National Institutes of Health
Conference Rooms C & D
6001 Executive Boulevard
Friday, December 7th, 2001 - Morning Session
P R O C E E D I N G S
Thursday, December 6th, 2001
Friday, December 7th, 2001
DR. GORDON: Let's just take a minute to sit quietly, and we will begin.
[Moment of silence observed.]
DR. GORDON: Thank you. I hope everybody had some rest last night. I just wanted to say again how much I appreciated the way we worked together yesterday, and everyone's willingness not only to contribute, but also to work toward consensus on some sometimes difficult issues. So it was really terrific, and I appreciate it greatly, and I am looking forward to today.
Steve, any announcements before we begin?
DR. GROFT: We don't have that large of an audience, but for that are here, we are changing the agenda a little bit. So you will see as we go on, it will be the second and third session that will change from yesterday.
DR. GORDON: The other thing is that because of changes in plane schedules, I have to leave at 4:00. Don Warren is going to be chairing the Public Comment Session.
So, Don, thank you very much. I appreciate that. And I appreciate it, those of you who can stay. I have to go to the West Coast tonight, and unfortunately, the later planes aren't running anymore. So I will be leaving at 4:00 today.
DR. GROFT: We will mention the fact that several of the commission members, because of the added security and having to leave early and catch planes, will not be here for the open public session. So it is just something we have to deal with, but we will make sure that those who do have to leave early will get copies of all the testimony that is presented at that time.
DR. GORDON: Great. We are going to begin, and we will be having sort of an informal lunch session in here, once again. We will ask the public to leave the room, and we will have the room to ourselves.
We will begin with Information Development and Dissemination. David is, as you know, ill and not here, so Tieraona will be -- Julia is doing this one? Okay.
So come on up, Julia.
Session V: Information Development and Dissemination
MS. SCOTT: Okay, I am under heavy pressure. Sitting in for David is quite a challenge, but at any rate, I will attempt to walk us through and get consensus under CAM Information, Development, and Dissemination; Issues 1 through 6, and Tieraona will do 7 through 10.
As has been our routine, I would like to go to the recommendation first, and then if there are any comments about supporting information for that recommendation, to deal with that secondly.
So we will start with the first recommendation.
DR. GORDON: Do you want us to be looking in the text rather than in the summary of recommendations?
MS. SCOTT: I prefer the text.
DR. GORDON: Okay.
MS. SCOTT: Thank you.
The first recommendation, under Information, Development, and Dissemination: The Commission recommends that the Secretary of DHHS establish an interdepartmental task force to identify and eliminate existing gaps in the development and dissemination of CAM information in the federal government, and that increased resources be provided to centralize CAM information for the public and the media.
This should include a toll free number that directs callers to the appropriate department, agency, and/or person for specific CAM information.
DR. WARREN: Wasn't this one of the possible functions of our CAM Central?
MS. SCOTT: This is listed in the federal CAM office. As throughout the report, for each category, there are a number of tasks that we felt, if there was going to be a federal CAM office, belonged there. And so, this particular one has been also listed under that office.
DR. WARREN: Good.
MS. SCOTT: No comments? Are we ready to move fast?
DR. FINS: In the background section, there was a very successful cancer CAM phone number that was used in the beginning of the 70s, I think, for information for cancer patients. So maybe there is some parallel legislative history or background that could justify this 800 number concept.
MS. AXELROD: There are actually a lot of 800 numbers, so we can list some of them if you think that would strengthen the text.
MS. SCOTT: Yes, so it is not a new concept.
Okay. Is there consensus on Recommendation No. 1?
DR. GORDON: Yes? Okay, good.
MS. SCOTT: Great. Oh, I'm sorry. Joe Pizzorno?
DR. PIZZORNO: I think an important that has to be dealt with here, or it would be nice if we could deal with it, is standards of evidence because it would be providing information to the consumer how we go about determining the quality of that information and how it should be recommended.
So I think there needs to be some strong discussion about different levels of quality of evidence and how that should be used to determine all information dissemination.
MS. SCOTT: Further on in the recommendations, I believe we do have a recommendation that speaks to the quality of the information.
MS. AXELROD: Eight-hundred numbers, typically, are referrals, they are clearinghouses. So NCCAM, NCI, others, would be providing them with information. The 800 number people are not going to be developing it.
The other part of your comment, I think Julia did say, will be elsewhere.
MS. SCOTT: There is a recommendation that follows, having to do with the quality of the information standards.
Recommendation No. 2.
DR. GORDON: Did you want to say anything more about that now, or are you okay with waiting until later?
DR. PIZZORNO: I don't believe the later recommendation addresses that, but when we get to it, I will bring it up again.
DR. GORDON: Okay.
MS. SCOTT: Well, why don't we get to it, and if we come up with a sentence, then we can decide whether it goes with the first recommendation or the recommendation that we are coming to.
Recommendation No. 2 has to do with the issue of availability and adequacy of CAM information for diverse groups of consumers.
The Commission recommends that resources be made available to (A) develop CAM informational materials at a level that most of the adult general public can understand and utilize; and (B) support national and local community leaders and organizations in identifying strategies and developing materials to enhance the availability of CAM information to the communities they represent and help prevent special populations from being targeted for products or services that are unnecessary, harmful, exorbitantly priced, or otherwise detrimental.
A little wordy.
DR. LOW DOG: Want a period somewhere?
MS. SCOTT: Yes. Probably a period and maybe some of this could actually in the text, is my thinking.
DR. PIZZORNO: Why are we only concerned about protecting special populations? It seems this applies to everyone.
DR. GORDON: What we might do is talk about everyone, and then say there will also be special attention for special populations, that there be particular efforts made to address this issue as it relates to special populations.
DR. PIZZORNO: Maybe another way is that some portions of the population are especially vulnerable to this and will require additional. Maybe something of that nature.
DR. GORDON: Do you want to provide some wording for that?
MS. SCOTT: It is in the text. It is here simply because we entitled this "For Diverse Groups." Are you suggesting that perhaps we need a general for the general population?
DR. PIZZORNO: I think all of this relates to everybody, but some populations are particular vulnerable.
MS. SCOTT: Right.
DR. PIZZORNO: So I was thinking maybe instead of "the communities they represent, and help prevent special populations from being targeted," we can reword it to something like "represent, with special attention to vulnerable populations." Just remove "help prevent special populations," and say "with special attention to vulnerable populations."
MS. SCOTT: I remember I was one of the dissenting people. I think I wanted something specifically that spoke to diverse groups, and especially the populations that typically are at the tail end of everything that is suggested. I think, very often in recommendations, when you do one for the general population, and then have a few words that say "with special attention to the special populations," very often, you don't get there.
So I think my argument for having a special recommendation for diverse populations was to bring it up a notch in priority. I mean, I agree with what you are saying, that everything that is here should be available for the total population, but somehow I wanted to see something with a little focus directly on those populations.
DR. FINS: Jim, one point on Part A, when you talk about understandability of this information, I think we should say something about it being available in a bilingual format for the Hispanic population, which is our major second language. I think we heard testimony from Dr. Huerta and others that this population was especially vulnerable.
The second point on the vulnerable special population question, there are ethnic communities that are vulnerable, but there are also lifecycle communities that are vulnerable.
We talked last time about hearings that Senator Breaux convened in the Senate Committee on Aging, where we heard about the elderly being horribly exploited through advertising campaigns, and taken advantage of, using the resources that they don't have to make purchases that they can't afford, and that will not help them, and perhaps even hurt them.
So I think we also may need to make special attention, and we can cite the hearings that Senator Breaux convened over the summer.
MS. SCOTT: So you think that that should be added to the text, or under Recommendations?
DR. FINS: I don't want someone to look at special population, or vulnerable population, and only think of it as an ethnic community, but also lifecycle, the elderly. I don't know what the right language is, but I just want that concept in.
MS. SCOTT: Okay. The text does include the different racial ethnic and culture groups, and does speak about language. But do you think there needs to be more?
DR. FINS: I think we should mention specifically the elderly, because that was the focus of the Senate hearings.
MS. SCOTT: Okay.
DR. GORDON: I would add the elderly and people with life-threatening illnesses, who are also vulnerable in that same way.
DR. FAIR: Maybe we should do a pilot project in Florida where they can't follow an arrow to a name down there, and if it passes there, it can pass anywhere.
DR. GORDON: The question Julia had, thought, was, are there any changes for the wording of the recommendation? I would like to get those now, if there are.
DR. WARREN: Could we look at Suggestion A, there, Development of CAM informational materials. The rest of that sentence, could we put that in the text somehow?
DR. GORDON: We could just say "easily comprehensible," or something like that.
MS. SCOTT: We have a lot of information out there that people cannot access because it is too technical, too medical-ese kind of talk. And so, our point here was that information is only useful if people can understand it. So I think we felt strongly, but I agree with Jim's little two words, easy to understand. We can work with that.
DR. WARREN: What about the statement: "CAM information to the communities they represent"? Can we eliminate "to the communities they represent"? You have already talked about the national and social community leaders and organizations. Maybe it is a little wordy there.
MS. SCOTT: Oh yes, it is definitely wordy. So you are suggesting let it stop at "information," and take out "to the communities they represent."
DR. WARREN: Yes.
MS. SCOTT: Or, just take this all out after it?
DR. WARREN: No, just "to the communities they represent." Then you would have a (C). After "and" there, you would have a (C), "help prevent special populations." So there are three parts to that recommendation.
DR. FINS: You could use a phrase like "underserved populations, the elderly and the chronically and terminally ill" as three categories in Part C.
MS. SCOTT: Actually, what you are suggesting for Part C is more descriptive of the rest of Part B. I mean, we could still name those special populations. It's not a problem.
DR. GORDON: Do you want to read it the way it is now?
MS. SCOTT: Do you have it, Corinne?
MS. AXELROD: "The Commission recommends that resources be made available to (A) develop CAM informational materials that are easy to understand and utilize; (B) support national and local community leaders and organizations in identifying strategies and developing materials to enhance the availability of CAM information; and (C) help prevent populations" --
MS. SCOTT: You said no (C).
MS. AXELROD: So forget the (C). "And help prevent populations such as the underserved, elderly, chronically or terminally ill from being targeted for products or services that are unnecessary, harmful, exorbitantly priced, or otherwise detrimental."
It is still a little wordy.
DR. GORDON: Great. Before we go on to 3, I want to go back to 1, because I have been reading it over and I agree with Joe. I just want to add one little piece in there. I'm sorry, it will be good for me.
"Interdepartmental task force, which includes representatives of the public and the CAM professions." It may be obvious, but I think it needs to be in there. The beginning of Recommendation No. 1, "The Commission recommends that the Secretary establish an interdepartmental task force which includes."
MS. SCOTT: Oh, I see.
DR. GORDON: We didn't use our phrasing "empowered and informed."
DR. GORDON: I'm sorry, what, Joe? Go ahead.
DR. FINS: Which includes "empowered and informed representatives of the community," which is our general phrase now for that.
DR. GORDON: Right, and "people with expertise in CAM therapies." The reason I am recommending this is because in the past, regulations have gotten promulgated where people don't know anything about CAM therapies, and it hasn't worked.
MS. AXELROD: I am not sure that it is then an interdepartmental task force, so we may have to change that because an interdepartmental task force is bringing people from the different departments within the federal government to look at their own materials and see where the gaps are. It doesn't preclude them from bringing in experts to assist them. But that is what an interdepartmental task force is.
DR. GORDON: We need to have people within the government who are expert as well.
MS. SCOTT: So we will just add "which includes people with expertise in CAM."
DR. GORDON: And then the representatives of the public as well.
MS. SCOTT: Informed and empowered representatives of the public. Okay. Effie?
DR. CHOW: Sorry, I want to go to No. 2, if we are finished with No. 1. I thought that ethnic minorities were going to be included in there, the aging, the chronically ill, somewhere, because that was one of the major concerns.
MS. SCOTT: Absolutely.
DR. CHOW: And the languages. So with the ethnic community in either (A) or (C).
MS. SCOTT: Yes, you are right. That was my point, too. I prefer to "ethnic" as opposed to "underserved" because I think a lot of people think of "underserved" as only being poor, and it doesn't deal with racial and ethnic discrimination.
DR. FINS: Can we put both in? Because there are underserved populations that are mainstream demographic that are vulnerable, and there are ethnic populations that are vulnerable, too.
MS. SCOTT: Fine. Okay, we are agreed? Do we need to read it again?
DR. FINS: More calls. We have a winner.
MS. SCOTT: Okay. Let's move on to No. 3. This also is dealing with Issue No. 2, which is Availability and Adequacy of CAM Information for Diverse Groups of Consumers.
"The Commission recommends that current efforts of the National Library of Medicine and the American Library Association, which are detailed in the text, to develop training materials and provide training to librarians in guiding people to find health information be expanded to include CAM information."
DR. FINS: Can I put some specific language in here? I think that patients, when they are consumers, they go to their public library, and for many people who do not have Internet access or are not necessarily all that health literate, the librarian should know how to use PubMed and MEDLINE.
I would maybe like to just put in a recommendation that the National Library of Medicine, if they don't already have some sort of program --
DR. LOW DOG: They do.
DR. FINS: They do.
DR. LOW DOG: Maybe just to continue funding it.
DR. FINS: Does it address the skill set for resourcing CAM questions?
MS. SCOTT: Health.
DR. LOW DOG: They have started to include CAM, though.
DR. FINS: It does? Okay.
MS. SCOTT: And this is what this recommendation is.
DR. FINS: Do we have data to know whether that is adequately funded?
DR. LOW DOG: Maybe just to ensure adequate funding for CAM.
DR. FINS: Because I think the current level probably should be expanded.
MS. SCOTT: You mean the funding.
DR. FINS: As Jefferson said, "To march an education is impossible," right? The library is the centerpiece of that. So I think we should direct resources to the local libraries, however we can.
DR. GORDON: I think, actually, this is a good instance where a specific funding recommendation could make a difference.
MS. AXELROD: We are going to be talking with the National Library of Medicine, so we will ask them if additional resources are needed. So we can put that in, but just as a caveat. We want to run it by them and see.
DR. FINS: The other to mention is that hands-on teaching is maybe very important for librarians to learn how to do these skills, and there are regional branches of the National Library of Medicine. So maybe we can get the National Library of Medicine in conjunction with its regional partners or something, so that there is an opportunity for an on-site training program.
DR. GROFT: I think, if you remember Dr. Lindberg's testimony, they do have training sessions throughout the country, and so it is something that I think we could provide a greater emphasis.
MS. SCOTT: Let's see what we have.
MS. AXELROD: "The Commission recommends that increased funding be provided to expand the current efforts of the National Library of Medicine and the American Library Association and its regional partners to develop training materials and provide training to librarians in guiding people to find health information, including CAM information."
DR. FINS: The regional partners would refer to the National Library of Medicine, not American Library Association.
MS. SCOTT: Okay? Are you all right with that? Consensus? Passed.
DR. GORDON: Yes.
Okay. We are on to Issue 3, which is accuracy and quality of CAM information on the Internet. Recommendation No. 4, "The Commission recommends that the Secretary of DHHS form a public-private partnership to review new and existing websites and develop voluntary standards that will promote accuracy, fairness, comprehensiveness, and timeliness of information on CAM Internet sites as well as disclosure of sources of support and any conflicts of interest. Sites reviewed and found in compliance with the standards could publicize this achievement and display a logo identified with this level of merit."
This recommendation is also one that is included in the federal CAM Office should it be funded.
DR. FINS: I would just change two words in the last line on 262, "Publicize this accreditation and display a logo associated with this level of merit," or "level of compliance." "Merit" is okay because it is meritocracy.
MS. SCOTT: Anyone else?
DR. GORDON: Julia, do you just want to comment on the precedent for disclosure of sources of support and any conflicts of interest? Is this really a new idea that we are coming up with or has it been instituted elsewhere?
MS. SCOTT: It has been instituted elsewhere, a lot with drugs. If there is a study done to have to say whether or not it was done by the --
DR. GORDON: Oh, I know. But has it been done on the Internet before?
MS. SCOTT: Well, you can answer that. I don't know that.
MS. AXELROD: Yes.
DR. GORDON: Who has done it? I am just curious.
MS. AXELROD: I don't recall the names of the organizations offhand. There have been attempts, as was addressed in the text, to do this with CAM sites but they have really not been effective.
DR. GORDON: What I am suggesting is that in the text it would be important to talk about this and that this is really a significant step forward to have not only the voluntary standards but also that kind of disclosure, that it is regarded as good ethical practice at medical meetings and that we feel the same needs to be taken onto the Internet.
MS. SCOTT: I think that's a good point.
So that information will be added to the text that would back this.
Are we okay with the recommendation as it is stated?
MS. SCOTT: Passed, great, with those changes.
We are on to Issue 4, availability of CAM information from other --
DR. GORDON: We have Nos. 5 and 6 to go.
MS. SCOTT: Oh, I'm sorry.
DR. GORDON: That's okay.
MS. SCOTT: I'm really moving ahead.
Okay. Recommendation 5. We are still on Issue 3: Accuracy and quality of CAM information on the Internet. "The Commission recommends that funding be provided to the Secretaries of DHHS and Department of Education to jointly conduct a public education campaign that teaches people, including students, how to evaluate health care information, including CAM information, particularly on the Internet."
DR. BERNIER: You have split an infinitive there. I don't know if you want to do that.
MS. SCOTT: Thank you, George. Corinne will take care of that.
MS. AXELROD: I am so embarrassed.
DR. FINS: Just to add to the text section, because I think a lot of these recommendations are generically good, above and beyond CAM, I just think we could say something about scientific literacy as an important skill of the citizen having to make choices from things like cloning to echinacea, as it were, and all of these educational interventions will bring everybody's knowledge base up. I just think it is generically good. It is not just about CAM literacy, it is a generic kind of skill set.
DR. GORDON: I just have a quick question. Do you think cloning is alternative medicine?
MS. SCOTT: No, echinacea.
DR. FINS: Only when done by aliens.
MS. AXELROD: Joe, did you want that in the recommendation, or in the text? The scientific literacy part, not the cloning.
MS. SCOTT: Joe? In the text?
DR. FINS: I am being abducted by an alien, I'm sorry.
MS. SCOTT: In the text?
DR. FINS: Yes.
MS. SCOTT: Thank you.
So we have consensus on Recommendation 5. Hearing no dissent, except for the split infinitive, which we will correct when we figure out what it is.
MS. SCOTT: No, it's okay.
MS. AXELROD: Tell us what it is.
MS. SCOTT: "Jointly conduct."
DR. BERNIER: When you say "to jointly conduct." It should be "to conduct jointly."
MS. SCOTT: "Jointly," okay. Back in school.
Recommendation 6: "The Commission recommends that Congress protect the privacy of individuals using CAM Internet sites by, (A) requiring all health information sites, including CAM sites, to disclose if users are tracked and how that information is utilized, including whether that information is sold to third parties and stored; and, (B) expanding existing legislation or regulations to assure that the privacy of CAM health information seekers on the Internet is protected."
DR. FAIR: Since we are on literacy, I think it is "ensure."
DR. LOW DOG: We would like to make a recommendation that all the staff take a course in literacy.
MS. SCOTT: With that change, do we have consensus?
MS. SCOTT: Great, okay.
Issue 4: Availability of CAM information from other countries and in other languages. We have one recommendation: "The Commission recommends that barriers to identifying and translating relevant articles, reports, and other materials be identified; strategies be developed to overcome these barriers; and that relevant and high-quality scientific materials are made available to researchers, clinicians, policymakers, and others."
DR. FINS: I like the spirit of this recommendation, but I think it is exceedingly ambitious and difficult to achieve, and I might tone it down a little bit by saying that PubMed and the National Library of Medicine should at least provide abstracts of relevant articles that are coming from other countries in different languages.
I mean, I think there is a mechanism to do this. It is very hard to translate things into full text, but we do get abstracts, in English, of foreign language publications, and then the investigator and the public can get that information.
Then, it is a problem, but I think it is a huge generic problem, and there is a mechanism to expand it under the rubric of the abstract service that is on PubMed.
DR. GORDON: The problem I have is that the abstracts are relatively easy to get in translation. It is the full text that is the difficult issue here. I agree it is a huge task.
Wayne, I am wondering if you have any thoughts in this realm of how we can make some differentiations between how we can get some full-text translations, or make a category of full-text translations without trying to go for all of them, so it will make it more feasible.
DR. JONAS: Well, you can't, obviously, do all of them, but what you do is, you have individuals who are knowledgeable about the literature, and in the native language do summaries of the area, and then select out the most pertinent studies and do full-text translations of those. I think that is the only feasible approach.
It's like the qi gong literature in Chinese medicine, it's a huge literature.
MS. SCOTT: Joe?
MR. PIZZORNO: I actually very much like the idea of going for full text. I don't know if you saw the article in JAMA in December '99, but they looked at 11 of the leading conventional medical journals and found that two-thirds of the abstracts were wrong -- I'm sorry, had inaccuracies in them, and that people, going by the abstracts, would often actually arrive at the wrong conclusions. So we need to have full-text translations for these evaluations.
DR. FINS: Maybe we just need to say something about the NCCAM. Maybe NCCAM, because this is an academic exercise, should review the pertinent literature and designate leading articles that they are aware of for translation, because I think to translate everything out there, we will get nothing, but if there is some kind of winnowing or editorial selection process, we are more likely to have the articles that you would want to read available in translation.
MR. GROFT: I think it could be a joint project between NCCAM and the Library of Medicine, and also, then, other governments or nations that are involved. There seems to be more and more international relationships being built, that we should take advantage of those opportunities.
DR. FINS: We should say the National Library of Medicine, in conjunction with NCCAM and other international bodies, should augment their editorial services to identify and translate leading articles.
DR. GORDON: That could be in the text, though. Are we okay with that? Because I think the recommendation would still be okay the way it is.
MS. SCOTT: Right, because it doesn't say that everything should be translated in the recommendations. It says relevant and high-quality scientific --
MR. GROFT: I think we would like to talk with the National Library of Medicine, also, before we come to total closure on this, and they may have some thoughts.
DR. FINS: I am just trying to point out --
MR. GROFT: We all want this to happen, and we need to think a little more about the feasibility side of it.
DR. GORDON: So, for now, can we then have some discussion, Steve, about the text, and stay with the recommendation as it is?
DR. FAIR: The only problem is that there have been several groups, American Society of Clinical Oncology -- [inaudible]. You have got to get individual acquiescence from the publisher to translate. Just simply having the Library of Medicine or PubMed do it -- [inaudible].
MS. SCOTT: Charlotte, if you leave yours on, then Bill is unable to speak. There is something going on between microphones.
SISTER KERR: But you need to know, which I have reported, this thing keeps going on. So it is calling us to speak.
MS. SCOTT: So we are going to leave the recommendation as is stated and beef up the text. Okay, thank you.
Issue No. 5: Information on training, certification, and other qualifications to enhance consumer knowledge and choice. We have two recommendations: "The Commission recommends that the states and local governments require all persons providing any kind of health services or products, including CAM, to make information easily accessible to consumers that explains their level and scope of training, so that consumers can make informed choices."
I guess, we did consider moving this to the Access section, but we will see. Comments?
DR. FINS: I think it is consistent with what we are going to recommend later, and under the rubric of informed consent and informed choices. People need to know who is doing what and who is accredited and whatever. So I think we might want to go back and tweak the recommendation and have parallel structure. What is going to happen next is delivery, but I think conceptually it is on target.
DR. WARREN: We started including CAM health services or products including CAM. Should we also put "and conventional"?
MS. SCOTT: Any kind of health service or product.
DR. WARREN: Then why do we put "including CAM"?
MS. SCOTT: You just want to put any kind of --
DR. WARREN: Put in there "provide any kind of health products," and then leave out "including CAM".
DR. GORDON: We may need, Don, to refer the recommendations back to CAM, so that there is a specificity about them.
DR. WARREN: I understand that, but are we also going to include "conventional" in that?
DR. GORDON: It's already happening in most jurisdictions, "conventional or CAM."
MS. SCOTT: "Conventional or CAM" instead of "including CAM." Okay, with that change --
DR. GORDON: I think there is confusion here. I think we are really talking about the providers and their scope of training. A product does not have a scope of training. So I think it is really, here, focused on the practitioner side, and not the product side. That is covered in DSHEA, and in supplements and things.
DR. LOW DOG: Where would you put health store clerks and people that are dispensing lots of medical information?
DR. FINS: I think that comes when we talk about --
DR. LOW DOG: You don't cover all that?
DR. FINS: We don't cover that. That was your committee.
DR. GORDON: I think that is an important area. Are all persons providing any kind of health services or advice about products --
DR. FINS: We are getting to products and practices in the next issue. I think we have to distinguish people who are professionally accredited practitioners. The role of health food store clerk, I think, needs to be addressed in the context of the information that is available.
DR. GORDON: Joe, that's true, but what about the whole area of people who are providing information about products who may not be offering services? You may come into an herbal store. There are a lot of places that just provide these products and they may or may not be offering the service, or they may offer a service and the products.
DR. FINS: They are offering a service, then they are practicing without appropriate certification, licensure, or registration. So, in others words, the question is, should they have some level of registration.
DR. GORDON: No, that is not the question we are addressing here. The question is, should they provide information about who they are and what they know.
MS. SCOTT: Right.
DR. GORDON: Regardless of what the regulations are. Do you understand what I am saying?
DR. FINS: Yes.
DR. GORDON: Because they may be licensed, they may be registered, they may just be hanging out on a street corner, but we are saying, let people know what your training is.
DR. FINS: I think we should start, in this recommendation, talking about people who are actually practicing in some degree to identify themselves. The issue of the people who are around the supplement question should probably be addressed when we address supplements.
So that, if we talk about any kind of modification to DSHEA or to labeling we should say that people who provide information, who sell these products should be adequately informed.
DR. GORDON: So you are basically saying this only applies to service providers?
DR. FINS: Right. I think you have to distinguish people who are vendors versus practitioners, and to try to put everything in the same recommendation is confusing.
MS. SCOTT: Well, actually, the text really only refers to the providers of health services. There is nothing in here that talks about folks who work in herbal stores or nutritional supplement stores. So if you are going to keep it in here we would have to go back into the text and get a paragraph or two about that group of people, so I think, to me, it sounds simpler to take out the "all products" and to deal with it when we get to the dietary supplements.
DR. FINS: Well, I think we can say --
MS. SCOTT: Yes.
DR. FINS: Can I suggest just for the practitioner side, "CAM practitioners or conventional practitioners dispensing CAM products," and then you address that product issue in the context of a practitioner. But you can't really -- I mean, the question is, these people are not pharmacists. And it raises a question: should an herbalist be registered like a pharmacist? We haven't addressed that at all.
DR. GORDON: I don't think this has anything to do, as I said, with registration or licensure or anything else. It just has to do with what people are doing. So the rules differ in different places for what you can do, but what we are saying is that anybody who is providing these services or providing products should let people know what they know.
MS. AXELROD: Add something to the text.
MS. SCOTT: The American Herbalist Guild took us on years ago and developed for its member that you had to give an informed disclosure when people came to see you because herbalists are not registered, licensed, or otherwise. So you put basically what your philosophy was and what your level of education was, what your training is or what it is not, and it was an attempt to try to let people know this. This is who I am and this is what I know and this is how I got that information. And then the consumer makes the decision if they want to see that person or not. I mean, they make that decision.
I am not attached to having "or products" here. I think that a significant amount of what goes on in the world right now is that, especially in the area of multi-level marketing, there is a tremendous amount of information that goes on. "Use this product to treat this, use that product to treat this." A tremendous amount of information is actually going on in that arena, and I am not sure if you consider that a service or not. They are not charging for their service, they are charging for the product which they sell, but that is a big, big area.
DR. FINS: That is an FTC issue, as we have talked about in other contexts, and --
MS. SCOTT: See, I am trying to separate out the --
DR. FINS: -- the media content.
MS. SCOTT: -- regulatory aspect here. All we are talking about here is information.
DR. FINS: The thing is, people who don't know what they don't know can't tell you that they don't know it.
MS. SCOTT: Yes, they can.
DR. FINS: I mean, we are going to talk about this next. Maybe we should defer this aspect, but the point is that the reason we have external bodies regulating people is so that there is external review of their scope of practice. I mean, do you think the person who is untrained is in a position to express their level of lack of training? I mean, there is an old saying, the more you know, the less you do, right?
MS. SCOTT: What they have been trained.
DR. GORDON: I think this is aside from regulation. This is stating a principal. If you are selling magnets and multi-level marketing, you should say, "All I know is what I read in the company promotional materials. This is who I am. I am not a magnetologist with an advanced degree in magnets. I am not a doctor." And I think we are stating a principal that is apart from the idea of regulation, and that is why I think it belongs under public information.
DR. FINS: What confuses me here is that you have --
MS. SCOTT: When you say training --
DR. FINS: No. You have two things here that the state is requiring people to report their level of knowledge and scope of training, which is something that the state also could keep a registry on for the practitioner folks, everything from registration to life insurance certification. So that is one category.
The other thing is disclosure, but disclosure may not constitute adequate protection as you go up into more risk benefit kinds of interventions.
DR. TIAN: I think the product and the services should be separated, and first of all, the regulated license people, you mentioned all the people. That is confusing. When you are talking about CAM providers, of course, they should report -- they should introduce themselves to the consumers to say what level, what kind of training. And the people selling products, they don't have to be CAM providers. They are not, they are salesmen. So we are talking about product, so I think there are two things we should separate.
DR. GORDON: Tieraona, where are you with this?
DR. LOW DOG: Well, I don't have a problem taking out the "or products" and leaving this if you are talking about just license. I mean, you get into this big thing then. I mean, it just becomes never-ending of who then is the state going to have to require to have what, so I certainly understand the problem there.
I also just don't want to minimize or I want to go on record as stating that I think that a lot of the misinformation out there and bad information that is being given out there is actually through the salespeople and salesforce of people who think perhaps they know more than they do. I am not sure how you are going to regulate or do that, and I am not sure this is the place. This is information.
MS. SCOTT: Okay.
DR. LOW DOG: So maybe we can take out the "or products" here but we have to address it some place.
MS. SCOTT: Well, another option would be to take out the "states and local governments." "The Commission recommends that all persons providing any kind of services or products."
DR. LOW DOG: There you go.
MS. SCOTT: So that we remove the concern.
DR. FINS: No. 9 actually captures the intention better.
MS. SCOTT: Right, right. So that might be a better choice, to just take out "state and local governments require." This was our thinker here. Corinne.
MR. PIZZORNO: I think we should leave in "products" and take out "services" because this is "services" are addressed later and also more thoroughly in access. This is about people providing products and information about products. I think that is what is the core of this recommendation.
DR. LOW DOG: It is also services information. I think it is what you are also providing. I like the idea, let me just say, of taking out "state and local." This is information so it is --
MS. SCOTT: Right. It is purely information.
DR. LOW DOG: We are recommending that people who provide health services or products, conventional or CAM, let the people that they are taking care of know what their level and scope is.
MS. SCOTT: Yes.
DR. GORDON: I would like to see if we have a consensus on this. Can we have a reading of it the way it is?
MS. SCOTT: Sure. "The Commission recommends that all persons providing any kind of health services or products, conventional or CAM, to make information easily available to consumers that explains their level and scope of training so that consumers can make informed choices."
DR. CHOW: Then who is going to be sure that that is carried out?
MS. SCOTT: You can't.
DR. FINS: I mean, I think No. 9 captures it. In other words, the way I disclose what I do is I have a license that the state gave me and it goes on my wall. Someone sees it, they see what my title is, and they know what the scope of that practice is. So I think No. 9 captures it for the practitioners. I think where people who fall below the radar screen for even registration and are more like vendors or salespeople, that comes under commerce and it is business practices. It is not medical practice, it is not CAM practice. It is vending.
DR. GORDON: I am not saying this statement is not that also, it is that.
MS. SCOTT: Right.
DR. GORDON: I think this is a very important statement for us to make publicly, to make to the people because what we are saying is we want full disclosure regardless of whether you are commercial. Whatever you are doing, if you are in this field we believe as a commission that you need to tell people who you are, what you are doing, what you know, and what you don't know. We are setting a standard. We can't enforce it but we are making, I think, a very important public statement. So people need to know that this is where we are coming from.
DR. LOW DOG: Isn't this what Minnesota did?
DR. GORDON: And it is about information.
DR. LOW DOG: Isn't this what Minnesota ended up doing? It was basically you have to tell people who you are and what you know.
I am not attached to the "products."
DR. GORDON: I think "products" should be in there. I think that you made a good case for it. I mean, this is my opinion. I think it is really important, that we need to be saying to people in the health food stores and everywhere else you tell people what you know and what you don't know.
DR. FINS: This is more of a conceptual idea. It is really not a recommendation because it doesn't have any way to be effectuated. Why don't we simply just put it in the text?
DR. GORDON: I will tell you why it is important to have it as a recommendation.
MS. SCOTT: Yes.
DR. GORDON: I think it is one of those things that will be picked up publicly and that we can use publicly to state our position. I think that people will respond. I can see the press already interested in this one, that we are taking a stand. We are not just going along with anything anybody does. I mean, I want people to do that for me and for my patients because I see this as a major public health issue.
MS. SCOTT: And I think, frankly, as some people think that we are all a pro-CAM commission that this really says that we hold these standards for everybody including those of us who support CAM.
DR. FINS: I think what I am troubled with is that this is necessary but it is not sufficient.
DR. GORDON: We are not saying it is necessarily sufficient. I think we are saying that it is an aspect of what needs to be done.
MS. SCOTT: Right.
DR. FINS: But I think it is important to say that because simple disclosure in and of itself is not enough to regulate or to have --
DR. GORDON: We are talking about information.
DR. FINS: But that is what it is. We are talking about disclosing one's level of competence or scope of practice, but that in and of itself is not enough.
DR. GORDON: No. 9 speaks to it.
MS. SCOTT: Right. We do need to go back to the text and make sure that we have something that relates to that.
DR. WARREN: And your wording. We are addressing CAM and conventional practitioners but we are also talking about retail sales, multi-level. I know they are different, but we are talking about just giving forth your qualifications. Can we add in there "retailers, CAM and conventional practitioners" as a clarification of actually what we are addressing?
MS. SCOTT: To be in the text?
DR. FINS: I mean, Julia, my concern is I think there is a difference between "professional practice" --
MS. SCOTT: I hear your concern.
DR. FINS: -- and "business practice."
MS. SCOTT: Yes.
DR. FINS: So if we said people who are selling versus providing products should engage in good business practice, which is different than the provision of care. Vendors are not licensed.
DR. GORDON: As Tieraona pointed out, neither are many CAM practitioners.
DR. FINS: But they --
DR. GORDON: May not be.
DR. FINS: -- they may be.
DR. GORDON: But they may not be, also.
I think we need to come to consensus on this because there are a number of other issues that I know that we are going to have long discussion about, so if we can understand that this is a recommendation that has to do with information and that there are other discussions that will come up regarding regulation and other issues later on.
Can we get a consensus on this one? Okay? And come to No. 9, Julia? If we have consensus, then we can move on to No. 9.
MS. SCOTT: Okay. And again, we can still revisit this when we get to the "Access" section to see if we can do some wordsmithing that will make it something that we can all live with, okay?
Okay. Let's go to Recommendation 9. "The Commission recommends that states and local governments make information on state guidelines, requirements, licensures, certification, and disciplinary actions of health providers, including CAM providers, readily available to the public."
DR. LOW DOG: Let me just go back to the last one just for a moment. Only that I don't want to set some standard for retail health food stores that is not required for other types of businesses. I know that there is a special issue here, but part of my problem is I could be a retailer and just sell glucosamine but I may not tell you anything about it. So do I have to list a whole disclosure thing just because I am selling glucosamine?
I mean, I think the part comes when you are providing health information to people or you are making recommendations about health. So I would need to say that we don't quite have consensus yet on 8, but we have those four choices. I would ask that this one just be allowed to come back to the working group. I am not saying we are going to get rid of it. I am just saying that maybe we could improve this. I think there needs to be a little bit more thinking and that I would ask that we have just the permission of the group to work on this over the next 10 days and get something back to the group. We would do it quickly.
DR. FAIR: I think a little more data, too. You mentioned a very, very important thing, that is the multi-level marketing. That goes on among physicians also. Can we get information as to what percentage of sales come through things like pharmacies and multi-level marketers and things like that?
Tom, is that kind of information available? I think that would help us in making a decision because right now just my impression is that I see multi-level marketing springing up, again, in Florida where there are a lot of elderly people and don't understand what they are talking about. So if you could tell me that multi-level marketing was a 10 percent market I would feel different than it was a 50 percent market.
MS. SCOTT: Corinne?
DR. LOW DOG: Corinne just made a comment for trying to get some closure here. "The Commission recommends that persons providing information on health services or products, conventional or CAM, make information easily available to consumers that explains their level." It is not so much that you are selling it, it is if you are providing information about it.
DR. GORDON: I think it has to be "providing services or information."
DR. LOW DOG: "Providing health services or information"?
DR. GORDON: "Information."
DR. FINS: "Providing services." Then, wouldn't it become the practice of an art? It gets into No. 9.
DR. GORDON: What I would like to do is either we move ahead with this or we send it back to the committee because we need to move ahead with the recommendations.
DR. FINS: But I think this little discussion here has put a spotlight on an area of regulation that we did not really consider before. You have got the supplement industry and the packaging and DSHEA, you have got the provider kinds of groups, and then you have the vendors, the retailers, and this is like what is happening at the store. Maybe it is something that our group and your group can work on because I think it is a gap.
DR. GORDON: That sounds great. What is the decision about this? Do we have consensus or do we send it back?
MS. SCOTT: Yes.
DR. GORDON: Send it back?
MS. SCOTT: Yes, I think the committee wants it back.
DR. GORDON: Okay. Fine.
MS. SCOTT: And again, we will take note during the "Access" discussion. We might be able to do it at the end of this, but if not we will take that.
DR. GORDON: One of the reasons I am pushing here, Joe, is because a number of the issues that are coming up are extremely complex and we have some very strong feelings in the group about them. So there is going to need to be a lot of discussion, so I want to move ahead as quickly as we can.
MS. SCOTT: We have got consensus on No. 9, correct?
DR. FAIR: Now, Julia, can you let us know the percentage? We have said a number of times that the primary source of information for the consumer is the 19-year-old clerk in the health food store, and I think we ought to see what the distribution is.
DR. GORDON: Joe, you and Bill are both asking this committee to begin to think about issues related to retailing and multi-level marketing and considering a recommendation, is that correct?
DR. FAIR: I think if we are going to make a reasonable recommendation we ought to know what the situation is right now.
DR. GORDON: Understood. Okay.
DR. FAIR: May I ask you one question from my ignorance? Or maybe Joe can answer. What is the difference between a naturopathic physician and a naturopathic doctor? That was a new one for me.
MR. PIZZORNO: Theoretically they are the same person. M.D. means naturopathic doctor. Naturopathic physician is how you are licensed in the state.
DR. FAIR: Okay.
MS. AXELROD: Actually, Joe, one of the documents provided to us went into great detail about the differences, which was quite a surprise to us and it was very confusing, so that is how this ended up in here. I don't recall the specifics but it seemed to be like night and day.
MS. SCOTT: Well, we can deal with that in the break and come back because we really do need to move along because we are coming to some heavy-duty recommendations.
Okay. We are on yours. Issue 6, accuracy of advertising of CAM products and practices. We have one recommendation. "The Commission recommends that additional support be provided to the Federal Trade Commission to, (A) expand efforts to identify false and deceptive CAM-related health claims and take appropriate enforcement action; and, (B) increase consumer education in identifying deceptive and unsubstantiated claims in all forms of marketing and advertising."
This recommendation is also -- oh, I'm sorry. I forgot to say from the beginning. Everyone got the memo yesterday from George. He had some comments on several of these recommendations. This is one of them if you want to refer to that page.
DR. GORDON: There is a two-page stapled memo from George DeVries.
MS. SCOTT: George DeVries.
DR. GORDON: Does everybody have a copy of that? If not, I am sure we can get other copies.
MS. SCOTT: "The Commission suggests that the public be solicited in achieving this objective." That is the final sentence of this recommendation, a suggestion from George.
MS. GUTIERREZ: On this recommendation, I would like to amend it slightly. The chiropractic experience has been that the FTC came after a chiropractor that prints literature and charged them with false and deceptive advertising. It cost him literally hundreds of thousands of dollars in court with an attorney, and he did win and it was completely resolved in his favor.
But if we are going to have the Federal Trade Commission investigate, I would like to see that we amend this recommendation to say that they utilize appropriate health professionals or CAM professionals to assist in the investigation because the FTC does not have experience in all the variety of professions.
MS. SCOTT: I am not sure if one can tell the FTC what to do, but your suggestion that we have it in a recommendation that they have people that they consult with with the appropriate expertise.
DR. FINS: In the text.
MS. SCOTT: In the text, okay. So that is acceptable.
DR. FINS: Not to revisit Recommendation 8, but this Recommendation 10 really addresses it. It is as if you said, "and (B) increase consumer education and identify deceptive and unsubstantiated claims in all forms of marketing and advertising, including at point of purchase."
So if you think about it, when a sales clerk says, this supplement will make you younger, take 10 years off your life, happy, or whatever, that person is engaging in a kind of marketeering and advertising which is not unlike what we are trying to get the FTC to regulate on the airwaves.
DR. LOW DOG: That would just be huge. You are going to have to take it on both ends, I think.
DR. FINS: I think the way it is written here, though, is it is not we are asking the FTC to do that. We are asking the consumer identifying deceptive and unsubstantiated claims, also, at the point of purchase.
So, in other words, we look back at our earlier recommendations on education, the libraries and all that. If a consumer could distinguish between a reasonable or an unreasonable or inflated claim at the point of purchase, that is kind of empowering the consumer. So they should not only listen with skepticism to what they hear on the radio, they should listen with skepticism to what they hear in the health food store.
MS. SCOTT: But that doesn't still address the people who work in those stores who should also --
DR. FINS: No, it is just a parallel recommendation.
MS. SCOTT: Okay, I see.
DR. FINS: So marketing including at point of purchase.
MR. CHAPPELL: Julia?
MS. SCOTT: I'm sorry, Tom?
MR. CHAPPELL: I just want to be sure everyone understands that a false claim on a product is still within the domain of the Food and Drug Administration so that in the case of a false claim or anything to do with a claim, that is still the business of the FDA. I am not sure people realize that.
I mean, it is one thing to say that DSHEA is handled by the FTC and that is true, but it is also true that the FDA is a regulatory body when it comes to the whole claim base.
I just also wanted the commissioners to know that it is very hard to get the FTC involved. You end up deciding whether you are going to write to the manufacturer and ask them to change. I mean, to use the leverage of the FTC is also very difficult.
MS. SCOTT: Tom, this recommendation deals specifically with advertising. We do get to the FDA's role in labeling and that kind of thing, but this recommendation is only aimed at advertising.
MR. CHAPPELL: Well, then I am only pointing out that advertising is a broad term. If you have an insert in a product, if you have a point-of-purchase material, it gets to be a gray area as to who is involved.
MS. SCOTT: Do you have some words how you would change this?
DR. FINS: Tom, if you said, "FDA in conjunction with the FTC," that would serve as a joint thing.
MS. AXELROD: The FDA and the FTC have an agreement which delineates who covers what, so this is actually very clear amongst the two agencies as to what FDA is overseeing and what FTC is overseeing.
MR. CHAPPELL: And Corinne, you are saying that the word "advertising" is the delineating boundary?
MS. AXELROD: Yes. So if you are talking about inserts in a dietary supplement, that is FDA, but if you are talking about advertising on radio, television, Internet, billboards, that is FTC.
MR. CHAPPELL: Right. That is my understanding as well but you are right. Inserts or outserts or POPs, those are FDA.
MS. SCOTT: Right.
DR. FINS: We have a recommendation. If you sit here, since really the FTC is the leading agency, getting back to what you meant by advertising, but to address Veronica's concern about having professional representation, we might want to say, "the FTC in conjunction with" or "in collaboration with the FDA" so that the overlap issue doesn't become a confounder, it just becomes additive. So, because we are making recommendations that the FDA have additional people on staff who have expertise in supplements down the road, so it would help mitigate the false prosecutions that were not indicated.
DR. GORDON: Can we have a recommendation for language here?
Joe, did you have a specific language there?
MS. SCOTT: I think Ken's got a clarifying quote.
DR. FISHER: Tom is absolutely right -- the term "health claim" is probably not the way to go -- and so is Joe, so it might well say, "expand efforts to identify false and deceptive advertising of CAM products and services and take appropriate action."
MS. AXELROD: Actually, Ken, this is directly from FTC information.
DR. FISHER: That is correct, but what I am saying is in rereading this, Corinne, the phrase "health claims," somebody is going to misinterpret that. So even though that agreement exists, if we get rid of the term "health claims" and say "advertising of product and services," then it clearly gets into FTC. And it comes home if you also add the words that Joe suggested, "at point-of-purchase." Although it isn't just a problem with that point-of-purchase, it needs another phrase which I don't have on the tip of my tongue. Maybe it is because much of this is advertising in journals and things you pick up at the supermarket and what you read on the Internet, et cetera, et cetera.
DR. LOW DOG: I fully support removing "health claims" because of its dual meaning in this industry and to use the language that Ken suggested about the advertising.
DR. FISHER: Yes, take out "FDA." And the other request for information, Veronica, most of the FTC investigations that go beyond the first level do include external experts. Unfortunately, they don't identify them all the time but we can put some language in the text to include that.
MS. SCOTT: Right. Okay. Can we have a rereading of the amended recommendation? Do you have it?
MS. AXELROD: "The Commission recommends that additional support be provided to the Federal Trade Commission to, (A) expand efforts to identify false and deceptive CAM-related health advertising and take appropriate enforcement action; and, (B) increase consumer education in identifying deceptive and unsubstantiated advertising in all forms of marketing and advertising, including" -- I guess that is a little redundant.
MS. SCOTT: At point-of-purchase.
MS. AXELROD: "Including at point-of-purchase."
DR. LOW DOG: Just a clarification. Does it read better "to identify false and deceptive advertising of CAM products and services"? To put the "advertising" in front of "CAM" and then keep it with "services and products" since we have taken out "health claims"?
DR. GORDON: Yes, it looks clearer to me.
We need to move along on this, Tom.
MR. CHAPPELL: I just want to make one more observation. The FTC does not intervene directly on these matters. You have to wait until a competitor complains about your claim. So I wonder if the commissioners are aware that that is how the process works, and if you aren't aware of that, do you want to be more intentional of your expectations of the FTC in this matter?
DR. GORDON: Maybe that is an issue that can be dealt with in the text, Tom, or what are you suggesting about the recommendation?
MR. CHAPPELL: Well, I think "expand efforts" isn't quite the right --
DR. GORDON: Does it have to be a competitor? It can't be a consumer?
MR. CHAPPELL: I don't know about that.
DR. GORDON: Steve is saying it can be anything.
MR. GROFT: I think if it is determined that there is a problem and I think it is the level of the problem as well as the seriousness of what is happening, so that is the criteria.
MR. CHAPPELL: The FTC is not playing a watchdog role here?
MR. GROFT: I cannot speak for the FTC, but what I have been able to see is that there just aren't sufficient resources to look at everything. But I think it is the same with FDA.
DR. FINS: The text says here -- I mean, the recommendation -- to identify, so it is not just to be responsive. And I think we can explain this problem in the text. I think people may want more of a surveillance role to identify.
MR. GROFT: And I think that is what George DeVries' add-on about the Commission suggests that public comment be solicited in achieving this objective to determine what are the problems and to look at it further and to come up with some possible solutions.
PARTICIPANT: Are people comfortable with George's addition?
MS. SCOTT: His suggestion was that it be in the text.
PARTICIPANT: I think he suggested public comment be solicited in achieving this objective.
MS. SCOTT: Oh, okay. George suggests that it be at the end of this recommendation and the Committee -- Corinne is telling us that the Committee suggests it be in the text.
DR. GORDON: Do we have consensus on this with the addition of George DeVries's sentence at the end?
DR. GORDON: Okay. Let's move ahead. I want to remind everybody that we have a number of recommendations that are complex coming up, so let's move as quickly as we can and really address the recommendation and recommendation language.
DR. LOW DOG: Okay. Issue No. 7, adequacy of information on manufacturing and safety of dietary supplements to assure consumer safety. We have Recommendation 11. "The Commission recommends that efforts of both the public and private sectors to assure the development, validation, and dissemination of analytical methods and reference materials for well-characterized dietary supplements to the public be enhanced and accelerated."
George DeVries added just as an addendum to the end of that, "The Commission is aware that Congress has taken steps towards this end and recommends that this progress be continued."
DR. WARREN: The whole statement, the whole recommendation.
DR. LOW DOG: Why?
DR. WARREN: Well, it doesn't have any way of implementation it doesn't seem like.
DR. LOW DOG: Oh, I would disagree. Office of Dietary Supplements, as well as a number of private groups, and you have also got USP. I mean, you have got a number of groups that are working on analytical methods right now well-characterized, especially botanical products. This is one of the biggest areas of problems that we face right now, is the ability to identify and use analytical methods to be able to identify and characterize these products.
DR. WARREN: The botanicals?
DR. LOW DOG: I mean, it is with other substances as well because you have got new products coming out all the time that need to have analytical methods developed for them. The botanicals are a unique situation, not a problem necessary but a unique situation only because they are such complex compounds.
So I strongly feel that this recommendation needs to remain a recommendation, because within the dietary supplement field, this is very important, and it is already happening, but we sure need funds to be able to do it. It will go a long way to improving quality.
DR. WARREN: Can we add something in that, then, to add more direction as to what group needs to address this?
MR. GROFT: If you would indulge us. When the appropriations language is finally agreed upon in conference, what I have seen so far, that there is some language that is going to direct the Office of Dietary Supplements and others to look at this, and they are going to be provided additional resources.
So I would like to hold, maybe, a final edit on this, based on what comes out of that but maybe get acceptance for this right here. Then if we have to tweak it, we will let you know. Plus, I will provide you the appropriations language that finally is agreed upon when it gets resolved, hopefully next week.
DR. WARREN: I am okay with that.
DR. LOW DOG: Any other issues? Veronica?
MS. GUTIERREZ: I would just like to suggest that George's last sentence -- it is more of an editorial comment -- that it go into the text and not remain part of the recommendation.
DR. LOW DOG: Okay. Do we have consensus, then, on the way Recommendation 11 stands, as it is in your text, with the addition of George's comments into the text?
DR. LOW DOG: Okay.
DR. FAIR: Minor point. Again, it is "ensure," not "assure."
MS. SCOTT: Corinne, Corinne, Corinne.
No. 12, "The Commission recommends that good manufacturing practices for dietary supplements be implemented to help assure the quality and composition of dietary supplements and that a study be commenced 12 to 18 months after the full implementation of the GMPs by an external organization to evaluate current efforts and provide recommendations for improvement."
George's was to keep that but with the edit, "The Commission recommends the timely promulgation of final regulations for GMP for dietary supplements with oversight by the U.S. Congress within 18 months after final promulgation."
DR. GORDON: I actually think George's is a substitute for the one that we have, I think. Because I think what it is, is it is a stronger, pithier statement than the one we have made.
MS. SCOTT: Either/or, or some combination of them. Comments?
MR. PIZZORNO: Just a general question because I noticed in some of the other sections coming up we are doing this, we are giving timelines. And I am wondering if that is practical or realistic. I am a little concerned. I think we can say "immediate" if it is really important, but to put a timeline on it when we don't know how long it is going to take for all this to go through Congress, I wonder about.
DR. GORDON: I think that George's recommendation comes out of direct consultations with Congress, and the 18-month timeline is one that they feel they can do and will do. I think it is one they would appreciate our guidance on in this recommendation.
DR. FINS: I want to echo what Joe is saying, but I think what we should do as a general framework is leave the timelines in the text. I think we should have some sort of preface saying that this body was constituted in a different time and that after the realities of September 11th the priorities, the funding, the budgetary constraints are different and we appreciate that not all these timelines will be started after we conclude our work and that we appreciate that there are different priorities.
I think it would be helpful to just contextualize the report in the context of the budgetary crisis, deficit spending, et cetera. Otherwise, I think we are going to be really perceived as being out of place. This way we have it both ways. We have we would like to do this in 18 months but we appreciate that the 18 months may not begin in this fiscal year, it may begin in the next fiscal year.
DR. GORDON: I just want to say with this one we have had recent --
DR. FINS: I am not saying about this one. This one might go through. But I am saying we have other places where we have timelines in the report and I just think it is important for us to say that the timeline may not be initiated in the fiscal year that we might have anticipated because there are competing priorities. This way we have a schedule but we are not going to be perceived as having failed if the schedule doesn't begin when we thought it would start because everything has changed.
DR. LOW DOG: I want comments but I just want to put out there to move things along so that we can start to get comments. I feel absolutely comfortable with George's language with the "timely promulgation." I like that word. We probably just didn't know it; that is why we didn't use it. And with the "oversight." And I do believe that the 18 months is appropriate in this particular place.
DR. TIAN: A question about 12 months to 18 months. Who recommended the time frame? If 18 is the total, why is there a range?
DR. LOW DOG: We are going to put 18.
DR. TIAN: Okay. Thank you. Why 18?
DR. LOW DOG: That is what the Congress has agreed that they could handle.
DR. TIAN: Thank you.
MS. SCOTT: It seems to me there is a difference between George's edit and what was in the original recommendation. I am wondering what happens to our recommendation that this study "be commenced after full implementation of the GMPs by an external organization" versus the Congress?
DR. GORDON: It will have more effect having Congress do the oversight than some as yet unconstituted external organization. I think the thing here is that they have got the juice. They can make it happen and they can make sure it is enforced.
DR. LOW DOG: Are we comfortable with that?
MS. SCOTT: That was fine.
DR. LOW DOG: Are there any other comments?
MR. GROFT: If I can just add, whenever there are proposed regulations you go out with a notice of proposed rulemaking and you are given a period of time, 60 days, 90 days, to comment.
It has been known that some final regulations have languished for months, and I think is just an effort to make sure that it moves along in a timely fashion and 18 months seemed to be enough time to get things done, especially when you have agreed-upon GMPs.
DR. LOW DOG: Are there any additional comments?
DR. LOW DOG: Do we have consensus? It has been proposed that we take the following: "The Commission recommends the timely promulgation of final regulations through GMP for dietary supplements with oversight by the U.S. Congress within 18 months after final promulgation." Do we have consensus that we will accept that recommendation?
DR. LOW DOG: Okay. Then, No. 13, "The Commission recommends that appropriate federal entities work with manufacturers and importers to monitor the quality of imported" -- I thought we had taken out "domestic" -- "imported dietary supplements to identify and prevent products that are contaminated or adulterated from entering the U.S. marketplace." And I thought we had intended to take out "and domestic" here.
Now, George had recommended that this recommendation be deleted as that there are already standards for this. My own recommendation would be that we consider that, "The Commission recommends that funding be increased to the appropriate federal entities to monitor the quality of imported dietary supplements to identify and prevent products that are contaminated or adulterated from entering the U.S. marketplace."
DR. GORDON: Are you proposing to do both 13 and 14 in that deal?
DR. LOW DOG: Yes.
DR. GORDON: Yes, okay.
DR. LOW DOG: I don't think we need both 13 and 14. I think that "and federal and other entities" perhaps because that could include some of the agencies that we have listed in 14. "To monitor imported," I don't think we need to have "domestic" because we are going to have GMPs in place some day, so I think that that is unnecessary. Your main problem is going to be still looking at your imported products.
DR. WARREN: So what you are proposing is George's last statement?
DR. LOW DOG: We are going to combine 13 and 14 and we are going to use his language about funding but we are going to leave the recommendation. We would get rid of 14. We would say, "The Commission recommends that funding be increased to appropriate federal and other agencies, entities to monitor the quality of imported dietary supplements," and I imagine that includes raw materials, "to identify and prevent products that are contaminated or adulterated from entering the U.S. marketplace."
I would say this is probably with finished products that we are most concerned with.
MR. PIZZORNO: Actually, I think that is a good modification for 35 and 36 because I think the FDA already has plenty of authority to do the domestic monitoring.
Also, I would strongly recommend removing any notice of the codex in this recommendation. There is extreme concern amongst the CAM professionals as well as some of the manufacturers that the codex has standards that are not appropriate for our market.
DR. LOW DOG: I would echo that we just take out all of those and we just put "appropriate federal and other entities," so that it would include others.
DR. GORDON: Can we have a reading and a call for consensus on this then, please?
DR. LOW DOG: "The Commission recommends that funding be increased to appropriate federal and other entities to monitor the quality of imported dietary supplements" --
DR. GORDON: I would say "foods and dietary supplements." I think that is important. It is in George's recommendation. "Foods and dietary supplements."
DR. LOW DOG: No, he said that that already exists for imported foods. No, I would say "dietary supplements." I wouldn't get into food here. That is a nightmare in its own mind.
"To identify and prevent products that are contaminated or adulterated from entering the U.S. marketplace."
DR. GORDON: Okay.
DR. LOW DOG: Yes, Tom?
MR. CHAPPELL: An herb for an herb tea is a food.
DR. LOW DOG: Do you want to include foods in here?
DR. GORDON: Yes, because a major issue has been with herbal contamination.
DR. LOW DOG: Well, you could use "raw material," "dietary supplement." You could include "raw materials." I am not sure it is under our charge to be talking about strawberries, bananas. I understand the thing, but "raw material," would that also cover?
DR. GORDON: I just think we need to go on record about the herbal issue because that is, as you know, a big one. Why don't we say "herbal foods"? Because you can send in a finished product, herbal tea, that is contaminated.
DR. LOW DOG: Okay. Dietary supplements and?
DR. GORDON: Herbal foods.
DR. LOW DOG: And herbal food. I know it is sold as a dietary supplement but tea is also a supplement.
DR. GORDON: I think people don't think sometimes of dietary supplements as herbs. They think of them as the vitamins, et cetera, and don't see that, so I think we need to be explicit since these are very much for public consumption.
MR. CHAPPELL: If you don't say food, you leave a big loophole.
DR. LOW DOG: Herbal foods.
MR. CHAPPELL: Fine.
DR. TIAN: Herbal food is a food or a dietary supplement?
MR. CHAPPELL: It depends upon your claim.
DR. LOW DOG: If you are just selling it as tea in the grocery store, it is just a food.
DR. TIAN: As food. Tea is food. Herbal food, if you claim as a dietary supplement, that will be dietary supplement, right? But a dietary supplement is not food.
MR. CHAPPELL: It depends on what you say it is for.
DR. TIAN: With three different categories coming into FDA regulation.
DR. LOW DOG: Right.
DR. TIAN: Am I correct?
DR. LOW DOG: Ken?
DR. FISHER: Dietary supplements are foods under the law. However, Tom is absolutely correct. What you claim its intended use is is what it is. The best example, which I have given you before, is citric acid. It can be a prescription drug, an over-the-counter drug, a boiler additive, indirect food additive, a direct food additive, and a grass substance. Whatever you intend its use to be is what the law regulates it as.
DR. LOW DOG: So I would like your opinion. Do you think that the language, "monitor the quality of imported dietary supplements and herbal foods" would be appropriate?
DR. FISHER: Well, I would suggest perhaps you change it to "indicate materials and products to be used as dietary supplements" or something like that because, I think you already said this, you don't want to get into the mishmash of foods.
DR. LOW DOG: No, no.
DR. FISHER: And it is getting even more complicated now with herbs being added to dairy beverages and the like.
DR. LOW DOG: So we can do two things at this point. My one thing is I would like to get general consensus with the agreement of this, knowing that we are going to take it back and get exactly the right specific language to make sure that we have covered the raw material-herbal food aspect of it. But I would like to double-check to make sure we have exactly the right language.
Do we have agreement with getting rid of 14 and amending 13?
DR. GORDON: Yes. I would just add that George's last line, "enforce the current law" is important to have there. "Enforce the current law against the importation of adulterated or contaminated products."
DR. LOW DOG: Okay. So do we have general consensus on this? And would we have your permission just to go back to the work group just to tweak the language a little to make sure that it is really accurate?
DR. GORDON: Okay. And then send that out to us.
DR. LOW DOG: Yes, we will. That and 8. We have several that we will get out to you quickly, okay?
Issue No. 8, adequacy of packaging and labeling information of dietary supplements for consumers and providers.
15. Very long. "The Commission recommends that information on benefits, appropriate use, and potential risks be made more easily available at the time of purchase through improved labeling, package inserts, and information at points of sale. When significant interactions with prescription or OTC drugs, foods, or other health products are known this information should be on the label. In addition, labels or information provided to consumers should identify possible risks to vulnerable populations such as children, the elderly, pregnant or nursing women, and those with certain health conditions or compromised immune systems. All information on labels should be in English even if another language is also included."
Now, I am just going to state here that George has recommended that this one and the next one and the next one -- no. It would be 15, 16, 18, and 19 all be deleted and use a different language, so I want to put that out there at the beginning. But I would like some comments and feedback on this recommendation.
DR. FINS: A very easy way to handle this is we could take what is now 15, 16, and 17, which are written as recommendations, put them in the text, and adopt George's recommendation as the single recommendation. I don't think we lose anything.
DR. LOW DOG: Right. Just to have more of this within the text. Let me just read it to you. "Due to the technical and complex legal and regulatory nature of the following items and the desire of the Commission to encourage adequate participation, consultation, and comment from the public with the federal government, it is the recommendation of this Commission that the U.S. Department of Health and Human Services and its agencies under its jurisdiction formally solicit additional public comment on the following subject matters: improving labeling and directions for use of dietary supplements; the registration of manufacturers of dietary supplements; improvement of the adverse event reporting system. Such formal public comment requests in the Federal Register should be followed by appropriate proposed rulemaking and/or oversight and legislative reform by the Congress."
DR. GORDON: Tieraona, I have a procedural question. Do you want to consider the recommendations separately or do you want to consider George's replacement recommendation?
DR. LOW DOG: I would like us to quickly go through what these recommendations are that are being suggested that be deleted. We just went through 15, which primarily is labeling issues.
16, this is about specific sections that deal with material facts and deal with labeling, which is in the text but again just stands out there right now.
And then, "The Commission recommends," No. 18, "that Congress require dietary supplement manufacturers and suppliers to register their products with the FDA and that the FDA encourage voluntary registration until such a requirement is in effect. This information is for the purpose of notifying manufacturers and suppliers in the event that a problem is identified with a product."
And then 19, "The Commission recommends that dietary supplement manufacturers and suppliers be required to maintain a record of adverse events and report serious AERs to the FDA to facilitate FDA's dissemination of information to other manufacturers and suppliers and the public and that the FDA promptly notify manufacturers of any severe and/or clinically significant adverse effects reported to the FDA to allow companies the opportunity to provide important information about known safety and product formulation."
MR. CHAPPELL: Thank you. I actually don't agree with George's recommendation. My feeling is that the expectations of this Commission have been that we were performing the very functions that George is asking that we displace to another group and to another time. We have been conducting public hearings, we have been hearing a lot about these three issues, and we are taking a stand and making a concrete recommendation in three areas. I don't feel comfortable passing the buck here, and I like the three recommendations that we have.
These are serious issues, and any time we waste on this is potentially hazardous to public health. So I want to affirm, if we are taking them one at a time, that 18 is a very straightforward -- I don't know what numbers you are using here. But if we are talking about 18, Tieraona?
DR. LOW DOG: 15, 18, and 19.
MR. CHAPPELL: Oh, I thought we were on 15.
DR. LOW DOG: We started with 15. 15, that is the one about labeling. Is that the one you are on?
MR. CHAPPELL: Oh, I beg your pardon. All right. Sorry. I am moving around here too much. I apologize for that.
DR. LOW DOG: That is okay.
MR. CHAPPELL: I was referring to George's 37, 38, 40, and 41. What do those correlate to?
DR. GORDON: 37 is 15.
DR. LOW DOG: 38 is 16. And then you have got 18 and 19.
DR. GORDON: Which are 40 and 41.
MR. CHAPPELL: Well, then, I like 18 and 19 that are dealing with the registration of products and the maintenance of better records of adverse events. And I think we should not lump these together and shift the action to another time and to another group. I think we should deal with these one by one here because some good hearing and good thought has gone into it.
DR. LOW DOG: Julia?
MS. SCOTT: I just wanted to say that I agree with Tom. I think each one of these recommendations are very thorough and I think it is right for this Commission to take this very public stand on these four issues.
DR. LOW DOG: Joe?
DR. FINS: I actually misspoke earlier because I was not tracking the right numbers, and I totally agree for the first time today with Tom. But not the first time ever.
DR. FINS: But I really think this is very important, and I understand the complexity of it and I think some of the language that George has shared with us maybe can preface this section so that we acknowledge that our deliberations may not be the final word. But I think the issue of the adverse event monitoring, the labeling, I mean these are important issues and we have spent a lot of time talking about it.
MR. PIZZORNO: I agree also. We have heard a lot and I think Ken made some good recommendations.
I have one technical question about the term "label." Does that include inserts?
MR. GROFT: Yes.
MR. PIZZORNO: Okay. Because my concern is we can't do this on the label, it has to be done on the insert. Okay.
DR. GORDON: Most labels are grayfish.
MS. SCOTT: Then, can we go through them individually, starting with No. 15?
DR. GORDON: There is a consensus on this that we want to go through them individually, okay.
DR. LOW DOG: Effie, did you have a comment?
DR. CHOW: No.
DR. LOW DOG: Okay. 15. Comments? It is long. Can some of this be moved to the text? Any feedback? Like the way it is?
DR. WARREN: I like the first sentence after you get the points of sale. Can the rest of that be put in text or do you think it needs to be in the recommendation? It is more of an explanation of what you said in the sentence.
DR. GORDON: I would agree with you, the first sentence is fine. I would think "potential interactions" is important to have in that sentence, though, and then we can put the rest in the text. There are interactions and just to indicate a little specificity.
DR. LOW DOG: Yes. Okay. Joe?
MR. PIZZORNO: I believe this is so important it all has to be in the recommendation except for the last sentence about "all information." Actually, I would include that, too.
MS. SCOTT: Yes.
MR. PIZZORNO: I hate long recommendations. I think everything here needs to be said right with the recommendation because it is all quite important.
DR. LOW DOG: Joe?
DR. FINS: I agree because I think that the interactions may be patient category-specific. So I think people and vulnerabilities based on the categories delineated here may be at a special risk, so if we are going to have some risk we should have the reason why they are at greater risk. I would go for the whole recommendation as well.
DR. LOW DOG: I would just like to say, though, that I think that one of the problems with interactions is that they are very difficult to identify and that theoretical interactions, I mean the label could go on forever because I mean a lot of this information is not known. I would like to have some language in there that says when there is a scientific agreement or when it is well known or well established. I think if you just start getting into the theoretical that we are not asking anybody else to do that with OTC medications. So I think it needs to be where it is well established or well known that those be included, and I believe that that is part of what the material facts are, so the two revolve.
Is there a problem with that? I don't know what the language would be. Well established?
DR. WARREN: You are taking out "potential"?
DR. GORDON: "Significant interactions."
DR. FINS: "Well established, significant interactions."
DR. LOW DOG: Yes, I just think that when you get to what is possible, anything is possible. And I think that is too vague a recommendation.
DR. GORDON: I want to push this along a little. Can we get a consensus? And it sounds like more people would like the longer version minus the last sentence.
DR. LOW DOG: I did not hear minus the last sentence.
DR. GORDON: Or do you want the last sentence in there? Last sentence in there?
DR. GORDON: Okay. So consensus on that?
MR. PIZZORNO: Yes, I really agree with Tieraona's perspective. We need to have strength in language so that it is not too broad. But I didn't hear exactly how we are going to do it. I heard "when well established, significant interactions," heard that part. But how about the risk to vulnerable populations? What language are we going to use there specifically?
DR. LOW DOG: I think you are going to have to use "established" or "known" or "highly suspicious." I don't have the exact language right here, but when you start to think about children, elders, certain health conditions, we just don't have that data. And when you start saying "possible," it is huge.
MR. PIZZORNO: Yes, I agree. We shouldn't use "possible," but what exact word are we going to use instead?
DR. GORDON: It would be nice to get a word now so we can put this one to bed.
DR. LOW DOG: Okay. Give me one.
MR. PIZZORNO: How about "probable"?
DR. GORDON: "Probable."
DR. LOW DOG: Or "likely." "Identified."
MR. PIZZORNO: "Likely" would be good, too.
DR. GORDON: Or "significant."
MR. PIZZORNO: "Likely significant."
DR. GORDON: "Likely and significant," okay?
DR. LOW DOG: Okay. Steve?
MR. GROFT: Yes. Again, I am looking at George's comments and I guess, being a former FDA'er, and the very last part that "such formal public comment requested in the Federal Register should be followed by appropriate proposed rulemaking and/or oversight and legislative reform." I just feel that he has given us in this recommendation what we want to happen.
What we are stating is what we have heard and what we are going to be -- what we want to happen, but in reality what we need is exactly what he stated in that last paragraph. Someone needs to go through that process, and we can sit here and say that we want all of these other things to happen but if we don't give the right direction in our recommendation or we miss the opportunity, it is gone.
I think what George gave us in the last paragraph is very clear direction to tell FDA or FTC to do their work, develop a proposed rule, which there is a process within the executive branch to develop legislation and you send it through, and then have Congress do some reform action. I think, to me, that is a logical progression of what we really need to have happen if you want things to happen out in the out years. These other things may make a splash now but do you want things to really happen by Congress, by FDA, and the FTC? That is my concern, I guess.
DR. FINS: Steve, is there any way we can invert George's recommendation? Because it looks like we are getting more information, we are going to have more deliberation, and more and more and more discussion, and it looks like we are turfing it versus we have reached our conclusion. If we started with that there should be appropriate rulemaking and oversight and legislative reform of Congress of these issues following the additional deliberative process.
In other words, no one would write the recommendations based on what we have done here. We are sort of making it a general thematic statement but there are particularities that need to be flushed out. But I think Tom's point and what worried Julia and me is that it sounds like we are just turfing it again.
MR. GROFT: No. We are not turfing it, we are not sending it on to another group. We are stating what needs to be done.
DR. FINS: But can we say it in a declarative statement to start with?
MR. GROFT: Sure. I think if you flip it and make this as the first part and then go into an explanation of what it is that we want to have done --
DR. FINS: We want to have public comment in the deliberative process.
MR. GROFT: Right. Into this process.
DR. LOW DOG: Right. Because I think one could argue, Steve, though, that every recommendation goes through this process. I mean every one.
So I think I would have to support putting that language in there but leaving the recommendations, having it in addition to but saying that this is what the Commission found. This is what you paid us this money and this is what we did for the last couple years and this is what we heard.
Because, of all the comments we heard there was an awful lot about dietary supplements -- it just kept coming up -- that people had issues with. And so I would support this. I think you need public comment. I think we need to talk to the manufacturers. I think we need a lot of that and then there needs to be oversight and legislative reform by the Congress because, obviously, we need that.
MR. GROFT: Do you think we really talk to the manufacturers adequately, though?
DR. LOW DOG: Have we talked to everybody to get their whole --
MR. GROFT: I know, but I am just raising the issue.
DR. LOW DOG: One could argue that we didn't talk to the people who are anti many of the CAM modalities enough. I mean so what we have got is what we have for the last two years based on what we have heard.
MR. CHAPPELL: I would just like everyone to know that the number one issue with consumers is safety around these products, and because we are not as a total society addressing that sales are down 25 percent and they will continue to decline until we address the safety concerns and the concerns indicated in this whole process. Time is of the essence and we have got to be deliberate and prepare for action because the consumer drove it and now the consumer is taking it down.
MR. GROFT: I agree with everything you said, Tom, but I think we have to be clearer what we want to happen. We have been asked to give administrative and legislative recommendations and I think we can do what you want to do but yet provide those recommendations that will generate action on the part of the administrative and the legislative branches.
DR. LOW DOG: I would like to call on Effie.
DR. CHOW: It seems to me that there is room for both.
DR. LOW DOG: Yes.
DR. CHOW: I think that we should include here maybe at first or after we make these recommendations and in the text explain that we have had a lot of testimonies and this is our strong recommendation. And then it needs to continue with an act of Congress.
MR. GROFT: Tom, this may be a place where we talk about the revised recommendation as far as the overarching recommendation. Maybe we could plug that into this section here as well and say that this is the ultimate concern to the Commission of the public health and safety.
MR. CHAPPELL: What you want to retain is, "Such formal comment requests should be followed by appropriate proposed rulemaking?" What is it you want to retain?
MR. GROFT: I would like to retain that particularly and we could, whether it be in the recommendation or in the text, that they go through the process that George identified above, that we make sure that the agencies and Congress get these events to occur.
DR. LOW DOG: Joe?
DR. CHOW: That is not to eliminate my recommendation.
MR. GROFT: No.
DR. CHOW: But to add Joe's in here and not impede it. Tom, you are feeling strongly. We all feel so strongly.
DR. GORDON: What are you saying exactly?
MR. GROFT: I think we would have to put it together to try to melt the two into a useful recommendation. Maybe I could spend some time here while we are working and then try to present it before we are finished.
DR. FINS: I think Steve gave us those 11 overreaching things yesterday, which I thought was an incredibly helpful synthesis and a good way to go. And what we might want to do is to take George's revised comments, Steve, invert it in the declarative, like this is what we want to do. And I think Tom is right, time is of the essence, but I think this is probably the fastest way to make progress. But we don't want to look like we are turfing it and delay it.
But I would take this, invert it, make this one of the 11 or one of the 12 and perhaps make our recommendations action items or derivatives that flesh it out. But I think this is probably the way that we are going to have more bang for the buck and more immediate action.
DR. LOW DOG: My own feeling, I would support doing both, having it additive and not substituted. But I do just want to take issue that I don't think that this subject matter is any more technical or complex than the issue of licensure, access, economics, or anything else that we have dealt with and that I am quite fine with putting this language in here but I think that it needs to be additive and not substituted for the recommendation.
DR. GORDON: We are 15 minutes behind. We have other recommendations.
DR. LOW DOG: We are almost done.
DR. GORDON: Let me make a suggestion and see, Tieraona, if this works for you.
Steve, are you saying you have the same thoughts about 18 and 19 as well or just about this one? What I am suggesting is that if we come up against the same concern for each of these, then what we need, it seems to me, is a referral back and a representation of these issues. I am not saying we shouldn't get out some of everybody's concerns here, but I am just thinking if we don't need to come to consensus on each of the recommendations now it would be helpful to know that, to give it back to you with Steve's assistance, and then to bring it back in 10 days. If that is not appropriate, then we can move ahead.
DR. LOW DOG: The only one that we didn't mention was we had 17, "The Commission recommends that the FDA and other agencies with regulatory responsibilities be provided with the necessary funds to employ additional professionals with expertise in dietary supplements."
Do people agree with that recommendation?
MR. PIZZORNO: George has a modification which, actually, I like better.
DR. LOW DOG: "The Commission recommends that the FDA be provided with additional resources to enforce requirements regarding truthful and non-misleading labeling of dietary supplements. In addition, FDA and other agencies with regulatory responsibilities are provided with additional funds to employ additional" -- so it is both giving them funding to enforce and giving them funding for additional professionals. It is an expansion of the recommendation so it includes both of their tasks that they need money for.
I would propose that we take George's edits as it gives funding for both of the areas that they need funding. Is there any dissent?
MR. CHAPPELL: I am not sure what is being asked. First of all, I am not sure what you are assuming will be incorporated as additive from George's. If you are saying as an additive you think the language of (A), (B), and (C), improving labeling, the registration of, (C) improvement of adverse, and such, public comment, that this is going to go back for more public comment, no, I am not in consent with that plan.
DR. LOW DOG: Okay.
MR. CHAPPELL: And if, on the other hand, what you consider additive is direction for oversight by Congress as we did before, I am in favor of that. But I am opposed to delaying any intent on the Commission's part to be clear about what we are recommending.
DR. LOW DOG: Okay. So if I heard what you are saying, you are talking about "be followed by appropriate proposed rulemaking and/or oversight and legislative reform" but you are not in agreement with going back for public comment. Is that what I understand, Tom?
MR. CHAPPELL: Yes.
DR. LOW DOG: Okay.
DR. GORDON: What I am hearing is that 15, 16, 18, and 19 still need discussion here and there is a sense of urgency, at least on your part, to get those out, that George's recommendation for the public comment is not one that you accept on those.
Since Tieraona just started 17 and gave the language on 17, do we have a consensus on that to George's language on 17?
Do you want to read it again?
DR. LOW DOG: It is about resources for FDA. "The Commission recommends that the FDA be provided with additional resources to enforce requirements regarding truthful and non-misleading labeling of dietary supplements. In addition, FDA and other agencies with regulatory responsibilities are provided with additional funds to employ additional professionals with expertise in dietary supplements."
And again, just being specific, what those funds are earmarked for, that is why there is specific earmarking.
MS. SCOTT: I like George's edits because I think it expands what we came up with, so I would move that we accept George's edit in place of No. 17.
DR. LOW DOG: Okay. Joe?
DR. FINS: There is a logical inconsistency here which I don't understand from George's comments here. If we know enough to recommend 39, why don't we know enough to recommend 37, 38, 40, and 41?
DR. LOW DOG: That is a really good question, Joe. That is what I said. I do not believe that these are so technical and complex that we cannot make a recommendation on them.
So I would like to hear in general these kinds of comments but I do believe because of time we are going to have to take this back and send it out for everybody to please comment on in the next 10 days.
DR. FINS: I think there is an overwhelming consensus on all of these recommendations and I think what we are discussing is tactics, how we deliver it in this report so that it actually gets played out. And we are not savvy enough in the ways of this city to know whether or not what we are recommending is going to expedite it or what George is recommending to expedite it. And I think that we have a consensus and I think we don't need to go back and discuss it. It is really a question of how do we present it in a way that leads to the least delay in its effectuation.
I mean Tom is concerned about the decrease in utilization. I am concerned about, as a physician, adverse events and the clear concurrence on this. Maybe the stylistic issue should be left.
DR. LOW DOG: I cannot speak for George, but I believe part of his comments may be also driven by are these the best recommendations and have we taken everything into account. I would have to argue that I think the recommendations are just that. They can be tweaked. I think they make a statement of what the Commission believes we have heard and what we believe at this time should be recommended.
I'm sorry. Has somebody got their hand up down there?
SISTER KERR: I can wait until you are finished.
DR. LOW DOG: I guess I am just having to have a process moment here because of time.
DR. GORDON: Okay. I think what we need --
MR. CHAPPELL: Mr. Chairman, I think that is the problem is that we have changed our process the last few minutes. We have stopped going through the recommendations one by one and in deference to one of our commissioners we are dealing with a complication here lumping things together, and I would like to go back now that we have had our discussion.
DR. GORDON: Fair enough. Let's go one by one. It is fine. Once again, lunch will be truncated. Not eliminated but truncated.
So let's go back. I agree with you, Tom, that we have taken a look at the overview and we have had a response from the Commissioners. Let's go back one by one but as quickly as we can looking at each of these recommendations and then, Steve, if you want to come back and talk about suggestions about process and about tactical issues, okay?
DR. LOW DOG: Thank you, Tom.
Did you have a comment?
SISTER KERR: Just a point of information. What is the committee that, for example, we are referring to Congress who is moving this and George was consulting with? Is this in the House at this point or what?
MR. GROFT: I don't know. These came from George.
SISTER KERR: I thought you said you knew who was doing this in Congress?
MR. GROFT: I know there is interest by the appropriations language.
SISTER KERR: Within the House?
MR. GROFT: Well, I saw it in the Senate appropriations language. When you look at the budgetary supplements, that which has appeared up to this point of the proposed budget for Labor, HHS, and Education, you will find references to dietary supplement activities.
DR. LOW DOG: Okay.
MR. GROFT: The Appropriations Committee.
DR. LOW DOG: No. 16, "The Commission recommends that the FDA develop guidelines to assist the dietary supplement industry in understanding and complying with the FFDCA sections of 201(N) and 403(A)(1) which require that material facts be included on labels of all products" --
DR. GORDON: I just want to make sure. We have consensus on No. 15, is that correct?
DR. LOW DOG: I thought we had already achieved that.
MR. CHAPPELL: I would like one more on 15. Tieraona, you brought to issue the problem of interactions, how long a label is this going to be. I will say that I am in 100 percent concurrence on everything else in here and I do believe that any known interactions should be brought to the consumer's attention.
I deal with labeling problems all day long developing new products, and I think the kind of information we want to bring forward here is at point of purchase to the best of our ability. So the question is, what are we doing to the whole packaging burden as we lay these expectations out? And it may not be possible to get all of this on a package at point of purchase for the consumer to hold this up and say, okay, here are the interactions, here is what it does, here is the safety data. It is a huge expectation and I don't know how this will all be worked out.
You know what it is like when you get a prescription drug. You get a printout of all the interactions. We don't want these products to be dispensed by pharmacists.
DR. GORDON: Tom, I'm sorry to interrupt, but now we have a recommendation for the language.
MR. CHAPPELL: Okay.
DR. GORDON: And we have "Access" and "Delivery" that we need to deal with this morning. We really need to move along, okay?
MS. SCOTT: Tom, are you saying we had agreed to insert "well established," "when well established, significant interactions"? Do you need more?
MR. CHAPPELL: No, I am just wondering where we are going to put it on the label. That is all.
DR. FINS: Label or insert, Tom?
MR. CHAPPELL: But an insert, you see, the consumer has to buy it.
DR. LOW DOG: "Significant." It is just like OTC bottles. You probably can't read it. You will need a magnifying glass to read the stuff on the label. I mean I was looking at some before I came here, aspirin, ibuprofen, and that. I mean it is tiny language. It is tiny but it is on the label.
MR. CHAPPELL: Okay.
DR. LOW DOG: Do we have consensus on this?
MR. CHAPPELL: Yes.
DR. LOW DOG: 16? If anybody understands it, could you comment on it?
DR. GORDON: Would you explain it to us?
DR. LOW DOG: Well, it really has to do with the fact that there is already a sentence or two about if you know that there is a potential problem a manufacturer has a duty to inform the public. It is very vague and it is very unclear and it is called material facts, but nobody has really done it yet and the FDA hasn't enforced it yet. I don't think anybody really understands it, and so this was the purpose. Is what we are saying in No. 15, actually, if you read it carefully, under the "Material Facts" it would seem that they would already be required to do all of this. The reality is that isn't happening and is it just because nobody is enforcing it or is it also because it is a little vague to understand exactly how it is implemented and processed?
So that was the purpose that the FDA, just like when they had to define what "significant scientific agreement meant," that they actually explained what does this mean and what are they expecting of manufacturers.
MR. CHAPPELL: So as a manufacturer, if I know that camomile heals cancer, then I am going to be forced into a new drug application and a long process. I won't be able to know that. I mean this is very problematic and I think it ought to be deleted.
I would like to hear justification for keeping it but my recommendation is to delete it because if you disclose the material information as a practical matter you would be wise as a manufacturer not to put the product on the market or to put it into a different channel for a new drug application or something else. It makes no sense to disclose a material fact because it would mean you would have to take a different course than the course that is available to you.
So I think this ought to be deleted, period.
DR. LOW DOG: I am not sure you quite got the material facts. I guess my one problem with having it as a recommendation is that I am not sure many people would really understand what it means, and would it be better off explained in the text and not in a recommendation?
DR. FINS: I think Tom's point here is demonstrating the difficulty in actually playing this out. They don't have the labels or the inserts yet to comply with the expectation that we are talking about. So, maybe the recommendation is that the FDA in collaboration with the private sector should develop standards of expectations for the labeling.
We have said here we want labeling, we want more information. But they don't know what to comply with and I would hate for one company to be writing one label and another company writing another label and having varying degrees of information. So we need a kind of standardization process and that could be brokered by the FDA, not so that we get into new drug applications and that level of complexity but we are creating a new regulatory expectation and there is no direction.
DR. LOW DOG: Wait, wait, wait. I would like to clarify the material facts. Because this recommendation is not about that. I just want to clarify, it is not about that. It is that the dietary supplement labeling include all facts that are material in light of consequences that may result from the use of the product or representations made about it. So if you know that there could be a consequence, a serious adverse event, you are obliged to put that on your label. That is already what is on the books. It is already there. It is just that it is not being done and it is unclear how many people understand it and it is not being enforced.
DR. FINS: What I am saying is that I think there should be a standardization process to assist the writing of this new category of label or insert. It's not an over-the-counter, it was a supplement, we didn't have this before, it is not a drug. So there has got to be some technical assistance.
MS. SCOTT: Guidelines.
DR. LOW DOG: Right. So that is what the guidelines would be asking for, to develop guidelines so that we could follow them, that people would know how to comply and be in compliance.
DR. FISHER: Just one thing, quickly, and that is, the federal Food and Drug and Cosmetic Act requires this of all products regulated by FDA. That is one of the reasons why PDR and the labeling cert on prescription drugs goes on and on and on, in about .4 typeset, for pages and pages.
The point is that it exists in the law and it has been overlooked for everything: foods; drugs; devices; et cetera. The people that come closest to following this are in the prescription drug area, but Tom is absolutely on target here.
My suggestion is that you might want to mention it because it is something that needs to be fixed and it isn't specific to dietary supplements.
MS. SCOTT: The question comes, should it be a recommendation? Should it be in the text?
DR. FISHER: Well, I take the Fifth Amendment on that. I am just going to consult, that is all.
DR. GORDON: I would like to get a recommendation from you. In the light of the discussion, do you still want it as a recommendation, and if so, with the explanation do we have consensus on it? Because we do need to move ahead.
DR. LOW DOG: My only concern is to remove it nobody will ever address it. But maybe we need to tweak the language that it is for all health products.
DR. GORDON: Well, our focus is on, I think it says very clearly, assisting the dietary supplement industry. We don't have to worry about anybody else right now. This is what we are concerned with. If we feel it is a good recommendation, let's come to consensus and move on.
DR. LOW DOG: Do we have consensus? Is there anybody who does not want this as a recommendation?
DR. LOW DOG: Or it can go in the text. The danger of it going in the text is something may not be done with it.
DR. FINS: We could leave the recommendation as is and explain in the text, capture the difficulty in translating this expectation into practice and the need for technical assistance and for the establishment of standards so that the manufacturers know what is the threshold, what do they report?
DR. GORDON: Okay. Tieraona, we are going to have to move along. We are a half an hour behind.
DR. LOW DOG: We have done 17 already.
18. We have already discussed it. This is about requiring dietary supplement manufacturers to register their products. The only thing I wanted to add was we say, "This information is for the purpose." I would say, "is only for the purpose of notifying manufacturers and suppliers."
DR. GORDON: Let me tell you one concern I have heard from people in the industry and from people in Congress as well, that this might be too onerous a burden because this means if you increase the amount of Vitamin C in your product from 50 milligrams to 100 milligrams you then have to notify the FDA. The concern --
DR. LOW DOG: No.
DR. GORDON: That is the reading that I have heard from people. It may not be true. But the feeling that I heard was that there was a concern that we would be, number one, to some degree burdening the manufacturers and even more giving the FDA a somewhat indigestible amount of information that they wouldn't be able to do much with. So the issue was, is there a way that we can formulate this so that it really deals with issues related to problems, adverse events that doesn't produce a whole lot of information that is going to be superfluous and not attended to? That is the concern that I have heard.
DR. LOW DOG: Thank you.
DR. FINS: Suppose we ask them to maintain their own registry that could be available in the event of an adverse event?
DR. LOW DOG: Let me just tell you how this one came about, and we can remove it, change it. I mean we are seeing it right now. I mean Germany is looking at removing Cava from the marketplace. They have until Friday, the manufacturers, to respond. The way that they notified everybody was because their products are registered, so they were able to contact all of the Cava manufacturers to be able to elicit comments and to also notify them of the potential health problems that they are finding with Cava.
If in this country you haven't a clue who is selling what, how will you know that you identified them and got the information? This is where it came from, not attached. I just wanted to give you the background.
DR. FINS: It doesn't need to be submitted to the FDA. It just needs to be available if there is a problem to be accessed in case there is an adverse event. In other words, the companies can maintain their own internal registries.
DR. LOW DOG: And how would the FDA notify in case of a product?
DR. FINS: So then, when there is an adverse event, they would notify the FDA.
DR. LOW DOG: What if the FDA knows it and not the company?
DR. FINS: Well, that could be disseminated from the FDA as an advisory. Basically, every supplement company is known to the FDA, presumably, or they should have at least registered. But each individual product need not be registered is perhaps what I am saying.
DR. LOW DOG: Companies are not, either.
DR. FINS: Maybe we should say companies should register so they are on an advisory and if there is an adverse event, all those manufacturers in the supplement industry will be told this particular supplement has been a problem. Check your registries to see if you are producing this supplement. And it can be done in a less burdensome kind of way.
But I think this points to the wisdom of George's recommendation that the details really need to be flushed out.
MS. SCOTT: Charlotte.
DR. LOW DOG: Is it Charlotte?
SISTER KERR: Yes. I just think it is being made more complicated. I obviously am not an expert in this field, but it sounds -- which is a comment on the general work. In honor of what you all have done, this is complex. I think the text is brilliant, and I think this makes sense unless someone can speak to why the FDA would actually not implement it, doesn't have funding, and it get left off the books. It sounds reasonable and it ought to go forward.
DR. LOW DOG: Yes. Corinne just wanted to remind us all that there has been already a lot of written information about this. There have been recommendations made about this: the GAO; the OIG report. So I mean this is not coming out of nowhere. This is other groups that have looked at this have suggested this.
I would also say that the details can be worked out. I never envisioned this as if you changed your level of Vitamin C that you had to notify somebody. I think the purpose was really to notify what ingredients you had so that if there was an adverse event, and that is also why I think the language needs to be clear that this information is only for the purpose of notifying manufacturers. That information is not to be used for any other purpose.
MR. CHAPPELL: I think this recommendation harmonizes with the request for more safety on behalf of the public because this allows us to respond quickly when we need to and it is not an onerous burden to register your product with the FDA. So I'm sorry to disagree on that point but this is not a big requirement. It is a very responsible thing to do.
DR. LOW DOG: Julia is asking to pass the recommendation. Is there any additional comment before we move to consensus? Joe?
MR. PIZZORNO: So the purpose of this is primarily for safety, and as we have done for the problem with the particular constituent, the manufacturers should be notified. It seems like there are two other options we could consider. One is to make sure every supplement manufacturer registers with the FDA and then receives notification of every adverse problem that comes up. Second option might be that they register with the FDA only the substances that they are using in their various products but not register every product.
DR. LOW DOG: Right.
MR. PIZZORNO: So I think we had three options we could consider here and I will lecture the pros and cons of each. Clearly, registering every product is going to be more onerous than the other two options I mentioned.
DR. GORDON: Do you have a suggestion for language, Joe, that would change or modify this language?
MR. PIZZORNO: I like the idea of Option No. 2 where you register -- or I guess maybe it is 3 in the order I gave it -- where you register with the FDA all the substances that you are using so that those manufacturers can be identified and quickly communicated with when there is a problem.
You don't like that, Julia?
MS. SCOTT: Somehow that seems more complicated. I am certainly not an expert in this area, but somehow that seems to make it more complicated, to determine the substances and then correlate it with products and then notification. It seems to add a step, to me.
DR. LOW DOG: Tom?
MR. CHAPPELL: I just need to say again because this is my business and because I am a manufacturer for us to register 100 products is not onerous. It is just a task to be done in the name of safety. We are not giving anything away and I need to hear from other manufacturers who think this is onerous.
MR. PIZZORNO: Tom, what does it cost you to do that for each product? How much does this cost you?
MR. CHAPPELL: First of all, we have all that information in our records. We have it in our files. It is sending of an e-mail, if you really want to know the truth. It is just data that exists. You are required to have this data already. It is just a matter of putting some name on it, some registration form of the FDA, and sending it to them. This data already exists in manufacturers' files.
DR. LOW DOG: We are going to have to really just keep them very brief and to the point because we have got to have closure.
Joe, a comment?
DR. FINS: Yes. I think they should register their products, they should register themselves, and they should be available for an adverse event notification and it should be a tri-part type phenomenon.
DR. LOW DOG: Do we have proposed edits to this or do we have consensus for it as it stands?
DR. GORDON: Are you talking about 18 or are you talking about 19?
DR. LOW DOG: I am talking about 18.
DR. GORDON: Okay.
DR. WARREN: I would like to edit. When you added "only for the purpose of notifying."
DR. LOW DOG: "Only for the purpose." I think that was my proposed edit.
DR. GORDON: Do we have consensus on that with the edit?
DR. LOW DOG: Okay. 19 we have already read. This was about dietary supplement manufacturers maintaining a record of adverse events and that they report serious adverse events to the FDA. We have also included here that that should be a two-way street, that the FDA should promptly notify manufacturers of anything. severe or clinically significant. We just think that this is inclusive because it also allows the companies to respond with any safety data or technical information that may assist them.
DR. FINS: So for 19 you should say, "In order to receive these notifications all supplement manufacturers should register with the FDA," so they were on their e-mail list?
DR. LOW DOG: Yes. If 18 is true, then 19 will follow.
DR. FINS: Right.
DR. LOW DOG: Okay? Do we have any problems with this recommendation?
DR. LOW DOG: Passed? Okay.
20, "The Commission recommends that additional resources and support be provided to the FDA to simplify the AER system and increase outreach activities to health professionals, including poison control centers, ER docs, CAM practitioners, mid-level marketers, and consumers to underscore the importance of reporting adverse events."
DR. FINS: I didn't like "simplify" because it looks like we are down-regulating. I would use a word like "strengthen."
DR. LOW DOG: And make less complicated. Have you used it? It is so cumbersome. I was just talking to the head of New Mexico Poison Control and he said that the reason nobody fills it out is because it takes so long to fill one of those out that nobody fills them out.
So I am not attached to the word "simplify," but "streamline" or something.
DR. GORDON: Yes. I think that is very important to do. It has got to be not overly onerous.
DR. LOW DOG: Because you and I, it would take you an hour to fill it out.
DR. FINS: Let's do "streamline."
DR. LOW DOG: Do we have any other comments or do we have agreement on the recommendation?
DR. LOW DOG: Okay. With modification.
DR. WARREN: With the modification of "streamline"?
DR. LOW DOG: "Streamline" instead of "simplify." I like that better.
DR. FINS: Can I just ask your staff, once we are all done here, if we can get a revised copy of the 50 or 60 recommendations with all these edits?
DR. LOW DOG: Okay. Just when you thought you were done, George had two other recommendations that have to do with this section here. And they are, "The Commission recommends that Congress and the administration enact meaningful legislative and administration reforms to provide greater incentives for private sector support of research on dietary supplements and other natural products that may not be patented." I would fully support that recommendation.
DR. GORDON: I think that goes back to Research, though, I would say.
DR. LOW DOG: Great.
DR. GORDON: It is related to some of the research recommendations that were already made.
DR. LOW DOG: Good. We will give that to them.
MR. PIZZORNO: Also, how about the next recommendation about the changes in the IRS tax code? It looks like it was crossed out. Where would that go?
DR. LOW DOG: We are just getting ready to read it.
MR. PIZZORNO: Okay.
DR. LOW DOG: It's a revised one.
DR. GORDON: That goes into reimbursement.
DR. LOW DOG: It's not ours.
DR. GORDON: It does not belong here.
DR. LOW DOG: Health insurance coverage.
DR. GORDON: So maybe, Maureen, can we cover that one this afternoon?
DR. LOW DOG: Yes.
DR. GORDON: If we have time, even though it is under the reimbursement, maybe we can begin to address George's other recommendation, because we don't have time right now. Do you understand what I am saying? We will address it in full committee as opposed to sending it back to a subcommittee right away, if we have time, even though it is in the Research recommendation, okay?
What about the first recommendation, "Congress conduct regular and timely oversight hearings"? We will come back to that one later on as well. We don't have time at this moment.
DR. LOW DOG: We are going to go back because there were a number of recommendations we have to go back with, and we are going to just send out a revision of this within the next 10 days.
DR. GORDON: What I am saying is, there is a recommendation here that George made that is not in any particular group that we will try to address later on.
DR. LOW DOG: Oh, about the recommendation. Sorry, the first one, "The Commission recommends that the U.S. Congress conduct."
DR. GORDON: Right.
DR. LOW DOG: Okay.
MR. GROFT: Would you want me to restate the recommendation that I would propose, based on what George had written?
"Recognizing the concerns addressed at its meetings, the Commission recommends that the U.S. Department of Health and Human Services, and its agencies under its jurisdiction," and the rest of it remain the same. That would be additive to what you have already agreed.
DR. GORDON: Say that again?
MR. GROFT: "The U.S. Department of Health and Human Services and its agencies under its jurisdiction formally solicit additional public comments on the following subject matters: (A); (B); and (C); and the like, to give direction to the Department to establish a formal process for doing what you want them to do."
DR. LOW DOG: Tom, are you okay with that, since I thought you specifically said that is not what you wanted?
MR. CHAPPELL: No, I am not okay with that.
MR. GROFT: I would like that to be additive to what you have already agreed upon, and the Commission has already agreed upon, in the other recommendations, but it is your call.
MR. CHAPPELL: Steve, if I understand, you are looking for a statement of ongoing public comment. Is that correct?
MR. GROFT: I am looking for the FDA and the Department to come up with a mechanism that is already in place to make legislative proposals to the legislative branch from the executive branch.
In so doing, you have to go through this process of conducting these hearings, addressing the issues, publishing in the Federal Register, much like what we did, as we published in the Federal Register, the question we would like to have answered. You solicit comments from the public about these issues, and then you develop a legislative initiative that then moves through the Department.
DR. LOW DOG: So, are we going to do that for every recommendation, since to get anywhere.
MR. GROFT: Someone will have to do it, yes, because I think there are enough controversies surrounding dietary supplements in the country, that it is worthy of a formal recommendation to move in such a manner immediately, and not to wait and let the marketplace take care of it.
DR. LOW DOG: Effie?
MR. CHAPPELL: I guess I am confused. I thought we had agreed as a process earlier that we were not taking on this particular edit and that we were instead going to act on the individual recommendations.
DR. GORDON: We did.
MR. CHAPPELL: We had agreed on that. He is bringing up another recommendation.
DR. GORDON: Another recommendation?
MR. GROFT: No, no. I am adding this other recommendation. You have already approved or accepted the 15, 16, 18, and 19 with edits.
MR. CHAPPELL: Yes.
MR. GROFT: Now I am asking for consideration for another recommendation.
MR. CHAPPELL: "It is specifically due to the technical and complex legal regulatory. "Is that the one you are adding?
MR. GROFT: Yes. But I would take out that first part and start with, "recognizing the concerns addressed at the Commission meetings, the Commission recommends," et cetera.
DR. LOW DOG: Effie?
DR. CHOW: Now, does it have to go through that process to have the Federal Register to follow up and have legislation reform for Congress? Can what we found in our hearings be made as a report to Congress and be put in the Congressional Record and also to have legislative reform made by Congress without going through that process?
MR. GROFT: Yes, it can be.
DR. CHOW: Because I think we had significant hearings.
MR. GROFT: It can be if Congress elects to do so. This is a way of having the executive branch put forth a proposed legislative proposal.
DR. CHOW: Okay.
DR. LOW DOG: I would like to take this back to committee, Steve, and then I would like to send out with it all written out and then I would really ask people to make sure you comment on it, though, so that we really know what people are not happy with so we can move forward today.
DR. CHOW: I haven't finished.
DR. LOW DOG: I'm sorry, Effie.
DR. CHOW: But what I am trying to do is like I am sensitive to what Tom is saying. If this is a necessary process to get legislation from Congress, then I go for it. But I see that that would delay our recommendations if we are recommending that they go through another process. So what I am trying to shortcut is that can our hearings go through the executive branch and that they make recommendation or they have to hear it themselves?
MR. GROFT: Well, it is altogether different. There are statutory requirements to move through and it is up to Congress to determine what they want to do as far as their individual pieces of legislation that they would introduce.
DR. LOW DOG: Right, because not all legislation goes through the Federal Register.
DR. CHOW: Then, in our text, or in our recommendation, we should say that this is extremely urgent and wanting to carry out these while this is still being implemented.
MR. GROFT: How about we bring it back to you? We will take it to the working group.
DR. GORDON: It sounds like the issue that is on the table is, will this recommendation undercut, in some way, the other recommendation?
MR. CHAPPELL: I have to affirm that very concern, and I do find this undermining. I find it back door lobbying and I don't appreciate it, I really don't. This has been an open process. We are being asked to say what we think.
If Congress wants to do this, let Congress decide to do this, but as a Commission, we have done our work, we have done our hearing, and we have come up with concrete recommendations. So I am in absolute opposition to this coming back as a recommendation.
DR. LOW DOG: Thank you.
DR. GORDON: Tieraona, what are you going to do? What is the resolution here?
DR. LOW DOG: Well, I am going to talk to my committee because this isn't just me.
Let me just say something. I think that there is an undercurrent here that I am just going to publicly say that Tom touched on. There is some feeling that there is something else going on under here that we are being asked to do. I am not opposed to getting public comment, and I don't think we have all the answers.
My question simply comes from the fact that this, to me, is no more complicated than all the other issues we are dealing with and yet we are treating it in a very special way. I mean products have already been singled out in a unique way anyway throughout this process, so I just think we need to go back to the committee.
George, we can pull him on the phone. I think we all need to talk, and then we will send you something within 10 days.
Tom, we will take all of your wisdom into account. And please, everybody just needs to comment, then, upon what we send back.
Session V Summary
DR. GORDON: Let me say that on this issue, what I am hearing is very strong concurrence, unanimous concurrence from the Commission, with the exception of George, but from everyone who is assembled here, that these recommendations should go through as discussed.
I am also hearing, from George and from Steve, concern that there be some other mechanism that needs to be addressed in terms of dealing with Congress, strong opposition from Tom, Tieraona saying, let's take it back and look at it with input from everybody, and then bring it back within 10 days.
Is that a fair summary?
DR. FINS: It sounds that way.
Tom, you have had the most experience with this of anybody here. Am I correct, I am hearing you say, it ain't broke so don't fix it, in a sense? I mean, the system works now?
MR. CHAPPELL: No. I am saying that the remedial measures recommended in these concrete recommendations will go a long way to fixing what is wrong. I am hearing that responsible recommendations of these kinds are not going to be welcomed by industry, and I am feeling pressure already about this.
I just need to act as a commissioner, not as a manufacturer. I am here as a commissioner for the charge that I was brought here for and I want us all to behave like commissioners. So I think how we deal with the recommendations outside these halls will be independent actions.
DR. GORDON: Okay. So feelings are clear of the commissioners, there is concurrence on the recommendations, there is an issue raised by George that is going back to the committee.
Tom, I urge you --
MR. CHAPPELL: Now that I am through with my other committee, this would give me a chance to be active on this committee.
DR. FINS: I think that this should be circulated to everybody, not just the subcommittee, because I think everybody feels that this is so important.
DR. LOW DOG: We are going to work on this but we are going to send it to everybody within 10 days. That is what we said. It is not going to go just to subcommittee.
DR. GORDON: Of all those recommendations that go back to the committees everything will be circulated to the entire Commission for all of the subcommittees, okay? And everyone will have an opportunity to participate in those discussions over the next 10 days.
MR. GROFT: And everyone will be informed of the teleconferences, the time and dates so you can participate.
DR. GORDON: No. 20. Final recommendation? We agreed to that? Okay.
Thank you very much, Joe and Tieraona and Corinne and everybody.
DR. GORDON: Basically, we have just gone over the conclusion of the last part. We also have condensation of Nos. 13 and 14, adding language about supplements and herbs. We have some minor changes to some of the other recommendations about which there was no dispute. There is consensus. There were some slight shifts in language.
Let me see here. There is one other that we brought back, one other that we brought back to the committee. No, I think we are fine on that.
In the one instance we accepted George's changes for the No. 34, otherwise known as No. 13. We added a couple other sentences. Commissioners suggested that public comment be solicited. Okay?
So let's take a 10-minute break, and then we come back and we do Access and Delivery.
DR. GORDON: We are going to begin with Access and Delivery in a moment, but before we do Bill has to leave early and I wonder if we can just take a moment to send him our love and blessings and healing energy and our healing wishes as he moves through this passage.
So if we could do that, just sit quietly with him for a moment.
[Moment of silence observed.]
DR. GORDON: Bill, thank you for all your contributions and for your staunchness in this work, and we will be setting the time for the next meeting at lunch and then we will see you then.
DR. FAIR: Okay. Well, thank you. I appreciate that. And when we first started doing things like that with Michael Learner it sort of left me cold, but I could really feel the warmth and the energy coming from all of you, so I appreciate it. Thank you.
Discussion Session III: Access and Delivery of CAM
MS. LARSON: With your indulgence, I would like to proceed as quickly as possible to get through this challenging area called Access and Delivery.
First, I would like to review what the action items were we were given on this committee in October and then to account very briefly for what we got done on the action item list and then review the process and then Dr. Fins will go through the recommendations.
We were asked here in October to, one, add an introduction that provides clear overview of demand side of complementary and alternative medicine access, and I believe that request came from both Jim Gordon and Tom Chappell. That has been done.
Also, contextualize the Pew Commission report recommendations to provide more relevancy for complementary and alternative medicine, and that has been done.
Update the text with more recent and specific recommendations made by the Pew Commission concerning regulation. That was a specific request from Dr. Gordon.
Enrich the narrative with a discussion about professional evolution of complementary and alternative medicine, and then lastly, enrich the narrative to include models of service delivery that refer to health disparities. I believe that was Joe Fins, Julia Scott, and mine.
Then we were asked to consider three new issues: products; care navigators; and oversight of organizations that provide complementary and alternative medicine. One we did and two we did not. The products, one we referred back to -- a moment there.
So I would like to go through again what the process that was set up is, one, because we need to be expeditious but we don't want to be expeditious instead of going into a quality, or having substantive discussions on these matters.
But (1) you would agree and you want to have it go forward; (2) you want some changes; (3) it is, I can't live with it; and (4) let's go back for the subcommittee to work on for the holidays.
DR. FINS: Let me just preface by saying that this section has a regulatory focus and we strongly feel based on our review of the literature that regulation and access go hand in hand. There is evidence to suggest that jurisdictions where practitioners do not have regulatory authority to practice leads to decreased numbers of those practitioners in those settings. So there is regional variation based on regulation, which in turn, impacts on access.
So the linkage, maybe, that was not as clear in October, between why we are focused on regulation so much and access, I want to make clear.
We are also not addressing questions of universal access. We are really talking about CAM access and we are really trying to promote public safety consistent with the executive order, public accountability, and maximizing the safe and effective access to qualified practitioners. Again, regulation leads to access and I hope that linkage is more clear.
The other thing that I want to stress is that the strength of this section may be as much in the background section as it is in the recommendations because we are trying to conceptualize a framework, I mean, that the whole group worked on very deliberately to try to maximize the ability of practitioners to practice safe and effective therapies and also to protect consumers, so we tried to lay out a taxonomy, and drew strongly upon the Pew recommendations.
So let me just briefly talk a little about that and then we will get to the recommendations. If we could just go to page 5, we talk about the relationship between regulation and access that I just talked about.
I want to just clarify for Jim, because he and I had some discussions and I want to clarify for you that the text does not defer, the way it was constructed, as adequately to the rights of the states to regulate these practices, and we don't in any way want to have a single federal standard, but really to develop national consensus on what the various practitioners should or should not do that the states could then take back and interpret in their own jurisdictions to write appropriate laws.
So on Line 15 it says, "Currently states regulate health care practices." We are not saying that should ever change and it just should be struck. It is a state prerogative to do this.
Again, on page 6 there is a citation about occupational regulation that you can look at, and I am not going to belabor it but let me go down to the Pew task force. I think it really resonates nicely with what the Education and Information groups have done, that we are saying that states should use standard and understandable language, there should be clarity about entry to practice recommendations and requirements, there should be initial and ongoing competence, that the boards, Veronica, that make those kinds of assessments should be appropriately constituted, so that people don't get sanctioned by people who don't really understand what they are regulating, and that there is a public education function, that the boards should, as part of a state process, educate consumers, and the disciplinary process should be fair. There should be evaluation tools and there should be an understanding of the links.
If you look at No. 10 between the health care system and regulation, I think the discussion we had earlier about the relationship between the IRB and research and the like I think is captured. The more you look at the Pew recommendations the more on target we think they are.
So we then moved on to say that in light of those kinds of recommendations and the problems that we have identified -- and I think someone yesterday talked about the gray zone.
Who was talking about the gray zone of practice, between research and practice and that gray zone?
We see the solution to the gray zone through licensure. In other words, that it is your scope of practice; it is what you do, and if you are beyond your scope of practice or beyond your conceptual framework, it is a referral question. If you are doing something that has yet to be proven, it could be a research question, but we want to try to make the gray zone a little less gray, make it smaller by clarifying and delineating what the scope of practice is.
Again, I want to stress that if people can practice, patients have access to the practitioners, and that is the relationship between access and regulation.
Now, on the following page here, we talk about a federal entity to help develop guidelines for practice standards. Again, this is a clearinghouse. There is a lot of discussion that needs to happen, a place where states can share their recommendations, everything from the Minnesota model to more regulated models and a clearinghouse function, and we think that, as Don is fond of saying it, CAM Central could be that kind of place to have this process, not to prescribe what the standards should be but help the evolution of standards to that end.
We then go on to some of the recommendations about the quality of the process, some of the expectations on page 11 about the importance of proper referral, that professionals know the limitations of their practice, and that, again, this is not a recommendation for CAM practitioners but for everybody, any practitioner who is caring for patients.
Then we laid out the kinds of mechanisms that exist, the mandatory licensure, title, registration, and exemption. And again, I think the exemption point here addresses some of the things we were talking about, the native and indigenous or religious healers that we were talking about that they come under this rubric.
And then after we have this discussion we say, and this has been the consensus of our group, that we believe the regulation is necessary, feasible, and highly beneficial. And I would add that on an access side, George DeVries has shared with us that an insurance company and payors want licensure and some kind of regulation because then they know who they are paying and who they are. It decreases potential, I guess presumably -- these are my words now -- liability concerns because you know who you are hiring and who you are paying.
So the other point we want to stress is that for CAM practitioners to be integrated into the mainstream, including funding streams and the like, they all need to have these kinds of validations through licensure or whatever.
Now, on the bottom of page 12 is an important point that I think we want to say that we are not going to solve this problem here because there is internal dispute among many of the emerging professions about what constitutes appropriate training and the like. I am fond of reminding you all of my offer to the acupuncturist to say, why don't we all go out for dinner and have this discussion and figure out how many hours it would be, and they wouldn't even take a free meal and have a meal.
That was meant for some of you to laugh, but I guess it is not that funny.
But the point is that this central body would be a way to sort of foster that collegiality and consensus.
I also want to say that I think Charlotte's point was made yesterday about this inherent differentiation and we don't want to standardize it and knock the creativity out of it. And I would like to distinguish excellence and individualization of practice, and they are not mutually exclusive and usually excellent practitioners are more creative. So having standards does not necessarily undermine the creative, artful side of the healing arts.
So, again, to try to get consensus, recognizing overlap of approaches, and again, on page 14 or so, having this central body again to, if it reads too strongly, to advise states not to prescribe or not to be dictatorial at all to the states.
And then we go on to talk about why all this is necessary. There is inconsistency, there is liability, there is a need for clarity for CAM practitioners so they have the appropriate legal authority to practice in their jurisdiction.
And then on page 16 or so we start trying to say that the various levels of regulation should be titrated to the risk benefit element of their approach, and then we talk about the various categories. And Joe Pizzorno was very helpful here in helping us with this taxonomy. All credit will go to Joe, all blame will go to me -- one Joe or the other. Joe Kaczmarczyk. Let's blame the other Joe. The Three Tenors, the three Joes.
So, we have got CAM professionals who are ready for licensure, the emerging professions, the static practitioner, and then, on the other side, the conventionally trained professional who is practicing a CAM modality and then the traditional healers. And again, we want to have these sort of choices laid out and states could categorize people in these categories depending on their view of where they fit -- we are not here to say where they fit -- so that consumers can make informed choices, so they know who they are dealing with.
So that is, I hope, pretty much the conceptual background to this, at least on the provider side. We are going to get to organizations in the next part of the discussion, and to that end we have a number of recommendations.
DR. GORDON: Just before you begin, are there gap recommendations, other recommendations, that people have for this section that are not included?
DR. FINS: Yes, okay.
DR. GORDON: You have some?
DR. FINS: Yes. We will get --
DR. GORDON: I have some as well, and I'm wondering if anyone else has any.
DR. FINS: Jim, why don't we go through this, and then we will add?
DR. GORDON: Fair enough.
DR. FINS: Because I think I know what your recommendations are, and I think they will make better sense as we progress up the food chain here.
DR. GORDON: Absolutely.
DR. FINS: But again, let me just say we went from micro to more macro. This part of the Access pizza is really related to the practitioner part, and then we are going to go from that to single office practice to places like WellSpace that are CAM offices or clinics, and then into integrated delivery systems. We are trying to do it sequentially, so let's try to leave the question to the practitioner regulation licensure stuff and then we will go to the recommendations.
DR. FAIR: Yes. I had trouble reading this as to the distinction between regulation and licensure, and I have talked to a lot of people and CAM practitioners and at least in my little survey there is a great deal of difference. I mean, the yoga teacher that does yoga, or the hard body yoga, June something like that, is not considered among yoga teachers as the same one that does medical yoga or restorative yoga. The same thing is true for massage.
I'm sorry George is not here because I asked George specifically this question the last time: What is the advantage of licensure over regulation, and his answer was, well, it is easy to get reimbursed if you are licensed as opposed to regulation.
So I think we need to establish standards, i.e. regulation. But do we really need to push for licensure in all areas?
DR. FINS: Well, we agree with that completely, and I think what you need to say is "registration versus regulation." If you go to page 11 and 12, we have got different levels. We are not saying that that yoga teacher should be licensed with a mandatory license or a title license or registration or exemption.
We are trying to say is that those standards need to be promulgated and we are saying two processes. One is there is a national, facilitated, federal clearinghouse as it were that tries to figure out that question. The distinction might be if you are providing a therapeutic yoga you may need to be registered, just for the sake of argument. If you are teaching a yoga class, you don't. If you are doing something that is more invasive, you may need to have a title license.
We are not making the recommendation here but we are saying we want to set up the mechanism that would allow the discussion to be in more detail and then the states would take that information and write their own regulations.
DR. FAIR: Well, just my position is I think regulation is absolutely necessary. I agree with you. There are too many people out there that wind up getting hurt by yoga. I think our chairman even got hurt by yoga at one time, is that right, Jim? And unsupervised yoga teachers.
And so, I think we need to establish the thing. It is just a question of licensure, which is a state function, and I think that, again, we could establish the standards for regulation but maybe not necessarily push for licensure in all cases.
DR. FINS: But again, we are not coming down on the particulars of who gets licensed or whatever. We are providing a taxonomy, we are hopefully setting up a structure, and again, even a federal entity would not make the call. It would just be a way of making some sort of expectations or guidelines and we will tweak that language depending on how the conversation goes this morning. We don't want to dictate on high. We want to facilitate the dialogue and then the states figure it out.
DR. FAIR: Thank you.
DR. FINS: All right. So the first recommendation is going to be -- are you going to do it?
MS. LARSON: You can read it.
DR. FINS: I can do it, all right.
So one of us would say that no later than six months -- and again, this time frame may be too short -- following receipt of the report the Secretary should establish a national policy advisory board that will support and coordinate efforts with a designated CAM office, again if that exists, develop policy guidelines on issues related to access and delivery of CAM that are more specific than we have had the chance to do here.
Now, I would just say before we go on, Linnea and Michele and I are probably all willing to collapse some of these things. There are some redundancies and that is a product of our editorial abilities. But I think basically the gist of the recommendation is really to have this kind of discussion about, at least at this point, licensure and the various standards.
DR. GORDON: Do I go first? Okay.
Wait. I didn't understand that last sentence, also. The first recommendation doesn't have anything to do with licensure, it has to do with access and delivery of CAM. Is that right?
DR. FINS: That's right.
DR. GORDON: So when you are talking about licensure, you are not talking about the first recommendation?
DR. FINS: It establishes a board to address issues of access and delivery. One of the sub-issues that they would address would be the regulation and licensure question.
DR. GORDON: The general issue, which I raised and have raised a bit with you before, is, I think we need to make some statements here about access and delivery to CAM, and I think we need to differentiate between those statements.
I mean, we have been listening to people for a year and a half. They have had a lot to say, we have learned a lot, we know a lot about access and delivery. I feel we should make some statements and recommendations and not just give everything over to the board. And I may have some specifics, but I just think in general that we need to have that sense that we are going to make some recommendations and we need to delineate between what we are going to recommend and what we think this board should address.
DR. FINS: Tom?
MR. CHAPPELL: Well, that is my sentiment on this particular recommendation. If you wanted to maintain the idea of the policy board, the recommendation might be strengthened by saying, "to include at least the following." That would carry forward at least the things that the commissioners feel strongly about, as we have had time to review this.
As a standard recommendation I can't accept it because it is a vessel without any content.
MS. LARSON: So you would add some specific language just saying to include what?
MR. CHAPPELL: I would defer to your fine committee to identify those.
DR. FINS: Before we get to this, I see the point and, again, this does not quite follow from what we were just talking about.
So I think the bigger question on the table, which again initially many of us hoped that the access and delivery and coverage and reimbursement group would be a single group because many of us felt that coverage and reimbursement was really whether or not there would be entitlement to various things and it would be whether it was covered or whether it was reimbursed, not whether you had access.
What we were trying to conceptualize was, even if you had all the money in the world and you had no limitations on your funding stream, would you have a system that would provide access and delivery of good services.
So I think whether or not there should be an entitlement question really, in my view, comes under the Coverage and Reimbursement section. We did not address that.
MR. PIZZORNO: Being part of this committee this is kind of an awkward thing to say but I think I need to say it. I really like the text. I think we did a good job on the text. I look at the recommendations and I don't feel like they reflect what we said in the text.
So for example, No. 52, I think it would be something like: "The Commission recommends that in order for the public to have access to safe and effective CAM therapies, that practitioners should be regulated and the forms of regulation that are appropriate are title licensure and registration." I think we need to say that. We said that in the text, but it got lost in the recommendations.
DR. FINS: I think you are absolutely right, and I think we did spend more time on the text side than the recommendation side, and that is just a function of our ability to get it done.
Is everybody comfortable with that kind of modification, that we believe that there should be a regulation, and that the categories would be mandatory licensure, as we said in the text, title licensure, registration, and exemption, and that there be a federal body to help foster the discussions about these categories as it applies to particular kinds of practitioners, so that states could then go back and institute appropriate regulations in their jurisdiction?
DR. GORDON: I am not satisfied with that as an opening statement about access and delivery at all. I think it has to be a statement about why people should have access, a general sense of what kinds of access American people should have to CAM therapies.
DR. FINS: You are getting us off point, Jim, but what is your kind of access that you are proposing?
DR. GORDON: I will give you two recommendations. One would be, "The Commission recommends that all health care settings and providers offer their patients access to CAM procedures and products for which there is evidence of safety and efficacy," and "access to" doesn't necessarily mean they have to provide it themselves. Let me just add that.
The second would be, "The Commission recommends that all health care settings and providers offer their patients guidance in making choices regarding the use of CAM as well as appropriate referrals to qualified CAM practitioners."
DR. FINS: Let's take the first one first. Not every hospital has a burn unit. Not every hospital has a psychiatry service. You are saying that all hospitals or facilities should provide all services to all people. And then we have the question of a lot of people don't have insurance so they are not in those systems. So, I mean you are talking about a universal entitlement to CAM modalities when we don't have universal access, and it also says that things are safe and effective. Well, a beta blocker is safe and effective but we don't pay for that.
DR. GORDON: This has nothing to do with payment. Let me just deal with --
DR. FINS: -- provide access without paying for it.
DR. GORDON: What I am saying is if a patient comes to see me I would give that patient access to the burn unit or the department of psychiatry or a CAM provider. That is a responsibility that I have as a physician. I am not necessarily providing the burn unit, but I am providing access to that unit.
I am not saying the wording is perfect. What I am trying to get at is, we have to have some fundamental statements both in the text and in the recommendations that we believe that people should have access to CAM services and providers.
That is part of our principles, that there should be access. I am not saying it has to be paid for, although that would be nice, but to give people access is something that seems to be very much within the domain of our principles.
DR. FINS: It seems to me that institutions do not refer patients to other practitioners. It is individual practitioners who refer. So it seems to be an educational request and not a institutional request.
DR. GORDON: Let me read again. And again, what I am trying to get at is based on the basic principles some ideas about access and delivery which I don't see in the recommendations. I see a lot of focus on regulation, licensure, ways to accommodate that and to approach it. I don't see anything addressing access and delivery.
So these would be two and they sort of go together. "The Commission recommends that all health care settings and providers offer their patients access to CAM procedures and products for which there is evidence of safety and efficacy."
The second is, "The Commission recommends that all health care settings and providers offer their patients guidance in making choices regarding the use of CAM as well as appropriate referrals to qualified CAM practitioners."
For example, in the area of 85 percent of all cancer patients, according to an M.D. Anderson study, want referrals, want information. They want to have access to these providers and their services. This is the reason we are here as a Commission, and to ignore in our recommendation something as basic as, this seems misguided.
DR. LOW DOG: Conceptually I would agree. I'm not sure what it means when you say, "offer their patients access to CAM." I don't know what that means, is all. Is it a referral? That would be a provider actually making the referral.
"That have been shown to be safe and effective." I just don't know what "access" means, because if I am out in the middle of the Navajo Reservation, I may want to refer you some place, but how am I supposed to provide your access to that?
DR. GORDON: I am certainly open to amendments to that to make it clearer.
MR. CHAPPELL: I have the same sentiment, that we have got to be more direct about what we mean by "access." I think the recommendations put us more in the position of interdependency upon other bodies that are going to have the ability to license or regulate.
So I think that has all been thought through very well, and I welcome the opportunity to go through the recommendations, but it is a paradox that we are talking about access and yet we are not offering access, and I think that is what Jim is trying to say, is, what does the consumer mean when they say, how do I get this.
So we need some recommendations that say, here is how you get this because, let's say I go to a doctor for a specific problem, a conventional doctor, and in my mind I know there may be a CAM alternative but it would be very helpful to me if that doctor said, well, here are your options.
Jim's second recommendation gets to that point. I think "access" implies help the public understand how they can get it, and I think we need recommendations that begin to enable that.
MS. LARSON: Charlotte, do you have a specific recommendation? We have two specific recommendations right now on the table that -- and you had one, too -- three that are in addition, or are changes to the No. 1 recommendation. Do you have one, Charlotte?
SISTER KERR: No, but as far as from what Tom is saying -- and I am going to ask the group to help me with this because it is almost as if I'm feeling there is a fundamental issue involved with CAM, and access and delivery that I don't know if we ever get to.
It's like what Tom just said, people want to know how to get access, and that is sort of how we are talking. One of our principles is an emphasis on health promotion and self-care. That is a big deal in CAM. Then we often collapse into CAM as modalities.
Well, what are we going to deliver? Acupuncture, homeopathy, chiropractic.
Now, this comes to recommendations. If we believe one of our principles is self-care and health promotion, what do we then say, under Access and Delivery, that allows a person access to that? What is it that is offered in the culture and the community to help promote that principle that we feel is inherent to CAM.
Of course, I probably think a lot of things, but one that certainly comes forward is certainly how I feel about the relationship of CAM to public health, but I wonder, as we go into this, if we are not going to need to think about how to speak to that better. Otherwise, we are into delivering a modality and it is not complete enough. I would like to ask for feedback on what I am saying.
DR. LOW DOG: Well, it comes back almost to some of the systems recommendations that you have to make when you talk about access. It is not just that people don't want to exercise, but sometimes it is not safe for them in their neighborhoods to go out to exercise. I mean, sometimes it is systems when you are talking about access and encouraging communities to become involved in providing safe places for people to engage in physical fitness and activities. So there are all kinds of things there that you could make recommendations on.
I just wanted to get back to defining access. I think that I agree, I think the recommendations need to be more direct about how we are going to address issues of access and I think the regulatory aspect is important. I think what I am hearing is that maybe that is not just what we open with, that it is important and interrelated, but maybe that is not our opening statement, and that maybe some of the recommendations for access can be very concrete. They can be very concrete recommendations about how we would do that.
I think one of the other fundamental issues that I just need to raise is that the question also becomes access to what, and I think you want to include safe and effective throughout there, because having access could be to anything. I think it needs to be for things that are effective, which is what Jim, I believe, included in your recommendation.
DR. FINS: I want to make a couple points. One is the referral is practitioner-based. I completely agree that if someone comes into an allopathic setting and encounters a practitioner, there should be appropriate referral, and that is predicated upon that practitioner being educated to know what is out there and make the appropriate referral. Institutions do not make referrals.
DR. GORDON: Not true, Jim. You go to a hospital, you go to an ER any time, they refer you to a clinic or to a practitioner.
DR. FINS: Who?
DR. GORDON: The institution in effect. It is a practitioner hired by the institution.
DR. FINS: A practitioner, right, but it is a practitioner-based referral.
DR. GORDON: It is a practitioner who is being paid by the institution, so the institution is legally responsible as well as the practitioner. I think it is a distinction without a difference.
DR. FINS: Well, it's both, it's both. All right?
MS. LARSON: We have an insistence.
DR. FINS: The other point that gets to Tieraona's last comment about paying for things that work, and this is where I think there is a tremendous amount of overlap to Coverage and Reimbursement. In that section the Commission recommends mechanisms on medical effectiveness and things that should be covered. You do not need to provide people with access to things that do not work, and there is a whole discussion in the Coverage and Reimbursement Section about how do you determine efficacy and then determine what gets covered. I think there is an overlap there.
DR. GORDON: Yes, I agree there is an overlap. I'm not talking about access to things that don't work, but we do offer access to things which sometimes are not covered.
MS. LARSON: Can I?
DR. GORDON: Sure. Please.
MS. LARSON: This is a very important discussion to have and we have had three very rich statements made. We do have on the table three recommendations, and this is a procedure or process. I really would like to have other commissioners actually make some comments on the specific recommendations that we have been given, and also on the body.
If you want us to say something as a Commission within the text, Charlotte, about access and delivery as you understand it, or how we can enfold the principles, we do need your assistance with language. I would like to get back, though, to the specific recommendations.
DR. GORDON: Can I reword and put the two recommendations in one? Would that address some of the issues that Tieraona has raised?
MS. LARSON: We have four.
DR. FINS: Generally, we have done one recommendation at a time, now we have got four. So it might be helpful to just focus on one at a time.
So, Jim, why don't you go first and we will continue.
DR. GORDON: Putting the two recommendations that I made in one: "The Commission recommends that all health care settings and providers offer their patients CAM procedures and products for which there is evidence of safety and efficacy and/or appropriate referrals to qualified practitioners, as well as guidance in making choices regarding the use of CAM."
So I am trying to say three things in one sentence, that you either offer the procedures -- "products," I don't think, has to be in there -- for which there is evidence of safety and efficacy, or you provide a referral, and you provide guidance to people coming into your practice or your setting to help them make decisions about CAM therapies.
DR. FINS: I would say that, "practitioners working in allopathic settings should refer patients for CAM interventions that are proven safe and effective when indicated."
The problem is that it implies an expectation on institutions that do not provide this service to provide this service. I think that one of the questions that we are dealing with here is that generally people who have gotten CAM services have not entered the CAM trajectory through the allopathic system, and when they enter the allopathic system, you are saying that there should be sensitivity in the allopathic system to the possibilities that exist in the CAM.
DR. GORDON: I am saying that all systems, allopathic and CAM, should provide that.
DR. FINS: But if somebody is in a CAM system, they are getting CAM therapy, and hopefully they would get CAM referrals, although they may not. If you saw a chiropractor, you may not get referred to a naturopath.
MS. LARSON: I think that, while I agree that in an ideal world when all the education has been put in place and all the research has been done, and we have done all of that and the continuing education is there, right now I could promise you that most, even well-intentioned, providers would not be able to do that because they don't know what is safe and effective, they don't know when they should refer to it. It is idealistic and something to move towards but --
DR. GORDON: That is exactly what I would like to do, head towards it.
DR. LOW DOG: I think it is different to say that you recommend it, versus that there is a direction that you want to go in.
DR. FINS: "We don't know how to do that" is a response. What we suggested in the later part of this chapter -- and again, we were doing it from micro to more macro concerns -- we were looking at integrated delivery systems.
DR. GORDON: Let me step back from this and say, if there is this much agreement, then if we bring this back to the committee, we can talk about it more, because I don't want to take up so much time on it here. I feel it is extremely important.
DR. FINS: I don't think there is disagreement, Jim. I think what we were saying is that we think, as a general principle, people should be referred to what is safe and effective, and I think we all agree with that.
What we said later on, is that we should have demonstration projects -- let me finish my response to your two recommendations, which were not on the agenda, and we were tracking here in a different sequence -- is that we were talking about access and delivery in an integrated delivery system.
There is a way of establishing that. Those practitioners that are working in an emergency room, as well intentioned as they might be, have no idea what is out there. They don't know what the resources are in the community. They are not well educated.
So we are saying, let's find the integrated delivery systems like what we saw in Washington State, and try to have RFPs so that other places can replicate that. We can learn from that experience and then actually concretize what you hope for. You and I have the same, I think, hope, but my point is that by saying it, it isn't so.
We are trying to set up demonstration projects so we can get along that trajectory and actually provide improved access and more integrated health care.
MS. LARSON: Joseph?
MR. PIZZORNO: This is a rich conversation, and I like the intent that Jim states, and Tieraona, I think, is right on, that this is something we can't do now, but I am also thinking about the issues we addressed on the Education Committee, and it is actually bi-directional. Just as we are saying we would like conventional practitioners to refer to CAM when appropriate, we also want CAM practitioners to refer to convention when appropriate.
So I am wondering if there is some language we can ask the committee to come up with that makes that kind of statement, and say, that is the ideal. It is going to take time to get there, but that is the ideal for best appropriate access to the most appropriate care.
MS. CHANG: In response to that, let me suggest, in lieu of what Jim has proposed, that this recommendation could maybe address all of it: "The Commission recommends that access to affordable, safe, and effective CAM services be better facilitated for all Americans."
Then after that, we can go into, both in the text and in operational recommendations, how we would do that. Does that work?
That is, by the way, one of the overreaching recommendations that the staff put together for your consideration in the document you got yesterday.
MS. LARSON: Do you have specific comments, Tom, on that one?
MS. LARSON: Does everybody have a copy of that document?
MS. LARSON: Yes. Michele is going to read Joe Pizzorno's new recommendation.
MS. CHANG: So, having started our first recommendation off with that more overreaching one, it would follow that: "In order for the public to have safe and effective access to qualified CAM practitioners, the Commission recommends that such practitioners be regulated, using a standardized and understandable framework that includes licensure and registration, and is accountable to the public."
DR. GORDON: That is not instead of No. 52, that is additional. Is that right?
MR. PIZZORNO: Let me add, I would actually merge 52 through 57 into one recommendation, and in the text. So I would start with that, and then merge these two together.
DR. GORDON: But, Joe, can we use the numbers in the book?
MR. PIZZORNO: Nos. 1 through 6.
MS. CHANG: What gets complicated here is that what you are all suggesting are really more overarching recommendations, and the ones that we have put into the text are more, if you will, action items or operational, so we still have to go through them.
DR. FINS: I think that what Joe wrote was good, and now if we can take the model of our specific recommendations as action items -- and I think this is really kind of an implicit endorsement of what Steve and the staff did, as far as putting in the overreaching comments, because a lot of this is cross-cutting.
So, can we hear that again, as an overreaching? And then these will be action items or sub-recommendations, or whatever.
MS. CHANG: "In order for the public to have safe and effective access to qualified CAM practitioners, the Commission recommends that such practitioners be regulated, using a standardized and understandable framework that includes licensure and registration, and is accountable to the public."
DR. GORDON: I thought you had four items, mandatory license, or title licensure --
MS. CHANG: Well, the two kinds of licensure, and then there is the registration, and then there is exemption.
DR. GORDON: Maybe those could be put in. I would feel more comfortable that way, as it was in the original recommendation.
DR. WARREN: When you start talking about the four levels of regulation by the state, start with the least, because I think licensure is the most extreme. I really don't prefer licensure for CAM practitioners, but it seems to be an insurance pay thing.
DR. FINS: Does anybody feel uncomfortable with the way it is written, in the sense that it sounds like it is being federalized? Because we really don't want to communicate that.
DR. GORDON: Let's read it again, because it is so important.
MS. CHANG: "In order for the public to have safe and effective access to qualified CAM practitioners, the Commission recommends that such practitioners be regulated, using a standardized and understandable framework that includes registration, the two types of licensure, and is accountable to the public."
DR. WARREN: How does it impact mom and pop?
DR. FINS: This is the level of micro-management. We saw a little bit of this with the DSHEA discussion. What we are saying, as the way to actualize this aspiration of the Commission, is that this national body would help to flesh out the benefits and burdens of various degrees of regulation. They would answer that question.
We are simply saying that we are in favor of some kind of regulation, but it is going to be determined on a case-by-case and state-by-state basis about, where do you draw the line and who gets put in which category. Some folks might be exempt, others may be fully licensed.
The simple point is, do we agree on regulation, not to say specifically who gets regulated how.
Okay, so that is accepted. Any dissent?
DR. FINS: All right, so let's move on to the first specific recommendation, which now, is put in the context as a way of achieving that.
MR. PIZZORNO: So this is No. 1. That's what I just said. Now we are going to talk about each of these as ways of doing it?
DR. FINS: Right.
MR. PIZZORNO: Okay, so as we go through, we can read them all, but I think that they could all be merged into one, which just says we are going to create this body and it is going to do X, Y, and Z, and just do it as one recommendation.
DR. FINS: Let's say that, "The Commission recommends that after a period of time" -- you think six months is enough time? Yes, okay. I agree with that here. "The Commission recommends," full name of the Commission, "that the Secretary," blah-blah-blah, "establish a national policy advisory board, which will" -- it is really Recommendation No. 2 -- "develop and publish" -- develop, not necessarily publish, because it seems too high on -- "develop a consensus on national standards for the practice of CAM that these standards will establish, and that the states could then use to effect local regulations," or something like that. I mean, it is not wordsmithed.
DR. GORDON: I really want to air some of the questions. Let's look at naturopathic medicine. If there are people who are practicing who are licensed naturopathic physicians who graduated from schools, that is one area. Then there are people who are just kind of giving out advice about baths or about diet in a kind of informal way for which they may or may not be paid.
I think standards are appropriate in certain instances. I am not sure they are appropriate everywhere and this comes back to the issue that you raised originally, how do we preserve the emergence of new professions, popular healing within this once we talk about minimum educational, ethical, and practice guidelines? So I am concerned about it and I don't know that we are leaving enough latitude when we do that.
DR. FINS: First of all, we are setting up a mechanism to answer precisely those kinds of questions, so I think that this body would have a focus group on naturopathy, since you used that example, the full range of people who graduated and maybe did a residency all the way to the other side of the spectrum of somebody who did a home study course in naturopathy.
They would hopefully develop a consensus on the recommendations, with the assistance of this body, that would publish some expectations, and then every state would still have the prerogative of setting the standard. We are not going to set the standard. We can't set the standard. We are a federal agency and we are not the states.
DR. GORDON: Can I read you an alternative version, just to give you another perspective on it? I am sort of taking one step back from where you have gotten to.
I would say: "The Commission recommends that the Secretary of HHS together with the Central Federal CAM Office convene a national policy advisory board," paren, "including representation of the public and state and local governments as well as CAM and conventional health professionals," close paren, "to address issues related to the licensing and certification of CAM professions, including whether or not national guidelines for CAM licenses," and that is vague, "are appropriate, and if so, in which circumstances."
DR. FINS: Tieraona?
DR. LOW DOG: I liked it until you got to the very end. I liked "all convening" and all of that.
I am just going to go out and not be politically correct at this moment. When I go get my nails done they have to have a license to cut my fingernails and it is a group where I go of all Vietnamese men and women and they have all gone through and they got their license so that they know how to clean the scissors and clean the manicures and there are potential blood products.
When I take my kids to the barber shop, some states require if you shampoo the hair sometimes you have to be licensed to actually shampoo somebody's hair, but certainly if you are cutting somebody's hair you have to have training and licensure.
I think that we sometimes pussyfoot around a little bit around the reality that we are making often recommendations about how you should eat, what herbs you should take, what dietary supplements you should have, if you should quit taking your drugs and medication. There is a lot of this going on and I think that minimal requirements are what addresses the public safety.
I don't think that means licensure for everything. I think that minimal standards are essential and are important and I think that the Commission needs to have that statement. And I don't think it says licensure, I just think that minimum requirements are essential.
If I have a plumber come to my home, I am assured that he is licensed. So why is health care somehow different?
DR. GORDON: I mean I would like to hear discussion, and if that is the case, if everyone is at that place, that is okay. I can live with it. I am just raising the issue.
DR. FINS: Effie?
DR. CHOW: Hi. I like what Jim said to the end statement. I like it to the end statement because he is saying for the group to decide what needs to be regulated and what doesn't. I go back to the self-care, self-help, and other people helping other people, how is that humongous group going to be taken into that, and really suppressing the most important aspect of CAM.
I am for regulation, but when it is carried to extreme and you say everybody has to have minimal regulations, there is a big problem there.
DR. TIAN: Yes. Regarding Recommendation No. 2, I don't like this word "minimum," because you mention that minimum educational, ethical, and practice. This is something wrong, because you put CAM practitioners third-class. I am talking about this page. Have you got my point?
So if it is ethical, it has to do to both, either conventional practitioner or CAM practitioner, same standard. Educational, you don't have to mention this word. Just educational or ethical, because we can't have a double standard.
DR. FINS: See, we have a conflict on the table. We have Ming arguing for excellence, the highest standards, then we have a more laissez-faire argument saying we don't want to regulate people.
DR. GORDON: No, I am not saying that. I am not saying we don't want to regulate. I am saying that we don't know, based on our deliberations, who we want to regulate and who we don't.
DR. FINS: Let me make it very clear. We are not going to decide that here. We agree as a body here on the overreaching principle that we were in favor of regulation.
The next action item here was whether or not this central body in CAM Central should play a role in facilitating this discussion, which is immensely complicated. It is going to be situational to each individual professional, and context, and what they are doing. It is a tremendous amount of effort, which was beyond the scope of our charge.
All we are saying is, should we recommend that this body exist to have these discussions.
MR. PIZZORNO: This conversation is disturbing in a lot of ways. We all agree we need to have regulation. I think we also all agree that we want to have regulation that is appropriate. There are some groups that don't need regulation, there are other groups that do need regulation.
Clearly, in areas where we have greater potential risk to the public and where we have practitioners who are trained at a high level we must have licensure because otherwise the public does not have access to them. That access is not public because of lack of legal authority, and also, there is not access because of things like insurance coverage.
Why are we having problems with it? It's pretty obvious.
So I stick with my statement the way it was, and now I would like to hear some modifications from Jim that may be appropriate but we need to be supportive of licensure where it is appropriate and registration where it is appropriate and if laissez-faire is appropriate some places, that's fine, too.
We have heard a lot of testimony here, and the testimony is pretty clear. If you have licensure, you have more safety.
DR. FINS: Maybe it is simply enough to say we are in favor of regulation and not micro manage how it gets actualized. I mean, do we not have this central body address it? I think it is kind of a logical place. It may end up happening there but maybe we don't have to go that far. Any thoughts on that?
DR. LOW DOG: Jim, could you just reread your recommendation? Because I liked it until the very end.
DR. GORDON: Okay, I will read it, but let me just say, Joe, that I would agree with you in some areas, and not in others. For example, the issue of national standards. We heard a lot of conflicting testimony. Some people said yes, many people said no as well. So that is not as clear.
MR. PIZZORNO: The established professions were consistent about national standards.
DR. GORDON: I'm sorry, what?
MR. PIZZORNO: The established professions were consistent about the importance of national standards.
DR. GORDON: No, they weren't.
MR. PIZZORNO: Yes, they were.
DR. GORDON: Acupuncture, Chinese medicine was not, for example.
MR. PIZZORNO: I didn't hear that from them.
DR. GORDON: Yes. Those were the folks who wouldn't go out to dinner with Joe.
MR. PIZZORNO: Well, that was a disagreement.
DR. GORDON: Acupuncturists.
MR. PIZZORNO: That was a disagreement between M.D.s who were doing acupuncture and the acupuncturists, okay.
DR. GORDON: I understand. I am just saying, it is not as consistent across the board.
Let me read the recommendation. I don't know that we are that far apart, either. Joe and I talked about this earlier. I feel we have got to grapple with these things, and once we are clear where we are, then the recommendations will follow.
I will read mine again. It is: "The Commissions recommends that the Secretary of HHS, together with the Central Federal CAM Office, convene a national policy advisory board," paren, "including representation of the public and state and local governments as well as CAM and conventional health professionals," close paren, "to address issues related to the licensing and certification of CAM professions, including whether or not national guidelines for CAM licensure are appropriate, and if so, in which circumstances."
MR. PIZZORNO: I don't like it. Sorry.
MS. LARSON: I think it is very, very important that we are very strong in saying, yes, we recognize that groups have such standards, and your wording at the end actually makes it a little bit mushy to me.
DR. LOW DOG: I liked it where you got to "licensure and regulation," or whatever. Even Minnesota, which is a more loose model, is still regulated. They just went about their own way of doing it, but it is still regulated because they saw the attempt for regulation, or that there was a necessary step.
So I would support your recommendation, but not the end part. I would leave it at "licensure and certification," or whatever, that you put.
DR. GORDON: What I was saying was not referring to regulation. I was getting back to your recommendation, but, I think, trying to make it clearer that we are not talking about licensing in every situation, "whether or not national guidelines for CAM licensure are appropriate, and if so, in which circumstances."
DR. FINS: Yes, but in our framework that we laid out initially, registration is maybe the minimum. There is also exemption.
MR. PIZZORNO: Actually, let's do both. Let's do mine first, and do yours second.
DR. FINS: That is the overreaching, which we agreed to, okay.
MR. PIZZORNO: But mine says we believe regulation is a good idea.
DR. FINS: Right.
MR. PIZZORNO: Okay, and then Jim's is saying about how to go about doing this national standard.
DR. FINS: If you use the word "modify" where you had your licensure and regulation, or whatever, maybe "the degree of" or "the appropriate level of" versus dictating. The point here is that this body is going to help draw the lines, and we don't know where the lines are.
I would agree there probably are some times when there is no need for anything, and there are other times where there is going to be a compelling need for licensure.
DR. GORDON: But we are in agreement.
DR. CHOW: That is what Jim's thing is saying, whether it is needed or not, and you are just confirming.
DR. FINS: We agree, but the way this reads, it sounds like it is less necessary than it is.
I think we have agreement. Why don't you read it, and maybe you can say the --
DR. GORDON: Okay, let me read it again: "The Commission recommends that the Secretary of HHS together with the Central Federal CAM Office convene a national policy advisory board," paren, "including representation of the public and state and local governments as well as CAM and conventional health professionals," close paren, "to address issues related to the licensing and certification of CAM professions, including whether or not" -- this is just something I wrote. It is certainly not complete -- "including whether or not national guidelines for CAM licenses are appropriate, and if so, in which circumstances."
DR. FINS: Two issues. Let's take the first part. You say "licensure," and we simply said, "as indicated by scope of practice," or something like that.
MR. PIZZORNO: Again, I want to suggest doing my recommendation first, and doing Jim's second. I also support Jim's without the last sentence.
DR. GORDON: Again, Joe and I talked about some of this earlier. We are down the road when we talk about developing uniform scopes of practice. That is down the road from where I think the advisory board needs to start out. We may need uniform scopes of practice, we may not. I don't think we should make that decision at this point. That is my issue.
DR. FINS: Suppose we use language of "determining the indication for and feasibility of"?
DR. GORDON: I think we need to state the problems and I think it needs to remain an open question as to the degree. We know regulation is necessary. What is the degree? It is going to be different in different circumstances.
We heard a lot testimony, Reiki people, other people. They don't want those regulations. I think we need to respect some of these emerging practices, which don't have high risk for danger where people are providing services, some of the self-help groups that feel they should not be included here.
I think we need to make it clear that we are not rushing in to create a national standard for everybody and to regulate them. That is the feeling, tone, and there are some specifics in the recommendations, a couple of which I pointed out, that bring that across. So that is what I am looking for.
DR. FINS: Michele?
MS. CHANG: The first is, "In order for the public to have safe and effective access to qualified CAM practitioners, the Commission recommends that such practitioners be regulated, using a standardized and understandable framework that includes registration, title licensing, mandatory licensing, and is accountable to the public."
DR. GORDON: You also had an exemption in there, too.
MS. CHANG: "Exemption and is accountable to the public," followed by: "The Commission recommends that the Secretary of HHS together with the Central Federal CAM Office convene a national policy advisory board," paren, "including representation of the public and state and local governments, as well as CAM and conventional health professionals," close paren, "to address issues related to the licensing and certification of CAM professions, including whether or not national guidelines for CAM licenses are appropriate, and if so, in which circumstances."
DR. FINS: How about something like the language of "whether there is a role for"? How is that? I mean, "whether there is a role for," which doesn't say that it is necessary or not necessary, but whether or not there should be a role, whether there is a role for national standards. Does that work?
MS. CHANG: So then it would be, "to address issues related to the licensing and certification of CAM professions" --
DR. FINS: "And whether or not there is a role for national standards."
MS. CHANG: "A role for national guidelines for CAM licenses."
DR. FINS: "Practitioners." Not licenses but CAM practitioners.
MR. CHAPPELL: I remember months ago we were also in this context speaking about transferring the learnings from those professions that had done a good job on self-regulation and self-development to those professional groups that were not as far along in their evolution.
So I mean we as a national group or national office could facilitate that kind of transfer of knowledge and learning and that that is different from trying to, certainly, adopt national standards. So I want to be sure we are not reaching out here beyond what we didn't want to do months ago in this regard and there is a facilitative training role that a national body could play here rather than an authoritative one.
DR. FINS: Tom, I think that is a great suggestion and certainly the intention, I think, that this body would provide technical assistance in a clearinghouse function and maybe that would follow as the next recommendation.
MS. CHANG: Could I just suggest, because we had said that what we might want to do since we have this overarching recommendation but do another overarching recommendation about establishing a national advisory policy board to do X, Y, and Z.
So if we could go ahead with the overarching recommendation, and then say we want to establish a national policy advisory board to provide technical assistance and develop policy guidelines on issues related to the access and delivery of CAM, including, Point 1, "issues related to licensing and certification of CAM professionals, including whether there is a role for national guidelines for CAM practitioners"; Point 2, we haven't gotten there yet.
What we would do is technical assistance action items, as well as policy ones like the one we just said.
DR. FINS: Point 2 would be, "facilitate exchange between the emerging professions to optimize the evolution of their development."
DR. GORDON: I want to come back to Joe's point, too. I think where there is a strong feeling the professions want licensure, we should support that. I feel that that needs to be stated as well, and I think this is very much of a pluralistic approach, so we are in agreement. I just want to leave the field open, and also make it possible for these professions that have matured to come into their own.
DR. FINS: Then maybe the next bullet item on that list that Tom has started us on is something about, "provide advice and guidance" -- but again, I don't want to be too strong -- "to states, as they develop their own standards for regulation and oversight of CAM practitioners and conventional providers," providing CAM services, in other words.
DR. GORDON: That is one piece. The other is helping the professions, which comes back to what Tom was saying, helping the professions to define themselves.
DR. FINS: We could have spent the last two years talking about the regulation of naturopathy and spent just as much time on that one single item.
As I envision this Central Office, is that they could have subcommittees working on various professions as they are emerging, and hopefully there would be cross-pollination and they would be able to talk with each other. Professions that were two steps ahead could share their insights and their evolution.
So I think we are all getting on the same page here. We have lost half of the group. These guys have defected to the next commission.
MS. LARSON: Joe, can I ask you a question? You wanted to collapse them into one. Would it be sufficient to cover the overarching recommendation and have those others as action items?
MR. PIZZORNO: Well, I think the second recommendation that was Jim's language, I think we could collapse. Nos. 1, 2, 3, 4, 5, and 6, could all be collapsed under that one, yes, as action items under that one.
MS. LARSON: Do we have consensus on what was just put forth by Joe Pizzorno, this is sent back to us with the purpose of condensing Recommendations 1 through 6 into specific action items under an overarching recommendation?
DR. GORDON: Yes, as long as they conform in spirit and content to those overarching recommendations.
MS. LARSON: Nos. 1 through 6.
MS. LARSON: Consensus. We will get back to you.
DR. FINS: Now, we have a 7 and a 7(a), which, 7, basically, now is directed to the states. We are encouraging them to work closely with this advisory body, so we are going to offer them services in the previous cluster of recommendations, and now we are asking them to work closely with HHS's advisory body through the Central Office to develop standard operational guidelines for the regulation oversight of licensed physicians practicing CAM.
Now, I think we should probably stop it there and leave, "which are based on national uniform scopes of practice," because we decided that was overreaching. We never really meant to say that.
MS. CHANG: Yes. I just want to give a background point on this. If you read the text, which I am sure you did, the Federation of State and Medical Boards will be putting out draft recommendations. Gerri talked about that, or you all talked about it, in Research. The difficulty that we saw is that they are somewhat broad, they don't provide some operational guidance to states that would really take them to the next step.
So what is being suggested here is that this national board, or whatever, take that next step to help to work with FSMB and state regulatory boards to make it a little clearer to states and more helpful to practitioners how to go about accomplishing the spirit of the draft guidelines of the FSMB which, by the way, have not yet been promulgated.
DR. FINS: I think it is important to just point out that we are really trying to provide a parody structure through this national office that the FSMB has for allopathic practice.
In other words, each state has its own medical board but then they come together and in a way form national policy through a national standard. What we are saying here is this body will try to do the same thing on the CAM side and have a national collaboration and also with each individual state.
DR. JONAS: Yes, I want to suggest that in terms of prioritizing which groups this board would work with, I think it would be better to work with the state legislators first and then the state medical boards second, because state medical boards generally have a fairly narrow scope around medical practice. This is obviously broader than that, and that is under the jurisdiction of the state legislative branches.
MS. LARSON: So, would you put in state legislatures?
DR. JONAS: Yes. I would put state legislators first, actually.
DR. GORDON: Okay, great. Effie?
DR. CHOW: It is the view of the medical acupuncturists and the traditional acupuncturists that we should prevent something like that happening in all the other fields of practice, and that consultation with respective professional CAM practices should be included in making recommendations as to the adequacy of training for the medical physician to practice CAM. I think that is really essential.
DR. FINS: I think this is where the cross-cutting recommendations are going to play out because some of that will be in the education, and some of it is in the constitution of these boards. So I think you are absolutely right.
DR. GORDON: I have two comments. One is, I don't think we should get to that level of specificity there, and number two, I think it is important that this apply not just to medical boards but to the boards of conventional practitioners generally, because, remember, we heard from the nurses about their concerns about these very same issues.
DR. FINS: Can we, Michele, just broaden it to other allopathic practitioners?
DR. GORDON: The issue that you mentioned is one of the hottest of all issues -- and I don't think we should try to push it -- not just with acupuncture but with chiropractors and massage therapists, and all different kinds of groups. I think we really need to not make any premature foreclosures here.
DR. CHOW: Oh, no. I am just speaking in-house here. That is not to be put into the recommendation.
DR. GORDON: Okay.
DR. CHOW: It is just so that we know that problems have arisen already.
DR. FINS: All right. I have reached closure on 7, and want to go now to 7(a), which is related. I don't think we will have trouble with it because we agreed to this yesterday. It's a new one and I don't think --
MS. LARSON: It's on your sheet.
DR. FINS: I don't think they have it on that. Do they have that?
MS. LARSON: "Insert new recommendation."
DR. FINS: Oh.
MS. LARSON: Here it is.
DR. FINS: Okay, good. I didn't have it.
So it is, basically: "The Commission recommends that CAM practitioners, or conventional practitioners who use CAM products" -- I can't read my own writing here. "The Commission recommends that CAM and conventional practitioners who use CAM services and interventions in IRB-approved research not be sanctioned by state regulatory boards solely for the use of such approaches."
We agreed to it, but this is written from the other side, that the board should not sanction the practitioner if he has had IRB approval. Before it was the other way around. It is the mirror image.
So, all in favor? We all agree?
DR. FINS: Okay. We are now moving up the food chain a little bit from the practitioner question to, more, organizations of care.
Recommendation No. 8. We are hopefully going to meet or have some more discussions with the joint commission, but if you give us your proxy, as it were, we will work on this.
The idea here is: "The Commission recommends that nationally recognized accrediting bodies assume leadership roles to review the most commonly used and evidence-based CAM modalities in their health care organizations, especially those with particular relevance to a coordinated care approach with respect to establishing accreditation standards."
In my view, this speaks directly to Jim's initial plea. It is a way of operationalizing what he said for integration, and what we are trying to do here is get the hospitals and the joint commission to think about what kind of expectations will they require of their member bodies.
Again, joint commission accreditation is often a proxy for state certification of the health care institution. So if we can get the joint commission to say there should be educational materials as part of patient/family education, which is a requirement on CAM, if there should be a relationship to CAM services in the community, et cetera, that is a way to help operationalize Jim's, I think, well-argued plea at the beginning to provide more access.
DR. GORDON: Just a question here. Are we talking about credentialing practitioners, or accrediting institutions?
DR. FINS: Institutions. Really, institutions that currently fall under the purview of the joint commission. Any of you who have gone through our joint commission accreditation survey know that everything from soup to nuts gets addressed, and policies get rewritten.
To effectuate change in complex health care settings is through this really comprehensive approach the joint commission has.
DR. GORDON: So when you say "nationally recognized accrediting bodies," you are speaking of JACO and others?
DR. FINS: Among others.
DR. GORDON: Okay, but you are not speaking of the massage therapists, you are speaking about bodies that are credentialing institutions. I just think that may need to be clearer in the recommendation.
DR. FINS: It is in the text. We are talking about facilities. We can tweak that, but just so it jives with the text.
MR. PIZZORNO: I don't get it. I don't see why we are doing No. 8, so would you try again? I heard you talk, but I don't see any reason for No. 8.
DR. FINS: Do you spend any time in allopathic hospitals? I mean, administratively in any way, community hospitals?
MR. PIZZORNO: No.
DR. FINS: I do, and for example, a few years ago they said pain has to be the fifth vital sign, and every hospital has to ask patients on a scale whether they are in pain or not. Well, now every hospital in America has an analog visual scale, and when you get your blood pressure taken, the nurse or the practitioner is supposed to ask you whether or not you are in pain. It has revolutionized pain assessment.
Is it everything that needs to be done? No. Is it a step in the right direction? Absolutely.
So these guys, they have a book full of standards, on how the refrigerators work all the way to how ethics committees or ethics processes should be developed. They have a section on patient/family education, for example. If they were to include education on CAM as one of their requirements and standards, a hospital would get surveyed every three years by a team of surveyors, they look at everything, and they would say, show me your patient/family education on CAM or referrals.
And so, what we want them to do is to develop an incremental approach with the spirit of this commission informing that through those discussions that are yet to be had, and other bodies to do that.
Trust me on this one, Joe.
DR. GORDON: Joe, I think the thing here is, that from my point of view -- I'm sorry, do you want to say something?
MR. PIZZORNO: Actually, I better understand, and so I would then make a modification to it. At the end of the second line where it says, "evidence-based CAM modalities," I would probably put in there, "practitioners and therapies." Look at St. John's wort. It is also who is in the community.
DR. GORDON: The addition I would like in there, Joe, is some of that context, that this is for the purpose of including these in the institution.
DR. FINS: It is in the text, but another example we could flesh out would be how would a hospital formulary integrate supplements into their mix?
DR. GORDON: All I am saying is that we need to understand the direction that this recommendation is moving in.
DR. FINS: Are you all in favor of the spirit and the intent of the recommendation regulation, No. 8?
DR. GORDON: Okay. "The Commission recommends that nationally recognized accredited bodies assume leadership roles to review the most commonly used and evidence-based CAM modalities, practitioners, and therapies, especially those with particular relevance to coordinated care approaches with respect to establishing accreditation standards."
We will tweak. We will tweak, we will get it back to you.
DR. GORDON: Yes. What I want to say is --
DR. FINS: I think we all want the same thing.
DR. GORDON: Right. There are a number of these recommendations for which we know the direction we are headed, but essentially we are sending them back to you all for the tweaking. So I would like those to come back to the group.
DR. FINS: But this is a minor tweak. On all the tweaks we had to do, this one is a minor one.
MS. GUTIERREZ: I would just like to make sure that we clarify in the statement after "accrediting bodies" we insert "for institutions," just to clarify.
DR. FINS: Right, right. Okay.
DR. PAZ: Well, one of the things with the institutions is that they are not always in one particular location. They may have satellites that are part of that institution.
DR. FINS: The joint commission, for example, when they accredit hospitals, and their satellite clinics go out and visit those clinics.
DR. CHOW: You will spell out "nationally recognized conventional accrediting bodies"? That is what we were talking about. There was a question about not a massage therapist. "Conventional accrediting bodies."
DR. FINS: "Conventional," you're right.
DR. CHOW: Then also, again, I would add "with consultation on CAM experts to determine the integration of."
DR. FINS: Yes. It refers to the text. We will just bring it down, but basically establishing accreditation standards in consultation with the usual suspects.
So we are now moving on to coordinated delivery systems. Again, we are moving from this sequence here, from the office-based doc, the practitioner, rather, to the clinic or the hospital, to now more integrated delivery systems.
What we recommended on page 28, rather, is again, to really flesh out the question that Jim raised at the outset. This could be, depending on how we organize this, a subset of that one, basically saying, look, we don't know how to do this all that well, and the bodies that we are talking about should fund and support efforts by the designated Federal Office on CAM to collaborate with private sector studies and demonstration projects that evaluate the usefulness, effectiveness, and cost benefits of collaborative care models at three delivery levels.
The three levels are office-based, freestanding CAM-type clinics like the Steer Clinic or Wellspace, and then into vertically integrated, primarily allopathic delivery systems. So there are three at three levels, okay?
There are things that can be learned from what is going on, say, in studying the Bastyr Outpatient Clinic and the Bastyr Medical School and its relationship to other care systems in the Seattle area, and we need to study that more so we can replicate it, and so it won't require charismatic leadership to happen. Anywhere it could happen, right, Joe?
DR. GORDON: I would like to add that the federal government make available information that is already available about these programs, that that be part of it as well as look at more demonstrations because if that information is available, then while the federal government is doing its own thing other people will be able to cite that information and move it ahead.
DR. FINS: Okay. Good point. Don?
DR. WARREN: I think this recommendation is okay. I think we need to accept it and move on.
DR. FINS: Thank you. Any dissent on that issue?
DR. GORDON: You are adjusting both No. 9 and No. 10? Because there are two recommendations here. We have gone from 9 onto 10, right?
DR. FINS: Oh, I'm sorry. I skipped No. 9. So we did No. 10, okay. So we have just approved No. 10.
No. 9. Okay. Go back to 27, which was on the bottom of the page.
This is basically that there should be more epidemiologic studies of CAM patterns of usage with special attention to ethnic and vulnerable populations. To understand what we are dealing with, again, to make the argument for the access argument, if the numbers are huge the entitlement should be great.
DR. WARREN: I believe we ought to accept this one, also.
DR. FINS: All in favor? Any dissent?
DR. FINS: Okay. Great.
No. 11. Now, these changed. All right. It is on your sheet of paper.
"In recognition of the need to promote more integrative models of care delivery, the Commission recommends demonstration projects using hospices as a model to explore means of integrating safe and effective CAM into an allopathic setting." The rationale, this expands upon No. 10 by using a model with a proven track record that shows where integration does occur primarily in an allopathic setting, and this might illustrate and lead to emerging efforts to develop more efficacious service delivery models that could be used in other settings.
MR. PIZZORNO: Could we add community health clinics? We left them out.
DR. GORDON: Yes.
MR. PIZZORNO: I think they belong right there.
DR. FINS: I think those are two places we have heard testimony from where there was good integration, and I think that is good because one is a preventative outpatient and the other is the beginning of when you are well and the other is when you are not. So I think it is a very nice balance there. That is great. And using that as a focal point to study delivery systems.
So all in favor of that?
DR. GORDON: Let me just think for a second if there is any --
DR. FINS: Oh, I'm sorry.
DR. GORDON: -- if there is another example that will --
DR. FINS: Well, I don't want to dilute the examples too much.
DR. GORDON: I understand.
MR. CHAPPELL: We are actually just trying to get a sense of prioritization of these, which you will get to, I guess, eventually.
DR. FINS: I am told by --
DR. GORDON: Let's just let it go and come up with something. I will get it to you.
DR. FINS: All right. No. 12 here was what we saw before with the indigenous healing traditions, and did we reach closure on that? It got deleted?
DR. GORDON: It got deleted.
DR. FINS: Okay. All right.
DR. GORDON: They got deleted in favor of looking at the recommendation you were proposing.
DR. FINS: Oh, now it is back. Okay.
So, here let me read it to you. "Within three years," -- again the time frame is correct -- "the Central Office should report to the Secretary on the use of indigenous healing traditions in the United States to identify commonly used best practices and challenges and potential areas for collaborative learning between such traditions and conventional care. The Commission urges this report to include recommendations for the future as regards appropriate protection of such traditions as well as research and development of such practices as part of community-based health care. Members from such traditions should be involved closely in this endeavor."
MR. PIZZORNO: We ought to want to add a little comment about education just in terms of recommendations, but include education because you transfer that over from education.
DR. FINS: Do you have a specific place where you want to put that?
MR. PIZZORNO: Yes.
DR. FINS: What line?
MR. PIZZORNO: "To include recommendations for the future as it regards appropriate education, protection of such traditions," just put this stuff --
DR. FINS: Okay. "Regards appropriate education," okay. Good.
DR. CHOW: Is there a description as to what the indigenous healing traditions include? Is it just the Native American or what other?
DR. FINS: Good point. Are we going to have a glossary in the back of the thing? Yes, so whatever word that we don't define in the text will be defined in the back. But it brings up the question, how expansive do we want this definition to be? Any thoughts? Because there are Hispanic traditional healers, there are Native American healers, there are traditional Chinese medicines.
DR. GORDON: I think we need to leave that up to this group. We can't define it right now.
DR. CHOW: It needs to be described.
DR. FINS: I think for the glossary I would be more expansive in this definition.
DR. GORDON: I think there are two things. In the text we can talk about some of the issues, some of the different kinds of traditions that come up, examples.
DR. FINS: Okay.
DR. GORDON: The other thing I think that is important here that we dropped out of the other section has to do with education.
DR. FINS: We added it.
DR. GORDON: Oh, and where did we add it?
DR. FINS: We said, "as regards appropriate education, protection of such traditions."
DR. GORDON: Okay. Fine. Thank you.
DR. FINS: Okay? Accept as written?
DR. GORDON: Yes.
DR. FINS: Okay. Great. All right.
DR. GORDON: I have got to go back to No. 11. I think that the most important models that have taken place, the earliest models were in the private and non-profit sector and the people who have been doing this work for many, many years, and I think we need to learn from those models. Collaborations between conventional physicians and CAM providers have gone on for a long time and so I think hospice and community clinics but we also have to say private and non-profit sectors there, too. Because they are just central to this whole issue.
DR. FINS: Yes, actually, that works beautifully because it tracks with our hierarchy. We have the individual practitioner, right, which would be what you are referring to. The second tier is the community clinic, and the third tier is something that is integrated in the delivery system. So that tracks beautifully.
DR. GORDON: Okay. So we fit in private and non-profit.
DR. FINS: Yes.
DR. GORDON: All right.
DR. FINS: The final recommendation is one that was presented to us, and it is not the product of our working group, but it is one that we were asked to convey.
I will just read it to you: "The federal government, including but not limited to the Department of Agriculture and Health and Human Services, should fund and support efforts by the designated Federal Office on CAM to evaluate the feasibility costs versus benefits and overall impact on allowing food stamp program participants to use food stamps to purchase specified single or multivitamin mineral products that do not exceed the nutritional recommendations of the Food and Nutrition Board of the Institute of Medicine."
DR. GORDON: Can you speak into the machines, please?
DR. LOW DOG: We were talking about safe and effective, and access to them. Don't we have that under Services and Products in one of our earlier recommendations? I mean, here you were specific, but --
DR. FINS: This is specific that people could use food stamps to buy supplements.
DR. GORDON: Joe, do you want to give a background on this?
MR. PIZZORNO: I think Michele will have to give background, because it wasn't the product of our working group.
MS. CHANG: I don't know how much background you want. I think, just to make it really quick and fast, there is at this time the possibility of such a program being put through Congress. It is being considered.
And so, what this recommendation does is put a little bit of a break on that and say, well, before we go ahead and invest in that program, why don't we do some studies, feasibility and impact studies.
The issue at discussion here is not so much whether a feasibility is a good thing to do before you implement a program of this magnitude, but rather, do we conceptually agree that this is a good idea at all.
DR. GORDON: I think this is just something we really need to know more about, because we haven't really discussed it. I'm sorry, go ahead.
DR. FISHER: I'm embarrassed. I was a chairman of a committee that several years ago recommended to the USDA that they allow food stamp participants to utilize food stamps to buy multivitamin mineral preparations. It was particularly based upon a consensus opinion of a bunch of nutrition scientists and others that this was perfectly logical because they should have the freedom to purchase dietary supplements of a multivitamin and mineral nature, not just across the board.
For the reasons which Michele has included on the page after this, USDA turned it down. I won't give you my opinion about what USDA did, but I think you probably could figure that out.
Basically, what has happened now, as Michele has indicated, it has been reintroduced into Congress. Quite frankly, it might strengthen what some people would like to be done if, instead of recommending a study, per se, as is in the guidelines, it might be useful to recommend that USDA change its administrative procedures because that is really the only impediment that stands in the way of giving the choice to food stamp participants.
There are a lot of other nuances in the background here, but really, suggesting that USDA review or reconsider its administrative procedures will probably get more done than calling for another study.
DR. LOW DOG: I think if we are talking about health promotion, wellness and prevention, primary prevention, immunizations is one example, but folate during pregnancy is certainly another, and that if we are talking about access, I don't know how you can support just a plain old multivitamin in food stamps, especially given the population that would benefit from it.
DR. GORDON: That would potentially benefit from it.
DR. LOW DOG: That would potentially benefit from it.
DR. GORDON: So, how would you like to change the wording, Ken or Tieraona, to reflect what Ken has suggested?
DR. FISHER: I think we have got some language, I think Michele has, when it got transferred from one section to the other, I think it has already been reviewed.
DR. FINS: Let me just suggest, since it is new to everybody and we haven't heard any testimony on this, that we get this information and we make it available for February, we come back, we consider it. If there is additional documentation, that we have that discussion.
I think it makes sense in many respects, but it also could be perceived as there are people who are on food stamps and they are going to somehow substitute this because they can't afford their food. I think we just have to be clear about what the intention is.
It sounds like you have got a very valid point, and the issue about pregnancy and folic acid is also critical. So, I think it would be premature.
DR. GORDON: Do you want to wait until February, or do you want to do it sooner than that? I think we need to do it sooner, Joe.
DR. FINS: I think we should do it in 10 days, not right now. Let's get a little more information on the table.
DR. GORDON: Okay.
DR. FINS: All right.
DR. GORDON: We are finished.
DR. GORDON: Veronica?
MS. GUTIERREZ: I would like to go back to the text. I saved this for last, page 11. I am a little uncomfortable on lines 14 through 16, and I would like to suggest, maybe, some other terminology.
It presently reads: "Most licensed CAM practitioners must follow a legal and ethical code to refer the patient to a licensed medical doctor when the patient's clinical condition exceeds the practitioner's scope of competence."
This works both ways, and I would like to suggest that it read: "Licensed practitioners must follow a legal and ethical code to refer the patient to another licensed health care provider when the patient's clinical condition exceeds the practitioner's scope of competence or understanding."
DR. GORDON: Sounds great.
DR. FINS: I think we have agreement to that. Do you have another one?
MS. GUTIERREZ: That's it.
DR. FINS: Okay, great.
DR. GORDON: Great.
DR. FINS: Thank you all.
DR. GORDON: Thank you, too. You did a fabulous job.
Let me just say that in this section we have many recommendations that are either going to be consolidated, significantly tweaked, or tweaked in a minor way. So what we will be looking for is, over the next 10 days, to discuss some of the issues that are still unresolved, and then after the 10 days, another look at the recommendations.
Okay? Everybody with me on that?
DR. GORDON: So we have consensus about general directions. I just want to make this point clear. There are many of these recommendations where we don't have consensus on the exact wording. So we need to see the exact wording in this 10-day period.
DR. JONAS: Jim, I think that maybe even more important than consensus on exact wording is going to be prioritization, and I think we really need to address that not just in this area but in the entire field because you are partly trying to do that with the consolidation of these, but as we saw in this particular session, when you go about doing the consolidation what often emerges is actually a new recommendation or an overarching recommendation which really is new.
And so, I think the prioritization issue is going to hopefully result in the emergence of overarching recommendations that are going to be different than we have in here. So we really need to get to this and have sufficient time to do that fairly soon.
The other thing that is going to come out is, which ones do you want up front? As I look at the list that you have, and I think about what is going to make some impact for the public benefit as opposed to ferreting out different sections for different licensed practitioners, it is No. 10, the demonstration projects in which they look at whole systems -- again, our first principle, holistic approach to care -- and we will actually see, does this help particular populations.
So I would put that on the top of the list as a concrete aspect. This is the kind of thing I think we need to address in all of these areas, but this, I think, is fairly clear here, also.
DR. FINS: I think, Dean, you are also right, and I think that --
DR. FINS: Geez.
DR. JONAS: Well, I said it for him.
DR. FINS: I'm sorry, Wayne. It is that abduction thing.
But what I think is really important, is that the way this thing has evolved, there are certain conceptual sequences. But the way we made sense of it is not how we necessarily have to present it to the public, because micro to macro may be a logical sequence, but it's not necessarily how it's going to be sold.
DR. JONAS: What makes me nervous is that I do not see an opportunity right now -- maybe it's planned in, and it just hasn't been discussed -- when this is going to happen for all these different sections and recommendations.
DR. GORDON: Steve, want to respond?
MR. GROFT: Wayne, you are absolutely correct. We do have to do something like this between now and when the report is even prepared in draft, so we will be working with the groups. Again, the important thing is that everyone has to read what we send out and get back with us in a timely fashion.
DR. GORDON: At the end of today, Steve is going to lead a discussion in the process of prioritization. That is all we can do here, is begin that discussion, and then, as Steve is suggesting, a lot of it will have to be within the groups and getting material back to the whole Commission.
DR. JONAS: Yes. I suggest in February, though it has to be resolved before that. It has to be resolved before we prepare the final report, and we need some guidelines as to how the various groups are going to go about their prioritization, so that they are not just all over the map, I think.
MR. GROFT: We will be doing that next week in our debriefing exercises there.
DR. GORDON: Yes. Your point is very well taken.
What I want to do now is give everyone an opportunity for proper nutrition. So what we are going to do is, we are going to take 20 minutes without a public meeting, where we will begin the process of eating, and we will just go over a couple of administration issues for ourselves, and then we will start again at 1:15. Don has said that he expects to get through it a little bit more quickly.
DR. WARREN: It's going to be about a minute and a half.
DR. GORDON: So we should have more time at the end to discuss some of the other issues regarding prioritization.
Thank you, Don.
[A lunch recess was taken at 12:55 p.m.]
+ + +
This is to certify that the attached proceedings
BEFORE: White House Commission on Complementary and Alternative Medicine
HELD: December 6-7, 2001
were held as herein appears and that this is the official
transcript thereof for the file of the Department or Commission.
SONIA GONZALEZ, Court Reporter
Thursday, December 6th, 2001
Friday, December 7th, 2001