The second category is I think the main category, and that is we need more research.  I mean if you look through these recommendations, there is do research in this, do research in that, et cetera, et cetera, and a lot of that comes down to supporting more good research.  So, I see that really as largely one recommendation under which a number of these things could fall, and that includes recommendations across all agencies that are involved in research, and it includes making sure that they are done in a collaborative way to address pertinent complementary and scientific issues.

          The third category was, in my opinion, what I think a lot of these fall into really has to do with the prioritization process, how do we go about prioritizing all these different things that we think need to be done.

          One of the reasons I think that is important is because if you end up with a long laundry list of things, it dilutes out, I think, the power of what the recommendations are.  If we just need more money and everybody should do it, and then you are just going to kind of list that, I think the question is how do you go about doing that.  Several of these recommendations fall into the area of how do we go about prioritizing that, and there are some recommendations that the Institute of Medicine, the National Science Foundation, and perhaps other bodies get involved in helping us to work with public and practitioner and scientific input to set up a proper prioritization process for that.

          There was several recommendations about the importance of ongoing review, systematic review and evaluation, there are a couple of groups that do that, and the importance of maintaining that on an up-to-date basis and providing simple public language descriptions of the results of that review, so kind of an ongoing process.

          Then, there were several categories that fall under the area of infrastructure and training.  One might say this is really in the area of do more research, you could perhaps put it as a subset underneath do more research, but our feeling was that it should be addressed specifically, that the importance of dual-trained individuals who understand both complementary medicine, as well as conventional science are important and that there needs to be a specific recommendation about infrastructure, that there needs to be a support of infrastructure, and a number of these recommendations have examples that we would put under here in terms of how infrastructure is currently supported in research, building core clinical sites, building basic research sites, building demonstration projects, and that should be done also in complementary and alternative medicine.

          The sixth category, which I kind of threw everything else in, but I called it Methods in Epistemology, which has to do with addressing methodology issues, because there is always ongoing, and should be ongoing, discussion about what is an appropriate methodology for answering particular questions, how could you go about doing that, and also, are there assumptions that come from many of the complementary medicine systems that are not readily addressed with straightforward standard research models, things like energy medicine, which was mentioned here frequently, how do you go about looking at whole systems -- holism is one of our guiding principles -- how would you go about doing that, relationship issues, spirituality, that type of thing.

          So those types of things that are really epistemological, but then have implications for how we go about doing research methodology, and so recommendations that address that specifically, methodology and epistemology would be another category.

          Anyway, that is kind of our thinking or at least some of my thinking.  Some of those categories are already there and have been lumped underneath that, but my suggestion is that as we go through these recommendations, that we think about trying to condense them further and if a recommendation is simply saying, for example, do more research and do it in this agency, then, hopefully, if we can agree on these general recommendations, then, we can say, yes, that will go in there and it is part of that.

          Did you want to say anything, Dean, or are there any comments on that?

          DR. ORNISH:  No, I think that was very eloquent.  I also just wanted to acknowledge the other members of this working group, George, Effie, Veronica, Bill, and Tieraona, and also to second your praise for Gerri and the other staff people who worked on this.

          Do you want to now just go through each individual recommendation or how do you want to proceed?

          DR. JONAS:  The issues, yes.

          DR. ORNISH:  Well, the first issue is increasing dialogue, cooperation, and collaboration among conventional and CAM practitioners, clinicians, and researchers.

          Rather than just reading it, I think you have all seen this.  The long and short of it is, as Wayne said, we think that we should increase dialogue, cooperation, and collaboration among the conventional and CAM practitioners, and gave examples of what some people are doing, just that, people who have testified before the Commission.

          The challenges are the lack of dialogue and the lack of mutual respect, and whether there is a willingness to enter into a dialogue.  I think that although in 1(A), on page 2, we talk about that the lack of dialogue impedes the progress and building knowledge about CAM, I think it might be worth making it reciprocal, as well, and saying that it also, I think, works to the disadvantage of conventional medicine, too.

          I wasn't quite as clear about 1(B), which are the cultural taboos that can affect the evaluation of research applications.  I was wondering if maybe --

          MS. POLLEN:  That was actually a quote from Marvin Cassman, who is Director of the Institute of General Medical Sciences, at the first research meeting in October of 2000.  He was just recognizing that there are cultural taboos in conventional medical circles that do impede the dialogue, and also when applications come in.  It is probably not only for CAM.  I mean there are other areas where this happens, as well, but he is looking for more openmindedness when he was saying this.

          DR. ORNISH:  Okay.  Cultural taboos, I mean needs just to be a little bit -- because we are talking about, it sounds like child incest or something, you know what I mean.  It is more of a prejudice or bias.

          The second one is developing research.  I think it should be clear that it is research grant applications of sufficient quality to compete.

          IRB familiarity is No. 3.

          No. 4 is including CAM professionals on advisory and review committees and in discussions.  I think it also should be and vice versa.  Again, it should be reciprocal, that we need to include conventional or allopathic people on CAM advisory boards and schools, research committees, review committees, and advisory committees.

          So, the two recommendations that are here, Wayne, do you want to just go through those?

          DR. JONAS:  Yes.  I think the first one is what I had outlined as the major category, and it is part of this major category, and that is to strengthen emerging dialogue between conventional medicine and CAM by developing way to enhance cooperation.  Then, it lists researchers, clinicians, research centers programs, et cetera.

          My suggestion is that we make this stronger by actually saying that we suggest that a series of ongoing meetings, conferences, to foster and develop collaborative research projects and discuss various issues in CAM be supported and sponsored.

          DR. ORNISH:  Under whose auspices?

          DR. JONAS:  Under whose auspices is the question.

          MR. CHAPPELL:  Well, that gets it by thought, as well, and by the way, I just think you have done a wonderful job, your committee and Gerri, thank you.

          As it relates to No. 19, you are beginning to get at what I am looking for, is there some operating idea of how this will be advanced forward rather than it just being lifted up as we need, can we become more specific in this paragraph and later language about whether you are recommending annual conferences or some organization of a body, but I do think we need to evolve to that specificity with a recommendation.

          DR. ORNISH:  I agree with what you are both saying, and maybe that could be done under the auspices of the NCCAM or the Institute of Medicine.  I think that by putting it under those kinds of organizations, it provides the credibility and the ability to draw people, because of the cultural taboos that you mentioned, that Gerri mentioned, it would be easier to get people to come to a meeting under those auspices than if it were just done ad hoc, I think.

          DR. JONAS:  Certainly, one of the possible ways is to dovetail this with CAM Central, which we are going to talk about a little later, which is an office that coordinates this, the various activities that we have been talking about, and one of their duties could be to put together or facilitate with various agencies, ongoing  collaborative dialogue meetings in particular areas.  So, that would be one specific way.

          I wouldn't want to make that the only way and maybe what we could do is then have several examples including that one as perhaps the first one and then Institute of Medicine, then, NCCAM-sponsored conferences, and this type of thing as examples as to how it could occur.

          DR. ORNISH:  Joe.

          DR. PIZZORNO:  Two things.  One, I would still like to see Wayne's I think brilliant triangle diagram of the different kinds of research and what is appropriate be submitted to the Commissioners and considered for inclusion in this document, because that is really quite, quite good.

          The second is a little technical change, but I think it will help.  On the third line, where you have "collaboration among conventional and CAM," I think there should be a colon there, because I want to ensure that conventional and CAM relates not just to research of clinicians and practitioners, but also research centers, programs, institutions, professional leadership organizations.

          MS. POLLEN:  A colon after researchers?

          DR. JONAS:  A colon after CAM.

          MS. POLLEN:  I see what you are saying, yes, okay.

          DR. JONAS:  So, that applies to all those things.  Now, that does not apply, of course, then to federal and state research and health agencies, so it will have to be separated as a separate clause.

          MS. POLLEN:  Right, we can do that.

          DR. ORNISH:  Other comments before we move on?  Jim.

          DR. GORDON:  I think it would be helpful, when you mention the specific coordinating agencies, CAM Central, IOM, NCCAM, to mention them as part of this paragraph.  If everybody agrees, then, we can move ahead with it and omit a step.

          DR. ORNISH:  Great.  Joe.

          DR. FINS:  I don't know exactly where this goes, but since you are talking about the relationship and the coordination between conventional and CAM research, I am just wondering -- and I have looked through this -- if this is the place where we discuss the issue of global budgets, are we robbing Peter to pay Paul.  I don't know if it is another issue for Saturday, but relative allocations.

          If we are talking about there is $20 billion to spend, how does it get spent?  Someone might be losing if CAM is gaining.  Have you considered that relationship?

          DR. JONAS:  I think we addressed that under research support actually, and where the big bucks go.  I agree, I think that is an important issue to address.

          DR. ORNISH:  Well, it is a critically important issue because if people think we are going to take money away from them, they are going to fight tooth and nail.

          On the other hand, since we don't have a budget surplus anymore, if we recommend that more money be allocated for that, then, it is going to come out of some else's budget.  Maybe it is not NIH's, but it is going to be some other program.  It will be harder to define whose it is, but it is going to make it more difficult.

          So, there is really a strategic question, is whether it is better to highlight that or just let it be a subtext.

          DR. FINS:  Because I think a corollary issue is how things get labeled, like, do you go in under CAM research, or do you go in under allopathic research if you have a funding strategy.

          DR. ORNISH:  Right.

          DR. FINS:  I don't know where this goes, but --

          DR. JONAS:  It goes actually under Recommendation 21, so when we get to that, let's readdress this, because I think it is very important.

          Recommendation 20 is, I think, fairly straightforward.  As Dean mentioned, we ought to make sure that it is a reciprocal balanced recommendation, so it is not simply that CAM practitioners ought to be sitting on one board, but there should be mutual membership on various advisory, journal, regulatory, advisory boards from the different professions.

          DR. WARREN:  You mentioned here licensed CAM professionals.  You are assuming that licensure is going to be a requirement?

          DR. JONAS:  Good question.

          DR. ORNISH:  I think we are actually.

          DR. WARREN:  I don't agree with that.

          DR. FINS:  How about appropriately credentialed because we are going to address it more robustly later?

          DR. WARREN:  I think that is much better than licensed.

          DR. ORNISH:  So, we will be dealing with the issue of licensure versus credentialing at another time, I presume.

          DR. LOW DOG:  I think that there is only a few places where that would be relevant, but I can tell you from New Mexico, that especially in areas of research, bringing in traditional indigenous healers, Navajo and Pueblo, involving them in the research, because you can't do research in those groups without their being there, and they have a lot of sort of restrictions on what they are going to allow us to do.

          So, I think that if we are just talking about license without including some specific areas where research is essential, and the inclusion of their healers would be important.

          I am in favor of licensure and training, but I think you need to be inclusive there.  I am only thinking of all that goes on in our own state, but there is no licensure in those groups, and yet they are intimately involved in our research process.

          DR. FINS:  Why don't we cross-reference the other sections?

          DR. ORNISH:  Because this area is going to be debated in a different subcommittee of whether licensure should be required, whether certification should be required, whether there is some groups that should be, as long as they disclose what training they have, they need to be neither licensed nor trained.

          I think we are in a way getting ahead of ourselves, because we haven't really resolved that issue.  I mean we could just say whatever we resolve that as, then, we will put here.

          DR. JONAS:  Gerri recommended at least for this wording, "appropriately qualified," which may vary depending upon what the topic is, and this type of thing.

          DR. ORNISH:  Okay. 

          DR. GORDON:  So, it would read essentially, "include appropriately qualified CAM professionals and traditional healers on research," et cetera, et cetera.

          DR. ORNISH:  Well, "traditional healers," could mean Native Americans, or it could mean Arnold Wellman [ph], I mean I am not sure what traditional healers means.

          DR. GORDON:  I was just trying to get the word that you want here.

          MS. POLLEN:  I think just "appropriately qualified."

          DR. GORDON:  Just "appropriately qualified."

          MS. POLLEN:  And not "traditional," just leave "appropriately qualified."

          DR. ORNISH:  What I was saying before, though, is it should be reciprocal, it should be both CAM and conventional, if we are using the term "conventional" for non-CAM, for allopathic, or whatever, so that it is clear that it goes in both directions.

          MS. POLLEN:  Yes.

          DR. GORDON:  I just want to get something clear.  So, you are saying that on the board of an acupuncture journal, there should be an M.D. who doesn't know anything about acupuncture?

          DR. ORNISH:  There should be an M.D. who has some experience with --they don't necessarily even need to know about acupuncture, but there should be somebody who has experience with experimental design, biostatistics.  Those kinds of things don't require knowledge of acupuncture to make good research.

          DR. GORDON:  I thought that is what you were saying.  I just want to make sure that people agree to that before we move on.

          DR. ORNISH:  I also think again, in the larger context, it makes it much more defensible and marginalizes people who would criticize.  You say, well, yes, we think that it should go in both directions.  Then, you have to argue about why it shouldn't be, and that tends to get people on the extremes.

          DR. GORDON:  This is a small question, but potentially a knotty one.  I just want to make sure everybody agrees.  If everybody agrees, that is fine.

          DR. ORNISH:  Knotty or naughty?

          DR. GORDON:  I think it is knotty because some people may say, well, look, here we are, we are this fledgling little group of people, if you put on an M.D. who is a qualified research in methodology who is a skeptic, he is not going to let us publish anything.

          DR. ORNISH:  Well, the fact that somebody is on a commission doesn't keep people from doing things, but I think that is exactly what people need, are a few skeptics on there, in both directions.  I think that is the whole nature of science, is to have skepticism.

          Just so you know where I am coming from, just to put my own biases on the table, what concerns me about both conventional and many CAM practitioners is a lack of skepticism, such a strong belief in the efficacy that there is a reluctance to submit it to more objective analysis.

          That is the kind of thing that I think that people on both sides could benefit from.

          DR. GORDON:  I wasn't talking about skepticism with a small "s," I was talking about it with a big "S" as a profession.

          DR. ORNISH:  As a cultural taboo.

          [Laughter.]

          DR. ORNISH:  Tieraona.

          DR. LOW DOG:  For one, I don't think that if you are a small fledgling acupuncture magazine, that you would hire an M.D. skeptic, so we are not saying which one would have to be on there, but I mean you could argue the other way, what would a massage therapist really know about invasive cardiology.

          I think that the door swings both ways.  I think that it is a good recommendation, Dean.  I think there should be inclusion, and by including, and I think it needs to go both ways, I really do, so I support that.

          DR. ORNISH:  We could just say "appropriately qualified."  "Appropriately qualified," I think covers a lot.  Again, we are not dictating to anyone, so it is not like these recommendations have the force of law, it is more of a general principle.

          Effie.

          DR. CHOW:  I think one of our big debates has been that people don't understand the principles of what is being called research.  I know that there are solid protocols, but protocols can be adjusted and still be good quality research, certain considerations to a particular practice.

          If someone doesn't know anything about it, someone with a big "S," they are going to be close-minded about the nuances, which perhaps makes it successful or not successful.  That doesn't mean fudging the results, nor fudging the guidelines or protocol.

          But I think it is really important that people are involved, and people, also, who know research protocol, that they should have some innate experience and knowledge about the particular CAM practice.  I think that has been a big discussion all this time.

          DR. ORNISH:  In the interests of time, would you be comfortable if we said "appropriately qualified?"  Does that give you enough room to cover the point that you are making?

          DR. CHOW:  I think, not really.  It depends on who reads the appropriate qualification, who defines it.  I think it should be stated that they should have knowledge, working knowledge with the particular practice that is being researched.

          DR. ORNISH:  Well, see, that is why we disagree, because I think that there are people who have experience in biostatistics and experimental design, who can help provide meaningful input into studies that they may not know very much at all about the intervention itself.

          I understand the point you are making, but I would be reluctant to limit this to say that they have to be.  Otherwise, if we are going to CAM people on conventional research journals, are we going to say that they have to be experienced interventional cardiologists and know how to do angioplasty before they could be part of a cardiology review board?  I mean I don't think we would take it on that side either.

          I think that everybody brings a dimension of expertise that can be useful, and I think like the blind man and the elephant, the more different dimensions you get, the closer to truth you get.  Even if one person isn't expert in all aspects of that particular discipline.

          DR. CHOW:  Well, I think that is moving so, maybe not specifics about cardio angioplasty, but acupuncturists, which were not required to know Western medical anatomy and physiology, is now being required to know anatomy and physiology from the Western standpoint, and also analysis and diagnosis by Western methods.

          So, they are being required as part of the training, and so I guess maybe not right away, but hopefully, that that is in the future, and in the near future, that researchers, if they want to do research in acupuncture -- well, let's use another -- in homeopathy, et cetera, that they must also have some training in that.

          I guess that goes with education of professionals.

          MS. CHANG:  With all due respect, I'm sorry, Dean and Wayne, you are way over your allotment on this particular topic.

          DR. JONAS:  What we could do is elaborate a little bit on what "qualified" means in terms of methodology, expertise in particular areas including complementary and the conventional areas on that, and then we will bring this back to you all.  I will bring it back to the committee and that type of thing.

          DR. ORNISH:  Can we move on now to Issue No. 2, Wayne?  Are you okay with that?

          DR. JONAS:  Yes.

          DR. ORNISH:  Issue No. 2 is conducting high-quality CAM research, prioritizing types of research needed, and assuring public input into the process.

          I will put my two cents' worth in.  I think that I would like to see something right up front about safety, efficacy, and cost-benefit before we get into too much of the specifics, again for all the reasons we have talked about, but other than that, I thought it was very well described.

          I have a few other minor points also as we get further along, particularly on page 4, the second paragraph, where it says, "Its the view of some CAM researchers that the requirements for CAM," I would say "were often higher than those for conventional research."  That paragraph, I think might be moved closer to the beginning of that section just for the very reasons we have been talking about.

          MS. POLLEN:  Moved forward.

          DR. JONAS:  Yes, moved forward.

          This category lumps several of the things that we discussed, and I think what we will do is maybe split them out, because it's huge.  As you will see in the recommendations, we have gotten 21 A to Z almost, and there is really the issue of support, doing more complementary medicine research, and then there is the issue of prioritization and obtaining public input.

          I think we would like to kind of massage these out a little bit, and we can adjust that, but I would like to go to the actual recommendation, if you will, which is on the bottom of page 5, No. 21, which really is the primary recommendation that there be more support.

          "The Commission recommends that all federal agencies with research or health-related responsibilities increase as relevant to their mission, support in a more proactive manner clinical research on the safety and efficacy of CAM practices and products, basic research on underlying mechanisms, and health services research to improve CAM use within the health care system."

          Any feedback or comments on this?

          DR. ORNISH:  Well, the first one is do you want to comment at all here about whether those a new dollars or whether those are reallocation of existing dollars, or is it better not to address that question at all?

          DR. JONAS:  I think we should.  Any comments on the general recommendation in terms of whether we should be more specific about that?  David.

          DR. BRESLER:  Yes, I would like to see some language including an addition to safety and efficacy, indications, contraindications, precautions, complications, I would like to have a fairly broad view if they are going to do this research.

          DR. JONAS:  You don't see that as falling under safety?

          DR. BRESLER:  It is not just safety, but I think indications of contraindications, too.  We have had a lot of discussion about interactions of CAM modalities with other kinds of modalities, and I think we have to stay vigilant of this if we are going to encourage this type of research.

          DR. ORNISH:  Good.  Who else?  Joe.

          DR. FINS:  I have two points.  I don't think it is strong enough overall.  I am not sure it is strong enough on the HRSA side, the health services dimension, it gets buried.  I know it is here, but it is not as prominent.  I think all of these things that are embedded in No. 21 perhaps deserve their own bullet because I think they are all different.

          I think that as I read through the later part of the report, there is a lot of redundancy and a lot of nitpicking kind of mechanistic kind of approaches, which I may not necessarily be a recommendation, but sort of background, but I think that we really want to identify these various areas.

          The other issue about the prioritization question is, it seems to me, Congress appropriates money and decides what the balance is between the various constituencies, disease constituencies and professional organizations, and the like.  So it is really their prerogative to set the standard.

          But what I was sort of hoping to see was some mechanism to help provide Congress with some guidance into knowing whether or not, in the context of a global budget, what the relationship, what the percentage should be, and I don't know how we can help them there, but I think it would be helpful if we could sort of characterize that somehow.

          DR. JONAS:  There is recommendation actually along those lines in terms of requesting that the IOM establish some prioritization approaches which then, of course, would go to a variety of individuals including Congress.

          DR. ORNISH:  I was just going to say that it may be that we simply -- I mean it would be hard for us to say, as a commission, for example, whether they should be appropriating new money or reallocating, because a lot of that will have to do with changing budget requirements.

          You know, we had a budget surplus this last year.  This year, we are already in deficit, but at the same time, it may be worth mentioning just what is self-evident, that it would be easier to effect this if there were new dollars coming in rather than reallocating existing dollars, or we may just want to remain silent on that.

          DR. JONAS:  Let's talk about the budget issue since it keeps coming back and hitting us in the head.  Does the Commission feel that there should be an emphasis that there be new money, set aside money, or support, because we are making all these suggestions that there needs to be more research, and the natural question is how to do that, and are we suggesting there be appropriations for that?

          DR. ORNISH:  I would like to suggest that we make a recommendation that increased funding be available for research in these areas, in safety, efficacy, health services, cost-benefit, whatever.  We might even just say, very explicitly, that, absent that, it will be very difficult to convince existing agencies to reallocate some of their current research budgets for these areas.

          I think certainly people in Congress will get that very easily, and it is just stating what is true, and then we are not really saying how much more it should be, but just the general principle gets outlined.

          DR. GORDON:  I think there is a real question here that we are sort of coming toward, and do we think research priorities ought to change, or do we simply say we want more money for this approach.

          If we say the latter, it is the safe thing to do.

          DR. ORNISH:  I don't understand that.

          DR. GORDON:  Let me just finish.

          DR. ORNISH:  I just want you to clarify, when you say research priorities should be changed or this, this is asking for research priorities to change.  I am just trying to understand.

          DR. GORDON:  What I am saying is there is a fixed amount of money basically.  I mean we can act as if there is going to be infinite amount of money, we know it is not true.  Do we want to make a statement about research priorities should shift in this direction as we make a statement a little bit later on saying that we ought to begin to shift some of the research priorities toward those things that can't be patented, for example?

          My answer is yes, but I want to put that out as a question for us to address, which is really in response to the issue that you raised, how do we look at budget.

          MR. CHAPPELL:  I agree with Jim that we ought to be looking at a shift in priorities at a minimum.

          DR. GORDON:  What Steve is saying, quite rightly, is this may be something we want to focus more on, on Saturday morning, because we have a lot of recommendations here, so I think that is a good idea, but I do think it is something we are going to have to grapple with.

          DR. ORNISH:  Well, then, if that is the case, then, shall we limit now discussions away from that area into the other recommendations themselves?

          MR. CHAPPELL:  If I could just finish my point.  You have been using the language safety, efficacy, and cost-benefit, and I didn't think that cost-benefit needed to be a qualifier, in fact, I would rather it not be a qualifier.  It is not in the language currently, so I am seeking clarification, is it your intent to put it in, if so, I have a problem with that.

          DR. ORNISH:  It is my idea to put it in, and the reasons is, is that I do think that one of the advantages of CAM, in our work, for example, we found that almost $30,000 were saved per patient by teaching them how to change lifestyle and diet rather than having, say, bypass surgery.

          It is something that can really appeal to people across the political spectrum to show that it not only is medically effective, it is also cost effective.  So, it doesn't mean that something has to be cost effective before it could be implemented or used, but it is simply studying that aspect of it, because many CAM modalities I think will be found to be more cost effective than their conventional counterparts.

          So, I am interested in why you have concerns, for why you would be opposed to that.

          MR. CHAPPELL:  It's on principle that I think we ought to be looking at it from a needs-based orientation, and not a calculation of which money is going to be invested for which greater gain.

          DR. ORNISH:  Anytime that Congress decides, like Medicare, decides to cover a new modality, it always goes to the Congressional Budget Office.  They do a cost-benefit analysis, and if that information isn't available, the CBO will almost always say something costs a lot of money.

          So, in a way, having those kind of data looking at cost-benefit can really advance the field in terms of getting the kind of widespread adoption and coverage that I think many of us are looking for.

          DR. GORDON:  Let me make a procedural point here a minute.  Michele is reminding me we are going to be coming back to some of these issues under coverage and reimbursement.  We have a large number of research recommendations that we got to get through and hear people's comments about.

          So, if we can postpone that discussion to coverage and reimbursement, I think it will simplify things.

          DR. ORNISH:  Okay.  Joe.

          DR. FINS:  A quick point on that because it is something that we depend upon research being conducted on cost-benefit analysis to make access and reimbursement and coverage kinds of arguments.  So, we have to keep it in here for the cogency later on.

          DR. ORNISH:  Okay.  Thank you.

          Do you want to move forward?

          DR. JONAS:  Yes, I think so.  I don't want to go through all the sub things even though I recognize that some of the subcategories underneath the numbers don't necessarily belong under those particular categories, but given the suggestion that we had in terms of some of the categories we talked about, including things like breaking out prioritization, then putting things like 21(G), 21(L), and that type of thing underneath those, the patent issue underneath those we will do that, but let's go to the major recommendations, I think, in the interest of time.

          No. 22 is the issue really about standards of evidence.

          DR. GORDON:  Wayne, excuse me.  So, how do you want us to deal with all of these things that are broken out, what is your thought about how we would proceed, because they are all fairly specific?  They are recommendations, even though they are kind of separate.

          DR. JONAS:  Do you want to go through all those, do we have another hour?

          DR. GORDON:  I think we either have to go through them and get some very quick response, or send them back to you and go through them the next time.

          DR. ORNISH:  I just need a point of clarification.  Wayne, are you suggesting that we consolidate these or that if anybody speak now or forever hold your peace, that they are okay?

          DR. JONAS:  Why don't we take these 21(A) through (D), and later you will get 21(F) through whatever, and say are there any general comments about these particular things.

          DR. PIZZORNO:  I think this is excellent, and there is a piece here, which I think may have been intended, but I don't think got said, and that is to research systems of healing, not just isolated modalities, because most of this therapy is part of a philosophy and integrated --

          DR. ORNISH:  It's under 21(C).

          DR. PIZZORNO:  Well, I read them all.  I just want to give the feedback to the committee that I don't think that comes across the way I think it needs to come across, systems of healing.

          MS. POLLEN:  Is that in 21(C) that you are looking at?

          DR. ORNISH:  Under 21(C), it says, "Complete biological systems and interacting biological systems including biofields and energy medicine."  What is missing there?

          DR. PIZZORNO:  I am talking about systems of healing, that is, under a philosophical approach, there is a way of treating a patient that uses multiple therapies consistent with their philosophical approach.  What you have here is different.  That is looking at the body as a whole.

          MS. POLLEN:  Is that something that is missing?

          DR. PIZZORNO:  Yes, it's missing, it is not stated.  For example, I will use naturopathic medicine as an example, which I know.  When a patient has asthma, I have seven different interventions I use, three which I use for one patient, and different ones I use for another patient, because a way of understanding the patient that leads to my intervention.  That kind of thinking, I don't see reflected here, to do that kind of evaluation.

          DR. ORNISH:  There is something on individualization therapies, though, in one of these sections, I don't remember where.

          DR. JONAS:  It is one of our guiding principles.

          DR. ORNISH:  Yes, it's one of the guiding principles is individualization of therapy earlier in the report.  Does it need to be repeated here also?

          DR. GORDON:  I think he is just adding that phrase, systems of healing I think takes care of it here.

          DR. JONAS:  I think that that is part of a category actually that has to do, in terms of addressing it, has to do with methods and epistemological approaches.

          DR. GORDON:  I have one issue that I think is omitted here under 21(A) that we had some testimony about, and this may be something we need to talk about on Saturday morning, which is how to help protect researchers, whether there is a shield that we can encourage NIH or other institutions to provide for researchers as they under take it.

          Gerri, do we have it somewhere else?

          MS. POLLEN:  Well, at this point it's in the background, and I think when we know a little more about what is going to be coming from the Federation of State Medical Boards, we will be able to elaborate a little more.  It is a little early at this point.

          DR. GORDON:  I was just saying it's an issue we need to address, that's all.

          MS. POLLEN:  It is mentioned actually in the background.

          DR. GORDON:  But as a recommendation.

          MS. POLLEN:  We will move it in here when we know a little more.

          DR. JONAS:  So, you are suggesting that that be moved in as a recommendation?

          DR. GORDON:  Exactly what the recommendation is, I don't know yet, but I am saying we need to address it as a recommendation, and we don't have to talk about it right now.  I am just saying we do need to talk about it at some point.

          DR. JONAS:  Just for my better understanding, is there an area that we have been talking about where that would fit under?

          DR. GORDON:  In a sense, it's separate, it related to practice, the practice-based research, so it may be brought in, in that context, but there may be other ways that one approaches it that are not practice-based, because there may be laboratory research or other kinds of research.

          So, I just think we need to consider it, and not now is all I am saying.

          DR. FINS:  I think it could be under the CAM investigator, the category, and there was language that we probably approved as a group earlier on in the pre-interim, Interim Report, where we linked up the immunity for the investigator if that investigator adhered to ethical guidelines, regulations, and submitted, and things were on protocol.  If they were flying freely in free flight, they were not immunized, but if they adhered to certain regulations, they would be.

          DR. ORNISH:  I think that is a really important distinction, and I am glad to hear you make it, because I think there is all the difference in the world between getting an IRB approval for an unproven approach to study it versus someone who has been doing illegally, trying to say, well, here are my data, I want you to take a look at them.

          DR. GORDON:  Dean, it is a complicated issue and I would like your committee to take a look at it.

          DR. ORNISH:  Okay.  Any other comments before I move on?

          DR. CHOW:  I just want to state that I think those two items are really important.

          DR. ORNISH:  Next.

          DR. JONAS:  Shall we move on to the section on 22, Recommendations 22?  The Commission recognizes it is essential that all biomedical research meet the highest standards of quality and recommends that standards of research quality for CAM be the same as for convention biomedical research, neither lower nor higher.

          Any comments on this or some of the subcategories which actually probably don't below under 22.  The first two, in my opinion, have to do with dialogue and ways of building infrastructure, for example, the NCI Score Program.

          DR. ORNISH:  One of the things that Wayne and I talked about earlier was there is a group of people who testified, who said that it is not really CAM or not CAM, either it is scientifically proven or it is not, and as journal editors we will publish good science whether it is CAM or not CAM, and I think with The New England Journal, I think we asked, well, how many CAM articles have you ever published, and they said "zero."

          So, I am not sure whether that is worth getting into here or not as an example, or whether it is just a subtext that we are working from.

          DR. BRESLER:  I think this is a really critical point, and unfortunately, I think it is very unlikely that anybody is going to rise to the occasion and sponsor these kinds of interdisciplinary meetings unless we put a little bit more teeth in it.

          It is the kind of thing that I would like to encourage matching funds from the government to match the private sector or to match foundations or to match other people to give them some incentives, because this is critically important, and they won't do it otherwise.  I would like a little more teeth in this one.

          DR. FINS:  I just want to, for the record, have this paper circulated from Controlled Clinical Trials. The title is "Do Certain Countries Produce Only Positive Results: A Systematic Review of Controlled Trials."

          They found, they looked at acupuncture, and they found that the countries where acupuncture was traditionally practiced invariably said it was effective, whereas, other countries didn't.

          So, this, I think, may help us unearth this notion of a double standard and how there is a perception of bias, both favorable and unfavorable, in the literature.  It may help you guys in the background section.

          DR. ORNISH:  Yes.  Maybe we could cite The New England Journal as an example of how the philosophy and the practice don't always come together, and then this paper as an example on the other end of the spectrum, so that we can have a more balanced approach.