WHITE HOUSE COMMISSION
COMPLEMENTARY and ALTERNATIVE MEDICINE POLICY
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Volume I (continued)
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Thursday, October 4, 2001
National Institutes of Health
Conference Rooms C & D
6001 Executive Boulevard
A F T E R N O O N S E S S I O N
MS. CHANG: We are ready to proceed.
Our facilitators are Dr. Wayne Jonas and Dr. Dean Ornish, and our staff lead is Geraldine Pollen.
So, if commissioners can take their seats and we can begin as soon as you all are ready.
Session III: Coordination of CAM Research
DR. ORNISH: I think we are ready.
Good afternoon, everybody. Wayne and I are going to facilitate this discussion. I think the general context that a lot of these things fall under is something that we talked briefly about earlier, which is that, particularly in the area of research, we recommend strongly that CAM research be held to the same standard, not higher, not lower, as conventional or allopathic medicine is, in a variety of different categories whether it is research funding, publications and medical and scientific journals, presentation at scientific meetings, FDA approvals of new drugs or devices, et cetera.
The reason that we feel that way is that again, it defines the middle ground, it in a way marginalizes many of the people who might criticize the work, because if we say, well, it should be held to the same standard, if they don't agree with that, then, they would be forced to say, well, no, we think it should be held to a higher standard, or we think it should be held to a lower standard, and, of course, I think those don't really gibe with the more American values of fairness and equity.
There are a number of recommendations in here, and we will go through them, but in the larger context, and I think the other issue that isn't really as clearly stated in this particular section as I would like it to be, is that a major compelling reason for increasing funding and making more research available in these areas is something that is self-evident to us, but may not be to many people who read this, which is that it is not whether or not people should be using CAM modalities, as Eisenberg and other people have talked about, the majority of Americans already are, and yet very little research has been done in these areas to either prove or disprove their safety and efficacy.
So, there is compelling need for research in the safety, efficacy, and cost effectiveness of these various approaches, as well as for negative findings. I think this is something that virtually everyone that we have heard with few exceptions, whether it is the defenders of conventional medicine, the journal editors, or so on, or the people who are leaders in the CAM community, I think everyone agrees that we need more research.
I think this is one area in particular that we can held build consensus around and help to increase the credibility for the rest of the report.
There are a number of recommendations in here, and Wayne wanted to try to simplify and categorize some of them into more general themes before we get into the actual themes.
Wayne, do you want to pick it up from here or are you still working on that area?
DR. JONAS: One of the issues that came up in our committee discussions a number of times -- and Gerri did a heroic effort in trying to address those and condense the huge number of laundry lists of challenges, recommendations, strategies, et cetera, that we had in this -- was that we really needed to try to simplify this and try to get it under a few categories where we could say, here is the primary recommendation, and then there are a number of examples of that or specific ways in which that could be implemented, et cetera.
If you think there is a lot of them in there now, you should have seen it before. She actually did I think a very good job of getting them condensed. Our feeling was we still need to do more of that to make them pointed and hopefully as effective as possible.
The suggestion was that we put them into kind of major categories and that the issue about the importance of research that Dean just mentioned, about the importance of holding these areas to the same standard as in conventional medicine meaning high quality, rigorous research that gives you information, the type of information that you need about safety, efficacy, mechanisms, et cetera, and the importance of it being relevant, so rigor, relevance, and quality.
That is the preamble really, that is kind of the background. That is an assumption that I think that we could assume that everyone on the Commission agrees with, that research is important and it should be done well, as was elaborated. So, the thought was this would then go into the preamble.
Then, the recommendations fall into what I think are largely six categories although what we could discuss is whether these are the best categories or whether there are other categories or whether we even need this many, if these could even be condensed further.
The first set of recommendations really has to do with the importance of partnership and dialogue, that there needs to be an increased interaction between those both in the scientific field and in the complementary medicine field, in the public and among scientists, so that they can understand better what they are looking for.
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.
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.
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.
DR. JONAS: A book came out two days ago that I edited on clinical research methods in complementary and alternative medicine, and I will see if I can bring a copy that addresses these issues and gives specific examples actually documented in the literature including that study. Maybe that could be useful to draw from to put In there.
DR. ORNISH: That would be great.
DR. GORDON: What about the three recommendations that are here, 22(A), 22(B) -- I mean I think we are agreed on 22 fundamentally.
DR. ORNISH: Let's go through them real quickly. 22(A), any comments or problems with that? I know, for example, the National Cancer Institute, I was on their first review committee on looking at CAM through the National Cancer Institute. It might be nice to mention them as an example of an organization who is already moving in that direction, that we want to encourage others to do.
DR. LOW DOG: Just for clarification, could we put an example on 22(C), request recommendations from the NSF on how to study in a credible manner high risk? Are you talking about like chelation?
DR. ORNISH: I was just actually trying to go through these. 22(A), any comments or questions? 22(B), any comments or questions?
DR. BRESLER: Just stronger than "encourage."
DR. ORNISH: Mandate?
DR. LOW DOG: No.
DR. ORNISH: Incentivize.
DR. JONAS: Stimulate.
DR. GROFT: There already are possibilities for workshops, and I know '96 or '97, where we had the large conference, or '95, I am not even sure, on acupuncture, research methodology surrounding acupuncture, so it is possible to do it. It is just a matter of someone taking the initiative, and I think NCCAM is doing that in some instances, but there is certainly the opportunity.
DR. ORNISH: What is we change "encourage" to "incentivize"?
MS. POLLEN: It could also be put on that are supported collaboratively by the public sector and the private sector together. That is another way of doing it.
DR. ORNISH: So, Tieraona, 22(C).
DR. LOW DOG: I had to read it a couple times to understand what it meant, and I am still not sure what it means, but I am thinking it is like chelation. Is that what it is intending to mean? I just think we need an example, because if I read it, I wasn't quite clear. I don't disagree with it, I just think we need to explain it better.
DR. JONAS: There is a background paper on this actually, and the specific reason this particular recommendation is targeted towards the National Science Foundation is because the recommendation is to look at the scientific issues of things that are generally taboo in conventional medicine, but are standard basic assumptions in every-day use in unconventional medicine, and this is a category, for example, where energy medicine fits in.
These areas are avoided by science generally, but they are very popular from the public perspective, and so how can we begin to bridge this gap, how can we begin to develop a process that encourages scientists to begin to explore these areas, and we can give some examples and change the language if you want to.
Something like chelation, which is really a socially controversial area, that is something that I would see falling more in the category of 21(L), I believe the recommendation is, which is asking for a similar process by the Institute of Medicine, and there are particular examples that we could put into that.
DR. LOW DOG: But, Wayne, why do we have "high risk" when we are talking about energy?
DR. JONAS: Because this is how it is perceived in the scientific community.
DR. LOW DOG: Risky?
DR. JONAS: Yes, absolutely, these are seen as areas that could not be examined by science or at least if they were examined by science, they would be very risky for one's career or for even discovering anything relevant. A lot of people feel like they are a waste of time, especially the scientific community, they don't think that anything is going to come of them.
DR. ORNISH: What if we just say "perceived as high risk by many convention researchers," or something like that as opposed to saying that they are high risk, they are perceived as high risk. Would that do it, Tieraona, for you?
DR. LOW DOG: I just think risk isn't the right word, "high risk."
DR. ORNISH: Unconventional? What word would you use? "Controversial."
DR. GORDON: Again, we have a huge number of recommendations to cover. If we are feeling uncomfortable, let's send it back to the committee and let them work on it, and come back to us, having heard some of the concerns in a better way.
DR. ORNISH: We will make recommendations that aren't so controversial.
DR. JONAS: I think we need to find out, though, what the issue is, Jim, in order to be able to figure out how to address this in the committee. Otherwise, it will come back to the committee, and we won't even --
DR. LOW DOG: But I am on your committee.
DR. JONAS: Well, then, don't say anything.
DR. LOW DOG: But when I read this, I hadn't heard where we had talked about like high risk, and so all I can tell you is if we lined up 100 people, 90 people wouldn't know what that meant. They wouldn't know that you were talking about energy stuff.
DR. ORNISH: Are you comfortable with "unconventional," would that work? Or "controversial," I mean?
DR. LOW DOG: Yes, emerging controversial.
DR. ORNISH: Great. Let's move on.
Recommendation 23. Any concerns or comments about that? Do you want to explain anything about it?
DR. JONAS: Any comments on this? This is the recommendation that basically says that we should have public input into this process including advisory committees, review boards, research teams.
DR. ORNISH: I was only going to add that it might be useful to draw the parallel with other accepted organizations -- accept is probably the wrong word -- conventional organizations that have advocacy groups, and we heard from some of them in their testimony, the breast cancer community, AIDS advocacy groups, the prostate cancer advocacy groups, et cetera.
DR. JONAS: Right. And there also are examples within the federal government where they are doing this. NCI has a whole program on training the public to be on these boards to properly represent their groups and their constituencies.
DR. ORNISH: Joe.
DR. FINS: Again, this has come up before, but institutional review boards do not set policy, they regulate research, so they are not, that second sentence, and public membership is mandated on IRBs, but IRBs do not set priorities, they regulate the research endeavor, so it is a little misleading. Under 23.
DR. GORDON: That issue also applies to the next several recommendations, too, and maybe this is providing a little more context, that is, already some of these things are either being recommended by other groups or, in the instance of 21(E), (F), and (G), NCCAM is already doing some work in these areas, and I think it is a matter of providing some of that context, and some of the questions about it will go if we do that.
DR. ORNISH: So, basically, just saying that these are already in process, and we are just encouraging more of that.
DR. JONAS: That applies to many of these areas actually.
DR. ORNISH: Would it be helpful, then, to distinguish where we are saying that we like this and we would like to see more of it versus something that is not being done, that we would like to see beginning?
DR. GORDON: That is my thought, and I think that is what Joe is saying, as well, if I am correct about that, that we need to be saying we are in agreement with other organizations that are already advancing these.
DR. ORNISH: It certainly makes it stronger to point out and educate the reader of the document that a lot of this is already going on by these conventional agencies, which gets us out of the us versus them mentality, but say there is already collaboration that is beginning, and we would like to see more of it.
DR. JONAS: Yes, I think that would be good to do throughout here actually.
MS. CHANG: Just a time check. You have about 25 minutes left.
DR. ORNISH: Plenty of time.
DR. JONAS: We are doing fine.
DR. ORNISH: Anything else on 23 before we move on, Joe?
DR. FINS: We talk about this and maybe it comes here, but I think everybody agrees since we have talked about this before, we talked about having the same sort of set of standards to evaluate the scientific method da-da-da-da, but I think we also want to say that research that is conducted in the CAM arena should follow the same ethical guidelines as conventional, and it is the expectation that there will be IRB review, et cetera, and that should be in here in the research chapter somewhere.
DR. ORNISH: I agree. Anything else before we move on?
Issue 3. Research, training, and infrastructure. Shall we just go straight to the recommendations in the interest of time since we know you have all read this? 21(E), (F), and (G). Any comments?
DR. PIZZORNO: 21(G), on the first line after "to enable," and insert in there "both CAM and conventional medicine investigators," just to recognize that we are enabling both types of investigators, research investigators.
DR. ORNISH: Okay. Good. Other comments on 21(E), (F), or (G)?
DR. FINS: Dean, I think we should, maybe, say that we should incentivize the relationship, joint submissions from CAM and non-CAM institutions. It is here, but somehow you will get a higher priority score if you go in jointly than if you go in separately.
DR. ORNISH: Something along the lines of how they incentivize studies of women or minorities -- I can't remember what the other ones are -- that all things being equal, you get extra credit if you include subjects or approaches like this.
DR. FINS: That fosters the synergism that you are stating out here in No. 3.
DR. ORNISH: Isn't that going to be in direct contradiction to the overarching theme of it should be held to the same standard, no higher, no lower? It almost makes it more like giving it an advantage.
DR. FINS: No, it is the same scientific standard, but you are saying that we believe that there will be better science if investigators from both sides of that street come in together, it will be a better product.
DR. GORDON: Again, this is another area where NCCAM, I think has done quite well in terms of encouraging this to happen, and we don't need to reinvent what they are doing. We need to indicate that they are doing it, we encourage them to do it, and move it ahead, and they are doing just what you are saying, Joe. They are saying if you are going to start one of these centers, you had better have CAM folks on the board along with conventional folks.
DR. ORNISH: Good.
MS. POLLEN: I need a clarification from Joe Pizzorno. You had a comment on 24 that I am not sure I got.
DR. PIZZORNO: 21(G)?
MS. POLLEN: Was it 21(G)?
DR. ORNISH: It was 21(G) he was referring to.
MS. POLLEN: Okay.
DR. PIZZORNO: After "enable," insert "both CAM and conventional medicine."
MS. POLLEN: Thank you.
DR. ORNISH: Other comments on these three recommendations?
DR. JONAS: I think linking to where this is already going on, because a lot of this is already going on, is important, however, I think what our recommendations should target really is the need to have this done in a broader number of agencies. There is one lead agency, and they have money to do it. So things get stimulated in that particular area. But we would like to see that coming from other agencies, within and without, outside the NIH.
DR. GORDON: In my opinion, it is a very good way to word it, because it indicates this is happening and we want to encourage it elsewhere, and we can do that throughout.
DR. JONAS: I agree. Most of this comes under stimulating more research, I think. My suggestion is that when we put those subcategories in there, we actually name agencies as potential areas where this could occur, that already to this, it is part of their job. Some of these are in here like this, but we will hopefully make it clear, like NCRR and other groups.
We need a glossary. Is a glossary in preparation?
DR. ORNISH: You mean with all the acronyms?
DR. JONAS: Abbreviations, terms.
DR. GROFT: That will all be taken care of in the final report, glossary and acronyms. We will have it all together in the final report.
DR. ORNISH: Effie, you had a comment?
DR. CHOW: I know things are happening and in every category we have been talking about that. We said that things are already happening in the system, and it is already happening in this department and everything.
Do we have an idea of really how much needs to be done in terms of research, because if people who are going to pick up this document and say, well, everything is happening already, and the comments here is that a lot has been happening.
Do we really mean that a lot has been happening, or is it some has been happening? I think we need to differentiate, and not just say we encourage more. Perhaps we need to think how much more we need and in what categories of research, et cetera, because if you talk about $100 million, $250 million for FDA to turn out one pill, 15 years to get one pill out into the public -- I know it has been changing -- but, how does research in CAM compare with that, instead of $30,000 for a year's research, or just $1 million for research on trying to establish the validity of a system of practice.
DR. ORNISH: I think you raise an important point about distinguishing the fact that while some things are ongoing and we encourage them, they are still at a fraction of a percentage of the overall NIH budget, let's say, and that on the one hand, we are glad these things are occurring, it makes our recommendations seem even more generalizable and acceptable, but we also need to point out, as you have indicated, that the magnitude of funding in many of these areas, or the magnitude of support is still only a fraction of what it could be or what it should be.
DR. CHOW: The other figure that we use is increased by 600 percent or 800 percent, I have been hearing this, and I mean funders will say, oh, wow, then, you don't need any money if they don't know what the level is, et cetera.
DR. ORNISH: I agree with you.
DR. CHOW: I think we have to be real careful about expounding that so much is going on.
DR. ORNISH: Thank you.
DR. LOW DOG: Would it be helpful, then, I mean because there was this nice chart at the back, which was enlightening for me, CAM spending, and then you had the NIH, which I found interesting for 2001, 89 million for NCCAM, but 192 spent, so actually, more than 100 million in the other institutes put together.
Maybe putting that with what the total budget for the NIH was for that year and what percentage of that went to CAM research, and while we applaud how much that is, what is it in percentage to the total budget of the NIH.
DR. PIZZORNO: I think it's about 1 percent.
DR. LOW DOG: But including that in here.
DR. ORNISH: I think putting on that chart, because if somebody is reading that, it might look at first glance like NCCAM is spending more money total than NHLBI as opposed to just that fraction of NHLBI that is going for CAM, and I think it would be useful to say what the denominator is of total spending in each of these organizations.
MS. POLLEN: In each of the institutes.
DR. JONAS: Including NCCAM.
DR. ORNISH: Well, with NCCAM, I presume it would be 100 percent.
DR. JONAS: Oh, is that right?
DR. ORNISH: Not when you were there.
DR. JONAS: We don't want to get into too much budget clipping because it is a political game, you want a big or a small number. But certainly, I think what I have been hearing is, the message is, we need more in this area. Proportionately, it is fairly small, so we need to stimulate it in some way. We need to incentivize it in some way.
So, in other words, just to leave things, as usual, to the committee is not adequate enough. Is that correct?
DR. ORNISH: Yes.
DR. FINS: In a way perhaps of tracking this is every institute knows a percentage of applications that scored high enough to be funded, but weren't funded because of resource issues, and maybe we could look at that and track it, and if the number of applications of projects, proposals that are well scored increases and the percentage goes down as the field goes larger, then, we might have a good indication that funding needs to be increased.
DR. JONAS: That actually is already out and NCCAM is less than the average in NIH.
DR. GORDON: Wayne and Dean, we really have a lot to go through. I think some of these specifics, assuming we are generally agreed, that it is better to communicate directly with the facilitators or with Gerri and get the information back to them, because otherwise, we will never get through these.
DR. ORNISH: Let's move on. Next.
DR. JONAS: 21(H) is addressing specifically the private sector issues.
DR. ORNISH: Why don't we just say, in the interests of time, we have got 21(H), (I), (J), (K), and (L). Any comments or questions? Why don't we just go through them real quickly.
21(H), any comments? Since I am getting very strong direction to move things along, I am going to move things along.
MR. CHAPPELL: I'm sorry, but this is important to me.
DR. ORNISH: I am not trying to do short shrift, I just want to see if there are comments or not. If you have any comments on 21(H), I would welcome them.
MR. CHAPPELL: I would like to have the recommendation explained in a little more detail for me. I don't know what you mean by "CAM patents." I have read the partnerships and the opportunity, you have the footnote. I would just like to know what you are intending by these recommendations.
DR. ORNISH: Part of the problem in CAM is that a lot of research on drugs is sponsored by the pharmaceutical companies that make them, a lot of research on stents or other devices ditto.
Part of the problem with CAM modalities is that there isn't a patentable device or drug that allows for investment in doing the kind of research, much of what gets funded in conventional medicine by drug and device manufacturers, and the fact that you can't patent many CAM approaches limits the amount of private sector funding that is available to do research.
I think that is all that we are talking about here, and trying to find ways to incentivize manufacturers to do that.
MR. CHAPPELL: If there is known bioactive properties to an herb, then, under the current laws, manufacturers are encouraged to apply for an NDA, so I am not sure the assumptions are actually correct in this.
There is protection. Once you have established the activity, bioactive component, then, the FDA wants you to apply for an NDA and get protection that way. We are not talking about millions of dollars of research, but probably a few hundred thousand.
So, I just want to be sure that we understand what the ground rules are currently.
DR. ORNISH: But, for example, if you are looking at a low fat diet and reversing heart disease, there is no bioactive component to patent, and yet the studies need to be funded.
So, how would you like us to clarify this?
DR. JONAS: The recommendation actually is to either solicit or conduct a study to examine these issues. It is not necessarily about what issues should be done. I am wondering how you would do that. I mean is there an agency, for example, or is there a group that could be the lead in terms of looking at these issues, how to stimulate private sector investment in research in complementary medicine products and practices?
MR. CHAPPELL: I think perhaps one way to proceed is to differentiate between the products and the practices or the modalities because I think there are differences in the way they are handled.
DR. JONAS: So, you would see two different --
MR. CHAPPELL: Well, I am hearing there are.
DR. ORNISH: Actually, the recommendation, as Wayne is saying, is to study this more with this intention. Is that something that you would be comfortable with?
MR. CHAPPELL: Yes.
DR. BRESLER: A comment. It seems to me, I mean I had raised this earlier in our hearings, too, but we have had not had input from the investment community about what kinds of incentives or ideas they would have that would bring them in.
I think one of the most obvious things is low interest loans which are missing from your language. If you look at things like the Stafford loan program and other examples in government, when the government wants to incentivize something, it makes money available to people very inexpensively.
Just in the language here, tax incentives mean nothing to a company that is not making a profit, okay, and early in the game we have a lot of fledgling industries that are not going to benefit from tax incentives, they are having a hard time getting their hands on capital.
DR. ORNISH: What if we just add tax incentives, loan interest loans, et cetera?
DR. BRESLER: I think we need to solicit the investment community's input to this, too.
DR. ORNISH: I agree, and that is why we are talking about doing a study as opposed to making recommendations right now.
DR. JONAS: This actually has already started and NCCAM had their industry conference, for example, which they brought in industry and had a dialogue about how to stimulate collaborative research in these areas.
DR. ORNISH: So, we need to make reference to that then.
DR. JONAS: Yes.
DR. ORNISH: Tieraona.
DR. LOW DOG: Yes, and could we change from projects to standardize the composition of CAM products, could we say projects to investigate ways to improve the quality or analysis of CAM products, because you are not going to standardize most of them.
MS. POLLEN: Proof of quality?
DR. LOW DOG: And the analytical methods and quality of CAM products.
DR. ORNISH: Weren't you arguing earlier about the importance of standardizing under DSHEA?
DR. LOW DOG: No, you will never hear me talking about, arguing really for standardization, because it is impossible for most botanicals. We are not at that place yet. However, quality control is not the same thing as standardization where you have identified some bioactive marker, and GMP should address identity and quality, but I think that is misleading that we are going to find standardization for all of this.
DR. ORNISH: Other comments?
DR. FINS: On 21(J), I think we should also mention in there the Bayh-Dole Act.
DR. ORNISH: B-a-y-h.
DR. JONAS: Any comments on solicit a study of FDA methods? 21(I).
DR. GORDON: This is a more general comment. We are recommending a lot of studies here and a couple in other places in this research, sort of studies of how to proceed. I think that we have to decide how many studies -- I mean it sort of gets to be a little cumbersome.
There may be some of these areas where we can make specific recommendations based on testimony that we have heard so far, and I would not recommend a lot of studies. I think it just delays things and doesn't really take on our responsibility.
I think we have some pretty good ideas under some of these, and my inclination is to ask you all to reconsider most of these studies, and not tell us to have studies, but tell us what to do.
I mean you have been meeting, and where do we go next?
DR. ORNISH: Let me just ask you, Jim, which ones -- let's go through them.
DR. GORDON: I think that we have heard some mechanisms, which we have already discussed in here, for incentivizing for development of products. We have heard that from some of the big manufacturers and from some of the small health food places.
I think we have a sense of how to proceed with studying difficult areas or challenging areas whether they are science that is sort of frontier, what we call frontier science.
Wayne, you did a piece of this. We had studies like you were the director of the OAM.
I think we should just come out and say it right now, and not bump it off to NSF or IOM. We know this stuff. I think that we need to surface that -- this is my feeling -- we need to surface that, have it back at the next meeting, and see where we are. If we agree, great, and if we don't, then, we can let it go and call for a study.
DR. ORNISH: Do you want to go through each of these recommendations that requests a study, and decide now whether you think it is ready for prime time or not?
DR. GORDON: My opinion is I would like you all to reconsider this as a group and tell us what we know right now, and not go in for a lot of study. There may be some specifics you haven't worked out, but I would like some general guidance about what to do and where to go next.
DR. ORNISH: Well, just as a process issue, Michele, we have until 3:30, right, which gives us another 40 minutes or so?
DR. GORDON: I am only going to need about 15 at the end to summarize, so I am okay with giving up that, but I don't think we can resolve these issues here in half an hour or 40 minutes. My feeling is I think this takes your committee meeting and really thinking hard through some of these issues.
DR. ORNISH: We can do that except we only have a few recommendations left, so we are going to have some time unless these last recommendations take a lot more time than I think they will.
DR. GORDON: We have got about 15 left.
DR. JONAS: No, we don't.
DR. GORDON: Yes, we do.
DR. ORNISH: The last pages, 12 and 13 and 14 are just a restatement of the ones we have already done.
DR. GORDON: I'm sorry, you are right. We have about four or five left.
DR. JONAS: We are just actually just about at the end.
DR. ORNISH: Why don't we go through those and if we have time, we can circle back to this, and if not, we will do it in the committee.
Before we leave 21(H), (I), (J), (K), (L) -- I feel like I am teaching my son the alphabet here -- any comments or questions? Effie.
DR. CHOW: A point of clarification here. The challenges are written in this section more as recommendations than challenges. I don't know, it seems to be.
DR. ORNISH: I'm sorry, I don't understand.
DR. CHOW: The challenges before the draft recommendation, I have written in this section more like recommendations than challenges.
DR. JONAS: Effie, you caught us. You figured out how we got rid of most of the recommendations.
DR. JONAS: We made them challenges.
The wording, in terms of a recommendation and an issue, it describes the issue, I think is important.
DR. CHOW: But the other spoke to kind of what the challenge is, but here it is like just stimulating, it speaks more like it is a recommendation, stimulating them. Anyway, I just throw that out.
The others are (H), (I), and (L), it says solicit a study, request a study. Do we want to lock us in, it is only one study? This says "a study."
DR. ORNISH: Before we get into that issue, why don't we circle back to see if we are going to just make recommendations rather than a study anyway.
DR. JONAS: Let me just clarify. We may be getting confused here about studies. I mean, there are studies which are research studies, which is one type of thing, and then there are suggestions that a particular agency group that evaluates areas and makes recommendations to the government about how to go about doing things.
The IOM is one, the NSF is others, there is a variety of groups. NIH does it in certain areas, et cetera. That is basically saying this is a complicated area, it is important, it needs to be addressed, and so as an overall government commission body, you are making a recommendation that this agency do this particular study, this particular evaluation.
Those can be put into different categories like we have talked about possibly organizing them, but some of them may be very important. The prioritization ones are going to be extremely important because those tell you, now you have some money; where are you going to put it; you can put it in the important stuff; or at least, how are you going to go about deciding that.
So, those are studies, those are specific studies that are solicited from particular agencies, and I think should be as specific as possible.
DR. CHOW: I understand about the nature of the study, but we said "a study." Are you going to lock yourself into a study or studies as necessary?
DR. JONAS: Well, my personal bias is that you actually say "a study," and you put it into a agency, and then that agency can convenes a committee like this, and says, gee, we can't address products and practices in the same thing, we need to have two groups or we need to have a series of studies, et cetera, but that is not our determination as to whether we want one or want another.
DR. ORNISH: Why don't we just table that for a moment because some of these, as Jim said, some of these things that we are requesting studies, if we have time, we may circle back and just make recommendations, in which case it is a moot issue.
MR. CHAPPELL: I think 21(H), forgetting the study part, I mean what we need is incentive for private sector research investment, so that the discovery has some kind of protection for marketability by the discoverer, whether that is an NDA, which gives you five years of marketing exclusivity while you are continuing the research, is it a patent, but clearly, this is needed.
So, what kind of incentive can you provide other than marketing protection either through a patent or an NDA? You can provide reimbursement or some sharing of the cost public/private to the manufacturer, because in CAM, you are dealing often with smaller companies, and they don't have the funds to do this.
I don't know whether you can differentiate between small and large company here, but I think the proper incentives are market exclusivity for a period of time and reimbursement to some extent of the research cost itself.
DR. ORNISH: Do you want to get into the -- there are really two levels here -- one is to say let's do a study, the other is to say let's incentivize the manufacturers, and the third is to actually get into specifics of what that would be.
Are you arguing for the latter or the third approach here?
MR. CHAPPELL: No, I am just trying to help you all get to more specific recommendations, and I am saying you are clearly on the right track when you address let's provide protection for the market, or let's provide reimbursement for the market or the research company.
I do think you are going to have to get a tax policy consultant, an intellectual properties consultant for you to get any more specific than that, and I am not sure you want to.
DR. ORNISH: Just in the interest of clarity, how would you like us to change 21(H)? We will take out the part about solicit a study.
MR. CHAPPELL: Other than to say "to provide," instead of "solicit a study," to provide private sector research investment in blah-blah-blah.
DR. ORNISH: Incentives, right, to provide incentives in those.
MR. CHAPPELL: Yes.
DR. ORNISH: And then leave the rest the way it is?
MR. CHAPPELL: Yes.
DR. ORNISH: I am trying to just be as specific as I can here. Got it. I agree with you. Are you comfortable with that?
MR. CHAPPELL: I think so. It's tough.
DR. ORNISH: I know it is.
DR. FINS: I really think that this 21(H), what Tom was just talking about, and 21(I), and to a lesser extent (J) and (K) are sort of in the wrong place. They are really not research questions, they are regulatory questions, and it is the good news/bad news part of what Tieraona was talking about before.
If we modify DSHEA, if we put more of an onus, Tom, on the private sector to provide services in compliance with new regulations, then, there has to be some perhaps compensatory mechanism to allow that to happen.
The reason we are sort of saying create a study to do this or that is because we still haven't reached a conclusion about how we are going to regulate supplements and whether they go to OTC or they go to real drugs, so it is part of that overall package.
I think we should perhaps shelve that, no pun intended, and put it all together because it really is the other half of the regulatory piece that Tieraona was talking about.
DR. ORNISH: Part of it is, I mean part of it isn't. The 21(I) clearly could go in the regulatory with those things which are designed to incentivize research.
DR. FINS: But that is a subset of the same problem. You know, 21(J) can stand there by itself as a generic statement, but that might also be part of the remedy related to the regulatory piece that we were talking about.
DR. ORNISH: There is no reason that it can't be in both places.
DR. JONAS: I think you are right, Joe, I think we need to actually rearrange these categories in all areas to get them a little bit further together, and then we may be able to eliminate and consolidate a number of those.
DR. FINS: But it relates to that regulatory piece. The other thing I just want to say real quickly is I think that it would be immensely helpful. I agree here completely with Jim, that 21(L) is such an important issue.
You will see tomorrow, I think, when we talk about the Access and Delivery piece, that we have begun to try to suggest a way of thinking about access and delivery, and also, to a lesser extent, the Educational section, that a little bit of a topology about, not necessarily make a recommendation that X percent of the NIH budget should go to CAM, but, how would you begin to dissect the argument for a fixed percentage, a needs-based kind of mechanism, an efficacy-based mechanism, and just begin to think about that so that the next entity that takes that question on will have the benefit of our deliberative process.
We probably can do more right now to make a recommendation, not a fixed recommendation, but just an argument that would be helpful for the next iteration.
DR. GORDON: I am going to agree with Joe and myself again. I think that applies to 21(L) and to 22(C), that there are no people probably on the planet than many of us sitting here who have thought longer and harder about these issues or are likely to for many years, and I think we just ought to give it our best shot.
DR. ORNISH: I think there is some value above and beyond whether we are qualified to make recommendations, I think there is value in having the National Science Foundation and the Institute of Medicine involved in the process, both in terms of building bridges and in terms of actually ultimately getting more funding in these areas.
DR. JONAS: I guess I am confused, Jim, by what you mean by "give it our best shot."
DR. GORDON: I think we should make our recommendations.
DR. JONAS: In terms of what the priorities are?
DR. GORDON: In terms of what the priorities are or what the criteria for deciding the priorities area.
DR. FINS: Even laying out the argument. I mean it is like what is the argument in favor of fixed number, what is the argument in the context of global budget, what is the argument for more money.
DR. GORDON: Right.
DR. FINS: And just lay out the argument, say, while we have not reached a conclusion that that is how we end up, we think these are issues that the IOM or NSF should consider, but at least we have taken what we know already, and we have put it down on paper, and it is planting the seed for the next phase of this.
DR. GORDON: Wayne, I remember very clearly when we were working with OAM, you had a very clear scheme and we discussed it at length for prioritization. It seemed perfectly good to me then, it may have to be revised somewhat, but that should be presented.
DR. JONAS: So, you would like that type of thing.
DR. GORDON: Yes, and as far as the sort of frontier science questions, again, several of us in this room have thought a lot about that. I agree with Dean, it is great to have the NSF and the IOM with us, but I think on these issues it is going to take a long time to get -- there has to be a study funded, they have to get involved.
I am happy for that to happen, but we don't need to wait for it. On some of the larger issues, we are very closely allied with them already, and we have indicated those issues.
DR. ORNISH: I think that makes a lot of sense. From the process standpoint, we will take this back to our subcommittee by conference call and see how far we get with it and come back and report to you.
DR. BRESLER: Dean, you also might want to solicit input from the various Commissioners as to what they think are the critical issues around this, too.
DR. ORNISH: Consider this an open invitation to anyone, and if you have any thoughts in these areas, please e-mail them to us, and we will discuss them at our committee meeting. If any of you have really strong feelings about it and want to participate in the conference call, we would welcome that, too.
MS. POLLEN: May I say something here? It would be better, I think, if you would just e-mail them to me, and then I would just make sure that everybody got them, nothing would fall through the cracks that way.
DR. ORNISH: Great. Is it okay with you if they want to participate in the call verbally?
MS. POLLEN: That's fine.
DR. ORNISH: Great. Moving along, where are we now?
DR. GORDON: 24 on page 11.
DR. FINS: I think it is sort of self-evident and it just doesn't make sense to me. I mean I don't think it adds anything.
DR. ORNISH: I would agree.
DR. FINS: I would delete it.
DR. ORNISH: How do you feel? Done. 25, any comments on either 25 or its subcategories? These are the last three we have.
DR. FINS: I think 25(A) is critically important, and it is about the utilization piece that has really, as I said earlier, has really gotten buried, so I think AHRQ has a huge role to play here.
It is not just treatments for use by private and public entities, but as well as systems of care and infrastructure and managed care and delivery systems, and those kinds of things. We are going to bring that up again in the access and delivery piece where we talk about demonstration projects, but I think it is a kind of public health research that needs to happen.
DR. GORDON: 25 seems very clear. I don't know if 25 gets lost among 25(A), 25(B), and 25(C) because we are not recommending a method for those systematic reviews to be done, and perhaps we should, because we get specific in the A, B, and C's, and I think maybe we should either -- it seems to me the most important thing is that those reviews get done, they get translated into language, so that everybody can understand them, that it happen on an ongoing basis.
I am not saying anything different from what you have. I am just trying to think of how to focus a little bit more.
DR. JONAS: Would you like it more specific?
DR. FINS: I think AHRQ has its own method, I mean it's health services research.
DR. GORDON: But it is not just AHRQ. See, that is the thing, AHRQ has done certain systematic reviews, but are we saying that we want all systematic reviews to be done through AHRQ or not? I don't think so. Do we want to encourage NCCAM?
I am just saying that we have a level of specificity in certain areas, but we leave it very vague in the sort of largest area, which is sponsoring the systematic reviews. It doesn't feel quite right to me. I feel like we should be a little more -- either a little more attention to detail with systematic reviews or it should be all part of one recommendation of which the creation of systematic reviews, and then the translation of those systematic reviews into forms that anybody can understand be done.
That seems to me to be the essence, and then where it is done are the particulars that come afterwards. Does that make sense to people?
DR. JONAS: In other words, not specify where it is done, but recommend that it should be done?
DR. GORDON: Again, it is just a matter of prematurely breaking things up here. We have to make it clear what we want to have happen, and then we can list underneath that a variety of different mechanisms through which it could happen or maybe we have specific as we want it to happen.
MS. POLLEN: May I ask a question? 25(C), does that begin to get to -- in other words, if that were developed a little more?
DR. GORDON: It is not so much that. I am simply saying that it is clear we want systematic -- the overarching points are we want systematic reviews, we want them to be developed perhaps in a variety of different places, and we want all the systematic reviews regardless of where they are developed to be made available in lay person's language easily, probably through the Central Office, but we haven't said that yet here, but somehow easily available.
DR. ORNISH: So, you would like to collapse all this into one?
DR. GORDON: Yes, exactly.
MS. POLLEN: That is what i was getting at, take that and develop it. Okay.
DR. ORNISH: That's fine.
DR. BRESLER: But to play devil's advocate for a moment, again, it brings up the issue, if we were to get very specific and ask NCCAM or AHRQ to do it, then, they can be mandated to do it, and then it becomes their problem to figure out specifically how to do it.
I am concerned when we throw this stuff in the air and say, well, it would kind of, sort of be a good idea if we kind of had some reviews, of all the priorities that everybody else has, it is going to fall through the cracks. If this is important to us, again, I think we should put some teeth in it and make a specific recommendation.
DR. FINS: I don't think AHRQ is especially well positioned to do health services kind of research that is really needed for the rollout of delivery and infrastructure kinds of issues, so I would like to have them specifically mentioned, but at the same time, I don't want this to be an exclusive mandate for two entities like NCCAM and AHRQ.
So, why don't we just say, such as NCCAM and AHRQ, and other --
MS. POLLEN: Examples.
DR. FINS: As examples, right, but not exclusively.
DR. ORNISH: IOM, Cochrane Collection.
DR. JONAS: But would you agree that the goal is to have a central updated source of the current evidence, clinical evidence on the safety and efficacy of complementary and alternative medicine maintained, produced and maintained?
DR. FINS: But it really goes back to what we talked about in the information section. I think we did a better job sort of flushing out what that would be earlier this morning in David's session than here.
The research folks are not the people generally who translate it into a package that is understandable by the public or media. That is an informatics kind of group or the Library of Science.
DR. JONAS: So, we should pull out things like guidelines, for example, out of this, and this should be really what is the current state of evidence on safety and efficacy, and that is a research role, if you will, or function.
Then, a lot of these other groups then would pull off of that in order to look at the implications, guidelines, et cetera, yes.
DR. GORDON: We have a minute and a half left and then try to make some kind of summary of where we are.
DR. ORNISH: Effie.
DR. CHOW: Systematic reviews of literature, research literature, I hope to go into non-English speaking, as well, and can be translated into English.
DR. JONAS: Should we say the world literature?
DR. CHOW: World literature, yes.
DR. JONAS: Available literature?
DR. CHOW: Well, when you say "world literature," does that mean non-English?
MS. POLLEN: Why don't we just say English and other languages?
DR. CHOW: Well, for example, Chinese medicine, there is a lot, and then in acupuncture, there is a lot of Chinese, but not in English.
DR. BRESLER: How about scientific literature?
DR. CHOW: Scientific, but different language, though.
DR. JONAS: Yes, emphasizing not just making it exclusive to English is what you are saying.
DR. CHOW: Right.
MS. POLLEN: How about English and other --
DR. FINS: Again, I think that is really in the information section, and we discussed it this morning, it is not here, and Medline does translate stuff.
DR. JONAS: So maybe a subtext thing saying that it shouldn't be exclusive to English language or limited to English language, I should say.
DR. GORDON: I am going to need the 15 minutes to present what I believe I have heard and get everybody's feedback. This is obviously a very complicated area.
Thank you, Wayne and Dean and Gerri, for wrestling with it and bringing it into the ring with you.
DR. GORDON: Let's go through the draft, take a look at the draft recommendation.
No. 19. There was definitely agreement with that recommendation, and there was a sense that that is going to dovetail with whatever we come up with in a recommendation about CAM Central.
No. 20. We eliminated trained and licensed and spoke about appropriately qualified CAM and conventional professionals, but we also suggested that the committee might take this one back and take a look at it, address some of the issues that were raised, and just come back with it again.
No. 21. There is a whole issue of cost-benefits that relates to recommendations about research funding that we are going to be addressing when we talk about both coverage and also access and delivery. So, we are going to have to review all of this in the light of what we come up with there.
It becomes clear that we need a separate discussion of budget recommendations. It is not clear when we are going to have that discussion. I think we need to wait and see what comes up from access and delivery and reimbursement, and then we can figure out whether we can begin that on Saturday morning or whether we have go defer that until December.
When it comes to research, there is an issue, I don't remember who raised it, I think perhaps it was Joe, about interactions and indications and contraindications that come up when we are looking at funding of research. That is an area that we want to pay attention to.
Under 21(A),(B), (C), and (D), there was general agreement. I think there is a sense as we go through all these 21's, that we want a simpler reordering, not so much that we want to change the recommendations, but we want all the 21's to be together, and 22's to be together.
Wayne, the system that you began to put up on the board may be the proper way to order it, but we need a simpler, clearer way of ordering these different categories of recommendations.
The other issue that we need to talk about is the protection of researchers. Did we put that up as a new issue, Ken, for Saturday morning, the guidelines for protection of researchers?
MS. POLLEN: Well, it is not really a new issue. It is one in which we are waiting --
DR. GORDON: It is in the background, but we need a recommendation about it is what I am saying.
MS. POLLEN: A draft recommendation now.
DR. GORDON: Let's see if we can do it on Saturday morning. If we can't, we will give it back. We may well just give it back to the committee and ask them to come up with a recommendation.
MS. CHANG: Or you can just put a placeholder, which is what we did in access and delivery. We put two placeholders in for that issue.
DR. GORDON: Okay. So, we are going to be coming back to it.
Nos. 22 and 23. Again, it looks to me like these may well be combined. We feel fine about those recommendations. With 22(C), as well as with 21(L), there was a feeling that we are asking our committee to make some recommendations there for us, tell us what we need to do.
No. 23. There was general agreement about public participation, and there is a consensus about that.
On 21(E), (F), and (G), there was a consensus and agreement with those recommendations, and I don't know if I got this right, on 21(G), I think there was a rewording, "Continue to support career development awards to enable both CAM and conventional investigators." I think that was added there, and otherwise, those went ahead as stated.
We are asking for some more specificity on 21(H), (I), (J), and (K), I believe, and I want to make sure this is where we are, we are asking the committee to take these as far as you can take them, and where you can't take them further, that is, in terms of making specific recommendations, put together a package of those issues that we don't have enough information about.
DR. FINS: On that particular cluster of issues, maybe a representative of your committee and Tieraona can perhaps --
MS. POLLEN: She is on that committee.
DR. FINS: Okay. Then, maybe just let Tieraona do it. That would work. But I think, again, the linkage to the regulation piece has got to be, I think, fleshed out and coordinated.
DR. GORDON: On No. 24, we deleted it. We deleted it because it is redundant of an earlier one.
No. 25, we agree on the general principles, and we are just asking for a reshaping of those recommendations, that is, with an understanding that that fits very closely, that the piece of developing systematic reviews is basically a research piece and that that research piece has a public information aspect, a kind of professional information aspect, and it also dovetails with David's work, David and his committee's work, on providing information to the public.
As we smooth out the Final Report, I think we can indicate here that we need to make these available to the public, and then David and his committee will be providing some of the specific mechanisms for making it available.
MR. CHAPPELL: I would like to ask you whether our recommendations should make an attempt to identify the operating idea to implement the recommendation or just to have the content of the recommendation itself.
DR. GORDON: I will give you my opinion, but I think that is a matter for discussion among all of us. My idea is the more we can get down to exactly how it is going to be implemented, where that is appropriate, let's do it, and where we can't do it, then, let's not do it. That is just my thought about it.
MR. CHAPPELL: Well, that is helpful because I think we could push some of these to more clarity or more creative thinking about that operating implementation strategy.
DR. GORDON: Steve.
DR. GROFT: Some of these recommendations where we want to direct to specific agencies or organizations, we should do so, and we can highlight that in the report, as well as the executive summary and list of recommendations later that will go out. So, we can do that.
MR. CHAPPELL: But sometimes it is not as simple as directing it to an existing agency, it is creating either the public/private group or --
DR. GROFT: Right. I think that perhaps if we can identify who you would want to do that or put it in terms of -- I think once we get through on Saturday morning, I think we will have an idea of where some of these things may be able to rest.
DR. GORDON: One of the advantages, too, of doing that is that that will help us advance our discussions, if it becomes clear that such and such belongs with the FDA or with NCCAM or any of the other agencies, we can move ahead discussions with them about how to implement it in these next few months.
So, where appropriate, it will be helpful.
DR. JONAS: Good summary, Jim.
DR. GORDON: Thank you, Wayne. Okay.
DR. GORDON: Do we have a break for 15 minutes?
MS. CHANG: We have a break for 15 minutes. Everyone back by 3:45 for Education and Training.
MS. CHANG: Session IV, Education and Training of Health Care Practitioners. Our facilitators are Drs. George Bernier and Joseph Pizzorno. Our staff lead is Dr. Joseph Kaczmarczyk.
If all the Commissioners could take their seats, please, and we will begin.
Session IV: Education and Training of
Health Care Practitioners
MS. CHANG: It is indeed.
DR. BERNIER: I would just like to open the discussion for a brief moment, I wanted to acknowledge on behalf of Joe Pizzorno and myself the work that David Bresler and Joe Fins, Buford Rolin, and Don Warren put into this.
We have seven issues and 12 recommendations, and I think it is fair to say that this is one of the focal points, the education part, as it is going to have its major impact upon the next generation of students, not just students of the CAM persuasion, but I think many traditional students, as well.
DR. PIZZORNO: The way we are going to do this, is I am going to give a quick overview of the challenges facing this committee. George will fill in my blunders and omissions. Then, we will give a chance for the committee members themselves to have a few words, and then we will get into each of the recommendations.
I think in may ways, while there was a lot of work done on this committee, it was in many ways one of the easier ones to do, and that is because if you look around this table, you will see a lot of people with a lot of education, so I think there is a shared value here that education is something that is important and that it is absolutely critical for the evolution of skills and things like patient safety and clinical outcomes.
We also realized it is important that both CAM and conventional institutions, faculty, students, and practitioners become much more educated about each other, and indeed there are some particular areas where there is specific education in conventional medicine that is necessary for CAM practitioners, and in CAM that is necessary for conventional medicine practitioners.
We also felt that because education is so important, that if we are expecting the CAM practices and professions to advance and become a more effective resource for the public, then, we needed to facilitate the educational systems.
That meant facilitating and funding curriculum development, faculty development, student scholarships, et cetera, and recognizing that quality of education and development of things like critical thinking skills and high quality content require investment.
So, we dealt with several issues, about eight of them: Access to funding and other resources for CAM faculty, curricula and program development; National Educational Standards to Practice CAM; Basic or core conventional health care curriculum for CAM students and practitioners; Traditional Healing Education and Training; Participation of CAM students in scholarship and loan programs; Basic or core CAM curriculum for conventional health care professionals at professional schools, postgraduate, and continuing education levels; and finally, Postgraduate and continuing education for CAM practitioners resembling that available to conventional health care providers.
DR. BERNIER: Our group had I think a very enjoyable experience in dealing with these issues, and I would like to ask each of the participants, if they feel comfortable about it, sharing with us their thoughts in a matter of 30 seconds or so.
DR. WARREN: Well, there were aspects of this that we agreed on and we didn't agree on. One, I don't know, I read it, but I can't remember it now, I have kind of gone through a brain lapse here, but recommended, I felt like we needed a basic background for every CAM practitioner in the United States.
I mean we are talking physiology, anatomy, biochemistry, pharmacology, and that is for all the CAM practitioners, but then, on the other hand, we also needed some of that same type of education for the conventional practitioners, and to weigh that and to get it into the systems is somewhat mind-boggling.
I think a lot of our recommendations we have here are good. I need somebody else to get me off the hook here.
DR. BERNIER: Buford.
MR. ROLIN: Thank you. I certainly concur with the recommendations and enjoyed working with our committee even though I wasn't always available. I'm sorry about that, but especially in the area of traditional healing, I was on the calls when we discussed that area.
I concur with what we have recommended here, and we will get into that discussion with the exception, and I will wait to comment on it, but I do appreciate the fact that we were all, on the basis of the information that I was able to provide, we came to consensus how to deal with the traditional healers and our recommendation for our workgroup.
But other than that, I think as we review the recommendations that have been made, you will certainly I am sure have some comments relative to, and perhaps some recommendations for some change, but it was a very thoughtful process in the efforts that we put into this.
DR. BERNIER: Thanks, Buford.
DR. FINS: Perhaps a little concern. I just want to say that I agree with most of what is recommended here, but I look forward to a fuller discussion of issues of love and forgiveness and the primary care role that is inferred for some of the naturopathic and other practitioners.
I was more comfortable with some demonstration kind of projects, but I just want to put that forward, and I look forward to a broad discussion with the full commission.
DR. BERNIER: Thank you.
I guess David is not available now. Perhaps we could go on to the issues, and that is a task that Joe and I will be splitting up. Joe.
DR. PIZZORNO: Issue No. 1, access to funding and other resources for CAM faculty, curricula, and program development. We discussed this area quite a bit because we realized that there is an issue of, on the one hand, some forces think we should have a level playing field and explicitly state that, while others feel that might be premature. So, the language we came up with is actually pretty similar to what we came up with at the July meeting, and so we have now two recommendations.
I am going to read those recommendations and ask any Commissioners to comment as they think necessary.
Recommendation No. 26. The Commission recommends that appropriate access to funding and other resources for CAM, faculty, curricula, and program development at accredited institutions and by licensed professions should be made possible by amending Title 7 and 8 of the PHS Act to authorize Health Resources and Service Administration, Bureau of Health Professions, to provide this type of support.
Now, there is actually a slight modification I would make to this, and that is on the second line, after "program development at," just put in there "CAM and conventional accredited institutions," and by license professions, put on "CAM and conventional medicine professions."
That is where we stand with that recommendation, so any comments or recommendations on this recommendation?
DR. LOW DOG: I need an explanation of Titles 7 and 8 of the PHS Act. Since we are asking to amend it, I need to know what it is.
DR. KACZMARCZYK: Those are the portions of the PHS Act that give the authority to the Bureau of Health Professions to give monies to schools, programs. It is their authorizing legislation. It tells them what they can and cannot do, and it is very, very specific right down to the detail of which professions.
DR. WARREN: Don't we intend right there for that amending to be handled if we do have CAM Central, for lack of a better word, that would be coordinated through that office as to what the amendment might entail?
DR. BERNIER: I don't think that that is a given.
DR. WARREN: I know it is not a given, it's a supposition.
DR. BERNIER: You were supposing?
DR. WARREN: I was, just me.
DR. WARREN: I told you there is a brain lapse.
DR. BERNIER: Joe.
DR. FINS: I want to say a little more about those Title 7 and 8, and again, I am not an expert on this, but I think the legislation was conceived really with an instrumental purpose in mind. Money was going to flow to engender services that were necessary for the public health.
This, along with loan guarantees and other kinds of entitlements, are directed to meet man and woman power issues necessary to meet primary health care and other kinds of health care needs.
I am concerned that we are giving a level of credence and credibility to certain kinds of practitioners prematurely, that ultimately, they may get, but they don't have right now, and redirecting what will be scarce resources to populations, to potentially underserved populations and from other medical institutions.
So, I am a little concerned about this. We have had long conversations about this on our phone conferences, but I think that this is a major, one of the most important recommendations we have made all day, and I think it really warrants more careful scrutiny and discussion.
DR. LOW DOG: I don't feel comfortable with the recommendation, the way it is.
DR. BERNIER: So, how would you modify it?
DR. LOW DOG: Well, I think it comes back to my problem. We defined CAM in this box, and we are saying that basically for CAM faculty, curricula, and program development, and we sort of took out just license now, I mean we moved that because it could be accredited. Some of these are not licensed, they are registered, et cetera. But I mean you could be a certified therapeutic touch practitioner, so are we going to send them out into Northern New Mexico to take care of the community, and then pay all their loans?
I mean what exactly does that mean? As somebody who works in a state that has seven counties that don't have a single health care provider, nurse, or anything else, nobody, I am concerned about the impact of that and how that is really going to benefit the communities in general.
In my understanding, those funds are already being cut back, the monies that are available to send people out, so I think if we are talking about what the public wants here, I think if you asked a community out in the middle of Northern New Mexico who do you want if you have a choice, I think I know what their answer would be.
So, I think in shrinking resources, and this is my problem, because some CAM professions may be at a place that they are ready to do this, but we are saying CAM like this big, general thing, which you refer back to your box, which is a whole bunch of stuff, that is probably not going to be much benefit to a community.
DR. BERNIER: You say if they don't have a choice, how would you feel if CAM providers were involved, if there were 13 counties in New Mexico that didn't have a health care provider, would you accept that?
DR. LOW DOG: I accept an imagery person to meet the health care needs or a visualization? It is not to say that they wouldn't have something to offer, but then you have to think of the logistics. You have to have a clinic for them to practice in. You have to set up the infrastructure for them to practice in.
I mean it's a whole big thing. I mean we deal with this in New Mexico all the time, as I am sure many other states do, but it is a big thing to set this whole thing up. I am just not sure. This is a big recommendation, and I think it needs more thought, that's all. I think it's too broad.
DR. BERNIER: How would you make it more narrow?
DR. LOW DOG: Well, if you are going to be specific, you need to specify which CAM practitioners you believe are at a point that could serve that function.
DR. PIZZORNO: Well, it says here "licensed CAM professions."
DR. LOW DOG: Your licensed massage therapist, your licensed hypnotherapist. I think we need to be careful of what the public needs and what the Public Health Service was designed to do. I am not saying that massage is not part of public health, I am not saying that at all. I am saying that these are underserved areas, and that if we start spreading funds and people, we may not give the people what they truly need in those communities.
DR. PIZZORNO: I think it is important to recognize what we are trying to create with this one is education. This is to support education at accredited CAM institutions, to support faculty and curriculum development. It is not about what you are dealing with, I believe is dealt with later on in another issue.
I mean it may be that we don't have exactly the right language here, we are relying on the recommendation we received for the language, but this is about education.
DR. GORDON: Joe, can you make it clear what you mean when you say it is about education, what are the parameters, what does it include, what does it exclude?
DR. PIZZORNO: The intent is to facilitate curricula, faculty development at accredited CAM institutions, just as we have currently for accredited conventional medicine institutions.
DR. FINS: Joe, it seems to me here that these Acts were really designed to have manpower issues downstream of education. That is really why education and manpower is linked, as Tieraona is suggesting.
It seems to me that what we really need to look at what is the effect of federal funding on education, have pilot grants of the sort that are already beginning to happen, but this is a sweeping change across the entire manpower spectrum, and I don't think there is evidence to say that dollars spent on this is better spent than on producing more neuropractitioners or more respiratory therapists or more primary care physicians, and especially in underserved areas.
DR. PIZZORNO: I would like to remind people that more members of the public are seeing CAM professionals now than conventional medicine practitioners, and right now all the money is going to conventional medicine only.
It is time that we realize that the public is demanding these services and expects that a portion of the funding we provide to conventional medicine go to also educate and facilitate the evolution of the CAM professions.
MR. CHAPPELL: I guess I am seeing the opportunity in this for some really important support for CAM. I remember our hearings in Seattle and remembering clearly the students talking about the difficulty they had in funding their education.
They were working alongside people that were funded because it was conventional medicines, and I just see this recommendation as being essentially and primarily for access to educational funds for students and faculty and program development.
There are going to be instances where some limited use of this will be for some situations that we might wish were otherwise, but this is essentially for a provision and a big gap that desperately needs to be funded.
So, I happen to like the recommendation as it is drafted. If there is any way to differentiate among CAM professionals, I am certainly willing to entertain that, but I don't know of any.
DR. BERNIER: Charlotte.
SISTER KERR: I am a little puzzled, Tieraona, in some of your comments, because of exactly what Joe said, as well as it is just allowing access and the consumer will decide, and we will evolve into by walking into the door of the various practitioners what is wanted. It may well be the chiropractor in a rural area, and the acupuncturist except for the injuries of an accident would be the best people to be there.
I think those priorities would be set within the system itself, I am sure, as far as what you do with a little bit of money.
DR. LOW DOG: I have no issues around education and funding for education, none, none. They are available for any profession that somebody wants to go into whether it is the healing profession or others. I think that education, there should be adequate resources for anybody to go get the education that they want.
So, I have no issue with that here with that aspect of it. I just need to say that I just cannot live with this continued quotation of an Eisenberg study that really has misled a lot of people. I have sent references on other studies to Steve Groft that have clearly showed that actually visits to CAM practitioners are really running between 6 and 10 percent of the population.
The Eisenberg study included everybody who took a Centrum, everybody who went to church, everybody who went to a prayer group or an Alcoholics Anonymous. That is not the same thing as what we are talking about here under CAM, because we have not included that under our CAM rubric.
So, I want us to be clear if we are talking about the population, who we really are talking about, 6 to 10 percent. Now, access and delivery, that will sort of broaden.
I just think you are going to have to be clear about, when there are scarce resources, let's imagine that this commission was told you are going to have $500 million, and that is how much you are going to have to spend, prioritize how you are going to spend it.
Then, I think we would be a little more focused on what really needs to happen. I think that demonstration projects are necessary for some of these in communities, and I would be totally supportive of some demonstration projects before we start amending legislation.
DR. BERNIER: Jim.
DR. GORDON: I want to make sure, Tieraona, that we are saying -- No. 26 is narrowly focused on education, has nothing to do with manpower, has nothing to do with National Health Service Corps. Am I right, Joe, in saying this, both Joes?
If this is just, for example, what has happened with NCCAM now is NCCAM has now made available money for CAM education programs. If this is something similar to that, if we are saying to HRSA through the Bureau of Health Professions let's make it competitive, so that an acupuncture program, as well as a nurse practitioner program, can apply for funds for educating of students, that is one thing.
If we are saying the money should be diverted from X to Y, that is another thing. And if we are talking about manpower or man and woman power in the community, that is a totally different thing.
I just want to assure that you stated clearly again and that everybody here understands what we are talking about in this No. 26 recommendation, and then we can go on to the others.
DR. PIZZORNO: Issue No. 5 deals with scholarship and loan programs, and I think much of what Tieraona is talking about is fitting under that.
DR. LOW DOG: Does that have nothing to do with Title 7?
DR. PIZZORNO: I don't know how all these titles and things work.
DR. FINS: It does. If you look at page 5 --
DR. PIZZORNO: We tried to.
DR. FINS: Recommendation 32 addresses it, so they are inextricably linked, as was said earlier, so the recommendation here is the reauthorization of 7 and 8 should be amended to include enabling legislation making CAM students eligible.
So, these are not isolated concerns, they are inextricably linked.
DR. PIZZORNO: So, let's differentiate between the two. One is support for education. The second is for loan forgiveness and rural practice kinds of things. Those are separate issues.
DR. FINS: That is why 7 and 8 are bad places to put this entitlement.
DR. PIZZORNO: So, you are saying these are the wrong place to put it.
DR. FINS: Because it is related to manpower, woman power, which is then related to access in underserved populations, and people who are vulnerable, who are in counties where there are no doctors, and we are going to put a massage therapist in and call it health care.
So, what I think we need to do is to find a different place to draw those funds. I mean, I am all in favor of education. Let's have hope scholarships, whatever we want to call them, for this sort of thing, but it shouldn't come out of this silo because I think the problem is that it gets to the issues of the underserved that Tieraona and I were speaking about.
DR. BERNIER: How would you solve this problem?
DR. PIZZORNO: Well, if we were to simply remove by amending Title such and such, et cetera, and leave the rest of it as is, would that work for you? Okay, and we will leave it to the government to decide how to do this.
DR. GROFT: I think what we will do then is get also the exact language in Title 7 and 8, and have the workgroup look at that in its entirety, and then come back with the decision or recommendation at that point.
I think what we would like to do, too, is then pass Title 7 and 8 out to the entire commission so that everybody can read it also.
DR. FINS: I think if we deleted the second half, I would be much more comfortable with it, and it becomes a pure educational issue, it is not a manpower issue, and then we could argue that these people are going to add value to communities, and it will be integrative versus alternative care.
DR. PIZZORNO: George, that sounds fine with me. Does that sound fine with you, just to limit the last part of that?
DR. BERNIER: Right, and take it back to the group.
SISTER KERR: Would you just clarify, then, what we are eliminating? Just No. 26, the second half? We are temporarily taking that out, and the committee will rethink it?
DR. PIZZORNO: Right, we will look at that and maybe there will be certain sections of that, that are appropriate, or maybe there is another mechanism that is more appropriate. We will take a look at that and figure it out.
SISTER KERR: I just had one other comment, and I so respect my fellow commissioners, I want to be clear. I had a feeling, Tieraona, and Joe, that there was an assumption that I didn't know was what you might have held, or I want to be sure I heard it, that you actually sound to me like you are assuming that almost all of the time the preference would be for a traditional Western medicine-trained doctor, at least the majority of CAM practices is a priority in the community, is that true, because I have to tell you, I am not sure I am there anymore.
If that is an assumption, then, we just need to clarify that.
DR. LOW DOG: Well, I would say if 90 to 94 percent of people are still utilizing the Western health care system, I think that that is a pretty strong indication that people have not completely abandoned it.
In a lot of our Northern New Mexico communities, we do have massage therapists, and we do have traditional Mexican-American healers. We have herbalists, and we have some Curanderos up in the North, and they do a good job taking care of the community, and there are still huge gaps missing for the chronic illnesses that are just killing these people.
My biggest fear is that we are going to somehow go down the path of saying, well, we have got a massage therapist in this county, so that we can check off the box that we have got a health care provider and we don't need to keep working to bring somebody else there.
There is no doubt that Western medicine fits in place especially in very isolated rural areas where when emergencies happen, it is very difficult to transport and get people into town. So, it is a place where Western medicine really excels is in very isolated rural areas in underserved populations.
SISTER KERR: I understand, Tieraona, what you are saying, but then when I heard this just now, that there would be cases where Western medicine's need -- it is as if it was an either/or conversation, and I don't think we are saying either/or, because I would agree with you, first-aid-wise, even though epidemiologically speaking, doctors are prepared for the 1 and the 1,000 at a university hospital, and that is not the majority of the needs in the community even though when you are dying and having a coronary, and you need a whatever, you need acute care.
But I don't think it's an either/or, and I respect what you are saying, and I hear that, I have been there, too, but I don't think we are having to make that decision and this decision that we are eliminating that the community will forsake then looking or valuing or needing the acute care doctor.
DR. FINS: I don't think it should be an either/or, and in conversations that we had at the very, very first meeting related to access, were about the issue of the paradox, providing access to CAM when there was an access to health care, would there be access to supplements and there is not a prescription drug benefit.
So, these things are inextricably linked, and what I think Tieraona and I are saying, and other members maybe are feeling, is that in a situation where you have the single choice, not discounting the value added that the CAM modality or the practitioner has, an immense value in many cases, that you basically want to play a kind of a defensive posture against accidents and sudden illness where there isn't a hospital nearby and you would like to have a primary care practitioner accessible.
It is just a basic safety net kind of issue. I think that by linking it to the Title 7 and 8 here, it ties it to the manpower issue, and that is our concern.
Ideally, CAM practitioners would be value added, it would be integrated, they would be part of a system that was already in place, but tragically, there are parts of this country that does not have access to primary health care.
DR. BERNIER: Tom.
MR. CHAPPELL: I am wondering if we are getting lost in some of the percentages that we have been talking about of how many people are accessing CAM. We have had the information from day one that over $30 billion is being spent by consumers on what they think are CAM solutions.
So, whether they are buying a brand name supplement from a large company is not important. What is important is that they are seeking CAM solutions, and they are spending money for that, and I think we need to just keep in mind that that is what is generating all the activity here is the consumer and the enormous spending power that they are driving behind it.
So, that is pretty persuasive in my mind about how the American public is seeking out these kinds of solutions, and we need to be reminded that we need to serve all those related that are providing that solution to consumers.
DR. BERNIER: I would like to suggest that everybody who is interested in it, look at the Annals of Internal Medicine over the last couple of months in which a lot of discussion and thought by very, very thoughtful people has gone into this very issue, and if we can do that, I think it would help us all.
DR. GORDON: George, I would actually ask Steve and Michele if they could get us copies of those. I agree with you, I think that would be very helpful for all of us to have.
I want to come back to this issue because I think the discussion is very valuable. I would like to focus on what we agree on, and then move on to some of the other areas.
What I am hearing, and I know I am sort of jumping my role right now, but I just want to move on with this, too, is that we do agree that there should be support for development of CAM curricula for both conventional and CAM practitioners. We don't agree at this time about Title 7 and 8, in fact, there is strong feeling against having Title 7 and 8 here in this.
That is kind of what I am hearing from us right now, and then I think we do need to tackle the other issues related to Title 7 and Title 8 as they come up later on.
I also think if we agree on that, we need to speak in the background, and I know Joe Kaczmarczyk knows this, about some of the efforts that are already moving ahead in terms of CAM education, and what we need here as part of the background piece is what is being done, what isn't being done, what are the limits in education, and we may or may not -- and I sort of give this back to you all as a committee -- want to think about are there scales of recommendations that we want to make or do we just want to make a statement saying that funds should be available, but given the fact that we are taking it out of the Title 7 and Title 8, and we are just looking at it as an entity, do we want to say something more specific about how much education money or how much money should be made available.
DR. FINS: It would be very helpful, George, maybe as a background piece, I mean I know that the average medical student who graduates from my medical school is $100,000 in debt, it would be interesting to have a sense of the data of the debt burden that various CAM students are engendering, and then have a sense of the scope of the problem, the number of students, the kind of numbers that would be involved just to get a sense of how big a problem this is.
DR. GORDON: I just want to say, Joe, that that actually goes to another question, another recommendation. This one is basically are we going to support the development of programs, are we going to support the development of a CAM program at your nursing school or my acupuncture school or et cetera, et cetera. So, that is more related to loans and scholarships, and the rest of it.
All these issues are so connected, it is hard to tease them out, but I think it is important that we do that.
DR. BERNIER: Thank you, Jim, for your bit of leadership there, well said.
So, let's move on to 27. The Commission recommends that joint research and educational programs involving CAM practitioners and conventional practitioners should be established and financial support for these programs should be identified.
I would probably put in there "CAM practitioners and institutions and conventional practitioners and institutions," because I think this is more of an institution practitioner rather than practitioner --
DR. GORDON: I don't quite understand the recommendation. One thing I don't understand is why we are having research in here.
DR. PIZZORNO: We probably should cut out the research because that has been said in the research section.
DR. FINS: I think research may be the way that happens in medical schools and Bastyr school, university, have collaborations with the University of Washington through research, so the doing of research is an educational experience, as well.
DR. GORDON: All I am pointing out is that we have to somehow have this dovetail with the research recommendations, where we have already made this recommendation regarding research, we haven't made it as far as education goes.
DR. BERNIER: I think it is a logical step.
DR. GORDON: Yes.
DR. BERNIER: Linnea.
MS. LARSON: My question is a clarification question, and it has to do with these programs should be identified, and the support should be identified, so the job of somebody is to say here is where the money is going to come from. I mean do we need a little bit more flushing out of that?
DR. PIZZORNO: I don't know. I think the staff has to advise us on that. I don't think we have been consistent up until now saying exactly where the money has to come from. So, I don't know if we should be doing that or not.
MS. LARSON: That is my question.
DR. PIZZORNO: I don't know.
MS. LARSON: So, we need some input about that.
DR. GORDON: This is continuing education, is that right?
DR. BERNIER: No, this is primary education.
DR. GORDON: What does it mean then?
DR. BERNIER: It is primary education.
DR. GORDON: Oh, because that is not clear, when you say involving -- this is all primary education for -- how is this different from 26?
DR. PIZZORNO: This is about trying to facilitate collaboration between CAM institutions and conventional institutions in doing education. So, for example, when CAM institutions are trying to develop their conventional basic sciences education, we want them to collaborate with conventional medical schools, and conversely, when conventional medical schools are trying to do CAM education on their campuses for their students, that they collaborate with CAM institutions.
DR. GORDON: I just think that all needs to be spelled out in here.
DR. PIZZORNO: Say it a little better.
DR. GORDON: Because I had no idea where it was taking place from the recommendation.
DR. FINS: I think this lends itself nicely to an RFP for a demonstration project to show mechanisms to foster that kind of collaboration, and sustain that collaboration.
DR. PIZZORNO: Any other commissioners with comments on this one?
DR. GORDON: I think we have said it somewhat better before, I hate to say something like that, but it is like the RFAs that NCCAM has now stipulates if you are going to do a program, you have CAM folks working with conventional folks to develop the program in the institution.
It is a straightforward idea, and I just think it needs to be presented a little more straightforwardly with a little more detail about what it is exactly that we are talking about here.
DR. PIZZORNO: Any other commissioner comments?
Okay, George, I pass the baton to you.
DR. BERNIER: Okay. The next issue deals with National Educational Standards to practice CAM. There is a background here which concludes with, "We recommend that CAM training courses should become more standardized and be accredited and validated by the appropriate professional bodies. All those who deliver CAM treatments, whether conventional health professionals or CAM professionals, should have received training in that discipline independently accredited by the appropriate regulatory body."
They went on to say, "This would protect the public who use CAM and would improve the transparency of the organization and make understanding what practitioners' qualifications mean in an easier way. It is clear to us that the quality and degree of standardization of training within each therapy are closely linked to how successful each individual therapy has been in overcoming internal division and coming together under the auspices of a single body that agrees core objectives for education and regulation."
The challenges on this are that this would include similarity to licensure and perceived encroachment on states' rights, a degree of complexity, multiple contentious issues, funding requirements, need for legislation and appropriations, questionable authority, and widespread resistance.
The recommendation has been made that the Commission recommend that National Education Standards for CAM modalities, therapies, and practices should be established by professional educational institution organizations linked with the proposed federal CAM coordinating office.
MS. LARSON: I have another technical question. I do not know, and I don't understand what this means. "The challenges include similarity," what is similar to what?
DR. BERNIER: It is similar to having a license, but it is not having a license.
MS. LARSON: You mean standardization is similar to licensure?
DR. BERNIER: I think that what is meant by the statement, it means that there would be similarity to licensure among the individuals who are either getting licensed or were not.
DR. FINS: My sense is that the problem that we are encountering here in having a standard educational approach across the spectrum of practitioners in differing jurisdictions and factions and everything, is similar to the problem that is encountered I think under the licensure rubric, as well.
DR. BERNIER: Right. It is clearly a very sticky issue. It would be hard for us to mandate or for the government to mandate that individuals go through a process of licensure attainment.
DR. PIZZORNO: George, I have a slightly different perspective what we are saying here. This was not meant to be licensing nor a substitute for licensing. This is rather to recommend that for these various professions, that they have National Educational Standards, so that there is consistency across the country in how education happens in these areas.
Now, licensing and things of that nature are separate, handled by states. This is more like accrediting bodies for various kinds of educational systems, so there is consistency. That is how I was reading this.
DR. FINS: Can I make a suggestion maybe to give this a little more focus as a recommendation, because I think it is a very important problem that George is commenting on.
We so hear in our testimony that different groups have different standards, and they can't agree on like the acupuncturists at how many hours, and I said why don't you guys go to dinner and come back and tell us, and they wouldn't even go to dinner with each other.
So, what I would maybe suggest -- remember that?
DR. BERNIER: Yes.
DR. FINS: I would suggest perhaps that we make a recommendation that the Department of Education might consider a pilot project bringing together an identified group or practitioners in one area, perhaps acupuncture, because it is very evolved, to see if they can have a summit on educational standards as a model program that might be then valuable for other CAM professions or emerging professions, because we really don't know how to bring these people together and have them agree, and they are coming from different backgrounds, different disciplines.
That is a focus, that could be a conference, that could be a facilitative kind of mode for the educational people who are trying to work out standards and consensus.
DR. BERNIER: If you were to do that, what modality would you begin with? I guess you would have to start with two.
DR. FINS: Since we heard a lot about the issues that related to acupuncture, might bring the leading organizations together and have a summit and see if they could work out what could begin to emerge as a national standard.
Again, it is not a governmental standard, but it is like they have all come together and created a new college of acupuncture or some governing body that everybody would agree to, and see if they could work out a compromise.
I think that would be a very important step for the emergence of the profession, and there may be lessons to be learned from other professions that have gone through this process.
DR. GUTIERREZ: I would like to say that I think we should get more information on the table about states' rights. I found through my experience in lobbying in the State of Washington anyway that the legislators were not well informed or educated about health issues and just wanted everybody off their backs, and so they would pass legislation based on who had the best lobbyist or the more dollars.
In chiropractic, we have 50 different state laws, and again it is a political issue depending on who has got the political clout at the moment. Down in Texas, chiropractors have been licensed to do manipulation under anesthesia, and there is one college that teaches that.
The chiropractors in Florida want the right to prescribe pain medication, and in a roundabout way to attempt that, they tried to get a chiropractic college at the University of Florida, and they were going to try to change the face of chiropractic across the United States with that university.
We have some states that allow chiropractors to do acupuncture, in Washington they don't. It was determined that breaking the skin is the practice of medicine, so chiropractors can't do that in Washington.
In California, up to a short time ago, they could deliver babies, and because the chiropractors in California wanted to deliver babies, the chiropractic colleges put that on their curriculum because they knew they would attract the students to their school that wanted to go back to California, and if they didn't change their curriculum, their student enrollment was down.
So, this is very, very complicated, and I don't know, I would like to have some sort of a survey of the states and just see how strongly the states feel about this.
I was on the Washington State Chiropractic Quality Assurance Commission for six years, and up to the time I left, we tested for minimal competency in chiropractic. When I got off, the Commission voted to abrogate the state's rights and let an outside agency with no accreditation or recognition test everybody, and once they passed the national boards, they just came into the State of Washington.
So, I think maybe we are assuming a lot about states' rights and their desire to control health issues, and I would like a much closer look at that.
DR. GORDON: I am struck by the fact that this seems like a good idea, but in fact, there are so many difficulties. I'm sorry Joe is not here. He raised the example of acupuncture.
If we remember back to that commission meeting, and remember those people sitting there and how they related or didn't relate to each other, I think we have a microcosm of some of the real difficulties, and to try to sort of create a national standard when there is so much difference, maybe the idea of beginning with some kinds of meetings to discuss to see if it can be done, many meetings to see if it can be done and if it is worth doing.
Veronica is bringing up all this whole other set of different state regulations. My sense is we are not there yet.
MS. LARSON: If I recall correctly, and I think we actually should check the testimony from February on the Education Subcommittee, that actually one of the recommendations that came out of that was a staged recommendation that said that we should move towards national standards. That was one of our recommendations that came out in February.
Now, the methods by which we will or can do this, one of the mechanisms is actually to make a recommendation for a summit, a study group that has many of these emerging professions involved in having discussion, but I think it should be a staged thing.
But I know clearly from our February meeting what came out in our workgroup on education is that we should be moving towards national, but it should be decided by the independent groups.
DR. LOW DOG: It sounded like there was -- I know they are interrelated again, but it sounded like we were saying one thing about national educational standards, but then we were also talking about practice, what you were allowed to do, if you could break the skin, if you could deliver babies, and that could be related to curriculum, I understand that, but they are a little bit different.
If you have educational standards all across, so that all schools will teach something, different states may vary on what they will allow you to do or not do, which is sort of the practice versus your education, which is what we are going to teach. Everybody is going to have this amount of knowledge when they come out. They may have some extra or whatever, but they are going to have this minimum amount of knowledge that everybody is going to come out and agree to.
It seems like there were two different things we were talking about, education and practice. I would agree with sort of an approach that is over time, but I think your national education standards are a little bit separate than what each state is going to allow you to do. What you are saying is everybody is going to have to have this amount of training.
SISTER KERR: I was going back to the actual recommendation, but I wanted to say that, Jim, I agree with you I think on this prematurity. Again, we are dealing with national standards and diversity, and I just don't think we have evolved yet enough, because again we are coming out particularly like in acupuncture where you have such a different conceptual framework fitting into this biomedical model that I still think we are thinking out of, at least in legislation.
Maybe until this evolution of consciousness occurs in the next three years, maybe the professional organizations ought to just keep grappling with it, but back to the recommendation.
This is just very simple. The sentence is just not clear to me, and I understand for myself that the intention was to say that the Commission recommends that national education standards for CAM da-da-da should be established by their own professional and educational institutions, isn't that correct? So, then that would be period.
And then we are saying we suggest -- I want to clarify -- that they collaborate with the proposed federal coordinating office, is that also what we are saying? Then, I think we should say it separately.
DR. GORDON: Michele pointed something out to me, which I think is really important, that we can advance the dialogue by talking about some of the contentious issues that are just mentioned here.
I think that if we can do that, if we can give an example, whether it is acupuncture, or it could be chiropractic, has a different set of contentious issues, if we can give a couple of examples and then talk about how we might forward the discussion, I feel like that is as far as we can get right now. I mean that is just my opinion.
If we can do that, which is kind of what Linnea was saying, as well, that we are moving in a direction -- we may decide not to have national standards, and that is also a possibility, but I feel like this discussion needs to go ahead partly because it is so contentious.
DR. BERNIER: Well said. Linnea.
MS. LARSON: I guess I keep wanting to refer to this, again back to February. It is our decision had been to say that the professional organizations and the institutions, if they have respective educational institutions, that they would be the ones who would set the standards, and following that, if something evolves in our many public/private partnership that says these are the educational standards for X profession, that that would emerge.
But I do think it was very clearly linked and also I want to speak to what you said. There is a very clear difference between education and practice, and practice actually comes under the regulatory mechanisms that would be under access and delivery, but I think we should spell that out very, very explicitly throughout this.
DR. GORDON: Linnea, I have a question for you. Let's say there are four different national organizations for four different sets of standards. How does that fit into what you are saying, which I think in some instances there are.
MS. LARSON: Well, I know that we took testimony in February, and I can say that I had a grid that had seven chiropractic organizations that made commentary and had very different recommendations.
I am mindful of that, but I think by saying that we do value that, that we are assisting what are called emerging professions to set a standard and to be on the same level playing field as other professions.
MS. CHANG: I will just give you a time check. You have 20 minutes.
DR. LOW DOG: I just want to make one comment since you quoted the House of Lords, just a little background in the UK, which I think is a little easier because there are not 50 states.
The herbalists over there, they had a very difficult time trying to get any sort of things moving forward in the UK, and part of the reason was everybody kept telling them, well, we have heard from several different groups, and you have all said different things.
What they told them, basically, the government, Medicines Control Agency, everybody said go home; go back, discuss this amongst yourselves, and when you can come back and speak with some sort of voice together, then we will talk to you, but right now there are so many of you, and you have so many different things to say, that we are just not going to deal with you.
It was to their disadvantage to move forward, to not be able to come up with some sort of agreements amongst themselves. It is a little background of where the House of Lords part of this, where it came from was because it says in there about overcoming internal divisions. It was the divisions amongst the practitioner groups themselves, not from outside but internal, that kept them from being able to move forward as a profession.
So, there are some valid reasons for trying to suggest that groups and organizations try to work with each other as this would probably benefit their moving forward.
DR. GORDON: Speaking of moving forward, I really feel we need to be mindful of the time. We have several other issues that are at least as complex as these two to deal with.
DR. BERNIER: I think we will proceed to the next stop, if that is okay. That dealt with Issue 3, which was the basic or core conventional health care curriculum for CAM students and practitioners.
The background on this is that a core curriculum for CAM students has been proposed to facilitate recognition of limits of clinical expertise and potential complications of interventions and appropriate referral to conventional health care providers.
You can see the rest of that there. The recommendation that had been made was that the Commission recommends that a basic curriculum and conventional health care and medical sciences for CAM students and practitioners should be developed to facilitate recognition of limits of clinical expertise and potential complications of interventions and appropriate referrals to conventional health care providers.
Comment on that? Yes, Veronica.
DR. GUTIERREZ: I just have one brief comment because I totally support this. The handout that I passed out from our office has a consent for care, and I support this recommendation, and as a follow up somewhere, I think we should encourage all providers to do something similar, so that every patient that enters their office knows what they can expect in the way of care and when an appropriate referral will be made.
DR. BERNIER: Thank you. Other comments, questions? Joe.
DR. FINS: That raises an issue that I think we have never discussed, and I think it's a Saturday point, that CAM therapy, there should be informed consent and refusal, and we should bring that mechanism to bear for these other interventions. I think that is just sort of an obvious point which we hadn't thought of yet, but it is important to say.
I also wanted to say one really quick thing about Linnea's point about the professions and the House of Lords. We have to recognize, I think, in the regulation of this, and the educational piece, that some of the groups that we think might emerge as professions are never, ever truly going to get there.
We can't turn something that is not going to be a profession into a profession. It has its own sociology, and if they want to evolve and emerge, they will have the status of a profession. If they don't, they won't, and we can't turn them into that.
DR. BERNIER: We can't make them do it.
DR. FINS: We can't make them do it, and the sociological forces might be that they will never do it, but at the same time, if they are not going to do it, we should not give them the privilege that comes along with being a member of an established profession.
DR. BERNIER: Further discussion? I think we have had a poor record of accepting proposals.
DR. GORDON: George, I think that with No. 29 and with No. 30, and we haven't heard from people about 30, my sense is there is general agreement about these.
I would like some more specificity about what we are talking about in both of them. I will just give you an example just to take and do with as a committee what you would like, but for me, what is important is that there is not just education about specific approaches in research, but that some of the education is experiential, that there is a look at the scientific literature, that there is an understanding of the philosophy and the world view, as well as the specific practices, that there is an understanding of the social and historical context of the particular approaches.
So, I would just like to add some meat to the bones of what we are talking about when we say there needs to be education about CAM practices.
DR. FINS: This recommendation was education about conventional care, at least on 29, it was the other way around.
DR. GORDON: Oh, I'm sorry, but the same way.
DR. FINS: But the more specificity that I would like to flush out is that limitation of their practice is not to provide CAM therapies to people who are, say, actively dying when, in fact, they should be made aware of the fact that they are at the end of their lives, and they may be better off with a hospice referral.
In other words, as we said, we asked Dr. Atkins if he ever had a treatment failure, and he said no. That sense of lack of perspective of one's limitation, all of us around this table have limitations, need to be made aware of that.
So, I think it is very important that especially for vulnerable populations, and I would say that patient near the end of their life who in desperation goes to a CAM practitioner with great expense and perhaps depriving themselves of appropriate pain management and other kinds of symptom relief is somebody who they need to be made aware of these other treatment modalities that are out there. So, that kind of self-regulation is critical.
DR. GORDON: I would say that that is true -- I'm sorry I got confused here -- but I think the same thing true of people who go to CAM practitioners who have a fracture. I mean the issue is there across the board, and I think we need to make it clear. I think what we are talking about is a little more specificity for the recommendation, but it sounds like everybody agrees.
DR. BERNIER: The time remaining for us I think is about six minutes.
MS. CHANG: About 12.
DR. BERNIER: Do they lock the doors?
MS. CHANG: I would continue until we get locked out.
DR. GORDON: I had a question about No. 30. Shouldn't we give more specificity to that or should we? Where are people with that?
DR. FINS: A lot like No. 27, which we already did recommend joint research, educational programs. So maybe we can bring those two together.
DR. GORDON: So, you are saying 30 should go with 27?
DR. FINS: Yes, and embellish both as we were sort of talking about 27.
SISTER KERR: My only comment, I don't have the answer to this, but I am appreciating Jim Gordon trying to get us to be more specific, like when we did the research part, who else but us, in terms of at a certain level.
The same, I kind of go in and out of what I am doing, like when I read 30, it is like we should encourage the collaboration and funding. Well, we knew we were going to say that. How is that specific enough, or is it that I have been into it too much? If I read this, I would say, god, they spent two years just to say we ought to encourage collaboration.
DR. GORDON: To pick up on Linnea's theme, I think that as I remember it, the workgroups in February worked out some of the specifics. Isn't that right? So, it is a matter of bringing those in.
I think even a few more specifics into the recommendation, so that people, as Charlotte is saying, they will look at the recommendation and instead of saying aha, they will say yeah.
DR. FINS: I think we really need to go back to the February meeting, because there is a lot of stuff that we actually had which needs to be resurrected. Gerri has all that stuff.
DR. BERNIER: We are at No. 31.
DR. PIZZORNO: Issue No. 4 is my responsibility. We tried to look at the somewhat unique needs of traditional healers, and we are defining traditional healers as those who function within a community that practice both through the traditions of that community, but also with the somewhat informal oversight of the community.
Working with Buford, we tried to establish our recommendation here that we thought would be appropriate. So, that is Recommendation No. 31.
That is the Commission recommends that traditional healers who practice within a community which provides traditions and oversight should be provided appropriate access to educational funding and allowed to continue to practice without state censure providing: (a) their clients are fully informed of their training or lack thereof; (b) they do not mislead their clients by use of titles of licensed professions, and (c) have not been censured by their community.
We put the last one in there because there were examples of people who were censured by their community, then going off into other communities claiming to have you might say an implied credential, and that would lead to public harm.
So, comments from the Commissioners?
DR. BRESLER: What do you mean by "lack of training"? Is a traditional practitioner supposed to say I never went to medical school, I never went to psych graduate school, I never went to chiropractic college, I never went to naturopathy school? I mean what is the intention of your group about stipulating lack of training?
It is one thing for somebody to say what training they got. It is a whole another thing to say what they didn't get.
DR. PIZZORNO: That is a valid point. That is a valid statement.
MR. CHAPPELL: I guess I am wondering why we need to provide any differentiation for traditional healing at all, because if I am a member of a particular native community, I can apply for any as long as all the other recommendations work, I can apply like any other citizen for those same funding sources.
I don't see why we are creating -- and believe me, I am very sensitive to inclusivity here -- I don't see the benefit of creating a special case situation for a traditional healer, because a traditional healer can get access to education if these other recommendations are enacted if they choose to.
But if they choose not to, then, they are the same status as they are now, which is the traditional healer honored by their community, fulfilling their service to their community. I think it is inappropriate for us to try to struggle here to create a special class of opportunity for a traditional healer because there is no need to. That traditional healer has access to the same opportunity as any other student for CAM education if these other recommendations pass.
DR. BERNIER: Tieraona?
DR. LOW DOG: I guess the thing would be is that we had said under the other recommendations about accredited institutions, and we talked about that there needed to be some sort of accredited school to be able to get funding, and I am not sure how much educational funding in reality a lot indigenous people are going to be seeking.
Part of this that I think is in -- well, there is an exception because on the Navajo, there is an apprenticeship program going on now, and it is not really like an accredited kind of school, but it is a tribally-recognized program to preserve the traditions of the Navajo healing systems, and I do not believe that there is access for them for federal funding for that.
So, it is not quite the same, and the other thing is that I think that it is important, not so much on the reservation, but also for having language about urban indians where they may be living in Albuquerque and they are traditional practitioners serving the needs of native people in that community, although they are not on the reservation anymore, and I think there should be language in there, I think it is important. I think it is a different system, and I think it would also extend to Mexican-American healers, as well.
DR. BERNIER: Thank you. Any further comments?
DR. CHOW: I think we have an example of Native American healing here, but many multicultural, the Puerto Rican healers, we were talking about Ayurveda medicine, the Chinese medicine, although we have kind of, pardon the word, but, sold ourselves out and kind of broken ourselves up into components. There still is the traditional Chinese medicine, where Buddhism in Dallas, and much of the spirituality is very much involved in it, and the Curanderos, et cetera.
I think there needs to be an emphasis on these particular systems, indigenous or multicultural systems, emphasis at this point. I think, later it might phase in, but there is a difference in educational expectations for here.
DR. BERNIER: Thank you. I think we had better end. Three minutes?
DR. GORDON: Four minutes, actually.
DR. BERNIER: Buford, could you comment on what you have heard so far about this recommendation, because you are right there in the firing line. Can you tell us what is needed, and what is not needed?
MR. ROLIN: Well, at this point I was provided some information just recently. I don't know, Tieraona, if you have seen this. It was published by the Johns Hopkins University Press for Dr. Rhodes.
In that one chapter of Dr. Rhodes, they talked about alternative medicine in the term of exploitation, and we do have some problems with that now, specifically, and I am glad to hear that Tieraona mentioned the fact of what the Navajos are doing.
It is also happening with other tribes, as well, because of the fact we have had people who have lived on our reservations and even married into the families, who have participated in the ceremonies and have left the reservations, gone out into the urban area or metropolitan areas, established their own traditional healing.
So, it is of real concern for us now, and the fact that we have even some one of these that they are referred to in the community that this is happening with, so we are real concerned about that, and it is very important now that we continue with the training process that we have, and that is within the family on the reservation.
As we also heard from the paper that we received from the Native Alliance, the system that they use, their families and the culture, it came into being. The same thing is happening on our reservations.
But what we are real fearful of, we don't object to someone going to a sweat lodge, we never have, but for someone to go to a sweat lodge and say that they are going through a healing, and then to go out into another community to start, yes, charging for that, we are opposed to, because normally, our traditional healers now, they don't receive any form of compensation with money. It is all part of the gifts of what you feel that you want to share with that individual for the services provided.
Unfortunately, it has been exploited in some areas, and we are concerned about that, and number of our tribes are really making an effort now to make sure that their traditional healers that practice remain within our area.
As it was also pointed out, the other issue and concern we have is we have so many of our people now who have moved into the urban areas. How do we continue to serve them?
Well, the only way they can be served now is if they go back to the reservation, but that is a concern, a genuine concern because they may have grown up where the traditional healers were included in the practice of treatment for them, and it is not available there.
But it also creates another problem, as Tieraona mentioned earlier, is those people going into another community and really not knowing what it is, the type of traditional healing that these people that lived there were involved in. It creates a problem for us, so we have some real concerns there.
Effie made a good point. There are other societies -- not societies, but I mean native people, Curanderos that she mentioned, the Puerto Ricans, and others who have their own system of traditional healing.
I think she has made a good point there, but I base this all on the fact that when we asked for those and had that hearing, we only had the few people, the few respondents that we did, but I think it is wise that we recognize that, and it is happening.
DR. GORDON: I would like to make a final point and then adjourn us to continue the discussion. One thing I want to say about this is I feel like the way that we need to treat traditional healers is with the appropriate respect.
I don't mean anybody here is disrespectful, I just mean that the way this is worded, it doesn't appreciate the internal consistency and the longevity and indeed the tradition that we are talking about.
So, I think as we have described traditional healing practices, the more we can relate to them as they are, and as they see the difficulties, the better the recommendation that we come up will wind up being.
We can come back to this for a moment tomorrow morning. I will give up 15 of my 30 minutes tomorrow, but that still only means we have half an hour to go through the rest of these, so I urge everybody to really take a look tonight again at these last recommendations, because some of them again I think you will are very thorny, as well as knotty.
So, when we come back tomorrow, let's really try to focus on those.
Thank you both very much and we will adjourn until 8:00 tomorrow morning.
[Recessed at 5:00 p.m., to reconvene Friday, October 5, 2001, at 8:00 a.m.]
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This is to certify that the attached proceedings
BEFORE THE: White House Commission on Complementary
and Alternative Medicine
HELD: October 4-6, 2001
were convened as herein appears, and that this is the official transcript thereof for the file of the Department or Commission.
DEBORAH TALLMAN, Court Reporter