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Thursday, February 21, 2002 &
Friday, February 22, 2002

Thursday, February 21, 2002 - Afternoon Session
  • Meeting Contents and Participants (10K bytes)
  • Thursday, February 21, 2002 - Morning Session (180K bytes)
  • Thursday, February 21, 2002 - Afternoon Session (251K bytes)
  • Friday, February 22, 2002 - Morning Session (304K bytes)
  • Friday, February 22, 2002 - Afternoon Session (277K bytes)

    Page 1

    A F T E R N O O N     S E S S I O N

    [Reconvened at 1:45 p.m.]

    DR. GORDON: We are going to begin again, and we are going to move through Research, and then Education and Training, and Access and Delivery. The way we are going to proceed, and I want to make sure the public knows this, this is going to be somewhat differently from this morning, that is, we are going to look at the recommendations with which we can live, and we are going to put those in one column, that Ken will put up on the board. Then, we are going to put the ones with which some or all of us can't live, and we are going to put them in the other column, and then we are going to discuss those, in turn, and then we are going to go back and look through the text and look at the supporting material and see if it works.

    Is everybody on-board, that this is the way we are going to proceed with this? The other thing is I just handed out a piece that I did sometime ago for the Alternative Therapies Journal, which Joe Fins has mentioned a couple of times, on the Flexner Report and the White House Commission. We don't have to discuss this now. We might want to talk about it a little bit tomorrow. I thought I would draw on some of this for the vision statement in talking about the role of the Commission. I think most of you may have seen this before, but I just wanted to hand it out again. Tom wanted to say something just before we begin the discussion on Research, and then we will begin with the recommendations on Research. Tom.

    MR. CHAPPELL: Thank you. I have a recommendation of how we handled some of these questions in the report, the language in the report that deals with whether we are trying to integrate CAM into conventional health care system or vice versa. My advice on this is a technical strategy as a writer. We could assume a social location as the voice of the writer, consistent with policymakers in Congress. That is, "social location" in writing is a term describing where, in the context of all the constituencies, is the voice from coming from, is the writer coming from. If we look at some of the language in the Research Section, you will see language like CAM integrating into the health care system. The question is, is CAM accountable to the health care system or is it accountable to health policy, and what is Congress to do here.

    I recommend that we modify the voice and location of the voice throughout the report to be that in the shoes of the Congress person, because it is in that location we are able to hold, we are able to be consistent with public policy expectations health policy, consumers, and so on, and when we address CAM issues, we can say we expect CAM to be accountable to public policy rather than accountable to conventional health system, and it also allows us to say we expect the same of conventional health system. I think the language could be modified, "nuanced" I guess is the word, which really would take away the concern I have been hearing here, is that this is really a report that is written in the context of conventional medicine. It does away with that, and it holds everybody accountable to the same standard, i.e., the shoes of Congress.

    Page 2

    DR. GORDON: Linnea, did you want to say something?

    MS. LARSON: Perhaps we need a little bit more clarity on this, what constitutes public policy. I think that that is maybe my one minute, and time me on this, is that we are making recommendations that have to do with legislative and administrative actions. That is what constitutes public policy, and the public policy has to do with such things as budget expenditures, which then the Congress takes action on. That is public policy. So, when I have been referring over and over again to let's be clear about what we are looking at when we say we are making recommendations, we recommend that the President do something through the administrative actions, and through congressional and laws. I don't think that that is quite accurate, Tom, what you are saying about the location of voice. I understand the concept.

    Open Discussion: Coordination of Research

    DR. GORDON: What I would like us to do is focus on the recommendations and see how these issues of voice and clarity are played out in specific recommendations. I again ask you, if there are issues, this is the time to bring them up. So, let's move through the recommendations first. First recommendation. Actually, we can look at the section. We can just look at all the recommendation section, and we can work with that section. Is that easier for people, or is it easier to work in the context of the text? Okay, fine. Let's look at Recommendation 1 on page 9. This is the Research. "Federal agencies should receive increased funding for clinical, basic, and health services CAM research." Should I read the action items along with that, as well, or do you just want to start with the recommendation? Start with the recommendation. Linnea.

    MS. LARSON: One of the points that Wayne brought up in his memo of a few weeks ago was the statement "CAM research." It is not CAM research, it is research on CAM, and I think that that is critical in terms of -- no, this doesn't have different standards than research methods, it is research on CAM. This is throughout the text and also throughout all of the recommendation and action items. So, simply switch from "CAM research" to "Research on CAM."

    DR. GORDON: Are we okay with that? Okay. That is a beginning. Thank you, Linnea. Joe.

    Page 3

    DR. FINS: I find it very vague. It is like what does this mean, increased funding for clinical, basic. I mean it is like yes, but at the expense of what, and it is not an actionable item really, and it is so vague, and there is not texturalization against other competing strea

    MS. I guess one of the things here about research is that -- go ahead, do you want to interrupt?

    MS. POLLEN: No, I don't want to interrupt, I want you to finish.

    DR. FINS: I think that part of the problem here is -- and it gets to the scarcity point that I made earlier -- is that NIH's budget has doubled in the last 10 years. It is probably not going to do the same, you know, there are lots of constraints, what is this against. I think we are better positioned to really talk about strategies to allow research to occur within the peer review mechanism that exists within the major funder.

    DR. GORDON: Gerri, go ahead. I was asking a question, but you may well be able to respond to it.

    MS. POLLEN: I agree that this recommendation needs more context. Instead of approaching it from the point of view of competing priorities, I think the context it needs, and the suggestion I will make, is the reason why the funding is needed. So, I have added a suggested continuation of that. "Federal agencies should receive increased funding for clinical, basic, and health services research in order to accelerate findings on safety and efficacy, or lack thereof, of CAM products and practices that are used widely by the public." That puts it into a context of why the funding is needed without getting into the budget aspects about where the money is going to come from. "Federal agencies should receive increased funding for clinical, basic, and health services research on CAM in order to accelerate findings on safety and efficacy, or lack thereof, of CAM products and practices that are used widely by the public."

    DR. GORDON: So, that is the revised recommendation, is that right, Gerri?

    MS. POLLEN: That is my suggestion.

    DR. GORDON: Joe.

    DR. FINS: This has a recommendation and a justification together. We need to make the recommendation and then we need to have the justification. That is the justification, that is not the recommendation. The recommendation is, you know, here is the recommendation. There should be an RFA for, or, you know, there should be joint initiatives for, to promote, there should be interagency cooperation, things like that.

    Page 4

    DR. GORDON: Joe, some of those are in the action steps. The rationale, as Joe Kaczmarczyk just explained to me, and that is what I was looking for Steve for, of breaking this down into recommendations and action steps was -- and, Steve, correct me if I am wrong in this -- that the recommendation was to be a more general piece, and the action steps were to be more specific.

    DR. GROFT: Yes, the idea being also the actions, as we state them, could actually be implementation strategies if we wanted to go that far, but I think we chose "actions" just as a word to describe what needed to be done. Originally, it was "action items," and people felt that was too bureaucratic, so we thought we would stay with "Actions."

    DR. LOW DOG: I would need some help from other people that know more about this area, but on the Action Item 1.1, when we talk about all federal agencies with research, and then funding initiatives, application proposals, CAM-focused offices, centers, that just seems very large, because there is so many agencies, and what kind of CAM professional, so is each group going to have a chiropractor and an acupuncturist and a herbalist and a massage therapist, and a naturopath, I mean it just becomes this kind of unwieldy thing when you think about it. My question, and it is more of a question, is with NCCAM and ODS and some of these groups that are pulling together expertise, and are doing research, and have congressional mandates, shouldn't those groups be more of the ones that are networking with all of these agencies, so that every agency doesn't have to have this full complement and cadre of all of these? It's a question, but when I read that, it just looks so big when you stop to actually think about it. It makes one question if because the expertise within CAM, and all the multidimensions is very large when you think about it, but it seems like it is better to have that in a centralized place where people can then refer than having them in every different agency. It is just a question.

    DR. GROFT: The problem is, though, every agency does their own research, and there is all the different focus. The Department of Energy does distinct research from NIH. So, if you remove Energy, say, and you don't specify them, or you miss someone, then, they say, well, it doesn't apply to us. I think that is why we tried to give the general approach, is that if you have an activity related to health care, then, you should think about CAM research, increasing your research for CAM activities. I guess that is the idea behind the broadness is we cannot spell out everyone, every agency.

    DR. LOW DOG: Should it be that you should increase your CAM-related activities, or are there other ways of making the language, because I am not sure that that would be absolutely relevant to what I am studying. There should not be a discrimination for research that is outside of the conventional paradigm, et cetera. I don't know, but I have some fundamental problem with 1.1 because it seems so big.

    Page 5

    DR. GROFT: It is big. I think because CAM is so big and touches so many aspects of the entire federal government and all the other agencies, that is part of the problem, part of the problem with CAM.

    DR. GORDON: Gerri.

    MS. POLLEN: Tierona, to get to a point you just made, I have two thoughts. One is instead of saying "All federal agencies with research or related health care missions," it could say, "All federal agencies should increase their research or related activities with respect to their missions." In the next sentence, it could say, "Activities could include," because they don't have to include all of that.

    DR. LOW DOG: I like that better.

    DR. GORDON: Tom.

    MR. CHAPPELL: I think that the format of the recommendation followed by the actions is a good format, and I would like to adopt it as the way we accept a recommendation. That is, we are going to work on the recommendation and the action steps. I don't think it is necessarily too broad. I don't think the audit that Gerri offered is necessary in the recommendation itself. So, I find the recommendation really succinct, inclusive, and to the point as it is presented along with the action steps, and the modification that Gerri suggested responding to Tierona's concern about broadness, I think would be fine. I just think the first recommendation, as it is, is also okay.

    MR. ROLIN: My comments, she answered once she did the modification, it's okay.

    DR. GORDON: I want to remind everybody we have a little less than an hour and a half, about an hour and 20 minutes for each of these three sections. So if these are things we can live with, with the modifications, let's move ahead. I also want to remind everybody -- and I am not trying to close off discussion -- I just want to remind everybody that we have also, many of these, including I believe this one, we have agreed to as a whole commission before. Go ahead, Joe.

    DR. FINS: Well, I guess the question is if somebody is running an institute, and has a certain number of staff positions, and they see that they have to have certain CAM-focused staff positions, does that mean they have to eliminate some of their research scientists? Will there be new money? I mean how does this thing get played out, and what are the consequences for the research infrastructure?

    Page 6

    DR. GORDON: Wayne can probably speak to more details. It can be played out in many ways. There is a mandate for all of these institutes at NIH to have somebody concerned with CAM in that institute. Sometimes that was a part-time job, sometimes it was a full job. Usually, there were many people who volunteered, who were interested in being CAM liaison and sort of working on the CAM efforts, and Wayne was involved with this right from the beginning. I think different institutes and different agencies respond differently. Wayne, do you want to add?

    DR. JONAS: They will each implement this in their own way as is appropriate. Again, that is one reason why I think the general recommendation is better because it is going to be implemented -- we are not dictating to them what the priorities should be, and I like the rewording of the action steps. So, this will be manifest anyway through their normal processes. I do think, however, that the issue of some kind of statement about proportionality probably should be in here somewhere, and this was brought up both by Max and by several other individuals. Right now the statement says more money, and as is pointed out, there may not be more money, and if there is not more money, then, the response was likely to be okay, well, we will do it when we get more money. So, attached to the idea of doing more research, there ought to be some kind of an assessment or evaluation by each of the institutes as to what the appropriate amount of research expenditures on CAM within their institute or within their agency should be, so that they can do an internal study and look at, okay, what do we need in this area compared to other areas appropriate to their mission.

    DR. GORDON: Wayne, do you have any suggestions on how to approach that?

    DR. JONAS: Well, I would suggest yes, that it is added as an additional action statement that deals with the issue of proportionality, you know, should research resources not be immediately available, then, there should be a study by each of the agencies to evaluate the proportional budget allocations appropriate for CAM activities relevant to their mission.

    DR. FINS: Do they have the option of saying zero if they don't think it's --

    DR. JONAS: Sure.

    DR. GORDON: What I would like to do is, as Wayne has stated it, is that an action item that we feel comfortable adding? Okay.

    DR. FINS: I am not sure I can agree to that, the way it is. I think I am in favor of more research, but I think it is pervasive, it is perhaps overly global. I think that agencies should have a mechanism to determine -- what I am saying is I don't think entities that are doing good research, that is important, should be distracted and diverted from their mission by doing something that diverts resources in a time of scarcity.

    Page 7

    DR. GORDON: Fine. I think the issue that Wayne has said is they should determine what proportionality, and it could be zero. That is up to them to determine.

    DR. FINS: But you have already stated in the first two lines that they should increase their research and related activities.

    DR. GORDON: Right.

    DR. FINS: What we should say, maybe the recommendations of the agency should determine how they might increase their research and related activities related to CAM through an internal mechanism, and then allocate funds accordingly. In other words, what is here, the premise starts with that they should increase and they should study. The question is they should study and then determine how they should increase.

    DR. GORDON: This is an important distinction, so let's have some discussion of this before we move ahead. Tom.

    MR. CHAPPELL: I don't think there is a single person that came into any of the hearings throughout the last two years that didn't express a need for increased funding on CAM. I just couldn't imagine presenting a recommendation that didn't request an increase in spending on research for CAM products and services.

    DR. BRESLER: I think maybe the way to reconcile this is to say that these agencies should include CAM in their considerations when prioritizing their projects. I think that is what we are asking, isn't it, that CAM-related projects and activities be included in their considerations?

    DR. GORDON: No, I think it's different from that, David. I think it is saying that the amount of research should be increased, and then Wayne's addendum says the degree to which it should be increased should be assessed.

    DR. JONAS: Had we requested to the NIH that they consider evaluating whether they should increase their funding for alternative medicine research, there would not be an NCCAM at this time. So, I think the strong language is a very important way of stating it.

    DR. FINS: I don't mean to get bogged down in this one, but I think once we settle this, others will follow, because this is sort of the overall picture. I think it is one thing to say that the NCCAM should have more funding. It's another thing to say that other agencies have to divert resources, and that is a distinction that I think is important.

    Page 8

    DR. JONAS: Let me rephrase that. Had it not occurred at the OAM, at the time of the OAM, there would not have been an OAM. I mean this was not something that was reasoned consideration by the federal agency who has an established mission. It was not on their radar screen. So, I think to weaken it when the need for research, if there was a universal statement, that certainly was one, so if we don't make that strongly, I think we have abdicated our primary responsibility in recommendations.

    DR. LOW DOG: I think partly what I am hearing though also is not just that we need more research, because I think we all agree to that -- I hope we all agree to that -- but that the statement is sort of all federal agencies, it is kind of very broad, and that was my original question, because I just don't know how they all work, in all honesty, to know if that is a reasonable recommendation that every single federal agency that does anything, anywhere, with any kind of health or research of any kind should have to implement research under CAM. I didn't know, it does me overly broad when you step back from it, which I think is different from saying that there should be research. I don't think anybody is questioning that. I think what I am hearing, is it necessary that all of these agencies do this. I can live with this language here, especially with the qualifier of if there is not enough money, letting people sort of internally do that. I could live with it, but I do think that it is a little sticky. When you read that, it does seem very grandiose.

    DR. FINS: The other question is, is it through the normal competitive process. If investigators apply and they get certain rankings, will this mean that some people who got ranked higher in a conventional sense, will get bumped, because the CAM investigator, that kind of research has to get funded? I would like some sort of additional qualifier here, you know, high quality, competitive research, because we don't want to simply fund CAM research, we want to fund competitive research that would meet the standards.

    SISTER KERR: The first, the most simple, is just because of the fear of the statement sounding so grandiose, just eliminate "all," and just put federal agencies with research or health-related missions. But my comment that I wanted to say first was that I think given Wayne's addendum, you cannot provide for every eventuality or criticism we are going to receive related to the inclusion of the request of CAM research, so we have to kind of get our grip on our anxiety and fear of what colleagues or other people might say. I just think that is part of the deal.

    DR. GORDON: Tierona.

    Page 9

    DR. LOW DOG: Can we just sort of see what we have got? We have got the recommendation as it is except we changed "Research on CAM" and "CAM research." Then, Gerri made an addendum for Action Item 1.1, and Charlotte has proposed that we just eliminate "all," which I will tell you I think makes the sentence read a little bit better. Then, we have left 1.2 by itself, and then 1.3 would be the item that Wayne added about proportionality. Can we have some consensus on that?

    DR. GORDON: The only thing I would add, I would make Wayne's item 1.2.

    DR. LOW DOG: Move it up? Fine.

    DR. GORDON: Tierona is asking for consensus on this recommendation. 1.1, then, the proportionality that Wayne suggested, and then 1.3 as it stands now.

    DR. FINS: The only thing I would want to insert here is something about the quality process. NIH funding means something because it means something. I mean NCCAM also has adopted standards that are commensurate with the other institutes. We heard that in testimony. So, I think here we should say something about through the competitive process, and if people are not competitive, they don't get funded. I mean qualitatively.

    DR. GORDON: That's the way it always is, Joe, there is no other way that funding happens. It is kind of a redundancy.

    DR. GROFT: Unless there are set-aside funds.

    DR. FINS: But this could be interpreted as saying so.

    DR. GROFT: That is up to the agencies and departments to determine themselves what they want to do with their funds, and if they do an evaluation and say, yes, we need to fund some CAM research, or there are some good proposals, if they receive some unsolicited proposals, they are going to be scored and then adjudged whether it is to be funded, and if they decide they need to fund things out of order, they go to second degree of council review. If the council says yes, we agree that it should be funded out of order, that review has taken place. I think there are adequate safeguards and protections that we are getting good research that is being funded. In fact, if you look at the level of funding and the competition factor for NCCAM coming up, it is going to be horrendous what they are able to support this year as far as new research grants. It is getting down into single digits again. There is no doubt you are getting high-quality research.

    Page 10

    DR. GORDON: Can everyone live with this one now? Essentially, what we are saying, recommending additional research funding, and it is up to each agency to determine how much and how it is going to fund, just the way they currently do.

    MS. POLLEN: I need clarification on whether the addition that I read at the beginning to the original recommendation should be used or not. COMMISSION MEMBERS: No.

    MS. POLLEN: So, just stop it as "Research on CAM," period, and don't have the rest of that.

    DR. GORDON: Stop at CAM. Let's look at No. 2. "Congress and the Administration should enact legislative and administrative reforms to provide greater incentives to stimulate private sector investment in CAM research."

    DR. FINS: We skipped 1.2.

    DR. GORDON: I thought we had agreement on that. Okay. "Congress should provide adequate public funding for research on frequently used or promising CAM products that will be unlikely to receive a patent, and therefore unlikely to attract private research support." That is a form of general guidance. Again, I am happy to hear statements about it. We have discussed this one several times. Tierona.

    DR. LOW DOG: If people don't like the wording, we could discuss it, but I think the real key part here, this goes back to prevalence. We talk about the prevalence of many of these dietary supplements, and botanicals in particular, that are commonly being ingested and used. The safety data is not available for them. It just hasn't been done, and it is growing in its research, but that was a lot of my impetus for this is because the safety data is just lacking for these. Even if you don't have efficacy data, if you can at least get safety data, that is I think important for the public health.

    DR. GORDON: David.

    DR. BRESLER: I think it should be "products and practices," because particularly in the mind-body medicine field, there is a lot of research that is also needed, and it is not around a product at all.

    DR. GORDON: I brought that up to Gerri before, and she responded as follows.

    MS. POLLEN: We are talking about patents here, and practices aren't patented. In other words, this is specifically products.

    Page 11

    DR. BRESLER: Where do we deal with Congress putting funding for non-products?

    MS. POLLEN: All through the rest of it.

    DR. GORDON: Look at Recommendation 3, David. I think that is covered there. Where are we now? Any other comments on this?

    DR. PIZZORNO: I would like to follow up on what Tierona had to say on 1.2. Suggest we insert between "funding for," and before "research," "efficacy and safety." If we can't get the efficacy, at least we can get the safety.

    DR. GORDON: I'm sorry, Joe.

    DR. PIZZORNO: 1.2, the first line. After "funding for," insert "efficacy and safety." Between "funding for" and the word "research," insert the words "efficacy and safety."

    DR. GORDON: I don't understand. Those are not modifiers. "Efficacy" and "safety" are not adjectives. Research on the safety and efficacy?

    DR. PIZZORNO: Yes, "of frequently used."

    MR. CHAPPELL: That is going to increase the price considerably of the research, Joe. Safety should be everyone's number one concern, and that costs one price, but if you want to understand the mechanisms of action of some of these herbs, boy, you have got a whole lot of additional work to do, and I am just not sure we should be that specific in this recommendation, but rather leave it to the institution itself to make that decision. I would rather leave it as it is just because I know that every agency is going to put safety first, and efficacy will have a price and a judgment.

    DR. GORDON: What you are also suggesting that mechanism of action may have nothing to do really with safety or efficacy directly.

    MR. CHAPPELL: I am saying that mechanism of action is very hard to determine, and I just think that is more costly research. Yes, it does equate to efficacy.

    DR. GORDON: Nobody is suggesting mechanism of action research in particular here.

    MR. CHAPPELL: When you mention efficacy, you certainly are.

    DR. LOW DOG: Tom's suggestion was just to leave it the way it is, which just says for research. That is what I heard, let's leave it open to the institutes to determine that.

    Page 12

    DR. FINS: I would like to delete the thing about the patent and private research support. I don't that adds -- did you already talk about this when I was out?

    DR. LOW DOG: I might disagree with you here only from a safety perspective. I feel that many of the supplements that are out there, because of the way that the DSHEA Act is written, do not require, in my opinion, adequate safety data before they are launched on the market. Now, many of these are already on the market, and nobody is going to pay for it, and unless you are going to overturn -- I'm sorry, I didn't mean to use that word -- unless you are going to revisit, redo, relook at the Dietary Supplement and Health Education Act, there is going to have to be some public funding, I think, for these products, and part of the reality is the reason that they are not going to be studied is because they are not patentable items.

    DR. GORDON: Let me point out that we are on Recommendation 1, and we have a number more to go. I want to see if we can get some kind of agreement.

    DR. FINS: Let me just say that I agree with that completely, and I think that is in the justification of why this is so compelling, but the way it reads here, one could read this and say it is to help the marketplace, whereas, the real goal is really to protect the public, so it kind of has a mixed message here.

    DR. GORDON: Joe, how would you reword it?

    DR. FINS: "In order to protect the public health and maximize benefits, Congress should provide adequate public funding for research on frequently used or promising" -- and I might want to say "supplements" here, not "CAM products" -- CAM products is better -- "CAM products." Then, the justification is, "This is necessary because there are items in the marketplace already, and because many of these items are not patentable, and would not lend themselves to New Drug Applications, there is an additional need for public support."

    DR. LOW DOG: So, you would suggest putting this into the text, the justification, buffing that up in the text, and then just including "in order to protect the public safety and maximize the benefits, Congress should provide." I think that is a good recommendation.

    DR. GORDON: So, where are we with that issue? Tom.

    MR. CHAPPELL: I would support striking the language about attracting private research and the patent issue, because it may complicate just basic research that we want done.

    Page 13

    DR. GORDON: Wayne, go ahead.

    DR. JONAS: I would say strike patent if you want, but the point about this is that we want some support for areas where private investment is not going to occur, whatever the reason.

    DR. LOW DOG: I think we addressed the issues of patentable and stimulation of private sector research in Recommendation 2, so I don't think, under 1.2 or 1.3, or whatever, whatever it is going to be, you could end with "products" period, and then we will move into discussing the next part.

    DR. GORDON: I feel comfortable with that as long as we make sure that the justification is outlined clearly in the text. Are we all right with this? Gerri.

    MS. POLLEN: "Patent" can come out, that is not necessary to be there. But if you take out, "unlikely receive private research support," that is the bridge to the next one. I am just saying if you don't think you need that bridge, and you want to stop it.

    DR. GORDON: I think it would be helpful to have the bridge myself. I also think it makes us stronger.

    DR. PIZZORNO: As Wayne said it, I agree.

    DR. GORDON: Can we keep part of the bridge then, "unlikely to attract private research support." Okay? Let's move on to No. 2 then.

    MS. LARSON: Do we have somebody taking down these exact words?

    DR. GORDON: We are trying to, and it is also being recorded, and we hope to get a transcript then. Thank you, Linnea. On to No. 2. Gerri is taking them down, we will have a transcript that we will have back in a couple of days. No. 2. "Congress and the Administration should enact legislative and administrative reforms to provide greater incentives to stimulate private sector investment and CAM research on products that may not be patentable." And then 2.1 through 2.4, which I am not going to read, you can read them yourself. What do you think? David.

    DR. BRESLER: Just again in the language, I don't know what they mean by "reforms." I would just strike "reforms to provide greater," just take those four words out, and just say, "should enact legislative and administrative incentives," and do we want to stipulate that those incentives could include low-interest loans, tax deductions, things of this sort, because the point is, is that this doesn't require an allocation?

    Page 14

    MS. POLLEN: That language is in the text because that was an earlier decision, we could pull it out and put it here, but originally, the decision was to leave that in the text. It could either way, if everybody wants it back in here, we can do that.

    DR. GORDON: Go ahead, Joe.

    DR. FINS: Not to nitpick, my concern about this is it looks like a subsidy to industry. Indeed, that is what it would be. There may be a precedent for it, but this looks like a subsidy to industry. It may result in lower tax revenues, and actually, what we are doing does two things. It protects the public health presumably, but it also could engender profitability for industry.

    DR. LOW DOG: Part of this was they had addressed this actually with orphan drugs, looking at how are you going to get pharmaceutical companies to spend the money when it is not very profitable to put the research in it. There was a time line on it. It wasn't forever, indefinite, and I don't know if we need to have that or not, but it was a way, without giving money, but a way of streamlining the process to help these pharmaceutical companies investigate research under these drugs that nobody would have studied. I think that unless we begin to address ways that companies will be able to do research and development on these products and spend R&D on them, it will not happen because the industry is not as large as the pharmaceutical companies, and because they cannot patent their product, there is no way to recoup or to have a market share or gain. It is a real problem with the industry, so I wouldn't think of it as really a subsidy, but we have done this in other areas where we have needed research, but there has been no incentive for the manufacturer to spend the money.

    DR. GORDON: I would like us, as we look through these, to think again. We have gone through virtually all of these in research have been approved before. Again, I am not trying to stifle discussion, but I want us to be really sure. We have gone over these, and I don't know why some of these issues haven't been discussed before, so I want to make sure the objections are crisp or the concerns are crisply stated, and that we move through them crisply. Okay? David.

    DR. BRESLER: Just real quickly, Joe, even if it might generate profitability in the private sector, those profits are going to be taxed, and that money will come back into the government, and there are government programs designed to do exactly that.

    DR. GROFT: Actually, one of the biggest ones is the SBIR program to stimulate small businesses.

    Page 15

    DR. GORDON: George.

    DR. BERNIER: Is it right to be on 2.4? Tierona, do you see the same down side to that, that has been voiced on the earlier ones? This is 2.4 with, "The manufacturers of CAM products and devices should become acquainted with potential sources of research funding and requirements they must meet to access such resources successfully?"

    DR. LOW DOG: I am not sure what you are asking, George.

    DR. BERNIER: I am asking you if it is the same issues of NIH supporting the manufacturers.

    DR. LOW DOG: Well, I think there is already a lot of collaboration that goes on with manufacturers of drugs, and there is a large amount of money, public funding, that goes into drug research right now, so I am not sure this is asking for something really that different. I think that if there is research funding -- if you are going to do a trial on Black Cohosh for menopause, you have to have a product. You have to have a product, and it has to be a product that is reproducible in a clinical trial, and so manufacturers should be made available of what research is out there, and that also begins to open up avenues for them to be able to participate in research on their product. I think this is important. I may be very off base, but I don't think so. I think that we are not asking for really that much that is not already done with public funds for drug research.

    DR. FINS: I have something that might make me a lot more comfortable, and I think maybe addresses George's concern, but I really want to hear what Tom would think about this, is that if a company is getting some sort of tax break or an incentive to do this kind of research, it is not necessarily to benefit the company, it is to benefit the public, and there should be some kind of quid pro quo about the disclosure of what is learned, which is comparable to the requirement for disclosure with a patent, for the exchange of the period of exclusivity with the discovery. So, I think that there has to be some nod towards disclosure of what is learned, so that we are not simply helping one company, but we are helping the entire industry, so if Tom's company, for example, was to learn something that was truly beneficial or truly dangerous with an incentive from sort of federal entitlement, I would expect that there would be disclosure of that discovery in the scientific literature.

    DR. GORDON: I think this might be something that could be discussed in the text. It doesn't sound like a recommendation. I am not sure how it would fit as a recommendation. It also feels like we are trying to hedge everything so carefully, Joe, and I just don't know. As a principle, it's a good principle, but how do you fit it in a recommendation?

    Page 16

    DR. FINS: You say, you know, and what is learned should be disclosed to benefit the public.

    DR. GORDON: Tom.

    MR. CHAPPELL: I just wonder what 2.4 is in there for at all. If we are trying to establish a voice of policymakers, do we need this at all? I think we should strike it.

    DR. FINS: It still brings back the issue for 2.1.

    DR. GORDON: Are we striking 2.4? Yes? Okay. Gerri, is there a reason not to?

    MS. POLLEN: No.

    DR. GORDON: One of the things I want to say is we have 20 minutes to go through the next seven recommendations. This is just a reality. I feel like we are trying to fine-tune these a little too much when we have already agreed on these, that there are major areas where we have questions and disagreements that we need to deal with. Joe, with all due respect, I feel like we have got to devote our time and energy to those, unless there is something really disturbing here.

    DR. FINS: I do think that the issue of writing a report that serves the supplement industry is something that we do not want to be a party to, and so I would really like to assert that any kind of federal entitlement is not a simple gift, but it is a gift in exchange for something. So, I would really strongly urge us, I think it is a safeguard to the intent of what we are all trying to do is to have some nod towards disclosure of what is learned to promote the public health, disclosure to promote the public health.

    MR. CHAPPELL: I had hoped not to comment on this one, but now I am drawn out. So, my comment, Joe, to your good suggestion is that your suggestion will deter industry research for two reasons. Private foundations do work on time, and nonprofit foundations don't. Secondly, private foundations keep information private. Manufacturers like to pay for work that is theirs. So, I am just giving you the motive of the person in the shoes of the company, and this is not an entitlement, it's an incentive. This is an incentive to draw them in to doing research on a product that they want to market. It is not an entitlement. It is not like getting a grant, an investment. If it's a grant, I would feel you have grounds to stand on, but where it is an incentive to say come on, do more research to make these products safe and efficacious, they will say okay, and then we want to go with our data as the basis of claims on our product, and that is our market right.

    Page 17

    DR. FINS: So, what kind of incentive are we talking about here? I was thinking like, you know, it is a tax break or something, which be like a grant.

    MR. CHAPPELL: But it is not a grant, it is not the same thing.

    DR. GROFT: Plus a grant, what comes out of a grant goes to the institution that receives the grant. It does not revert to the government. The institution receives the benefits of what the research has done.

    MR. CHAPPELL: If I have a university do research for us, the university has an obligation to publish that data. Right?

    DR. FINS: If you are a not-for-profit.

    DR. GROFT: And the publication of data depends on the reviewers and the journal who you submit for publication. They may elect not to publish.

    DR. GORDON: Julia, and we have got to move ahead with this.

    MS. SCOTT: I am really concerned about the process and the amount of time that we are spending here. We cannot fine-tune every recommendation, we cannot read into how it is going to be implemented. I think it would really be helpful if we, Jim, have some decision about how we are going to pass these things. Is consensus going to be enough, or does everybody have to sign on the dotted line at this moment? If we could just move things, and say is there general consensus, and if one person or two people have a problem with it, put a little tick by it, and we can come back to it. But I don't think we are going to get anywhere. The afternoon has gone, and we have got two more subject areas.

    DR. GORDON: The problem is, Julia, from my point of view, I don't know when we will have time to come back to those one or two people, which is why I am try to hear -- I am trying to strike a balance between moving as quickly as possible and hearing --

    MS. SCOTT: I feel that, and I really feel for the remarks. I can see people's side of it, but at some point we are going to have to decide if 19 people are in consensus, and one person is against it, whether the whole show stops or not. I mean this is a practical consideration. I love the richness of the discussion, but we do have a deadline.

    DR. GORDON: Do we have a general consensus that we need to move ahead? Can I see hands?

    Page 18

    DR. JONAS: Jim, I have wording changes on the recommendations, and I have several of them. I would like to do that, because I generally agree with almost all the recommendations that are here. I would just like to have those discussed if we could.

    DR. GORDON: Either that or we could have a later dinner tonight, stay longer, and come earlier. That is another option if people want to take this time, we will eat later and wake up earlier, or we can try to move ahead expeditiously within the time frame that is set.

    DR. JONAS: Move ahead.

    DR. GORDON: Okay. We have struck 2.4. I think we need at least some statement in the text talking about the public good, and that our work is in the service of promoting the public good. I think we can accommodate that easily. Joe, I hope that will be of help to you.

    DR. JONAS: Jim, I actually have a specific wording. This is where I think David's prior suggestion about putting practices in ought to go, under this recommendation. "Products that may not be patentable and practices that may not be profitable," because there are good CAM practices, health care practices that you don't get paid for, and we should also incentivize those, not saying how, but we want to see those incentivized in the private sector.

    DR. GORDON: Is everybody okay with that? Adding that, and practices that may not be profitable? I have got to see. Linnea, yes, adding that or not?

    MS. LARSON: Yes.

    DR. GORDON: Let's move on to No. 3 then. "Federal, private, and nonprofit sectors should support research on CAM practices that build on lifestyle and self-care and on therapeutic approaches that integrate CAM and conventional medicine." Veronica.

    MS. GUTIERREZ: One word change. I would like to strike "therapeutic" and insert "other approaches."

    DR. GORDON: I don't understand.

    MS. GUTIERREZ: Line 2 in the recommendation, "lifestyle and self-care and on therapeutic approaches," I would like to strike "therapeutic" and say "other approaches." In many cases, therapeutic approaches is exclusionary.

    DR. WARREN: I agree.

    Page 19

    DR. GORDON: I am not sure I understand. What does that mean?

    MS. GUTIERREZ: Not all CAM practices are therapeutic. In the diagnosis and treatment model, there are other approaches like Qigong, for example, that are approached --

    DR. GORDON: That is a therapeutic approach.

    MS. GUTIERREZ: Do you consider yourself therapeutic?

    DR. CHOW: Yes. It is also diagnostic.

    DR. GORDON: I am not sure what the issue is here.

    DR. FINS: She is saying it's too narrow.

    MS. GUTIERREZ: I thought it was too narrow, that's right.

    DR. GORDON: Strike "therapeutic"?

    DR. WARREN: She mentioned "other" approaches.

    DR. GORDON: Linnea.

    MS. LARSON: I have no idea what "CAM practices that build on lifestyle," what the heck does that mean? Whose lifestyle are we talking about?

    DR. GORDON: Who formulated the recommendation?

    MS. POLLEN: I think it was Jim.

    DR. GORDON: Me? I never use the word "lifestyle."

    DR. JONAS: Lifestyle involves diet, exercise, stress management.

    DR. GORDON: What about build on self-care, and not say lifestyle?

    DR. CHOW: Lifestyle is a little bit different from self-care. When you talk about self-care, it is more therapeutic sort of type. Lifestyle is doing things every day that you do to keep well and enjoy being well, instead of because of a problem.

    DR. GORDON: Linnea, you raised the issue.

    Page 20

    DR. JONAS: Religious and spiritual practices are part of a lifestyle, but they are not necessarily self-care.

    DR. GORDON: We need to go one way or the other with this now.

    MR. CHAPPELL: Leave it alone.

    DR. GORDON: To me, Linnea's point is well taken. Lifestyle is a word I don't particularly like. I mean I am not the only one, but I am just pointing out that it is one of those funny words that people have lots of feelings about one way or the other.

    DR. FINS: If somebody read this, they wouldn't even know what to make as an implementation. It is just vague. I think what we are trying to say here, you know, is to promote wellness, health promotion kinds of things that are not like disease-oriented. I think what we are trying to get at is the kind of research that is not geared towards the treatment of illness, but the promotion of wellness. That may be is what build on lifestyle, self-care, those are elements that promote wellness. Maybe we should fund research that promotes wellness.

    DR. GORDON: I think we say it very nicely in the action statement.

    DR. LOW DOG: That should be the recommendation, the action item.

    DR. GORDON: So, the recommendation and action item are the same here. Okay.

    DR. FINS: How about behaviors that promote wellness versus wellness behaviors?

    DR. GORDON: Fine. Very good, Joe, thank you. It reads, "The federal government should stimulate private investment and research on CAM modalities and approaches that are designed to improve self-care and behaviors that promote wellness."

    DR. FINS: Can i just say that that is narrower? It was "Federal, private, and nonprofit." Here, it is just private investment. So, you want to say, "The federal and private should support research on CAM modalities and approaches."

    DR. GORDON: I want to announce that I have just been given tea and cookies.

    DR. FINS: The next course is a Prilosec or something.

    Page 21

    DR. GORDON: What do we want to do? Do we want to make the recommendation and the action item the same, or do we want to leave, "Federal, private, and nonprofit sectors?"

    COMMISSION MEMBER: I would add all three phrases.

    DR. GORDON: Okay. Let us move ahead.

    Recommendation 4.

    COMMISSION MEMBER: What was that?

    DR. GORDON: "Federal, private, and nonprofit sectors should support research on CAM practices that build on self-care and on approaches that integrate CAM and conventional medicine."

    DR. FINS: No, no, no. My understanding is, "Federal, private, and nonprofit sectors should stimulate research on CAM modalities and approaches that are designed to improve self-care and behaviors that promote wellness."

    DR. GORDON: Perfect. Okay. That is the recommendation. The action item is just the federal government.

    DR. PIZZORNO: I think the recommendation is the action item.

    DR. GORDON: Is the recommendation the action item here?

    DR. PIZZORNO: Yes.

    DR. LOW DOG: It is just a question because we were talking about trying to condense our recommendations. Since we added in practices that may not be profitable under Recommendation 2, and we have taken away the action item and just made it a recommendation, can't we just make the recommendation an action item under Recommendation 2?

    DR. GORDON: Is that okay with everybody? Make 3.1, 2.4. Okay.

    DR. LOW DOG: And we got rid of a recommendation.

    DR. GORDON: Let's move on to Recommendation 4. "Federal, private, and nonprofit sectors should support new and innovative CAM research on CAM practices and products, and on core questions posed by frontier areas of scientific study associated with CAM that might expand our understanding of health and disease." That is a long one. Wayne, any comment about that one?

    Page 22

    DR. JONAS: Yes. Actually, I have a lot of comments on this one. I think this should be reorganized to split out the specific aspects that we want to see underneath those, because it is combining a variety of things, CAM practices and products, frontier areas, things that might expand our understanding of health and disease. Under the action items, I would have to think about how this could be reworded, but under the action items, there are specific issues about prioritizing research that should be done by a particular agency, the IOM, about frontier sciences that should be done by a particular agency, the NSF, about prevention and health care, which should be done by a particular agency, the CDC, and I think that those things ought to be specified under action items. You could keep this one fairly general, if you wanted to, the actual recommendation, and then underneath it, put the specific action items that specified which activity, dealing with what section we would like to see it addressed, because it is clearer which agencies would be the ones that need to do that, and that would make it more concrete. I am afraid I haven't written these all out. They are actually in here, but the study on prioritization of research and research strategies, which is a task that the IOM has already done in the conventional medicine area, and this should be applied to these areas, looking at how frontier sciences can be properly investigated, and that is something that the NSF should do, and CAM could probably do that, but I think the NSF should be involved in that.

    The role of complementary medicine in prevention in public health, that is a mandate for the CDC. Examining the importance of health services research and review standards is something that AHRQ does, so we ought to specify, I think, those are items that we would like to see each of those agencies do, that would "concretize," if you will, Recommendation 4. World Health Organization is under here, under 4.2, that is not a federal agency, but we might suggest that NCCAM, working with the World Health Organization, then also specifically study how to investigate traditional medical practices, and they have actually started on that once before, and reinforce that, it's on the way. That would be my suggestion is that they be made concrete.

    DR. GORDON: Any comments?

    DR. LOW DOG: I fully support those, because we talked earlier about not being specific enough and sort of being vague. I think this really clarifies, and this is what these institutions and groups already do.

    DR. GORDON: Okay. I want to ask if we can have a general consensus that Wayne will take these and make them more specific, and then that will be part of what gets submitted back to us. Wayne, you are up for that? Great. Is everybody with me on this one? Okay. Let's move on to No. 5. "It should be duly noted that human subjects participating in CAM-related clinical trials are entitled to the same protections as required in conventional medical research," and then there are four action items, which I ask you to look at. I think we went over these pretty carefully.

    Page 23

    DR. LOW DOG: It doesn't sound like a recommendation when you say it should be duly noted.

    DR. GORDON: It doesn't sound like a recommendation, does it.

    DR. FINS: Just say, "Human subjects participating in."

    DR. GORDON: Okay. But that is still not --

    DR. FINS: How about, "Investigators engaged in CAM-related clinical trials should ensure that human subjects participating in clinical research receive the same protections as required in conventional medical research?"

    DR. GORDON: How does that sound? Great. Everybody? Thank you, Joe. Let's look at the action item.

    DR. FINS: I think these are okay. There is a little bit in Recommendation 6, which is related. It is a slight edit, but this section is okay.

    DR. GORDON: Are we okay with these action items?

    DR. LOW DOG: Jim, just at this corner of the table. "Federal agencies and investigators," not just "Investigators," in the recommendation.

    DR. GORDON: I'm sorry, how would that be said?

    DR. LOW DOG: Five. In the recommendation.

    DR. GORDON: Say it out loud.

    DR. LOW DOG: We had, "Investigators in federal agencies involved" -- "should assure," I can't remember verbatim.

    DR. GORDON: You are just adding "Federal agencies."

    DR. LOW DOG: Yes.

    DR. GORDON: Okay, everybody?

    MS. POLLEN: Why are we adding "Federal agencies?"

    DR. JONAS: Because we are making recommendations to a federal agency. We are trying to make it an actual recommendation.

    DR. FINS: We are saying any investigator engaged in research must adhere.

    Page 24

    DR. JONAS: Federal agencies should be involved in assuring that that happens.

    DR. FINS: And they are. The OHPR does.

    DR. JONAS: Oh, it does?

    DR. FINS: Well, that is part of their mandate.

    DR. LOW DOG: So, we don't need that?

    DR. FINS: Can we read back what we have?

    MS. POLLEN: At this point we have, "Investigators engaged in clinical research on CAM should ensure that human subjects participating in clinical trials are entitled to the same protections as required in conventional medical research."

    DR. FINS: We could add more specificity by saying the Office of Human Research Protections. No? Okay.

    DR. JONAS: No, but I do think we need to make sure that federal agencies take this on as a responsibility, because they are not doing this in all CAM research.

    DR. FINS: Why don't we preface it by saying, "Federal agencies responsible for the oversight of human subjects research should ensure that."

    MS. POLLEN: We can say it, but it is sort of a foregone conclusion.

    DR. FINS: No, it is not a foregone conclusion, and Wayne is telling me it doesn't happen, and the question is there is no enforcement. The problem is that they enforce research compliance at universities, major universities, but some of these investigators are outside the scope of the conventional paradigm, and if they are engaged in human subjects research, they should be under the purview of OHPR.

    DR. GORDON: Does everybody agree on this then? Please, everybody stay with us, okay? Not just because I want your attention, but because we may need your attention. You may pick up something. Anybody in this room may pick up something that the rest of us miss, so please hang in there with all these recommendations.

    DR. JONAS: Jim, I would also, in that same light, change that one word "clinical trials" to "clinical studies" or "clinical investigations."

    Page 25

    DR. GORDON: In two words, explain why.

    DR. JONAS: Because there is a lot of clinical research that goes on that is not clinical trials. It still needs the assurance of subject protection.

    DR. FINS: Any human subjects study, not necessarily a clinical trial, but any human subjects research, period, is covered.

    DR. GORDON: Let's move on to Recommendation 6. "State professional regulatory bodies should include language in their guidelines stating that licensed or other authorized practitioners will not be sanctioned solely because they are engaged in CAM research if they are: One, engaged in research that is approved by an appropriately constituted IRB; two, are following the requirements for the protection of human subjects; three, are meeting the same licensing or other authorizing standards of practice to which all similarly licensed or authorized practitioners are held." Don.

    DR. WARREN: I think we ought to start on the third line, after "CAM research," and drop everything else in that recommendation.

    DR. FINS: No.

    DR. WARREN: I think if they are engaged in research that is approved by an IRB, the rest of that recommendation, I don't like. I think it's sanctioned solely because they are engaged in CAM research, and then you put a bunch of stipulations in there, that they have to be in an IRB, they have to be -- I am looking at it.

    DR. GORDON: Another way to look at it is that we have already made those stipulations in the previous recommendation, so it may not be necessary because it's redundant, because the previous recommendation essentially says that all these thing have to be done. Joe, go ahead.

    DR. FINS: This engendered a lot of discussion, and the intention here was that state regulatory bodies should not sanction these individuals simply because they are engaged in this research if they meet certain stipulations. One is that it is approved by an appropriately constituted IRB and are following -- I would just add "federal requirements for the protection of human subjects." This last part, No. 3, is something that is new to me. I don't think it was in the previous iteration. Since they might be practicing outside the scope of their practice and it is not practice, it's research, it is probably not productive here.

    DR. GORDON: Gerri.

    Page 26

    MS. POLLEN: This was recommended by a lawyer who works for the Attorney General, the State of Washington, and it is important because one of the issues was the concern that practitioners had of losing their license. So, it was recommended that we make it very clear that as long as the practitioner was meeting the licensing or authorizing standards of practice, that other similarly licensed or authorized practitioners are held, that they would then be able to retain -- the concern about losing a license would not be a concern anymore.

    DR. FINS: But you are saying that up top, by saying licensed or other authorized practitioners. Presumably, they are authorized to do the kind of practice they are engaged in, in general, but here, we are talking specifically about research. This recommendation has been misrepresented in some media reports after the last meeting, and I sought to correct that in I think it was the blue sheet, and we communicated with the editor of that journal for clarification, but the goal here was to say that if somebody has met the objectives of an appropriately constituted IRB and are following federal human subjects protection, and they are engaged in research, that in and of itself is not a reason for sanction. If they are practicing out of the scope of practice, that is another issue, but part of the IRB process would be to ensure that appropriately credentialed, appropriately qualified, this is part of those regulations, that they were entitled to do this research. So what we are trying to say is if you want to do CAM research, this kind of participation in this process, which are very high ethical standards, should give you some kind of protection against arbitrary sanction simply because you are engaged in research.

    DR. GORDON: Gerri is shaking her head.

    MS. POLLEN: Just having IRB approval is not going to do it by itself. You also have to be meeting the requirements of your profession. That is what that last part is saying. The standards of practice must be met in all cases. It is not enough just to have IRB approval.

    DR. FINS: I understand what you are saying. I don't know how to resolve this expeditiously, and I am sensitive to Julia's comment about time, but you say here "licensed or authorized practitioners." That presupposes that they are doing research that is within the reasonableness of what they are doing, but these guys are doing research that is -- it is not within their scope of practice necessarily.

    SISTER KERR: Aren't you saying they are doing something in their practice that is not licensed? Like if I am not an acupuncturist, and I am doing acupuncture doing a research project, you are just saying I can't do that. But that is just like a muddling statement to just say you are supposed to follow licensure laws.

    Page 27

    DR. GORDON: I am still not sure what the confusion is here, but if you can elucidate, Joe, if you can shed some light on this.

    DR. PIZZORNO: I think my understanding is that we are trying to do two things here. One is for practitioners engaged in research that is not the standard of practice, that they are not prosecuted to be engaged in such research. However, we don't want to open the door that the person can do anything they want and just say that they are doing it as research. This has to be worded very carefully, and I think the wording is fine except for "authorizing standards of practice." I am concerned that that phrase there puts them right back into the liability issue. I don't think that phrase should be in there.

    MS. POLLEN: If someone doesn't receive a license, but some other standard of practice, how would you say it, that is authorizing them to practice?

    DR. GORDON: It's a registration rather than licensing.

    MS. POLLEN: Yes, this wasn't meant to be a catch-all for all other.

    DR. PIZZORNO: Make it "authorization to practice." Just remove that word "standards of practice." Standards of practice is a specific phrase.

    DR. GORDON: Or "other authorization to practice."

    DR. PIZZORNO: Yes, "authorization to practice." That would take care of that.

    MS. POLLEN: I think that would do it.

    DR. GORDON: Don, you had a concern. Do you want to re-voice that, or are you okay with this now?

    DR. WARREN: I am just concerned that anybody engaged in anything with CAM may be construed as research at this point, and state boards may come in and say, well, we are going to nail you because you are doing CAM.

    DR. GORDON: I couldn't hear.

    DR. WARREN: State boards may come in and just say, well, you are doing CAM, so you are going to be guilty of malpractice or whatever.

    DR. GORDON: But it says they cannot be sanctioned solely because they are engaged in CAM research.

    Page 28

    DR. WARREN: That's right, and that is where I said let's drop the rest of it.

    DR. FINS: I think the issue here is if someone is engaged in CAM practice, there are issues of licensure and everything, and that exists here. What we are saying if someone is engaged in a clinical protocol, they have gone through the process of review, they have met federal expectations through the agency of their local IRB, and that in a sense should give them some sort of deference with respect to the state medical board. We are simply saying that the mere fact that they are engaged in research about novel issues should not lead to sanction. This protects the researcher who complies with regulations.

    DR. GORDON: I think, Don, the difference is this is addressed purely to research.

    DR. FINS: Research, not practice.

    DR. GORDON: This is the issue that was brought up by the people who were doing research on NEAT and by Nick Gonzalez, as well, the whole issue of how do you move the research agenda ahead and provide some sort of protection from unfair prosecution for these people. So, this is purely a research, and not a practice issue. I don't know that Nos. 1, 2, and 3 are necessary because I think they are covered by what is under 5, but I am not opposed to it. We already have said this once.

    DR. FINS: Well, this relates to the state boards. I don't think we talk about state boards elsewhere.

    DR. GORDON: Can we get agreement on this with the change?

    DR. FINS: Jim, maybe to make it a little less stand-alone, and to put it in the context, why don't we make this 5.5, and not Recommendation 6, because then it sits better with its neighboring recommendation about research.

    DR. GORDON: No, I think it needs to be alone because it is a separate point. It is a separate kind of shield. I think it is a very important recommendation, and it is separate from the rest.

    DR. FINS: If I could, the text should capture the justification, that this to meant to incentivize the investigator involved in CAM research, not only to realize the obligation to follow these rules, but that there is something protective in complying with the regulations, because it confers an element of immunity against idiosyncratic prosecution simply because they are engaged in research.

    DR. WARREN: But another thing is that most CAM practices are a research project in the making.

    Page 29

    DR. FINS: Well, then, they should be in clinical trials.

    DR. GORDON: This is offering an incentive for people to do research in a sense. It is saying, look, if you want to do something that is a little bit out of the ordinary, that you think is very useful, you get an IRB to do it, and we will say, as a White House Commission, we feel you should be protected. So, it is a way of incentivizing research. I don't think it is negative about people doing practice, whatever practice you are doing, that is a whole other area which we may need to come back to when we talk about regulation and practice.

    DR. FINS: And that's about a licensure issue.

    DR. GORDON: And licensure. Do you follow, Don? This is really just purely a research issue here. Veronica.

    MS. GUTIERREZ: What about grandfathering in? I mean we are talking about the ideal that may be implemented sometime in the future. What about right now, any consideration?

    DR. FINS: There is zero tolerance for human subjects protection, I think, and that is a categorical.

    DR. GORDON: I will just say two words about this. I think this potentially can help the field tremendously. We have done research under these strictures. We set up our own IRB, we have done research, it has been fine, and I think it can really help move things ahead. I think the practice issue and the persecution in practice is a whole other issue that we need to look at later, but this is saying, okay, let's get those CAM folks out there doing research, and let's help them do it.

    DR. WARREN: It was the persecution that I was concerned about, that I read into this, and I am okay if we are going on to something else.

    DR. GORDON: Let's move on Recommendation No. 7. "To facilitate CAM integration into the health care system, increased efforts should be made to strengthen the emerging dialogue among CAM and conventional medical practitioners, researchers, and accredited research institutions, federal and state research, health care and regulatory agencies, the private and nonprofit sectors, and the general public." Eight action items. Tom.

    Page 30

    MR. CHAPPELL: This is one of those cases where the introduction to facilitate CAM integration into the health care system, I feel that the language is moving accountability to the conventional health care system. What I would like to do is to strike that introductory phrase and then the rest of the recommendation stands alone, and the whole action steps are clean in terms of that.

    DR. GORDON: Is everyone okay with that? Okay. Thank you, Tom.

    DR. FINS: I have one minor thing on 7.7. Everything else to me looks okay. This line 9. "IRB should consider requiring that all research subjects be asked about their use of herbals or dietary supplements, and hospitals should consider requiring that all inpatients and outpatients should be asked about their supplement use." First of all, IRBs do not dictate the research agenda, so that clearly doesn't make sense to me, and I think that should be struck, and the issue about hospitals getting information is kind of prescriptive and we deal with this in Access and Delivery, I think later on and elsewhere. I just think this 7.7 is problematic on two fronts, and maybe would suggest humbly that we just delete it.

    DR. GORDON: Other comments on that, 7.7?

    DR. JONAS: I agree. The hospital issue is not a research issue, it's a practice issue. IRBs, however, can specify that this is what you have to collect on your patients, and if that is not done, if they are not aware of it, then, a lot of that hidden stuff will not be found out, as evidence the NIH study, for example.

    MS. POLLEN: Yes, this is based on what the NIH is doing at the clinical center, and the IRBs, I think are appropriate for this section. The part on the hospital could be taken out.

    DR. GORDON: Are you okay with that, Joe?

    DR. FINS: Wayne, you are saying that this is kind of like --

    DR. JONAS: It is saying that those that approve research should be aware or should try to be sure that investigators collect this information on these practices basically.

    DR. FINS: Could we say in appropriate trials? I mean there are certain trials -- is this a categorical, across the board at the NIH for everybody?

    DR. JONAS: Well, let's put it this way. NIH did a random survey of people enrolled in their intramural clinical trials, and only asked about herbs. Sixteen percent of them were using some kind of herb or supplement at the time, and nobody knew about it.

    Page 31

    DR. FINS: You are saying this could alter outcomes.

    DR. JONAS: Yes.

    DR. FINS: Okay, I agree.

    DR. GORDON: Have we got this one? Perfect. Let's move on to No. 8.

    DR. WARREN: So on 7, we struck --

    DR. GORDON: We struck that first part.

    DR. WARREN: The first part or the last part?

    DR. GORDON: We struck the first part of the recommendation and the last part of 7.7, the hospital part.

    DR. WARREN: Okay.

    DR. GORDON: Recommendation No. 8, page 22. "Public and private resources should be increased to strengthen the CAM research and research training infrastructure, conventional, medical, and CAM institutions, and to expand the cadre of basic clinical and health services researchers who are knowledgeable about CAM and have received rigorous research training." Joe.

    DR. FINS: I agree with that, but I think there was somewhere here we have no -- as far as I could tell, nowhere where we are setting priorities. We have never made a recommendation that NIH should look at their aggregate cadre and determine priorities. I mean there should be some sort of priority-setting recommendation, and it struck me here that this might be the place to set up an intramural mechanism to determine priorities vis-a-vis the relationship between CAM funding and other kinds of funding, because, really, this might be at the expense of what. I think if we made a recommendation to this end, we would probably do more to promote more funding rather than less funding, and in the absence of it, it is kind of vague.

    DR. GORDON: Can you give an example of that kind of recommendation?

    DR. FINS: We could say that, you know, the leadership of -- you know, there is an interagency or inter-institute sort of council look at ways to appropriately allocate, you know, the kind of language Wayne had suggested before about proportionality, just so there is some mechanism where the decision can be made in a way that doesn't dictate what the numbers should be, but we say that there is some mechanism, so that this discussion occurs.

    Page 32

    DR. GORDON: Does somebody want to suggest wording? Wayne, Linnea, Tom?

    MR. CHAPPELL: I don't think the wording is appropriate because again, you just have to leave this consideration to the judgment of the leadership of the various agencies. If, on the other hand, we wanted to make a prioritizing recommendation about what recommendations in total we think are more important than the other, that's fine, but the kind of tradeoff that I hear Joe talking about is really beyond our reach, and it is the holistic view that the head of the agency needs to consider, how much is going to go into CAM, you know, strengthening CAM researchers versus whatever else they are doing. But our directive here is to be sure that more dollars are going into the training of researchers of CAM practices. That is the directive, and I don't think it is up to us to try to suggest to the ultimate agency how they are going to spread that money.

    DR. GORDON: I wanted to check in with you, Linnea, because you were concerned about specificity, whether you had a thought about this.

    MS. LARSON: No.

    DR. GORDON: Okay. Wayne.

    DR. JONAS: I think this recommendation actually is supposed to be targeted, and it looks like most all of it is targeted to research training. So, in the actual recommendation, that is a bit confusing because it says, "CAM research and research training," when we already made a general recommendation about CAM research in general, so I think we should strike the CAM research, focus it specifically on training.

    DR. GROFT: Wayne, I think that is research infrastructure. Maybe we should rephrase it.

    DR. JONAS: Well, it says, "research training infrastructure."

    DR. GROFT: Maybe "research infrastructure and research training infrastructure."

    DR. GORDON: How would you like it to be?

    DR. JONAS: I am just trying to get clarified. Is this supposed to be research infrastructure and training instead of research training infrastructure?

    Page 33

    MS. POLLEN: Research training and research infrastructure, or it could be the other way around.

    DR. JONAS: They are separate issues, training and infrastructure.

    MS. POLLEN: Well, it is not as crisply written as it should be. I will clarify that.

    DR. JONAS: I think that would help because then the Recommendation 8.4 makes sense, which is about developing research infrastructure.

    MS. POLLEN: Right.

    DR. GORDON: Do we have a rewording of the recommendation?

    MS. POLLEN: Yes.

    DR. GORDON: Go ahead, give it to us.

    MS. POLLEN: "Public and private resources should be increased to strengthen CAM research training, and research infrastructure at conventional, medical, and CAM institutions to expand." So, I could either say "research infrastructure and research training" or "research training and research infrastructure." The infrastructure is more than research training. It includes research training.

    DR. JONAS: I agree. I mean you can just say "research training and infrastructure" or "infrastructure and training," however you want to do it. I don't think you have to use "research" twice.

    DR. GORDON: Having said that, what about the issue that is still on the table? Joe suggested that we might want some language about prioritization. Wayne's response was we are already doing it enough here?

    DR. JONAS: In the original recommendation under 4, where we said we want to have these things looked at and prioritization, we have something under there, and in the ones that I am going to rewrite, there actually is a specific request to do prioritization and address the issue of prioritization. So, I am not sure if we need to stick that in this one also. I think it is assumed under our general one. You could add something similar to what we did under Recommendation 1, in there, saying, you know, proportionality and prioritization need to be addressed, there should be a study by the institutes to look at this or whatever, the agencies to look at this. It doesn't matter to me.

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    DR. FINS: I think as long as it is somewhere in this section. It doesn't matter if it is here or somewhere else.

    DR. GORDON: You are saying it could be in the text, discussing the issue?

    DR. FINS: It's in a recommendation.

    DR. GORDON: It is in the first recommendation now. We added it. Is that okay?

    DR. FINS: Yes. I agree with Tom, we don't want to micromanage it, but I think there should be some nod towards the importance of, you know, realizing that there is not an unlimited pie. I think Veronica said this morning about "should" and everything. I have trouble here with telling medical schools what they should or should not do. One is perhaps an unfunded mandate, and two, as an abridgement of academic freedom. I think we heard that from the AAMC when we had some discussions with them. I just think that language like "should" here, there is probably a more productive way of characterizing that.

    DR. GORDON: George.

    DR. BERNIER: There are a number of phrases you can use, but "ought to be considered" or "should consider."

    DR. GORDON: The concern I have had personally about the "consider," is they are already considering it. The question is how do we help them to take the next step beyond "consider," because considering, as you know, can go on for a long, long time. The idea is there, so how do we do that?

    DR. PIZZORNO: I think different from what it has been in the past, we are not telling the institutions to do this, we are saying the funding should be provided for it, and then institutions will have the incentive to do it.

    DR. FINS: If you look at 8.2, the institutions should support da-da-da-da. Some of it is true, Joe, but some of them, it is what they themselves are doing.

    DR. GORDON: Funding should be made available. That is a federal function. That comes back to Linnea's concern, and then it gets away from the "should," and says we are going to make funding available to you to do this.

    DR. FINS: I think the parallel structure for 8.1 would also be good, because we are asking the leadership "should" develop. So, if we say "funding should be promoted to develop programs."

    Page 35

    DR. GORDON: -- accredited CAM to develop, how about that?

    DR. FINS: That's better.

    DR. GORDON: Got that, Gerri? All right, let's go on.

    Recommendation No. 9. "Public and private resources should be used to support, conduct, and update systematic reviews of the peer-reviewed research literature on the safety and efficacy of CAM practices and products." I have a problem here that I don't see addressed. I want to make sure that that information is available in a form that is easily understood by the general public. This is not just research for researchers, this is research for everybody. So, that is what I would like to add, and I felt somehow that got dropped out. Gerri.

    MS. POLLEN: [Off mike.] 9.2 does say specifically --

    DR. GORDON: I know, but it says for the public, but there is information available for the public now, that the public cannot comprehend.

    MS. POLLEN: That is why that one is written, so that hopefully, it will be very explicit that it be in language -- okay.

    DR. GORDON: "Systems and treatments that can be easily understood by both health care practitioners and the general public."

    DR. LOW DOG: I think that's fine to add that here, but no, that we have expanded a lot on that under the Information Section. We have really addressed this.

    DR. GORDON: But I think we need to have it here under Research, as well.

    MS. POLLEN: Easily understandable.

    DR. GORDON: Easily understood --

    MS. POLLEN: By health care practitioners.

    DR. GORDON: And the general public. Any other issues here? Wayne.

    DR. JONAS: I would just like to add "collate" after "conduct." It's implied in the action steps, but I would like to put it in there. What I would like to see actually is something like clinical evidence, I mean where they actually have a summary ongoing, updated, one source using the same standards, so you can go, aha, here it is, and now I can go back and check and see what the current update is, and this type of stuff.

    Page 36

    DR. GORDON: That is what we had in the document, and this is justified by the text. These are the recommendations. Are there issues in the text? We have agreement on the recommendations, which is wonderful, and we have hashed it out. We have taken perhaps a little longer than we would like. What are the issues in the text that need to be addressed? Tom and Joe.

    MR. CHAPPELL: I just want to repeat that where we see the phrase "integrate into health care system," I would like that language changed. If we look at page 2-25 and 3-25 -- I'm sorry, it appears on page 2, line 25, on page 3, line 25, and it's the language, "integrated into the health care system." It's about CAM being integrated.

    MS. SCOTT: It's line 8 on page 2 in our binders.

    DR. GORDON: Page 2, line 8.

    MR. CHAPPELL: Do you see my point?

    DR. GORDON: Tom, why don't you express your concern and say how you would rather see it be.

    MR. CHAPPELL: I would like simply the writer to change his or her location by standing in the shoes of the Congress, and talking about holding accountability of safe and effective CAM treatments rather than talking about integrating them into the health care system. This is the point that I made at the opening of the morning.

    DR. GORDON: Any other comments on Tom's comment? Joe.

    DR. FINS: I gather, Tom, that you don't want these CAM treatments and approaches to be subsumed by.

    MR. CHAPPELL: That's right.

    DR. FINS: However, there is an alternative maybe, because I think we want the safe and effective integration of CAM and conventional treatments. In other words, if it is not into a system of conventional medicine together to promote the public good, I appreciate what you are trying to capture about not being subsumed or overwhelmed or diluted, but at the same time, I also want to try to convey a sense that these two things have to mesh without being diluted, if that is how people can be best protected. I don't know what the language is.

    DR. GORDON: You wanted to talk about the use of safe and effective CAM treatments both within and outside of the conventional medical system, something like that.

    Page 37

    MR. CHAPPELL: I agree with that, Jim. In fact, you could say, "to contribute to the accountability of safe and effective CAM treatments" period, so you don't have to talk about it being integrated.

    DR. FINS: I think this represents kind of a philosophical divide here. I fully appreciate the point you are making about the sort of independent legitimacy of these endeavors outside of integration. My concern is that there is a need for a relationship between these two entities, these two worlds.

    DR. GORDON: Can we instruct the writer to take account of both the independent development and of the relationship? Would that satisfy both of you?

    MR. CHAPPELL: Sure. I want both systems to be accountable to the public.

    DR. GORDON: Exactly.

    MR. CHAPPELL: That is the language I am striving for.

    DR. FINS: They have to be accountable when they are engaged together.

    MR. CHAPPELL: No, they do not.

    DR. GORDON: They do, don't you think?

    MR. CHAPPELL: No, that is not my objective. My objective is to hold each system accountable for safety.

    DR. GORDON: They are all accountable to the public.

    MR. CHAPPELL: Right.

    DR. GORDON: Whether it is integrated or not integrated, it is still accountable to the public.

    MR. CHAPPELL: That is correct. I have supported all of the integrated language in the research, and I would in many systems, but I don't think it has to be integrated. I want it to be accountable to good public health policy, and that is what I would like our recommendations to be, whether it is conventional medicine or CAM, but I am not asking that it be integrated.

    DR. GORDON: I am not hearing real opposition. I think you are saying integration is one of the areas that has to be accountable, and he is saying if it is not integrated, it still has to be accountable.

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    DR. FINS: Right, we don't disagree on that, but the point is that simply being accountable in their own distinct world is not enough.

    MR. CHAPPELL: Accountable for safety and efficacy?

    DR. FINS: Right.

    MR. CHAPPELL: I think it is enough.

    DR. FINS: Let me just make an example. St. John's wort is safe and effective. In combination with a protease inhibitor, it may not be safe, and it may be less effective. A protease inhibitor is safe and effective on its own side, but when these things are brought together, that is really to me a central important --

    DR. GORDON: I don't think, Joe, that what he is saying violates what you are saying in any way. It is still accountable. I mean whether it is used together or used separately, there is no difference.

    MR. CHAPPELL: There is only one world view in this statement at the present time, the way it is stated, and that is CAM needs to integrate into the conventional health care system, and I don't think that that is our vision.

    DR. GORDON: I don't think that that is part of our world view.

    MR. CHAPPELL: It is not, but I am just talking about this sentence.

    DR. GORDON: It is talking repeatedly about integration and collaboration.

    MR. CHAPPELL: Right, and so I would like the language combed.

    MR. CHAPPELL: If everybody understands this principle, that we are talking about collaboration, and the point is well taken, and not just integration, can we move on because we are already at 3:30? Linnea.

    MS. LARSON: I know we already settled this. I just wanted to add one little tweak to the last one on 9. "Public and private resources should be used to support, conduct, collate, and update systematic reviews of the peer-reviewed research literature on the safety and efficacy and cost-benefit of CAM practices and products."

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    DR. GORDON: Okay, everybody? Please nod your heads. We are talking about text here. General comments on the text.

    DR. JONAS: Prior to the first recommendation is what I consider the heart of the research discussion, the text. I mean there are other things spread throughout, but I think these are some of the key issues. I have a number of fairly minor edits, I think wording changes that I don't need to go over in detail, because a lot of them are fairly minor. However, there are a few things that I think I am obligated to at least say about because they may have some meaning differences.

    DR. GORDON: Okay.

    DR. JONAS: There are a couple of things that I think need to be added. I think the way the definition of CAM is co-opted by all parties to decide what research is being done or not being done, and where dollars go is extremely important. The CAM community will co-opt things that are traditional, that are conventional medical aspects, and say, oh, this is actually CAM all along. The conventional community will then co-opt standard things that they have been doing all along, and say, oh, now it is a supplement, so it's CAM, and this type of thing. That has major consequences for the shift of research funding dollars and prioritization. So, I think we should describe that issue at least, so that people are aware that this is there, and that therefore the need for prioritization process. So, that links us back to the actual recommendation where we say the IOM and others should -- but primarily the IOM -- should establish prioritization and definitional criteria. So, I would like to add that in.

    DR. GORDON: Is everybody with Wayne on that, or any questions about what he is saying?

    MS. POLLEN: Yes.

    DR. GORDON: Are we all right with that?

    MS. POLLEN: I am not. I am not quite sure I know where Wayne -- Wayne, where were you with that?

    DR. JONAS: Well, I was going to stick it under No. 1, somewhere under No. 1.

    MS. POLLEN: No. 1, you mean Recommendation 1?

    DR. JONAS: No, under text No. 1, Research Support under Current CAM Research Activities. Probably I would do it on the third page, maybe line 18 or something in there, but we can find a place, because it is really a topic that is not addressed at all in here.

    Page 40

    MS. POLLEN: And that is again the same issue which you brought up for the recommendation, which was the proportionality issue?

    DR. JONAS: Well, it relates to the prioritization issue.

    MS. POLLEN: Prioritization.

    DR. JONAS: Yes.

    DR. GORDON: Are you going to want to say anything about criteria for prioritization?

    DR. JONAS: Well, yes, I would like to, but I think that those issues can be left to -- if that occurs, if the IOM says all right, we are going to do our process for looking at the prioritization, which, by the way, they have already said they would do, they developed a whole plan for doing it, in fact, then, that can be addressed at that time. I do think that to talk about the definitional issues as a way in which, without prioritization process, all sides begin to co-opt research dollars, and therefore, don't allow you to do proportionality estimates on these areas, should be at least stated in there as a challenge that justifies then this. I would like to least say something about the definitional issues in terms of how that influences. I do think that a statement about -- I don't think the federal government should be expected to fund all things that are non-patentable, that is impossible, and some statement in there to that effect. We have said that we think that they should fund more that is not patentable, but I think it should be clear that we are not going to rely on the federal government to do this, we need to be aware of that, that this is going a token in many ways.

    MS. POLLEN: A bridge there could be that because the need is now, the federal government has to do what is necessary, but at the same time, there needs to be stimulation for the private sector.

    DR. JONAS: Exactly, and we have that.

    MS. POLLEN: And eventually, there will be less federal and more private.

    DR. JONAS: I agree. We should make that clear in the text.

    DR. GORDON: You can't lose the thrust that the federal government needs to step out and do it now, Wayne.

    DR. JONAS: No, I agree. I am not saying not to do it. I just think that we should be aware that it is never going to be able to do it all, and we shouldn't be expecting that this should be the sole source. On No. 3, in terms of the whole person, I think we also ought to add a little bit more emphasis on whole systems, whole persons and whole systems, and we have talked about that, it is fairly easy, the importance of looking at whole systems, and that is actually being done.

    Page 41

    MS. POLLEN: Wayne, whole systems is picked up under Expanding Areas of Scientific Inquiry.

    DR. JONAS: I saw that, and I thought it was weak in that area, but we could expand it in that area, too, if you wanted to. I would like to have something about it under Whole Persons and Whole Syste

    MS. I think there ought to be something to emphasize that, and maybe it's a rearrangement of what is in there.

    DR. GORDON: Are we all right on this, as well? Good. Go ahead, Wayne.

    DR. JONAS: I think that we should put something in about the need to really look at research methodology for two purposes, one of which is to come up with standards that are applicable to complementary and alternative medicine, and this is probably the most problematic area, and let me explain what I mean. The way I would phrase it is that we need to come up with creative methodologies, "innovative," you could use, et cetera, et cetera, to address areas that don't fit currently into a neat little bundle in terms of standard approaches. For example, what if you never come up with an active ingredient, or you don't know what the active ingredients are in an herbal product, then, you will never be able to just plug it into a drug trial. You can approximate it, but you can never just plug it in like you would do a drug trial.

    DR. GORDON: You would put that under No. 5?

    DR. JONAS: Yes, I would put that under No. 5 exactly. Another area is behavioral medicine and mind-body types of techniques that involve learning. It doesn't mean you can't do good research on it, but it means that there need to be creative ways of addressing this, and this then backs up one of the recommendations that will go under No. 4, which is that the NIH should focus on development of creative methodologies that are specifically applicable to CAM in those areas. There is a number of other minor things. I don't think that they are that important. I could actually put that also under Pluralism.

    DR. GORDON: So, these are some changes, and, Wayne, you are going to be working on these with Gerri, is that right?

    DR. JONAS: Yes.

    DR. GORDON: Don had an issue, and then Joe.

    DR. WARREN: Page 1, line 6. Instead of saying, "Cost effectiveness of CAM treatments," let's change that to "CAM care, and to discover the basic mechanisms underlying this care," instead of these treatments. Not all of CAM is treatments, but it is care, though.

    Page 42

    DR. GORDON: Is that okay with people? Let me see a show of hands. Okay.

    DR. FINS: I think on page 3, to strengthen the argument here, lines 11 to 17, it would be helpful just to have percent success rates and how that compares with the other institutes.

    DR. GORDON: Percent success rates?

    DR. FINS: Scores, you know, people with certain scores and what percent rates, because if they are high scored, and as Steve said, they are in single digits, and other institutes are in double digits, then, that makes --

    DR. GORDON: Can we get that information, Gerri, you think? Some of it may be a little hard.

    MS. POLLEN: It may be very difficult to get that at this point.

    DR. GORDON: We could probably get the NCCAM information, but not so easy to get the information from the other institutes.

    MS. POLLEN: That's right.

    DR. FINS: It is not a "must do," but I think it is worthy of an effort. I just want to echo on page 4, lines 15 and 17, I think we have to really tread very carefully about the patent issue, intellectual property issue. We just have a couple of lines here, and I think it is better to just lay out why funding is necessary versus a resolution. I think all this, the technology transfer, these are very complicated issues, and I think it is simply enough to say that there is a public health need, the kind of what we talked about with the recommendation, to protect the public. This is not always amenable to private funding for a variety of reasons including patentability, intellectual transfer of innovation, et cetera, and not get as much into it.

    DR. GORDON: Let me make sure that everybody understands and that Gerri in particular understands, that everybody understands and agrees, and that Gerri understands.

    DR. LOW DOG: Part of what I am hearing, though, is also that we don't have to come up with all the answers for how these things are going to be implemented, that we can pose the problems and the reasons why they exist, and then we are making recommendations for people to try to figure out how to incentivize it. We don't have to create the answers. We may come up with the wrong ones. I think that is what I am hearing.

    Page 43

    DR. FINS: We haven't heard testimony and we haven't studied it in depth to make cogent suggestions about the resolution --

    DR. GORDON: Joe, can you give a sense, maybe a clearer sense because people are a little confused of what you would like in place of that?

    DR. FINS: I would say lines 15 through 18 or so, like we are making recommendations about tax incentives, market exclusivity, and resolution of intellectual property issues. I think it is a little too prescriptive based on the nature of the testimony we heard, the expertise around this table, and the fact that there is a depth of scholarship in this area that we haven't even begun to tap. So, I think it is better to posit the problem than to try to fix it. I know you are saying "might consider," but it still comes across as too --

    DR. GORDON: David.

    DR. BRESLER: Actually, at the New York meeting, there were representatives of Wall Street there that some of us had a chance to talk to for a while about what was going on, they attended our hearings. These were some of the things that they had suggested could stimulate interest in them getting involved in investing in this. I don't think it is prescriptive. I think these are action-oriented recommendations that we are going to make. I would vote to keep them in.

    DR. GORDON: Julia.

    MS. SCOTT: I agree that we should keep them in. They are not prescriptive. They are suggestions of ways in which it might be done. I think the other thing we need to keep in mind is, you know, you send up a policy recommendation to Congress. It takes on a life of its own, and they are going to whittle it down and change it, you know, to do the minimum, many of us think. So, we don't need to do that for ourselves. I think it is great to highlight pitfalls that might happen, but I don't think we need to cut it down or be that prescriptive, which I don't think we are in this case.

    DR. FINS: I think it is an area of great interest and promise, and I just would editorially just tinker with it a little bit. On page 5, I think that there is an element here about this going back to the very first introductory section about respect for the whole person, and I think we want to say something here about convergence and shared, you know, concerns about the broader bio-psychosocial model, not to say that only CAM is concerned about health and the whole person, going back to what we agreed to this morning.

    Page 44

    DR. GORDON: How is everybody with that, okay?

    DR. FINS: We agreed on it this morning, it is just consistent, I think.

    DR. GORDON: I just wanted to make sure.

    DR. FINS: On page 7, the expanding area of scientific inquiry. I am reminded what Marcia Angell said, "Science is science," and I agree that there is a need for novel approaches. You would use language like "novel approaches that maintain rigor," that maybe employ the social sciences, as well as the biological sciences, but this seems like a kind of a swipe at science, you know, "moderate reductionistic expertise," which I am not always a proponent of reductionism myself, so I find myself sort of out of place arguing for reductionism, but reductionism has its place at times. I think we want to maintain the rigor of science here. We shouldn't develop a methodology that generates an answer that we want, but methodology that is rigorous.

    DR. JONAS: Would you like a word change somewhere on this, on page 7? Do you want to get rid of "modern reductionistic expertise," or maybe make it approaches or something like this? I think maybe the way it is expressed is perhaps a little unclear in the sense that what we want is we want to look at whole systems. I think people are doing that. In fact, even conventional research, they are doing that, and perhaps we are talking about kind of objective measurements or something like this.

    MS. POLLEN: Aren't we talking about bringing together both approaches?

    DR. GORDON: Joe's point is that science is science, and Wayne's point is yes, science is science, and there are many kinds of science that need to be used. I don't think there is a contradiction, and I think that his approach will resolve it.

    DR. JONAS: I am just wondering, are there some wording changes in this particular section that you would feel more comfortable with?

    DR. FINS: I think a lot of us feel that, for example, acupuncture might one day be explainable through the biological sciences, through imaging studies. There is already some preliminary evidence that the neuroreceptors in the brain light up when acupuncture is done. So, I don't think we want to necessarily foster the sense that because we don't have the science to explain it now, that science one day could not necessarily explain it. On line 16, Wayne, the spectrum includes areas of challenge, biological scientific concepts, and assumptions. So, you are challenging the scientific method, the scientific paradigm with some of these issues. Some of these things are not studyable by science. Some of these things are not scientific questions, like spirituality, that is a different kind of question.

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    DR. JONAS: Perhaps the word is materialistic, challenge materialistic assumptions.

    DR. FINS: I would say current biological and scientific assumptions. I think current would help a lot.

    DR. JONAS: Current.

    DR. FINS: How about our current state of knowledge, because I mean current state of knowledge about biological and scientific concepts and assumptions, but we are not challenging the scientific method. We are just challenging -- it is challenging the current state of scientific knowledge. I can live with that if you guys can live with it.

    DR. GORDON: I would like to live with it, and I would like to move on.

    DR. FINS: I am done.

    DR. GORDON: Any other issues here? We are now done with this section. We are going to take 10-minute break and then we will come back and look at Education and Training. Thank you, everybody.


    Open Discussion: Education and Training

    DR. GORDON: We are going to begin. The plan is as follows. We are going to begin with Education and Training, and then we are going to go to CAM Central, because some Commissioners are going to be working on Access and Delivery overnight. Speaking of overnight, we are staying here until 7:00, and we will start again -- unless we pick up the pace, we are staying here until 7:00, and we start again at 7:00 tomorrow morning.

    MS. SCOTT: Wait a minute. You need to say that again when the rest of the people are here.

    DR. GORDON: I will. Let's get started. I will make the announcement again when they come back, but let's get started on Education and Training. We are going to proceed the same way we did with consent. Yes? Okay. Julia is nodding her head. I want to see other heads, signs of consciousness. Good.

    Page 46

    The first recommendation. "The education and training of CAM and conventional practitioners should be improved to ensure public safety and to increase the availability of qualified CAM practitioners and knowledgeable conventional practitioners." That is on page 1. The first action item is on page 7.

    DR. LOW DOG: I just want to say, as a general comment, the formatting should be consistent.

    DR. GORDON: Is that okay with everybody? Consistency of format. Is that okay with all the staff, is everybody tuned in on this one? Okay.

    DR. KACZMARCZYK: It was that way previously.

    DR. GORDON: Are we agreed? The implication, Joe, is that the commissioners then decided they wanted a different format? We need to make sure that, as commissioners, we agree with Tierona's suggestion that we want the same format for every section.


    DR. GORDON: Great. There is the first recommendation and then action item. The first action item is page 7. The second is page 9. Third is page 10, and so on. You have to look through the whole text.

    DR. GROFT: I think what we tried to do here was meet the suggestion that we put the action item close to the language in the text itself. I think that is why they are separated.

    DR. WARREN: On Recommendation 1, line 25, page 1, it says, "should be improved." That implies deficiency. Could we put in there, instead of "improved," put "structured" as a recommendation? It says, "conventional practitioners should be improved." I would like to change "improved" to "structured."

    Recommendation 1, page 1, line 25, fourth word, change from "improved" to "structured."

    DR. GORDON: Should be structured to ensure, I see.

    DR. WARREN: Basically, we are talking about education and training.

    DR. GORDON: Because the way it is now implies that it is not in good shape across the board.

    DR. JONAS: What about "facilitated"?

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    DR. WARREN: No. Should be facilitated, education and training should be facilitated to ensure public safety? No.

    DR. GORDON: How about designed?

    DR. WARREN: I will take "designed." It makes sense, but "facilitate" doesn't really turn me on.

    DR. GORDON: What is on the floor right now?

    DR. LOW DOG: The Recommendation 1 on page 1. "The education and training of CAM and conventional practitioners should be designed to ensure public safety."

    DR. GORDON: So, we are okay with "designed"?


    DR. GORDON: Other issues and recommendations?

    DR. PIZZORNO: Would you go back to why "improved" is not accurate because "designed" implies they are not designed to do this, or using "structured" means they are not structured to do this currently.

    DR. WARREN: To me, it seems like when you say "improved," implies that it is worse than could be. It is, we know that, but I don't know, I like something a little more positive. "Improved" has more of a negative connotation to me.

    DR. PIZZORNO: How about "enhanced"?

    DR. WARREN: We will take bids on this. I move we accept this with the word "improved" changed to "designed," and accepted as written.

    DR. GORDON: Okay. Julia.

    MS. SCOTT: I have a problem with the second part of that sentence, "to increase the availability of qualified CAM practitioners and knowledgeable conventional practitioners." So conventional don't have to be qualified? I don't understand.

    DR. LOW DOG: Could it be partly that some of these practitioners may not be licensed, so we are using the word "qualified," because some of them may not be licensed practitioners, and conventional practitioners pretty much, by definition, have to have licensure. I think that was maybe the reason "qualified" was chosen instead of using "licensed."

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    DR. GORDON: I thought of another word, which might be "scientifically-grounded CAM practitioners." I am open to other possibilities. What we are talking about here, I think we need to look at the action items, and the action items, there is something about them I think that may not quite fit with the overall recommendation, because the action items are largely for CAM professionals to learn more about Western scientific methods, and for Western professionals to learn more about CAM approaches, so that is why I am trying to balance the overall recommendation. Tierona.

    DR. LOW DOG: I have a more fundamental challenge on this section here, which is because we are using the term "CAM," that it is just then all-embracing. I am not sure how much yoga instructors, how much Western science they really have to have. I am not sure how much Reiki therapists or polarity. I think there is all these different levels, and so what we have just done is scientifically-grounded CAM practitioners, and yet there is a big spectrum of those.

    DR. GORDON: How would you reconceptualize this recommendation in this section given what you are talking about, given that wide spectrum?

    DR. LOW DOG: Well, I don't mind the recommendation as it stands. I think the text needs work, but when you say that the education should be designed to ensure public safety, that sort of means that each group, you are going to look at what their necessity is of how much they need to know of this, and then to increase the availability of a qualified CAM practitioner, that, you are just saying if he or she is a yoga teacher, that they are qualified to teach yoga, but that may not be the same requirement as somebody else, so I am fine with it.

    DR. GORDON: So, you are okay with the current wording then?

    DR. LOW DOG: Yes.

    DR. GORDON: Linnea.

    MS. LARSON: I don't have anything else really to offer than I do think that there really is an embedded assumption here, that that which we have now has not provided an assurance of public safety, and that actually what we are asking for is a recognition that public safety, in what we think of as two worlds, is the most important thing. That is the recognition. After that recognition is that whatever action items come will be to design to improve public safety. But there is an implication in here, whether we substitute designed, enhanced, or whatever, that public safety has not existed. I think it is simply just I can't get my mind around the right words.

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    DR. GORDON: What is your position about the statement you just made? Do you think we ought to be focusing more in the text on public safety? I heard what you said, but I am not sure what the implication is.

    MS. LARSON: The implication is that we need to have a better crafted recommendation. It is not within the text, it is a better crafted recommendation. At this minute, I don't have it at the top of my head.

    DR. GORDON: Okay.

    MS. LARSON: It is simply the systems that have existed for education have always included some level of public safety. What we are asking at some level is to set up that qualified or licensed increases perhaps the public safety. That is another of the implications.

    DR. GORDON: Charlotte.

    SISTER KERR: I just pretend I don't know anything, and I look at Recommendation 1, and I see it as just a big run-on sentence, and it is just not clear, just to start there. I would say Recommendation 1. "The education and training of CAM and conventional practitioners should be" -- let's just say -- "designed to ensure public safety." What I can't even help us with is what the heck we are trying to say in the second part. Are we saying the education and training of CAM and conventional practitioners should increase the availability of quality CAM practitioners -- period? Are we saying that? And then are we saying da-da-da should be to increase knowledgeable conventional practitioners? If we are saying that, that's all crazy.

    DR. GORDON: Is what? I'm sorry.

    SISTER KERR: It is not even a statement to me that is clear. Is that what we are saying? Is it basically three sentences, that education and training should increase the availability of qualified CAM practitioners?

    DR. GORDON: I think you are right. It is a little confusing, because it is two different thoughts. One is increasing availability, and the other is ensuring public safety, and it may have somewhat different mechanis


    SISTER KERR: I think someone should say in just third grade language what are we saying. We know the first one, we have got that, we want designed to ensure public safety. Now, what do we want to say?

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    DR. GORDON: Joe K., do you have a comment on this?

    DR. KACZMARCZYK: As I recall, the work group wanted to express two different views or ideas. Number one was the overriding emphasis on public safety. Number two was increasing the availability of both qualified CAM practitioners and knowledgeable conventional practitioners. That was the intent of the work group as I recall it. Joe Pizzorno.

    DR. PIZZORNO: I would like to suggest a slight reword here. I think that is what we are talking about. "The education and training of CAM and conventional practitioners should be designed to ensure public safety and improve health." I think that gets what we are trying to do.

    DR. GORDON: So, basically, you are eliminating the second thought because it is confusing and confounding, I assume.

    SISTER KERR: It would be a very important recommendation if we want to say, we want to recommend that the number of qualified complementary practitioners be increased. I mean that is very dramatic and specific, but is that just the recommendation? No specificity, no whatever.

    DR. GORDON: I have Tierona, I have Joe, and I have George Bernier. I'm sorry, go ahead, George, in his role as co-chair of this committee.

    DR. BERNIER: Another way of expressing those three ideas together would be to say, "The education and training of CAM and conventional practitioners should be strengthened to ensure public safety and to increase the availability of both CAM qualified practitioners and of knowledgeable conventional practitioners." I think it was a pretty strong feeling of the committee that it was important to include both the CAM physicians and the conventional.

    DR. GORDON: Tierona.

    DR. LOW DOG: I agree that we need rewording, but when I read this, it is not to increase actually sort of let's bring on thousands more people, but actually, of the people that are already out there, to increase their knowledge base, so that those that are out there or those that are in training will have increased knowledge relevant to what they are practicing -- I mean that is part of it, too -- relevant to what their role is going to be and their scope, but your whole argument in this text is that conventional professionals need to know more about complementary and alternative medicine, so that they are more knowledgeable about what is out there. The other argument was -- and I do have some caveats there -- that depending upon what your scope of practice is as a complementary and alternative medicine practitioner, that you have an understanding of Western sciences, and so that if we have this sort of cross-training, that that will somehow enhance the public safety. When I read this, I am not getting that we are going to increase the absolute number, but what we are doing, we are making more knowledgeable practitioners of both CAM providers and conventional providers.

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    DR. GORDON: I just want to check. Is that the intention, Joe, of this? If we are agreed on the intention, we can work on the wording.

    DR. PIZZORNO: Let me try again. "The education and training of CAM and conventional practitioners should be designed to ensure public safety, improve health, and increase the availability of qualified and knowledgeable CAM and conventional practitioners."

    SISTER KERR: I thought the ending was really good. I just had the question. You included "ensure public safety, improve health." You just feel that you want to amplify that?

    DR. PIZZORNO: That's why we are doing it. We want the practitioner to be more effective in improving the health of the population.

    SISTER KERR: And to increase the availability of qualified and knowledgeable CAM and conventional practitioners. If that is the intention, then, I think that is certainly clear.

    DR. GORDON: Joe.

    DR. FINS: I guess what is missing is the aspect of cross-training. It seems to me that if we could somehow capture in a preamble to this, you know, to promote the health of the American public as they make use of conventional and CAM modalities together and in isolation. You know, we recognize the need to improve the training of CAM and conventional practitioners.

    DR. GORDON: What about just adding at the end, "and enhance collaboration among them?"

    DR. FINS: But that is an access and delivery kind of thing.

    DR. GORDON: I am not sure what you are looking for.

    DR. FINS: I am saying that, again, the metaphor that I keep on thinking about is people going back and forth between two worlds, and we can't protect them in each of the worlds if we don't protect them as they move back and forth in the transitions. I think in order to meet the needs of the American citizenry as they make use of conventional and CAM modalities and treatments, together and in isolation, we need to have a work force that is appropriately trained with the interface. I need to know something about acupuncture when my patients are visiting Effie, and she needs to perhaps know something about hepatitis B, so if a person comes in icteric, she will know to use universal precautions, and those kinds of issues.

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    DR. GORDON: My question to you is, does that need to be expressed in the recommendation, or can that be an action item?

    MS. SCOTT: No, it doesn't, it's in the action item.

    DR. GORDON: Was there anyone else before -- Julia is next.

    MS. SCOTT: I was just going to say that a lot of what Joe is speaking to is in the specific actions. They are hard to find. I went to the Recommendation Section because they are all together. In this one, it is labeled 1.2, but there are two, 1.2's on the recommendation page, so maybe in the text they will be separated out. They are? Okay. So, I guess it is 1.3.

    DR. LOW DOG: Have we gotten consensus on this?

    DR. GORDON: No, I don't think we have consensus. First of all, I would suggest that everybody look at the action items, and I know it requires a little paging through, and then see whether the recommendation, as stated and as amended, works with the action items or whether it doesn't.

    MS. SCOTT: I would like to recommend that as Joe read the recommendation, it stand, and our other Joe's consideration of cross-training, et cetera, it is, I believe, covered in the action statements, as well as it is included in methodology when you teach. We can't do every detail of curriculum planning, and I think the spirit of that is definitely contained both in the recommendation and in the action.

    DR. GORDON: Don?

    DR. WARREN: Are we on action items now or what are we on?

    DR. GORDON: I want everybody to look at the action items, so you know what they are, and you see how they go together with the recommendation, and then I would like a restatement of the recommendation for everyone's consideration. So, just a take a minute and look at the action items, if you would. In this instance, all the action items go with one recommendation, so it is important to get the whole picture.

    DR. LOW DOG: Maybe we should go through the action ite


    DR. GORDON: The first action item is on page 7. "Conventional health professional schools, postgraduate training programs, and continuing education programs should develop core curricula of knowledge about CAM in conjunction with CAM experts and CAM institutions, so that conventional health professionals can discuss CAM with their patients and clients and guide them in the appropriate use of CAM." Veronica.

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    MS. GUTIERREZ: I did e-mail a message about this. I thought the phrase "and guide them in the appropriate use of CAM" resembled the gatekeeper mentality, and I would like to see the sentence end with "patients and clients." That way we keep personal biases out of it.

    DR. GORDON: Let's have any discussion about that recommendation. Joe.

    DR. FINS: I agree, it is really not about directing people, but maybe to maximize the benefits and minimize the risks. I would also take out this little parenthetical here, "in conjunction with CAM experts and CAM institutions." That can be put in the text because all we are saying here is that these schools should develop a core curriculum about CAM, that would prepare -- prepare the conventional health practitioner or professional to discuss the risks and benefits of their patients' use --

    DR. GORDON: We now have a suggestion, an amendment, and a second suggestion. Tierona.

    DR. LOW DOG: I also wish to take out "in conjunction with CAM experts and CAM institutions," because we also don't do the same when we talk about CAM education, we don't list in conjunction with conventional, so I think keeping parity there. I just want to comment about the "guiding" them. I am not attached to that particular language, but there are a lot of people that are using CAM products that are not under the guidance of anybody. They just go the health food store, they just purchase things, and nobody is giving them any kind of guidance, and I think it is to everybody, the chiropractors and the pharmacists and the dietitians and the doctor, I think everybody has to help guide folks, because a lot of what is being consumed out there is not being done through a CAM professional, it is just being purchased at a health food store or through multilevel marketing.

    DR. GORDON: I want to come back to the second point that Joe raised, the "in conjunction with CAM experts and CAM institutions." At least a couple of people have said that should be stricken because it doesn't work both ways. George.

    DR. BERNIER: I think it was very clear with this group anyway that we felt it was critical for the CAM-accomplished individuals to be able to pass that education on to the conventional medical student, postgraduate, et cetera. It seems to me we are running in two different directions here.

    DR. FINS: I agree with that. I am just saying that it should be in the text, but not necessarily in the recommendation, like how you do it. I agree with the sentiment, but I think it goes into the text.

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    DR. GORDON: Is that okay, put that in the text, and not in the action item? I want to see heads. I want to see if that is all right. We are going to put in the text, and take out of the action item, the phrase, "in conjunction with CAM experts and CAM institution."

    DR. KACZMARCZYK: It is already in the text.

    DR. GORDON: Then, we take it out of the action. Fine. Let's go back to the second point that was raised regarding the last clause here, "and guide them in the appropriate use of CAM." There have been a couple of opinions expressed. Other opinions on this one? My own opinion, in case you were wondering --

    DR. FINS: You have been very judicious about sharing your opinion, and I really want to congratulate you for holding back. You have been great.

    DR. GORDON: The reason that I think this could be important, and I am not totally wedded to it, but I think the concept is important because one of the main issues that I hear from patients, particularly patients with serious illness, is I want my doctor to help me figure out what to do, not just discuss CAM. That is the first step. But they want to know, if they are going to see an oncologist, they would like that oncologist to refer them to somebody to give them more guidance about how to use these approaches, so that is why I felt it was important to put in here.

    DR. PAZ: Well, you know, there is actually a fair amount of people who are not knowledgeable about CAM and their practices, so they do ask what would be appropriate. So, I think that would be very important to know.

    DR. PIZZORNO: Veronica, was there other language you would suggest?

    MS. GUTIERREZ: Language, no. If somebody felt that that was an issue, which is the other side of the scale, I suppose of what I am talking about, what I deal with in my office on a regular basis. Perhaps there could be the discussion in the guidance relating to CAM, could be in the text of the document instead of the recommendation, and I will tell you my problem with "appropriate" use of CAM, it is just relating to chiropractic. People have concepts of chiropractic that are as old as the profession itself, and we don't all twist necks, we don't all twist low backs, and we don't all apply force, but there are many, many medical doctors in our community that say, oh, don't go to a chiropractor, you know, you have got osteoporosis, or whatever. Right at the present time, I don't think it is appropriate. Maybe it's a visionary thing that we can incorporate in the text.

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    DR. GORDON: Joe.

    DR. FINS: The point here, it is coupled with education, and that is why I want to use the word "prepare" them, that we should have these things to prepare these practitioners, so that they can discuss, but I think guidance is important. It is not in any way meant to be like in a gatekeeper mode. It is really to have the heart-to-heart kind of conversation that allows patients to make informed -- maybe informed choices. Maybe that is the metaphor, "to prepare patients to make informed choices about therapeutic options."

    DR. GORDON: Linnea.

    MS. LARSON: I had a solution to the recommendation.

    DR. GORDON: Okay. We will come back to it. Joe.

    DR. PIZZORNO: The majority of health care in this country is provided by medical doctors, and the majority of their patients are using CAM in one form or another, and the majority of them are doing it without guidance. So, this is a problem that has to be addressed. I think one of the problems we have historically is we don't trust the guidance they would get, because either they are not knowledgeable or they have biases, but we are about fixing that. We need to fix this in a primary care environment, so people do get appropriate guidance, and that is why I was asking you for some other kind of wording we can use.

    MS. GUTIERREZ: I like the phrase "informed choices," and perhaps the professionals can discuss CAM with their patients, and encourage all decisions be made out of informed choices, or something of that type. That is no problem.

    DR. GORDON: Joe.

    DR. FINS: Conventional health professional schools, postgraduate training programs, and continuing medical education programs should consider -- I mean that is the other issue -- should develop core curriculum about CAM to prepare conventional health professionals, so they can discuss CAM with their patients to help patients make informed choices about the use of CAM modalities, something like that.

    DR. GORDON: So, you are crossing out the "discuss," and you are saying to help patients and clients make informed choices.

    DR. FINS: Yes, because it is a collaborative model, and it gets at Veronica's concern that we are kind of pushing them in one direction. The patient is making the choice, we are not making the choice.

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    DR. GORDON: It feels okay to me. Does it feel okay to everybody? Okay. Let's do it. We are going to move on to Action Item 1.2. For those who came late, after the break, we are going to be working until 7:00 tonight, and we are going to be starting at 7:00 tomorrow morning.

    DR. FINS: This is part of new wellness effort.

    DR. GORDON: After two hours of yoga the first thing in the morning.

    MR. CHAPPELL: I would be available earlier than that, if you would like, tomorrow morning.

    DR. GORDON: I have to take care of the animals and the fields first, so I can't get here until 7:00. 1.2. "All CAM education and training programs should develop curricula that reflect the fundamental elements of biomedical science and conventional practice in order to ensure safe and beneficial care of patients." Tierona.

    DR. LOW DOG: This comes back to my earlier comment about we need to phrase this in a way that it is relevant to the practice, what they are doing, because again if you are doing yoga or Tai Chi or Reiki, I am not sure how much of this you need.

    MS. LARSON: Same comment that I had.

    DR. GORDON: Same comment. Okay. Good. Joe, do you have a suggestion about how to rephrase it?

    DR. FINS: Yes.

    DR. GORDON: Good. Please.

    DR. FINS: So it is consistent with their scope of practice.

    DR. LOW DOG: Conventional practice?

    DR. FINS: [Off mike.] -- that reflect the fundamental elements of biomedical science and conventional practice consistent with the scope of their practice, their CAM practice.

    DR. LOW DOG: Just their practice.

    DR. GORDON: How about "develop curricula consistent with their practice?"

    DR. FINS: Consistent with their scope of practice.

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    DR. GORDON: Scope of practice. That way, it is less clumsy. Okay? Are we all right with this one?

    DR. FINS: "All CAM education and training programs should develop curricula consistent with the practitioner's scope of practice that reflects the fundamental elements of biomedical science and conventional practice in order to ensure safe and beneficial care of patients." We have an extra "practice" in there we can take out.

    DR. GORDON: Tierona, you look troubled.

    DR. LOW DOG: I just actually think it reads better when you put develop curricula that reflect the fundamental elements of biomedical science and conventional medicine or whatever relevant or consistent with their scope of practice because I think that is where it fits. Or you can use conventional therapy, conventional medicine, you can put whatever you want, or just the elements of biomedical science.

    DR. GORDON: Let's have someone state it, please. Do you want to state it, Tierona, or, Joe, do you want to state it?

    DR. LOW DOG: "All CAM education and training programs should develop curricula that reflect the fundamental elements of biomedical science and conventional medicine consistent with the practitioner's scope of practice in order to ensure safe and beneficial care of patients."

    DR. KACZMARCZYK: Excuse me. Instead of "conventional medicine," I think it should be broader, "conventional health care."

    DR. FINS: Instead of saying "consistent," say "relevant" now, "to the practitioner's scope of practice."

    DR. LOW DOG: Can you put "in order to ensure patient safety" or something?

    DR. GORDON: The question is do we have to add that last phrase, because that's in the recommendation.

    DR. FINS: That's in the original recommendation, which we will get back to.

    DR. GORDON: I just don't think we have to keep repeating that every time if it's in the original recommendation. Let's read it once more without that last phrase.

    DR. LOW DOG: "All CAM education and training programs should develop curricula that reflect the fundamental elements of biomedical medicine and conventional health care relevant to the practitioner's scope of practice."

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    DR. GORDON: Don.

    DR. WARREN: Did we change "biomedical science" to "biomedical medicine," which is what you just said?

    DR. LOW DOG: Oh, is that what I said?

    DR. WARREN: Yes.

    DR. LOW DOG: I didn't mean to say that. I meant to say "science."

    DR. WARREN: It should read, "All CAM education and training programs should develop curricula that reflect the fundamental elements of biomedical science and conventional health care consistent with the practitioner's scope of practice."

    DR. GORDON: Relevant.

    DR. FINS: One more delete stylistically. Instead of saying "All," just say "CAM education and training programs."

    DR. GORDON: "And foster collaboration between CAM and conventional students, practitioners, researchers, educators, institutions, and organizations." Comments, additions, questions? Okay. I just added one phrase, "To foster critical discussion and collaboration."

    DR. FINS: No.

    DR. GORDON: No, you don't like that?

    DR. FINS: It is implied in there.

    DR. GORDON: Fair enough. Are we okay with this? All right. Onward. "Increased federal, state and private sector support should be made available to expand CAM faculty, curricula, and program development at accredited CAM and conventional institutions." How are we with that? I added one little addition, which I will offer up. I would say, "Expand and critically evaluate." We don't need to put it in, I am just think it's important that we evaluate the efforts that we make in this direction.

    DR. FINS: I think it is very important. I would endorse that strongly.

    DR. GORDON: We are not really critically evaluating faculty.

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    DR. KACZMARCZYK: Well, it's faculty development, Jim, it's not faculty.

    DR. GORDON: Faculty development, okay. Is that okay, faculty development? All right.

    MS. GUTIERREZ: If the institution is accredited, isn't that the job of the accrediting agency to critically evaluate faculty curricula?

    DR. GORDON: My thought is that, for example, we have a grant at Georgetown to develop a CAM curriculum. A significant part of that grant is evaluating how well the curriculum works for the students. I am just adding it. The reason I am adding it is because I think it says we are serious about this, this in not merely giving some money to folks. We really want to find out how it works. That is why I want to put it in there.

    DR. FINS: Maybe there is another action item here that is consistent with your insight here. Maybe support should be made available to accrediting bodies to critically evaluate. I am saying like LCME, for example, we have no recommendations about LCME that go into, say, medical schools to accredit them. We have nothing about that, that I am aware of, in any of this, and the accrediting bodies, if they are going to accredit, say, a medical school's program in CAM education, so this is just on the conventional side, they are going to need some kind of guidance. Now, maybe this is the next stage. Maybe George could comment on that.

    DR. BERNIER: Actually, the LCME knows a lot more about what is happening in the CAM education process than I think we give them credit for. I can see that being over the next few years, a really key part of it, but I think at the moment, I would not add that last phrase.

    DR. GORDON: 1.5, page 17. "The eligibility of CAM students for existing loan programs should be expanded."

    MS. LARSON: I have a substitute recommendation that actually orients it to something that is doable. It is, "The Department of Health and Human Services should conduct a study to determine whether and in what ways and to what extent should eligibility be expanded to students of CAM." So, it sets it up before we just willy-nilly, say, open everything up, and it gives direction to it. That is something that we need to discuss.

    DR. GORDON: Joe.

    DR. PIZZORNO: Aren't the chiropractors already included in the Heal Loan Program now?

    Page 60

    DR. KACZMARCZYK: In the text, it states that chiropractic students are included in two loan programs, Heal and SDS, which is Scholarships for Disadvantaged Students.

    DR. GORDON: Joe, expand on that a little. So, what is it saying and what is not being said?

    DR. KACZMARCZYK: I don't understand your question.

    DR. GORDON: You are saying two programs allow chiropractors in. In all states?

    DR. KACZMARCZYK: These are federal progra


    DR. GORDON: And other programs do not allow chiropractors, is that right?

    DR. KACZMARCZYK: Those, to the best of my knowledge, are the only programs that include CAM students.

    DR. PIZZORNO: I think for those two programs, that students at accredited CAM institutions should be included, because that pretty much is going to limit it to those that have licensing standards. I think those are the ones that are accredited.

    DR. GORDON: What is your position vis-a-vis Linnea's substitute?

    DR. PIZZORNO: Since the doors already have been opened to those two programs for chiropractors, I think that any CAM student at an accredited institution should be eligible to those programs, but to open up other programs, I think we should go through this process that you discussed. I am kind of separating the two pieces.

    DR. GORDON: Go ahead, Linnea.

    MS. LARSON: So, you are saying, you limit it to those programs, such as Scholarships for Disadvantaged Students and those from the Heal Program that already have scholarships and loans available for chiropractic students, and that you limit it also to those in accredited complementary and alternative medicine institutions, and then the rest of the programs that you would have feasibility studies for.

    DR. PIZZORNO: Yes, I did, I agree.

    DR. GORDON: Tierona.

    Page 61

    DR. LOW DOG: These are loans, right, and you have got to pay them back. So, you have got to pay them back. Why is it even an issue? I just don't understand it. I mean if you are going to borrow money to get an education, whatever that education may be, if it's accredited, I just don't understand. I think it is different when you are talking about loan forgiveness and primary care, and all that kind of stuff. This, to me, just speaks about loans and being able to get a low interest loan to go to school. I would expect that whether you are going to be a teacher, or you are going to be a chiropractor, or whatever, so I just support that they should be expanded, because they are loans, you are going to pay them back.

    DR. WARREN: Aren't these loans federally guaranteed loans, so that if you decide not to pay them back, the Feds pick up the tab, and then they go after you.

    MR. CHAPPELL: I am fine with the action as it is stated originally.

    DR. FINS: I have a couple points. One is that chiropractic was singled out because it met a need. They went through with this process, said these folks are qualified for these loans because they fulfill a need. I think Linnea's language that if other disciplines meet a certain need, then, maybe it's considerable as an option, but the one thing that I would -- and I am willing to kind of think about that -- the thing that I want to distinguish, though, is the National Health Services Corps scholarship, which has all kinds of associations with what is primary and underserved populations.

    DR. GORDON: That's the next one.

    DR. FINS: I think that is very different than the kind of language that Linnea had, you know, looking at the viability of this without an endorsement of it.

    DR. GORDON: I have a question, and this follows up what Tierona said, and Joe or others, Steve might be able to answer. If I can get a loan to go to school to study Serbo-Croat or to study becoming a beautician, why shouldn't I be able to get a loan to go to school to be a naturopathic physician? I don't understand. I am sort of essentially saying the same thing Tierona is saying, reminding us that many of us may have gotten loans to go to college to study snowboarding or whatever it is we studied in college. Charlotte.

    SISTER KERR: I want to say my clarification of it, but in response to that, too, it may be that the committee should know more details to this, but what I wanted to say, I hear two options. One would be the statement that Linnea made, which is that we do a study, and part two of that was what Joe said, that the professionals within accredited schools would be eligible, so that is A. B was to leave 1.5 as it was based on this philosophy that, hey, if you want to go to school, you should be eligible. If we go with B, which I am called B, 1.5 as it is, I think we should be very specific like the eligibility of CAM students should be included in existing loan and scholarship programs, period. Now, the only C is whether or not there is some other information that we don't know, that is making this a big deal.

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    DR. GORDON: That is what I am trying to find out. Joe.

    DR. KACZMARCZYK: It is not a big deal. The two loan programs that are referenced in the text, that is, Heal and the Scholarship for Disadvantaged Students are based on financial needs. They are administered by the Bureau of Health Professions, Health Resources and Services Administration. They are included in legislation in Title 7, and it looks like in the 2003 budget, many of those programs are going to have significantly reduced funding. Those programs are administered in part by the institutions, specifically, the SDS, so the money would go from the federal government to the institution, and the institution would then actually implement and manage that particular program, and these are based on the financial need of the student.

    DR. FINS: But also they have met certainly their professions.

    DR. KACZMARCZYK: The profession is mentioned in the legislative language. Unless the profession is indicated specifically in the legislative language, a student of that profession cannot participate in either Heal or SDS, and the current legislative language specifies that chiropractic students are eligible for participation in Heal and SDS.

    DR. GORDON: How does this relate to -- and maybe Joe Pizzorno can answer this, too -- how does this relate to ordinary loans that all students can get?

    DR. PIZZORNO: Students at accredited CAM institutions are eligible for the same financial aid as colleges. The reason Heal exists and these others is because health care education is, at a graduate level, more expensive than the regular loan programs that are available. So, this basically adds to the loan limit that students can get.

    DR. GORDON: The first thing I would like to say that we need some of this background in here to understand why this is important and why this is even an issue, which is not immediately apparent to me or to Tierona. Joe, go ahead.

    DR. PIZZORNO: It is a problem because the students doing graduate education in CAM have tuition and room and board, and such, which is substantially in excess of the Stafford loan, which is what they are eligible for. So, this is to put them on the same ground of getting more in debt as conventional medical practitioners.

    DR. GORDON: So, there is a clarification. Linnea.

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    MS. LARSON: I actually think that in the text, it is there. It just is not as clear as we want it. That is one of my suggestions. Actually, I have a visual aid of a grid, saying this is who is eligible, and this is how it works. I have actually written it out if anybody wants it.

    DR. GORDON: George.

    DR. BERNIER: I just want to be sure that we are all looking at the same deck of cards. The students who are in the CAM programs are not eligible by the way the rules are written for the disbursal of HRSA loans or other ones that primary care physicians in the United States during their education can be fully funded through that, so it would require that the law be changed.

    DR. FINS: And that means to designate those folks as primary care providers, which is, in my view, problematic, but my understanding from Joe here, is that this is a different pool of money that doesn't require the primary care designation, which is to me a critical distinction.

    DR. GORDON: Can we have a recommendation for how to word this action item?

    DR. LOW DOG: I just had another question, though, that I am still unclear about. Say it wasn't a health-related field, if I am going to go to law school, and it was going to be $20,000 for the year, and I didn't have anybody to help me, what funding would I go to for that? I mean I just don't understand enough about the way loans work for these kinds of things to know what is available. I guess I am an advocate for people being able to take out loans for education, and I just think that that is important because it is going to be paid back, so how do you make that available to people to get education, but I don't really know the extent of what is available out there and what other kinds of loans people could get. If you are taking it away from a certain pot that doesn't have a lot of money, then, that is an issue that has to be considered. I just don't feel like I know enough about this to know where people are going to go get their -- where do people get their money?

    DR. PAZ: One of the things to also think about is that with the loans, there is different amounts of interest rates of them, and some are much higher than others. Some of these federal ones have much lower interest rates than some of the others.

    DR. TIAN: If I understand, I think that for CAM students, they do have it difficult to get a loan. First of all, the school, for instance, either traditional Chinese medicine or acupuncture school, this school has to be nationally accredited, otherwise, you can't get a loan. I think the point here is very important. We want to help those students they can get a loan, even that school may not be accredited now, may be in the future, but again it takes about three years, sometimes five years to get accredited, so I think that point is very important we should mention it.

    Page 64

    DR. GORDON: Let's come back once again. We have the action item, we have Linnea's revision or alternate version or Joe's alternate --

    DR. FINS: No, I don't have it. You see, I think this gets back to some fundamental issues about whether something is a profession, whether somebody is going to an accredited institution or not, whether there is an unlimited pool of money for loans, you know, if you said to me, you know, this money will prevent a respiratory therapist from going to school versus somebody to go to an unaccredited traditional Chinese medicine school, you know, those are tough choices.

    DR. GORDON: I would like somebody to make a proposal. This is a very good discussion, and I think we are getting ready for a proposal here. We want to say something about loans, and I want to know, do we want to say what is written down here, do we want to say what Linnea said, or based on this discussion, do we want to say something else? Tom.

    MR. CHAPPELL: My recommendation is that this concern be dealt with in the copy of the text, and that the action remain as it is originally stated.

    DR. GORDON: So that the action is the same as it is here.

    MR. CHAPPELL: That's right.

    DR. GORDON: And that the concerns be described in the text.

    MR. CHAPPELL: Correct.

    DR. GORDON: Linnea, do you want to respond or say whatever you have to say?

    MS. LARSON: It's clarified if you look at the text with respect to loans and scholarships. It sets out there are these progra

    MS. The one that gets into the issues about primary care is the National Health Service Corps. There is a rationale for this in the text. This is as it stands, and it is open enough. The one that is the trickiest is the one that relates to the definition of primary care.

    DR. GORDON: If that is the case, I would like to get final on this action item, and then move to that, that relates to primary care, which is the next action item.

    DR. FINS: Linnea, do you still have your text somewhere, your original proposal?

    Page 65

    MS. LARSON: 1.5 now has two parts to it.

    DR. FINS: If we took Linnea's recommendation, we have here the way Tom has written in 1.5 now, it is "Existing Loan Programs," which would include all of them, all three categories. I think we might have agreement on Heal and SDS. If we took Linnea's initial recommendation and said that they should conduct a study to determine whether, in what ways, to what extent eligibility should be expanded for Heal and SDS and accredited institutions. The second question is the National Health Service Corps, which is a separate issue, but I mean we might be able to agree to one, and not the other.

    DR. GORDON: She said something a little different, Joe. I think what Linnea said was that chiropractors are getting the loans, all other CAM practitioners should get the loans, and that other loan areas should be explored and studied. You said it more nicely than that, though. Go ahead, Linnea.

    MS. LARSON: The text needs a little bit tightening up in terms of clarity of the progra

    MS. They are spelled out. There is an SDS program. There is a Heal program. There are some programs that only -- most of these progra

    MS. We are not talking here at all about the National Health Service Corps. If this 1.5, as it stands, what Joe Pizzorno would like would be to add the portion of accredited, those who come from accredited schools. Then, we break it down into two separate recommendations. But the text can justify and has to be spelled out, because the text says this is what is available.

    DR. GORDON: Can we have the wording on this, please?

    DR. PIZZORNO: Here is what I would like to suggest. "CAM students at accredited institutions should be eligible for Heal and SDS loans." So we just say just those programs just for accredited students.

    MR. CHAPPELL: Then, who are we excluding?

    DR. FINS: Those who don't go to accredited schools.

    DR. PIZZORNO: And other loan and scholarship programs are not included. We are just doing just those two progra


    MS. LARSON: I think that is really good and clear, but what I feel unable to do in coming to closure to that is until I have that further discussion on the primary care and the other progra


    Page 66

    DR. GORDON: This is separate.

    MS. LARSON: I know, but it may be limiting. I may want to include that in this recommendation.

    DR. GORDON: Let's bracket this one. If we are agreed on this one, for now let's leave it at this, and then let's go on to No. 1.6. Tom, are we okay with this one?

    MR. CHAPPELL: I am not familiar enough with what schools we would be excluding that are not accredited.

    DR. GORDON: Ming said schools that are not yet accredited or schools that never will be accredited.

    DR. FINS: And students shouldn't go to those schools.

    MR. CHAPPELL: And does the student loan program require accreditation anyway? Then, why are we editing the statement?

    DR. PIZZORNO: Because if we don't say they have to go to accredited schools, that means all schools are open, and I believe we should not open loans to students in schools that aren't accredited because accreditation is our national standard to determine that schools have qualified faculty, good quality education, et cetera.

    MR. CHAPPELL: I guess I would argue that we all have to start somewhere before we get accredited. In your experience, were you accredited on day 1 of year 1? Then, how do these people have a financial strategy that includes loans?

    DR. PIZZORNO: It is part of the challenge for the student.

    MR. CHAPPELL: It's not a scholarship, it's just a walk up the ladder, and these perfectly good -- and there will be new ones, and there will be more, they have a right for students to have eligibility for loans, as well, so, no, I don't agree with the edit at all.

    DR. FINS: It seems to me it is unfair to the student to impose a burden of indebtedness to an entity, you know, based on an experience that doesn't give them a quality educational product, and schools should be able to get accredited.

    MR. CHAPPELL: But they did get a quality experience at many of these schools that started before they were accredited. That is part of the chicken and the egg issue.

    DR. GORDON: This is real difference of opinion. Let's hear some other thoughts about this, and see if there is some way we can reconcile it. Joe, go ahead.

    Page 67

    DR. PIZZORNO: Tom, having gone through this process, I am sympathetic to the challenge. As a practical matter, I cannot envision the Department of Education accepting the responsibility to provide loans to schools that aren't accredited. It would open up the door to huge abuses of the system. There has to be some way to determine which schools should have eligibility for loans and which ones shouldn't, and without some kind of standard, it's impossible.

    DR. LOW DOG: I would just support that because part of even the accreditation process is just how you protect the students, you know, how are their grades done, it is this huge process, and the students really have no protection in unaccredited schools. It doesn't mean that they are not good, but I don't think we are ever going to get this passed, if it's not through an accredited school.

    MR. CHAPPELL: I'll go along.

    DR. GORDON: Thank you, everybody, on this one.

    DR. WARREN: Who does the accrediting, is it a nationally accredited school or is it a state?

    DR. GORDON: What does it say, Joe, in the Heal regulations?

    DR. KACZMARCZYK: Department of Education.

    DR. PIZZORNO: The Department of Education publishes a book of all the schools that are approved for accreditation.

    DR. GORDON: Do you want to read that again, Joe?

    DR. PIZZORNO: "CAM students at accredited institutions should be eligible for Heal and SDS loans."

    DR. GORDON: Julia.

    MS. SCOTT: I'm sorry, I got lost in all of that. I just want to make sure I got this. 1.5 now has two different sections, or there is one? There is one. Okay. So, what we are expecting is Joe's edit.

    DR. GORDON: Just as he said it. Joe's revision of Linnea's edit, yes.

    DR. GORDON: One of the nice things about this recommendation is it has specificity, and it makes very clear recommendation, and I think the fact that we make it accredited schools makes it very believable to the Department of Education, as well. Let's move on to a more complex issue, 1.6, which I will read. "The Department of Health and Human Services should conduct demonstration projects to determine the feasibility of CAM students participating in the National Health Service Corps Scholarship Program." Tierona.

    Page 68

    DR. LOW DOG: I would like to move that we take Linnea's recommendation from the last recommendation or action item or whatever, but just make it relevant for this, for the feasibility studies.

    DR. GORDON: Somebody with a mike, read it.

    DR. KACZMARCZYK: "The Department of Health and Human Services should conduct a study to determine whether and in what ways and to what extent should eligibility be expanded to students of CAM in the National Health Service Corps Scholarship."

    DR. FINS: That would be 1.6?

    DR. KACZMARCZYK: That would be 1.6, that is correct.

    DR. GORDON: Let's discuss it. Tierona, go ahead.

    DR. LOW DOG: I just wanted to finish my thought because I had thought, on our conference call for this section, that it may have Maureen that had said that before you start doing a demonstration project or whatever, you need to actually have feasibility studies, and you need to sort of thing through the process. I think it needs to go back a step from the demonstration project to this, and also to determine which CAM providers, if any, would be eligible for this. So, I would propose that.

    DR. GORDON: Other comments on this?

    DR. KACZMARCZYK: Much of that is addressed in the text.

    DR. GORDON: I'm sorry. What, Joe?

    DR. KACZMARCZYK: Much of Tierona's concerns is addressed in the text.

    DR. GORDON: Joe.

    DR. PIZZORNO: I agree we need to do a study first. I think we also said that, and if feasible, then demonstration projects should go forward.

    DR. FINS: The whole thing here, as I understand it, is to be part of this program, you have to be providing service after you have been trained as a primary care provider. That is the sine qua non for this scholarship program. I will not be convinced that these folks, even that small subset of people, are equivalent as primary care providers. With all due respect to what a naturopath would bring to the patient's well-being, that individual does not have the skill set of a family practitioner, an ob-gyn, a pediatrician or an internist. The scope of training differs. The duration of training differs, and I think it puts the public at risk to say that these folks, who bring other things to the table, are primary care providers, especially when we are talking about underserved communities that would be the recipients of these individuals. This loan program is predicated upon people paying back with their expertise to underserved communities. If you look at all the things that they are meant to do on page 16, these are not necessarily services that they are trained to provide.

    Page 69

    DR. GORDON: Charlotte.

    SISTER KERR: From what we have just said, with all respect, nobody is debating that right now, and also, as far as the state, I guess Washington, naturopaths have been defined to be able to do primary care. So, the point is Linnea's proposal anyway is just saying we want to do studies, so it's an opinion. But I want to say this just for a sense of history, if you look back in our History Section, page 5, Recent History of CAM, it is very interesting to note, "The vast majority of primary medical care in this country was provided by botanical healers, midwives, chiropractors, homeopaths, and an assortment of other lay healers." Of course, it did progress, but, you know, it is just a point that we could discuss for a long time what the primary care is.

    DR. LOW DOG: But, Joe, I guess I just want to ask the question, if we are talking about a feasibility study, which will evaluate all of this and determine if a direct entry midwife, who is licensed interstate, would be able to provide some women's health services in a community. All we are saying, I think, is that somebody other than us should probably go away and look at this issue, and they may come back and say not yet, not now. But is there a problem with the feasibility study, I guess?

    DR. FINS: Should I respond or should I wait?

    DR. GORDON: Why don't you respond.

    DR. FINS: Congress just decided that chiropractic was not primary care, and primary care means something special. It is not to say that others don't provide first-person care, but it is a scope of practice and a kind of expertise. I would much prefer some kind of consideration of alternative loan sources that do not somehow equate this with primary care. The fact that Washington State has done this doesn't mean that it's right. It might mean there was good lobbying or there was a constituency or whatever. It is not necessarily the way that the country should go.

    MS. LARSON: I would actually like to have that recommendation read again, so it is very clear. It is about a feasibility study, and it says what, whether or not, and to whom this is extended. Secondly, I would like to make a comment that I really do not know what this is. It is Senate Bill something or other that is on the table right now that actually looks to expand -- what I was just talking about -- to include what I think has been a significant absence is behavioral scientists within this domain. They are not considered primary care, but I can tell you that a physician or a nurse practitioner without the necessary behavioral science is crippled, and most of the community health centers do not have those services provided. So, I am just saying this is all it is, is a feasibility study.

    Page 70

    DR. KACZMARCZYK: The legislation you are referring is the NHSC reauthorization.

    DR. GORDON: Veronica.

    MS. GUTIERREZ: I was going to suggest amending the sentence at the end, the 1.6 remaining the way it is, and adding, "If this is found to be congruent with legislative intent," because at the time Title 7 was written, and I am not even sure when that is, medicine was the politically dominant health care model, and that has changed. I know there are a lot of legislators that have talked to our national organizations, and are willing to revisit the Title 7 the way it is defined. So, rather than even proceeding with feasibility studies, and so forth, I am willing to go on the line and offer that this be done if it is found to be congruent with legislative intent, and if it is not, I am more than willing to give up the battle. Secondly, I would like to say not opening the door for this opportunity is not congruent with even one of our guiding principles of the Commission.

    DR. PIZZORNO: I have to say, Joe, I am surprised that you are objecting to this because I thought this was what you and I had worked out.

    DR. FINS: That was something else.

    DR. PIZZORNO: I'm sorry, I thought this was what we agreed to. We actually agreed to a demonstration project. We actually stepped back to do a feasibility study. I am actually quite confident in doing a feasibility study that will lead to a demonstration project, because we are already doing it in Washington State, and it is working great. So, let's just make it a more formal process. Let's do this.

    DR. GORDON: Tierona.

    DR. LOW DOG: Part of when you are talking about the feasibility study, it may address if this should be value added, if it should be done in conjunction, but I think that that is partly what is left to the feasibility study, is to actually try to address all of those issues. I think this is a good compromise for a very sticky subject, I really do. I think the feasibility study, it is not saying let's go do it, it is saying let's look at all the available options and let's see what comes out of it. That may be paring, it may be not a rural primary care. It may be saying inner city. I think that there are so many options that we just don't want to limit ourselves to it, but we want to just say feasibility studies because we don't know what would show up.

    DR. GORDON: Joe K.

    Page 71

    DR. KACZMARCZYK: I think this would be vastly improved if we took the words "demonstration projects," out and used "feasibility study."

    DR. GORDON: We are discussing the amended version.

    DR. KACZMARCZYK: I brought this up because the two other Joe's were going back to a previous issue about demonstration projects. So for clarity, let's just stick to the feasibility study, and not the previously discussed demonstration projects.

    DR. FINS: I just want to see, Joe, because yes, that it was in conjunction. In other words, my real concern is value-added. I think you and I both agreed that we would both be uncomfortable having naturopaths designated in an isolated area as the only practitioner.

    DR. PIZZORNO: We don't agree, because I have graduates out there doing that right now.

    DR. GORDON: I think we are not talking about a demonstration project. We are talking about a feasibility study. What we are saying is, we are open to the possibility. We're not saying, let's do it. We're saying we are open to the possibility that this may have value. That's it.

    DR. FINS: Why do we have to link the possibility of value to a program that is exclusively for primary care providers? That's the question. Why don't we say that there needs to be another feasibility study to determine a new loan forgiveness scheme, or program, outside of the National Health Service Corps, because the National Health Service Corps is about primary care. It is not about other providers.

    DR. GORDON: Joe, I practiced Chinese medicine for 25 years. In China, there are people who practice Chinese medicine who have a pretty good Western medical education as well, even though their licensure is Chinese medicine. I bet they would be quite good at doing primary care practice. I would love to see what it looks like. They are doing it in China. So I'm just saying the possibility. Naturopathic medicine is expanding and growing in all kinds of ways. You deliver babies, don't you? Naturopathic physicians deliver babies, they do minor surgery, they can give injections, they can do many, many things. I think we just don't know, and that's why I think it is fair to see in an open-minded way does this work or doesn't it work. That's where I am.

    DR. FINS: Why don't we study and see whether it works or not, and not link it to the question of loan forgiveness.

    Page 72

    SISTER KERR: I have a sense you have a feeling that something will be lost in doing this rather than what is the opportunity in revisiting a definition of primary care and who could possibly help people. But, wait. There is the worry that there is a big pot of money and that it won't be enough because, first of all, what I have always been advised in legislation, just like in writing your home budget, you may say, "I need prescription glasses. I want to put that in the budget," and they come back and say, "Too bad. We can only afford the dime store." So, if we look at the pot of this money for loans, it will be shared or one will be deleted or whatever, but we are not to have to worry about that. So, what is the concern for you, which is obviously very important?

    DR. FINS: It is really not about the money because I think overall all these programs are under-funded. So, we are really talking about the equivalence, the move towards equivalency between scopes of practice and training that are not commensurate.

    SISTER KERR: In your definition. That is --

    DR. FINS: Huh?

    SISTER KERR: In your definition they are not commensurate.

    DR. FINS: In my definition, and I think a lot of internists would have a hard time with that.

    SISTER KERR: So then, that is the protection, but as Jim said, like acupuncture, for example, in Chinese medicine is primary care in China. The bottom line, millions of people, that is primary care. Acupuncture is a system of preventive medicine. We talked about using in sick care. I learned it as preventive.

    DR. GORDON: Effie had her hand up, and Tieraona had her hand up.

    DR. CHOW: I know we have gotten into debates like this before, and it comes down to definition. So many times we have gotten into trouble with all this debate because we don't have definition of primary care other than the medical primary care. So I don't know. I haven't heard anything further about the glossary definition.

    DR. FINS: In the Public Health Service Act, Section 3.30 on the bottom of 15. It is not my definition, it is by statute.

    DR. CHOW: I am not saying it is your definition. I am just saying that that is the traditional definition.

    DR. GORDON: I think the issue, though -- excuse me for interrupting -- Joe, is if this is primary care, then, as defined, the question arises, can these other people provide it. That is an open question. I mean, at least that is the way I see it. I am not trying to convince you.

    Page 73

    DR. FINS: This, to me, is, I think I can say without any kind of doubt, the most important issue for me. This may reflect a world view kind of thing, and I may have a hard time with it. However this turns out, you may want to go forward without me, and that is perfectly fine. I think the country will be served by an articulation of the issues, and hopefully, something will, in a Hegelian sense, synergize out of it. I just have a hard time with it and I have had a hard time expressing it to this group based on where people are coming from and what their own backgrounds are. I respect everybody's point of view. I respect barefoot doctors in China. I understand that, but I would not equate a barefoot doctor with a fully trained family practitioner and internist. So I think this may be a discussion that we could continue at dinner at Ming's house but it may not be fruitful to continue it here. I say that with all humility.

    DR. GORDON: I appreciate that. I just want to clarify one thing. I was not talking about barefoot doctors. I was talking about people who have been through the complete training in Chinese medicine who have also had significant Western medical training. Barefoot doctors is a whole other category. I am talking about people with a very deep knowledge of Western science who happen not to be M.D.s but who happen to practice Chinese medicine. This isn't, again, part of the discussion. I shouldn't carry on. I'm supposed to cut discussion off, but I would suggest that if you go down this list, it is entirely possible the naturopathic physicians might do everything on this list of primary care. Just saying that as a possibility, I think we just don't know. That is where I am. I will shut up now. Tieraona, Linnea, Tom, and let's close with Joe.

    DR. LOW DOG: I need better clarification because when it said that NHSC scholarship programs are limited to U.S. citizens enrolled or accepted for enrollment in fully accredited U.S. allopathic or osteopathic medical schools, nurse practitioner, nurse midwifery P.A. schools, or dental schools, dentists are not primary care. I guess my problem here is that I have no position at this moment. Rather, I believe that a naturopath, a midwife, a massage therapist, I have no opinion on whether they should be in this program or not, but I am fully willing to engage in a feasibility study where people will look at the issues with objectivity and try to figure out how do we maximize benefits for the public. Again, I just want to point out, when I read this, nurse midwifery programs, they do not teach people to do all of primary care. A nurse midwife out in a rural area does not do all of primary care. Neither does a dentist. So I'm not sure if maybe I am just misunderstanding the NHSC. Maybe I just don't understand it enough.

    DR. KACZMARCZYK: As the law is currently written, those are the health professions which are eligible for participation. The text originally said pilot program parenthetically after dentists. That is currently a pilot program.

    Page 74

    DR. LOW DOG: Oh, that's a pilot program?

    DR. KACZMARCZYK: Yes. That pilot program was removed in the editing because the document as a whole is too long, too verbose, and efforts were made, wherever possible, to abbreviate it.

    DR. GORDON: Linnea, Tom, and George Bernier.

    MS. LARSON: The only thing I would have to say is to second what Tieraona said and that all we are looking at is simply the feasibility. That's it. Also, if we look at 1996 Institute of Medicine Book on Primary Care and what they look at as a primary care team, that is different, okay? We are not excluding and saying there is equivalency. Having worked in a community health center in which there were recipients of National Health Service Corps, I can tell you how devastating these areas are. We need people. We need, quote, behavioral science people in there. We're not asking that a substitute physician or whatever, we're asking for a feasibility study because we want to expand the possibilities, at least in my mind, for collaboration, for collaboration.

    DR. GORDON: Tom.

    MR. CHAPPELL: I support the language as we have been referring to the feasibility study because I think the consumer, whose interests we represent here, needs to have more opportunity to make the choice of primary care. It has nothing to do with how many years of education that professional has had, it has to do with how confident the consumer will ultimately feel in selecting a given practitioner for primary care based on their experience in working with that professional. We have got to open up the opportunity for that model, or various models, to be determined by the feasibility study.

    DR. GORDON: Joe.

    DR. PIZZORNO: Just real quickly, Joe, I look forward to this conversation continuing in the evening, but I want to assure you I don't consider a naturopathic doctor, a broadly trained chiropractor, a Chinese-trained Chinese medicine person to be the equivalent of a medical doctor. Clearly, they have different abilities and such. However, I do maintain with a great degree of confidence, because I have done it, that in a primary care setting we have a lot to offer. We are not replacing you, but there are many places where what we have to offer is of great value. That door needs to be opened and understood.

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    DR. FINS: May I? Linnea said something that might be a way of tweaking this. I want to just suggest it but not commit to it, because I really need to see it in print. We might want to say something that, recognizing to provide comprehensive primary care is a team approach, and there are lots of different ways of contributing to primary care, under the rubric that there may be a mechanism to include people who add to the comprehensive quality of palliative and the contributions of each. So primary care, but it is comprehensive. I mean, you see this in managed care companies or managed care situations where it is better to have the visiting nurse, and the doctor, and people, all in the aggregate, together. I think maybe we have to think a little bit out of the box, which is stuff that we said at the very first meeting, we've got to think out of the box. Maybe we need to think about the definition of primary care, not primary care practitioners but the comprehensive quality of primary care, which involves a lot of different kinds of practitioners.

    MS. LARSON: That was my intent. We have an excellent example that is given by the Institute of Medicine in 1996. It is superb. It goes into detail about the collaborative team, et cetera.

    DR. GORDON: George, and then Conchita, and then let's come to a close.

    DR. BERNIER: I guess we are dealing with two issues, the 1.5 and the 1.6. The 1.5, we passed?

    MS. LARSON: Yes.

    DR. BERNIER: The 1.6, I think there are just lots and lots of ways of looking at it. I know we had had some very long talks about it, and it seems to me that we could go into the demonstration projects or their equivalent without destroying what seems to be a really good process that has gone on so far. I think everybody is tired, but I would like to urge that the group very strongly consider supporting the idea of having expanded loan programs and then the No. 1.6, to look at that as the opportunity to really test how students from various backgrounds are able to contribute to the well-being of the patient.

    DR. PAZ: Coming from a state that is mostly under-doctored, and we do occasionally, rarely, get National Health Service Corps primary physicians, the fear would be that they would send an alternative therapist or a practitioner in place of a physician. I would probably support it if we could include that team approach in the wording.

    DR. GORDON: Tieraona, go ahead.

    Page 76

    DR. LOW DOG: I just wondered if in the text we could expand upon the notion of team approaches, referencing back to the 1996 study that really talked about this -- the way we are moving in medicine, anyway, is co-management -- and really explore that within the text, so that it sets the stage when we talk about a feasibility study. If you want to include in the language about teams or whatever. This would set the foundation for the recommendation.

    DR. GORDON: Joe.

    DR. FINS: Maybe the most time-effective way is if a few of us over dinner take a pad out, and we just try to work this out.

    DR. GORDON: Julia, did you want to say something?

    MS. SCOTT: I guess I just want to say I support the recommendation for a feasibility study to see if there is anything, or any way, that roles could be expanded and other students can be accepted. It doesn't say that we are training people to take the place of, or anything.

    DR. GORDON: Linnea, will you bring it to a close?

    MS. LARSON: I like the the action item as it stands, and I think that it can have a rationale in the text that makes reference to the 1996 description of the Institute of Medicine that says, this is what we see and this is what is needed. So that is a rationale.

    DR. GORDON: So let me tell you what I am hearing. What I am hearing is that everyone, with the exception of Joe -- and Joe may as well, Joe Fins -- feels good about the feasibility study if the groundwork is laid to discuss teamwork, to discuss the issues, to discuss that this is not replacement in the text. We still have to come back to the original recommendation. So let's proceed with that in mind, and it would be wonderful if you all wanted to gather and pull some of that together.

    DR. LOW DOG: We can revisit this in the morning?

    DR. GORDON: We can revisit it in the morning if you would like, yes. Let's move ahead. Yes, Linnea.

    MS. LARSON: Did we settle on the recommendation? I have a solution. Are we still going through the action items?

    DR. GORDON: We have one hour and 10 minutes until 7:00, in which time we need to finish both this section and CAM Central. So let's move forward with the recommendations. We are now on No. 1.7 on page 19, the action item. Is everybody with me on this? "The Department of Health and Human Services, and other federal departments and agencies, should convene conferences of the leaders of CAM, conventional health, public health, evolving health professions, and the public, of educational institutions, and of appropriate organizations to facilitate establishment of CAM education and training. Subsequently, the guidelines should be made available to the states and professions for their consideration." Comments about this. Does this action item feel comfortable?

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    DR. FINS: Can I be out of character for a minute, and say I like it?

    DR. GORDON: All right. Are we okay with this?

    PARTICIPANTS [En masse]: Yes.

    DR. GORDON: Thank you. No. 1.8: "Demonstration projects of residencies in post-graduate training for appropriately educated and trained CAM practitioners should be conducted to determine the feasibility of such programs and their impact on clinical competency, quality of health care, and collaboration with conventional providers."

    DR. FINS: I thought, last time, we talked about "post-graduate training programs," and left "residency" out because "residency" entangled us with something, I don't remember anymore, about GME monies. We just decided as a compromise. So we struck "residency in post-graduate training programs for." I thought we had compromised on it, "demonstration projects."

    DR. GORDON: You said "post-graduate training," but struck "residency"?

    DR. FINS: Yes. "Demonstration projects and post-graduate training programs for appropriately educated and trained," to avoid a morass with GME funding.

    DR. GORDON: How does that sound? Joe, speak up, please.

    DR. PIZZORNO: Because we are training people to be primary care providers in many of our professions, we really need the residencies. So if we want to do demonstration projects, that's fine, but this is something that is critical. I know the naturopathic profession, the chiropractic profession, and now the acupuncture profession, we are all adopting residency programs. This is something that we need to enhance our clinical training. So if you want to do a demonstration project, that's fine, but I think we should be there.

    DR. GORDON: Joe, can you explain the difference between post-graduate training and residency, why that word is particularly important to you?

    DR. PIZZORNO: I don't know.

    DR. PIZZORNO: We call them "residencies" because that is what we are doing.

    Page 78

    DR. GORDON: "Residencies" used to mean that you were in residence in the place, so you would sleep over in the hospital. I mean, I believe that is where it came from.

    DR. PIZZORNO: Well, we do have several programs that are like that at hospitals right now. I know the chiropractors do, and I know the naturopathics do.

    DR. GORDON: Other comments? George, did you want to make a comment about this?

    DR. BERNIER: You were saying what residents are. Most physicians, after four years of medical school, have three years of training. If they are going to go into a sub-specialty of the given area, that is an additional two, three, four years. So, it is really a time thing. You have to have a significant base of people to be able to fill out in a guaranteed way the residency slots, and that is, really, a very difficult thing to do unless you have got the manpower. I think that the big problem was that was discussed at that meeting was that the manpower just wasn't going to be there to fill out the slots.

    DR. GORDON: Joe, go ahead.

    DR. FINS: I think part of it is that a residency implies the same issue, that accredited residencies are eligible for GME monies. So, if you have not evolved to an accredited residency program, you are not eligible. On page 20, lines 25 and 26, the text says that these projects would be distinct from current GME education funding streams, which are a major source of funding for hospitals and really supports residency training programs, indirectly the care of the under-served throughout the country.

    DR. GORDON: I'm sorry. Where are you?

    DR. FINS: On page 20, lines 25 and 26. Page 20, lines 25 and 26. So, I do not want to imperil GME funding streams because hospitals are already strapped with the Balanced Budget Act, and to somehow take money away from that to do this would really, I think, hurt inner city hospitals and the under-served. So, the issue of calling these things residencies links it up with that. Post-graduate training programs, really, is what we are talking about because some of these programs will not have yet evolved into residencies. Residency is something more concretized, and post-graduate training programs are not necessarily eligible for GME funding because they are not accredited in the same way.

    DR. GORDON: Tieraona.

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    DR. LOW DOG: Well, I hate to go back a step, but I had thought we had actually discussed a feasibility study because part of what we were looking at was which CAM practitioners. Some CAM practitioners may be at a place where even potentially residencies may be appropriate. Others, residencies wouldn't even be appropriate but post-graduate training might be more appropriate. Some, it may just be continuing education is all they need to really keep up. So, I thought we had actually talked about stepping back to look at all of this so that we can address the next step instead of just jumping into a demonstration project because you haven't even defined which ones and who and for how long or anything else. Feasibility studies would at least look at all of those things and determine which groups of people may be ready for that next step or not.

    DR. GORDON: Joe K.

    DR. KACZMARCZYK: That is the intent, and I think, as you suggested, if it is stated as "feasibility studies of" blah blah blah, I think it would accomplish what everyone hopes it would.

    DR. GORDON: Joe Fins has asked Joe K. to fill in the "blah-blah-blah."

    DR. KACZMARCZYK: I think that is filler at this time, B-L-A-H.

    DR. KACZMARCZYK: I think, seriously, if you just restate it, so that it reads: "Feasibility studies of residencies and post-graduate training for appropriately educated and trained CAM practitioners should be conducted to determine." Then you could go into the types of practitioners in their settings and their impact on clinical competency, quality of health care, and collaboration with conventional providers.

    DR. FINS: I think that we should really stress right there that this is distinct from GME sources of funding. It is in the text.

    DR. LOW DOG: In the text I would suggest that we clearly state that if these feasibility studies show that certain groups may be ready for that, that we should say in the text that additional funding, separate additional funding, should be provided for this. It should be clearly stated in there based on whatever happens with the feasibility so we are not taking away funds from the GME but additional funds would be set aside. You would have to have a new pot to take from.

    DR. FINS: If it demonstrated the value-added.

    DR. LOW DOG: Exactly. Which may or may not happen.

    Page 80

    DR. GORDON: Joe, do you want to come back to us with the wording, the precise wording, tomorrow morning? Would you do that, Joe K.?


    DR. GORDON: Great. Thank you.

    Let's move on. Is that okay with everybody? Good. No. 1.9, page 22: "All practitioners who provide CAM services and products should consider completing appropriate CAM continuing education programs to enhance and protect the public's safety." Joe.

    DR. PIZZORNO: I don't like the "consider" there.

    DR. GORDON: I don't, either; "should complete."

    DR. FINS: This links up the licensure stuff later on. I mean, for ongoing certification as a condition of that sort of thing practitioners should meet appropriate CME program guidelines. I mean, Charlotte, and I think Effie, were talking about their CME with acupuncture hours. We were talking about this during the break. So the issue people have is requirements, and I think we should encourage that as part of what it means to be a trained professional.

    DR. GORDON: I would also add something else, and I am adding this partly in consideration of a conversation I had with Dean. So let me read it to you, because I think it is an important note. I know it will be an important element for him. I think it is fair enough. "All practitioners who provide CAM services and products should complete appropriate CAM continuing education programs, dash, which would include critical evaluations of the discipline and approach to enhance and protect the public's health and safety." So if I am doing my continuing ed in acupuncture, I would also get somebody telling me, well, what do the studies look like, and what do we know now, and what did we know three months ago, and where are we in the practice. I think it would make him feel somewhat more comfortable about some of these other disciplines.

    DR. KACZMARCZYK: You spoke so quickly that no one got that except for Linnea.

    DR. GORDON: Sorry, what's that?

    DR. KACZMARCZYK: Could you repeat the clause?

    DR. GORDON: Sure. Read it again?

    DR. KACZMARCZYK: Yes, please.

    Page 81

    DR. GORDON: "All practitioners who provide CAM services and products should complete appropriate CAM continuing education programs, which would include critical evaluations of the discipline or approach," -- dashes around that -- "which would include critical evaluations of the discipline or approach," dash, "to enhance and protect the public's health and safety."

    DR. FINS: Take "all" out.

    DR. GORDON: Take "all" out. Okay, fine. Is that okay? Everybody okay with it? Great. Yes, Linnea?

    MS. LARSON: Let's go back.

    DR. GORDON: Are you ready to go back to the initial recommendation? We are back on page 1.

    MS. LARSON: How does this sound? "The education and training of complementary and alternative medicine practitioners and conventional practitioners should be designed to ensure public safety," comma, "improve health," comma, "increase the availability of qualified and knowledgeable CAM and conventional practitioners, and enhance the collaboration between them."

    DR. PIZZORNO: Good.

    DR. GORDON: How does that sound? You want to read it once more so everybody can get it? Because we will want it up or down now. We will revise and so forth.

    MS. LARSON: "The education and training of complementary and alternative medicine practitioners and conventional health care practitioners should be designed to ensure public safety," comma, "improve health," comma, "increase the availability of qualified and knowledgeable CAM practitioners and conventional practitioners, and enhance collaboration between them."

    DR. GORDON: Charlotte.

    SISTER KERR: I think it's great. Even though we are saying "conventional" and "CAM," should we say "among them"?

    DR. GORDON: Julia, do you have a question or comment? She's saying "among" as opposed to "between." Are we okay with this? Let me see heads. Joe, you okay?

    DR. FINS: I guess. Yes, it sounds fine.

    DR. GORDON: I want to check in with everybody. Is this one okay? This is very important. This frames all the action items that follow.
    [No response.]

    Page 82

    DR. GORDON: Thank you. Thank you very much. Is there anything else in the text that we need to address here that we have not addressed in our discussions?

    DR. FINS: We still have to write No. 1.6, or whatever.

    DR. GORDON: Well, we have the No. 1.6, we have the textual justification that has to be written.

    MS. LARSON: I understood he didn't want it in the action statement, though, that has to be worked on further.

    DR. GORDON: I'm sorry?

    MS. LARSON: I understood Joe to say that perhaps in the context it might be good but he may want to say something in the action statement as well.

    DR. GORDON: All right.

    MS. LARSON: So that has to be re-looked at.

    DR. GORDON: We can bring that back tomorrow. Who is going to be working on that? Joe and Linnea, and Joe.

    DR. FINS: It may be Tieraona, too.

    DR. GORDON: Tieraona, okay.

    DR. FINS: And George.

    DR. GORDON: You guys have got to have time to eat, though, too.

    DR. FINS: Yes.

    DR. GORDON: George, you are going to be involved in it. All right. Anything in the text that needs to be addressed. Joe.

    DR. PIZZORNO: Joe K., this is for you. This is on page 20, line 4, and says, "In outpatient clinics that are not affiliated with any hospitals," two of the residency programs are affiliated with hospitals.

    DR. KACZMARCZYK: I have the total of three naturopathic residencies. There are 40 slots. At National College there are 27 positions. Three are outpatient, three are hospital, one is hospital-affiliated outpatient. Twenty-one of those are first-year residencies, six of those are second-year. At Bastyr, there is a total of eight. All eight are outpatient. Six are first year, two are in the second year. At Southwest College, there are five total. They are described as outpatient but they have hospital rotations at Maricopa County. Four of those are first-year, two are -- excuse me, one is second-year. So we looked at that and decided the best way to summarize it succinctly was as it is written there.

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    DR. GORDON: Suggestion.

    DR. PIZZORNO: Thank you for the good summary of the residencies. I agree, they are primarily outpatient residencies, but the point I am trying to make is there are a couple of them that are at hospitals. I think that should be stated, that's all.

    DR. GORDON: Other issues. Tom.

    MR. CHAPPELL: I just would like to know if we should be stating dentists interested in oral-body systemic health is one of the alternative modalities. Of course, it is a very significant new piece of information and emerging work in dentistry, and yet in the modalities where we described the modalities, we never mentioned dentists in CAM.

    DR. GORDON: Where would you put it, Tom or Don?

    MR. CHAPPELL: I'm looking first at page 2. It says, "In a study of allopathic medical schools with no" blobbity blah. It talks about 10 CAM modalities. Now, that is referring to a specific study, but again, the dentist is not mentioned there. Or, the chart going back to the Research section where we had the different modalities. It is the dentist interested in oral-body systemic health. It is a huge piece of research.

    DR. GORDON: Joe, do you have any comments on the Education section here with dentists?

    DR. KACZMARCZYK: Dentists are mentioned along with the other conventional health care professionals in allied health in two sections. Or, I shouldn't say two sections. In two different areas in the text when the language tried to be more inclusive because it is saying, this should be not be restricted to just medical education. This needs to be expanded to all the conventional health care, including but not limited to, and you can go on and on and on.

    DR. GORDON: Joe, a question for you. In the statistics on CAM teaching in medical schools, is there a similar survey of dental schools that has been done?

    DR. KACZMARCZYK: I am not aware of any.

    DR. GORDON: I don't know of any, either.

    DR. KACZMARCZYK: I am not aware of any.

    DR. GORDON: Tom.

    Page 84

    MR. CHAPPELL: What was the question?

    DR. GORDON: The question was, is there a similar survey of CAM teaching in dental schools.

    MR. CHAPPELL: I happen to know of some that are considering changing their curricula very much in the near term. We will get Don to accelerate that information.

    DR. GORDON: Don, do you want to address that?

    MR. CHAPPELL: Do I want to address it?

    DR. GORDON: No, did Don want to. I thought Don might have something to add.

    DR. WARREN: At this time I am not aware of any dental school that has a CAM program active. The biggest thing they have is the "Scope Manual on Nutrition," which is about 28 pages, and that is it.

    MR. CHAPPELL: I am aware of one school.

    DR. WARREN: Is it active now?

    MR. CHAPPELL: It is not active yet, but they are in the process.

    DR. WARREN: Good.

    DR. GORDON: So, the question is, how do you want to address this.

    MR. CHAPPELL: When you look at the amount of money that is going to be spent in research oral cavity/body systemic health, it is amazing. I mean, the body of knowledge is already there.

    DR. GORDON: We are talking about the Education section. Do we have a place where we want to address it here, right now?

    MR. CHAPPELL: That is why I raised the question. I don't want to see us lose the opportunity to be inclusive of this new field. It is major.

    DR. GORDON: I am asking a specific question. Where do we want to address this, and how.

    MR. CHAPPELL: Joe, where do you think we should put it?

    DR. KACZMARCZYK: At this time I do not know.

    Page 85

    MR. CHAPPELL: Well, can we sleep on it?

    DR. GORDON: Tom, I think if you could find a place or places in the text specifically where you think it might need to be addressed, it would be helpful to us and then we could take that up tomorrow, okay? Joe.

    DR. FINS: A couple of things. I have a bunch of things I am just going to ramble through. I don't think any of it is major but just little stuff. Page 1, we mentioned national guidelines are needed for education and training. I think that we have talked about having national guidelines are kind of problematic, imposing them on the medical schools here. When Jerry and I were doing the Education thing before it switched, we were very clear that just core elements of competencies but not guidelines that will be imposed upon the schools. So I would try to address that. I mean, we need to establish there are curricular elements needed for CAM education and training, or something like that. In other words, not to impose guidelines from some central office.

    DR. GORDON: I think you are right. Even if we wanted to, it is much too early. We haven't established the groundwork, especially in this opening portion.

    DR. FINS: The next thing is on pages 4 and 5, bottom of 4 and the top of 5, I really found this kind of in the advocacy tone, that we want to give medical students the opportunity to personally experience CAM and self-care. I mean it is like saying, we want medical students to experience a colon cystectomy so they can have the experience of surgery.

    DR. GORDON: Joe, let me respond to this. I feel this is an absolutely crucial element of CAM education, that we are talking about self-care. We are not talking about surgery. You cannot teach self-care unless you experience it. You can teach surgery without having had surgery. I think there is a fundamental difference. I don't think, I know it is of fundamental importance.

    DR. FINS: It has an element of proselytizing CAM.

    DR. GORDON: I think it can be worded, perhaps, differently, but I think the element is that there are certain things that you can't be taught simply as academic subjects. They have to be learned in order to be able to teach self-care. This is a long argument, but I feel extraordinarily strongly about this, that you cannot teach self-care without learning it yourself.

    DR. LOW DOG: But perhaps, then, the language should be more specific about self-care instead of CAM.

    Page 86

    DR. GORDON: Fine. That's fine.

    DR. LOW DOG: Maybe even some specificities inside parentheses what that means.

    DR. FINS: Moving on, a few more things. On page 13, line 20. Well, there is a "G" there, "bringing." I am not sure. A lot of these entities are not necessarily funding sources. They are more sort of professional associations, so I don't know if any of them are actually funding sources.

    DR. GORDON: Fair enough. That one okay, people?

    DR. KACZMARCZYK: Excuse me. The intent was to bring together funding sources and organizations such as. It is funding sources plus these organizations.

    DR. FINS: Say, "organizations with funding sources."

    DR. GORDON: "Funding sources together with organizations," right, Joe?

    DR. KACZMARCZYK: Yes. That is the intent.

    DR. FINS: Good.

    DR. GORDON: I have got one question, and I asked this before and I am still not clear on this, Joe K. On the third line on page 15, the point you are making about exclusive participation, it just isn't coming across clearly. What are you trying to tell us?

    DR. KACZMARCZYK: The point that I am endeavoring to make here is that this particular program, that is NHSC, is not terribly effective when it meets only 10 to 15 percent of the identified need.

    DR. GORDON: Now, is that because students are not applying for it or because there are not enough slots?

    DR. KACZMARCZYK: There are, apparently, a host of reasons for this, and I would not presume to speak at this time for NHSC, but it would appear as if number one is that the demand far exceeds the supply. Two, there are so many administrative impediments. For example, the particular geographic area has to be designated as a health professional shortage area, which has its own set of requirements that it becomes rather difficult to meet all of these requirements, and then the profession has to be named in the legislation and those individuals have to meet certain criteria, and there is a competitive award process, and it goes on and on and on and on.

    Page 87

    DR. GORDON: What I am saying is that the idea of exclusive participation leads us off in the wrong direction. What you are really saying is that because of a variety of impediments the NHSC cannot fulfill its primary care function or can only fulfill 12 to 15 percent of the spots. Is that right?

    DR. KACZMARCZYK: In short, yes.

    DR. GORDON: Tieraona.

    DR. LOW DOG: Are we still on text? Are we working through the text?

    DR. GORDON: We are still on text, yes.

    DR. LOW DOG: I had some problems reading through this text. I know it is the end of the day, but Joe, I think we could tighten it up a bit. Basically, we say that 72.5 percent of medical schools teach CAM. That's 91 out of 125, but more needs to be done. I mean, so part of it doesn't seem to flow very well from what we are trying to say and get across.

    DR. GORDON: Tieraona, why don't you suggest a better way to do it.

    DR. LOW DOG: Well, I actually have moved the paragraphs around on my computer and changed it around a little bit. Maybe we could just print it off and see how people like it. I think it just reads easier. I think there are ways to manipulate the paragraphs around so they flow nicer.

    DR. KACZMARCZYK: These have been manipulated so many times that they have fingerprints on them. Most recently, they were manipulated by copy editing.

    DR. LOW DOG: Then, on page 3, I don't know why we talked about things like, "while many CAM courses are taught," lines 16 through 18, "are taught either from an advocacy or neutral view, some believe that all CAM courses should be taught critically." Well, of course. I mean, I don't know why we would even say that. Of course they should be taught critically. I mean, just like any other course. I don't understand that statement.

    DR. GORDON: So, how would you reword it?

    DR. LOW DOG: I mean, I guess you have to include something, but it just seems like of course you would teach or we would hope that you would teach the course critically. It shouldn't be from an advocacy view. I mean, it should just be taught critically the way you would expect any subject to be.

    Page 88

    DR. GORDON: So, would you like to say that, "and all CAM courses should be taught critically" or something like that?

    DR. LOW DOG: Or, "as all conventional courses should be taught." They should all be taught critically. Otherwise, I don't really understand what it means.

    DR. KACZMARCZYK: Excuse me. That particular reference was from Wallace Sampson.

    DR. LOW DOG: Sampson, I know.

    DR. KACZMARCZYK: That is why it was included.

    DR. LOW DOG: Well, in all due deference, but --

    DR. GORDON: But it is not "some believe."

    DR. LOW DOG: What I am saying is, we should all believe that. We should all say that they should be taught critically, and all classes should.

    DR. GORDON: Do we have agreement on that? You are sort of quoting Sampson's assessment, right? We want our assessment, and our assessment is that all CAM courses need to be taught critically, is that correct?

    DR. LOW DOG: Of course it should be.

    DR. GORDON: "Like all conventional courses."

    DR. LOW DOG: Right. Let's see. I did most of this on my computer.

    DR. GORDON: Tieraona, if there specific editorial suggestions for tightening, maybe you can get together with Joe --

    DR. LOW DOG: With Joe.

    DR. GORDON: -- and work on that.

    DR. LOW DOG: I would be glad to.

    DR. GORDON: Any other text issues?

    DR. LOW DOG: Oh, one other one. I didn't know why we, on page 18, line 13, "For physicians practicing medical acupuncture which confused," and I know that means "not to be confused," "which should not be confused or equated with traditional Chinese acupuncture." I don't know why that whole sentence is in there, why that whole little place between the parentheses. It seems somewhat inflammatory to me because, for physicians practicing medical acupuncture, the American Board is the administrative board. I don't know that we need the, "which shouldn't be confused or equated with." I would leave it out. I think there are places in here that are like that. They are a bit inflammatory. That was 13 through 15 on page 18.

    Page 89

    DR. GORDON: Page 18, line 14. So, Tieraona, I agree with you on this. Are there other inflammatory places or unnecessarily inflammatory places?

    DR. LOW DOG: There are two places like that.

    DR. GORDON: Where somebody is being singled out and where a kind of negative statement is being made, is that what you are saying?

    DR. KACZMARCZYK: The intent was not negative. It was mentioned as an illustration.

    DR. LOW DOG: With all due respect, though, listening to all those people that sat at those tables over there, people will read that as an inflammatory statement.

    DR. KACZMARCZYK: So it needs to be made less?

    DR. GORDON: I would just eliminate it.

    DR. LOW DOG: I would just leave that part out.

    DR. GORDON: Just eliminate that one. Are we okay with that?
    [No response.]

    DR. GORDON: Are there any others like that? Tieraona, if there are others?

    DR. LOW DOG: [Off mike.]

    DR. GORDON: So, the general principle is that we are trying to make positive statements, and unless it is absolutely necessary, we don't have to make all these distinctions. Is that the general principle?

    DR. LOW DOG: Yes.

    DR. GORDON: With me? Buford, with me? Don? It is a good thing you're with me because you're up next. Joe, anything else that we should be looking at that we need to think about and you can see? We're okay, we're fine? We're cool here? Great. Thank you, thank you very much. Thank you, Joe K. Yes, Tom.

    MR. CHAPPELL: I have those edits completed, if you would like to hear them.

    DR. GORDON: I'm sorry?

    MR. CHAPPELL: I have the dental edits, if you would like to hear them. There are three locations in the text that you asked me to work on. I have done it. Do you want it?

    Page 90

    DR. GORDON: I just want to make sure we get through CAM Central, and we want to end by 7:00, which is 37 minutes from now, or approximately. It takes two minutes. Then maybe, if we are still conscious, we can come back and Tom can present us with that history. Shall we break for three minutes? Five minutes. A five-minute break. We will come back, and we will go to CAM Central. Thank you.


    Coordinating and Centralizing Federal CAM Activities

    DR. GORDON: Don is present and accounted for. We will do the same thing that we did with the other sections. I will read the recommendations, then we will go back and look at the recommendations first, and then we will look at the text. Let's say that this is the only one that has had a unanimous consensus up to this point. Recommendation: "The President, Secretary of Health and Human Services, or Congress, should create an office to coordinate and facilitate integration of safe and effective complementary and alternative health practices and products into the nation's health care system." I will read the three action items, and then we will go over the whole thing.

    Action Item 1.1: "The office should be established at the highest possible and most appropriate federal level with sufficient staff and budget to meet its responsibilities." No. 1.2: "The office should charter an advisory council with members from both the private and public sectors to guide and advise the office about its activities. We will go through them, and then we will go back over them.

    No. 1.3: "The office's responsibilities should include but not be limited to coordinating federal CAM activities; serving as a federal CAM policy liaison with conventional health care and CAM professionals, organizations, institutions, and commercial ventures; planning, facilitating and convening conferences, workshops, and advisory groups; acting as a centralized federal point of contact regarding CAM for the public, CAM practitioners, conventional health care providers, and the media; and facilitating implementation of the Commission's recommendations and actions." As Don has pointed out, we had unanimous agreement on this before. So let's start with the recommendation and see if we still have agreement. Any comments on this? David, and Linnea.

    Page 91

    DR. BRESLER: My first thought when I saw this report was that it was bass ackwards and that wellness was in the front of it and CAM Central was in the end. I think that this is one of the single most important recommendations that comes out of all of our work because it represents the next step of where we are going. I'm thinking from several points of view, including introducing this to the media, that this ought to be our number one hit. It ought to be right after the introduction. We ought to really feature this as one of the prime recommendations that we make because it is very easy to justify why. When people ask us what you guys have done for the last two years, we have really looked at how to centralize this within the federal government. I think that could be a great accomplishment.

    DR. GORDON: Linnea, and Effie.

    MS. LARSON: I don't have at this time worked out a No. 1.4, but I do have the beginnings of a second sentence of the text that then would tie into an action item. Can I elaborate a little bit?

    DR. GORDON: Do you want to give us a hint, or do you want to just come back to it?

    MS. LARSON: I think that the second sentence should have to do with the full range of CAM perspectives are part of the decision-making dialogue that guides this office and policy and implementation activity. That should be the second sentence, and you should excise the stuff about HIV and attention deficit, et cetera.

    DR. GORDON: Wait. I'm sorry. I don't understand where we are. In the text or in the recommendation?

    MS. LARSON: I was making a statement that I actually think that there should be a No. 1.4 action item that I have not come up, but it would be related to this idea that I just articulated. The idea would actually follow the first sentence of the text, okay?

    DR. GORDON: Can you articulate this in the next 15 minutes or so? Write it down.

    MS. LARSON: Yes, I hope to.

    DR. GORDON: Great. Thank you. We will come back to you, then. Effie, you had something you wanted to say.

    DR. CHOW: I wanted to underscore what David said, and this is something that was said before, about that this is one of the central important things and it should be up in front. It is the only thing that everybody has come to an agreement on. Within the text itself, then, it said that one of the most key issues or key functions of this CAM Central is to facilitate the follow-up of the implementation of the Commission's recommendations and actions, and it is the last line in the whole recommendation. That should be first, too, as well. We tend to put last the most important thing.

    Page 92

    DR. GORDON: So, you are suggesting that the last line of No. 1.3 should be earlier in the action steps?

    DR. CHOW: Yes, because it is stated in the body that one of the most pressing --

    DR. GORDON: Where would you put it?

    DR. CHOW: I would put it, probably, in No. 1.3, and right at the first, as the responsibility.

    DR. GORDON: Don, do you or Joe want to address why you did it the way you did it?

    DR. WARREN: I think what we were talking more about, when we put the implementation of the Commission's recommendation actions back at the very end of this, is we didn't want to seem like we were really being self-serving. We want to do these other things and in addition to that also implement all these things. I am really glad you all want to put this the first in the report. I think it is neat, but that is not the charge that we have and I think we need to address our charge first and then follow it up with other things.

    DR. GORDON: Thank you. Joe, did you want to add anything to that, or Steve?

    DR. KACZMARCZYK: I agree with what Don said. Those responsibilities are laid out in a very deliberate sequence. There is a logic to that sequence, and Steve would agree to that because we have talked about that at length.

    DR. GORDON: It is important to reiterate so everybody is on the same page with this, we understand the reasoning why it has been done this way. Steve.

    DR. GROFT: If there is an office -- it is almost a given that it is going to occur -- I think the other activities there in No. 1.3 need an emphasis to say that this is what the office should do. What we are missing is not an office to implement the recommendations, even though it is, but we really need some group to coordinate the federal activities and the rest of the other activities before we get to the implementation. Again, if the group feels that we should be moving that up?

    DR. GORDON: I think it is important, Steve, that this is articulated very clearly why we are doing it, and then we can discuss other ways to approach it.

    Page 93

    DR. GROFT: I think that was it, that we felt that the other activities really needed the emphasis and that once the office is created, it is a given that they would be responsible for overseeing the recommendations and the other activities.

    DR. GORDON: Effie, and Charlotte.

    DR. CHOW: I appreciate the explanation. However, I don't think the development of a CAM office is to serve ourselves because this is what has come up from the other groups, too, from the Georgetown group and previously. There should be a central coordination office.

    DR. GORDON: I am not sure what you are saying.

    DR. GROFT: I don't disagree with that at all, Effie. I am in agreement. I just think what I was referring to was really the implementation, that statement about the implementation of the Commission's recommendations.

    DR. GORDON: Charlotte, and then Tom.

    SISTER KERR: I missed the first few minutes and I had a little lag in my thinking, so I apologize if you all did more of this than I am aware of. This goes just to the general, basic introduction of how we identified three areas where this office could go: executive, DHHS, et cetera. For myself at this point without any further information, I have felt that we should say where we think it should go rather than leave it up. My question, then, is we don't do that, from what I can see, in the final draft here. I really don't think it should go in the White House because it changes with the administration. Also, whatever the other office we had, surgeon general. So, my request is, do we, as a group, want to consider actually giving a recommendation so that we really hold it. As we say, the public stressed the importance of creating a sustainable environment, so I would like to really look at that again.

    DR. GORDON: Don, do you want to address that?

    DR. WARREN: I believe that with the wording and the appropriations for next year that we can assume at this point that it is going to be in the Secretary's office, Department of Health and Human Services, in one part of it.

    DR. GORDON: Yes, but it is not worded that way. It is really worded as several options.

    Page 94

    DR. GROFT: I think in wording this we were trying to be consistent with what the administration had advised on some other recently formed commissions in which they said to express options if we could not come to an agreement. I think we also wanted to give the administration the opportunity to identify where they felt it would be most appropriate. Again, I think the text talks so much about DHHS somewhere there, but again, I think it was just to give them the options.

    DR. WARREN: When we wrote this, we didn't know about the wording. Now, should we, since we know about the wording, eliminate the other options? Or, should we give the branch and the Secretary a chance to put it where they wish, give them the option, don't hem them into a corner?

    DR. GORDON: That is a question that is on the table. This relates both to the recommendation and to Action No. 1.1. Let's have some discussion about it. You have raised the question. Tom, and Joe. Tom has had his hand up for a bit. Yes, go ahead.

    MR. CHAPPELL: I wanted to address the order of the presentation of this recommendation.

    DR. GORDON: Can we just focus on one issue, because we have been all over the map. So, if we can focus on this first issue now and then we can come back to the order, okay? So, the issue that we are talking about is, should we make a specific recommendation about the location of the office. Let's try to focus on this. Joe, you wanted to say something about that?

    DR. KACZMARCZYK: The way I see it is that if you provide a list of options that is consistent with the information that Steve described, but also, and more importantly, increases the likelihood of the creation of this office.

    DR. GORDON: Effie.

    DR. CHOW: I think I agree that giving them the option that we can always set priorities, and they will set their own priorities anyway, but offering our preference.

    DR. GORDON: You would like to offer a preference?

    DR. CHOW: Yes.

    DR. GORDON: What would your preference be?

    DR. CHOW: One is that it should be in the President's office, and with Congress, right away, taking action to put it through Congress.

    Page 95

    DR. GORDON: That it would be at the Secretary's office? Where should it be, though?

    DR. CHOW: In the President's office.

    DR. GORDON: In the White House?

    DR. CHOW: In the White House, yes, and then Congress right away take action to legislate it into official being, so there is longevity.

    DR. GORDON: Other comments about this.

    DR. CHOW: Well, can I just add, because it was set up at the President's level, and we are one of the few commissions out of the 200 commissions that have been appointed by the President, by executive order -- I'm sorry?

    DR. PAZ: It was a different president.

    DR. CHOW: Well, but still, it is there, and I think we should operate at a optimistic level.

    DR. GORDON: So there is a specific recommendation. You are making the recommendation that we say where it should be and that we say in particular that it should be part of the White House, right?

    DR. CHOW: With Congress taking action to make it permanent. I am saying, offer the other option, too.

    DR. GORDON: Congress has already taken an action. Steve, do you want to clarify what Congress has already said? It is important to see what the lay of the land is. If we are making recommendations into the wind, we have to know that.

    DR. GROFT: In the appropriations language that came from the House-Senate Conference Committee, there was language that the committee urged the Secretary, or encouraged the Secretary of HHS, to establish an office or an activity within the Department to coordinate CAM activities. I can get the specific language for you.

    DR. GORDON: That is basically the gist of it?

    DR. GROFT: Right.

    DR. GORDON: So already there is legislation saying put it within the department. So, let's continue with the discussion. Yes. I'm sorry. Joe.

    Page 96

    DR. KACZMARCZYK: The specific language was, "The Conferees urge the Secretary of the Department of Health and Human Services to form a coordinating unit to review the commission's report and implement ways of improving coordination of the department's many CAM-related activities," end of quote.

    DR. GORDON: Don.

    DR. WARREN: Let me say, we are not trying to name this entity, either. We are just calling it, as they say, a "unit." They will probably put whatever name they want to on it.

    DR. GORDON: Other comments about this issue. Do we want to recommend -- yes, Charlotte -- where it should be?

    SISTER KERR: Well, I am just making my comment further. I am continuing to be open, but my sense is that this is even being recommended because of Senator Harkin, who is doing this. I think if we felt clear that we should go ahead and be congruent with that, which is to say HHS. I do think, even though I don't know and I assume and I think great things about the administration, that it is more consistent to leave it in the Department of Health and Human Services, which is what I hear you having as a value, Effie, which perhaps either I or you are not as clear of where will it be the most consistent. It sounds like HHS. I think what we would have, even though we want to be permissive and inclusive and all of this, and respectful, that it is okay for us to say, we looked at all of it and here is where we came down as a committee. I think it is a clear energy force, if we feel that way, if we are all conscious of HHS, the language is in, we know what we are doing, it will happen.

    DR. GORDON: Steve wanted to say something.

    DR. GROFT: I don't know if you recall the preceding sentence. It said, "The Conferees understand the White House Commission on Complementary and Alternative Medicine Policy will release its final report early in 2002." So, that was the preceding sentence. Then, "The Conferees urge the Secretary." So, I think we could construct language, as we have done in others, stating that we are encouraged, the Commission was encouraged, by the language included in the appropriations bill for DHHS and we agree that an office should be established within DHHS. Or, if we want to retain the options, any way I think is okay. I think, get one, though.

    DR. GORDON: Yes, Tieraona.

    DR. LOW DOG: I would agree with Charlotte. I think that if you have already got the momentum and there has already been recommendations going on the table that you should move with that and be grateful.

    Page 97

    DR. GORDON: We have had a couple of recommendations. I don't know how you feel at this point, Effie, but there have been a couple of recommendations to go with the direction that Congress is moving in and recommend that it be at the level of the secretary of HHS. Is that correct?

    DR. CHOW: I just heard that today. I mean, what you are reporting now.

    DR. GORDON: No, I understand.

    DR. CHOW: I just heard that today, so certainly, I believe in going with where the action is.

    DR. GORDON: So, should we make that specific recommendation? Don.

    DR. WARREN: These things are in the text here. I think we need to give the options just in case one falls through. That is my own personal belief.

    DR. GORDON: All three options that you listed?

    DR. WARREN: Yes.

    DR. WARREN: If the group says one, then we will do one.

    MR. CHAPPELL: I agree with that, and if we want to add a paragraph in that section where we list the three options, we just add a couple of sentences indicating that we are aware of the current legislation. That would be fine, but I like the idea of leaving the three options.

    DR. GORDON: David.

    DR. BRESLER: I, of course, go the other way. I think it should be at the White House because my concern is that it is going to end up in somebody's drawer somewhere and nothing is going to happen. I would be okay to go with HHS if there were some language in it that would say that we want to put it in the area where it is going to get the most support and where this work is going to continue, wherever that tends to be. We have had this discussion and we have spent a lot of time talking about the advantages of all these different options, and again, I would like to see it go where it has got the greatest likelihood of continuing.

    DR. GORDON: So we have some differences of opinions. Julia.

    Page 98

    MS. SCOTT: I want to weigh in on the other side of not putting it in the White House, dependent upon whatever administration is there. I think we have seen some pretty significant offices just about disbanded with the change of the administration: AIDS and many of the women's progra

    MS. I think it makes sense -- we are talking about the health of the nation -- to have it attached to the organization that is charged with the agenda for the health of the nation. So, I think, maybe as a part of what Tom said about putting it in the text, that it could be placed in several places, but I do feel as a Commission we could come out and strongly recommend that it be in HHS. The reality is, it could be changed in Congress. I mean, if they wanted to change it, they could.

    DR. GORDON: I would just like to say something as a long-time Washington resident. The trend is very much in the direction of it going to HHS. HHS is getting ready for it. I don't think the White House wants it. There is no great interest in it right now. They have a lot of other things on their mind. I don't think it is realistic.

    DR. BRESLER: So, Jim, let me ask you, then, one of the concerns that we had is it is going on in agencies way outside of HHS: in Agriculture, in Energy, and some of these other government agencies. Is there some way that we can acknowledge that and say that it needs to be coordinated beyond the department?

    DR. GORDON: I think that is there in the text. I am pretty sure that that has been made clear, that HHS is the location for it and the place from which coordination will take place. Steve, you have been around as long as I have, and Joe has been around for a while, and others, too. Isn't that your sense of where it is headed and what is happening?

    DR. GROFT: That appears to be the case.

    DR. GORDON: So, I think that we can't ensure anything. I am just going to put out my synthesis of what I am hearing. I think it is fair enough to put the three possible locations, talk about the advantages and disadvantages of each, and then, perhaps, come down on the side of the location of the highest level of HHS. The problem is, the White House is incredibly vulnerable to change. The surgeon general has variable power, depending on who is the surgeon general and who is the president. HHS is always going to be there. If there had been tremendous enthusiasm in the administration, I would say, great, let's try to get it at the White House, but that is not what we have at this point.

    DR. BRESLER: How about at the Supreme Court?

    Page 99

    DR. GORDON: So, let me make that as a suggestion, that we put down, maybe, a little bit more on the advantages and disadvantages, we talk about the legislation, and we say that we feel that it appears to us that HHS would be an appropriate home for this. Does this feel okay, Wayne? You know the scene, too.

    DR. JONAS: Yes, I agree. I mean, there are pros and cons to all this, but the pros of putting it at HHS versus the White House are much greater than the cons. To me, it is a non-issue. I think, certainly, when you describe the roles, the down side in HHS is that it has less jurisdiction over some of the other federal agencies that we are targeting. However, if you put in some of the roles that this specifically is to look at the other federal agencies, it is going to do that anyway. It is much more likely, given the current climate, that there would be appropriations to actually allow it to do something in there.

    DR. GORDON: Joe, yes.

    DR. FINS: I kind of agree. I think it will be less prone to ideological influences in Health and Human Services, and I think that would be for the long-term probably better.

    DR. GORDON: So, do we have agreement on this? Great. There are a couple of other issues that have been raised. Tom, do you have another issue?

    MR. CHAPPELL: On the order.

    DR. GORDON: Right. Thank you.

    MR. CHAPPELL: I heard the explanation of why you don't feel placing it in the front of the report is appropriate, but I would argue that I do think we have the license to put this where we want. I like the boldness of this right up front. It is very provocative. Not provocative, it is bold and it is crisp, and it suggests something very important that they are about to read. It lends importance to the whole rest of the report.

    DR. GORDON: So this is a discussion about the placement of this whole section on CAM Central. Other comments on this. Sorry. Julia, and Joe.

    MS. SCOTT: I'm sorry. This kind of throws me. I thought we were going to go through the action steps first.

    DR. GORDON: Thank you.

    MS. SCOTT: Then we can talk about the placement.

    Page 100

    DR. GORDON: Fair enough. Joe, do you want to say something?

    MR. CHAPPELL: I think on the placement issue, I mean I think --

    DR. GORDON: Wait. Let's not talk about the placement issue now. Let's go through the action steps -- I think this is a better order -- and then come back to the placement issue.

    DR. GROFT: Tom, when I spoke about the placement, I was really referring to Action No. 1.3 and the discussion of the facilitating implementation of the Commission's recommendations. I wasn't talking about the positioning of the recommendation itself and this section, so just to clarify that. We are still open. We will talk about that in a little bit.

    DR. GORDON: So, let's go through the action ite

    MS. Thank you, Julia, for bringing us back. Then we can talk about the placement of this section, okay? So Action No. 1.1, I am assuming that we are putting in there "HHS," right? We are being specific in Action Item No. 1.1. We have that agreement?
    [No response.]

    DR. GORDON: No. 1.2. Any issues on No. 1.2? Yes, Joe.

    DR. PIZZORNO: To the advisory body, I think we should specify that it includes CAM and conventional medicine practitioners.

    DR. GORDON: How would you have it read, Joe?

    DR. PIZZORNO: No. 1.2, it says, "with members from both the private and public sectors, comma, including CAM and conventional practitioners to guide and advise."

    DR. FINS: On page 4. You say this on page 4, line 6 to 13.

    DR. GORDON: But he is questioning whether it should be in the action item and the recommendation. Your suggestion is, it should be. Yes, Don.

    DR. WARREN: Another thing, the word "stakeholders" in here, I think we need to change that to "interested parties in CAM," which would include practitioners.

    DR. GORDON: That is not in the action item?

    DR. WARREN: No.

    DR. GORDON: So, can we deal with Joe's addition to the Action Item No. 1.2? Are we in agreement on that? Tieraona.

    Page 101

    DR. LOW DOG: I guess my only thing there is if you are going to start listing who you are going to have, then that is an incomplete list. I mean, that is the only thing, is that including CAM and conventional practitioners, I mean it would also be researchers and scientists.

    DR. GORDON: Right.

    DR. LOW DOG: I mean, so I guess I am not clear if we have explained this in the text, why it does need to be in the action item, because it is also an incomplete list, then. That is just a question.

    DR. GORDON: Joe, can you explain why you feel it is important to have it in the action item?

    DR. PIZZORNO: Because I believe that they are the two most critical on the list, and I want to make sure that they are specifically included.

    DR. GORDON: Effie, and Tom.

    DR. CHOW: I think what is critical should go into the action line because a lot of people don't go and look at the text. I think it should be in there, too.

    DR. GORDON: You agree with Joe?

    DR. CHOW: Yes.

    DR. GORDON: Tom.

    MR. CHAPPELL: I guess I would leave this makeup of the advisory council to the office, the newly formed office. This particular group was not made up of CAM practitioners and conventional doctors, and we did pretty well.

    DR. GORDON: In part. I think that the way the recommendation reads would be "including conventional and CAM practitioners as well as members of the public and private sector."

    MR. CHAPPELL: I see.

    DR. GORDON: It is not exclusive.

    MR. CHAPPELL: I see.

    DR. GORDON: That is what you had in mind.

    Page 102

    DR. LOW DOG: I'm sorry, but I guess if you are going to say what is critical, I think in an advisory council like this it is very important that you would have rigorous scientists on here as well advising. So I am not sure that I think this is the most critical aspect of this advisory council, so my only question is, can this be really discussed well in the text about how there needs to be a well thought of group and what we would envision this to be. I don't think it would just be the practitioners that are your critical aspect on this advisory council.

    DR. GORDON: Joe.

    DR. PIZZORNO: Tieraona, I agree with you. The challenge is the experience we already have with the NIH. It started out with some CAM people being on it. They virtually all got eliminated. We had to put legislation into Congress to require that they be on the advisory board. So, unless we are really specific that CAM professionals must be included, they will just get left out for one reason or another. Just practical experience.

    DR. GORDON: Are we okay, then, with including that? We are not saying it is restricted to them, we are just indicating the importance of including those two groups. Okay? Great. No. 1.3. How are we with the content and the order? Don, do you want to say something?

    DR. WARREN: Well, all these five parts of this No. 1.3 were designed to give us the broadest maximum efficiency or effectiveness in this office, and I think they ought to stay the way they are.

    DR. GORDON: Are we okay with this? Or, are there comments or corrections or critiques of this? Joe, please.

    DR. FINS: We are not talking about the text? I am not sure. What are we doing? PARTICIPANT: We are talking about the actions.

    DR. FINS: Okay, then.

    DR. GORDON: I would like to get agreement, if we can, on this and then look at the text and then look at No. 1.4.

    DR. CHOW: I still think that "facilitating implementation of the Commission's recommendation and action" should be up front there.

    DR. GORDON: Can we have a discussion about that? Does anybody want to make any comments on that? Effie is suggesting that the last part be the first in No. 1.3. Yes, David.

    Page 103

    DR. BRESLER: Again, there may be some issues in which we don't reach consensus or have quite different opinions in our recommendations. Again, putting this up front, we can say that it could also continue to explore areas that the Commission was not able to complete or was not able to resolve.

    DR. FINS: I think having No. 3 last, I mean it is there. Putting it first looks like we are trying to perpetuate ourselves. I think it is more modest to say there should be an office, there should be an advisory body, and they should do all these things and also consider the implementation of these recommendations. I mean, it is a little more prudential and a little more like we did our thing, we sunsetted, this is the next process.

    DR. GORDON: George.

    DR. BERNIER: Yes, I would agree with that. I don't think it is our responsibility or our privilege to name the committee.

    DR. GROFT: I actually tend to agree that it is better to have it last. It is pretty clear what we want to have happen.

    DR. GORDON: For me, this is one of the issues that is clear in making statements to the press. It is an important issue, and it is already happening. So I don't think we need to belabor it. If it weren't happening, I might want to push it more, but since there is already a congressional mandate for it to happen, I feel much more comfortable being kind of relaxed about it. Steve, you are a long-time observer of the scene.

    DR. GROFT: To me, the significant point is to create an office and then things get done. Without creating an office, you don't have that focus of activity. What the placement is, it's not really that important to me. I mean, as a person in the government, I just look for language that enables me to go and work in a particular area that needs to be worked on. You do what you can do in the time, and there is a time and place that you are able to facilitate the implementation of these activities.

    DR. GORDON: Thank you, Steve. Effie, and then Joe.

    DR. CHOW: I think it has been misunderstood. I didn't mean put 1.3 up to 1.1. I'm just talking about the reorder of the activities in 1.3

    DR. GORDON: Oh, I see.

    DR. CHOW: Within 1.3, the implementation.

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    DR. GROFT: I think you want to move up the "and facilitating implementation of the Commission's recommendations and actions" to within No. 1.3, up to the beginning.

    DR. CHOW: No.

    DR. GORDON: No, no, no. She is saying moving all of 1.3.

    DR. GROFT: Oh, okay. Then I misunderstood it, too.

    DR. CHOW: I don't mean that. That is what you people are thinking I said.

    MS. SCOTT: What she means is, she wanted to take that last sentence and put it as part of the first sentence of No. 1.3.

    DR. CHOW: No. 1.3.

    MS. SCOTT: "The office's responsibilities should include facilitating the implementation of the Commission's recommendations and actions," and then continuing on with, "serving as a federal CAM policy liaison."

    DR. GORDON: So that is a suggestion. What is the response? Do we want it the way it is? Do we want to put "facilitating implementation of the Commission's recommendations" first in this order? Let's get a show of hands. This should be a simple up-and-down. Do we want "facilitating implementation of the Commission's recommendations and actions" to be the first item in No. 1.3? How many would like that?

    [Show of hands.]

    DR. GORDON: How many would like it to be the last item?
    [Show of hands.]

    DR. GORDON: The majority says it is the last item. I mean, we all want it there, it's just a question of placement. Is there a No. 1.4 that you have for us?

    MS. LARSON: I can't do it.

    DR. GORDON: Linnea was looking for a No. 1.4.

    MS. LARSON: I can't do it.

    DR. GORDON: Yes, Joe, go ahead.

    Page 105

    DR. FINS: Just a couple things. I don't remember, on page 1, that parents of children with ADHD, these various folks specifically talked about the need to coordinate an effort. If that is there, that's fine.

    DR. GORDON: No, what they primarily talked about, they wanted more information, they weren't able to get information, they weren't able to get the government to pay, they couldn't figure out who in the government to deal with.

    DR. FINS: It has been deleted? Let me just say one more thing. On page 4, when we are talking about who is going to be on the committee or this advisory thing, I agree with it being in HHS. I think that is a good idea. I just raise this as an issue, really, for the government aficionados here, whether or not we want to say something about this body having some representation from the Office of the Domestic Policy advisor.

    DR. GORDON: I think that is a great idea.

    DR. FINS: As a way of reaching out to other federal agencies that are domestic but not in HHS.

    DR. GORDON: I think that is a really important addition, and there may be several agencies that we want to list in here. Do we have a sense of agreement on that? Because all we have here is HHS agencies, and we may want to give a couple of examples. So, we are in accord with that? I would say Department of Defense, VA. I mean, those are the clear ones. PARTICIPANT: Education.

    DR. GORDON: Good. So we will put that in. Joe K., are we okay with that? Okay. I'm sorry. Tom, and Tieraona.

    MR. CHAPPELL: I am sensitive to the fact that we are guests for dinner tonight at a private home, and I feel a real strong obligation to adjourn right now.

    DR. GORDON: So if there are any other textual issues, we will take them up first thing tomorrow morning, and then we will take up Tom's dental concerns.

    DR. GORDON: Will we have Access and Delivery first? Or, do you want to put Access off? Access first? Put it off. So we will do Information first, at 7:00. I apologize, but I am concerned. I do not want to leave us hanging at 3:00 or any other time. I want us to complete our work, so we begin at 7:00 tomorrow morning promptly. Thank you all very much.

    Page 106


    [Whereupon, at 7:16 p.m., the meeting was recessed to reconvene the following day, Friday, February 22, 2002 at 7:00 a.m.]

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    This is to certify that the attached proceedings
    BEFORE:          White House Commission on Complementary
                     and Alternative Medicine Policy
    HELD:            February 21-22, 2002
    were held as herein appears and that this is the official
    transcript thereof for the file of the Department or
    DEBORAH TALLMAN, Court Reporter