DR. ORNISH:  He will weave it into that. 

          DR. JONAS:  This is slightly different.  Actually, Dean, I will send this to you so you can look at the phraseology of all of these items and then you can circulate them among anybody else that you want.

          DR. ORNISH:  Good.

          DR. JONAS:  But I think that the issue here in this paragraph is that we want to make sure -- there are agencies that already do other types of research and that have it as their main focus, and so we should put that in there.

          One suggestion I had is that we stick in, for example, after agency for health care research quality or key to research progress, that it is clear that similar support and coordination efforts are needed in other federal research agencies.  Okay? 

          So, in other words, we talked about the success of the NIH's effort in these areas and some of the other agencies, and we should put a statement in there simply saying we like this trend, we think other agencies should be involved in this, so we recommend providing similar support in other federal research agencies.

          DR. ORNISH:  But would you say in all of them?

          DR. JONAS:  Excuse me?

          DR. GORDON:  Would you turn on your mike, please, when you speak?

          DR. LOW DOG:  Sorry. 

          DR. GORDON:  He is on page 6.

          DR. LOW DOG:  I thought that where we were at -- okay.  I was in the wrong place.  Go ahead.  I was on page 5.  I thought Dean had us between 16 and 23, and I was just saying is that part of what you were doing?

          DR. JONAS:  Yes, exactly.

          DR. GORDON:  Yes?

          MS. AXELROD:  I have a question then.  The outcomes, you will be replacing this reference to outcome studies.  But what about the sentence that starts with anecdotal reports?  Are you going to replace that as well, or does that remain?

          DR. JONAS:  Yes, I think we can weave it into it, yes.  Okay.

          DR. ORNISH:  It is going to be woven into it.  And I apologize for skipping around here.  So that takes care of 16 through 21.  Lines 23, on page 5, through line 6 on page 6, any comments about that?  Any changes anybody made?

          DR. JONAS:  I had one general question as to whether we wanted to say anything about -- this is a land mine, so maybe we should put it off for later -- patents, along the lines, or something along the lines of incentivizing investment in private research into these areas.  Whether we say it is patents or not may be debatable, perhaps leave that out, but some phrase about the importance of incentivizing private sector research.

          DR. GORDON:  Are you referring to the sentence in funding initiatives for studying unpatentable products?  Or are you referring to something else?

          DR. JONAS:  Yes.  What I am suggesting is that we also add in there that we would like to see incentives for correcting this problem, which is lack of incentives to fund research in these areas.

          DR. GORDON:  I am wondering if we shouldn't wait.  The way we have it is general.  If we can wait until we really develop specific -- I would rather wait until we have specific recommendations on that, rather than go out sort of halfway with it.

          DR. JONAS:  Okay, but wouldn't you agree that it is important and we would like to try to incentivize the private sector in investment in that?  That is what I am suggesting.

          DR. ORNISH:  Why don't we make it in the most generic terms, just like you said, encouraging the private sector to invest in CAM research. 

          DR. JONAS:  This is sort of negative.  This is like, well, nobody is going to invest in this area.

          DR. ORNISH:  Yes, I think that is a good idea.  So, Gerri, can you just add some language to that effect, or Wayne, when you e-mail me, can you just put that in there?  I like that.

          DR. GORDON:  Say it again, and let's make sure.

          DR. ORNISH:  It is saying to encourage the private, on page 5, line 27, something like encouraging the private sector to invest in CAM research and delivery.

          DR. GORDON:  But that is in addition to what we have said here.

          DR. ORNISH:  Yes. 

          DR. GORDON:  Okay.  So is everybody clear that there is a distinction here, that there are two initiatives that we are talking about?  One has to do with encouraging public research funding for those approaches that can't be patented.  And then this is in addition, which is having incentives for people in the private sector to --

          DR. ORNISH:  No.  We are not getting into that.  It is a red flag.  We are not saying we want to offer incentives.  We are just saying we want to encourage the private sector to invest in CAM research.

          DR. GORDON:  But I am just saying those are two different topics.

          DR. ORNISH:  They are two different topics.  One is a red flag, when you talk about --

          DR. GORDON:  No, no, no, those are not the two I am talking about.  One is public investment, and the other is encouraging private investment.  Okay?

          DR. ORNISH:  I am only saying we are going to encourage private investment, that we don't put incentivizing in.  That is all.

          DR. GORDON:  Understood.  Okay. 

          MS. AXELROD:  On page 6, 19 through 21, does talk about federal agencies -- wait.  Private sector, rather, I'm sorry, including foundations, manufacturers and pharmaceutical companies.  So that is private sector.  Where do you want to put the addition you just made?  Do you want to put it there, or do you want to put it --

          DR. ORNISH:  It goes better there, you are right.

          MS. AXELROD:  At the end?

          DR. ORNISH:  Yes.

          MS. AXELROD:  Add it there?

          DR. ORNISH:  Yes.

          MS. AXELROD:  Okay.  Okay.

          DR. ORNISH:  Encourage.

          MS. AXELROD:  Encourage.

          DR. GORDON:  Okay.  I want to say just one word on process.  We need to move quickly, but if people are confused and don't understand, please, you know, raise your hand and say so, and we will try to clarify it as we go.

          DR. ORNISH:  Yes, just in the interest of process, if we could just agree that the burden of responsibility is on you to jump in and say I don't understand, or slow down, or, you know, I don't agree with you.  And the silence is taken as an assent.

          But I do have a problem on line 19, on page 6, when you use the word required.  I would say encouraged.  ON page 6, line 19.  Adequate support for CAM research is not only required, I would say encouraged, to avoid pushing people's buttons, because then you are basically requiring the private sector foundations, et cetera, to do these things.

          You know, what we haven't done is the previous paragraph, line 7 through 17.  Any comments, suggested revisions, problems?

          DR. FINS:  I have just a generic question, and this is not the level of specificity here, but the question is what do we mean by strong support?  How much against what?  You know, do we have to justify this in the context of a current allocation to NIH?  Is it additional money?  Because I think that will be, you know, a red flag.

          DR. ORNISH:  You want to just take out the word continued?  Or are you saying the other direction?

          DR. FINS:  Well, I am asking the question, you know.  And the other issue which has been brought up on other occasions, whether or not NC CAM is -- we all agree that that is the entity that we are seeking to maintain and support, and whether or not there is language about fostering even more collaborations with the other institutes.

          Can we state it stronger, like to -- I think some kind of language that just, you know, stresses the importance of enhanced collaboration.  I mean recognize the current existence of collaboration, but that we believe that to bring the basic science talent, which --

          DR. ORNISH:  But lines 12 through 14 address that.  You want to reword that in some way?

          DR. GORDON:  I will tell you my problem, which is related to this, is I don't like the passive voice.  I think this has got to be more active.  Passive voice always comes off sounding weak, no matter what you are saying.  So I think we need to make these statements, and I think it will clarify our intention if we make the statement in the active voice.

          DR. FINS:  Encourage.  You know, we recognize collaboration between NC CAM and other NIH research institutes, and we encourage additional collaboration, especially with their basic science colleagues at the NIH.  I mean that sort of language, and that is the intent.

          DR. JONAS:  Yes, I guess I wouldn't highlight a specific thing that we think the NIH should do with its own colleagues.  I would be a little bit hesitant of that.  I do think we should put something more strong in there, and I mentioned this before, but I will say it again, is that, right before -- and I wrote this.  I didn't write it on the numbered thing because I didn't get that until yesterday -- but right after the Centers and Agency for Health Care Quality and Research is key research.

          Just before it, during the testimony, the importance of CAM-associated activities, we should put in a phrase that is stronger, that is, it is clear that a similar support, meaning similar to what has gone in already to the NIH, and coordination efforts are needed in other federal agencies.

          DR. ORNISH:  But then aren't you doing the very thing that you are saying we shouldn't be doing, which is dictating to the NIH what they should be doing?

          DR. JONAS:  I am not dictating this to the NIH at all.  I am dictating this to the Congress and President, that they should do this with all federal agencies.

          DR. GORDON:  I think, Dean, this response to your question and concern about red flag, I think we have to come down, if we believe that more research funding is necessary, we need to say so quite clearly.

          DR. ORNISH:  I don't have any objection to that.  I actually support it.

          DR. JONAS:  And I do want to put in, I do think we should say something about basic science research in there, and I guess --

          DR. ORNISH:  I like that, too, and I think that is only going to make our case stronger with the people who are going to be our most vocal critics.

          DR. JONAS:  I would suggest actually it go up above after safety and efficacy on page 5, line 21, that we simply add another phrase in there that emphasizes the important basic science research, such as an effort to investigate the underlying mechanisms, assumption of CAM modalities is also needed.

          DR. ORNISH:  That is good.  Gerri, are you okay with that?

          DR. CHOW:  Yes, I want to say that this is still coming from the voice of the people, and I agree, we need to be strong.  Whereas we can't change the strength of what the people are saying because we are afraid of land mines, and it isn't us that are stepping in land mines.  And so I just want to bring that out again because we are afraid because we think it is coming from our mouths, and it isn't, it is coming from the people's mouth.

          DR. ORNISH:  Well, let me just clarify, as someone who has been the most vocal proponent of that particular concern, I am not afraid of this.  I am only trying to be as skillful as we can in not getting shot out of the water before we begin.  I think all the things that Wayne and Joe and others have proposed I think actually makes this stronger.  I don't see any land mines in the things that they talked about.

          So it is really a non-issue, but in general, it is not a question of being afraid or whose voice it is.  It is really a question of being skillful.

          DR. GORDON:  But I would add with Effie that it has to be clear it is both the people's voice and it is our voice, and that we are reflecting the people's voice.

          DR. ORNISH:  Well, then maybe we need to say that at the very beginning, because that would apply throughout the document, something that this is a synthesis of the testimony that we have heard, in addition to our own perspective, or something like that, because it is important for the reader to know who is speaking, and who they are speaking for.

          DR. CHOW:  Excuse me.  It is in here.

          DR. ORNISH:  But I do think we have to be careful that since we have heard so many diametrically opposing points of view, that we are not necessarily speaking for all the people, because if we were, that would be impossible.

          DR. GORDON:  Wayne?

          DR. JONAS:  I have a suggestion as to how to do this.  I think it is important.  It is one of our six principles, Number 6, actually, up here on our principles.  My suggestion is again there is a very simple way to do this that I don't think would raise a lot of land mines, and that is under page 6, Item 17, to simply add a phrase to that effect, Effie, such as procedures for the more effective input of public interest and priorities in research are needed.

          DR. GORDON:  Great.  I like that.

          DR. JONAS:  Does that sound all right?

          DR. ORNISH:  In a way it extends what Effie was saying, that we are speaking for the public here, but we are encouraging the people to make their voice heard.  I like that.

          DR. GORDON:  I would like to call time, unless there is a major sticking point, because we really need to move on to the next section.

          DR. ORNISH:  This is a process, Wayne, where you are going to send me an e-mail that incorporates all the things that we talked about, and a copy to Gerri?  And Gerri, who is going to do what first, just so we know?

          DR. JONAS:  Why don't you modify what we talked about?

          Gerri, send it to me.  I will send it back to both of you, and then you can do whatever you want with that.

          DR. GORDON:  Let me just say that any emendations that we make, this has all got to move very fast, okay?  So if anybody is being asked or is taking on the responsibility of doing a piece, it has to come to the staff within a day or two at max.  Okay? 

          Thank you, Dean.  Are we okay now to move on?  Regulatory activities.  Tieraona, do you want to move with this?

            Regulatory Activities: Research

          DR. LOW DOG:  So we are just starting where we left off there, on page 6.  Again, this is where we are looking at the whole discussion about dietary supplements, primarily.

          Comments?  I will give you a minute to kind of look it over.

          DR. JONAS:  I would just like to make one general comment about it, is, I thought a lot of it could be condensed.  It seemed like sections of it were kind of redundant.  We were saying things more than once.

          For example, starting with line 15, those two paragraphs, I had the sense that those had been stated in other ways, and I would just suggest that you look back through this section and maybe see if you can condense some of those.  Page 7, starting with line 15, those two paragraphs, I am not saying eliminate them, but I am saying that they could be condensed.

          There is another, the paragraph on public testimony, the end of that, also, again kind of reiterated the same idea about supplement quality, et cetera, et cetera.  I mean, the point is that we want good quality supplement aspects, and we don't need to say it three times, if we could say it once.

          DR. GORDON:  So basically, this is an editorial comment, not a context comment?

          DR. JONAS:  Exactly.

          DR. GORDON:  Okay.

          DR. CHOW:  Wayne, I am not clear about the two paragraphs.  The one starting on line 15, and then the one on 22?

          DR. JONAS:  The two paragraphs starting on page 7, line 15 through page 8, line 3.

          DR. CHOW:  Okay.

          DR. JONAS:  And then the end of the paragraph, starting on page 8, line 25.  Those two -- those three paragraphs seem to have a lot of redundant material in them, and you might just look at condensing that.

          DR. GORDON:  Thank you.  Michele's hand is up.

          DR. LOW DOG:  Michele?

          MS. CHANG:  Yes.  We had talked a little bit about wanting to be positive, to acknowledge the good things that agencies or organizations have already done.  One of the things that we heard testimony on was from the FDA to say that they have made headway along the lines of developing these good manufacturing practices and guidelines, but they are just not out.

          So it has kind of gone in and out of this version as to whether or not we should make passing reference to the fact that FDA has done something that the public is calling for, that everyone wants, and yet it hasn't been seen yet.

          So, again, to kind of walk that fine line between not getting squelched --

          DR. LOW DOG:  I think we really want to put in there, though, they need to get those GMPs out.  They have been sort of keeping those things for quite a while, and the industry is waiting for them.  So I think there needs to be the recommendation that they pull those GMPs out.

          I think, also, just for clarification on lines, when we get to 23, 24, and 25, the FDA's regulations on GMPs, where you are talking about accurate labeling, that is not a GMP function there.  So you just need to separate those out, GMPs and what they deal with, and be clear what they are.  A lot of people are not clear what those will do, but that is not about your labeling.

          You want to separate that out, that labeling is important and that the FDA needs to make sure that companies are in compliance with DSHEA structure and function claims on their labels, that they need to meet the requirements that have been set out in DSHEA.

          Yes?

          MS. MILLER:  I just want to add to what Michele said, just for a little clarification.  The GMPs are out of FDA.  It is the Office of Management and Budget that they are not out of.  So it is not FDA that is holding it up, it is OMB right now.

          DR. LOW DOG:  Can we also be a little bit more specific where we are talking about method validations, where we are talking about needing to support programs that are developing, methods?

          DR. GORDON:  Tieraona, where are you in the text?

          DR. LOW DOG:  Well, it is kind of down here on 28 and 29, page 7.  We use interesting language like "standardizing the identity and purity."  "Standardization" is its own term in this category.  I would be more clear that methods for identification, standard methods and characterization, need to be done because we only have them for a few herbs.

          DR. FISHER:  The operative word is "compositional quality."

          DR. LOW DOG:  There you go, Ken.

          DR. GORDON:  Okay.  Now on this, if there are those kinds of technical issues, it is important that that be conveyed either here or afterwards, between you and the staff.

          DR. LOW DOG:  Who is the staff person that did this?  Okay.

          Well, can part of it be where just the staff and I could talk?

          DR. GORDON:  I think you just need to let people know where that is going to happen and get a general assent that that is fine, and then you can do it.

          DR. LOW DOG:  Right.

          DR. GORDON:  Okay?

          DR. LOW DOG:  Well, I will do it tonight on the plane, and then I can just e-mail it to you, and then it can go around to anybody.  But I think it is all very good.  I think there is some redundancy, and I think some of the language is a little confusing when you use standardization and you use other things.  So I just think we can tidy it up.

          DR. GORDON:  Okay.  Xiaoming?

          DR. TIAN:  I think for this paragraph, I feel the tone is tight or connective because this regulatory research, page 6, mentions GMPs.  They have so many problems, but it is my understanding the majority of this population that take dietary supplements do not have problems.  The minority, only a few problems should be addressed.  We have plenty.  We mention here plenty, right?

          Should we put a few sentences to give an impression that, generally speaking, dietary supplements are safe and people are using them?

          Otherwise, we see all the problems.  Mention that dietary supplements do not meet GMP.  GMP is for drugs.  We are not talking about a drug, we are talking about the dietary supplement.  So there is no such standard.

          Must everything meet the standard as a drug?  Which is impossible, especially for all the small factories that can make that.

          DR. GORDON:  Steve, do you want to respond?

          DR. GROFT:  Ken is going to.

          DR. FISHER:  I was just going to correct that.  As Corinne said, they are waiting to be vetted in OMB, but we can't say that.  What you need to say is, and it practically says it, the way it is written, there is a need for good manufacturing practices for dietary supplements.  That will get the message across right there.  There is no use pointing a finger at who is holding it up.

          DR. LOW DOG:  There will be GMPs.  There will be GMPs, and the GMPs are actually under food for now.

          DR. TIAN:  Not yet.

          DR. LOW DOG:  No.  There are GMPs because they are dietary supplements.

          DR. TIAN:  No, not yet.  There are small companies, they have a license to make that.  They don't need a GMP to sell the product.

          DR. LOW DOG:  Yes.  That is right, a small company.

          DR. TIAN:  It is high-quality check, with this issue, with the FDA, and there is no need because that is the qualification for the drug.  For each state that they have license, they have to meet the license.  They have to go there to the state level.  They will check all the factory, if you want to produce any product.

          So if we had to meet GMP, I am afraid there probably is 10,000, maybe more than 10,000 small factories that cannot make products.

          MR. FISHER:  Ming, you are correct when you refer to drugs.  You probably got an answer from the drug side of the house, but there are GMPs on the food side of the house, as well as standards of identity, and now in the mill are basically good manufacturing practices for supplements, and that is what has not yet been publicly available.

          So you are correct for drugs, but this is something on the other side of the house.

          DR. TIAN:  In the future.

          MR. FISHER:  Well, it should have been about three or four years ago.

          DR. TIAN:  Well, it is still in the future, right?

          MR. FISHER:  Yes.

          DR. TIAN:  Whenever it is available --

          DR. GORDON:  We need to move along.

          DR. LOW DOG:  Joe, do you have a comment?

          DR. FINS:  I'm sorry I missed a little at the beginning of this conversation, so I have some other comments when you are done with this section.

          DR. LOW DOG:  Okay.  I think one of the proposals made was about putting a positive spin on it.  I do think that that is important, that many companies are trying to do good quality, and that there is a huge consumption of herbs, and that there have been problems identified within the industry, but I think we probably want to put that in a realistic perspective instead of just, this is a renegade industry and everything is in disarray.

          DR. GORDON:  Yes.  I think that the other thing that perhaps needs to be even stronger than it is here, is that the companies have been active in promulgating GMPs.

          DR. LOW DOG:  Yes.  So all of those things, I think, should set the tone for this, looking for maximizing the benefit and the optimism of these.

          DR. FINS:  One of the things we talked about yesterday is that this is a consumer-driven movement.  Consumer protection is part of the enfranchisement of being an enfranchised consumer.  I think that in this area, under the second paragraph of the section -- what page is that?

          DR. LOW DOG:  Page 7.

          DR. FINS:  Page 7, right.  Okay, got it.  There, I think we need to mention explicitly the Blendon study about not withstanding the interest in access and dah-dah-dah-dah-dah, a recent study also demonstrated a desire for increased regulation, maintenance of safety, et cetera, et cetera.  So it is balanced.  We have a parity between access, consumer-driven, and consumer protection at the same time.

          DR. GORDON:  Just one point about the Blendon study, there was even more interest in having access.

          DR. FINS:  Right, right.  I mean, the paper said it, exactly.  That is the point, access is something that is not safe, it is not an access that we want to foster.  I think, at the same time, we don't want to leave the impression that all this stuff is very dangerous.  I think we want to be balanced.  I think Blendon works very well in that context.

          DR. JONAS:  Principle 3: Accountability and access must be linked.  I had a sentence that I did not understand at all.  I couldn't understand it after reading it, and this is on page 8, the paragraph that begins with page 5, in this last sentence that starts on line 9, 9 to 13.

          "To accomplish this, current AER systems must be strengthened by both the private and public sectors, and outreach activities to communicate to CAM and conventional health professionals and consumers the importance of AER, of CAM products, must be improved."

          I don't understand that.  Is that a --

          DR. GORDON:  Well, Wayne, you know why?  You have got two sentences there, to begin with.

          DR. JONAS:  Oh.

          DR. GORDON:  So it makes it a little more difficult.

          DR. JONAS:  Is there a period somewhere in between there?

          DR. GORDON:  There should be.

          DR. JONAS:  Oh.  Okay, well, maybe that could just be rewritten.

          DR. FINS:  It is the German reporter.

          DR. JONAS:  It is the German reporter.

          [Laughter.]

          DR. FINS:  Right here, I think it makes sense to mention explicitly the OIG report.

          How do people feel about that?  Because it really is adverse event reporting.  It is recommendation that is out there.  I think it is very prudential.  How do folks feel about that?  It would go here, I think.

          DR. LOW DOG:  So the Inspector General?

          DR. FINS:  The Office of the Inspector General.

          SPEAKER:  Also, there are two GAO reports on this topic as well that I think might be helpful.

          DR. LOW DOG:  I think where you can put some data, where people have actually looked at this, I think it is important to build some data into this report.

          DR. GORDON:  Let me just say something.  We have three more minutes for this topic.

          DR. JONAS:  I mean, like we have said with other topics, we really need to contextualize this within the current ongoing efforts on adverse event reporting and safety, and that kind of stuff, and say CAM should be included in those as an important area to address.

          DR. FINS:  We could say, constant with the efforts of the OIG's report, we endorse increase vigilance for AERs.

          DR. ORNISH:  When I was just outside taking a phone call, somebody came up to me and said that there were a number of things in here that he is concerned about, that are inconsistent with some legal things that are out there now, and suggested that we have an attorney who is well versed in this area take a look at it so we don't look foolish.

          So I am just being the messenger here.

          DR. LOW DOG:  Right.  We are aware that there is some real stuff in here.  We are going to clean it up.

          DR. GORDON:  Charlotte?

          DR. LOW DOG:  Oh, Charlotte, I am going right to you.  George has been waiting.

          SISTER KERR:  Oh, sure.

          DR. BERNIER:  On page 8, the first full sentence, I don't understand.  That is, "In its consideration of these global issues, the efforts of the World Health Organization will be reviewed by the Commission."

          DR. TIAN:  I don't understand it either.  What material are you asking me to review?

          DR. GROFT:  That would be the report that we are awaiting from the World Health Organization on botanicals, I believe it is, that we have been in touch with.

          DR. BERNIER:  Well, it ought to precede this item, because I think it sort of stands alone.

          DR. GROFT:  Okay.

          DR. LOW DOG:  It is kind of vague.  You are not clear what it means.  So that is kind of an editorial comment.  The sentence, it is unclear what it means.

          DR. GORDON:  I think you are right, but the previous sentence describes what the issues are, and then this one is hanging out there a bit.

          DR. LOW DOG:  Charlotte?

          SISTER KERR:  Mine is probably an editorial request.  I keep thinking of this more and more as a teaching tool for the great population that will read it.

          When you think about how you wording things, can you think of it as a teaching tool or user friendly as much as possible?  Like Wayne's paragraph, I really think is a teaching paragraph in the research.  What you are saying, even the different language, the AER, that really is for the beginner and the consumer and the legislators.

          DR. LOW DOG:  The congress people.

          SISTER KERR:  Thank you.

          DR. LOW DOG:  Okay.  Good point.

          Joe?

          DR. FINS:  The same section, but a different theme, on page 9, sentences 11 through 20 or so.  We are talking about research regulation, and I want to say something here specifically about the need for adequate informed consent, protection of human subjects.

          Then this verb really bothers me, "navigate the IRB process."  It sounds like you want to navigate around, and that is certainly not what we want to imply.  You want it to be consonant with the highest ethical principles and standards, and I think that needs to be explicitly stated.

          DR. GORDON:  I think the intention there was what was testified to by a number of practitioners who said they needed help with creating an IRB or working with an IRB.  So your point is well taken.  That was the intention of the statement.

          DR. FINS:  Yes.  Good.

          DR. JONAS:  We also heard individuals say that IRBs need help in knowing how to handle and deal with CAM proposals.

          DR. FINS:  Talking about contextualization, I think we want to mention Greg Kosky's [ph] office and the Office of Human Research Protection, the important work that that office is doing consonant with that effort, et cetera.

          DR. JONAS:  And the efforts, really, to revise the whole look at the IRB procedures and membership and that type of thing, which is currently going on now, stimulated by an entirely different area, but still directly related to this.

          DR. GORDON:  How much of this do we want in this paragraph?

          DR. LOW DOG:  I am not attached to the navigator or working with it, but I think whenever we can give a positive example of what is being done now and what is out there to feed into this, wherever you can support it with data, and wherever you can support it with what is actively going on now, I think it gives credence to the argument, I think it gives credence to the recommendation.

          So if there are a few sentences that go before this that would indicate how this is already being done or who is doing it, I think it just gives the recommendation more strength.

          DR. GORDON:  I would agree with that.  I think the issue here is, how much do we want to talk about the IRB process in here.  I think that we need to make a general statement.  It is something we can go into, including all, as Wayne is suggesting, all of the complexities of dealing with IRBs on both sides, or all sides.  That has got to come later.  I think we can indicate it, but not go into the detail here.

          DR. FINS:  I think the generic statement about adhering to ethical standards, informed consent, protection of human subjects.

          DR. GORDON:  I would also say collaboration between the CAM and the conventional world in developing IRBs is crucial.

          DR. FINS:  Right.  I think because otherwise it is not completely informed, and that it makes informed consent impossible.

          DR. LOW DOG:  One other issue, just in this section.  Is there a reason why we sort of shied away from making some sort of recommendation, that, also what we heard was that DSHEA be fully implemented?  Is there a reason why we sort of just didn't say that?

          Because if you read this, one could question if we are questioning DSHEA or suggesting that it somehow be reworked, and I don't think that is what we want to do, but we never, in here, say anywhere really that DSHEA should be fully implemented.

          DR. GORDON:  I think you are right.  I think we should say up front and clear DSHEA should be fully implemented.

          DR. FINS:  That's right.  Also, I think the other issue is, fully implemented, and then it should be evaluated, and then the appropriate oversight should go back and revisit this.

          DR. LOW DOG:  George.

          MR. DeVRIES:  My concern is, in terms of DSHEA, I think we should stay away from criticism or review of the law.  I think we should stay focused.  A lot of thought was given to it.  It has not been fully implemented.  Our position should be fully implement it.

          DR. FINS:  Can you say fully implement it, and then have it evaluated after an appropriate interval?

          MR. DeVRIES:  Why would you go there?  We don't say evaluate the FDA in their function.

          DR. LOW DOG:  I understand Joe's point, though, because a lot of times there is some sort of accountability or evaluation for lots of things we set into place.  I don't think we need