WHITE HOUSE COMMISSION
COMPLEMENTARY and ALTERNATIVE MEDICINE POLICY
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Thursday, October 4, 2001
National Institutes of Health
Conference Rooms C & D
6001 Executive Boulevard
James S. Gordon, M.D., Director
The Center for Mind-Body Medicine
George M. Bernier, Jr., M.D.
Vice President for Education
University of Texas Medical Branch
David Bresler, Ph.D., LAc, OME,
Founder and Executive Director
The Bresler Center, Inc.
Co-Founder and President
Tom's of Maine, Inc.
Effie Poy Yew Chow, Ph.D., R.N., DiplAc (NCCA)
President, East-West Academy of Healing Arts
George T. DeVries, III
Chairman, CEO, American Specialty Health Plans
William R. Fair, M.D. [Not present]
Attending Surgeon, Urology (Emeritus)
Memorial Sloan-Kettering Cancer Center
Chairman, Clinical Advisory Board of Health, LLC
Joseph J. Fins, M.D., F.A.C.P.
Associate Professor of Medicine,
Weill Medical College of Cornell University
Director of Medical Ethics,
New York Presbyterian Hospital-Cornell Campus
Veronica Gutierrez, D.C.
Gutierrez Family Chiropractic
Wayne B. Jonas, M.D.
Department of Family Medicine
Uniformed Services University of the Health Sciences
F. Edward Hebert School of Medicine
Charlotte Kerr, R.S.M.
Traditional Acupuncture Institute, Inc.
Linnea S. Larson, LCSW, LMFT
West Suburban Health Care
Center for Integrative Medicine
Tieraona Low Dog, M.D., A.H.G.
Dean Ornish, M.D.
Preventive Medicine Research Institute
Clinical Professor of Medicine
University of California, San Francisco
Conchita M. Paz, M.D.
Joseph E. Pizzorno, Jr., N.D.
Co-Founder/Founding President, Bastyr University
Buford L. Rolin
Poarch Band of Creek Indians
Julia R. Scott
National Black Women's Health Project
Xiaoming Tian, M.D., LAc
Director, Wildwood Acupuncture Center
Academy of Acupuncture & Chinese Medicine
Donald W. Warren, D.D.S.
Diplomate of the American Board of
Head, Neck & Facial Pain
Stephen C. Groft, Pharm.D.
Michele M. Chang, C.M.F., M.P.H.
Joseph M. Kaczmarczyk, D.O., M.P.H.
Senior Medical Advisor
Corinne Axelrod, M.P.H.
Senior Program Analyst
Geraldine B. Pollen, M.A.
Senior Program Analyst
Doris A. Kingsbury
Kenneth D. Fisher, Ph.D.
Senior Scientific Advisor
Maureen Miller, R.N., M.P.H.
Senior Policy Advisor
P R O C E E D I N G S
DR. GORDON: I would like for us to begin with a moment of silence and this time, in the silence, to use it as a moment for remembrance for those who lost so much in the events of September 11th. So, if we could all just sit in silence and in solidarity with them.
[Moment of silence observed.]
DR. GORDON: Thank you. Thank you all very much.
DR. GORDON: Just a couple of things to begin with. One is it seems to me that our work, always important, takes on a whole new dimension in the light of the kinds of healing that we all, and all of us as part of a nation, need after the events of September 11th.
What we would like to do is on Saturday morning, we will set aside a little bit of time, if there is specific thoughts that people have about the contribution that CAM might make to the general process of healing in our country, and we can focus on that on the 11th.
I wanted also just to say how grateful I am to all of you for being here. I think it is really important that we are here and that we are together, and that we are here in the Washington area at this time. It is a very important statement about the importance of our work and about how healing and help is so necessary right now.
The other thing I wanted to say before Steve goes into the order of how we are going to proceed is, as some of you know, I was out of the country. I was actually in the middle of a war when this war began over here. It was very strange being in Macedonia and then coming back here.
One of things that I appreciate so much is all the work that everybody has done in preparing for this meeting, all the Commissioners and all the staff. It is just an extraordinary document that we are going to be working with these next three days. I am terribly grateful to everybody for all the work that everybody put into it.
Steve is going to talk about how we are going to move through the next couple of days and then we are going to move through quickly, and Michele is going to be keeping us on time, all of us, very strictly on time as we move through.
DR. GROFT: Good morning, everyone. I would like to express my gratitude for you all willing to come back and join us. I think we were prepared to have a teleconference, but once we heard that everyone was able to attend, we just did away with those plans, so thank you very much, I really do appreciate it, especially also for your work.
Since the Interim Progress Report, which as I mentioned in an e-mail to you was signed off by the Secretary last Friday afternoon, and we have copies of it at the desk and we will be putting it up on our Internet site to make it available for comments, and anything that anybody would like to respond to that, your friends or colleagues, just ask them to send us a note, and we will communicate that information to you, as well, so I do appreciate it.
I just want to mention, two other people who are in the room, Mary Plummer and Mandy Stoneberger, a couple people from our Committee Management Office, if you want to stand up really briefly.
They ask you to update your files as far as conflict of interest and everything else. It is not a matter of them wanting to know everything that is going on, and this information is confidential, but we need to know where funds come from, where your support is coming from, so if anyone raises an issue we can say yes, we know about this and you are cleared as a member of the Commission.
We don't take these things lightly. We just never know where people will be asking us, when they will be asking us for information about the Commission. We had this early on about the membership, so I would ask you just to please update the requests that are provided to you on a regular basis. Usually, it is at each meeting.
I think as we approach the meeting, especially as we have completed the Interim Progress Report, we were looking at how would we pull this meeting off, how would we begin to write the Final Report, and there were two possible approaches that we thought about and normally you would go through I guess.
One is to write the report and then develop the recommendations. The other way is to develop the recommendations and define the issues, and then write the report. I think after the whole process of going through and preparing the Interim Progress Report, we thought that we needed the foundation on agreement with the issues and recommendations, and that is why I think we took the approach we did of trying to define issues and recommendations that we could discuss at this meeting, develop some of the background information for the Final Report, although the background information that you received and is in front of you really is the rationale for the recommendations.
That may change, and probably will change, as we go through the next three days as we being to prepare the final report, at least the Draft Final Report, for the December meeting that we will be discussing at that point in time.
So, we will be picking up maybe more appropriate examples, better ideas, better concepts, so this is fluid and it will remain fluid until we have final agreement on the part of the Commission either in December or perhaps at a later meeting depending on the progress that we make.
We ask you not to focus so much on the language in the text of the background information, but we really want to focus on the issues and recommendations that are before you.
The workgroups will continue to function as they have. They will be responsible for developing that section of the Final Report that they are currently working on. So, it is going to carry through until completion, so each of the workgroups will maintain their status and their activity level.
People have said can we change, we prefer that you don't, but if someone wants to join another group, they are welcome. I think you all realize how much work is involved with each individual group, especially the facilitators, so I don't know how many people want to take on an extra burden of an additional workgroup, because it has been a lot of work.
Today, tomorrow, and Saturday morning, we tried to break out each of the sessions into two-hour periods. We will open up with a 10-minute introduction by the facilitator or co-facilitators, talking about the process, how they got to where they are, some of the remaining issues that are problematic. These are the types of things that will be brought out.
We then will have five minutes to go around to the other workgroup members to see if they have anything additional to add to what the facilitators mention in the introductory comments.
Following that, we will move into about a 75-minute discussion of the issues and recommendations that are before you. We will just sort of run through and see if there are areas of agreement or disagreement, and then we will take it from there.
I will be passing out a little bit of a cheat sheet here that has all of the issues, the time frames, and then the disposition of the issues and recommendations.
After the discussion, we will have about 30 minutes that Jim will take to take care of the recommendations and the issues, and we will be asking you to make some decision whether to accept the issue or recommendation as presented, accept it with change, return the issue to the working group with all the discussion that we have, delete the issue of recommendation.
There may be some of the recommendations that you want to knock out, and not include, or determine that it shouldn't be the status of a recommendation, they may not be worthy of that as far as emphasis.
If there are new issues or recommendations, and we think there will be, we ask you to limit your discussion of that issue, that new issue, a very, very brief discussion. We have time on Saturday morning to pick up and discuss in greater detail the new issues.
We only want to get them on the table now. Our concern with the very limited amount of time is if we spend a lot of time working on the new issues, we will never complete the recommendations that are presented. So, I think what we would like to have is, raise the issue, your brief rationale for your concern, state it, and then get out. You know, we are finished with it for now. We will bring it back. The workgroup, then, will address that as they prepare the draft of the report. So, I think we have to rely upon the workgroups to do their work, and they will be in touch with the individual who raised the issue or the concern.
So, I hope that is okay. We just are reluctant to spend 10, 15 minutes out of 75 on a new issue, that the workgroup really needs to hear from you and then expand a little bit in their procedures.
So, I ask you to be patient and let the workgroup do their thing after this meeting to bring this to completion for you.
I think that is about it. I apologize for some of the confusion, but we have to be out of here at 5:00 both days. It is security, added security. They are closing government facilities at 5:00 for meetings, so we will be bumped out of here.
What happened, also, we tried to get the meeting at the Pooks Hill Marriott for Saturday morning. They had no meeting room, so we are going to what is called the Marriott Suites Hotel over on Democracy Boulevard, not real far from here, and we will make arrangements again to get you out to the Marriott Suites Democracy Boulevard location, which is a breezeway walk over to our offices.
Once we heard that we didn't have the Pooks Hill Marriott for meeting space, we ran over there, and they fortunately had a space for us to meet. So, my apologies for the confusion on that Saturday. Again, that is quite accessible to the interstates and to the airport, so it will be a little bit easier I think in the long run.
On Saturday morning also, I will talk about how we are going to prepare the Final Report. We have procedures in place to continue utilizing the workgroups, and all of that will be discussed on Saturday morning. A couple of you I think have to leave, and we will make sure you get a copy of what we will be talking about at that point in time.
DR. GORDON: Thank you, Steve.
Let me just make sure that everybody is on the same page with how we are going to proceed. If there are any questions about that, we can deal with them now.
The basic idea after the presentations by the workgroup facilitator and by any additional comments, and after any additional comments from workgroup members, is that the major discussion of all the recommendations will take place in that next 75 minutes.
The final 30 minutes is -- and that will be led by the facilitators -- the final 30 minutes is to make sure that we are all on the same page as we move ahead, and that part I will facilitate.
My job is just to make sure that we have heard each other correctly and that we agree about where we are, and that we put a recommendation into one of the categories that Steve mentioned, that Ken has listed up on that board, that either we accept it or we change it, there is a new issue, we decide we don't want to make that recommendation, et cetera.
So, I am going to ask a question at that point, which will worded something like can we live with this recommendation, and if we can, then, we will put it up there in that category; if we can't, it will go back to that workgroup.
So, this is a continuing process. If we decide we can't live with the recommendation, then, it is up to the workgroup to keep on working with it, and working with whoever has issues or concerns.
One of the things that Steve said that I think is important to emphasize is if you have concerns or issues about any recommendation, the workgroup will be available to you, but we really want each person who has those concerns to get in touch with the workgroup facilitator and to make those concerns clear. Okay?
So, if there is an issue, let whoever is in charge of that particular workgroup know about the issue, so they can grapple with it and if you have new information you want to bring to them.
Once again, if there are new issues, new possible recommendations, we will just raise them and then come back to them on Saturday morning.
Any questions about the way we are going to proceed for Steve, me, or Michele, or anybody? Michele.
MS. CHANG: I just want to mention as we start each new topic, we are going to ask the facilitator or facilitators and the staff lead to move from where they are sitting now to that table there, so that everyone can see them clearly. Take your name plate with you.
DR. GORDON: Just one thing about my role. In the early discussion, I am a member of the Commission, the facilitator is in charge, and then I will step back and my job is to help make sure we have the recommendations as everybody wants it in the final 30 minutes.
MS. CHANG: I am going to start the clock at 90 minutes for the full discussion, which includes your 10-minute overview and member group around the table, and I will give you a 10-minute warning when you need to start summing up to get ready for the disposition.
MR. CHAPPELL: Would you repeat the time sequence?
MS. CHANG: Yes. I am going to set the timer at 90 minutes, which includes the 10-minutes overview and the 5-minute comment by other members of your workgroup before you move into the full discussion. I will give you a 10-minute warning, so that you know that you need to start to summing up.
MR. CHAPPELL: Great.
Session I: Definition of CAM
MR. CHAPPELL: Good morning, everybody. This particular session is on the definition of CAM and the guiding principles that we commissioners have crafted as a way of helping our readers, our audience understand how we oriented to the topic in a kind of world view perspective.
I am going to help us through the section on the CAM description and definition, Dr. Jones will help us with the guiding principles, and Jim Swyers, the writer of the material, will contribute as he wishes.
I want to thank particularly Jim Swyers for the great work that he has done for this group, this committee. It has not been an easy topic, trying to get our hands wrapped around the definition of CAM has not been easy, and I just want to thank Jim for his good listening and good encouragement and good drafting for us.
I also want to thank our committee for the time and attention, thought, and guidance that each has given on this process.
With that as way of introductions, shall I proceed with my piece? Fine.
DR. JONAS: Tom is going to go through the definitional issues, I am going to go through the guiding principle issues, but we are all in part of this together.
MR. CHAPPELL: Great. In looking at the definition of CAM, I will be referring us all to pages 1 through 6. The structure of our dialogue will be built around basically describing CAM, speaking about the marginalization issue of CAM, talking about the differentiation of the different practices of CAM, some of the common characteristics of CAM, and then looking at a summary definition of CAM. So, that is the structure of my portion for us.
Why don't we begin then looking at pages 1 and 2 as we look at the while question of describing and defining. We tried to say let's define CAM, and throughout our sessions over the last year and a half, this has been a provoking question, are we all talking about the same thing here, or do we really need to come up with a definition.
So, my thanks to those of you that have been probing and forcing us to wrestle with this. As you can see by our attempt to define CAM, it began with a description of CAM. It is just too broad to wrestle to the ground that simply, so we have let ourselves cast the net here with being sure that we are touching down on all of the points that we need to in describing CAM, and that is what you have before you.
It is a diverse set of both ancient and modern health care systems and practices. These systems and practices, not always supported in the Western countries, focus on the support and stimulation of the healing processes and on the whole person care to prevent and treat illness.
The health care system and practices are shown on the following table, and there you see the diversity in the chart and have gained increasing acceptance and recognition by mainstream health care. This is our attempt to circumscribe the various modalities and practices.
Before I move on to the marginalization section, could we have some discussion?
DR. JONAS: I just want to mention this definition. Just to kind of reorient you, I think we have talked about this before, there have been multiple different definitions that have come down through the years and we had in our discussion and certainly in our subcommittee we saw many of these.
Jim put together a very nice kind of summary list of definitions that have come over a number of years. This one is one that has been pulled from, and modified slightly from, the Cochrane definition, which in turn was pulled from an OAM definition working committee on definitions back in 1995. So, this is kind of the link to this particular one.
This had input from a number of international groups, so it was felt that this was important that this be something that would have worldwide applicability or at least the potential to have worldwide applicability in those areas. So, that is just a little bit about the history and the background of that.
MR. CHAPPELL: Great. That is helpful, Wayne.
DR. LOW DOG: Just a couple thoughts. Especially given the state in the United States and how we are going to talk about dietary supplements and that, complementary and alternative medicine is a diverse set of both ancient and modern health care systems practices and products.
I do think that in many cases, people are using dietary supplements without the context of anything, and I think it is a multibillion dollar business in this country, and I think products may be appropriate there.
The other thing is, these systems and practices which are not usually available or supported in most Western countries. I am not sure I know what we are trying to say, but it is not really accurate when you consider that osteopathy, chiropractic, naturopathy, homeopathy, therapeutic touch, applied kinesiology, and relaxation therapy really developed in the West. That is their origin. That is where they came from. Spiritual healing, nutritional therapy, aromatherapy, and herbal medicine are really worldwide.
I think what we are trying to say there is that it is not supported often by the dominant systems within Western countries, but to say that they are not available, when that is where they came from and they still flourish, I think is somewhat misleading.
Those were my only two comments.
MR. CHAPPELL: Thank you very much.
DR. PIZZORNO: Actually, I would just like to start with a general comment. On the long cross-country flight, I had a chance to sit down and read this document in one sitting in its entirety.
I actually would like to compliment the staff and the commissioners for an incredibly well-done job. This document is very, very impressive. If I had my druthers, I would say I move to accept and let's all go home.
It is still 5:00 in the morning for me. I would also like, as a comment, to second Tieraona's insightful comments. Indeed, many of these did arrive from the West and I think there needs to be some tweak in the language to recognize that.
DR. JONAS: I just want to say there is no word originated from in this, Tieraona. Maybe we want to change tweak the readily available or something like this, there is no statement in here about that they did not originate from.
DR. LOW DOG: My comment, though, is that I think it is somewhat misleading or not usually available. I mean chiropractic and osteopathy are readily available, therapeutic touch is readily available, herbal medicine is across the board in the United States. I mean you can buy it at any health food store or Wal Mart.
Spiritual therapy goes on in churches every day all around this country, so I think it is a bit misleading. This comes back to the problem again about when you are saying CAM, some of which are not supported by the dominant systems or medical systems of Western countries.
I think that what we are really talking about is not so much availability as the acceptance of them, and that is what leads to marginalization.
DR. JONAS: I think availability is also part of it. I mean access is a whole section that we are talking about, so it is certainly not one that we would take out.
We had in the original definition from the OAM, and actually, Cochrane I think maintained it, the word "dominant" meaning the politically dominant, and I think it was stated "politically dominant," was part of the definition, which the committee decided we wanted to alter or remove.
Is that reasonable? I mean am I hearing that we should insert that back in?
MR. CHAPPELL: Dr. Gordon.
DR. GORDON: Wayne, one of the things that might help address some of your concerns, Tieraona, is to have more of the history and the background to give a sense of where the different perspectives and where the different practices are coming from.
I agree that the definition needs to alter slightly to accommodate these concerns, but if we provide a sense of the development of some of these modalities and how they have entered into the world and the United States, not a huge treatise, but some background, I think that that will be helpful in helping us understand where we are in this issue.
MR. SWYERS: One of the main pieces here that we have talked about is doing a history like that, and I think that will help inform some of the language in this, but I think right now we need to focus on the major pieces, because this is kind of different than the other sections, we are actually reviewing text, but I think now we need to focus on the major chunks and then we will go back and we will wordsmith this.
As we see those other pieces fall into place, it will help inform our definition and some of our descriptions.
MR. CHAPPELL: Go ahead.
SISTER KERR: I would like to request, Wayne, Tieraona started speaking, I think it might benefit us to read that definition that included the politically dominant and why we perhaps thought it might be a yellow flashing light to the listeners.
The other thing is, is it appropriate to point out that we have another summary definition of CAM on page 6?
MR. CHAPPELL: We are coming to that.
SISTER KERR: Just because of where people strayed, thank you.
MR. CHAPPELL: Thank you. I would like to take as a guideline to any edits to this work, that we simply ask ourselves whether a specific phrase or word choice, whether it needs to be there at all.
I think if we are going to be building the case for the history and including that, that history section will speak for itself, but when we get to the actual description or definition of CAM, I think we have to ask whether or not that language needs to be there at all.
In the case of the phrase "which are not usually available or supported in most Western countries," I just don't think that needs to be there at all.
So, that is kind of the way we can comb without asking the Commissioners to wordsmith this from here, I am just giving us some guidelines of if there is going to be a history section, and there will be, perhaps some of this can drop right out and we just get the focus right to what it is we do, what is it we are all about.
Go ahead, Joe.
DR. FINS: Thanks, Tom. I want to just piggyback on what Charlotte was getting to because I think that her flashing forward to page 6 is I think relevant, because I think this definition is more of a historical conception, and what you have on page 6, which we will get to and I don't want to discuss now, is probably more reflective of what we all believe.
So, I think that the reason why you have the dominant, and you were trying to do the history and go forward at the same time. So I think if we simply said the prevailing views from Cochrane, and the earlier reports, viewed CAM as blah-blah-blah, because if we go to page 6, which we are not going to get to, it is a more integrative tone. This is more dualistic and antagonistic and defensive. So, I think we have evolved to page 6.
This is a historical definition, and not necessarily a definition that we are currently embracing. I think that might be my reading of how it played out.
MR. CHAPPELL: Thank you, Joe.
DR. CHOW: Just onto that statement, I think if we change the word from "usually," like someone suggested "readily," I think available means not only the fact that it is available on the shelves and acupuncture is available, homeopathy is available, and chiropractic is available, but it is available limited because of finances, as well.
This is what I am interpreting into this. It is not readily available and supported in most Western countries, is that it is not funded, we have to pay out of our own pocket usually for these CAM services or products.
So, for me, I think that is important to keep that in, maybe not "usually," you know, that word. Maybe "readily" is more suitable. Maybe we need to say "financial" in there.
MR. CHAPPELL: I am not accepting edits to the language. What I am accepting is what thought is missing for you, what thought is in the way, what thought is missing for you.
DR. CHOW: This is what I am presenting is that the financial aspect is not apparent in here.
MR. CHAPPELL: Okay, financial limitations is not apparent.
DR. CHOW: Yes.
MR. CHAPPELL: Thank you, Effie.
DR. LOW DOG: I think Charlotte's and Joe's comments, I would just like to echo that perhaps leading in, since this is really what you begin to read when you first read the report, I think a non-defensive, antagonistic opening is important, I think for the people that are reading it.
When I read it, and I am a pro-CAM person, I felt I had a lot of disagreements with it, and I am pro. I like the definition on page 6 quite well, and I just want to echo sort of what has been said, just for consideration when we are looking at it.
MR. CHAPPELL: I think we could actually open this section with the summary definition, and I am even asking whether we should be dealing with the guiding principles before we get to the definition, because the guiding principles really are the orientation of the whole report.
My reflections on this are to flip the guiding principles to the very front and then move into the description and definition of CAM, and to everyone's concern here about the summary, in fact, I was going to open our discussion on the summary paragraph because I think that is where the real work becomes focused.
We could open that section with the definition and then proceed from there. I see some heads nodding. Yes, Joe?
DR. FINS: The work that I didn't see anywhere in the whole chapter was "integrative." In fact, the very last sentence of that paragraph, the summary definition, is saying that the lines are getting blurrier. In fact, I think we want to encourage that blurriness a little bit.
There may be a way of trying to say that patients, as we have said many times, patients don't define themselves as CAM or allopathic, they are just patients, and they are going back and forth and the lines are blurred, because they are going back and forth.
So, I think we need to recognize that up front, and that is really the motivation for the entire commission, that people are utilizing it, so the inversion might be helpful.
MR. CHAPPELL: Thank you.
DR. JONAS: I think it is a double-edged sword. Certainly, "integrative" and encouraging the blurriness of the definition is accurate. On the other hand, it can come back to bite you and that suddenly there is no field called CAM.
Yesterday, I was meeting with some folks at the NIH, and they were talking about all the CAM research they were doing, and I looked at it and I said, boy, this is the stuff that has been going on in the intramural program at NIH for years, but now all of a sudden it is redefined as CAM.
So, I think we have to be careful about being too integrative. We just have to be sensitive to that, because a powerful system, the politically dominant system can indeed swallow up and claim an area without really getting the fundamental issues of holism, of healing, et cetera, and end up kind of focusing on products. This is a new way to look at the kind of products we haven't looked at before. So we have to be a bit careful with keeping the boundaries blurry.
There are some advantages to try to at least be clear about what the core issues are that we want to make sure are unique to complementary medicine, or at least what complementary medicine is providing.
MR. CHAPPELL: I would like to ask the group to go to page 6 to look at the summary definition of CAM, and then we will work backwards from there.
Go ahead, Joe.
DR. FINS: I take Wayne's point seriously. I think perhaps a diagram right here, Figure 1, might be a Ven diagram, which shows that there are polarities, there are elements of allopathic and CAM medicine which do not overlap, but there is an area in between that does. Very simple; everybody would understand that.
That would also show that we are trying to create in integration while maintaining the differences that are instrumental and valuable to our health care system.
DR. JONAS: I like the idea that one of our goals is to properly integrate, and that puts this kind of blurriness into a positive perspective, I think, a proactive perspective. So I would like to have that term in there.
MR. CHAPPELL: Thank you.
Let's look at the summary definition. I will just ask whether there are any thoughts that are missing there for you or thoughts that are simply not stating it as you understand it.
DR. ORNISH: This may fall into your definition of wordsmithing language except that I think that this particular paragraph, of course, is crucial to the entire document because it is really defining what the rest of the document is about.
When we say that it is other than those intrinsic to mainstream health care, I just want to emphasize that we start by marginalizing ourselves. I think that what I would like to see as a common theme throughout the document is something that we really take the middle ground that says that it marginalizes people who are going to criticize the report.
For example, in our report, what we talk about later, to say that CAM research should be held to the same standards as non-CAM research, no higher, no lower. Well, that is kind of hard to argue with. Then, you force people to say no, it should be held to a different standard, and that marginalizes their argument.
Here, we are in effect, marginalizing ourselves literally by the definition of saying that is outside the mainstream, when I think one of the reasons that the Commission was formed in the first place was Eisenberg's, and other's, research, talking about how it really in many ways is mainstream.
So, I think those words have such different connotations that we should choose them carefully, and if there is some way that we can say even in the definition that this is something, it is not a question of should people be using this marginalized stuff, but rather they already are in some way even more so than conventional medicine, and therefore, that is why these are worth looking at. That, to me, is what is missing here.
MR. CHAPPELL: Thank you.
DR. FINS: Along those lines, it is really a means and ends kind of argument. You know, allopathic medicine, primary care, general primary internal medicine, family practice might have the same ends, but a different means to the same ends. So, that might be a way of overcoming this sort of dualistic or dichotomous language that sets up a false antagonism between the goals of the holistic CAM provider and the holistic allopathic provider or modality.
This is an aspirational model that applies to different vehicles to achieve the same end.
MR. CHAPPELL: Yes, Dr. Gordon.
DR. GORDON: This is really just procedural. I think that the more that the facilitators, as the discussion kind of comes to a natural end about a particular issue, the more you can sum up what you have heard and where you see things going, the easier it will make it for us to move along, so I am just giving that back to you.
MR. CHAPPELL: Thank you.
DR. PIZZORNO: I think one of the challenges we are facing here is a historic perspective where this clearly was way outside the mainstream, and now a more moderate perspective where there is definitely some overlap and some mutual appreciation.
So, I think maybe if we put some historic language in here just for some of the separations, it will help clarify this, because clearly, this did come from outside the conventional academic institution, federally-funded system that has dominated health care in this country for so long.
MR. CHAPPELL: Great. Thank you.
DR. LOW DOG: I am going to raise it now because it is going to come up again and again, but when we talk about the major CAM systems, we have never identified the major CAM systems. We listed a whole bunch of systems, but we didn't say these are the major CAM systems, and when we refer in this document to major CAM systems, this is what we are referring to.
DR. JONAS: Do you want to list them?
DR. LOW DOG: Well, that is my problem.
DR. JONAS: It is our problem, too.
DR. LOW DOG: I think if we are going to use the phrase, though, my first question would be, if I didn't know much about this and I am somebody reading this in Congress, I would say, well, what are they; what are the major CAM systems; what are you talking about.
DR. JONAS: You can list some of them very easily, Ayurvedic, et cetera, et cetera.
DR. LOW DOG: Just put them down there then.
DR. JONAS: But the problem with listing them, as you know, is that some are not listed.
DR. LOW DOG: I think we are going to have to deal with it, though. If you are going to use it as the major CAM systems, then you are going to build all these systems, have X, Y, and Z, and they do X, Y, and Z, and they are this, you have to define them. Whether it is difficult or not, if we are going to use the phrase, it is going to have to be defined, because we build an awful lot upon it.
MR. CHAPPELL: I am hearing a lot of comments that are addressing the history of the CAM movement and how that has begun very much in polarity with the Western culture, and yet how that has come to an integrative state in many different modalities today, that there are some that are still not as well accepted or incorporated, but there are some that are very much in the integrative reality in this country.
So, I think if we add history and evolution as notions in our definition, those will help bring about this kind of where we are today and it gets at what it is. I think this is the struggle with this definition, what is CAM.
I don't mean to belittle all the work that has been done. It is just to say what it is now can be achieved if we offer the historical perspective in the drafting, the evolution to date of specific practices.
Then, quite frankly, we can't describe this unless we are addressing the world view, the very different perspective that we have. This is why I feel that the guiding principles will serve the definition better if they come before the definition, because it helps the reader get oriented to the fact that we are not a group just about illness, we are about illness and wellness. That very difference has set up apart.
So, I would encourage us to flip the order, help us throughout the drafting get clearer on history, evolution, how certain practices have moved from polarities to integration, and then really focusing on what this is.
Those would be my thoughts, Jim, in trying to help identify what I am hearing.
DR. GORDON: What I was going to say is, it might be helpful if we had a sense that what Dean and Joe in particular were talking about, about focusing on aspiration rather than opposition, if there were some kind of commonality among all of us about that at this point.
I am saying that partly because I agree that I think that that is more important and that the definition is going to be crucial, so we need to be in tone, as well as in the specific words.
MR. CHAPPELL: Good. Thank you.
DR. FINS: Following on what Tom said, I think it is very helpful, but just to put it into a philosophical context, it is very Hegelian. There is antithesis and a new synthesis. That is part of how this has happened. There has been a reaction to, and a moving towards, which is an integrative model.
There are some things that are clearly not intentioned, and are in parallel. So, I think there are really two ways that we got to CAM, and the other thing, Tom, you said what CAM is, but it is also is and becoming, whatever this new thing is.
So, it is a moving target, and I think we have to acknowledge that the very fact of producing this document changes a lot of definitions. So, it is an evolutionary phenomenon and I don't think we want to be static, and I think it is very much an evolutionary framework.
MR. CHAPPELL: Thank you, Joe. Yes, Dean.
DR. ORNISH: Again, I won't belabor this point, but particularly at the very beginning of the document, to the degree that it is read as a criticism, it is harder, people stop listening.
When we talk about systematic and consistent suppression of CAM professions, et cetera, I mean that just immediately polarizes people and to a degree that I think is really counterproductive, if there is some way we could find a different way to express that.
MR. CHAPPELL: Yes, Tieraona.
DR. LOW DOG: But I think it is important that it is included in the document, because it gives the context to where we are today, so I think that it needs to go into the historical section.
So, my comments would be that I like the guiding principles, that we start with those. They are very positive, and when you read them, I think we are going to have very little disagreement over them. I think they are powerful. This is who we are, this is the commission, this was our charge, these were our guiding principles, and then we go into it.
You could put the summary of CAM, and then you could give a historical context. I don't think it has to be antagonistic, I think that it can be factual, and it also gives place to how science did bring about very positive changes, as well, but how things through a number of reasons happened and that some of these are considered mainstream and some are not.
I think it is important in the document to have a historical context of how we are, but I think when that is what you open with and that is what you read to begin with, it just is hard to read.
DR. ORNISH: When you talk about systematic suppression, those are strong words, I mean really.
MR. CHAPPELL: Can we hear from Jim for a moment, please. Jim.
MR. SWYERS: I think what Tieraona is saying makes sense. I had not envisioned putting the guiding principles in the introduction of the report, but I think that might be a better place for them than here. I like the way she laid it out.
DR. YOUNG: Great.
DR. PIZZORNO: I have some mixed feelings here. On the one hand, I agree with you, we don't want to be antagonistic, but on the other hand, we have to talk about the historic reality. The historic reality is that the AMA lost an antitrust lawsuit that documented the systematic suppression, and right now, today, the state medical associations are blocking the licensure of other of the CAM professions in states all across this country, so it is happening today.
I don't want to be antagonistic, but let's not pretend that this is not happening.
MR. CHAPPELL: I think these matters can be handled just as we have been speaking. First of all, we open the section with the guiding principles, i.e., world view. Next, we have a description of the history of this as we have been describing it, although we might open that section with the summary definition, but either the summary definition at that point or following, but I think we can craft this with a different structure and a better focus.
So, I think all these comments are helpful. I am running out of time on my section. I am just going to take your comments here as ways to address more specifically the sections of the CAM material on pages 1 through 6, which are very well identified I think, but we will work on the order of presentation and the tonality without forsaking any kind of accuracy in the history.
MS. CHANG: Tom, just so you know, you have got about 10 minutes for this part of it.
MR. CHAPPELL: Well, but according to what was handed out here, I had only 20 minutes, and I have been 30 minutes so far.
MS. CHANG: I think you have pretty much put the two together, the description of CAM and the summary definition of CAM. So I have given you 40 minutes for that. So, you have about 10 minutes before Wayne's part.
MR. CHAPPELL: Okay. Joe.
DR. FINS: On the point here of showing how we are moving towards integration, I think a nice example, which I would like to see sprinkled throughout the report, is the role of hospice as a meeting ground for the allopathic and the CAM.
In other words, if we are looking at this evolution and this new synergism that is evolving, that is a nice part of the middle of the Ven diagram is really end of life care and the hospice movement when you are using therapy, you can get massage, you can get morphine, you can get a PCA pump, you can get radiation. I mean there is a lot of things.
So, I think that is an example of how people are kind of coming together in that aspirational model, like on page 5, in that area, we are talking about spirituality.
MR. CHAPPELL: Thank you, Joe. Effie, and then I will take a few minutes just to look at the section.
DR. JONAS: Go ahead. I just want to mention one thing related to what Joe and Dean have said.
MR. CHAPPELL: Why don't you go ahead, then, and then we will go to Effie.
DR. JONAS: I have a suggestion. I like the idea of a Ven diagram. It is a moving target, there is a spectrum of CAM all the way from things that are clearly antagonistic and outside of mainstream, all the way to things that it is hard to tell the difference, and, in fact, there is no difference.
I would just like to suggest we introduce something like the Ven diagram illustrating the spectrum and illustrating that it is dynamic, that, in fact, it is changing, that there are things that used to be very much outside and that are now much closer, there are things that are emerging, there are things that are completely overlapping, and that one of our goals is to really move these things closer and closer together to have a common understanding and get them into the health care system when they are safe and effective.
I think the idea of a spectrum, especially a dynamic spectrum, which we could then illustrate with a figure, might be a very useful way of doing this, and also illustrating I think, as Dean and others have mentioned, a little more emphasis on the fact that these are being used and that they are actually, at least for the public, already part of the mainstream, which I think needs to be very clear and perhaps up front.
MR. CHAPPELL: Effie, and then Dean, then Joe.
DR. CHOW: I also like the spectrum and diagram aspect, too. I hope the history will go back to reporting on the times in the 70s when people were being jailed, acupuncturists were being jailed, and so it shows the evolution, homeopathists were being jailed and Christopher Hill, the holistic practitioner, was being jailed, and how we have to help them get out of jail, and so forth, to now that acupuncture is being funded, and then the integration like the model that Joe gave, the total integration. So it does give the history of the difficulties that it has come through.
I think we have to remember always, because I think a lot of comment of fear and antagonism is because we think that the Commission Report is coming from us as Commissioners, but we are really speaking for the people, and I think we have to keep that in mind and that we must speak for the people that have spoken so forthright about the prosecution that is still going on.
I think it is our duty to speak to those aspects without talking about antagonism from our standpoint, but from the fact that we have heard this from the people, and we must represent the people from both ends, from the traditionalists, who want to integrate and don't know how to integrate, and from the people who have been trying to practice and have been indicted, and still find great difficulty.
So, if we keep remembering that we are speaking for the people, and this document isn't from us only as Commissioners, perhaps that might help us from being fearful of speaking what is the truth right now.
MR. CHAPPELL: Thank you, Effie.
DR. ORNISH: For me, it is not an issue of being fearful, it is an issue of being what I think is being accurate, and I have I guess what really amounts to a process question, which is, I have pretty strong feelings about this language, "the marginalization of CAM results into the systematic and consistent suppression of CAM professions, institutions, and practitioners by mainstream health care professions through a variety of political, institutional, and economic means."
That is such inflammatory language, and I don't agree with it. I mean, there are certainly examples, as Joe Pizzorno has pointed out, and we will agree to, I have certainly had my own experiences, but in terms of making it so sweeping, systematic, consistent, I don't agree with that.
So the question is, if one or more Commissioners has a minority point of view that he feels strongly about it, I am not quite sure what the process is at this point.
MR. CHAPPELL: Dr. Gordon, would you comment on that?
DR. GORDON: My perspective is, I agree with both sides. I think there has been some systematic oppression, but I think that it can be dealt with in a way without making it inflammatory. I think there is some truth in the history, that is part of the historical segment, and I would really hope that as we move ahead, we can find common ground.
I mean, I think this is really our effort here throughout these three days, and as we have ahead, is to see if there is a way that we can come together, not to serve us, but it is going to serve the public far better if we can come to a shared perspective.
So, we may need to come back to this at some later time to understand what each of us means in each of the sides, and then give it back to Tom and Wayne and the group, and ask them to come up with a way of talking about it that makes sense to all of us.
So, that is what I am hoping for rather than a minority perspective.
DR. ORNISH: I am leaning towards something that says we recognize that at times there have been examples of suppression, et cetera, et cetera. We are encouraged that there seems to be a growing movement and commonality of purpose, something that puts it in that kind of perspective, as opposed to the way it currently reads.
MR. CHAPPELL: I would support that as well, Dean.
Joe, and then Joe.
DR. PIZZORNO: I want to be very clear that I agree with the intent that Jim and Dean just stated. We should say this in the least antagonistic way and the most facilitating cooperation and collaboration way that we can, and we cannot leave out the historic reality that CAM practitioners and institutions have had to deal with.
My teachers were taken out in handcuffs in front of their patients for practicing what is now becoming popular. So, this is what happened.
MR. CHAPPELL: I think what I am hearing is that there is a need to structure this historical section in terms of where we have been, where we are now, and then where we are trying to go. Those are the three frames of time that I think might help this moving target, this evolutionary aspect of CAM.
That way, you are able to honor the realities of the historical ugliness of this. That is just documentation, it is not orientation of language or attitude. You can talk then about where we are now, Jim. I think we can do where we have been, where we are, and where we need to go as this kind of evolutionary issue.
That is what is making this whole task so difficult for us all, because we can't get into the same time frame together to have a dialogue, and unless you do break it down that way, we can't reach agreement, and I think that is one way to do it, that there is a historical reality, there is a real flux of where we are now, and there is a real hope of where we need to go on this.
I am going to encourage that kind of frame to the historical piece. That will allow us to be much more specific about what CAM is and how it relates to the aspirations and orientation of the Commissioners, because we have a world view that has shifted from the historical perspective here.
That is how I am offering up these combinations of suggestions. I am almost out of time, and, Joe, I know wants to say something.
DR. FINS: I want to echo what you said, I completely agree with that historical evolution, but I also want to say that this Ven diagram concept can also be utilized as a political picture, because the more overlap there is, the more consensus there is, and consensus is really what we are after.
So, maybe we need two pictures. We have the Ven diagram from 30 years ago, like this, and we show the convergence, not the complete overlap but that there is an evolution. There wasn't consensus to even have a commission like this 10 or 15 years ago. There is now. There is a political balance.
The bigger that overlap can be, the more attraction this will have politically, because we have all agreed to that overlap.
MR. CHAPPELL: Great. Charlotte.
SISTER KERR: I just wanted to say, and it is congruent with what has been said in your summarizations, but for myself, I would like to speak that the spirit of this chapter for me was that it was to be an invitation to the reader to listen to the story about the evolution of healing in America. This is why these points Dean and Joe, and all, are making, when you talk to someone, you invite them to listen.
You have to, I believe, start with a conceptual framework, the overview that I think that people want to hear, the world view piece that we don't have yet. The history, you don't start off with, which has been acknowledged, the marginalization, that kind of conversation at the beginning.
This is just a point I have, and I don't know what will happen when we get to reading the overview, conceptualization, or the world view part, how congruent are we as a commission, still. My own feeling is when we get to that, we may have some discussion we didn't expect, and that will affect, of course, this whole chapter.
MR. CHAPPELL: Thank you, Charlotte.
DR. GORDON: I just wanted to make a procedural point that as we go through the day, it is important that the order that is here is not necessarily the order of the report, and that is still to be determined.
So, in this section, marginalization, just for an example, could be very much fitted into a history section that could be further down in the list. Just because something is at the top now, doesn't mean it stays at the top. That is really up to all of us, and to the workgroups in particular.
MR. CHAPPELL: I want to thank the commissioners for each of your contributions. This is very, very helpful. I think you have given us very good guidance, and I think we can accomplish what I hear many of us asking.
DR. JONAS: Are we ready to talk about principles? Let's turn to page 6, Guiding Principles of the Commission. These actually are taken directly from those 10 principles that were initially put up on the flip charts that the different groups came up with and then were kind of put together.
There has been an attempt to simplify them. The initial ones, some of them had quite a number of words in them that were overlapping, so this version is an attempt to kind of bring some of those overlapping things together into a single set, and also to put a label on them, which certainly all of this is open to change, but a descriptor that kind of encapsulates what that "principle" is, because if you have an entire paragraph, you have to look at the entire paragraph to say, well, what is this about; what is the meaning about.
So that, the bold terms are really terms to try to help you identify what the core issue is. It may be that we want to make that several words or several phrases, or something like that, without making it too long, so that then one can't get the gist of it.
In some ways, we have been preempted by the Institute of Medicine, because many of the principles, not all of them, and I think this is an important area for discussion, have been outlined in the 10 principles and core values of the National Academy of Sciences' report on the way to improve health care in the 21st Century. That is on page 8, "Crossing the Quality Chasm."
Does anybody know, has this been published? Is it is officially out and sanctioned, and this type of thing? Because I think before, it was not officially out.
So, here are core 10 beliefs. I have marked the first five as being almost exactly parallel with many of the core principles that we have in ours. Some of the others deal with health system management, which this is largely about, so I think we are really in congruence with some of the mainstream thinking that is going on in terms of what is needed in the health care system.
I like that. I would like to make sure to emphasize that bond, and it may be that the wording of these principles are such that we can make it clearer that we are congruent with those. So, that is one item I think that needs to be discussed.
The second item is, these are not in priority order, and I think it is important that we figure out, is there a priority to these and, if so, what do we want to have up front, and not.
MR. CHAPPELL: Thank you. I actually would like to begin with the opening paragraph of this section. I do think, knowing that this will probably come at the beginning of the document now, that we need to address this shifting paradigm or shifting world view from preoccupation with illness to one that is concerned with both illness and wellness and that CAM is very much the promotor of health.
I would like to see this paragraph identify the part that we play in helping to promote this shift in world view or paradigm from a focus on illness to a focus on illness and wellness.
It doesn't occur anywhere, yet we speak about it all the time in these meetings, and this would be in the introductory paragraph of whether we call them guiding principles or whatever, this really helps set up that shift.
We can do that apolitically and very positively by referring to a shifting paradigm of health orientation.
DR. JONAS: Yes, I agree with that. In many ways I think the summary definition, which I personally think ought to be up front, I think when you are starting something, you ought to have at least some kind of definition up front and then go to the guiding principles, but they all should be crammed in as close to the front as you can.
Actually, I think we have some wording in there about the world view of shifting more towards wellness and health promotion, so I like that. I think maybe we should make sure that is in the principles.
Joe, and then Linnea.
DR. FINS: I just want to say, though, that there really are parallel tracks here and I wish Dean were here, but the Framingham study and cholesterol management and Healthy People 2000 and 2010, the United States Public Health Service and the great work that they do, we are doing a lot of the same things in parallel, so again, to overcome the dichotomous world view.
One vector ended up being coronary bypass grafts, another vector was Dean Ornish's work. They both have similar origins and different vehicles to achieve promotion of cardiovascular health. So, I think that that is one thing.
The other point, if I could put a hierarchical thing in first, I think the partnership is probably something we want to maybe highlight in a rank order as being so important, because partnership enables all the other things.
DR. JONAS: Let's not get into prioritization yet because that is an area that I think we should discuss. Just other general comments about the principles, and then I think we actually have time to go through the principles and then say, all right, then, which ones do you want first and are there some wording changes that you would like, unlike the wordsmithing of the definitions, I would like to see some wordsmithings on these preparations.
Does that sound like a reasonable approach, should we do that? Yes.
MS. LARSON: This is to the comment of the similarity between some of the principles and the core beliefs, core beliefs of Crossing the Quality Chasm. We might want to actually highlight that and be saying this is noteworthy that two independent bodies came up with very similar core principles, beliefs, and then to actually detail how they are.
You made a statement, Wayne, the first five, so then we write here is the correspondence, and I think it is important to say these are two independent bodies that came up with these at similar times, but with no overlap.
DR. JONAS: So, make the link more clear.
MS. LARSON: Make the link more clear. Also, I have a technical question. I have no idea about what "safety is a system of property" means.
DR. JONAS: Actually, that relates I think directly to complementary issues because, in general, many CAM practices are inherently more safe than more aggressive types of approaches, so it is a system, it is a property of the system of many CAM practices, I think if you were make an analogy of that or make an example of that.
I think CAM is an example of systems in which safety is more inherent than some other types of more aggressive practices, but I am not sure if that is what they meant.
Shall we go through the principles? I think we should do that, again realizing that the initial phrase, we might want to make it clearer like instead of just saying "evidence," saying "the importance of evidence," or a small phrase to kind of capture that.
DR. GORDON: Wayne, that is fine. If there are other issues, though, that you want to cover here, or anyone else wants to cover, we need to leave some time for those, as well, in your section.
DR. JONAS: Well, there was nothing on my section, but there may be some other things earlier than this that people want to talk about.
DR. GORDON: If you want to spend some time on these and then leave at least 10 minutes at the end, and maybe Michele can give you a signal, and if there are other issues that people have, they can raise those issues and we can talk about them before we come to see where we are at the end.
DR. JONAS: Who is going to signal me?
MS. CHANG: The problem is when you have approximately 12 minutes for just the guiding principles, and then you have got five minutes each for mission statement and historical context. So, how you want to manage that is up to you.
DR. JONAS: Jim, are you referring to other issues besides those?
DR. GORDON: If there are any other issues besides the ones you have listed here.
DR. JONAS: How much time do I have for the guiding principles?
MS. CHANG: You have about 12 minutes left.
DR. JONAS: When I have 10 minutes left, let me know, and we will go to other issues.
MR. SWYERS: Since we have already dealt with historical context, we could probably go into that at that time.
DR. JONAS: Let me make a suggestion. Rather than now going through and wordsmithing each one, which I think maybe would be a secondary thing, I think we should talk about priorities and links, so how about if I open that up. I think Joe had already mentioned that, one, partnerships was important.
Is there a particular order, are there particular principles that you think should go up front?
DR. FINS: Crossing the Quality Chasm in the earlier IOM report about quality and safety was about systems, so there may be a segue there between systems of care and partnerships. You can't have a system without partnerships and dialogue and communication, so that might be an umbrella under which everything else follows just logically.
DR. GORDON: The issue that seems important to me is that it be very focused on people, on individual people and on sort of the community of people rather than from a professional perspective.
I think if we focus on issues like wholeness at the beginning, and if when it comes to partnership, part of that partnership is also the partnership between ordinary people, whom we call patients, and people who are professionals.
For me, that is the strongest feeling that needs to be there. I am not deprecating any of the other pieces, but I feel that that is our up front representation that needs to be in that area.
DR. JONAS: We have got two votes for partnerships, one for wholeness.
MS. SCOTT: I do support what Jim is saying. For me, I think the bolded words are not resonating with me. Wholeness was one word I had down, safety, wellness, equity, and it may be embodied in all of this, so I would just like to keep open the idea that we would not necessarily stick with these bolded words, because they don't bring that wholeness, people perspective.
DR. JONAS: Right. So, taking the bolded phrases and making them more phrases similar to in the IOM report, which gives a little bit more meaning to it without doing a whole paragraph.
MS. SCOTT: Right now that is what I am feeling.
SISTER KERR: I would just like to point out, and I have brought this up many times over the last months, and as a group, I would like us to decide what we would like to do.
Under Health and Healing, we often have statements throughout the report that we have been working on, interim included, when it started, you see the line that says, "The body has remarkable capacity," do we want to, as a group, state things like the body-mind has a remarkable capacity for healing? Do we believe that as a group?
We say, when we start with wholeness, as Jim is pointing out is a good place to start, we talk about body-mind-spirit, environment da-da-da, but I think today, we should decide, so that when we read the report, all the time we are consistent. Do we want to say body-mind-spirit, do we want to say body-mind, and assume that includes spirit, and do we not want to do it?
Thank you. So, what do we want to do?
DR. JONAS: Well, I know what you want to do. I agree, I think we should put in body-mind-spirit actually.
DR. PIZZORNO: I would like to second what Jim suggested, as well as what Charlotte suggested. I like the idea of the first principles being those which emphasize the philosophy of healing and wholeness. Charlotte, thank you very much for the body-mind-spirit language. I think that is wonderful. We should use that consistently.
DR. JONAS: So, is that a vote for health and healing being somewhere towards the front?
DR. PIZZORNO: Absolutely, wholeness, health, and healing right there at the front. That is what this is about. A little bit of wordsmithing on the principles, after "Practitioners," I would add to words, "disciplines, institutions."
DR. JONAS: Where are we?
DR. PIZZORNO: Under "Partnerships," right after "Practitioners, complementary practitioners," add "disciplines, institutions."
DR. JONAS: "Disciplines, institutions." Okay.
DR. PIZZORNO: It would just be more comprehensive in how we are stating this.
DR. JONAS: Okay. Other comments?
DR. FINS: I worry about it getting a little too fuzzy and a little too -- I mean I agree with it in principle as something that informs my own work as a physician, but I think that it can be misunderstood, it can antagonize people. Secular science might be antagonized by notions of spirit in this context.
So, I think we need to be very careful. Maybe Dean can help me here, but I think it is his red flag land mine comment.
DR. ORNISH: I wasn't called on.
DR. JONAS: You are called on.
DR. ORNISH: Thank you. I think all of us certainly agree with the idea. Maybe if we could have somewhere in here, just like you defined earlier on that CAM -- there is some footnote here -- basically, you are saying, like on page 6, complementary and alternative and integrative are kind of synonymous. Maybe we could say somewhere that when we say "body," as a general principle, we are talking about the larger issues that encompass the psychosocial, the emotional, and spiritual dimensions.
I personally think that language sounds better than body-mind-spirit, and that when we talk about the body, you know, throughout the document, we are not limiting it to that, but that every time you say it, just like you don't say he or she, even though you might say when we say he, we really mean all genders. It just becomes clumsy and awkward to have to actually say that every time you mention the word "body."
MR. SWYERS: So, you are suggesting a footnote.
DR. ORNISH: Well, just something that says, early on, that as one of the overall principles, that we are talking about incorporating the psychosocial, the emotional, the spiritual dimensions, and that later in the document, when we make reference to the term "body," it is really in that larger context. And leave it at that. I don't think you have to say it every time.
SISTER KERR: I think I would understand what is being said. I think "body-mind" has become more the generic term that includes the body-mind-spirit environment. If you are going to footnote something, I mean, this could get deep here in terms of issues of he/she, et cetera, and gender.
I think maybe I would eliminate it all and put "spirit" if I wanted to make a point, but since I am trying not to be too radical here, I think the body-mind footnote is a common use.
DR. FINS: Another possibility is to give it the importance that it is due and put it in the historical section as a major element of what has motivated CAM in contrast to the secular, scientific, allopathic approach. We don't want to give it short shrift, but we also don't want it to be pervasively antagonistic that people would find it offensive.
DR. JONAS: I think that is an excellent point.
MS. CHANG: Wayne, you have about 10 minutes.
DR. LOW DOG: I thought if we put something like wholeness at the beginning, I also am in favor of that, and it says, "Health involves all aspects of life, mind, body, spirit, relationships, environment," and if that is our opening statement, I think that is a powerful one to begin with, and I agree, too, that if you start reading mind, body, spirit throughout, that it also loses its power when it is used like that, but I think that that is an important one to open with, because I think it truly does reflect healing on all kinds of levels.
DR. JONAS: So, another vote for wholeness being up front, right, and healing, I think also partnerships, and I think relationships is a word that is not too up front out here, but is inherent, and we maybe want to make it more up front is another thing that I heard. It is up front in the IOM report.
MR. CHAPPELL: I do think we need to, as we order the priorities here, these priorities need to come from the true perspective of where we are as a CAM community, and not trying to tailor a document for a particular reader.
This is the most powerful presentation we can make in this section as a group of commissioners because this is saying what we believe, what are the core values, and I look at something like evidence, and I agree that that needs to be certainly in the first half of the group, but I don't think that it needs to be first just because we are trying to speak to an audience that is trying to dismiss us.
Therefore, I think we need to be true to ourselves on this, be strategic in the way we use some of these other principles like evidence, but I don't want to see us dilute our power. So, I am agreeing with the idea of wholeness and health and healing, partnerships, prevention. I mean, my goodness, that is what we are about.
DR. JONAS: Comments on evidence?
DR. WARREN: Well, I am looking at what does a holistic practice really entail, and your guiding principles is part of every bit of it. What is utmost in this whole thing is health and healing and wholeness for the patient. Those are the first two.
I like wholeness first because it defines life, it defines mind, it defines body, and it helps define what health and healing is. So, I would say wholeness one, health and healing No. 2. No. 3 is every single person that walks into our office is an individual. I think No. 3 ought to be an individual.
No. 4, every individual has choices. No. 5, every individual is educated and needs empowerment. No. 6, I think prevention. No. 7, the public involvement in the prevention through education and empowerment. No. 8, dissemination of that information.
No. 9, then, you get to evidence, and No. 10, you get to the partnerships.
DR. JONAS: I am going to take two very short comments, and that's it.
DR. FINS: I think there is a confusion here between principles and process. Health and healing, wholeness, individuality, I think are principles. Process is evidence, dissemination, partnership, in other words, so we are talking about two different categories of things here.
MR. CHAPPELL: No, we are not. No, we are not. I am just going to intervene here. We are talking about what we deeply believe in as a group of people, and that is why we scripted this group. That is why we put this group, and then we started calling them something else. These are our core values. This is what we believe in.
DR. FINS: Right, we believe in all of this, these are all principle beliefs.
MR. CHAPPELL: Right, we do believe in all of that.
DR. FINS: What I am saying, though, is that, for example, evidence is a way of achieving health, healing, wholeness, and individuality. Using that, but evidence, in and of itself, is a subset of those more transcended principles.
MR. CHAPPELL: I don't agree with that.
DR. JONAS: Tieraona asked one, and then I am going to ask everybody to do what George just did, but I want you to write it down, and we are going to actually see kind of what we come up with.
DR. LOW DOG: That is kind of where I was at. I just wanted to, before we do that, I like the first four, but I think evidence then drives a lot of -- to have education, to have dissemination of that education, to have all of that, you have to have some evidence for what you are talking about.
I would have ranked it a little bit higher up, but probably No. 5, and then driving it on the rest. I agree, I think that as a provider of healing, as somebody that works in that field, I think most of us are driven pretty much by seeing our patients as being whole, and their freedom of choice and their individuality, but I would rank evidence higher. I would have put it up around No. 5.
DR. JONAS: One of the things I hear is that it would be nice to kind of link some of these, so that you can see how one follows, and what you mentioned, certainly individuality and the importance of choice, and this type of thing, that that could probably be done better throughout here after we get kind of our priorities established is to try to link those.
Dean, last comment.
DR. ORNISH: Real quick. I mean, even under "evidence," I think if we could put something in there, instead of just saying that it will enhance the development and delivery of these services and products, something that turn out to be scientifically valid, the way it reads now is like we want to get evidence to do things that we want to do as opposed to looking at evidence to see which things are worth doing, and I think that is a really critical thing that anyone is going to pick up on as a bias of the Commission if we don't change that.
DR. JONAS: I would have some wording issues on that because I do not word that in that statement. I see help to identify, in other words, you use scientific evidence actually to find what is safe and effective. I mean that is how I read that.
DR. ORNISH: Well, apparently other people share this, too, so if you could just put something at the end, something along the lines that those that turn out to have, those that are scientifically based, those that have evidence to support them as opposed to --
DR. FINS: The phrase "generating evidence" in the sense that you are fabricating evidence.
DR. ORNISH: That is important actually. You are trying to come up with evidence to prove what you think you already know as opposed to trying to search for truth.
DR. JONAS: Okay. So, wording on that, so that it makes it a little bit stronger in terms of -- yes.
DR. GORDON: I think one thing that would be helpful, and I know you want to get specific words, but it may be helpful in this period of time to get some of the principles flushed out, just as we are doing with evidence for all of the different categories, and then the point that you make about linking them, I think seems crucial to everyone.
I think the more we can contribute to expanding and focusing what we mean, just the way Dean and Joe were doing with you, on each of these, the better.
DR. JONAS: How much time do I have?
MS. CHANG: Just a few more minutes before you need to finish up with mission.
DR. FINS: May I make a parliamentary question here? I am just wondering, I think we are reaching consensus on this. I don't know what the utility is of a half-hour for Jim to do what these guys seem to be doing already. If we could maybe get more time for them to finish up.
DR. GORDON: I think on this one we can, because I feel like I have a pretty good order, so I would like to give them 15 more minutes and just take 15 at the end.
DR. FINS: Thank you, Mr. Chairman.
MR. SWYERS: Yes, I think it would be helpful at the end if we can summarize just for my purposes to try to figure out where to go from here.
DR. JONAS: So, we have 15 minutes, we have been reprieved. Breathe.
DR. BERNIER: I would like to cast my vote for the inclusion of evidence as one of the very strong parts of our outcome. It is I think something which is more and more being looked for and being utilized.
DR. JONAS: Another vote for evidence, and so, as has already been mentioned, a rewording of it to make it clearer that we are really trying to separate the wheat from the chaff, if you will.
DR. PIZZORNO: I fully agree with the comments that Dean and George stated, and maybe something along the lines of we perform the research to provide evidence to enhance the development of these healing arts to make them more effective and safe. I think that is both issues, the safety and efficacy.
I don't know how you put in language to say, remove things that don't work, but it would be nice if we have some kind of language like that.
DR. JONAS: I think you can say it.
DR. FINS: I think safety should be one of the bullets, which somehow is not here. We are going to talk a lot about adverse event monitoring and the OIG report, to be consistent, we need to do that.
DR. JONAS: You are proposing another principle?
DR. FINS: I might be, if it is not here.
DR. JONAS: So more emphasis on safety.
DR. FINS: Well, it is a subset of evidence, but evidence means something else, so I don't think I am proposing something that we haven't agreed upon.
MR. CHAPPELL: I think, Joe, what we need to do is move from the single word "evidence" to the phrase "evidence of safety and efficacy."
DR. FINS: Yes, evidence of safety and efficacy.
MR. CHAPPELL: That is where your phrase can be more helpful than the single word.
DR. FINS: The other point which I think might be very helpful, and it gets back to the point that Tom completely disagreed with, but I know we fundamentally agree, is in a paragraph here, we set out those over-reaching points that are embedded in these other principles, again, health, healing, wholeness, and individuality as the core issues.
Then, maybe we just do it alphabetically, in other words, because I think we could really split a lot of hairs, and if we say it is alphabetical, which we believe they all are very important, because I think that some of us feel very strongly about evidence, others are going to feel very strongly about choice. This might be a way of reaching a Solomonic compromise without spending a lot of time, and then it's all there, we apprise all of these points.
So, I just put that out as a possible hedge to compromise.
DR. JONAS: Thank you.
DR. GORDON: I think that is one way to do it, but I kind of like the idea of trying to pull it together in a coherent way, so that each of these 10 flow into each other. I understand the notion of compromise, but I think it becomes a much stronger statement if it is done narratively that way.
DR. JONAS: Ming.
DR. TIAN: I have a suggestion. I think a good idea was using efficacy and safety for the first one. I still prefer we put that the first, because I believe that CAM is a medicine. If it is a medicine, you have to answer the first question, efficacy and the safety.
The other principles are important, but again, if there is no efficacy, there is no safety, you are not talking about a medicine. I think all the 10 principles are very important, but I prefer this will be the first.
DR. LOW DOG: I just think that evidence needs to rank high up there. I just think that healing is something much more than that. I think that healing, I mean the "who," I think did a good job, sort of it is the active integration of our minds, bodies, spirits, and social beings, and that that is really what healing is all about.
That, I think is true whether you are talking mainstream or CAM. So, I think some statement about who we are, the essential essence of who we are, about holism, I think is very important.
I don't think evidence should be down at the bottom of the list, because I think it then informs how you are going to do education and prevention, and I think all of those things without evidence, you don't know what you are doing, so I think it needs to be up there, but I am still high on the list for sort of the healing overarching principle.
The IOM, I think they talked about sort of healing relationships and patients, so even they, they had evidence as No. 5.
DR. JONAS: Their fifth bullet was evidence. You want it higher than that?
DR. LOW DOG: I want it higher.
DR. JONAS: You mentioned one thing, Tieraona, that I wonder if it is a general consensus, is that we at least conceptually in the text somewhere link to the WHO definition of health.
DR. FINS: That has been widely criticized as being way too expansive. It has been criticized as being overly inclusive and saying that health has gotten to other human sectors, and it is no longer health care, it is something else.
DR. ORNISH: I just want to say I really like Tom's suggestion about expanding the word "evidence" to "evidence of safety and efficacy." I do think that should be first for a lot of reasons. It really brings people together.
It is not distorting what we say to please another reader, but it is also mindful of the fact that this is something that really brings everybody together, and then it marginalizes opposition, because if you say we are in favor of evidence of safety and efficacy, then, what do people say, oh no, we want things that aren't safe and effective?
You know what I am saying, it really seizes to the high ground and the middle ground all at the same time, so I like your suggestion.
DR. JONAS: Strategically, politically, and strategically correct, yes, not just correct, but valuable for integration purposes.
DR. CHOW: I have always liked the broad statement of the World Health Organization, and if we delineate that further with our own definitions, I think it would be a nice combination.
I think the four, wholeness, health and healing, individuality, and choice can be put in a nice paragraph, and then evidence comes right after that, before the others, and the others, it is okay.
DR. JONAS: So, put them in.
DR. CHOW: Yes.
MS. SCOTT: I feel very strongly that wholeness needs to be first. I would recommend we really could fold in wholeness, health, and healing as one, and then I could support evidence being No. 2, evidence for safety and efficacy being No. 2, and then the rest following, individuality, choice, because I think they are both important.
I originally had evidence as No. 5, but based on the discussion, I could see moving it up to a No. 2, but I really think the essence of CAM is really between wholeness, health, and healing.
DR. JONAS: Health and healing, right. Okay.
DR. LOW DOG: I like Julia's suggestion, and I think combining wholeness, health, and healing, I think makes sense, that that could be just as if we were doing evidence, safety, and efficacy, I mean that we have sort of made the phrase, I think that that goes.
I think that also, it is recognizing all of those aspects that drives evidence. You know, evidence doesn't exist on its own. You have to have it within some sort of context, and it is partly through defining wholeness and the body's ability to heal that will drive some of the new research that is going to be done.
So, I still think that wholeness, health, and healing, and I think again, it could be 1, make it 1, and then, No. 2, your evidence, safety, and efficacy, No. 2, which is right beneath it. So, I would support Julia's.
DR. JONAS: I think they are both very important. I would be careful not to make them one. I think they are different. I think healing processes, the stimulation of healing process is one concept, and the idea of then everything being connected and the importance of paying attention to that is another concept, but I wouldn't merge them.
MR. CHAPPELL: Yes, Wayne, I support your comment there. I do think they are different enough to be treated separately, to combine them will dilute the opportunity, so the order of priority, I think is great, but I would like to see them kept separate.
DR. JONAS: Joe has the last word, and then I am going to summarize.
DR. FINS: Maybe as a compromise, because there is the evidence crowd that will not be happy, maybe if the opening paragraph, Julie, maybe if you could live with this, the opening paragraph stresses wholeness, health, and healing, and then the first bullet is the evidence, efficacy, and safety, and then the second bullet would be health, healing, and wholeness, if we broke that up, in other words, so it is in the opening paragraph as an important over-reaching principle.
Then, we get the evidence, efficacy, and safety, and then health, healing, and wholeness as 2 and 3, so we have kind of created an evidence sandwich.
DR. LOW DOG: I just wanted to ask Joe something. Joe, I am just in full support of evidence, but I am confused where we are blocking on this wholeness as being the first. Is it the word "wholeness," because this is a principle that guides us in mainstream medicine, this is what we all believe.
We didn't become physicians to study evidence. I mean we believed in humans and their wholeness, and we wanted to participate in that process, and evidence supports the art of medicine.
We are artists basically that use evidence to support what we do, but it seems like the fundamental foundation of all medicine, all healing all around the world is this belief, and I am not sure if wholeness should be it, or health.
Maybe it is the word "wholeness" that is a trigger or something, I am not sure, but I think we could come up with some phrase. I think evidence then supports that, but that is the core value. I am just wondering where we are at with that.
DR. FINS: I guess the issue, if we define wholeness as mind, body, and spirit, we don't have evidence for faith, so there is a tension. So, it is a language issue. Again, I don't want to be overly defensive, but I think we have to write a defensive document.
DR. ORNISH: A mindful document. Again, I think if you can bring people in at the beginning, around something that everybody agrees on, it just makes everything flow easier. It is not a rank order of values, of importance, it is the best strategy of bringing people in, that's all.
DR. JONAS: I have Charlotte over here and then I want to just make a couple summary comments, because I think -- are we getting towards the end?
MS. CHANG: You have five minutes for summary and five minutes for a mission statement.
SISTER KERR: I would like to give Tieraona an award for her statement, please, and then I would like to say, when we look at the National Academy Institute, the 10 principles, they have healing relationships as No. 1, and patients' needs and values.
So, when we get into, we call it sort of individuality and partnerships, I am not so sure our partnership paragraph emphasizes health coach and patient, or practitioner and patient enough, but I think we have got to get back here to sort of the art form and what we are all about in relationship.
DR. JONAS: Okay. We have heard a lot of comments, I am sure we will hear more, and welcome to accept any suggestions on wording, principles, et cetera. What I have heard is that we need to do some changing of the phraseology especially the areas in bold, for example, in order to get it clearer about what we want, in some cases, maybe mixing some of the areas, so that we get the principles out.
We have had a number of suggestions, I would welcome some suggestions from you, and I am going to ask you to do that in just a minute. The importance of wholeness and healing are clearly there. The importance of evidence, safety and efficacy is clearly there.
The emphasis on relationships and the development of relationships is not so clearly here and needs to be brought out.
I think linking in perhaps a more specific way to some of these IOM issues, as well as to some of the others like Healthy People 2000, perhaps the World Health Organization, et cetera, would be something we would also look at, making clear that we are talking about mind-body-spirit, perhaps not in every single phrase, but in one of the up front statements or at least in one of the guiding principles.
What I would like to ask you to do now is I would like you all to take a piece of paper, and I want to spend five minutes, and I want you to rank order on that piece of paper, 1 to 10, the principles, and I would like next to the principles, I would like you to put if you have any wording changes to the bolded areas.
Remember, we have to keep that pretty short, notice the IOM is a phrase, not even a sentence, and that you rank order your principles from 1 to 10 with any kind of changes in the phraseology of the bold statement in that, and, Michele, if you could collect those, we will take those.
DR. JONAS: Tom recommended doing the top five. Is that reasonable? Okay. So, just do five, that is a minute each. I am trying to get both the order and also some phrase changes that you might want to have in that, and we will take a look at those and try to put those together for revision of this.
DR. GORDON: Wayne, Steve has reminded me that the audience has not seen the 10 principles. Do you want to read them out loud, the way they are written down here?
DR. GROFT: Just the bold parts.
DR. JONAS: Just the bold parts?
DR. GORDON: Yes.
DR. JONAS: I will try to paraphrase them a bit perhaps.
The first one is on evidence, that is, commitment to using science and evidence-based medicine for identifying safe and active, effective practices.
The second one is dissemination of quality information, promoting efforts to thoroughly examine the current evidence and make information about that available in a timely fashion.
The third one is prevention, emphasizing the importance of the promotion of health in addition to the treatment of disease and its prevention.
The fourth or the next one is health and healing, emphasizing the marked ability of individuals to heal and recover, and to support that. Wholeness, that health involves all aspects of life, mind, body, spirit, relationships, and environment.
Individuality, recognition that the person is unique and has a right to have their health care customized to that uniqueness. Choice, the freedom, individuals should have the ability to choose freely among the safe and effective therapies that are available.
The next is education and empowerment, especially emphasis on educating individuals continuously about prevention, healthy lifestyles, and empowering them to self-care.
The next is public involvement, recognizing the public and consumer as being the main driving factor in this and that they become more integrally involved in setting prioritizations and decisions.
The last one was partnerships, emphasizing that good health requires collaborative teamwork between conventional practitioners, research, and also between health care practitioner, patients, and among patients, both in research and in --.
MS. CHANG: I am going to come around and get these now. Wayne, do you want people's names on these or do you care?
DR. JONAS: It is up to you. Optional.
MS. CHANG: We are out of time, unless the chair cedes you some of his time.
DR. JONAS: Well, the historical context, I don't think we need to talk about. I guess I would just like, I mean the plan is to do a mission statement, so perhaps just a general comment on is that something that people would like to see and would like to see us try to come up with a mission statement.
DR. GORDON: Wayne, do you want to say what you mean, a little bit more, by "a mission statement"?
DR. JONAS: Tom? He is much better at that than I am.
MR. CHAPPELL: I am wondering whether the mission statement was a thought that came out of the core values, what we believe work. I am trying to remember the origin of the mission statement.
Basically, if we have got a set of core beliefs which we are calling guiding principles, that is sort of the philosophical orientation, and then the mission statement is more what are we going to do about it. It is the here what we are about.
I am not sure a mission statement is actually relevant for us, so I want to raise my doubt about the need for it, but I don't want to preempt Wayne's idea about this, or Jim's. I have forgotten where this came from.
DR. JONAS: I do too, actually. Linnea.
MS. LARSON: We actually had a mission, and it was given by the Executive Order. I think that highlighting the Executive Order, and this is how we have organized our understanding under the guiding principles is useful.
DR. JONAS: That was actually my sense, too, is that this was sort of a reiteration of what our charge was, and that is our mission, is to try to meet that charge, so that comes out of the Executive Order. I didn't know if we wanted to rephrase that or emphasize that. I mean, it is going to be right up front in the actual report.
MS. LARSON: I really do believe that we need to emphasize and quote directly what that Executive Order is and then make it very clear about how we have shaped what we are doing, and that would be our mission.
MR. CHAPPELL: That is very helpful, Linnea, and I think it is probably worth the task. Let's try it. It is the action orientation of the Commissioners' work, whereas, the guiding principles are more the belief orientation, one's belief, one's action.
Why don't we give it a try. I am willing to have our committee give this a try, unless you already have done it.
DR. JONAS: A mission statement?
MR. CHAPPELL: Yes.
DR. JONAS: No.
What I heard is that maybe we don't need one actually, as long as the charge, what we have been tasked with is up front.
DR. GORDON: It is time now. We have 15 minutes, in which I am going to give back, feed back, my understanding of what we have agreed on, and what we perhaps haven't agreed on, and get your response as to whether this is an accurate reflection of what everybody has heard.
Let me say that this section is different from all the ones that will follow, because we are not talking about recommendations here, we are talking about the structure of the section itself, so we are at a different stage with this particular section. So, I feel comfortable, and hopefully it will work, taking less time.
When we come up with a lot of recommendations, there may be much more discussion that will go on. I will say where we are, and people will then have a lot of different thoughts about whether or not we really are there and what we should do with the recommendations.
So, let me go through this as quickly as I can, and as I go through this, I want to find out if this is accurate as I go through each one. So, if you could all make some kind of motion to indicate that it is or it is not.
First of all, when it comes to definition, and, please, especially, Wayne, you and Tom, if your understanding is different, please feel free to jump in.
The definition on page 6 is the one that everyone felt much more comfortable with rather than the definition that the document opened with, is that correct?
This may seem kind of dopey to go through each one so carefully, but I really want to make sure because these are the instructions that we are giving back to each of the groups as they do the presentations. So, that is number one, okay, everybody? Yes. Good.
The second is that the emphasis is on the kind of goals and the aspiration rather than on conflict in presenting the whole field, is that correct, is the feeling tone? Okay.
Third, that there is a sense of some of the issues related to history and related to some of the conflict will be dealt with in the context of presenting where we have been, where we are, and where we are going. Correct? Okay.
Fourth, there is an importance placed on emphasizing areas of overlap and that diagrams may be useful in presenting some of this information. Okay.
One of the other issues that was raised here, that seemed important, is that there be an emphasis on the fact that people are actually using these approaches and that there was a feeling, a number of people felt that that wasn't as strongly emphasized in the section on definition and on where we are right now.
Beyond that, Joe raised one example, and I think other people have in the past raised other examples that it may be useful both here and elsewhere to present a number of examples. It may have to do with hospice, it may have to do with school wellness, it may have to do with treatment of chronic illness, to illustrate some of these points. Okay? All right.
That is what I have on definition, and as I said, integration and spectrum be both emphasized, that there is an integration of some approaches and that there is a spectrum and some approaches are not integrated, but that they are part of the whole CAM world.
Generally speaking, what I heard, and this I really want to make sure we are correct on, is that we would begin with definition and then move into guiding principles. Is that correct? Tom, no, you are not in agreement?
MR. CHAPPELL: No, I am not in agreement with that.
DR. GORDON: Okay. So, let's check and see where we are with that, because is there general agreement on that? If there is not general agreement, and if there is significant disagreement, then, we need to bring it back to refer the order of presentation back to the subgroup, so I would like to get some feedback about that now, definition first or principles first, or are we not clear yet.
MR. CHAPPELL: For me, the first piece of business to do in a communication piece is to address the shift in world view, and it is basically the orientation question.
We have said this time and again throughout the material that we need to have a special section on this. We have come this far with it. It needs to be presented early on, and then we move into the definition of CAM, and then into the history.
DR. GORDON: I am going to move this part of this discussion along very fast. I want to hear other opinions about that, so we can make a disposition of this order of order.
DR. ORNISH: Well, I would vote for putting definitions first, not as a relative value, but just to orient the reader, particularly since I would say that the majority of people reading this may be people in the media and politics, or whoever, who don't have much familiarity.
I remember in medical school when we get lectures, and there was a certain assumption that you had a basic familiarity with things, which for me wasn't the case, and it was totally confusing. I think it is nice to kind of define things and then go to the historical perspective and values.
DR. GORDON: Wayne, and then Veronica.
DR. JONAS: I agree. I think we should world view shift as something --
DR. GORDON: I'm sorry, have what?
DR. JONAS: The shift in world view and what that is should be up front.
DR. GORDON: Before definition?
DR. JONAS: Yes.
DR. GORDON: Okay. Veronica, and then Linnea and Joe.
DR. GUTIERREZ: I support Tom's model myself.
DR. GORDON: Which one do you support?
DR. GUTIERREZ: The world view.
DR. GORDON: The world view first?
DR. GUTIERREZ: Yes.
DR. GORDON: Linnea, and then Joe.
MS. LARSON: Maybe I am back in organic chemistry, but I really like those boxes that says here are the definitions, and then we will explain it.
DR. GORDON: Joe.
DR. PIZZORNO: It seems to me that we will have some kind of an executive summary to start out this thing. I think that there we will need to put the definition.
When we get into this section, I think it is much more important to start with the world view and principles, and such, and then show how we then arrived at the definition. So, I think we will achieve both needs that way.
DR. GORDON: Effie.
DR. CHOW: I go with what Joe has just said, that assuming that the definition is in the executive summary, and the world view is very appropriate to be up front here.
DR. GORDON: Let's hear from Jim Swyers. Will we have an executive summary, so we can see how it flows?
MR. SWYERS: Typically, you wouldn't write an executive summary until the report is done, but what we had envisioned was this definition section was not going to be the first section of the report, but what I am hearing is that people would like the guiding principles put in the introductory section of the report. That will be done by December.
DR. GROFT: I think there is a format that we use in reports to Congress, and I think where you capture the most important parts are in the executive summary, which actually precedes then the full report.
MR. SWYERS: Typically, you wait until the full report is done, then, you write the executive summary.
DR. GROFT: We are capturing what you are saying as far as what are the important issues. I think as we go along, we will earmark those as to go into the executive summary. You will have a chance to read that shortly after the December meeting. Maybe we will even have a draft.
DR. GORDON: I think, Steve, we will need it. If we are going to resolve the issue on which a significant number of people want to have the principles first, others want to have the definition first, I think we have got to see how, and the proposition that Joe made was to see how it looks with the executive summary with the definition, and then moving the principles.
I think we need to see it if we are going to make a decision about it.
DR. GROFT: We can prepare one. It would definitely be a draft, and based on what follows, then, at the December meeting. As far as the full report, there will be changes, but I think we could prepare one, but to have you keep in mind that it is very preliminary based on where we are on December 5th as opposed to December 8th.
DR. GORDON: Effie, do you have anything?
DR. CHOW: No.
DR. GORDON: Julia.
MS. SCOTT: I am just confused. Perhaps, Tom, you can tell me the difference. What are you thinking about in terms of the world view as different from the history?
MR. CHAPPELL: The world view is that section dealing with the guiding principles. It will have an opening paragraph that talks about the shifting paradigm. That is what we meant by a world view. History is walking you through the evolutionary stages.
DR. GORDON: My personal opinion is definition is better right up front. I think that, clearly, we have different opinions. I think what we need to do is to see the way you do it in December, to sort of refer this back to your group, see how you present it, see if you are satisfied with it, understanding that we are putting this up front.
It sounds like there is general agreement that this is what we want up front at the beginning of our report. Is that correct?
SISTER KERR: Jim, say "this" specifically, rather than "we want this," because I am getting confused on, are we going to do overview first or definition first.
DR. GORDON: I'm sorry, what, Charlotte?
SISTER KERR: When you say "this," say what you meant. Did you mean we agree that the overview should come first, or did you mean the definition should come first?
DR. GORDON: What I meant is that this whole section that we have been talking about, as I am understanding the general sense, is this is what we want at the beginning of our report, together with the issue about the mission we have been given by Congress and by the Administration.
Is that correct? I can't read body language all together. I just need to know if we are on -- yes, okay.
MR. SWYERS: Jim, what I am hearing is that in the introductory section, people want to have the guiding principles included in that, and then, the next section could start with the definition of CAM.
DR. GORDON: That is what I am hearing, but I am not hearing that unanimously. I am hearing that at least several of us are saying the other way, that we want to see the definition first, but more people are saying they want to see the guiding principles first.
My sense of us is that we should give it back to the subgroup and let them show us how they are going to do it, and then set aside time for discussion of this in December.
Does that make sense to everybody? Okay.
I want to move very quickly through the second part of our discussion about the guiding principles.
First of all, again, there is something of a division here. The more general sense was that in the guiding principles, that wholeness and health and healing need to be absolutely up front and that evidence is second in importance, but very close behind it. That is the general sense of what I am hearing, with some people saying evidence should be first.
What Wayne and Tom then do is collect our preferences for how it should go, with what the order should be. My sense is, again, that this is something, and I don't think this is going to happen in every instance with every other group, but I think with this group in particular, because we are at an earlier stage, we are referring much more back to the group.
So, Wayne and Tom, my sense is that what we are looking for from you is to take what you have gotten from us, both in the discussion and in the written comments, and to reshape and re-present the principles in a coherent narrative order back to us including possible name changes for some of the categories.
Is that what everybody has a sense of? First of all, Wayne and Tom, is that your sense? And everybody else agreeing with that? Again, we will be spending time, taking a look at that when we come back in December.
The second piece has to do with that there was a strong feeling, and I am just focusing on what we have said, that there needs to be more emphasis on partnership and relationship among all parties in the healing process than is currently here in the document. Okay?
The third piece is the issue of body, mind, and spirit, that somehow there needs to be some statements about that we don't want to get cumbersome or invoke something continually that begins to sound like jargon, but we want you to grapple with the inclusion of body, mind, and spirit, and then present it in a way that is not continually repetitive.
Is that right, Charlotte, does that reflect everybody's feeling about that?
There is also a strong sense of emphasizing, in the principles, safety, as well as efficacy, that that is an issue that needs to be addressed.
Finally, we want to relate our efforts to define guiding principles in particular to the IOM report, and to indicate in a kind of generous way that even though there are differences between some of the principles or particular to what we are doing, that there is a kind of coherence with the larger movement of which the IOM report is a representation.
That is what I have heard from this discussion, and we are finishing right on time.
MR. CHAPPELL: Shall we have a break? That was well done.
DR. GORDON: It was well done all around. Thank you.
MS. CHANG: We do have a break. Please, please, please, I implore you to come back at 10:30.
Then if David Bresler, Tieraona Low Dog, and Corinne Axelrod could be at the front table, we can get started right away.
DR. GROFT: Just a thank you to Tom Chappell and Wayne Jonas and Jim Swyers for putting this session together. Thanks very much for your work.
MS. CHANG: This is actually Session II. I am going to give you 15 minutes for the overview and then the workgroup around the table, and then we will start your discussion period for 75 minutes. I will give you a warning time just to let you know what the time checks are periodically.
DR. GORDON: Because you weren't here in the beginning, the more you can sort of focus on the issues that you need feedback about and where you are not hearing something you need to hear from people, address the question directly about what you would like to get back. That will make the task of figuring out where we go from here easier at the end.
Session II: Information Development and Dissemination
DR. BRESLER: We have been working on this section of our report together and kind of brainstorming, but we are very open to other ideas and suggestions from other commissioners, maybe some things that we hadn't considered.
Basically, we have many recommendations in this session, 10 recommendations that we need to go through, and we will go through them one by one. Again, the emphasis doesn't need to be on wordsmithing at this point, but let's make sure that what we are recommending really reflects the consensus of the Commission, and let's make sure we are not missing something in our recommendations that we think is important to include.
Tieraona, have you got other comments?
DR. LOW DOG: Let's just get going.
DR. BRESLER: Yes, let's get going.
I hope that people have had a chance to look through this. Probably one of the real concerns we have had in our group is about information that is on the Internet. As most of you know, this is a bit problematic because due to free speech, people can say basically whatever they want to say within certain limits, make any claims and representations that they want, and they have a lot of protection under free speech to be able to do that.
As a result, there is a lot of misleading, inaccurate, or downright fraudulent information on the Internet, which we think needs to be addressed, and that is basically what issue 1 begins to do.
We also have concerns about access to the Internet. Fortunately, through schools, a lot of children have access to the Internet, but approximately half the population probably doesn't.
That is going to be changing over time, as we know, but again, we have concerns about making sure that people have the ability to check the reliability of information that they are getting on the Internet, because some of it could be potentially hazardous to them.
In your report, there is one typographical error that I caught on page No. 1 of this section. It is the bottom of the first paragraph, "WebMD reports 4.7 unique visits," I am sure it is 4.7 million unique visits. We don't know what it is now.
Are people pretty much familiar with this, do we need to have more discussion? We have talked about this before, but let's look at the recommendations and see how people feel about it.
Our first recommendation that we have discussed is to form some sort of public/private partnership of a review board that can look at this information kind of like other standards boards are in place for rating movies and the movie industry, a way of evaluating the accuracy of information, setting up standards, making sure that claims are evidence based and identifying when they are not, and so forth, and so on, and basically, being able to give like the Good Housekeeping Seal of Approval and an appropriate logo that is associated with that, to those sites that are in compliance with the recommendations of the standards board.
I don't think that it was so much our intent to have a rating system where Internet sites would be A, B, C, D, and so forth, but rather to develop certain guidelines for presenting information, for documenting the source of any claims or representations that are made, and hopefully, those sites that are in compliance with those guidelines will get this seal of approval.
So, basically, the first recommendation is that we establish a public/private partnership to develop voluntary standards to promote accuracy, and so forth, and to develop some sort of process to continually review Internet science and new sites as they come aboard, and those who do meet the standards of such a review board would be able to say that they do and to use some sort of identification, perhaps a logo saying that they have met those standards. This is pretty much what the first recommendation is about.
Can we open it to discussion now, do people have any ideas, concerns, or thoughts about this particular recommendation? Joe.
DR. FINS: Yes, I think we should cite a parallel to -- I think it was called the Vancouver Agreement, that the leading medical editors of the journals use to have voluntary standards, that there is a precedent for that, and I would like to concretize Recommendation No. 2 more specifically and suggest that the National Science Foundation develop an RFP or some kind of mechanism for scientific literacy, which is critically important, and there may be also the National Library Association has some kind of partnership there, you might mention them later on --
DR. BRESLER: Yes, we do.
DR. FINS: But I think it is also relevant here.
DR. BRESLER: Other thoughts and comments?
Let's stick with the first recommendation. Let's take them one at a time.
DR. GORDON: Just a point of procedure. Joe is addressing Recommendation No. 2, not No. 1, right?
DR. FINS: Both. We are on Issue 1, but there are three recommendations.
DR. GORDON: Right, but David has just mentioned the first recommendation.
DR. FINS: Oh, I'm sorry.
DR. GORDON: So, if we can focus on that one, that would be helpful.
DR. BRESLER: What we want to focus on now is this idea of public/private review board. As we have previously discussed, the idea would be to have people from academia, people from interest groups, people representing the public, consumer advocates, and so forth, and so on, just to basically set policies and procedures for identifying information and the source of any claims or representations that are made, and the extent to which people are in compliance with that, they would get that seal of approval.
DR. ORNISH: As Joe was saying, there is a more recent conference of medical editors that came out about a month ago, editors of JAMA, New England Journal circulation, Lancet, et cetera, that specifically address the issue of conflict of interest and how important that is to address. Particularly, they were referring to drug companies funding research on drugs and then suppressing the articles if they didn't show favorable findings, that kind of stuff.
So, I think, as Joe was indicating, to the degree we can cite other precedents that directly relate to this, it certainly makes it more mainstream and sees as the middle ground, as well as I think being a good precedent.
The other thing, though, is I think there are already some existing agreements. I know like WebMD has in terms of privacy and accuracy, and I know Dr. Koop took a lot of flak for those issues, and he has come up with some stuff, too.
I am not familiar exactly what they are, but it would be nice to include that in here, too.
DR. BRESLER: I want to table that for a minute because there is some concern about Recommendation No. 3 that we will discuss in a moment, but let's stick with No. 1, about this public/private review board.
Does this reflect the general consensus of the Commission, are we all in agreement that this would be an important thing to do, to have some sort of agency that has interest from both sides?
DR. FINS: I think I actually made this recommendation at an earlier meeting, but I want to modify the idea just a tad, maybe with the preamble saying, "While recognizing the importance of freedom of speech, the Commission recommends," not in any way abridging, but just being clear that you can say whatever you want, but it may not be credible.
DR. BRESLER: We have always been clear that this is voluntary standards that we are asking for and that people, just like certification in any kind of agency, people can apply for it and be reviewed, and if they meet the standards, they get the seal of approval. It is a voluntary program. I think we have always considered it that way, but your point is well taken, that we need to emphasize that in no way is it our intention to restrain the freedom of speech through this recommendation.
Other concerns about this? Does this generally reflect the consensus of the Commission, that we would like to see such a public/private review board to help give consumers some idea as to the accuracy of information that they are finding?
May I ask, does anybody have any objection to this recommendation? Can we move on?
DR. FINS: Maybe there should be some reporting mechanism, of we come up with CAM Central or some idea down the road, what does this Commission do, and how does that information get disseminated? I mean what is the feedback loop?
DR. BRESLER: Again, I think our thinking about it was that an Internet site could apply to this commission or board, or whatever it is called, for their seal of approval, there will be a review process in which people will go and take a look at the information that they are providing.
There needs to be a way to update that and make sure people would have to reapply or recertify periodically, like we do in continuing education programs. I mean, we don't want to give somebody certification that is good forever. So there does need to be a way of, not necessarily policing, but watching those people that have given the seal of approval and make sure that they continue to deserve it.
Again, these things, the mechanics of it, need to be worked out further down the line.
DR. GORDON: I think one thing about the mechanics is some of this will relate to recommendations later on, for example, for the Central Office, so that that may be the place out of which this comes.
I think we shouldn't focus too much, as we go through these recommendations, on figuring out all the mechanics and implementation because otherwise we will get bogged down, and we can come back at that later on when we have the whole picture in front of us.
MR. ROLIN: Just a comment. I am concerned about the fact that not all people will have the Internet. So definitely, I would support the idea of some type of report, and that can be worked out within those mechanisms.
DR. BRESLER: Can we move on to the next recommendation?
The next recommendation is that the public really needs to know how to evaluate the information that is coming across the Internet, and this recommendation was to establish a public education campaign that teaches people how to evaluate information and again to look at it in partnership with schools and other educational institutions that use computers, that have an interest in the Internet, and basically to look at it as a set of fundamental skills in being able to get the information that you want and to be able to check to see if it is accurate information.
This is basically an educational campaign. That is what this recommendation is about.
Do people have comments or concerns about this recommendation? Joe made a comment that I think is very well taken, that we ought to look and see what the Library Association is doing, we ought to look and see what NSF and some of the other agencies are doing along these lines to increase literacy in terms of getting access to health information on the Internet, and I think that that possibly should be incorporated into our recommendations.
Other comments or thoughts about this?
SISTER KERR: I know you addressed this with the library, teaching people how to use it, but have you thought, how would this look differently if we did not have access to the Internet, and are we considering carefully the population that will not? Particularly, who knows what is going to happen in the future?
But just to be sure it has been thought of, and then to say, but at this point in history we have got the Internet, so we won't, obviously, use billboards as much. Are we thinking about it enough?
DR. BRESLER: We are going to be coming to some of these discussions about access issues and ways of getting information to other people in Issues 2 and 3, but I think we could see the possibility that there will be industries developed to take information off the Internet and provide it to people that don't have access, that if people have a health care concern, there are probably going to be private sector businesses that basically will do that, will do a search for you, will check things out, and so forth. I think this is probably going to be a growth industry that will enhance access, but we will discuss access more in the next issues.
Again, we are going to focus on the public education campaign to basically let people know how to get information off the Internet and how to check the accuracy of it, and again in collaboration with other organizations or institutions that have a similar interest.
DR. GORDON: I have a procedure point and then a content point. The procedure point is one of the things that we should be thinking about is how we are going to order the recommendations. I mentioned this earlier, as well, whether or not, for example, the issue that you raised, Charlotte, should be combined here in this place. That is, making access more easily available to people who don't have access.
The content point that I would like to make maybe follows up on what Joe was saying. I think it is important that we say that it is all scientific information, of which CAM is a part, and I think that this is the domain that we are working in, or we are stating right from the beginning the principles of evaluating should be similar.
DR. BRESLER: Which, again, makes a lot of sense to be working with other organizations and institutions who have a concern and are already probably working on this issue.
DR. FINS: It also allows us to be funded by different sources of appropriations, everything from the Defense Department, if we are talking about misinformation about bioterrorism, all the way to the Department of Education.
So, it really is a tremendously generic problem, of which CAM here is a subset.
DR. BRESLER: Other comments?
DR. PIZZORNO: I am not sure where this best fits in, maybe one of the earlier ones. I really like this because there is a lot of bad information on the Internet that we have to be careful about, but how do we set this up in such a way that we facilitate, and not become simply a censorship body by vested interests?
Unfortunately, this happened a lot in our history as a nation, and unfortunately, I don't know how to do that, because we need to help people determine what is good information, but we don't want vested interests to keep out ideas they don't want to see come into the system.
DR. BRESLER: Tom?
MR. CHAPPELL: Thank you, Joe, for that comment. I have been noodling with that as we have been talking, and I do think that in your first recommendation, you are talking about developing the standards. I mean what that means to me is that by practice, you are going to have some standards. There may be some standards that are uniform to all practices, but I am still trying to make the link between the efficacy of the practice and the information that is being provided on a website here.
DR. GORDON: Speak a little closer to the mike, everybody, so you make sure that the audience can hear and we get everything recorded, too.
DR. BRESLER: Say a little more about it, Tom.
MR. CHAPPELL: Well, I am trying to avoid creating a censorship organization, too, because that is negative and controlling as opposed to promotion of information that is credible and efficacious.
I am wondering if you could give me an example of what a standard would look like. You have said to promote accuracy. I know I am back on No. 1, but it is related to No. 2, as well.
DR. BRESLER: That is okay. The way I think about it, I sit on the editorial review board of several professional journals. Those journals have standards which need to be met for articles that are submitted in terms of representations and claims that they make.
I think that our thoughts are, it is not to tell people what to put on the Internet or what not to put on the Internet. It is to look at the validity of claims and representations that are being made and how well documented the sources are that support those claims and representations are.
It is to establish the same kinds of standards for making claims and representations on the Internet as we would in setting standards for what constitutes a random clinical trial, what constitutes peer review, what constitutes various other types of claims that you make on the basis of your research.
Those are fairly well standardized by these journals now, and my way of thinking about it is basically to establish standards and to put the seal of approval on those Internet sites that do that.
When they make a claim and they say there is no scientific basis, it is all anecdotal information, and there is not yet any published controlled studies to document this, but here are four case studies. Basically, to validate any claims and representations, and to provide the source or the basis that validates those claims, I think that is our intention.
MR. CHAPPELL: Thank you.
DR. BRESLER: We need to move on in a minute.
DR. FINS: Just to pepper the setup here, Jefferson said, "Democracy without education is impossible." So, we are not in any way constricting choice, but we want people to be able to make informed educated choices.
DR. BRESLER: Good. Any other comments about these because we are going to spend a little bit of time on the third one.
DR. PIZZORNO: These are very well stated. I was thinking about when we had that presentation by the Berkeley Wellness Letter and by Goldberg's group. Both of them are publishing things, and they were both looking at the same information, and had totally separate conclusions, and I think both were on the extremes, and the truth was somewhere in between.
Again, how do we facilitate that we get the truth that is in between those two extremes, that we don't let either group dominate this process, so that when people are given advice on what is reliable and what is not reliable, that we are not too restrictive, but we are also not too inclusive.
DR. BRESLER: Well, what would make sense to me is that there are some issues in which there is evidence in both directions, and part of the standards are, in those kinds of situations, both sides need to be presented fairly.
Again, it is for this group, this public/private group, to establish those standards, and they are going to take some time to do it. It is not for us to establish those standards right now. We are making the recommendation that a group needs to be formed in order to do that.
Any further discussion about this one?
Again, the question that Tieraona raises is do we want to talk about transparency, potential conflicts of interest, full disclosure, and so forth. Again, I wouldn't get into the mechanics of what such a body might do. We are just basically recommending that a body be formed to do this.
Is that clear?
DR. GORDON: I think that the issue of transparency may be one that we want to talk about on Saturday morning. That may be a new issue that we want to bring to this particular area of information or maybe to all the areas. So, let's put that down as a possibility.
DR. BRESLER: Okay. Moving on, the third recommendation has to do with privacy and confidentiality of information. As you will recall, we heard a lot of testimony about this from various people, and a large number of people are very concerned that when they go to visit an Internet site, that they are going to be tracked and that either the health insurance company, big brother, their employer, the government, whoever, is going to look at where they are visiting on the Internet and it is going to have an impact on health insurance premiums, things of this sort.
Now, the language in our recommendation is what I want to discuss for a few moments because in the recommendation we say, "The Commission recommends that the privacy of individuals using CAM Internet sites be protected by encouraging CAM sites to disclose if users are tracked and how that information is utilized."
The question that I have is I think we ought to put more teeth into this one. I would like to make that a requirement. I would like it to read, "The Commission recommends that the privacy of individuals using CAM Internet sites be protected by requiring CAM sites to disclose if users are tracked and how that information is utilized."
Can we have some discussion about this?
DR. BERNIER: How would you police that?
DR. BRESLER: Comments? How would we police that?
DR. FINS: I think that is addressed in Issue 2 about the FTC and all that. The point here is whether or not we would endorse such a thing.
DR. GORDON: It could also be in Recommendation 1 of this voluntary group, that that would be a condition of being a member of that voluntary group.
DR. BRESLER: Good point. Here is an opportunity also to look at what other agencies are doing. This is not a unique concern of people going on to CAM sites.
DR. FINS: Did you guys come up with any information on HIPAA and how it relates to this, because there may be provisions in HIPAA that we are not aware of.
MS. AXELROD: The information on HIPAA is still evolving, but that is one thing that we want to just make sure that CAM is included, so that it is not like the CAM Internet sites would really be treated any different than the other health information sites, but it is not clear to us at this point if those sites are included, so that is what we want to make sure about.
DR. FINS: It might be wise to mention that HIPAA, for instance, it is kind of evolving, any evolution or amendment to HIPAA consider the CAM-related issues. Now, HIPAA is a very complicated piece of legislation, but that is where a lot of this stuff is happening.
DR. GORDON: Joe, do you want to explain?
DR. FINS: It is about the confidentiality of the medical record and the exchange of information between providers within organizations, between organizations, and liability for disclosure.
Even the originating institution, as I understand, and I am not an expert -- it would be liable if I were -- passing between me and Effie, if something happened between George and Effie, I could conceivably be responsible for this. So there is a chain of responsibility.
Again, I am not an expert, but I think that we need to envelop this in the context of major legislation on privacy and confidentiality that is out there right now.
MS. AXELROD: It is partly addressed in Part B of this recommendation because there is some other legislation that addresses this issue, as well, so we can add this to the background information that it is HIPAA and other legislation, and just make sure that CAM is included in those.
DR. BRESLER: I would like to focus for just a minute in how much teeth we want to put into this recommendation.
Are people comfortable saying that we want to encourage CAM sites to disclose if they are tracking people, or do we want to say that we require them, we recommend that they be required to disclose if they are tracking people?
SISTER KERR: I don't know the technology, but I would like to say "required."
DR. BRESLER: Other comments? Everybody is nodding their head. Is there any objection to changing the language from "encouraging" to "requiring"? Does anybody have any concerns about that?
DR. ORNISH: I just think it needs to be clear that we are not saying this is something unique to CAM, as Joe was saying. I think that, here again, if we can not make this marginalized, or make this part of the mainstream, it has a double benefit. It makes the particular recommendation more acceptable, but it also makes it clear that this can be part of the mainstream.
DR. BRESLER: I think we are all in agreement with that.
Any further comments or discussion about this recommendation? Okay.
Let's move on to Issue 2. Issue 2 is regarding adequacy and accessibility of CAM information from the Federal Government. Does everybody remember this one? Basically, there is lots of agencies within the government that have interest in this in various ways, and I think we are still learning about other agencies in the government who already are fairly far down the line and nobody knew about it. Why reinvent the wheel? The idea is some coordination between all the federal efforts to provide information, to assemble information, sponsor research, things of this sort.
The recommendation is for an interagency task force basically to identify what information we need that we are not getting, and also to develop strategies to stay up with activities of the government along these directions and to improve communication links.
We talked about Internet, too, but are people familiar with Firstgov.gov? I had never heard of it until I got it from this document, and I can only imagine what other resources might be lurking within the federal infrastructure that could be tremendously valuable to all of us interested in this.
Again, the recommendation is that an interagency task force be established to see what is going on, identify those gaps, and do something about it.
DR. GORDON: Although I agree with that, I think that the whole recommendation is a little too tentative for my taste. I really feel we have to not only identify, but to develop strategies for remedying the gaps, I would say, number one, and number two, I think we need to indicate that we are responsive to the questions that people are asking, which is basically does glucosamine work for my arthritis or not, what is the state of the evidence for all these various approaches.
I think the way it is worded here, it is too vague and it doesn't really deal with the central issue of what works, what doesn't, and where can I find people who are qualified to help me with it.
DR. BRESLER: Again, we are focusing on what is going on within the Federal Government.
DR. GORDON: I know, but they have been asking these questions right from the beginning. For example, in the early days of the OAM, 70 percent of all questions were from people with cancer and their families saying what else can I do.
I think that we have got to address those concerns and indicate that we want to remedy those concerns that people have, and give them the information that they want.
DR. BRESLER: Remedy them by telling them what activities are going on within the Federal Government that could be of interest to them?
DR. GORDON: No, no, remedying them by telling them -- which is I thought we had pretty consistent testimony on that -- that people are saying we want the government, whether in partnership with private groups or not, we want the government to be able to provide us, as an impartial arbiter, and some of the government agencies including particularly NCCAM are trying to do some of this. What can you tell us about these approaches?
DR. BRESLER: Joe.
DR. FINS: I don't think that is my recollection of it, and I think Recommendation 1 under Issue 1 was to address it. In other words, I think everybody was uncomfortable with saying there was one site that said glucosamine worked or that was a definitive site. The idea was to have a plurality of sites that met a certain set of standards, and then with education that the consumer would have, they would be able to navigate that a bit.
I think they have a single voice about what works and what doesn't work. First of all, I don't think that is an answerable question. I mean does chemotherapy work in a particular cancer? Well, there is a lot of disagreement about the particulars.
DR. GORDON: But at least what you can do is you present the state of the art, and that is what people are looking for. Let's say, does chemotherapy, what is the nature of the literature, the research literature out there about X and Y, and we come to some of that later on when we talk about some of the meta-analyses or systematic analyses that we are looking for.
DR. FINS: As a clinician, when I have a question about what works, what I do is I go to the National Library of Medicine, and I do a search. I find articles that have reached a threshold and been indexed as NLM, so I think for No. 2, Issue No. 2, that I didn't see NLM mentioned, I know it is mentioned in Issue 3, but I think NLM is the leadership organization for this information kind of constellation.
I would also, just dovetailing about the cancer patient who is looking for a CAM modality, I would also link it up with NGOs, responsible NGOs, like the National Hospice Association, so a patient would have an idea about what are the options. It is not exclusively a government --
DR. GORDON: I hear what you are saying and I think the linkages are good, but CAM already has a statutory responsibility to provide information, and I think we have to take account of that, as well, here. That is part of the authorizing legislation for the OAM, was that there be information made available.
All I am saying is I think we have to address the public -- what you are talking about has been significantly as researchers' or clinicians' concerns -- we have to really respond to the public need for information.
DR. FINS: The National Library of Medicine has Pub Med, which is a site specifically designed for the public. I think, getting back to what we were talking about this morning, the point is that there is this integrative continuum, so somebody might not know they are looking for CAM information, so they wouldn't go to the NCCAM site, but they might go to the National Library of Medicine and find glucosamine, because they were looking under nonsteroidals and arthritis, and they found a paper that said nonsteroidals versus glucosamine, they say, well, that sounds better, and I have got an ulcer, that might be a better choice.
DR. BRESLER: This issue, to me, is not about CAM Central and having an authoritative source within the government that can tell people what the status of information is, and so forth.
This particular issue, the way that we have recommended it, is about finding out what is going on within the government and all the different agencies, linking it together, so that people know what is going on in the government, seeing what gaps are there that need to be addressed, and remedying them.
DR. GORDON: I hear you. I think then the issue becomes one of ordering recommendations, because the most important thing to the public is not all the things that are going on in the government. The most important thing is what do I do next. So, it is a different issue, and I appreciate the clarification.
I think we do have to look at the way we have ordered things in order to present it in a way that people will say okay, they are meeting my needs and here is another issue.
DR. FINS: There is a micro and a macro economic dimension to this. It is like what an individual person encounters is based on these macro economic decisions about what the agencies are doing. So, they are related, and maybe when we set up the structure of this chapter, you might consider the infrastructure that would need to be in place to allow consumers and patients to make informed choices, and they are mutually reinforcing.
MS. CHANG: Just a time check. You have 20 minutes left for this section.
DR. BRESLER: I understand. I was just pushing forward and I was going to tell everybody the same thing. We have a lot of material to cover, so we are going to need to go relatively quickly.
Sticking with Recommendation No. 4, is there any further discussion or concerns about it? Effie.
DR. CHOW: Would you see this as being part of this other section, Coordinating and Centralizing Federal CAM Efforts, that this is one aspect of what we are recommending on the whole?
DR. BRESLER: Yes, and as you will see in Recommendation No. 5, we really address it more specifically. Let's stick with Recommendation 4. I would like to get this one wrapped.
Any other concerns or comments about it?
DR. FINS: Does this relate to enforcement issues, as well, or is that in a different place?
DR. BRESLER: We hadn't considered that.
DR. FINS: Should we? I would really like to give the FTC authority to enforce --
DR. BRESLER: I think what we are trying to do right now is find out what the hell is going on, what agencies are doing what kinds of things, and who is doing nothing, where is the big gap, what agencies should be doing things that aren't.
That is really the intention of this recommendation: what is being done; how can we coordinate the efforts of these agencies, so that they are not duplicating efforts; and what things in the public's interest need to be done by the government that are not being done. This is the intention of this recommendation.
MS. AXELROD: I just want to add this is not just about the Internet. This is the Internet, this is fact sheets, these are all information from the government that comes in all sources.
The government produces a lot of fact sheets, they have a lot of clearing houses, there is a lot of toll-free numbers, but if somebody is looking for information on arthritis or diabetes, there is FDA, there is CDC, there is HRSA. They all have their pamphlets, they all have their sources of information.
We want to get those agencies at the table to look at that and make sure that they have some CAM information in there. So, it is a way of bringing them onboard with this, identifying where the gaps are in the information they are producing, and enhancing the links, so that the consumer will have easier access to this information that is right now all over the place.
DR. BRESLER: Is everybody clear about this? Any further discussion? Five follows on it.
DR. CHOW: I think this is very necessary, this recommendation. Do I see in there, after what you just said, that it is promoting agencies that don't have information to CAM, to include CAM information? I don't see this in here. It should be included in here?
MS. AXELROD: Well, if you bring all these parties to the table and talk about the gaps in their CAM information, it is going to happen, and it is not explicitly in here. We can certainly add that.
DR. CHOW: Okay.
DR. BRESLER: Moving to Recommendation No. 5. It is basically once we have determined what is going on in the government with CAM, we would like to have one centralized place where consumers or other interested parties could go and find it out.
Any comments about this particular recommendation? We were going to establish a toll-free number and just as that information is assembled, it needs to be utilized in a form that can be helpful to consumers who are looking to find out what the government is doing in particular areas.
DR. WARREN: I like this. We are going to discuss this Saturday morning also.
DR. BRESLER: Good. Effie?
DR. CHOW: I wonder whether it is established in DHHS, because I think in our other centralized CAM effort, we are questioning whether it is really good to be in DHHS or the Secretary's Office or elsewhere.
So, I don't know whether saying specifically DHHS, or it could say within government in this recommendation.
DR. BRESLER: Joe.
DR. FINS: I have no problem with having a place for information, but I do have problems with practicing medicine or anything over the phone, and I would hate this to be a kind of a proxy for --
So, I think we have to be very clear that we delineate the parameter of the activity, and it is just an information source, but it is not clinical advice.
DR. BRESLER: It is not even close, Joe. What we are saying is these are the activities of the Federal Government around this issue.
DR. FINS: That's right. I just want that on the record, and I don't think we disagree, but I think we have to understand that people will be calling up with medical questions about what is wrong with them, and whatever enabling legislation or regulation has to make it very clear that this is just a generic information source, and not a clinical enterprise.
DR. BRESLER: It is information about what the government is doing, it is not necessarily information about what the consumer should do for their particular problem.
DR. FINS: But you know that is how people are going to use it.
DR. BRESLER: We know.
We need to move on quickly. Any further comments about this? Does anybody have any concerns about this? Wayne.
DR. JONAS: I think the last issue that was brought up is an important one to address, and that is, what is going to be the public value of this. If the vast majority of the public is calling to get clinical information, and they don't get it, then, it is not going to be something that is very publicly useful.
We found this at NCCAM. I mean there is a public clearinghouse specifically mandated at NCCAM to do that, and they do answer questions, but they don't give out clinical advice and clinical information, and when people call there to try to get that information, they are not going to get it.
It may be that there needs to be, that the perceived value of this from our perspective may not be what the majority of people who are going to use this line would perceive as a value, so that has to be addressed in some say.
DR. BRESLER: Well, again, I think if such an agency were in place, I bet every one of us would learn about activities in the government that has gone on that we didn't have a clue about, and because of those activities, there needs to be some kind of centralization of those activities. That is what this is to address. Okay. And we understand your concerns that it not be to provide specific medical diagnosis or treatment, that is obvious.
DR. PIZZORNO: How much does this duplicate what is already being done at NCCAM?
DR. BRESLER: Do you have comments about that, Wayne?
DR. JONAS: Well, I haven't tracked and followed the recent events, because I know they are actually growing that, and there are actually some representatives here who are involved in the clearinghouse, and we should probably get close with them to find out what they are doing, because it may be that they are doing a lot of this.
DR. GORDON: One thing we could do -- it is a long subject -- maybe Anita could talk with you about what is going on. Now, Anita Green, do you all know Anita Green, everybody?
Anita, do you want to raise your hand? Sure, come up.
DR. BRESLER: We don't have time now, Jim.
DR. JONAS: Chris Thompson is here, and she actually runs the clearinghouse.
DR. GROFT: We will get together with Chris. We have 10 minutes to finish the rest of our session. Let us get together with them and we will get the information for you.
DR. BRESLER: Is everybody okay? All right.
Issue No. 3 is about availability and adequacy of information, basically about access, the diverse groups of consumers. We have two recommendations based on this. Number one, that in partnership with NLM and the American Library Association, that we provide specific information to librarians to help people find CAM information on the Internet and within the library system.
Comments about this one? Does anybody have any concerns about it?
The second recommendation that CAM information materials be at a level, at a reading level that the public can understand and utilize. We gave you some background information about that, and that specific information be targeted to specific groups.
Comments about this? Is everybody in agreement with this?
MR. CHAPPELL: I am wondering if this goes far enough in scope to accomplish the aim of informing particular groups. I recall at one point during the hearing process we discussed the sort of training tours, people going into communities to try to help make people more aware of what the possibilities are with CAM.
I am just concerned that again a source like a library, as sound as that appears to be, whether that is enough to really communicate the benefits of CAM practices and products to particular diverse groups as opposed to going in like a public health issue, making this a public health issue and saying we are intentional about an education program that reaches very specific populations.
DR. BRESLER: A comment, Tieraona?
DR. LOW DOG: Yes, just as another person here. I felt that we have more of this under Issue 5, false and deceptive health claims on the Internet. Here, we talk about limited language skills, cultural isolation, poverty, and we make recommendations about bringing national and local leaders of communities, of special populations, together, and I am not sure why we have got under the Internet, because actually, culturally isolated people with limited language skills, they are not the biggest users of the Internet.
DR. BRESLER: Right.
DR. LOW DOG: I think that would actually fit better under Issue 3 where we expand and -- because I think this addresses some of your comments, Tom, about local leaders of communities working with groups, bringing them together, and how do we get information to them, because the only thing we are talking about here is unnecessarily harmful or detrimental aspects of CAM, nothing potentially beneficial at all.
So, we fit it under this Internet, false, deceptive health claims, and I think it should be moved.
DR. BRESLER: For the sake of simplicity and time, can I make a recommendation? This particular recommendation is in regards to the library system, which is a major infrastructure that is in place in every city in America, and how we can work with that infrastructure and upgrade the skills of those librarians to make that an information source.
In addition, as a separate issue and recommendation, I like what Tieraona said, that perhaps we should get a consortium of interested parties together to discuss how we go into those communities and provide information, as Tom is recommending.
DR. LOW DOG: It's already here.
DR. BRESLER: It's in No. 10.
DR. LOW DOG: I am just suggesting that we move it, that we move it out of False and Deceptive Health Claims on the Internet, and we put it under Availability and Adequacy of CAM Information, and include it under library recommendations, that's all.
DR. FINS: So, you are saying move 10?
DR. BRESLER: Yes.
DR. FINS: I just want to put a little more teeth into No. 6 just on that point.
DR. BRESLER: Go ahead.
DR. FINS: You are saying training materials be developed. I think we should say we should recommend an appropriation to build the infrastructure of local libraries and librarians by giving them training in assisting the public in educating them about access and health care information on the Internet including CAM.
I think the First Lady would probably be a proponent of that, so we should look for that alliance, being a librarian, and I think that again, this gets back and dovetails back with the scientific literacy questions and the fact that people don't necessarily start off their search looking for CAM information.
They look for information about what is wrong with them, and they might end up in CAM, they might not, it depends, and it is a generic skill set.
DR. BRESLER: Jim?
DR. GORDON: I was just going to ask Joe, so, how would you amend that recommendation then?
DR. FINS: A new sentence. The Commission recommends federal appropriations for local librarians for training, to assist the public in utilizing health care information on the Internet.
DR. LOW DOG: Including CAM.
DR. FINS: Including CAM materials.
DR. BRESLER: Is everybody okay with that? Any concerns about that? We will take that back to our committee.
Any concerns about Recommendation 6 and 7? We are pretty much in agreement that it has to be in a language that is comprehensible to people. Any comments? Joe?
DR. FINS: For background, the AMA has a program on literacy that might provide helpful citations about this that could go into the background section.
DR. BRESLER: Anything else on this?
DR. GORDON: The other thing there is the issue that Tom raised, I am not sure where we are on that regarding No. 7. Does No. 10 take care of that?
DR. LOW DOG: Yes. On page 6 of this report, where we have, "Due to limited language skills," et cetera, et cetera, we have included that under Internet. We have suggested moving that under here, and moving Recommendation 10 under there. So it expands and fits.
DR. GORDON: The No. 10 statement is a kind of protective statement, and I think it needs to be also a more positive statement about educating and providing strategies of information.
DR. BRESLER: Does everybody follow that, we are moving No. 10 to 3, and taking Jim's comments? Any further comments about this? Tom?
MR. CHAPPELL: I would just like to point out that I think what this is all trying to serve is that CAM is a public health issue. I am not sure we are broadly stating it to have that kind of level of value and importance in our time.
CAM is as important as dental hygiene or nutrition. It is a public health issue, and I don't want to lose that general overview of what is driving what we are trying to do about information and accessibility of that information.
DR. BRESLER: Well, would you be comfortable with us saying that because it is a public health issue, going back to No. 10, that we feel it is important to get a coalition of people that have interests in communities and public health within the communities, and so forth, and so on, and to frame it in that way? Would that be comfortable for you?
MR. CHAPPELL: Yes, that is fine for that specific piece, and I am making my comment in general in lots of uses, too.
DR. BRESLER: Good.
DR. FINS: Just another vector of information, which I think goes in Issue 3 as a new kind of recommendation, we shouldn't forget the corporation for Public Broadcasting, PBS, and opportunities for disseminating more information. It is not just the Internet, not just libraries, so that is another very important site. We heard testimony from those folks and other media outlets, but I mean those are ones that do receive, I think, still some federal appropriations.
DR. BRESLER: Other comments? Quickly because time is short.
Moving on to Issue No. 4, there is a tremendous amount of information and good scientific information being done in other countries and other research institutions that are basically unknown by researchers, clinicians, others here, and this is a recommendation that barriers to access to this information be addressed and this information be translated and made available.
Comments about this? Tom?
MR. CHAPPELL: Will this public/private interagency be awarding the seal of acceptance to international websites?
DR. BRESLER: Comments? If they apply for it and they meet the criteria, I see no problem with it.
Does anybody have any concerns about this? Joe?
DR. FINS: Just justification, recognizing globalization and the plurality of populations that have made America their home, we think this is even more relevant and important.
DR. BRESLER: Any other concerns on the part of Commissioners, are we all in agreement with this recommendation?
Moving on, we have had a lot of discussion about false and deceptive health claims on the Internet. This is Issue No. 5. We have two recommendations, one, that we support the FTC in its efforts to identify false and deceptive advertising or health-related claims on the Internet, and to take action about those; to monitor various minority groups or other constituencies that we think are particularly vulnerable to deceptive claims in advertising. Again, an educational campaign for consumers and to help them identify deceptive and unsubstantiated claims.
Now again, this is a broader issue, and it relates to any health care information that is on the Internet. But again, a lot of this does focus down on CAM-related sites. So we want to address this.
DR. GUTIERREZ: I would just like to recount a chiropractic experience. We had a chiropractor who was sued by the FTC for some literature that he publishes for the entire profession, and the FTC saw that as fraudulent advertising, and he was in the legal process for over six years.
It cost him many dollars, obviously, and if we are going to use the FTC at all, I think we should recommend that the FTC put CAM-type providers on their review board, so that when they look at it, they are not looking at it with their own limited perspective.
This chiropractor did win, but it was a horrific battle.
DR. BRESLER: Comments about this recommendation?
DR. LOW DOG: I would support that recommendation. It is not really if we want to involve the FTC, they are already are involved. They are there, and we have to deal with them. But the recommendation that they might include people that are experts in this area, I think is a good recommendation.
DR. BRESLER: I do, too.
SISTER KERR: I don't remember where now, but so much -- at least, one of the things I learned, and, I think, as a group we learned, is that we needed to be at the level of decisionmaking and advisors as CAM people.
But my question becomes, in light of, particularly, what Veronica said, and as Tieraona just said, well, we are dealing with FTC whether we want to or not. What happens if they say, well, we can't get to that recommendation for 12 years?
It is a big deal. Can we say more than that? Can you put in a time? Is there anything else? Because I don't know that all these boards, and all, that we are recommending they put us on, whether it is insurance companies or HCFA, or whatever, are going to do it. It is a big deal.
DR. BRESLER: Comments? Joe?
DR. FINS: I think we have a very strong ally here. Senator Breaux had really remarkable hearings a few weeks ago, in the context of the elderly being taken advantage of by health fraud, and so I think there may be a real confluence here, and I just wanted, as a segue, say we probably should cite that testimony.
I would modify the recommendation regarding the FTC. I would say it is not our prerogative to suggest who gets appointed to FTC, but rather to say that the FTC consult with its brother and sister organizations like NCCAM in the federal infrastructure to get appropriate information, but I don't think membership is necessarily our purview.
DR. BRESLER: To consult with other agencies that have expertise in this area.
DR. LOW DOG: Yes.
DR. BRESLER: Comments? Joe?
DR. PIZZORNO: I have two things. One is I really support the recommendation of including CAM professionals. Second is under the challenges, just a technical piece. I know that the number of successful actions taken now is 10, so just before we publish the report, staff should contact the FTC and see what the current status is, because there are a lot of cases ongoing right now.
DR. BRESLER: Good point. Linnea?
MS. LARSON: I guess I am already to the recommendation, the specifics, and it is just a clarification. I think it is problematic to have highlighted "Spanish-speaking." You know, it's English and all.
DR. BRESLER: Is everybody okay with that? Jim?
DR. GORDON: I think when we look at how we are going to make a recommendation for what the FTC should be including in terms of expertise, we can look at what Tieraona will be talking about very soon with the FDA, and I think we can make similar kinds of recommendations across the board for federal agencies. That will make it more consistent, and it will become clear as we move on to the next section.
DR. BRESLER: Okay. Time is tight. Do we have any other burning comments?
Moving on quickly, I think the next two are fairly straightforward recommendations. It is basically about disclosure of training, certification and qualifications of CAM practitioners to consumers to make more informed choices. We have two recommendations, basically that it is a requirement that health professionals clearly identify and post information. It explains the level and scope of training.
No. 2, let's take them together, that state and local governments make information about their guidelines, requirements, and so forth, because it is tremendously diverse. In some states, even psychologists are not licensed and anybody can call themselves a psychologist. People in that state need to know that.
DR. FINS: When we get to the education section, the group had come up with a kind of taxonomy or hierarchy, and there is also a little bit of that in the access and delivery, so I think this is really not the place where we really get into the detail, but it will need to be cross-referenced because it is probably addressed more fully elsewhere in the report.
DR. BRESLER: The only other thing that I would mention is it seems to me that information under challenges on page 3, where it talks about information on licensing and certification requirements, and different providers or different levels of training, and so forth, it seems like this paragraph would fit better under Issue 6 than under Issue 2.
Anyway, let's look at these two recommendations. Are there any further concerns or comments from Commissioners about these two?
Great. Thank you all very much.
DR. LOW DOG: Okay. Moving right along. Now we are sort of moving into the product side, if you will, of CAM, and adverse events, labeling, and that. We want to start with Issue No. 7 on page 7, and this is relating to adverse events reporting.
We all know that with the recent OIG report, that really said that this was inadequate, the system that is in place now, and one could argue that it is inadequate kind of across the board. It is a dinosaur of a system really.
So, we have the background and the challenges here, but I wanted us to focus on our recommendations here, and I want to clarify something in the recommendation because if you read it right now, it says, "The Commission recommends that the adverse event report system be strengthened by" -- and then it has "encouraging voluntary registration of dietary manufacturers, so that the FDA can identify and contact them if an adverse event is reported." This is a system that is in place in Europe, so that if there is a problem with a particular ingredient, that you know who you need to contact immediately to notify them.
Then, if you go to C, it says, "mandating registration," so it looks like we have both. We just wanted you to know that we are going to rework that. That is just a wording issue.
We wanted to encourage voluntary registration until mandatory registration could be implemented, that we believe this actually should be mandatory, but this is an interim sort of step until that takes place. So, if you were confused by that, we apologize.
Then B, requiring dietary supplement manufacturers to report serious adverse events to the FDA, which is required of all other OTC medications, so if somebody is reporting something, you should be required to report that to the appropriate body.
D. Simplifying the system. To facilitate increased usage and easier reporting of adverse events, and increasing outreach activities to everybody really, health care professionals all across the board, really everybody, and also patients and consumers, so that they know where to go, but right now it's very cumbersome to try to go onto the FDA and report an adverse event, and most people would become frustrated in the attempt and just stop. So, we wanted that to be made easier, as well.
DR. PIZZORNO: Again, excellent recommendation. I wonder if under the last one, D, if we should include in there the people who actually sell the dietary supplements, like health food store employees, because they are kind of a separate category, and yet they are selling a lot of these things to the consumers.
DR. LOW DOG: Pharmacies, retailers. Again, I think it needs to be a campaign for everybody. Yes, I think everybody.
Is there any disagreement with that? Joe?
DR. FINS: I want to add a section F or something. This is all reporting of what happens. It presumes that things that happen get reported.
DR. LOW DOG: Surveillance.
DR. FINS: So I would like a surveillance function exactly, and I think that CDC should be involved in that, and those kinds of activities and any kind of citations by FDA that pose a real public health threat should be reported in MMWR, so that everybody who is not necessarily in the FDA loop will hear about it, who were just the rank and file practitioners.
DR. LOW DOG: I think that is a good recommendation.
DR. GORDON: I am not clear what you are saying because you are saying surveillance and you are saying reporting, so can you clarify that a little?
DR. FINS: If there is an epidemic or something, the CDC is involved in tracking and identifying it, and then characterizing it and reporting is. It is part of a containment strategy, and I am looking for some sort of parallel language.
If something were out there that posed a threat to the public health, like the tryptophan story a few years ago, how would that get disseminated, how would that get identified, because it is really an epidemic, because it is really an epidemic. It looks initially like an epidemic of a new disease that has to be figured out, and it may not be apparently a supplement or drug interaction or causal relationships.
DR. LOW DOG: Right. I think it is important that if there is not one central place, what normally happens now is it is reported in so many different places that it would be very difficult to see if there was any kind of pattern.
So, I think the point of this is to try to have, one, make one central area where adverse events are reported, and then to have somebody that sort of oversees that and makes accessible that information if there looks to be a real health problem.
DR. FINS: Just maybe to clarify, but a word like epidemiologic surveillance versus a recipient of information to know what is going on and to help to characterize it, but maybe Joe K. and Corinne can help us with the public health language here.
DR. LOW DOG: We can take this back, and if there is anybody that really has an issue with that, I mean I would like to leave some of those things to the group to try to re-present to everybody with our working on it.
DR. FINS: There is another mechanism that actually came up in my own hospital, where the consideration was, if we want to allow supplements into the hospital, how does a hospital deal with that question in the context of an established hospital formulary system. We are talking here about a macro, sort of a national system, I think -- adverse monitoring within organizations -- and how institutions would begin to integrate this stuff into their setting.
It is something I think may be really ripe for an RFP. How do you integrate a conventional formulary with a supplemental inclusion, do you limit it to certain manufacturers, certain drugs, do people bring in their own drugs?
DR. GORDON: I would like to say that this is a new issue.
DR. LOW DOG: I think that is a great question for Saturday. Would somebody keep track of those things for Saturday?
DR. GORDON: Yes.
DR. LOW DOG: So, I would like to leave that for that discussion, because I think that is important, Joe. Is everybody pretty much in agreement with this recommendation No. 13 under Issue 7?
DR. GORDON: Tieraona, I would just like to get a clearer sense of the voluntary to mandatory, a little bit more about the background on that, and just make sure that everybody is --if you could explain it a little bit more and then get a sense whether everybody is in agreement and if you see any down side to it, too, so we could discuss that.
DR. LOW DOG: I think that it will probably require some sort of legislation to make a mandatory registration, so obviously, that may or may not happen, right, I mean because of that, but we do feel that there should be at least an attempt. We believe that that is where we should move, our group did, but we would strongly suggest that there be a voluntary registration at this point until legislation could be enacted, and whether that happens or not, I think there needs to be something in the interim.
Now, they do this in other countries, and you are supposed to clearly put What is in your product on your label, so this shouldn't be something hidden from view. You don't have to get your formulas or your recipes, you just have to provide what are your major ingredients, what are your ingredients that are in your product, so if there is some sort of adverse event, manufacturers could be notified immediately.
We do not have that system in place, and if we did have a bad batch of something in this country, if there was a contaminant, et cetera, that came in, there would be very little way of trying to go back and figure out who we needed to notify.
DR. GORDON: My point is that this is potentially a very strong recommendation, and I just want to make sure the Commissioners are aware that this is strong, this would require legislation, that it is well backed up with documentation by your group.
DR. LOW DOG: I think we can get the information. If you think we need to strengthen that, we certainly can. We can also bring in how they do it in other countries including Europe, their system, which they are a little more advanced in some ways of following this, and if you think that would be important, we could do that.
DR. GORDON: I do, and I also wanted to make sure that everybody is on board with this one, because it is a major recommendation and does have legislative implications.
DR. LOW DOG: Does anybody not agree or strongly feel that we should not be recommending for legislation for mandatory registration?
SISTER KERR: Why wouldn't we recommend it?
DR. LOW DOG: Well, that is what I am asking.
SISTER KERR: What is the coaching on that? The other one is what does it mean to report serious and who decides what is serious?
DR. LOW DOG: Well, a lot of things end up getting reported that may be just a tummy upset, or things like that. Serious adverse events tend to be ones that are more serious and may require hospitalization, or enough that you would have go visit somebody, a practitioner.
So, those are already laid out what constitutes serious adverse events.
DR. FINS: It is in the OIG report.
DR. LOW DOG: Right. But I guess I would like to know, is there anybody that dissents on this or do we have an agreement on going towards mandatory?
MR. DeVRIES: I am wondering if we have enough information to really make a good decision. I guess what I am questioning is, we have a recommendation. Have we really gotten some outside input, whether it be in terms of legislation, what it is going to take to get the legislation done, or in terms of regulation, what it is going to take to regulate, and what the perceptions are, and the input of people outside of this commission who maybe are more directly involved and have perhaps a level of understanding that would help us in formulating a recommendation.
I feel like I am somewhere in the middle, I can neither support it nor oppose it, because I just don't have enough information right now.
DR. LOW DOG: Joe?
DR. FINS: I think the issue is that if, god forbid, something were to happen, and the manufacturer was not registered, you cannot fix that after the fact. We are just saying register. We are just saying know how to reach you so we can get additional information about the formulary and what was constituted in the supplement.
So, it is really, I mean I don't think it is all that stringent, and it seems to me it is common sense, and it is good public health, and it would be a good preventative strategy, and I don't think it is going to adversely affect that marketplace in a way that would be anything other than that.
It is sort of like -- and I think Tieraona's idea of having it as initially a voluntary thing -- that we encourage that. People could say they have voluntarily registered, which, as a consumer, I would be more likely to buy that product, that one that didn't choose to voluntarily register before there was any legislation.
MS. AXELROD: I just want to mention that the OIG report addresses this in depth, and they recommend mandatory registration. Just for the sake of the length of the document, we didn't include everything from the OIG report, but we can put a little bit more in if that would make people more comfortable.
DR. LOW DOG: I think doing that, but also I am saying, with a lead-in sentence, similar to mechanisms that are in place in Europe where dietary supplements are available and widely used, so that it is consistent also.
MR. CHAPPELL: Item C. So, if a company has 300 different products, they are going to list the ingredients and formula of all those products?
DR. LOW DOG: They are going to list the ingredients, right.
MR. CHAPPELL: Some kind of order of importance.
DR. LOW DOG: Exactly. You don't have to put your formulas in.
MR. CHAPPELL: You run into this in your profession as do I, and it is not the ingredient, but it is the adulterant. How are we going to discern between the adulterant and the ingredient itself?
DR. LOW DOG: I think that's a great question. I mean part of this will be implemented when GMPs are implemented. I mean so part of that, we will take care of. If it is an adulterant or a contaminant in a product, but we trace it back to like with plantain, in 1996, if we know that the plantain was actually contaminated with fox glove, we have a way then to get to all the people that are selling plantain, so that they know that we have had contamination, and we can inform them of batches that we believe were contaminated.
Everybody should be keeping lot numbers and all of that, so they should be able to test, but if you have no way of knowing, and that is what happened in '96, there was no way to know who to contact who may have even purchased the contaminated plantain.
MR. CHAPPELL: Perhaps then this recommendation ought to be including language that cross-references to GMPs in that regard, because I think is an important feature.
DR. GORDON: Come closer to the mike, please.
MS. CHANG: Tieraona, this is a time check. Fifteen minutes.
DR. LOW DOG: All right. So, Tom, we have got that, too. We move on to Issue No. 8. We are going to rework this a little bit as far as wording goes. We would like actually Issue No. 8 to be Issue No. 9. We are going to move quality control up front, ahead of labeling, just for the way it flows, just so you know that.
So, I would like to look at Issue 9 first, if you just would, quality control of dietary supplements to assure consumer safety. Here, again, we are going to tweak the language a little bit, but I would like us to look at the recommendations here.
"The Commission recommends that the FDA's Good Manufacturing Practices be implemented to help assure the purity of dietary supplements."
Is there any dissent on that? Ming?
DR. TIAN: I have a question for you. You talk about purity. What does that mean?
DR. LOW DOG: I had a little issue with purity, too. Be implemented, I think to help assure either safety, or just the Commission recommends that the FDA's Good Manufacturing Practices be implemented to help assure the safety of dietary supplements."
DR. TIAN: Can we say quality instead of purity?
DR. LOW DOG: Quality?
DR. TIAN: Yes, and also you talk about the GMP. That is special GMP procedure for dietary supplement, it is not for pharmaceutical company.
DR. LOW DOG: Right.
DR. TIAN: Because if I understand, a lot of dietary supplements are not purified. It's naturally get extract. We don't even know more than 100 of few hundred components in it.
DR. LOW DOG: Right.
DR. TIAN: All right.
DR. LOW DOG: And we can be more specific actually in the dietary supplement. These have been agreed by industry, and we are just waiting. They are just kind of held up right now.
DR. TIAN: They have different standard. We don't want, also, it is impossible to improve that quality up to the pharmaceutical standard. There are two standards. We ask too much, we will kill everybody.
DR. LOW DOG: We are just looking for the ones, and we will be more specific in our language of the dietary supplement, Good Manufacturing Practice, that have already been agreed to including industry member representation. It is not pharmaceuticals.
DR. TIAN: Okay. Thank you. And page 10, second paragraph, No. 15. You mention limited to the products with industry-approved standards. What does that mean?
DR. LOW DOG: Where are we?
DR. TIAN: Page 10.
DR. LOW DOG: Did I skip something?
DR. TIAN: Yes, but this is the same question.
DR. LOW DOG: I would like to come back to that. That is under Issue 8. Let's come back to that. We will, I promise, get to that.
DR. TIAN: Okay. Thank you.
DR. LOW DOG: Do we have consensus with changing also from "purity" to "quality," which I think is a better word, and we are going to make sure we include the proper GMP, so everybody knows what we are specifically talking about? Do we have consensus on this? Tom?
MR. CHAPPELL: I believe I heard safety and quality.
DR. LOW DOG: Quality and safety being a relative term, safety. 17. The Commission recommends that the DHHS, USDA, Environmental Protection Agency, U.S. Custom Services, and other appropriate federal departments and agencies work with manufacturers and importers to monitor the quality of imported and domestic dietary supplements and identify and prevent contaminated or adulterated products from entering the U.S. marketplace when possible. And then DHHS, USDA, EPA, and others work with the WHO and other appropriate international organizations to establish guidelines to help assure the purity, or quality, I guess, or herbal ingredients and, where possible, set international standards for consistency.
Questions? Comments? Issues?
And also just supporting for initiatives that we mentioned somewhere here about AOAC, USP, NSF, other groups that are setting standards, that we probably want to move that into this section. That is just a technical -- never mind, forget it. Technical thing for us. This goes there.
Any questions or problems with that recommendation? Basically, that we have had some issues and problems with contaminants and adulterants in a number of the raw botanicals and formulas, prepared formulas that have come into this country, so there has been a desire to try to get a handle on that.
MR. CHAPPELL: Yes, thank you for that reference. I am wondering why we include domestic in this?
DR. LOW DOG: Is there a reason you would not include domestic of our raw botanicals and raw materials here for adulteration and contaminants, which we have known to be a problem for many, many, many, many years, echinacea being a prime example of substitution with parfineum and tegra folium.
So, I mean we have issues of substitution, adulteration, and contaminants here in this country, as well. It is not just foreign material.
MR. CHAPPELL: I guess I just would like to ask how manufacturers would proceed under normal circumstances with this recommendation.
DR. LOW DOG: I think this is more of an issue of trying to get some of the agencies involved to help in this whole big arena. As long as manufacturers are pretty much following GMP, they are going to be doing the best that they can. I think that we need to perhaps involve some of the other agencies to look for ways of identifying quality and ways of helping to assure that we are identifying adulterants and contaminants when possible. It is a big task.
MR. CHAPPELL: I appreciate that. I am just wondering is that covered in 16 for domestic companies. I guess what I don't want to do is accomplish 16 and then put on additional encumbrances and bureaucracies that prevent domestic companies from proceeding in an orderly way to get their products to market.
DR. LOW DOG: So, your issue is with the word "domestic" here.
MR. CHAPPELL: Yes.
DR. LOW DOG: Because you believe that if they are in compliance with 16, 17 naturally follows.
MR. CHAPPELL: I think 17 really deals with imports.
DR. LOW DOG: We will take that and work with that. That's a good point, Tom.
DR. FINS: The other thing is whether or not there is a role under 17 with the appropriate state agencies, as well. It is not a purely federal problem, but there are state departments of housing, environmental protection, et cetera.
DR. LOW DOG: Any other comments? Those were good comments. Anything else? Joe?
DR. PIZZORNO: One piece left out here, and it may actually be a totally new issue, but I would just like to raise it for the committee to consider, is we haven't dealt with the Environmental Protection Act about some of these botanicals being well crafted, being endangered species.
It seems to me that this would be an appropriate place somewhere in this section to discuss that.
DR. LOW DOG: Threatened and endangered, working with groups like United Plant Savers, working on that. Okay. New issue.
DR. GORDON: That would be a new issue, right?
DR. LOW DOG: Make sure we write that down. That's good.
Anything else? Is there sort of general agreement about this? We can tweak it a little bit and add some things, look at the domestic issues and GMP, sort of look at that and bring it back to you all. But is there general consensus?
DR. FINS: Is there a role for DEA in any of this? There is some herbals that would be under their jurisdiction.
DR. LOW DOG: Yes, but they are not being sold at Wal Mart.
I am going to move to 8 kind of quickly here, Issue 8, that we skipped over. This was about labeling, adequacy of labeling. Part of what we are going to do here, part of this has to do with labeling, but part of it has to do with quality control.
So, if you say that your St. John's wort has 0.3 percent hypericin, and it doesn't actually have it, is that a labeling issue or is that a GMP issue? I mean did you not meet your label claim because of your analysis, your analytical method, or your quality control.
We are going to take that and tweak that a little bit and re-present that to you, okay, because we think we can make it clearer for people that are reading this.
Our big thing with labeling is the issue about structure/function claims, drug claims, some of the issues that were raised by a number of people who presented here. This is what we wanted to address, safety, people putting what is known if there are safety risks on their potential interactions, and also the issue, then, of benefit, structure/function.
So the recommendations that were made, where the Commission recommends that the availability of consumer information of dietary supplements be increased through improved labeling, package inserts, and information at points of sale, inclusion of information on possible interactions with prescription or OTC meds, foods, or other health products, and I think we should put "when known" or "when established," because a lot of it is very theoretical right now, and theoretically, anything could interact with anything, so I think we need to tweak that a little, and inclusion of information on possible risks to vulnerable populations, such as children, elders, pregnant, nursing women, and those with certain health conditions that compromise the immune system.
Basically, if we know that there is somebody who shouldn't be taking this, should it be on the label.
DR. GORDON: Tieraona, here, I think that the recommendation needs to be much more specific about the whole area of what kind of information we feel should be on there. You present it in the section on Challenges, and also just in discussing the issue, but the recommendation just says "improved information," and I think this is an area where we can make -- I am not saying we have to do it in this next few minutes, decide what to do -- but I want to hear from the Commissioners.
My personal opinion is we need to provide more of the available information about what we know about the utility of these substances that are being marketed.
DR. GORDON: All right. Joe, and then Tom.
DR. FINS: It is sort of along the lines of what Jim was suggesting, we have a little more specificity. Another area which I don't think you have covered is the issue of dosages and toxicity. In other words, if people take one vitamin C, it is one thing, if they take a tremendous amount, they get kidney stones, so I mean I think we want to have people aware of what a safe dose is or what the recommended dose is, so they don't get toxic by taking too much.
DR. LOW DOG: Tom.
MR. CHAPPELL: I think it might help you to begin -- the doorway here is either a DSHEA claim, it is claim based, it is either a DSHEA claim or an over-the-counter drug. If it's an over-the-counter drug, there is a monograph that requires certain dosages that you must adhere to, the language of the claim must be adhered to.
If it's a DSHEA claim, there is strict language about what you can say, and then if you have knowledge of the biological activity of any one ingredient in there, that doesn't fall under either DSHEA or OTC, you are really required to apply for a New Drug Application, because it's a drug and you are not claiming it to be.
I think we have to ask how are our aims going to mesh with the regulatory world today, which is claim based. That is the starting point in improving information, and if we think we have the liberty of adding information to the label, believe me, we do not. The FDA will absolutely slam us for saying, oh, in addition to the zinc citrate that we have in this toothpaste that is going to help your gums, we have chamomile in there, too.
Well, good luck. If you have got clinical evidence to show that chamomile is helping the gums, then, you will be invited to do a New Drug Application, but this is so structured that I just want us to be aware we don't have the liberty of providing a lot of information to consumers that we might like to, but we are very much constrained by the regulatory world here.
DR. LOW DOG: One could divide this really into two pieces, one which is benefit, and the other which is risk, because much of this right now is -- because it's really two parts, isn't it -- one is the structure/function claim or drug claim, and the discussion of soft claims and somewhere where that might be in there.
The other then is potential risks -- I hear you, Michele -- is the potential risks, which is then about adverse effects or risks for certain populations or interactions with particular drugs. So, we have two pieces.
This one really focused on or our attempt was to really focus on Recommendation 14, on potential interaction, harm, side effects, that aspect of the label. Do you have any concerns about that?
MR. CHAPPELL: Only to say that the whole world wants to know about interactions.
DR. LOW DOG: No kidding.
MR. CHAPPELL: I am just wondering where the burden has to lie here for providing that information.
DR. GORDON: Just a point of procedure or order. We will take 10 more minutes, because I think this is really important to focus as much as we can on this.
MR. CHAPPELL: There are a whole world of pharmacists. May I speak?
DR. LOW DOG: Yes.
MR. CHAPPELL: There are 110,000 pharmacists out there that would like to know more about drug interaction. As you say, we need to tweak this, but since there is so much analytical information required here, and further study on interactions, that I am concerned that we may be setting up a hope here that we can't deliver on.
DR. LOW DOG: Right. I think it is an excellent point. We are going to work on the language. We have discussed this on when it is known, when it is clearly established. Certainly, we do know for some things, where it has been clearly established and there is consensus, but we want to work on this a little bit and bring it back to the group.
DR. FINS: This gets us back to what we do with DSHEA. I think we have all sort of agreed that that is a huge thing and it is probably not something we can really modify at this point, but I do think, my understanding, in a sense, DSHEA was written, not to make claims that were too grandiose, but it really didn't address the toxicity or the risk side.
I think the way to carve it out, and we are providing more information about interactions, about toxicities, about vulnerable populations, all of that is protective and, if anything, it doesn't enhance the desirability of people wanting to take these entities, it is not an inflated kind of claim.
So, I think that in the spirit of the public health, given all the testimony that we have heard and the interactions that we have been aware of, I think we are really operating under the spirit of DSHEA, but we are providing absolutely necessary information that would allow people to maximize their utilization of these products in a safe and efficacious manner.
I think we have to, as you were beginning to suggest, it is about the toxicity, it is the down side that we are providing more information on, and not necessarily the up side. I don't think that is inconsistent with what was the legislative intent.
I think the other thing I would couple in here is that we should track this information, the FDA should track this information, and there could be a possibility of revisiting this legislation in a more formal way down the road, that there should be a report to the Secretary in five years based on if our recommendations are implemented, because I think that this remains an open kind of question. It is not a question we want to open right now, but there should be some future revisiting of these concerns.
DR. LOW DOG: Dean.
DR. ORNISH: Just to emphasize again, I think it is really important to add issues like this. I know it is going to be, as more research is done, more side effects will be known. There is an article coming out next month in The New England Journal showing that antioxidants interfere with statin drugs, for example. So, I think addressing this issue now will be important now and even more important later.
DR. LOW DOG: Thank you, Dean. Thank you for all those comments. We are going to work on that a little bit, and we will bring it back.
DR. GORDON: I have one more, which I believe is a new issue, which we raised several times in the course of the hearings, which is should there be some kind of education for health food store employees.
DR. LOW DOG: Put that for Saturday.
DR. GORDON: Thank you. That is what I wanted to do. I just wanted to raise it now, though.
DR. LOW DOG: Yes. Put that on our agenda.
Recommendation 15. The Commission recommends that claims of standardization be limited to products with industry-approved standards.
That, we need to go back and rework, who is the industry, what standards, which products. So, we would like to beg your forgiveness and sort of go back and rework that a little bit and re-present that to the group.
Finally, in our last one, Issue No. 10, on page 11. Federal oversight to assure public access to, and safety of, dietary supplements.
Recommendation 18. The Commission recommends that there be adequate staff of professionals within the FDA and NIH with expertise in dietary supplements especially areas other than vitamins and minerals, plant, animal, et cetera.
This could include hiring people with these specific skills and/or providing training to current staff, and may require increased staffing levels or funding. Many of the biologics and the plants are extremely different than looking at vitamin and mineral metabolisms. They bring their whole set of issues and sometimes we feel that maybe these organizations might need increased funding to be able to enhance their staff for people that have special expertise in those areas.
DR. PIZZORNO: Another good recommendation. I would also like to suggest that after the "adequate staff of professionals," say "and an advisory board, which includes amongst others, CAM professionals experienced in clinical use of these agents."
DR. GORDON: Excellent.
DR. LOW DOG: Corinne. Go ahead, Corinne, you can speak.
MS. AXELROD: I think there should be a little bit of discussion on that because we don't want to be telling FDA what to do. Part of that is just their management, if they choose to have an advisory board or not. I think there are a lot of implications.
So I would just like to be aware that advisory boards are not just casually assembled and have a lot of implications that, maybe, we should discuss.
DR. LOW DOG: Thank you, Corinne.
DR. BRESLER: I want to talk about this point, too, because there are lots of people that have academic information about biochemistry and physiology of some of these products and supplements, and so forth, but have no experience clinically whatsoever in their utilization.
I do think this is an important point. Maybe the language we use is to encourage the FDA or something like that, but I think it does need to be addressed. Clinicians with clinical expertise need to be involved in decisionmaking at this level, I think.
DR. GROFT: Tieraona, if I may add, that there is an advisory board already in existence for dietary supplements at the FDA.
DR. LOW DOG: You are so good. Thank you, Steve.
MR. CHAPPELL: I am really not sure what I want to say, but I am having trouble with this. As I have been sitting here for a year and a half, the concern is about safety more than efficacy on these products. As I speak as a company involved in herbal products -- I didn't say a professional, because I am not a professional -- I know that we don't know enough about the mechanisms of action of these individual herbs to understand what to use for a marker to establish a standard.
For us to be seeking standardization of, let's say, a DSHEA-type claim product, we really need more knowledge than we know today. On the other hand, if we are talking about standardization of an OTC item, the OTC has a benchmark. We know what the drug is that is accomplishing the effectiveness.
The OTC, that already is set up, so we are really talking about DSHEA items here, and there is so little known about the individual herbal mechanism of action that I would think we ought to be encouraging, not claims of standardization, but rather more knowledge on the bioactive ingredients.
DR. LOW DOG: Tom, I hear exactly what you are saying. That is why we didn't go through 15. You are back on Recommendation 15. We are on Recommendation 18.
MR. CHAPPELL: I beg your pardon. I thought we were talking about 15.
DR. LOW DOG: No, we left that one. We said we would like to beg your forgiveness, because that needs a tremendous amount of work. We are real aware of those issues, so we don't like Recommendation 15. We would like to rework it with your permission and bring it back.
MR. CHAPPELL: Okay. Well, you didn't have my permission to take it away yet. I wanted to comment on it.
DR. LOW DOG: We were out of time, that's all, we were aware of the issues.
DR. GORDON: Procedurally, Tom, what might be most helpful is if, Tom, if you worked with Tieraona and that committee on No. 15.
DR. LOW DOG: He is on now. We realized all the pitfalls with that one, so we wanted to come back to it.
On 18, anything else on Recommendation 18? Ming.
DR. TIAN: I think the advisory board is very necessary, very important, and the advisory board, I would suggest to have some subcommittees for different CAM products or subjects, because the qualification to be an advisor, to understand all the 31 CAM, we are talking about the definition, who could do that, understand everything? I am afraid not.
I think it is very important. We must have a subcommittee and also to hire the qualified person to be advisors. I don't feel shy to recommend this to the FDA, and as we all know, and you can't ask FDA officers to understand everything.
DR. LOW DOG: Thank you.
DR. GORDON: It is time for us to come to a close here, and then we can come back to where we are on all these issues as we go over them.
DR. LOW DOG: If they could keep their comments very brief, could we hear from Wayne and Effie just real quickly? They were waiting.
DR. GORDON: Sure, go ahead.
DR. JONAS: I had a very short thing. I assume you are going to change this about staff, adequate staff. I would not include that. I think that was along the lines -- I wouldn't word it that way, I don't think we should be dictating how much or what kind of staff that particular federal offices should have. That is really in their purview of management.
The collaboration aspect, the importance of having input from experts in particular areas including clinical experts is important, but I wouldn't say you need to hire more people.
DR. LOW DOG: Okay, leave it out.
DR. CHOW: I would like to confirm what Xiaoming said, and in addition, that it is not just people from institutions, but individuals, because at some point we mentioned include institution, but individuals who don't belong to institutions and are known as excellent practitioners should be considered as part of advisory, subcommittees or whatever.
DR. GORDON: We have minutes. I am going to move through it again pretty quickly. Thank you very much, Tieraona and David and Corinne. This is really a very nice job of making recommendations and taking us through it.
I am just going to go through the recommendations one by one.
Basically, No. 1 is approved as is. If you have a problem, I think the best way is if there are issues with my summary, raise your hand or turn on the mike and let me know or let us all know.
No. 1 is approved as is.
No. 2. The issue had to do with we want to find out what other kinds of education campaigns are going on. We are talking, not just about CAM information, but information about science and medicine more generally.
No. 3. There was a strong sentiment for changing "encouraging" to "requiring," and there was an issue raised here about the whole transparency of the process. I think this is a larger issue that all of the groups need to take into account as we go back and formulate both issues and recommendations. It is not just one that applies here.
Recommendation No. 4. There was a recommendation that -- go ahead, Joe.
DR. FINS: Point of order. You are obviously going through this, not mentioning everything that was covered.
DR. GORDON: Right.
DR. FINS: But things that were said that were agreed upon are still on the table, like, for example, the relationship to HIPAA is just an example in No. 3.
DR. GORDON: Right, exactly. I am not giving every detail, but I am trying to deal with the recommendation, and that is sort of filling in.
No. 4. One that did come out strongly was to find out what is going on with NCCAM as we make that recommendation.
In No. 4 and No. 5, we sort of ran into some confusion because this is really about letting people know what is happening in the government. This is not necessarily about providing definitive information. It became clear that as this is presented, the distinction between the provision of information and providing, in a sense, information about information has to be made.
DR. BRESLER: Back up one second.
DR. GORDON: Go ahead, David.
DR. BRESLER: Go ahead, Corinne.
MS. AXELROD: I just want a clarification on Recommendation 4, what the disposition is, please.
DR. GORDON: The understanding is that we need to find out what NCCAM is doing and include that as part of our background information and as part of our understanding and statement about what is going on. If that reshapes the recommendation in any significant way, that needs to be brought back here, otherwise, it is all right as stands.
Is that okay? Did you have something on that, Corinne?
MS. AXELROD: My understanding was that that was approved and that we can certainly add the background information.
DR. GORDON: That is my understanding, as well, unless there is some way in which it changes things materially.
DR. BRESLER: We will bring it back to you if it does.
DR. GORDON: On to No. 6. Here, there is an emphasis on providing other kinds -- on working with local librarians and other media other than the Internet needed to be included in No. 6, in that recommendation, but that otherwise, the recommendation was as stands.
DR. FINS: Didn't we want to put an actual appropriation?
DR. GORDON: I'm sorry, what?
DR. FINS: An actual appropriation for infrastructure building and training of librarians, in other words, it is not that we are encouraging a partnership, we are actually talking about real money going to libraries in our communities to train librarians.
DR. GORDON: Let's check on that.
DR. GROFT: Yes, I think we want to check on that because I think some of that is already going on with the Library of Medicine. When Dr. Lindberg spoke at our session, he talked about --
DR. FINS: I don't think it was to local libraries.
DR. GROFT: Yes.
DR. FINS: We need more information on that.
DR. GORDON: Let's get some more information on that.
DR. GROFT: We will get more information for you on that.
DR. GORDON: No. 7 is as stands, and then the recommendation was that No. 10 go in this section. No. 10, if everybody looks at No. 10 on page 6, we are not just talking about protecting the constituency, we are talking more generally about educating those and other constituencies.
DR. BRESLER: And also determining the needs of those communities, as well.
DR. GORDON: Right.
No. 8. This was accepted with just the understanding that we ought to provide a context and talk about globalization as we talk about No. 8.
No. 9. There was some concern about wording here. In particular, one of the issues had to do with not to focus on Spanish media, but I think Linnea said that we are talking about all media and all languages and that we needed to somehow tie in education here, as well, and that if we are talking about the FTC, that we have to make sure that the FTC understands the issues that are involved.
There was a suggestion that some of the wording that we used when we talk about the FDA might be brought in here, as well.
Is everybody following what I am saying here? The kind of information that the FTC needs in order to make these judgments, they may not have at this point, and that they may need the same kind of input that we describe in a later recommendation about the FDA.
I think we can just bring that recommendation back with those additions. Does that feel okay to everybody? Okay. I will take silence for agreement.
Recommendation 11 was approved as is.
Recommendation 12 was also approved with the understanding that the issues, that this is simply a recommendation for making information available. This does not relate to the guidelines for licensure or credentialing, which will be dealt with elsewhere.
No. 13. There was considerable discussion about. There was general agreement, although some questions about mandatory registration. There are two issues here. One had to do with mandatory registration, and George DeVries in particular wanted to hear a little bit more from the group before we went ahead with that.
Then, there was a second issue, an addition of an (F) here to (A), (B), (C), (D), (E), and that Joe Fins was talking about, which I think there was general agreement about, about some kind of centralization of the functioning of monitoring adverse events and making information about them widely available.
My sense of this one is that to be absolutely sure, that we just want some of that background, Tieraona, that you were talking about gathering and presenting, and that you can bring it back to the group, but that there was a general feeling that the movement from voluntary to mandatory made sense, but just some questions about exactly what that might mean.
Is that fair enough? Okay.
MR. DeVRIES: Let me ask a question, though, because I think I was the one who voiced the question, and I am not sure anybody else did. I didn't actually sense a general feeling that -- I think that was more my question, is that right?
DR. GORDON: Right.
MR. DeVRIES: I think we can move ahead on this. I would just like to follow up maybe directly with you, if I can, and maybe talk with you off-line. I think that will be adequate.
DR. GORDON: Fine. Is that okay with everyone? Perfect.
No. 14. This one, both No. 14 and No. 15, goes back to the group, to the workgroup, for refinement, and refinement particularly about issues both of benefits, harm, how we make decisions about what should be included, what should not be included, and then, coming into No. 15, what the whole issues are with standardization, and the subcommittee recognized those needed to be elaborated on.
DR. FINS: Jim, could I just ask, I think No. 14 is so critically important, I want to be a little more clear about what we think, if I could.
DR. GORDON: Sure, go ahead.
DR. FINS: If we can nail this down, because the specific question is whether or not we feel under the umbrella of DSHEA, whether additional information about the toxicity, the risk, the drug interactions, all of that information should now be included, not making the kind of claim for efficacy stuff which is clearly prohibited under DSHEA, but in the spirit of protecting the public, that we would recommend a consideration of that kind of information in the package insert.
I didn't hear people against that, but I just wonder if we could kind of get more clarity on that point.
MR. CHAPPELL: Well, at the present time, it is against the law.
MR. DeVRIES: I understand that.
DR. FINS: But we are here to recommend modification or reconsideration, again, trying within the spirit of the existing law, within the spirit of DSHEA, FDA might be able to make, not a statutory change, but a regulatory interpretation in the context of what is going on here.
DR. GROFT: When you get into your work in different areas, I think it is an area that we need to explore further, and I am never hesitant, and I think it is within our mandate that was provided in the Executive Order, for us to make administrative and legislative recommendations on what we feel is necessary to improve the access and delivery of CAM products and services.
To me, I think it is just something we have to look at in greater detail, and if the Commission feels that some changes are necessary, I think we have to be willing to go ahead and make those changes and recommendations to whoever is appropriate.
DR. GORDON: Thank you. Yes, I feel the mandate is not only there in terms of safety issues, Tieraona, I feel the mandate is also, is it possible to provide information if there is a meta-analysis of studies on St. John's wort; is there some way that we can make a recommendation that that information be made available.
DR. LOW DOG: What I think we would like to do is we would like to separate that recommendation into probably two parts, to two, one really looking at benefit and claim information, and the other looking at potential interaction and side effects, and we will work on that.
DR. GORDON: Joe, go ahead.
DR. PIZZORNO: I would like to second the issue about more appropriate language for making claims, because my concern is without being able to make appropriate claims, such as when there really is clinical evidence, that without being able to make claims, you kind of open up the door to anything being claimed, but if you have a good quality claim opportunity on the label of practice materials, then, people know they can write on this and they don't have to believe or consider the other stuff.
DR. GORDON: David.
DR. BRESLER: Just a point of information. Can a label refer people to an information source, can a label refer people to a book, an article, or an Internet site?
DR. GORDON: I think that what we need to do is explore all those questions. Again, we are taking this very seriously, as we should, but I think Steve's point is well taken, we can make recommendations.
Our job is to help the public be better informed and use these products safely and appropriately, and so I think we are in a position where we can make recommendations. The question is what kind of recommendations and how we should make them.
DR. GROFT: Just to bring up to date a little bit, one of the comments that were made when we received the Interim Progress Report we submitted for approval, one of the comments that came back from the FDA was the suggestion that perhaps we need to be more aggressive in recommending that or encouraging how we want to word it, that sponsors move products to a New Drug Application stage that Tom mentioned, as far as only then, to me, is adequate information really available, that is looked at, is reviewed, peer reviewed, and then said this is the current state of knowledge.
But I think realistically, we are now in the Internet age, and information that years ago you only could go find way deep in the literature, is not up front on page 1. I think we have got to look at how people are retrieving information. We have heard how people are retrieving it.
I think we need to be rather aggressive in our stance of what we are saying that people need. I think that is realistic for us to do, as well.
DR. GORDON: So, this is an issue we really want, you take back, consider, listen, and all those who are interested in this group, please be in touch with Tieraona and David, and help them work on this issue.
Let's move along. Nos. 15, 16, and 17, we changed "purity" to "quality" and "safety," and there was general agreement about that. There was general agreement about the recommendations although there was some concern on No. 17 whether, if No. 16 were enacted, if GMPs were actually put forward, whether we needed to mandate the domestic surveillance, as well as international. So, maybe you can just bring that piece of it back.
No. 18. There was concern with the FDA, that on the advisory board, there be the kind of clinical expertise that is necessary to help evaluate some of these approaches. There was agreement about the recommendation as a whole.
That was the only area where there was an additional feeling that it would be helpful, since there already is an advisory board, we don't need to make that recommendation, but that clinical expertise be included on the advisory board.
That is the recommendations, and it is time for lunch.
MS. AXELROD: There is another part to that last one, that Wayne had wanted the staff part to be deleted, the adequate staff part.
DR. GORDON: Right.
DR. WARREN: When we start talking about the labeling of these dietary supplements and all their possible interactions with drugs, I was just kind of tipping the scale to one side. Shouldn't methotrexate have a label on it that says don't use it in combination with B complex vitamins.
DR. GORDON: Good point. Let's talk a little about that as a new issue, and then we can report back to this group. Let's bring that up again, if we can bring that up on Saturday. Thank you.
DR. GROFT: I would just like to remind you that after these recommendations are formulated here on the next three days, we are going to meet with the federal agencies involved and others to talk about what the Commission is thinking and to get their input into where things are currently and how might they be changed.
I think there are a number of federal agencies that would like to see changes, but until you get a legislative approach, things can't change because of the requirements. We will be doing some follow up on this meeting aggressively with the federal agencies.
DR. GORDON: This is great. Thank you everybody for being really on time.
MS. CHANG: Lunch is in Conference Room A, which is across the hall and down a bit. This room will be closed during our lunch break, so, visitors, you will have to go outside. You can leave your books and everything on the table, and we will reconvene at 1:30.
[A lunch recess was taken at 12:30 p.m.]
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