Other comments or questions? Tieraona.

DR. LOW DOG: I think I am somewhat with David there. Do we have to, in this Interim Report, say things like we think that the double-blind, randomized, controlled trial is the gold standard? I think Katchuk's [ph] recent article was kind of interesting, gold standard or golden calf.

I think Tom, when he pointed out sort of at the beginning about high standards of design and execution, I think he sort of hit it that we need to come up with the highest standard of design that is applicable for each modality or specific thing we are trying to study, and at some point I thought we had talked about recommending bringing together some of the best minds to start to look at other ways that other designs of research could be applied to things like acupuncture or massage, and I think it is important to remember that other modalities, such as psychology, have been dealing with this for almost 50 years.

Double-blinded RCTs don't work in that discipline either, and so it is not unique to CAM, but I would still like to throw back to the group when we had talked about one of our recommendations being that there is some sort of consensus group or think tank that comes together to try to come up with some designs, I thought that was a good recommendation.

DR. GORDON: I just want to make one process point. These discussions up until tomorrow afternoon are not about the Interim Report. These discussions are really to give us the whole scope that we will be looking at as we develop the Final Report.

So, don't worry about settling the questions now or settling them for the Interim Report. This is really laying out the whole territory.

DR. ORNISH: I have to say I am really confused because I thought this was exactly about the Interim Report.

DR. GORDON: No. That is what we need to clarify.

DR. ORNISH: I mean we have got a copy of the Interim Report, and we are asked to discuss the Interim Report.

DR. GORDON: Let me try to clarify and then Steve can add, too. We had discussions about how to structure the meeting, and one of our concerns was if we did it the way we did it, that exactly the misunderstanding that would happen might happen.

The idea of this meeting, the major part of this meeting is to give us the vision based on everything we have heard over the last 10 months and everything that we have discussed as a commission, both in small groups and in the large groups, to give us the vision of where we are headed looking toward March 2002.

All of the discussions for the next day and a half are about where we are headed. The Interim Report is a moment in time, that we have created a draft of that moment in time, and that moment in time is meant to say where we are right now. That is, what do we know for sure, some of what we know for sure right now, where we do have a consensus, but without all the details filled in, and some of where we are headed.

So, if you look at the Interim Report, it gives a feeling for where we are and a feeling for where we are headed, and there are perhaps half a dozen or maybe 10 recommendations contained within that.

What we are asking everybody to do now is to step back and look at the long term, look at everything that we have learned and where we are going as a whole commission as of March 2002, and if these discussions then modify the Interim Report, which we will talk about at the end, so be it, then, we will use that information, but don't be thinking in these discussions of coming up with recommendations for the Interim Report, think more of what is the territory that we are going to be looking at in the Final Report.

That is the basic idea. So, it is much broader than the Interim Report, and that is why we want to surface, not only issues in which we have consensus, but also issues where there is not consensus in these discussions, and, in fact, in some ways the issues where there is not consensus are even more important than the ones where there is consensus in these discussions, because those are the areas that we want to be exploring over the next months.

DR. ORNISH: Let me just say in response to what Jim said, that I think that is very helpful. What I would like to propose for your consideration is that, at least with the time I am doing, is to try to highlight where we do have consensus and where we don't. I think that can be very useful, but also to see if we can find ways of -- I think Tieraona's language was really great.

You know we could argue about whether everything should be a randomized, controlled trial or not, whether you can measure certain things like energy or not, and get really bogged down in that, but when you come up with a sentence like we want to come up with research using the highest standard of design appropriate for the modality study, which is what you were just saying, I think we could all agree on that.

It conveys the intent without getting bogged down in the details that might create controversy where we could have consensus, and allows everyone who reads it to project onto there what that means to them.

I think that is really brilliant, I mean what you said, so would that be a good way of going about this? Tieraona, you wanted to say something.

DR. LOW DOG: No, I am done.

DR. ORNISH: Are you sure?

DR. LOW DOG: Yes.

DR. ORNISH: Wayne.

DR. JONAS: Now, I am very confused because I read the materials we got ahead of time including two versions apparently of the Interim Report, which maybe I am just confused about; one, the draft Interim Report here and then things that were in the briefing book which were different than that, although complementary.

Now, I have this thing for discussion parts and I have no idea where this fits in, and I think we need more discussion about what we are going to focus on here in this meeting. I will give you my bias. My bias is not to be broad and general. I think we have been doing that for the last year.

We have some language here that is very useful, it is concrete, there is terms in there. There is things that are going to move this forward in terms of eventually putting them in the report, and I would like to see us discuss that.

DR. ORNISH: Thank you.

Tom.

MR. CHAPPELL: I think we can do both. I think we can use the draft as a point of departure, it's a work in progress, and we can keep where we are headed in mind by building on the document. So, I feel, I mean for myself, it just seems logical that we comment on where we find the draft at the present time and build upon it for clarity or creativity, because we are still looking for solutions. So, that is how I interpret what we need to do.

DR. GROFT: I think what we want to do here is give you the opportunity to look at all of the recommendations that the Commission has received at this point and then at the conclusion of the day and a half session, then, to get some agreement on the Interim Report.

DR. ORNISH: I don't see these goals as mutually exclusive by any means. We can talk about these goals as they relate to the Interim Report, but at the same time, try to find language that we can use to build consensus or, if not, then, we can outline things we need to have for further discussion. So, that is how I would like to use this time.

Michele.

MS. CHANG: Just to clarify in response to what Wayne said, the two drafts of the Interim Report that you have are actually identical. One is formatted differently, so that you can use it more easily in the discussions tomorrow.

I would guess that you would want to try to use the one that is in your briefing book that we have gave you this morning, because it is numbered by lines, you can refer to line 14, you know, whatever, it will be easier for everyone to follow since you have the same draft. Regretfully, we didn't give that to you early enough for you to have only the one copy, but that is really the only difference between the two drafts.

The second thing is that every discussion session has a set of worksheets that are identical to this overhead that we are providing for the public. They are just for you to follow along, the major discussion topics that we are hoping that you will cover during the hour that you have per topic, and that is what those are for.

DR. ORNISH: I would like to move along just so we can actually focus on these issues.

Yes, Joe.

DR. FINS: I want to just say that I don't think the two objectives are mutually exclusive, and I think those should have kind of an eye towards the end of the two-day process of the Interim Report.

Getting back to your charge, Dean, about research, if you would like to do that, I think we should say in addition to the statement about the methodology which Tieraona said so well, but I think we want to talk about the need for basic science research and translating from the bedside back to the bench and understanding the biological foundations of something that might be very promising.

The other is in the health services research, that is, integration of these modalities into a traditional system and studying the sociology and methodology by which successful programs have integrative care plans, because I think that is a different kind of research, so I wouldn't want that to get lost in the shuffle.

DR. ORNISH: No, I agree with both of those, and that is something that we have been talking about also that Gerri actually gave me a whole handout on health services research and talking about the Institute of Medicine, the Agency for Health Research and Quality, and other governmental agencies that are involved in that, because those are key allies that we can work with.

Just to follow up on your point, Wayne, are comfortable as the former head of what is now the National Center for CAM, what Tieraona said about research with the highest standard of design appropriate for the modality study, is that specific enough for you, or would you want more specificity than that?

DR. JONAS: No, I think the wording is misleading because it uses a hierarchical language, that there is a higher and lower standard of design, and we have had a lot of discussions over the past year about the importance of matching the goals of research with the particular type of information that you are going to get, and it isn't in a hierarchy, it is really in a strategy, and that for different uses, there are different types of research and research designs, and within those you need to have high quality research.

So, I think it is a bit misleading because people interpret that, when you say highest, lowest, as a hierarchical approach, when what we need is a strategic approach, and I would suggest the language needs to be modified appropriately.

DR. ORNISH: So, what would you suggest, Wayne?

DR. JONAS: Well, should we go to the language? That is why I wanted to focus on the language in the Interim Report.

DR. ORNISH: Well, if you look at the language in the Interim Report, on page 5, lines 7 through 10 --

DR. JONAS: I would like to do that.

DR. ORNISH: It is a lot easier if we can use the ones that are numbered, just because everybody can refer to it quickly, and then you can just cross-reference it.

DR. JONAS: Except now I will have to find where the numbers correspond to the one that I wrote in, but anyway, here is some language.

DR. ORNISH: It is also page 3 towards the bottom of the original. That is easier.

DR. JONAS: Well, the page number of the original I wrote over.

DR. ORNISH: The original is page 3 towards the bottom.

DR. JONAS: Exactly, where it says, "To be methodologically sound, studies need to be focused, good design," et cetera. There were two items that were listed in there, which were both fine. I suggest another phrase, "that research should be designed to provide the types of information most useful for those seeking and delivering CAM services, such as the public and practitioners," not in lieu of, in addition to, in other words, perhaps a third item.

You listed 1, 2, 3. It was noted that in seeking evidence about CAM modalities: one, research methodologies should be appropriate, et cetera; two, creativity in research flexibility. I would have to think about that wording if that same format was going to be addressed.

DR. ORNISH: It may be worth commenting as an example for the kinds of discussions we are going to have in the next two days, of the level of detail that we want to get into, at least as far as an Interim Report would be concerned.

DR. JONAS: Right, I agree. You asked for wording, and I was hesitant to provide that.

DR. ORNISH: No, no, I am glad you did, because I think it illustrates an important point, and that is, I don't know the answer, I am not saying one way or the other, but I think that clearly, the more specific we get into, the more we are going to offend one group or another. In other words, the people, the Marcia Angells, for example, who testified that there is either good science or not, it is CAM or not CAM, to the degree that we start talking about flexibility of research design, we are going to be pushing their buttons.

On the other hand, if we make a more general statement saying that we want the highest quality research without necessarily implying a hierarchy of values or of designs, is that specific enough for an Interim Report? That is the question.

DR. GORDON: Let me just make a comment. I think that is certainly specific enough. The Interim Report is not meant to be exquisitely specific in all of these. I think the larger issue, though, as we think through recommendations for the Final Report, it may become more important because we may want to make specific recommendations about funding priorities.

Again, I see this as less important for the Interim Report and more important to shape our thinking for the Final Report, as long as we are not off track for the Interim Report.

DR. ORNISH: Well, then, maybe what we can do is try to do a parallel track here, where we come up with language that we could perhaps build consensus around for the Interim Report that is more vague, but still conveys an important idea, and then keep in mind the kinds of issues that Wayne and others are raising that we need to be more specific about in the Final Report.

Is that a general approach that we can all agree on? I want to call on people that haven't been called on.

DR. GORDON: Great. That would be really helpful.

DR. ORNISH: Jim, are you okay with that?

DR. GORDON: I am fine. That is excellent. In fact, that is exactly what we are looking for from this discussion.

DR. JONAS: I agree with that, and along those lines I would agree with what David said, and others said, is that we need to make sure that what is communicated in this document is that research is to provide tools for a variety of constituencies and audiences, and those tools must be appropriate to the type of information that those audiences need.

Within those research tools, they have to be obviously high quality tools. You can't have your hammer that breaks. So, it is really about coordination, and that is really what the title of the thing is, coordinating research, so it is about research strategies, identifying the audiences, and the type of information they need, and then making sure that the prioritization process for research then is going to deliver that type of information.

DR. ORNISH: Thank you. That is very helpful.

DR. JONAS: I think, just as a subset of that, and this is what I think David referred to, is that the public needs to be an integral part of that prioritization process.

We need to develop processes whereby the public can have educated and influential input into the prioritization process, and that should be an effort in this area, and that is what coordination is about.

It is not so much about saying you should do this type of research or that type of research. It is really about the process that leads to the public's input and other audience's input into the development of research and then ultimately the funding.

DR. ORNISH: Thanks, Wayne.

Charlotte.

SISTER KERR: I had wanted also to speak to the need for specificity in terms of research. I point to one of my colleague commissioner's statements, page 13 in the original book, and I was wondering if, in our thinking, that we could speak in a way that teaches when we speak about research even in our report.

This is just sort of a sketch statement. For example, if we said something like research, everybody wants a rigorous product. This is taken from a colleague.

2. Evidence based usually refers to double-blind studies.

3. What about outcomes research in health education, the sociological, epidemiological, anthropological, psychological research advances.

4. We strongly recommend looking into innovative research methodologies.

5. It takes into account the advancements we have made in science that is not the same old double-blind method.

My point there is I think both the content there is specific and good, and also, it is a way in which you teach as you make your recommendation.

Thank you.

DR. ORNISH: Thank you.

Joe.

DR. PIZZORNO: This is a request to Wayne. At the CAM industry summit meeting in May in Arizona, that Wayne, Jim, George, and I were at, Wayne presented a diagram of CAM research and broke it down according to the appropriate types of research to be done and who the target audiences were, and how then ranked its quality.

Wayne, I thought it was brilliant. I think a copy should be made available to all the Commission members and also to the staff, because I think you laid out a blueprint for how we can recommend appropriate research for the questions being asked. I think that is a key element is what is the appropriate research.

DR. ORNISH: Thank you. Wayne, can you do that?

DR. JONAS: Yes.

DR. ORNISH: Great. Other comments? Joe.

DR. FINS: I don't think necessarily what people want is the way that we gauge the level of scientific rigor. I haven't read what you have written on this, but I think it is not necessarily a democratic endeavor to decide whether something works or not.

If an advocate wants to believe in something, it doesn't really matter what the science says. So, I think we have to have the hierarchy. You know, things are more clearly defined as you go up that hierarchical tree. But having said that, and wanting to cast this in a positive way, I think we should say that when possible, the highest standard of design appropriate for the modality being studied should be employed, however, the Commission recognizes that there is an evolving need to design new methodologic strategies to understand these complex and difficult questions, and resources should be funneled in that direction to make this kind of compromise methodology that is more synergistic than indicting of the scientific method.

DR. ORNISH: Right. My suggestion for the Interim Report is that we don't get into that issue at all, that we simply say we want the highest quality of research, leave it deliberately vague, and not get into do we need to come up with new experimental design methodologies.

DR. FINS: There is a fundamental question on the table here, that we are sort of talking around, and that is what kind of valence do we put on science, do we believe in science or do we discount science, and it is a fundamental kind of question, so I think we need to be very careful.

DR. ORNISH: But, Joe, I think we addressed that issue at the very beginning when I said do we all have consensus about the importance of science and helping people sort through these, and I think we all agreed on that.

DR. FINS: Yes, but certain kinds of research cease to be science.

DR. LOW DOG: Right, because your statement actually was research, did we all agree on research.

DR. ORNISH: Scientifically based research. Is there any agreement on the general concept of the value of scientifically based research and applying that to CAM?

DR. GORDON: To help clarify this, I am not sure what the difference is between your position and what Dean is saying. I think this needs to be articulated a bit more.

DR. ORNISH: I understand what he is saying. He is saying that there actually is a hierarchy in research, that randomized, controlled trials are better than anecdotal case reports, and we need to state that, and I am saying whether or not I agree with you is irrelevant, that for the interim report, I think we shouldn't get into that issue at all.

I think if you say randomized, controlled trials are better, you are going to offend people like Wayne. If you say that randomized, controlled trials aren't as good, you are going to offend people like Marcia Angell.

MR. CHAPPELL: I think the materials we have been given on page 5, sentences 7 through 14, provide the framework for any further clarification or specificity that may be needed, but I don't know of anybody that has come before us in the hearing process that would find this language anything less than a rational approach, a scientific and a rational approach to providing some kind of evidence.

Evidence can be established no matter what modality we are involved with, and this gives us a framework, which is why I think it is so valuable to us, and every modality can take this into their specific world just so long as they are meeting these criteria. That is why I think this is so valuable, and I haven't heard anything yet that really improves on this.

I think this is the language we need to ask do we have consensus on this as we think about the peer-reviewed journals that have been before us, all the groups that have been before us. It seems to me that this provides the direction.

These are the objectives and parameters that need to be met if we are going to allow CAM to move into all the elements of freedom and equality that we seek. I would like to see consensus asked for on these sentences.

DR. ORNISH: Okay. Bill.

DR. FAIR: Well, maybe taking the surgical approach to this, if we don't have good research right now, there are two reasons. Either we don't have the right people doing the research or we are not doing it correctly.

I think one of the things that we really need is to consider bringing in basic scientists and others who are not interested in CAM right now to study the problems, and the way that is done is by providing the money. I can think of my own field of prostate cancer. Ten years ago, there were no basic scientists really, except a handful, interested in prostate cancer. They didn't know a prostate from a mushroom.

But at the last meeting of the American Urologic Association, 16,000 people, there were as many basic scientists as there were urologists, and they have brought urologic research, particularly in prostate cancer, to the forefront. I mean we have PSA to follow, which is an advantage, but many of the innovative approaches to tumor vaccines are coming out of urologic research.

What made this possible is the SPORE mechanism, Specialized Programs of Research Excellence, which specifically went out to institutions to encourage them, bringing people into the area of prostate cancer research that never were involved before. These were statisticians and basic scientists of all ilks.

The second thing I would like to see in there, that unlike traditional biomedicine where we can pick out one point at a time, and it has been written in here several times, I think we have to hold fast to the idea that we evaluate a system rather than a specific program.

I talked to friends at the New York Botanical Garden with whom we did some work, and they are the experts in herbs, but they call themselves ethnobotanists because they recognize that taking that herb out of the cultural milieu in which is it is being used may have a totally different effect.

I have had thousands of people call me and say, what are those herbs you were taking, and I said, well, listen, you know, I resigned my job, I started doing yoga, I started meditating, I started this, started that, and maybe the herbs had some effect, but I am not willing to say what one thing was.

So, when we study these things, and I know people like Roland and Tieraona would agree with this, we need to study them within the context of the system in which they are delivered, and not just take one thing out and look at it.

DR. ORNISH: Thank you.

Well, that is a good segue into the second topic, which is the federal government's commitment to, and support for, CAM research, biomedical health services, et cetera, through federal agencies with research and research-related responsibilities and their missions.

Just to bring up one point related to that, a number of people who testified said, okay, we have got the National Center for Complementary Alternative Medicine, but that is a small fraction of the overall NIH budget, how much of this should be part of the NIH overall mission as opposed to being something segregated off into the NCCAM. Certainly the idea of increasing funding for CAM research, I think is something that we may be able to build consensus around.

Do any people have any thoughts on this particular topic?

We could start with the language that is in the draft of the Interim Report that we received. Do we have consensus around that, or are there areas that we don't?

DR. GORDON: Dean, I wanted to raise a somewhat larger issue. I think that we need to think through, as time goes on, where the bulk of funding ought to go from our perspective.

DR. ORNISH: Ought to go and be from, as well.

DR. GORDON: Exactly. So, issues like funding approaches to whole systems or complex interventions, if we have some consensus on that, then, we can begin to develop some thoughts about that for the Final Report, health services research.

I think that the tasks that we may want to, without saying exactly who is going to do that, because that is not so much our function, our function is to look at the overall picture, what directions do we, as a commission, feel that research should be taking, is it different from the present direction that research is taking.

DR. ORNISH: Can we all agree on a statement something along the lines that we recommend that there be more funding in CAM research and from the basic science levels, as Bill Fair said, to health services research, to clinical outcomes, to systems outcomes? Do we have any disagreement on that?

Then, the question next would be where does that money come from, how much, and to whom, but at least in terms of what, is that something that there is any difference on? David.

DR. BRESLER: I do have some thoughts about it because research is often considered a luxury when budgets are tight, and I would like somehow the Commission to put some sense of urgency behind our request for research.

People are using these modalities anyway, and I think somebody has to take the responsibility to say what is safe and what is not safe, and what is more efficacious than conventional treatments that we have because people are already engaged in these practices, and I think there is a sense of urgency in getting this research out there. It is not just a luxury that when we have the funds, let's do it, but it needs to be done now.

DR. ORNISH: Thank you.

Other comments?

DR. GORDON: I just wanted to make a comment about what David said. I think that is exactly the kind of comment that is enormously useful to us in helping us to shape where we are going with the final report especially, so I just want to thank you and just point that out to everybody, that where you have those kinds of perspectives, please say them, don't be shy in case you were thinking of being shy about it.

DR. FAIR: Well, again, I would just like to point out that giving more money to the same old crowd is not the way to go. I think we have to have something in there that would indicate that we would reach out to people that are not involved in CAM research right now, particularly the basic scientists, who can really help forward the field, because often it is just like in conventional medicine, the basic scientists have all these wonderful techniques that can solve the problems, but they don't know the problems, and the clinicians are struggling with it at the bedside, and they don't know the basic techniques which could help them.

So, we really do need this bridge, and whether it is a SPORE mechanism or something else, and if I were a congressman and I was looking at something that said give more money to the guys who have been struggling with this for 20 years and haven't made any progress, I would not be very enthused about it.

DR. ORNISH: Bill, just to interrupt you, we have already agreed with you. We agreed that we should say there should be more money for basic science research. Is there something more than that?

DR. FAIR: No. I guess I didn't recognize you agreed with me.

[Laughter.]

MS. CHANG: Dean, we have 10 minutes for this.

DR. ORNISH: I know, that is why I am being a little bit abrupt here, so forgive me for cutting you off. We still have four more areas to go into.

Joe, can we skip this and can we go on now?

DR. FINS: I want to embellish something that Bill Fair said, that I think is important to just put on the table, is that we are talking should all the money go to NCCAM or should it go to their brother and sister institutes in the NIH, for the basic science and the other institutes.

I think that there should be some sort of cost-sharing mechanism or revenue sharing, because I think that NCCAM can do certain things well, like the promotion of expertise and training grants, and that sort of thing, but I think that if something does come up that is related to heart disease, the National Heart, Lung, and Blood Institute might be a better place for it, and we should recognize that.

DR. ORNISH: But are you saying -- this is where it gets controversial -- that the NHLBI, for example, should use their existing funding and allocate some of it to CAM research, or there should be additional funding for NHLBI for CAM research?

DR. FINS: That brings up the other question, is that if we increase funding for this entity, it is at the cost of something else, if we are talking about a global budget, unless we increase the expenditures.

So, I think that that is a legitimate and important question as we are in balanced budget territory.

DR. ORNISH: Well, it is particularly true if you are talking -- you are talking about the global overall U.S. budget -- but if you take the budget of a particular NIH institution, and you say we want you to reallocate some of that money versus giving them new money, that makes all the difference in the world in terms of how receptive they would be.

DR. FINS: I personally think it should be new money, because it is an additional added and value-added function, but I think there should be some mechanism to have the NCCAM and the partner institutes working together in a more synergistic way, especially if we want to access the basic scientists that Bill is talking about.

DR. GROFT: Just real briefly, I think you have to remember that there is a great deal of cost sharing going on already within the NCCAM and the institutes of NIH and other government agencies. Wayne has some experience with this, I think, in setting up some of the studies, but I think it is occurring even more, but it is a good message to put forward.

DR. ORNISH: Michele, we got started about 15 minutes late plus we spent a lot of this time just talking about the format of how to talk about these things. I am wondering if we could have a few minutes extra to at least continue the full hour of what we started.

MS. CHANG: I think we have built in a little bit of a buffer, about 10 minutes, but that was just a break stretch before we start the regulatory discussion, so at your discretion, five is what I am hearing.

DR. ORNISH: Effie, you haven't said anything.

DR. CHOW: I wonder whether it has to be either/or, you know, with the NIH, because I think there is a combination and also public monies, private monies, you know, from the businesses, and so forth, so it is both private and public, and where the source comes from, I don't think we even need to be that specific.

I want to go back to a very generic field, is that we have never really defined what evidence based means. We keep using evidence based, all the testimonies, et cetera, and I am the one that keeps hammering, but we don't have it written down as to what evidence based is.

I cornered Wayne at the meeting one time, and he said it ranges anywhere from an example by a person, as long as it is identified that the person says it is my observation.

DR. ORNISH: In the interest of time, we have already discussed this. What we would like to do is rather than getting into the definition of what is evidence, what is the hierarchy, is it a randomized control, is it an anecdotal case report, is it something in the middle, to just simply leave it deliberately vague to be defined more clearly in the Final Report.

Am I saying this clearly enough?

DR. GORDON: I think that is true, but I think the issue that is there is there needs to be more of a discussion about this and more information provided the Commissioners, and I would anticipate having that kind of discussion in depth in the October meeting. It is clearly one of the areas that is still there.

DR. ORNISH: Exactly, because it is such a wide-ranging discussion, there are so many aspects to it, there is no way we are going to make much progress about it now other than to say I would like to table it for later, because it is so important, Effie. It is not to diminish it, but, as I say, it is because it is so important we need to discuss it at a time when we have adequate time to do that.

DR. CHOW: Okay.

DR. ORNISH: I really do want to move on to the other issues.

DR. LOW DOG: Could you just make a note, though, that I think that is one area that we are going to have a hard time with consensus on. I think the staff has to really allow some time for this.

DR. ORNISH: I completely agree with you, and that is part of the reason I don't really want to get into it now.

DR. GORDON: What I am going to do incidentally is when we are finished with each of the discussions, I am going to give a summary of some of the hard issues that are still out there, as well as some of the ones where we have agreement, and if my assessment is incorrect, I will accept correction.

DR. ORNISH: Thank you.

Wayne, before we move on, do you have something brief?

DR. JONAS: Yes, just related to what we had been talking about before, is I think we should make this a very positive spin, and it is in here, continued support for the NIH, NCCAM, HQR, et cetera, and I think we should build on that and say look at this example, look at what has happened at the NIH by simply starting a little, old office in there, you know, several years ago, so it is clear that similar types of activities and support coordination efforts are needed in other federal agencies. If we want to list them, we can, but perhaps not even list them.

DR. ORNISH: We have 10 minutes left. We haven't even gotten to the last four things. Tom, can this wait, or is it something that is really urgent?

MR. CHAPPELL: It hasn't been said.

DR. ORNISH: Okay.

MR. CHAPPELL: CAM is value-added. I think unless we always think about value-added, we are going to continue to play in the either/or world.

If we are trying to bring a new realm of health and wellness to the consumers, we need to be able to think that this is going to take extra money - always value-added, always requiring more funds than we are talking about. It is not an either/or.

So, I just want to introduce the notion, it is my point of view that we need to be thinking about bringing additional funds and resources to the research or any of these processes we are talking about.

DR. ORNISH: Thank you.

Can we move on to the next, which is the dialogue and interaction between the conventional medical research community and the CAM research community.

Does anybody have any thoughts or ideas about that? Joe.

DR. PIZZORNO: I would like to make a couple word changes. Rather than "dialogue and interaction," I prefer a strong term "collaboration."

DR. ORNISH: How do you see that as being different?

DR. PIZZORNO: I would like to see us strongly recommend that conventional and CAM institutions do research together rather than just talk to each other, and I think it is critical because CAM institutions understand this medicine, conventional institutions understand how to do research, we need them both working together, not just talking to each other.

DR. ORNISH: Thank you.

Other comments on this topic?

MS. SCOTT: I just wanted to also bring in the consumer in this. I think one of the issues for us in the advocacy community, certainly around women's health, has been that research is done in a vacuum and done in these white towers and without the input of consumers, and nowhere in the seven points here do I really see an emphasis on the involvement of the consumers.

Conventional research has been absent that voice, and about 10 years ago, in the women's movement certainly, there was a push to make sure that advocates and consumers were involved in decisions around research, what gets research, the development of the questions, the protocol, and I see CAM, you know, with the broader vision of the inclusion of the person it is aimed at, at the highest level.

I think any document that we come up with has to show, both in words and spirit, the involvement of consumers in research, and not just as the people who are being researched.

DR. ORNISH: Thank you.

Other comments before we go on to the next one?

DR. WARREN: Yes, I have got a question. The role of CAM research community, what is the CAM research community if it is not the practitioners utilizing CAM?

DR. ORNISH: Well, I think it is left deliberately vague, because as I read it, that could be anyone from the basic scientists working in CAM to the clinicians, as you referred to, to the health services research. It could be anyone who is involved with CAM research at any level.

Moving on to the next one. Again, forgive me, I will apologize in advance if I seem rude or abrupt, but I am just trying to get everything in here in the limited amount of time we have.

DR. GORDON: You are doing your job. That's great.

DR. ORNISH: Thank you. Someone has got to do it.

The role of academic health centers in CAM institutions. Any comments? Joe.

DR. PIZZORNO: One of my dreams for a couple of decades is to recognize that conventional medicine has advanced substantially because of academic health centers in conventional medicine. We need academic health centers in CAM, as well.

DR. ORNISH: As separate institutions or bringing CAM into academic medical institutions?

DR. PIZZORNO: Clearly, as separate institutions and including in conventional, as well.

DR. ORNISH: Okay. Any other comments on that before we move on to the next issue? Effie.

DR. CHOW: Oftentimes or most times, the centers that are funded are placed into academic health centers, and people that are hired to head those programs know nothing about CAM.

They may know research, but they know nothing about CAM, and I think there should be something that says they should know about CAM, have experience with CAM, because they call the CAM community and they are paid $100,000, you know, a year, and they get volunteer information from the CAM community. It is a little bit unfair. This is not just one case, it has been many cases that it has happened this way.

DR. ORNISH: Thank you.

Bill.

DR. FAIR: I would just like us to obviously include the academic health centers, but not make it to the point that that is the only place where good research can be done. Your own institutions is a perfect example, and at our center, we have a consumer advisory board that directs us in what kind of things we should do, and so forth.

So, good research can be done outside of academic health centers, and even the CCAP Cancer Program is an example of that, that you can get a collection of physicians in private practice and come up with some meaningful data.

So, I wouldn't want it to slant it that it had to be academic health centers because you know the problems of that sort.

DR. ORNISH: Right. Presumably, this will be inclusive and not exclusive.

DR. JONAS: Dean, I think one way to do that actually is to emphasize building a research infrastructure rather than focusing on one particular group that would be doing that and saying we need to build a research infrastructure, and then you could list a number of groups that might be involved in that.

DR. ORNISH: Good.

DR. CHOW: And that assistance can go to the CAM institutions for research.

DR. ORNISH: Got it. Okay. Moving on here again, forgive me for being so directed.

Coverage of CAM Research Results in Medical Journals. We heard a number of people saying that there already is CAM coverage in medical journals, and yet when pressed, you would say how many, like from The New England Journal, CAM researches have you published, and they would say zero. So, the question is how to resolve that discrepancy.

George.

DR. BERNIER: I just wanted to suggest that we make it scientific in medical journals, because you might be able to attract a body of investigators that would be different.

DR. ORNISH: Thank you. Other comments on that?

DR. LOW DOG: Dean, one thing I thought was interesting was when asking the medical journals about their peer reviewers for CAM, they said that they were self-described, which was kind of interesting to me, so people just sort of describe themselves as liking massage or knowing about it, and we don't do that. They ask if you are going to be a reviewer, what your board specialty is, I mean so you don't just sort of say I like cardiology.

DR. ORNISH: So, would it be enough to just say that we want well-credentialed and qualified reviewers?

DR. LOW DOG: Yes, I think that that came out of there.

DR. ORNISH: I think that is something we can all agree on. Again, it is specific enough, but being vague enough that we don't have to get into controversy. I don't think anybody would take a position that we want unqualified reviewers.

DR. GORDON: Let me just add one thing. I think that the distinction that Tieraona is making, and that we are making here, is a very important one with that concrete example. Again, this is another place where a concrete example of the difference between current practice and what we would advise is very important and can be very useful.

DR. ORNISH: I agree.

Let me just finish here. We have got two more to go, and we have got a couple minutes. One is the Private and Philanthropic Sector Involvement in CAM Research. People have already said that in one way or another that it would be nice to bring in the private and philanthropic sector. I think we can all agree that there should be increased support for CAM research from the private and philanthropic sector. That is kind of a no-brainer.

DR. JONAS: Dean, does that include business, private?

DR. ORNISH: Private sector would include business, individuals, private foundations, I think anybody that has money who wants to --

DR. JONAS: So, the key issue is incentivize, and Tom could probably address that.

DR. ORNISH: Tom.

MR. CHAPPELL: Only that the private sector will want the data to be private, number one, and everything we have talked about so far presumes the publication of the data, so they will have a different issue.

The second would be whether or not there is any exclusivity of the information.

DR. ORNISH: I think those are important points, but probably more detailed than we need to get into here.

MR. CHAPPELL: Okay.

DR. ORNISH: I know there are a number of private people, individuals, corporations that fund research that don't demand exclusivity. Those are important issues, but again I would save them for the October discussion at this point.

DR. GORDON: One other thing I want to say about those issues is I think it is important that the agenda be set by as wide a body as possible. One of the problems sometimes of public-private partnerships is that the established agenda is always the one that is propagated, so that the government may say, well, we would like you to do a little more work in this area, and I think having private and philanthropic groups involved can open up the field a great deal, and we can address this in more detail later. I just want to make that as a principle, that this is not about saying you have to do it my way, this is about all of us getting together and figuring out what is the best thing to be looking at.

DR. ORNISH: The last issue, I think we will defer to Tieraona's discussion.

Joe, did you want to add anything?

DR. FINS: I am not exactly sure what that discussion will be, but on No. 7, just briefly, I think that whoever engages in research should adhere to standards for the protection of human subjects research whether they are within academia or outside of academia, there should be IRB protections, et cetera.

DR. ORNISH: I think that is something we can all agree on. I don't think anyone is going to take a position against that.

DR. ORNISH: So in summary, then, I think we have several areas that, as I hear you all, we have consensus on, but if I misheard you, or if I am misunderstanding you, please jump in.

One is, I think we all agree that there should be more research to fund CAM, that it should cover the entire spectrum of research, basic science, health services, clinical research, that there is a sense of urgency for funding, that it should be as widely inclusive as possible, not just more money to the same old crowd, as Bill would say, that it should also include consumers' involvement, as well as other advocacy groups; that the money should go not just to NCCAM, but also to the NIH, that new money is more likely to be welcomed, and not to be viewed as controversial or as threatening; that it should be the highest standard of design, whatever language we come up with, it doesn't necessarily apply a hierarchy.

I guess the language that is in here, that we have already gone over, I think we are all pretty comfortable with that paragraph that begins, "To address the need for dependable information, it was generally agreed that research that meets high standards of study design and execution is required," and the rest of that paragraph. That is page 5, beginning line 7 on the one that is line numbered, and page 3 at the bottom of the original version.

There is some question about whether there should be separate CAM academic medical centers or including CAM in existing medical centers, but I think we could all agree that CAM should be supported as widely as possible, in as many different venues as possible, which would include academic medical centers, but not necessarily limited to that, that we want to build a research infrastructure.

That there should be well-credentialed reviewers for journals, which would include scientific, as well as medical journals, and that any research should adhere to basic human studies, IRB protections.

There is a controversy having to do with what constitutes evidence based, is there a hierarchy of experimental design or is that not necessarily true; which areas of CAM should be funded, and who should do the funding and to what amount, and are there areas unique to CAM that require special designs like energy medicine, for example.

Have I missed anything, and do we have any differences about where we agree and where we disagree, or my assessment of where we agree or disagree?

DR. BRESLER: I would just add some language saying that research is urgently needed since consumers are using these modalities anyway.

DR. ORNISH: Good. I agree. Anything else?

[No response.]

DR. GORDON: Dean, I would say you have done a terrific job of summarizing, so I don't have to summarize anything else, and I really appreciate it.

DR. ORNISH: Thanks. I have more respect for Jim, what you have to do now.

DR. GORDON: Thank you. It was a great job. We have pulled it together. We are going to take a five-minute break and then we will begin on the next topic.

DR. GROFT: Let me make just one comment to the audience. The report may not necessarily be available on July 16th. The report will be submitted to the Office of the Secretary of the Department of Health and Human Services by the 16th, as requested last year at the first meeting of the Commission. So, when it is released to the public, we are not sure.

If you have any questions, please come and see me at the break or during the two days of meetings. Thank you.

[Recess.]

DR. LOW DOG: All right, if we can get started again. We are actually starting at No. 7 down here, The Role of Government Regulatory Agencies, Federal and State, Regarding CAM Research.

Here, if you can refer in your briefing book under the first section on page 4, so we are sort of all in the same place, under the first tab, Coordination of Research and Regulatory Activities, and then on page 4, you will find under No. 6, where we talk about state medical boards here.

We would just like some comments and feedback. Tab I, page 4.

You may have noticed there is also a notation. We want to expand this beyond just state medical boards, because state medical boards are what are regulating physicians. We would like to include all licensing bodies basically for acupuncture, chiropractic, other licensing boards, as well, not limit that just to physicians.

Do we have any thoughts or comments on this topic here, on how we can improve the role of the government regulatory agencies in research, in CAM research?

[No response.]

DR. LOW DOG: Part of what we heard here also was about some of the fear that some CAM practitioners had about really stating what they were doing, what kinds of treatments they were using, et cetera, for fear that somehow they would be punished or sanctioned by the state medical boards. I think this is where some of this comes in, is when we have got nonconventional or nonstandard sort of treatments, what are the limitations that keep people from applying for research.

We heard good examples of this with the NCI and their best-case series, but then we had CAM practitioners that talked about how they have been afraid to come forward to apply for research because they are afraid that they somehow would be sanctioned for that.

So, this is sort of the areas that we are talking about, how do we begin to resolve or address those issues and do we have recommendations around this.

DR. GORDON: Tieraona, do you want to talk about some of the problems that the people raised when they testified, some of the community-based CAM researchers raised, so that people can respond to that? They may not remember.

DR. LOW DOG: Well, I think that the ones where Nick Gonzalez came, and there were several other practitioners that were there with him on that panel. They talked about an open hostility towards what they did, and they felt that because of that hostility, and also the lack of information, they just didn't know how to go about accessing where do you go if you think you have got a treatment that might work for something, where do you begin to go.

When you are practicing medicine or treating disease, and you may be beyond your scope of practice, I think there are some real fears that somehow they would be persecuted or prosecuted.

So, we are sort of giving them this dilemma. We are saying you need to prove what you do, but we are going to make it very difficult for you to come forward because we may take legal action or sanction you in some way if you come forward and say this is what you are doing.

So, it is sort of this dilemma that these practitioners described themselves in. So, if we are talking about medical boards or we are talking about licensing agencies, and we are talking about governments, and we are talking about then the reality of these people out there that are treating cancer, treating HIV, treating conditions, and they think they may have something, how do we begin to address that, and are there recommendations that we can make about this very real problem.

DR. GORDON: Let me just expand a little bit on that. One of the issues is people who are doing clinical work often do not have the expertise to do the research. They don't have the funds to do the research, and there is the fear of this kind of prosecution or persecution.

So, I think all three of those have to be addressed, and one of the issues that we have discussed over the last 10 years really is what Berkeley Bedell has called, and does call, field studies, field research, going out and helping people in the field do this work, which requires experts and requires money.

Then, the other issue which I think I may have mentioned, that I have talked about more recently with NCI, with Drs. Jeff White and Bob Woody [ph], among others, is how do we provide and do we want to recommend providing some kind of shield for people who are doing legitimate research with an IRB as they do the research on these conditions.

Those are a little more specifics about some of these issues, and we can clearly, as a commission, we can make recommendations in these areas, and I think it is an important one that we ought to hear people's opinions about.

DR. LOW DOG: Effie.

DR. CHOW: I know this is about research, but education goes into this, and so, therefore, the state doesn't necessarily know what we do federally, like the Commission being existant. Perhaps there needs to be an educational aspect to the government regulatory bodies about the activities that is more accepted now, because many of them are still kind of their head in the sand.

This is what goes back to the definition of "evidence based," what it means, because it scares the community. They think it is that white tower out there and very complex, and it is.

So I guess I am recommending education at all levels in order to move through this.

DR. LOW DOG: Joe.

DR. FINS: One of the things, going back to the Nuremberg Code, was that anyone who did research would have to have the same level of competence to provide the clinical care, so what this suggests is we need to have partnerships because to do this kind of research, collegially and responsibly, a CAM provider would have to partner with perhaps a doctor who cared for the disease under consideration to make sure the person got the best available, you know, traditional care, and this was complementary and additive.

So, I think we should foster mechanisms for that, and I think if we bring them in and they have IRB approval, an IRB would probably not approve it if the investigator wasn't credentialed.

So, it gets back to Effie's point about education and licensure, so I think it is a kind of a Gordian Knot, and it gets more and more complicated. But I think the thing is here that it has to be done collaboratively, and I think we have to foster the collaboration word again. Otherwise, it can't be done appropriately.

DR. GORDON: Maybe one of the things we can do is, for example, to point to the model that Nick Gonzalez and NCI and NCCAM have been doing, which was we really presented as a model of a way to work together, where there is support for the research, there is work with a major mainstream institution, and at the same time, somebody is doing a very innovative and controversial therapy. So, I would suggest that as one model.

I think that we also have to address the earlier stage, though. I speak from the experience of our cancer conference over all these years, of finding people who are doing work that they believe is extremely helpful, that their patients believe is extremely helpful.

They don't have the resources even to put together the best-case series that is the first level of evidence that NCI and NCCAM are asking them for, and I feel like I would like to once again say that there should be support to help people develop their research models, and that the CAPCAM panel that NCI and NCCAM have created is a beginning of this in the field of cancer.

Such a panel does not exist in any other field. So, it is an interesting model. I believe it is a good model. It has not yet gone as far as I would hope it would do in terms of reaching out and providing support, but they are trying to reach out and bring people in for a best-case series, but something like that needs to be available. Cancer is not the only illness or condition we are dealing with.

DR. LOW DOG: Can you put that in some sort of a simple, two-sentence kind of suggestion or recommendation, Jim, about best-case series research, because it is applicable to arthritis, it is applicable to diabetes, it is applicable to all the other institutes within the NIH and other academic centers and research centers, as well?

DR. GORDON: I will. Just at this moment, what I would say is that we, as a commission, feel that it is important for research institutes, including NCCAM and the NIH institutes, and others, as well, to provide support for people who are beginning the process of doing research on promising CAM approaches, something like that.

DR. LOW DOG: Any other comments on this? Veronica.

DR. GUTIERREZ: I am thinking of a medical doctor in Washington State that has given up his medical license because of some approaches that he is using, and more recently I have heard he is thinking about going to Minnesota because of the law that is in place there.

I am wondering, and there is probably an organization in place already, a place we could have people who are serious about having their approaches researched. They could file somehow with their interest, their desire, their intent to pursue the research because it will take a long time to get all 50 state boards and professions on line with this, but perhaps we could have them file someplace, which would give them an umbrella of protection. It would make them legitimate in what they are doing, and let the public and all levels of government know that they are serious about their intent.

I think this would weed out a lot of people who are doing things less legitimate.

DR. WARREN: Which means by coming clean, they have protection against board actions.

DR. LOW DOG: Right, and I think part of our mission here is to support practitioners, but it is also to protect the public. Certainly, if you have somehow registered, then, you would also be expected to maintain certain ethical standards and informed consent.

DR. WARREN: Basically, do no harm.

DR. LOW DOG: Right.

George.

DR. BERNIER: We have understood that there are some CAM practitioners who are not licensed since that doesn't come in their discipline. Would the same kind of guidance be offered for those individuals, the same kind of protection we have talked about them having licensure. We have also talked about the fact that not all practitioners are licensed. How would doing research fit into that situation?

DR. LOW DOG: How would you see that?

DR. BERNIER: I would think that it probably would end up without going through any regulatory body, and I am not advocating that.

DR. GORDON: I would see that if that occasion arose, for example, Feldenkrais practitioners in many instances have said they are not particularly interested, they may not be interested in licensure, but if they have a legitimate study that they would like to do, I would see it going the same route potentially through this. You would need the same protection of human subjects, they would need the same kind of consultation with people who knew about research or they might, and they would certainly need the same level of support that anyone else might to develop a study.

So, I don't think the licensure or non-licensure necessarily would make the difference. The standards could be just as rigorous if they didn't have licensure if they were going to be protected under this kind of research clause.

DR. LOW DOG: Does anyone know the answer on sort of the extent of the Nuremberg Code, because that actually is in violation of that?

DR. GORDON: What is in violation of it?

DR. LOW DOG: Of having a practitioner that is not deemed clinically competent to be able to manage that disease. That is part of the Nuremberg Code. So, I think one would have to take into consideration --

DR. GORDON: But that doesn't have to do with licensure or non-licensure. The issue is not licensure.

DR. LOW DOG: Well, you have to be able to define competency, though, and so you will have to have some sort of mechanism for determining competency in somebody who is not licensed, where there is no body even if it is their own body that would develop that.

DR. FINS: Maybe what we could posit is a certification for NCCAM-related research, so that it is a special certification process if they want to engage in this even if they are not licensed, but it would be rigorous in order to protect the subjects involved and to ensure that there is adequate referral at the follow-up, but some sort of certification process.

DR. WARREN: You are not talking about a restrictive type of certification, though.

DR. FINS: No, just if they want to participate in the best-case scenario kind of scenario.

DR. WARREN: I see licensure as almost a censorship.

DR. LOW DOG: I don't think we are getting licensure here. I think that there is a distinction that is being made between research here and practice. You can practice, going out and practicing. If you are participating in research, though, because of some of the horrors in our history of research, there have been codes that have been set in place to protect human subjects, and part of that is you have to be competent, clinically competent to be able to care for that person.

In individuals who are not licensed, that competency will be difficult to ascertain. So, I think Joe's recommendation there is simply that through NCCAM or through NIH, the NCI, other places, there could be some sort of instrument set in place that would allow them to participate in research, so you are not censoring them, so this is different from practicing and participating in research and research on subjects.

Are there any final thoughts on that before we move on, because we have got the juicy stuff still coming?

[No response.]

DR. LOW DOG: If you will turn over to page 8 in the same area you are at, the FDA Insert No. 2, the Draft Issues and Recommendations. That will sort of help guide you with some of the language that has already been attempted to answer some of these next questions.

The first one obviously has to come down to the whole DSHEA, which everybody has raised issues around Dietary Supplements Health Education Act across the board. This was the staff's attempt to try to address some of these issues, and I would like some comments and feedback where we have got adverse event reporting, if we can start there. Page 8 in your briefing book, the FDA Insert No. 2.

I think this is a big area about DSHEA, and I was sensitive to Tom's point about botanicals not sort of overtaking the whole commission here, because there has been so much focus, but I think we need to address it and see where we come and where we have consensus on this.

George.

MR. DeVRIES: In terms of AER, it seems like the same rules should apply for conventional, as well as CAM practitioners. There shouldn't be a higher standard or a lower standard for CAM would be my suggestion.

DR. FINS: The OIG report that some of us had, I guess, says that the standard for these agents is lower than over-the-counter drugs, and they have a whole series of recommendations that seem very prudent and well reasoned. That might be something, you know, you are not getting into the details, but it might be a way of embellishing what was intended in DSHEA in the OIG report from the Department of Health and Human Services. They are very concrete recommendations.

DR. GORDON: Maybe one thing we need to do is make sure that at least a summary of that report is available for everybody.

DR. LOW DOG: We have gotten it, the OIG report.

DR. GORDON: So that we can all take a look at that between now and the October meeting to have a sense of what is recommended.

DR. LOW DOG: Dean.

DR. ORNISH: I just want to point out that Senators Harkin and Hatch were the authors of DSHEA, and so anything we say about it, we should say with that in mind.

DR. LOW DOG: I think we should keep that in mind, but we should also just keep in mind what we really need to do on the Commission, as well, and what is in the best interests of the public.

Adverse event reporting, OIG was interesting, because you need to get some industry buy-in here, and the report was quite interesting because a number of the industry and industry-advocating bodies had some real issues with it, because they see this as being more under food adverse reporting than pharmaceutical drugs because of the language of DSHEA, as well, so I think that it was an interesting report.

DR. ORNISH: I just want to clarify that I am not saying that we should abandon the interests of the public in favor of politics. I am simply saying that for the Interim Report, we might want to avoid taking positions that are more controversial than they need to be or more specific than they need to be, that's all.

DR. GORDON: I think for the Interim Report, what is in the Interim Report, and I think the focus that everybody needs to turn to first in their minds, is looking at what the provisions are of DSHEA and what is not being implemented. I think that covers such a huge territory at this point including the adverse events reporting. There are plenty of sort of language in DSHEA that is pushing for much better reporting of adverse events, it is just not happening, just as there is language in DSHEA about good manufacturing practices, which have still not been implemented.

I think that we are in the area where we really have not worked with DSHEA to see what it can do at this point, and part of what we can I think is to lend our weight to implementing DSHEA as it was meant to be implemented.

DR. LOW DOG: I think that that is a real important point. If we recognize or believe that there is beneficial effects from dietary supplements, that some dietary supplements and botanicals can be beneficial, and we are trying to maximize the benefit to the public, part of maximizing that benefit will also be assuring the public that there is a route for reporting adverse effects and that manufacturers can be notified when there is a potential problem quickly.

I think some of the European models would be interesting to look at, how they go about reporting adverse effects. We would have never determined the problems with St. John's wort in this country as rapidly as they were able to find, isolate, and discover the problem in Europe only because of the way they report these problems, and notifying manufacturers rapidly of the problem.

In this country, if there are 1,000 manufacturers making a botanical product A, and nobody knows who they are, there is no way to really get the information out to the manufacturer. We can put a very positive spin on this including making sure that DSHEA is implemented and the funds are implemented, but I think that adverse events, there has been a lot in the media lately, and I think the consumers are concerned about this, so we really do want to address it.

DR. ORNISH: Just to follow up on the point I was trying to make, it is my understanding that with DSHEA, at least from talking to Peter Reinecke, is that the legislation is that it needs to be truthful, non-misleading, and substantiated, and yet, the FDA has never asked the company to substantiate its claim.

The question -- and this is really not a point, it is really a question -- is it simply a question of implementing DSHEA or revising DSHEA? Is the language there, but it is not being implemented, or is it not really there at all?

DR. LOW DOG: Joe.

DR. FINS: The OIG report does not make any comment as far as I can tell about amending DSHEA. It just has other recommendations, which would be in concordance with the goals of DSHEA. It is an implementation issue.

So, I don't think we necessarily have to make it more complicated. I mean this I think would be a very important first step in identifying adverse events, which they say are less than 1 percent, actually come to regulatory attention.

I think you are going to put it in a positive light, which I think is important if we are talking about consumer choice, we also want to talk about consumer protection. This is in that spirit that I think it is being recommended.

DR. LOW DOG: Do we all have consensus that we would like to recommend funding, so that FDA could fully do its job to be able to implement DSHEA? Is there anybody that really doesn't agree with that?

[No response.]

DR. LOW DOG: Any other comments? Bill.

DR. FAIR: Maybe you or Joe could answer this. I am curious, the business about less than 1 percent, the FDA receives reports on less than 1 percent of all adverse events.

Now, in my experience, we are all familiar with the Pomerantz study showing there is 106,000 deaths per year from adverse effects to standard medication, and I think adverse effects on clinical trials are very assiduously reported, but I can tell you my experience is that a lot of adverse effects goes on in the routine hospital that are never, ever reported, so I don't know what this 1 percent, how that relates to the total, you know, the denominator of adverse effects going on in the hospital in a voluntary report. I suspect it is very low also.

DR. LOW DOG: I think we would agree that adverse event reporting is low across the board, period, by all, and that we don't want to single out CAM as somehow being this dangerous dietary supplements or this dangerous thing.

DR. FAIR: Exactly, that is my point.

DR. LOW DOG: I don't think we want to do that, yet, I think it is irresponsible to say that we are going to go down the same path that is bad in conventional medicine, just as in conventional medicine, that dietary supplements, there should be an adverse event report for serious adverse events, so that we can detect trends or patterns where they might arise, or certain groups, that a certain dietary supplement, a particular group where that may be dangerous for a particular health condition.

So, I think that those are important. I don't think this Commission, I think we have to make some sort of statement about it without overburdening, without making a big thing about this, I think we do need to address it.

DR. FAIR: Okay. That is my point.

MR. CHAPPELL: To reinforce your point and your question about the efficacy of DSHEA, DSHEA gives manufacturers a range of language that it can use for claims. It gives a boundary as to what it cannot say, and then it requires substantiations of what it is they are saying.

So, if FDA were to implement DSHEA, they would be able to contact manufacturers and find out whether or not those files, their files contain the necessary substantiations. So, it is a rational piece of legislation and it is a model for implementation that is done elsewhere and it is something that can be implemented.

DR. LOW DOG: So, again, what I am hearing from you is that the funding and that should be in place, so that DSHEA could be fully implemented and that perhaps it is premature or not accurate to say it doesn't work because it has never been fully implemented, so nobody really knows if when it is fully implemented, if there is holes.

MR. CHAPPELL: I am just wondering whether we should be asking for funding or not. I think we should just ask that it be implemented, because who is to say whether you give them the funds, that it still will be implemented. I mean the point is our claim should be that FDA implement DSHEA. I am not sure we should ask for additional funding, but just implement DSHEA.

DR. LOW DOG: Yes, I think that FDA was pretty clear when they were here, that they were given this big burden and were given no additional funds, and from speaking to people at FDA, perhaps we could just say whatever is necessary basically, and that maybe the funds should be earmarked, Tom, for this particular --

MR. CHAPPELL: I don't know enough about implementation strategy at this point to comment on that, but I will go with your wisdom on that.

DR. LOW DOG: Joe.

DR. PIZZORNO: Two comments. First, although we have talked about this a lot in our discussions, I don't see this showing up in the actual recommendations, that is, the need to have CAM professionals involved in advisory boards for the FDA and these other regulatory agencies. I think we just need to be real explicit in our statement that that happens.

The second is in talking to leaders in the natural products industry, they are in full support of FDA fully implementing DSHEA, however, they are concerned about simply giving a blank amount of more money to FDA. They would recommend that that money be clearly identified with specifics tasks the FDA must accomplish.

So, I think the regulation we need is there, let's make sure it is going to implement it.

DR. FINS: I think, you know, what we could perhaps suggest is that full implementation of DSHEA, consideration of the OIG report, and some sort of reporting back to Congress or an oversight committee at a designated period of time to revisit the legislation with additional data.

DR. LOW DOG: One of the issues that has also come up has been about research and dietary supplements and proprietary protection, and we have heard from pharmaceutical companies, as well as industry members, that this has been a real barrier in their opinion to furthering research or paying for research because if they pay and go through a new drug application, and go through all the rigors that come along with that, and then get to make a drug claim on the product, you can still go to the health food store and buy any one of those types of similar products off the shelf, and they have no way of recouping their investment.

Now, that has been raised by a number of people, and I just wanted to know any thoughts about that.

MR. CHAPPELL: First of all, the route of the NDA allows you to complete that process with a very clear claim, and that claim is disease prevention based. It is a tighter, bigger promise than you are allowed to make with DSHEA. So, it is worth the pursuit to be able to make a tighter claim.

Secondly, there are lots of ways that you can formulate a product to put it into the range of an invention. Those opportunities presently exist. If I want to mix three different kinds of echinacea, no, I am not going to be able to make a patent, build a patent around that, but if I have different ways of processing echinacea, I have an opportunity for a process patent.

So, I feel that natural substances, as they are, are natural substances. They are there for the public, and whatever we do as manufacturers to provide those substances for their benefit, that is public domain. If there is something I do to a formula that is an invention, then, it ought to be allowed for an invention, but those opportunities exist today.

I see no need for changes in patent laws, and I do see a benefit as a provider to consumer benefits to go the extra mile to make the promise that you can't make in DSHEA, to say this product will do the specific thing you are looking for, and that is worth getting an NDA for.

It is long and expensive, but you make those judgments in a business, so I have to say it would be nice if there were a middle ground here, where you didn't have to spend five years or $5 million, and I am open to that possibility, so there is a great gap between DSHEA and an NDA, and we ought to look to how you can fill, and that is addressed in some of these other recommendations here, but at present, I don't see that the intellectual properties laws need to be changed.

DR. GORDON: Wayne.

DR. JONAS: I just want to reiterate that. I think that we will get into a Pandora's box if we try to say change NDA, change patent law, that type of thing, but to ask for a middle ground, a description of something that will allow us, it is not a drug, it is not a food, et cetera, but then would allow some protection for the primary purpose of incentivizing the production of these products in a reasonable, scientifically-based, quality way, it would be a proactive statement that we could make and that the federal government could be involved in.

MS. CHANG: We have about 10 minutes left, Tieraona.

DR. LOW DOG: Okay. David.

DR. BRESLER: I think there are other precedents also in ways that the government has stimulated or incentivized the private sector to do research, particularly through tax credits or low interest loans.

I think somebody does have to do the basic research on just plain echinacea. You know, we need to know that. I think that we can take a strong stand on recommending more creative ways to incentivize the private sector to do the research that is needed.

Look how the private sector has carried forth pharmaceutical research, for example, and again, if tax credits or low-interest loans, I mean I think given the climate, these things would be very attractive to the private sector right now, and this is definitely something the government can do to stimulate research in things it is interested in.

DR. LOW DOG: Some of this was addressed under Issue 4 on page 11 in your briefing book, but again, reading through some of this I think would be helpful.

One of the recommendations was also about package inserts, that one of the issues to the public is because of the nature of structure/function claims, it leads the average consumer sometimes feeling a little bit at a loss to really know what these substances are really for, or if there is people that shouldn't be particularly using them, if there is cases where there may be interactions with particular drugs.

One of the recommendations that was listed under Issue 4, that I would just like some comment on, was about package inserts that may also include who shouldn't take it, or there might be a potential drug interaction with, or if you shouldn't take it if you have high blood pressure, and more information about the product. That is a recommendation that was put forth here. Any comments on that?

Again, if we are looking at maximizing the benefit of CAM to the public, one of the things is take a look at what consumers often complain about is that they are not quite sure what some of these are actually meant to do because sometimes a structure/function claim can be kind of vague.

Should we make any more recommendations for package inserts, and are we concerned, are there any public safety issues we should be thinking about here?

DR. WARREN: You are dealing with over-the-counter stuff, though, with this. The practitioner is supposed to know the interactions.

DR. LOW DOG: Many people just self-medicate, though, Don, so they just go to the store, and they just buy on their own, they are not seeking a primary care or a naturopath or acupuncture, they are just buying off the shelf.

DR. FINS: There is a paradox here. In trying to not give extra credence to a supplement, the labeling was such that it didn't give the consumer enough information, and we need to really I think rectify that with clarity in labeling and maybe having some sort of board, you know, professional lay board to sort of assess the level at which these things are written just to protect people.

I think the Bob Blendon article that was circulated suggests that the overwhelming number of Americans want more regulation in this area. What form it takes, I think is a complicated one, and the use of supplements is going down because of all the recent publicity about some of the adverse events, so I think people need information, and I think the labeling has to be accessible in a way that people can understand it, because we get claims that are kind of confusing because they were intending not to be definitive.

DR. LOW DOG: Tom.

MR. CHAPPELL: The guidelines that we adopted earlier this morning in terms of coming up with evidence-based results, outcomes, you know, if we use that same language for looking at herbs and their effect on the body, we would be able to go beyond DSHEA and we would not have to go the full route of the NDA. That is what I am talking about for middle ground.

It doesn't cost a lot of money to decide that you want to find out if an herb does a specific solution. It just needs objective goals and scientific methods and testing, and then trials. It really doesn't take an NDA to establish that. This is my concern.

DR. LOW DOG: You raise an interesting issue about methods and testing. That has also been raised, is that it is very difficult. At this point, there are not established and validated methods for many of these supplements, so testing is difficult because a manufacturer may be using a different method than the laboratory that tests it, and this has been one of the problems with looking at natural products is that at this point, many of them don't have a validated method.

I think we will hear more about that later, but I think that there may want to be some language in there about just supporting that as basic science and also organizations that are working on that, that we would like to support those endeavors.

Any comment on that? Jim.

DR. GORDON: I would just like to get a sense, if we do have some kind of consensus, on this issue about providing information before we move on to another topic, because I think it is a really, really important one, it is one that we mention in the Interim Report, and one that I think we may need to lay out in considerably more detail for the Final Report.

So, I would just like to ask people if there is a consensus that we, as a commission, feel that somehow information, whatever the state of the art of information is about the different products, needs to be available to the people who are using the products.

DR. LOW DOG: Ming?

DR. TIAN: I think the label, we all know the label law by FDA. I think the problem is how do we deliver the information to the public, as well as the medical profession, because this label law does block the people to know. As manufacturer, you can't tell patients or tell the public that it works for arthritis or that it works for osteoporosis. How do we do that, because this is for American people, to maximize the best benefits, but however, if we don't change it, if we don't give the manufacturer or company or doctors the right to share the information, how do we do that?

DR. LOW DOG: Joe.

DR. FINS: Maybe we want to distinguish between the claim and the side effects, so like you can't make a claim about ginkgo biloba, but you might want to say if you are on warfarin or Coumadin, you shouldn't take this drug because it also can further thin your blood, so maybe it is on the adverse side that we want to get more specific, and not on the claim side, which is as yet unproven.

DR. GORDON: My feeling is I would like to give people somehow the evidence that is there, whatever it is. If there is no evidence, there is no evidence, and that is fine to say. If there is evidence to somehow present it, I just feel on all sides of the question, what the benefits, what the disadvantages, what the side effects, what the interactions are.

DR. LOW DOG: Any other comment? Joe.

DR. PIZZORNO: I feel very strongly the public needs to be educated on how to use these things properly, and I have major doubts about whether we can do it on a label. I think that this is an issue that has come up again and again. We need to provide multiple pathways for access for the public of what is most current, and while the label has to have some information, maybe the best thing the label could do is simply provide a web site address and/or other resources people can go to, to find out more about it.

DR. LOW DOG: Tom.

MR. CHAPPELL: There are over 100,000 deaths each year for drug interaction, drug with drug, synthetic with synthetic, so we need to recognize the context within which we are talking about interaction with herbs and herbs with drugs.

I think in order to have a goal to provide more information, Jim, we have got to break this task down into some manageable phases, short term, long term, because this whole business of herbalism will just give you a breakdown mentally and financially and everywhere, and until you begin to chunk it down, you can't make it into manageable, so I think part of our recommendation should be to recommend some first stage, second stage, short term, long term, you know, the first 15, the next 10 or whatever are the most popular, but we are going to have to approach it this way because it is unmanageable.

DR. LOW DOG: A lot of scope. Jim had asked for consensus a little while ago about adverse events and sort of providing information, and I think it was also about benefit, as well, but under Issue 5, on page 12, it just makes a few recommendations, one, about warnings about potential interactions, warnings for pediatric use or pregnant women, nursing women, where that information might be known.

Again, I just want to know if there is consensus on that where it is known, and let's just be real honest, that we haven't begun to understand where the potential interactions are, and this will be somewhat hard to do. Much of it will be theoretical.

When I read this, while I am very much in favor of it, where it is known, it is going to be also a difficult task because much of this is theoretical information at this point, where there are potential problems.

George.

MR. DeVRIES: I am in favor of it in general, but what I would say as a caveat is I know that, you know, Micromedics has a drug-herb interaction guide on St. John's wort alone, there is 86 known interactions. So, the amount of disclosure is pretty significant, just in the context of there will be a lot of information here which may be overwhelming for some consumers.

DR. LOW DOG: And wouldn't fit on a label.

MR. DeVRIES: You are definitely not talking a label, you are definitely talking insert. I mean there is no way to fit the amount of information I have seen on that interaction guide for St. John's wort is pages and pages and pages.

DR. GORDON: What we are talking about right now is both a general principle and then what everybody is raising is the complexity of the issue. If we are agreed on the general principle, we can start wrestling with some of the complexity at the October meeting and try to get some information between now and October about different alternatives, different ways to do this.

DR. LOW DOG: Effie.

MS. CHANG: I'm sorry, excuse me. I just want to let you all know we are out of time for this session.

DR. LOW DOG: We will just have these last two comments.

DR. CHOW: I agree with a lot of things that are said. One thing I caution is that I think Tom, it is, and Bill brought out the traditional system of medicine has a lot of reactions and numbers, and so forth, and I think we need to look at the safety for the people, but I don't think we need to alarm people. We need to put it in perspective that, yes, we are cautionary about this, but make some statement in comparison with what Western medicine is, you know, the amount of side effects versus the drug effects, the supplement effects, so it puts it into perspective. Otherwise, people read this recommendation of making all these adverse reactions.

I definitely feel that we need to put some positive things in there along with the adversities, not just emphasize the adversities, and do have this comparative kind of knowledge somewhere, not on a label, but somewhere, web site, et cetera.

DR. LOW DOG: Tom.

MR. CHAPPELL: As we have discussed, oversight of composition, quality, safety of botanicals is doable. There are experts in this country, like yourself, who know what the adverse effects are for a large number of herbs. It is very well documented in many, many files.

My interest here would be to see us convene a review board of those experts, so that this review board gives credence to a particular herb. Now, if that review board were either CAM office or industry, then, you can maintain flexibility and continuity. If, however, that review board is within the FDA, then, you have stopped all the progress of product development.

It has to go inside a regulatory agency over which you have no control for time and priorities, and so forth, and I am very concerned about subjecting product development progress for consumers, bringing health in this area in a system that gets bogged down within the FDA. So, I would rather see this recommendation be handled outside the FDA.

DR. LOW DOG: On Issue No. 6, on page 12, actually, it was recommended, and this recommendation within the FDA, but it was again sort of an Office of Botanical Products, so that you had people with expertise in this area, that have more expertise in handling it, so it doesn't get bogged down.

Jim, would you like to summarize for us?

DR. GORDON: Yes. The first part of the discussion had to do with facilitating research, and there was a general agreement that encouraging partnership between CAM and conventional researchers was one way to go and an important way to develop research.

Secondly, it was understood that both technical assistance and money would be necessary to help people in the field to begin research in a number of these areas.

Next, it was understood that those people who are going to be doing research in areas that were at this point unconventional, might well need an umbrella of protection as they are doing the research, and that that umbrella of protection would be protection both for the researchers, and, of course, for the people on whom they were doing research.

This is an area of general agreement. I don't think we have really begun to, or we just began to wrestle with the particulars of this area. It is pretty complex, but there was a general sense that we ought to encourage and protect people as they are doing research and, at the same time, we needed to ensure that there was safety and that all those who were involved in the research were protected by people who had a deep knowledge of the conditions that were being treated, that they were involved in the research, as well.

DR. FINS: The contingency element.

DR. GORDON: Yes, that their participation in the research, and I think we used Nick Gonzalez as one example of a kind of developed phase of this where this is participation of both an institution, academic medical institution, and adventurous private researcher, and government funding, but there was also the recognition that at earlier stages, there may need to be something like field studies, which has been very much a part of the agenda for the OAM and NCCAM from the beginning, where people in the field are helped to do the research, protected while they do it, while the subjects, as well, are being protected, and that ethical standards would need to be established.

I am a little vague on this because I think we are still vague, and this is clearly an area we need to address more.

We then turned our attention to issues related to products rather than research procedures, and there was a general agreement that DSHEA needs to be implemented and that we need to make at some point recommendations that whatever funding for the FDA be directed clearly at the implementation of DSHEA, that there be a clear connection between any recommendations we make for funding and that that funding be used for DSHEA.

In thinking about implementation of DSHEA, it was agreed that we all ought to have a look at the Office of the Inspector General report and that we also need more information about European models of reporting and notifying, and have someone who is working with the office now, who is doing a special project on what is happening internationally, and we can ask her to help us gather some of this information and have that available for everybody.

It is clear in thinking about issues like adverse events and interactions that we understand that although these are extremely important areas, that they are obviously areas that are not just confined to CAM approaches, and that was pointed out by several people, and that whatever discussion we have about that, this is just understood as a public health issue across the board.

One of the other issues on which there was substantial agreement, and I think this addresses the last question that was raised, is that there has to be participation of CAM professionals and experts in all issues related to the development of supplements, of herbals, and all issues related to adverse events reporting, that this is not something that can be done by people who are purely outside the field, and I think this is a general recommendation that we were making in a number of different areas.

Another issue that was raised, and I felt there was consensus on, is that we need to begin to look toward finding a middle ground between DSHEA and New Drug Applications, that perhaps there is a special area for botanicals and other traditionally used substances, and that we may well be working toward making some recommendations about what that middle ground will look like.

It is also clear that in the area of information, that the board, how that is going to fall out, whether that is inside the FDA, outside the FDA, I don't feel like we have a consensus on. That is clearly an area which we need more discussion about.

We understand the need for a middle ground, we don't know exactly where that middle ground is going to lie. We understand the need for CAM professionals to be involved in establishing that middle ground.

Also, it is clear that much more information is needed -- and I am sure we will come back to this somewhat in the sessions on public information -- but in this area of products related to regulation of products, that there needs to be a great deal more information available, and clear that there need to be many ways of providing that information, that the label is not going to be the way to provide this complex information.

Again this is an area that it is pretty clear we have to deal with much more as we move along, how that information is going to be provided, we don't have specific recommendations for.

That is my summary of what we have been doing this last hour or so.

Anything else?

DR. FINS: Just one thing. If, in fact, some of these recommendations are taken in, that there is some sort of sunset clause where we would then have feedback to an oversight committee to evaluate and look at new legislative paradigms.

DR. GORDON: Thank you, Joe.

DR. LOW DOG: Good job.

DR. GORDON: Thank you, Tieraona.

We will come back promptly at 1:30 and then we will have an hour and 45 minutes for the next discussion. So, thank you, everybody. Have a good lunch.

MS. CHANG: Just to let the public know, we will be vacating this room during our lunch break, and the doors will be locked, so make sure you take your things with you, and we will open up around 1:20 or so.

[Lunch recess taken at 12:35 p.m.]

+ + +

[1:40 p.m.]

DR. GORDON: We are going to begin now and we are going to be talking about Education, Training, Credentialing and Licensing.

It's the Joe-II's or the two Joes. Joe Pizzorno will be leading the discussion, and Joe Kaczmarczyk will be working with him.

DR. PIZZORNO: I thought our conversation at lunch was interesting. Actually, it coincides quite well with how I want to run this session. I would like to actually start our first part of the conversation with a discussion of our process.

In general, I think we should have a fairly focused and defined way of going about this, so that we arrive at the conclusions and the recommendations that we are looking for.

I am going to direct us in a three-step process. Step No. 1 is to clearly understand the questions that we are being asked to address. I will spend a few minutes on an overview of what I think those to be.

Step No. 2 -- and I think this is important -- is that we answer the question what are the characteristics of a good recommendation. I think that is a scenario that we have been having some challenges with. I want us to be real clear about when we see a good recommendation, how do we know it.

Step No. 3 will then be to look at the recommendations and come as close to a consensus as we can on those recommendations.

So, I will be using the same process both for the educational component of it, as well as the licensing component of it.

Are there any questions about that before we start?

[No response.]

DR. PIZZORNO: So, let's start with the Education and Training. You all have on your desks this handout that Joe K. put together addressing the various issues.

When I look at these, I see two key themes, you might say, that come through, both the recommendations as summarized by the staff, and also in looking at the documentation we have received in the full booklet. Also, I would like to take this opportunity to congratulate the staff for I think some excellent organizational material that they have provided for us.

So, the two issues I see are, number one, level the playing field both in terms of resources, as well as accountability. The second I see is a strong emphasis on cross-training, that is, training of CAM professionals in conventional medicine, as well as conventional medicine in understanding what CAM is about, as well as training together.

There is an adage in medical education that I think is very appropriate here, and that is practitioners who train together practice together, and I think the more cross-training we can do, the better.

So, given those as kind of the themes, and we are starting out looking at the recommendations, as summarized here by Joe Kaczmarczyk, what are the characteristics of a good recommendation? What should that recommendation look like for us to know that this is something we want to pass on to the President and Congress?

As people talk about this, I will be taking notes, so please excuse me. Linnea, do you have something to say?

MS. LARSON: Thank you. I have four criteria. The first is clear and jargon-free. The second is non-global and of achievable scope.

DR. PIZZORNO: Please slow down just a little bit. The first one was clear?

MS. LARSON: And jargon-free.

The second is non-global and of achievable scope.

DR. PIZZORNO: Could you explain that more, what you mean by that?

MS. LARSON: You don't lump everything together. It is a point, a troublesome point for me is the use of a term called "CAM community," that is a global. We need to be more specific.

The third, for me, was operationalizable meaning who does what, when, and how to effectuate the recommendation.

The last was evaluable, how would you know if a recommendation was followed.

DR. PIZZORNO: I think those are excellent recommendations. Also, another statement on process. My preference would be for people to present what they think are good recommendations first, get them all on the table, and then once we hear what everybody think are good recommendations, then, we will go back and start discussing them and evaluating them. It is okay to ask the person who made a recommendation what they meant by that.

Tieraona.

DR. LOW DOG: I guess Linnea raises the point about CAM community and also then coming to the language of a basic CAM curriculum. What is that? You go to a medical school and you say we want a basic CAM curriculum. What is that, what are you defining as CAM?

Some of the statistics that we are quoting in some of this paper is, you know, 1 in 3 Americans, 42 percent, and yet when you look at what that covered, that meant everybody that was taking a multivitamin, people going to Weight Watchers, people going to Alcoholics Anonymous.

We are quoting those statistics as CAM, as people utilizing it, but I don't think that is what this group intends is Weight Watchers as CAM curriculum or as part of the CAM community. So, I think again, we are going to have to define what exactly we are talking about because it is a very large and diverse group, and I think that was part of Linnea's point, was about the community, and it speaks right to the heart of this, the need for basic CAM curriculum, what exactly are you asking the medical schools to do.

I am not asking for specifics here. I am just saying that it is fundamental, someplace we are going to have to address that, because we keep throwing it out everywhere, and that would be my first question is what is it.

DR. PIZZORNO: Other comments about what would be an identification of a good recommendation?

[No response.]

DR. PIZZORNO: Okay. Well, I will prime the pump here a little bit.

How about something like educational standards consistent with the skill base that is expected?

DR. GORDON: I don't know quite what that means.

DR. PIZZORNO: It is very clear to me. How do I say it differently? If a CAM educational program is purported to develop a certain level of skill in a modality, therapy, diagnostic procedure, whatever, then, the curriculum must be consistent with demonstrating that that skill has been actually created in that individual receiving that training.

DR. GORDON: Joe, I'm sorry, what does that have to do with good recommendation?

DR. PIZZORNO: Maybe that is a recommendation.

DR. LOW DOG: That's a recommendation.

DR. PIZZORNO: That's the recommendation, yes.

DR. GORDON: Maybe we need a little more clarification. Do we agree that these, what Linnea has said, that these are the qualities a good recommendation should have, because you have kind of got us down that road a little ways, and I feel like we may need to finish up that piece of the journey.

DR. PIZZORNO: Yes, I want to finish that piece of the journey first. What does a good recommendation look like?

DR. LOW DOG: Could I just ask for clarification? I thought at lunch we had said we were going to do this tomorrow at lunchtime?

DR. PIZZORNO: Jim asked us to do it now.

DR. LOW DOG: Fine, fine, fine.

DR. PIZZORNO: I had already planned this out, so I thought it was good it came up at lunch.

DR. LOW DOG: Very good, Joe, okay.

DR. PIZZORNO: Also, you could also look at the recommendations generically, which I think that Linnea did. We also can look at recommendations particularly to the area of education, what do good recommendations look like in the area of education.

So, a recommendation in the area of education, what are some other characteristics that would be indicated it's a good recommendation, or are we ready to discuss what we have now?

MR. CHAPPELL: A recommendation that honors both our historical approach, as well as our new ideas for CAM, so it honors both Western and CAM modalities, that the outcomes contribute to that.

DR. GORDON: Related to that, I would add that a good recommendation is one that is based on some experience that is trustworthy and enlightening. So, for example, a good recommendation in the field of education might be based on one or more model programs that we have heard testimony about or participating in, so that we have a basis on which to make the recommendation, that it is not simply a theoretical recommendation.

DR. PIZZORNO: Effie?

DR. CHOW: I don't know whether this answers any question, but I think in a good recommendation, I agree with Linnea, we need a good objective, but to get a good objective, we have to be clear about the definition of what we are talking about.

It goes back again to definition. CAM, we don't have a definition of CAM. You know, we have been working on it, but how can you recommend a CAM curricula if we don't know what CAM is, whether on a global scale or a detailed scale. So, I go back to that.

First, you have to define what it is you are requesting for CAM curricula, so define that, and objective methodology and outcome and evaluation. That's a proposal, you know, a recommendation.

I believe again that we have to have a global view in order to talk about the specifics.

DR. PIZZORNO: Thank you. Any other recommendations about how to characterize a good recommendation?

[No response.]

DR. PIZZORNO: Let me just read what I have got here and let's give people a chance to chat about it because I think we have a consistency here, one being clear and jargon-free. I am going to kind of go through and read these things. If anybody has a problem with it or wants to ask a question or change it, raise your hand.

So, clear and jargon-free. I am going to split this into two. The non-global and achievable in scope. I am going to make this just achievable in scope because I want to do the non-global more thoroughly under defining what CAM is.

No. 2. Achievable in scope. Okay with that? Okay.

No. 3. Operationalizable, who does what, when, and how. By the way, my spelling checker says that is not a word, but I guess we will live with it.

MS. LARSON: I was typing fast.

DR. PIZZORNO: Are you okay with that? Okay.

No. 4. Evaluable, and that is also being kicked out by Microsoft spelling, how would you know if the recommendation was followed.

No. 5. Non-global meaning define CAM. It is not a homogeneous community and standards need to be appropriately defined according to the practice.

Are you okay with this? Okay.

No. 6. Honors historic approach, as well as new ideas for CAM.

MR. CHAPPELL: That was historic approach of Western Medicine, as well as new ideas for CAM.

DR. PIZZORNO: Say that again. I didn't quite follow you.

MR. CHAPPELL: A good recommendation will lead to an honoring of both Western Medicine and CAM modalities.

DR. PIZZORNO: How about if we say it this way - honors historic CAM and conventional approaches, as well as new ideas for CAM? Does that state what you are saying?

MR. CHAPPELL: Sure.

DR. PIZZORNO: Okay.

No. 7. Based on some experience that is trustworthy and enlightening.

Are we okay? Okay.

So, let's keep these characteristics of a good recommendation in mind now as we go through and look at these recommendations. I think Joe Kaczmarczyk has done a nice job of summarizing these in this handout that you have, so let's go through this.

What I would like to do is we have basically three recommendations. Let's look at each of these and ask if you are okay with it or how you might want to modify them.

So, we are looking at now page 3. We are looking at the worksheet, not at the Interim Report.

So, basically, undergraduate, graduate, and continuing education in CAM curricula. Basically, what we are saying here is we are looking at curriculum which is both in conventional education, both undergraduate and postgraduate and continuing education, as well as in CAM education, undergraduate, graduate, and postgraduate, ensuring that there is cross-training in each of those areas as appropriate for the practice.

Any comments or additions to these?

DR. WARREN: How many years do we add to the average training to accomplish this goal, or what do we have to supplant in the curriculum as it is right now to put any courses in CAM into their curriculum?

DR. ORNISH: I suggest that might be a good topic for October. What are some general guidelines, the details of how they are implemented, we can defer it for now?

DR. PIZZORNO: I think that is very astute. We are looking at general guidelines at this point, not specific details. We don't have time to do a lot of detail, I agree.

DR. ORNISH: Not that it is not important, just that we don't have time for it now.

DR. PIZZORNO: I'm sorry I cut you off. I think we have agreement that there should be some familiarization with CAM and conventional medical school education.

Do we have agreement with that basic concept or are you not agreeing with that?

DR. WARREN: I am okay with that.

DR. PIZZORNO: I think everybody pretty much agrees with that.

Bill.

DR. FAIR: I don't understand what you mean by "undergraduate." Now, if someone is taking political science as an undergraduate, once you go to medical school --

DR. PIZZORNO: Pre-M.D. is all we are saying. In medical school, but before they graduate with their M.D. degree is what we are talking about.

DR. FINS: Undergraduate medical education and postgraduate pre-residency.

MR. DeVRIES: But as an undergraduate applying to medical school, you could major in a variety of things.

DR. PIZZORNO: Let's be clear about the language. By "undergraduate," we mean when they are in medical school, but before they get their M.D. degree.

George.

DR. BERNIER: Would this be mandated to have the educational program, to have a common one, say, across the country?

DR. PIZZORNO: Jim, I am going to leave that to you to mention.

DR. GORDON: I think that is a subject for considerable discussion. I feel like the consensus we have come to is that there should be a program. Whether it should be the same program for everybody and whether it should be mandated, I don't know if we have a consensus on either of those yet.

DR. FINS: I actually chaired the subcommittee that looked into this issue, and we explicitly did not come to an agreement on a mandate, it was a recommendation, and if you go back and look at the minutes -- Gerri, am I right on that?

MS. POLLEN: Yes.

DR. FINS: Yes, because I think we had trouble with groups like the AAMC, and we would have problems with academic freedom.

DR. GORDON: My feeling about this one is that this is one we really need to spend some time on exactly where we want to come out, having heard that report of that committee. When we come back in October, we need to feel we want to be on that as a whole commission.

But the other point, I don't want to lose that Joe made, are we agreed that we are recommending that there be a CAM curriculum for undergraduates in conventional health care education? Okay.

DR. PIZZORNO: Tieraona, you had your hand up.

DR. LOW DOG: Yes, and if this isn't appropriate, just tell me so. I guess part of the thing is from research to education, are we going to make any statement about at what point is there enough research that it shouldn't be seen as CAM, and that is just part of medical education?

I guess one of the worries for me has always been a philosophical one, that if it is always CAM, so it is a separate Thursday class and it is on CAM, it is sort of always the stepchild, it is kind of always out there and separate, but not equal. In some cases, I think that is absolutely appropriate because there is not the research yet that should make that standard in a medical school, but are we at any point going to just say something about, I mean at what point is there enough evidence, 32 randomized, controlled trials, peer-reviewed journals, I mean at what point does it leave being CAM and just be part of medicine that should be just taught in the curriculum, because if we are talking about level playing fields, it seems in some cases if we continue to look at it as CAM, it is always going to be over there, and you are never going to learn about it, and it is always going to be something less than conventional medicine.

DR. PIZZORNO: Linnea, go for it.

MS. LARSON: It was just a sidebar. That is supposed to be answered tomorrow.

DR. ORNISH: In a way, Tieraona, what you have raised is the same point that Marcia Angell was making, which is, you know, we don't even need to call anything CAM, either it is scientifically proven or it isn't. So, if we really follow that argument to its logical conclusion, we don't need to do anything. We just say, well, just treat CAM the way we treat everything else, and if it has got science, fine, if it doesn't, fine, and there should be no distinction, but I don't think that is what you are saying, is it?

DR. LOW DOG: No.

DR. ORNISH: So, how is that different?

DR. LOW DOG: Let me just pick something like glucosamine because it's easy. At what point is there enough research that shows that glucosamine may modify the progression of osteoarthritis, and it shouldn't be CAM. It should just be in your rheumatology lectures and pharmacology. You just learn about glucosamine right next to the NSAIDs.

Why does that have to always be CAM, and are we going to address that? Maybe we are not, and I am okay with that, too. I am just saying that at some point, if it is always seen as CAM, it will never be integrated into any sort of curriculum, and I think that some of these things deserve to be integrated.

DR. ORNISH: But what you are saying, Tieraona, is that as long as it is unproven, it's CAM, and once it's proven, it is no longer CAM, but you don't really mean that either, I don't think, but that is really logically what you are saying.

DR. LOW DOG: No, I am saying that it is because we still define CAM as this -- to me, we have never really resolved the issue of what is CAM and the CAM community, so that has still never been resolved in my mind, and glucosamine, to me, the way it is used and prescribed does not fit into a traditional alternative philosophical model. It is used specifically as a mediating agent in osteoarthritis, so it doesn't fit within a system, but it is lumped under CAM, because it is a CAM approach.

What I am saying is those lines become very blurry to me, and I am concerned that always if some of these things are always seen as CAM, that there is going to be a general perspective that it is always somehow less than.

DR. ORNISH: I get the point, but I am just saying again you still haven't addressed my issue, which is that if you followed your argument logically, then, as long as it is unproven, it's CAM, but once it is proven, like glucosamine, you know, it has got enough history, the randomized trials that show it is effective, so then it is no longer CAM, it is just standard medicine as though CAM isn't standard medicine or only things that are unproven are CAM.

I think it is a central issue because it has been raised in one form or another by a number of different people, and I think we need to get some clarity, at least in a philosophical sense, because this is going to be something that people are going to be criticizing our report, Interim or Final Report, about, and they are going to say, well, what do you mean, I mean because there are a number of people who say you don't need a National Center for Complementary and Alternative Medicine at NIH. If it has got good science, it will be funded.

Well, it hasn't been until now, and the reason was because it isn't a level playing field, or you will have the journal editors will say we don't need to call it CAM or not, if it has got good science, we will publish it, except that you have something like The New England Journal, who has never published any articles on CAM even though they will say, oh, yeah, we are just waiting for a good article to come along.

So, that is the real issue that we have to address here.

DR. PIZZORNO: Thank you. This is an excellent discussion, and I think you both raised key points. I would like to summarize them, unfortunately, I can't type them while I am talking, and that is, I think, Tieraona, you bring up, too, I thing a crystal-clear point that if we define CAM as modalities, then, we have really lost the whole conversation. I think what Dean has said is consistent with that, too.

CAM is about systems of healing, and within those systems of healing, we have both a philosophical precept, as well as therapies that are used, and research can be done within those systems of healing that document whether those therapies are efficacious or not, and they still belong within those systems of healing.

Simply defining that once something has been proven, it therefore now goes into conventional medicine and no longer is CAM, is not a pathway I think we want to follow.

Equally important, we ought to recognize that the CAM professions overlap each other and overlap conventional medicine. Speaking as a naturopathic doctor, I suture wounds, I take out splinters. Is that conventional medicine because conventional medical doctors do it? And conversely, if a medical doctor prescribes glucosamine sulfate because it is more effective than many of the NSAIDs, is that all of a sudden not appropriate in CAM?

I think that the point I would like to see us get to is that each system of healing must have high-quality education that ensures its practitioners understand and effectively practice their modalities, and that these modalities be consistently applied, consistently evaluated and tested by rigorous modern science.

So, some hands are up. Jim, and then Tom.

DR. GORDON: I would just like to, although I appreciate the distinctions, I would like to add another perspective to the whole issue of CAM or not CAM. I see this very much as an evolutionary process and that we are evolving toward a medicine and a healing that is much broader than any of the systems that we now have in play.

I think that the time is coming that as things are proved, they will be included in different ways, but right now we are at a particular political juncture and a kind of ideological juncture where we need to call attention to those things that are outside of conventional medicine because conventional medicine is limited, and because it has had in some ways blinders on in looking at these other approaches.

I think that may always be the case, that there may always need to be some kind of National Center for Complementary and Alternative Medicine because any orthodoxy tends to be blind to anything that is outside of the orthodoxy.

So, in a sense what we are talking about is enlarging the boundaries of medicine and healing in a variety of ways. Now, we may come to a point at which the orthodoxy is open to and embraces all other systems of healing and treats them with equal respect, or we may not, but right now we are not at that place.

MR. CHAPPELL: I have been waiting for some time.

DR. PIZZORNO: Tom, you are next.

MR. CHAPPELL: I think Jim is right, that we are at a particular point in our cultural life, and it does need to be so named as it is, but we also in the recommendations have decided that we would be visionary and be talking five and 10 years in terms of our context.

So, 10 years from now, how our particular systems resolve care or healing will be different in terms of the methodology, than the methodology we understand today as being standard. So, I would just say perhaps we are going to evolve to a distinction between natural medicine and standard medicine.

DR. PIZZORNO: I followed you until the last sentence. Would you go again?

MR. CHAPPELL: I am suggesting that the CAM modalities lead to, once they are proven and have the kind of efficacy that we are seeking, they become categorized as natural medicine as distinct from standard medicine.

DR. GORDON: Since I started this piece of the discussion, just two sentences. One is I see us evolving in a direction in which those distinctions may not be the most important distinctions at all, that the distinctions may have to do with very different things, for example, that we may conceptualize medicine quite differently.

If we go back to our Hippocratic roots in Western Medicine, for example, and we pay attention to those principles, and we really apply those principles, then, we understand that we only use drugs and surgery in extreme instances, and that we tend to use self-healing as the basis of our health care.

So, I am looking for a larger, no more of a dichotomy, but more of a system in which different, sort of basic principle are invoked, and that all of the different systems of healing have the capacity to participate in this larger system.

DR. PIZZORNO: Effie, and then Charlotte.

DR. CHOW: Thank you. The gist of the conversation has mostly been the fact of integrating CAM into medicine, that it becomes medicine once it is proven, so it's second rate. I know I was brought up that Chinese Medicine was second rate in my young days and that it was not to be listened to.

So, in a sense, we are putting CAM under that category, too, in a sense. When it is proven, then, it can become medicine. Well, the discussion here was, on the term, was it becomes part of medicine.

We are not only talking about medical school, we are talking about all health professionals. Then, we did talk about that we are really dealing with health and lifestyle, all of that. That seems to get dropped away often in our conversation.

So, what is it, is it a one world health care, lifestyle, and getting away from medicine? I just want to go back again. A lot of this kind of chaos in thinking is lacking a clear definition of where CAM is and the direction of CAM.

Anyway, I want to reinforce that it isn't medicine we are really talking about, it really is an overall health and with all the other social aspects and lifestyle aspects we are talking about.

DR. PIZZORNO: Thank you.

Charlotte will be next, and then Dean. Clearly, we have opened up a huge unresolved issue with the Commission here in terms of definitions and such, and we will need to come to resolution on this.

Charlotte.

SISTER KERR: Thank you for that comment. I think maybe this does move on to the next meeting, but I wanted to say something about our definition of science, and we have heard enough speakers to hear some of the discussion and controversy in that definition.

Certainly, Dr. Russ Roy and Friends of Health spoke to this, but I would say we are evolving in this definition of science and that we are enlarging the boundaries of science, and it is my opinion that it is actually this philosophical and changing scientific or present scientific framework that is making it difficult for us to speak in the areas of soul and spirituality, which is an area that we still haven't quite included yet.

I just wanted to make that point now. Thank you.

DR. PIZZORNO: Dean.

DR. ORNISH: I just think that part of the problem may come with the very words "complementary and alternative medicine," and we have heard many people testify that we should be thinking more in terms of terms like "integrative medicine" rather than CAM, because CAM, by its definition, is something outside traditional medicine or Western allopathic medicine.

I would love to see a report titled something like towards an integrative medicine, and then it gets away from the kind of judgmental things that Effie was talking about. It is not second rate because there are many things in allopathic medicine that are unproven, just like there are many things in CAM that are unproven and that we are really talking about leveling the playing field, applying the same standards of evidence based, whatever we end up determining is evidence based, across the board, and integrating them, and then it addresses the issues that Tieraona raised, is if it is glucosamine, it becomes part of standard medical practice, then, we are really integrating it, and we don't have to then arbitrarily say at what point does it cross the line from being alternative to traditional, that there is a whole spectrum that we are really trying to move everything, the unproven parts of allopathic, the unproven parts of CAM towards an evidence-based approach and integrating the best of everything that works and finding the best systems to use for any given patient.

DR. PIZZORNO: Thank you. I think that is well said. I want to follow up also on what Jim said. Are we here because we want to develop the best medicine, and I think we recognize the huge value of pluralism in health care, that each of these disciplines has its place, and we want to have each of them evolve and if some of us get some parts of the answer better than others, the others should be able to use it, and we should not lose that individuality and pluralism.

Joe Fins, and then Veronica.

DR. FINS: Thank you, Joe Pizzorno. I think this has been very interesting because there is like a sociology issue here. You know, there are things that work and things that don't work. There are things that are safe and things that are unsafe. That is sort of a universal.

But what is different is the sociology of how glucosamine got to patients with arthritis versus nonsteroidals. I think that is something that we might want to just put in the Final Report, that we can have the same endpoint, have different ways of getting there, and that the different paths have different challenges and different opportunities, but it is not the science that is different, it is not efficacy that is different, it is the history of the progression of the discovery to the clinic.

I think there are the market forces, there are different paradigms, I mean there are lots of reasons why it is that way, but I think we are sort of getting focused on whether glucosamine should be treated any differently than a nonsteroidal.

The answer is no, but I think the reason we are having this discussion is because we somehow have to straddle two different historical paradigms of how those agents got to the bedside.

DR. PIZZORNO: Okay. Charlotte, just a real quick thing, and then on to Veronica.

SISTER KERR: I just want to know, what you just said, you said it da-da-da-da, it is not because our science is different, but so-and-so. Am I the only one sitting at this table who thinks maybe there is some kind of different science? It is really, truly just a question, because of what I just said before this.

Are we not questioning the definition of science at all as we understand it for the last bit of history? Dean summarize it all by defining it under science, and then there would be one kind of medicine.

DR. FINS: My comments were limited to the question of the evaluation of a therapeutic agent. I mean I think we are products of Baconian science. I mean that is sort of the paradigm that the Western World at least is in.

Does it mean it is an exclusive paradigm? Probably not, but there are other ways of looking at these issues, but that is a philosophical question that won't be in the Interim Report. It is used, so I don't think we can really address that now.

DR. PIZZORNO: Do you want to answer it?

DR. FINS: I can't answer that.

DR. PIZZORNO: Thanks, Joe.

Veronica, and then Jim.

DR. GUTIERREZ: Words are very powerful, can be very powerful, and I think when we talk in terms of training, education, credentialing, and so forth, we need to choose our words carefully.

I personally don't think we will ever have a level playing field when we use the term "medicine," because there is a lot of people who contribute to health, who aren't in that classification.

I am very comfortable with, for example, a term like mainstream health care, which could encompass everybody and make them comfortable, but medicine has 100-plus years connotation to the word, and not everybody would be comfortable under that umbrella.

DR. PIZZORNO: Bill, one last comment, and then I want to finalize this recommendation.

DR. FAIR: Unfortunately, I didn't hear all of Tieraona's comments, but I think the glucosamine story is a very appropriate one. The use of glucosamine didn't arise from the medical profession. Consumers were using it, and like any leaders, the doctors said let's find out where the people are going and get in front of them say follow me, and basically, that is what happened.

So, it wasn't the clinical trials that showed that glucosamine was good, and that is why people used it, so I think that we have to be aware that some of these things will arise just from common usage or traditional healing or whatever.

Secondly, I am a bit concerned about the term "integrative medicine." We gave a lot of thought to the type, of what we would call our center when we opened it in Soho, and integrative medicine, the connotation I found, at least in the New York area, was that meant doctors practicing CAM medicine. It is another topic, but I don't think doctors can do it well and physicians can do it well.

I think that something like complementary more fits the bill. I am just afraid if we use "integrative," we would be sort of endorsing a physician-controlled system.

DR. PIZZORNO: So, let's get back to what was the original intent of, number one, basic undergraduate, graduate, and continuing education in CAM curriculum.

I think, number one, as Joe Kaczmarczyk reminded me, that is to ensure that all practitioners, regardless of type, can talk with their patients about CAM, number one. So, the medical doctor needs to be able to advise their patient about CAM practice.

Conversely, I believe very strongly all CAM practitioners must understand conventional medicine well enough to talk with conventional medicine practitioners. My experience has been that so much of the distrust that has evolved between conventional and alternative medicine has been the lack of ability to talk to each other and also the fact that we tend to see each other's failures, which gives us a skewed perspective.

So, looking at this recommendation as stated here, and realizing that our intent here at this stage at least is to recommend, not mandate, is there anybody that can't live with what we have right here?

DR. GORDON: I would just like to add that I think it is talking with, it is also appreciating the limits of one's one abilities. I think this is a crucial area that everybody needs to understand what they know about and what they don't know about, and also finally, the other element is to be able to refer to other people intelligently.

DR. PIZZORNO: Perhaps a better term consistent with what Bill had said, was I much prefer the term "collaborative medicine" rather than "integrative medicine," because collaborative medicine recognizes we each have strengths and weaknesses, and what is best for our patients is to talk to each other and figure out what is best for our patients, not to alienate each other.

Joe Fins.

DR. FINS: Just on the referral issue that Jim mentioned, I just want to hammer home again the importance of referral in allopathic and in CAM therapy to palliative care when patients are terminally ill and dying. I mean there are resources that are available for end-of-life care in palliative medicine in the hospice situation, and people can be diverted from that by both allopathic and conventional CAM practitioners, and we need to be attentive to that referral for people who are desperately ill, whatever the paradigm.

DR. PIZZORNO: George.