FAIR: I think that one could have incentives for the employers, in pointing out to them the advantage in wellness and prevention programs. I could live with -- what was the other term, "discussion"?
DR. ORNISH: Discussion.
DR. FAIR: Live with "discussion," I guess.
DR. ORNISH: Bill, let me just take one minute just to explain to you, it's not that I have gone soft. I used to be much more of a zealot, and I learned that it really turned more people off than it helped, because even more than being healthy, people want to feel free and that they're choosing and they're in control. As soon as I tell somebody, don't do this, and don't eat that, and don't smoke this, and do this, and do that, they immediately want to do the opposite. It's just human nature. It goes back to, don't eat the apple, and that didn't work very well either, and that was God talking.
So I have just learned to try to give people the information, give them the support, and make sure they feel free to chose, and paradoxically they are much more likely to make and maintain these choices than if they feel they are doing it because someone is pushing them to do it.
DR. LOW DOG: Isn't that partly what we said part of the motivation for people using complementary and alternative medicine was, they wanted to feel empowered, they wanted to make their own choices, they wanted to be in control, and here we are trying to take it away.
DR. ORNISH: Precisely. Exactly. It's not that I feel any less passionately about these things, it's just I have learned to be more skillful about them than I used to be.
DR. FAIR: Well, it's not taking away. We have a number of small businesses in our center in Soho, and we were approached by small companies, six or eight people, and when it got to talking with the management, they said, no, we can't afford that.
So that is all I was saying. I mean, it wasn't the employees that were opposed to it, it was the employers.
DR. ORNISH: So you can't force them, though.
DR. FAIR: You can't force them into it, that's right.
DR. ORNISH: All right, No. 7. Thank you for your comments, everyone.
"The Commission recommends that the Secretary at DHHS establish a task force to develop strategies to incorporate CAM wellness and prevention activities in federal programs such as," blah-blah-blah.
Any comments?
DR. GORDON: Dean, can you just lay out the reasoning. In both of these are task force recommendations. Why are you recommending a task force rather than specific implementation now, and what are the pros and cons? What did you weigh when you made that decision?
DR. ORNISH: Well, because we don't have specific recommendations. I mean, these all have their own individual needs. Meals on Wheels provides meals to elderly people or disadvantaged people. They may need more fat diet if they are malnourished.
There is such a spectrum of needs here, that it is hard to make recommendations that apply equally to each of them. So that's where that came from.
DR. GORDON: A second question related to both of these, just for simplification, is it possible that the same task force could address both of these areas, the ones in No. 7 and No. 8?
DR. ORNISH: Well, they could, they're just that much more diverse. I mean, what tied together Recommendation No. 7 is it has to do with families, mothers, children, infants, as opposed to veterans and things like that. One is more facilities-based, and the other is more --
DR. LOW DOG: Right, but we do have maternal and child health programs and school health programs under No. 8.
DR. ORNISH: That's true. It could be combined. It's just going to make a longer list.
DR. GROFT: Actually, Dean, as you prepare a workshop and design one, you could think of various ways to do this, that you have a number of breakout sessions for each of the groups, and then bring the group back in for a general session. We do it all the time. It could be done.
DR. GORDON: I think it would be important to get an energy behind this recommendation in the text, conveying the sense that this a wonderful opportunity to really take a look.
I think the other thing that needs to be incorporated is what you have down below, is the recommendation for demonstration projects. I am wondering, are you planning to incorporate that in both?
DR. ORNISH: Well, I thought that it would come out of the task force, that would be one of the options. The task force might recommend to do a demonstration, or they might recommend that there is enough evidence already to implement. I think it is going to vary. Some things there is more evidence for than others, and some they need to gather more data.
DR. GORDON: Let me just finish the one thought. My suggestion would be that you include both of those thoughts, at least in the text so that we have a sense of what the job of the task force would be.
DR. ORNISH: Okay. Thank you.
DR. CHOW: I have a question. Could these activities of the task force be through the Center for Complementary and Alternative Medicine? No? It has to be through the Secretary of DHHS?
DR. GORDON: Do you want to address that?
DR. GROFT: The National Center is so research-focused that these activities are pretty much --
DR. CHOW: I'm talking about the center that we are recommending.
DR. GROFT: That's not a center. It would be an office of some type.
DR. CHOW: Yes, the office of something.
DR. GROFT: Yes, you could extend that to be the sponsoring organization. It could be the surgeon-general, it could be the Secretary, it could be a White Commission, a presidential task force to look at these things.
DR. CHOW: The point of my question was, can it be stated that it could be function of the -- what are we calling it?
DR. WARREN: CAM Central.
DR. CHOW: CAM Center, that's what I said.
DR. GROFT: I think that was the idea behind giving it to the Secretary of DHHS, that we didn't want to lose it. We want someone to do it, and we did not want to wait until there was an office, if there is an office. I think that was the idea behind making it a Secretary of DHHS activity.
But I would hope that if there is an office, that they would be involved in something like this.
DR. WARREN: Our Potential Responsibility to CAM handout you all got, this is covered on page 7 of that. This is covered on page 7 of the Potential Responsibilities and Activities of the CAM Office. I had it listed when I read this on CAM Central, and then we got this from Joe today.
I like the aspect of putting it in with the possibility of the Secretary of DHHS because if, for some reason, CAM Central doesn't get funded, or doesn't get created, then at least we still have the door open there.
DR. ORNISH: Charlotte, you had a comment?
SISTER KERR: Two comments. The first is, I think Access and Delivery folks did some good things when they put some timetables in their recommendations. The question would be whether or not it is appropriate or desirable to suggest that DHHS establish a task force, for example, and offer a certain amount of time. So that either can be discussed or dropped. Maybe no one else thinks that is important.
My second thing is, and this was discussed when the Wellness met by telephone, I was at least the one person I know of who felt that we should have a specific recommendation for a demo project. I suggested the VA system. I said that I felt it was a system that is contained. Number one, the people deserve it who are veterans, and we have some good data from people who have presented of what is going to happen in this system. This country is in for a big shock in terms of cost.
I thought something was going to be written up as a demo project or a pilot project.
DR. ORNISH: It may very well be that the VA is a good place to do it, but I think if we are going to say that there should be a task force to sort this out, it would be undercutting them to then mandate that this is what they do. So I think we should either mandate it or have a task force, but not do both.
DR. GORDON: What I don't see here is the armed services, and I think that this is a really important area that we need to be addressing, the wellness programs for the armed services, DOD.
DR. ORNISH: Yes, we should add that. That's a good point. Thank you.
DR. JONAS: I was going to actually mention that, that the DOD has major emphasis on health promotion and wellness. They have programs that look at this, specifically, and would do it on their own if we recommended it.
The other thing, too, I was going to suggest is that, at the recent Georgetown Policy Conference, there were a number of working groups, and I was on the Public Health Working Group. They actually developed a number, I think, of good suggestions for the facilitating, looking at CAM and its relationship to public health issues, including things like 2010 and that type of thing. It might be worthwhile looking over that report to see if there is language, either for background or recommendation materials that might be more specific, focused, and useful, perhaps. So that was just a suggestion.
That may be true for some of the other things in that meeting also, because they were looking at policy issues. It might be worthwhile just to look it over and say, are there things that are missed; what was the emphasis, that type of thing, for this report. I think a lot of what they did very much paralleled what we are already doing here.
SISTER KERR: I just want to follow up. I guess I felt pretty strongly about my recommendation, and at that point, I don't guess I remember, or I missed, the idea of the task force. All of us, I think, fluctuate at times about how specific we want to be or visionary, and Bill's statement, and I want to get that in there.
I guess I don't want to wait on the task force. We have got so much data. We are going bankrupt. We have got a lot of people who deserve some healing and kindness and help, more than, I'm sure, they are already getting. Why can't we make a recommendation?
DR. GORDON: I think we can. If you would like to make a recommendation, we actually have some minutes. So do you want to take a few minutes while we go, and then make a recommendation for demonstration projects?
DR. ORNISH: I mean, the easiest way to do it would just be to say that the Commission recommends that the Secretary of DHHS develop strategies to incorporate safe and effective CAM in wellness, prevention in health care and delivery programs such as, blah-blah-blah.
Is that what you have in mind? Or, do you want to take even "such as," and just say "at the Department of VA, community and migrant health centers"? Is that what you want to say?
So instead of "in health care delivery programs, such as the Department of the VA," et cetera, you would just say "in health care delivery programs, including." In other words, that it would be a mandate.
SISTER KERR: The reason this got left, as I understood, on the phone discussion, was, I don't know enough about research. For example, if I want to help the veterans and I know what the system is going through, but I don't know enough, for example, on a project, we would have to pick a particular a problem, a particular kind of disability.
DR. GORDON: I think all you have to do is name the population or the place, and that is to say that there should be a demonstration project incorporating safe and effective CAM wellness programs. I would say large-scale demonstration -- I'm sort of riffing on what you are saying -- for both veterans and in the Department of Defense. I mean, those are very obvious places. They are very needed.
The Defense Department has actually been having wellness programs, including CAM therapies, for 20 years. I worked in one of them, helped out with one at Walter Reed 20 years ago. It's a great place to do it, and it could be very high visibility, and it's real important.
DR. ORNISH: The Department of Defense funded us to train the Walter Reed Army Medical Center here. We can actually order people to meditate now, which is great. Give me 15 minutes of meditation now. Sir, yes, sir.
MS. AXELROD: Can I just add some clarification about the reason that we put in a task force? There certainly are other options, but we wanted to specify somebody to be responsible for this to occur, and that is why we put the Secretary of DHHS. However, many of these programs are not in HHS.
DOD, the VA hospitals, Meals on Wheels, several of these others, by establishing a task force, the Secretary can actually bring people from other departments together, because it is either that, or we specify the Secretary of DOD, or go through the litany of all of them.
So that was one of the reasons. The other reason, of course, is just to bring people to the table, to build support, and to share strategies because many of them are already doing some of this. DOD can tell the VA what they are doing, and vice versa. So that is the reasoning behind that.
SISTER KERR: All this is good, even Dean, when he gave his little recommendation how it could be written, and then Jim amplified on it.
I guess what is in my mind so much, and what Corinne just said, and you could write it with that in mind, is, I think a lot of what Dannion actually has presented. He gave us a lot of good data, if it's all accurate. I think if it is being done, it certainly hasn't been focused enough to touch on to that. I only know what I have had testified to.
So it is still a statement of, you could have the task force, and we could also just say we feel that one possible recommendation that we feel strongly about is this one. And if the group doesn't agree, it's okay. Well, I don't know if it's okay or not, but we can discuss it.
DR. GORDON: It is entirely possible to recommend the task force and recommend demonstrations. One does not preclude the other. Do you want to put it into words, or do you want to take what we --
SISTER KERR: I think a basic statement like Dean said, and amplify it with whatever the other areas, sounds like it is okay to me.
DR. CHOW: I have -- for Charlotte's recommendation, too, because I agreed with her when she made that recommendation. I have worked with the Armed Forces about 15 years ago with Chinese medicine and qi gong. Also, the VA, I have worked with them.
If you got research or a study through the VA, it can go right through the whole system. It is a monolithic system. That is really great. So perhaps we could put a time frame, again, that we would like to have it done within such a time.
No? No time frame? Well, there was a discussion of time frame in the previous one.
SISTER KERR: Thank you for that comment. Let's try writing what we heard, to start with. Dean, can you repeat your statement?
DR. ORNISH: Well, I will say I am actually very happy with it the way it reads right now, but if you are trying to make it stronger, you would just simply take out the words "establish a task force to develop strategies" --
SISTER KERR: No, excuse me. I was leaving 7 and 8 alone, and adding another one that would just be a separate statement for a recommendation to do a demo project within the VA system or Armed Forces, or whatever, to include, as you said, safe and effective CAM practices.
DR. ORNISH: What question are you trying to answer?
SISTER KERR: I am trying to make a recommendation.
DR. ORNISH: No, no, no. If you are doing a demonstration project, you are trying to demonstrate something. What are you trying to demonstrate?
SISTER KERR: That safe and effective CAM practices -- that is why I was saying I didn't know, would help what within that population.
DR. ORNISH: Well, that's the whole point.
SISTER KERR: Well, that's where I started way back.
DR. ORNISH: You have to have a hypothesis to test.
SISTER KERR: Well, I am being told I don't.
DR. ORNISH: Pardon me?
DR. JONAS: The particular item in the demonstration project would be determined by the VA, and the particular modalities and conditions that they need to look at. So I don't think that would go in a recommendation.
DR. ORNISH: Well, that is why we have a task force, because if you are not going to make a specific recommendation for a specific demonstration, then you have to delegate it to someone else to do that.
DR. JONAS: I understand, but I think what Charlotte is saying is that the task force is fine. That is a great recommendation, but she would like an additional recommendation that is more focused on a demonstration project, rather than a general suggestion for a task force to look at strategies, which could be anything from sunrise to sunset.
DR. ORNISH: Okay. So how about if you say that at the end of paragraph 8, add a sentence that says something to the effect that this task force should design a demonstration project?
DR. GORDON: I think she is saying that there is a separate track, there is the task force track and there is another track for demonstration projects.
DR. ORNISH: I get that, but the point is that you have to either say what the demonstration project is, or you have to say who is going to design it. So who better to design it then the task force that is spending time looking at all this stuff. I mean, you could ask the Secretary of DHHS to design it, but they're not going to.
DR. JONAS: The VA would design it.
DR. ORNISH: The head of the VA is certainly not going to design it. They could, but they won't.
DR. JONAS: If we recommended it to the VA, the VA would delegate somebody.
DR. CHOW: They would delegate, yes.
DR. ORNISH: Again, what are you trying to do? I mean, demonstration projects are nice, but what are you trying to demonstrate?
DR. JONAS: Well, a wellness intervention, a CAM and wellness intervention. I mean, it depends on what you want.
DR. CHOW: For example, where they have reached a plateau with their people, and having worked with them, a lot of them have reached a plateau that can go further if they included CAM.
DR. ORNISH: A plateau in what?
DR. CHOW: Mobility.
DR. GORDON: Be specific in terms of research design.
DR. CHOW: They can decide what that is, what is their pressing point, what haven't they gotten the best --
DR. ORNISH: But we have to say something. If we are going to recommend a demonstration project, we have to give some indication of what question we are trying to answer.
DR. LOW DOG: I think I would like to support the demonstration project. It has to be demonstrating something. We have to have a question that you are going to develop a demonstration project around.
DR. ORNISH: I mean, this is a little bit backwards. Normally, you have a question and you say, let's design a demonstration project, not, oh, we would like a demonstration project, what question can we come up with.
DR. JONAS: Okay, we have decided over here. We want it on quality of life and quality of dying.
DR. GORDON: A demonstration project of safe and effective CAM practices, enhances sense of well being, locus of control, and decreases stress in members of the Armed Forces, and then the population that uses the VA hospitals; two demonstration projects, something like that. I think if we can leave it general.
SISTER KERR: Quality of life and quality of dying.
DR. ORNISH: One at a time. I'm sorry.
SISTER KERR: Quality of life and quality of dying.
DR. ORNISH: Well, I'm not saying that we need to suggest a demonstration, I'm just saying that we either need to suggest one, or we need to delegate to someone else to suggest it, that's all.
SISTER KERR: You are saying that you think it should go to the task force who would be the people to create the demonstration project, and we are saying that perhaps there is another alternative, and that we may want to make a separate recommendation that would go through the VA, and that we wish that they would apply the safe and effective complementary medicine practices to issues such as quality of life, quality of dying, and Jim said something else. So this is what we are debating right now.
DR. LOW DOG: My only comment would be, if we are going to make a recommendation for a demonstration project, that we are very clear and thoughtful what we are asking that to do.
DR. ORNISH: Exactly.
DR. LOW DOG: Because the task force may be able to do a better job of coming up and identifying, working with the VA, asking them for their input and looking at their statistics of how it would be most beneficial to them.
DR. ORNISH: That is the point I was trying to make. Thank you. That was the point I was trying to do, but I didn't do it as eloquently. What if we just put a sentence at the end of paragraph 8, that we encourage demonstration projects to be conducted in this area? Do you want to just leave it like that? And we don't have to say who is going to be --
DR. CHOW: But I think not everything must go through the task force.
DR. ORNISH: I didn't say that.
DR. CHOW: Well, when it is in this recommendation, it does. It goes through the task force. The thing is, if we recommend a demonstration project, they might decide to set up a task force to do that, or the director himself might say, "Hey, that's a great idea. Okay, I'm assigning somebody to do this," and they can do the survey as well. They have staff that could do this.
DR. ORNISH: Why don't we have a separate recommendation for No. 9, that says something to the effect, we encourage one or more demonstration projects to be conducted to evaluate the safety and efficacy of CAM wellness and prevention activities in these various things that you have got listed here.
Would you all be okay with that?
DR. CHOW: No, it is not to evaluate the safety and efficacy.
DR. ORNISH: Then what is it?
DR. CHOW: It is using safe and, whatever the --
DR. ORNISH: Well, if you already know it is effective, then you don't need to do a demonstration project.
MR. CHAPPELL: No, it is to evaluate the benefit on the vulnerable populations.
DR. CHOW: The impact, that is the word, of the use, of the safety and efficacy, to see whether it increases their level of wellness, and quality of life, and mobility, and depression, and all of that.
MR. CHAPPELL: I mean, the study is as much to find out just how far-reaching the benefits are itself. So I do think a separate recommendation is appropriate, Dean, if you can craft it.
DR. ORNISH: So, would all be able to live with a separate recommendation that says, "The Commission recommends that funding be provided to conduct demonstration projects to evaluate the safety and efficacy of CAM wellness and prevention activities in the Department of Veterans Affairs, community migrant health centers, maternal and child health programs, school health programs, and the Department of Defense"?
MR. CHAPPELL: No.
DR. GORDON: No. I don't think people are being that broad. I think that that may dilute it. I think that we are saying there are two places, clearly, where there has been interest in this work for many years: Veterans Affairs; Department of Defense. I think if we focus on those two, people will find a very receptive audience. If we focus on some of the other centers, they are going to say, what is this all about. That is where the task force is really important, to help focus activities.
MS. AXELROD: Can I read a revised recommendation to see if this will work for everybody? "The Commission recommends that funding be provided for one or more demonstration projects to utilize safe and effective CAM practices in federally funded wellness and health promotion programs."
MR. CHAPPELL: If I am understanding, what we are trying to do is measure the impact of safe and effective CAM practices, so I would insert the words "impact of."
DR. GORDON: I would like to remind us we have nine minutes. So can we agree on a wording, and then see if we have a consensus, and then move on to the final recommendation?
DR. ORNISH: I can agree with what Corinne just said? Do I have a second?
SISTER KERR: No. I would like to say, "The Commission recommends that funding be provided for one or more -- this is what Corinne is saying -- demonstration projects to evaluate the impact of safe and effective CAM practices within the VA and DOD population."
DR. ORNISH: We can live with that, I think.
SISTER KERR: You got that, Corinne?
DR. ORNISH: Is that okay?
MS. AXELROD: Yes, but I just want to question that you are specifying the VA and the DOD, where other people would strongly advocate that it be at a community migrant health center, or it might be some other program. I am just wondering if you all want to specify that, or add others, or how you want to address that.
SISTER KERR: I think the group does have to decide that. I specifically had some insight in the sense of helping the VA folks. Other folks have been talking Department of Defense. So I can't speak to that one.
DR. ORNISH: I think I would say, after hearing all this, while my initial reaction would be to include all of these other things, in these times that we are living in, that there might be something to be said for including the DOD and VA by name, to the degree we want to try to make this more palatable and less whimpy, because a lot of people think CAM equals whimp. So if we can get the DOD and VA in there, then suddenly we have the macho factor alongside it. So I would say, God bless this recommendation, and God bless America.
We have to finish No. 9. Oh, Charlotte, would you read yours again?
DR. GORDON: Let me just check. Are we okay with this recommendation? We have consensus?
[No response.]
DR. GORDON: Okay, great.
DR. ORNISH: So, Charlotte, would you read it again so Corinne can copy it down.
SISTER KERR: Corinne had started, "The Commission recommends that funding be provided," and she suggested "one or more demonstration projects to evaluate the impact." Is that correct?
MR. CHAPPELL: That's right.
SISTER KERR: "Of safe and effective CAM practices in the VA and DOD population." I would like to acknowledge the comments I have received through the ethers in writing this.
DR. ORNISH: Recommendation No. 9, our last one. We have got a few minutes left. "The Commission recommends that the Secretary of DHHS establish a task force to develop strategies to incorporate CAM wellness and prevention activities in the nation's hospitals and long-term care facilities, and programs serving the aging and dying, and those with chronic illnesses."
Is that too redundant with what we have got already? Can that be combined with one of the earlier recommendations?
MS. AXELROD: One is federal, one is not.
DR. ORNISH: One is federal, one is not. Okay.
Comments?
DR. BERNIER: You might well want to have people who work in the various wellness and prevention activities to be part of that population that is being studied. That would be a way of getting an additional people involved.
DR. ORNISH: Well, we are not talking about doing a demonstration or study here. We are talking about actually incorporating safe and effective CAM wellness and prevention activities.
DR. BERNIER: You say in the long-term facilities, et cetera. I was wondering about just involving the group of people who are there, the self-care providers. That is just a thought.
DR. ORNISH: I think it is a very good thought. I am just debating whether it goes here or in the text, that's all. But it is a very good thought.
If you all don't mind, we could add safe and effective.
MS. AXELROD: It is already in the text. If you look at 3.13 through 3.19.
DR. ORNISH: Page 12, line 3.13 to 3.19. Other comments or questions, or concerns, or thoughts, or feelings?
DR. GORDON: I just wanted to circle back to one note I had on the text, which is around 306: "Should be easily integrated into clinical management." We need some sense of what that means, the integration of these practices, and also the expansion. That is just a sidebar here.
DR. ORNISH: Okay, thanks. Anything else? Whoops, we are out of time.
DR. GORDON: Where are we, Dean?
DR. ORNISH: I think we are done.
DR. GORDON: Where are we with No. 9? Okay?
DR. ORNISH: We were going to add "safe and effective," but I think other than that, we're okay. Then we never resolved the issue about putting Issue 1 and 2, flipping them back the way they were before.
Bill is not here, is he? Is he coming back? Any other thoughts about that particular issue, Issue 1 and Issue 2.
DR. GORDON: Julia wanted to say something.
MS. SCOTT: I remember we had a long discussion about this on the telephone.
DR. ORNISH: Right.
MS. SCOTT: The reason why we decided to switch 2 with 1, and it was to go from the macro to the micro. Our first recommendation, we wanted to address the nation. So Recommendations 1 and 2 were focused on the nation, and then we subdivided to the subpopulations.
DR. ORNISH: Right. We went from the general to being specific.
MS. SCOTT: In terms of importance, we picked children as the first important population. So that is why it ended up as 2, not to diminish the recommendation, but to have more order with this section. So that, we talked about national objectives for every citizen, and then we talked about the subpopulations, with children being the top priority of the other subpopulations.
DR. ORNISH: Yes. That is exactly right.
MS. SCOTT: It made sense to me then, and it still makes sense to me now. I think switching it now kind of throws the whole thing off kilter. I say that, understanding that the whole order of the report, and outline of the report, is still up for discussion. But I think that was our sense when we were talking on the phone on why we ordered it in this way.
DR. ORNISH: Well, you're right, that is why we did it, and it certainly makes more sense from a structural standpoint.
But, Bill, given how strongly you feel about it, I want to make sure that you feel regarded. If you feel like you would rather have this moved up, I mean, I would rather sacrifice the structure for the content.
DR. FAIR: I think nothing in this book is more important to me than that, to be honest with you. I think that is the future of our nation. When I look at the problems down the road from obesity and lack of exercise, it is astonishing what that will do to our national health care bill in 20 years. My approach has always been the best defense is a good offense, and go with the thing that is most important to you first.
DR. ORNISH: Okay. Well, in deference to you, I would recommend that we just do that.
DR. FAIR: Thank you.
DR. ORNISH: I think we should each get one thing that we can say, that's really important to me.
DR. GORDON: We have differing perspectives. Do we have a consensus on this? Should we try it?
Julia, you had another voice. Should we try it the other way, with children first?
MS. SCOTT: I am perfectly open to trying anything. I just thought I would remind everybody we did spend a lot of time on this, and that was our rationale. It is open to discussion.
DR. GORDON: I think maybe some of this can be addressed in the text. The text can move from this macro level, and then come down on the side of children, and then move back out again to the healthy behaviors.
DR. ORNISH: Well, I would actually take it a step further. I completely agree, Julia, that that is why we did it, but given how strongly Bill feels about it, out of deference to Bill, I would say, let's just make that the first, and that way, the first recommendation will be the one that he care the most about.
DR. FAIR: Well, thank you. I appreciate it. To me, the whole field is so depressing, to see the children, particularly young women, who are taking up smoking now in a big time way. We are just now getting the message across.
DR. GORDON: Great. Dean, thank you very much for your heroic efforts this afternoon.
DR. ORNISH: Thank you all.
Session IV Summary
DR. GORDON: Thank you everybody. We have come through on time. We have done our work. We have consensus. We added a recommendation for demonstration projects. We reversed the order of Issues 1 and 2, and we made several small changes in wording, and we discussed the issue of consolidating task forces. That is where we are.
Steve, do you want to conclude?
DR. GROFT: George DeVries has sent us a number of comments on reimbursement and coverage, and other issues that he would like us to look at in his absence. So we gave you those this afternoon.
Tomorrow, during the Coverage and Reimbursement discussion, Maureen will lead the discussion, but George will be piped in through our sound system. So he will be here in voice to help guide us as well. He has done an awful lot of work up to this point for this section.
I have one other piece of information to hand out. It is something Dr. Singh had asked that we distribute regarding Ayurveda medicine, and our plans are to meet with him and discuss his concerns outside of this meeting. Several of the local commission members will travel down to the Indian Embassy to discuss with him the concerns about Ayurveda here in the United States.
DR. GORDON: Once again, thank you all. This is a great day. We really did a lot of work.
[Applause.]
DR. GORDON: We will be back at 8:00 tomorrow morning.
[Whereupon, at 5:00 p.m., the meeting was recessed to reconvene the following day, Friday, December 7, 2001, at 8:00 a.m.]
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CERTIFICATION
This is to certify that the attached proceedings
BEFORE: White House Commission on Complementary
and Alternative Medicine
HELD: December 6-7, 2001
were held as herein appears and that this is the official
transcript thereof for the file of the Department or
Commission.
DEBORAH TALLMAN, Court Reporter
Meeting Home
Participants
Thursday, December 6th, 2001
Contents
Morning Session
Afternoon Session
Friday, December 7th, 2001
Contents
Morning Session
Afternoon Session