Discussion

DR. SHINE: I have separate questions for David and Cathie. David, you have talked about randomized controlled trials. You have also emphasized that, in a number of the kinds of therapies we are discussing, the role of the provider is extremely important. A randomized control trial implies the notion that you are objectively evaluating an intervention and that whomever applied that intervention could show it would work. In this situation, it is the intervention and the provider together, with a particular belief, enthusiasm, or whatever is appropriate in terms of the effectiveness of what you are doing. Do you end up comparing an enthusiastic provider against a non-enthusiastic provider, or a set of enthusiastic providers doing the therapy in different ways?

I understand how one performs an herbal trial, for example, but I am puzzled as to how, in a number of these therapies, you conduct a randomized control trial when you are looking at the effect of both the intervention and the enthusiasm of the provider.

For Cathie, I am curious: has the recent emergence of a number of these toxicities and so forth had any kind of effect suggesting that Congress will revisit regulatory issues? Do you see this as not simply being on the horizon?

DR. WOTEKI: My answer is going to be quick. I don’t see anything on the horizon with respect to major review or revision of the existing legislation. The single exception to that would be if there is a very large outbreak of disease associated with one of these supplements that might lead the political will to revisit it, but it doesn’t seem to be there.



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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine Discussion DR. SHINE: I have separate questions for David and Cathie. David, you have talked about randomized controlled trials. You have also emphasized that, in a number of the kinds of therapies we are discussing, the role of the provider is extremely important. A randomized control trial implies the notion that you are objectively evaluating an intervention and that whomever applied that intervention could show it would work. In this situation, it is the intervention and the provider together, with a particular belief, enthusiasm, or whatever is appropriate in terms of the effectiveness of what you are doing. Do you end up comparing an enthusiastic provider against a non-enthusiastic provider, or a set of enthusiastic providers doing the therapy in different ways? I understand how one performs an herbal trial, for example, but I am puzzled as to how, in a number of these therapies, you conduct a randomized control trial when you are looking at the effect of both the intervention and the enthusiasm of the provider. For Cathie, I am curious: has the recent emergence of a number of these toxicities and so forth had any kind of effect suggesting that Congress will revisit regulatory issues? Do you see this as not simply being on the horizon? DR. WOTEKI: My answer is going to be quick. I don’t see anything on the horizon with respect to major review or revision of the existing legislation. The single exception to that would be if there is a very large outbreak of disease associated with one of these supplements that might lead the political will to revisit it, but it doesn’t seem to be there.

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine DR. EISENBERG: Ken, your point is well taken, and I think you point out how complex it is to design studies that provide an answer with which one can be satisfied. Certainly, things taken orally that we can control with a credible sham placebo pill are the easiest. I think once you get into provider–dependent interventions, again, the methodologists have been very creative. In the area where we think modality is the key to the efficacy, we try to standardize the intervention as best as possible. Even there, just to stick with it for a moment, you get into a conundrum. Do you use the same point for nausea in all patients, or do you let 10 qualified acupuncturists from five different Asian traditions pick their own, hoping there will be some overlap? The NIH has, in a rather remarkable way, opted to fund projects to follow each of those trajectories. Some studies will standardize the acupuncture points or the massage points or the chiropractic approaches, where herbs for irritable bowel will leave it up to the practitioner to diagnose and treat, as is their normal practice. We end up with three arm studies. The study for irritable bowel in JAMA was one of these studies that used that paradigm. There is also tremendous creativity in how to appropriately blind and create controls that are credible for some of these techniques. There are actually, I think, fairly good examples of sham placebo devices that can be used in patients who are naive to acupuncture, which are spring loaded and go through a tube. The person who is naive to real acupuncture, when punctured by this sham acupuncture needle, which is on a spring, feels the needle touching the skin but it never touches the skin; that is one level of control. Whether that is satisfactory for all questions about acupuncture is another question. I guess what I am trying to say, without appearing or being overly defensive, is that each study has its own limited number of questions it can ask and answer authoritatively. That is precisely why this field needs people who are trained in clinical epidemiology, who understand the modalities as they are used—not just the rules of evidence, and why we need universities that are willing to bring in clinicians from the different professions to ask how this is actually practiced, before devising a randomized trial that meets reductionistic requirements, which has little or no bearing to the way you and your colleagues actually practice it. This is not easy. It is very messy science. If you extend that to herbs, they are the messiest of all. Even if you can give a credible sham foultasting elixir that tastes like the foul-tasting elixir of herbs, the consistency

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine of the herbal products being used and the ability to acquire an IND for them, and then to contemplate an interaction to them, is a great challenge. So, it is hard work, but again, I think the right people now are invested. The open-minded skeptics are asking, “what have we got here in each of these studies?” My hope is that my colleagues will assure that the science is done well, so we don’t assume prematurely that we have the answers before we actually have them. PARTICIPANT: I was wondering, David, if you would comment on some policy that we have evolved at the Center for Substance Abuse Treatment, of the Substance Abuse and Mental Health Services Administration, that suggests the notion for the need for randomized clinical trial results, and may actually shed some light on your question of which should come first. That is, starting in about 1994 and 1995 with a program called the Rural, Remote, and Culturally Distinct Populations Program, populations were funded for comprehensive culturally appropriate substance abuse treatments. Community interventions were implemented, such as a program in Hawaii funded to include traditional Hawaiian healing practices, and several programs serving Native American communities were funded to include sweat lodges. There were also programs funded to include acupuncture. What they had in common was that they were high demand, low cost, safe, but non-evidence-based treatments that were allowed to be included in a comprehensive treatment setting. That program has become more operationalized. What we are working on at the Center for Substance Abuse Treatment is developing guidelines on acupuncture incorporation into addiction treatment programs, and we are doing a treatment improvement protocol on that. Admittedly, the evidence for acupuncture being efficacious in addiction treatment is somewhat lacking. I find it promising but not conclusive. At the same time, this is used by several hundred different programs. In substance abuse treatment programs in particular, we noticed that time and treatment of almost any sort has a significant improvement on the long-term outcome. If we have a treatment, such as acupuncture or a sweat lodge, that brings people into the treatment setting, as long as it is comprehensive, then that may improve outcome, if not through efficacy, perhaps through increased utilization or compliance with treatment.

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine It would be hard to subject a sweat lodge to a randomized control trial. We still like to think of it as having a role, at least, in comprehensive, culturally-competent drug abuse treatment that is community oriented. DR. EISENBERG: I don’t know how to respond other than to say this is another example where the research is often complicated by the fact that we are trying to help patients in the absence of a reductionistic trial. Sometimes these things don’t lend themselves to randomized trials and credible controls as we know them or would like them. You are talking about whole, culturally sensitive approaches to individuals who have substance abuse, and whether it is the intervention— culturally acceptable as it is—the practitioners who are providing it, the ambience, et cetera, or the ambience itself. Again, it is nice when those kinds of things lend themselves to a randomized trial. I would say, respectfully, that acupuncture could lend itself to more randomized trials for substance abuse than it has. Historically, as you know, the data have been wanting there. I agree with you. I don’t think that all these things lend themselves to a definitive trial. Yet, if you take a step back and you say, let’s look at it from a health service perspective: are we doing more good than harm if we allow access to a given population at very high risk and/or high morbidity and mortality to have access to these therapies? What does it do to their clinical outcomes and costs?—that is a different question. I think from a public health standpoint, you get an answer to your public health question. From an NIH scientific standpoint, you don’t know what the actual cause and effect relationship of the individual components is. Alan Trachtenberg, who is the acting director of the Office of Alternative Medicine, and I have debated these and other questions for some time. I don’t think there is a clear solution. I think this is one of the messy parts of the equation. PARTICIPANT: One aspect, I think, of the solution might be trials that look at—as the unit of analysis, rather than the individual patient or subject—the treatment program. DR. EISENBERG: Right, and at the population it serves, I agree. Unfortunately, the NIH doesn’t usually fund those kinds of projects. In spite of the $200 million of resources, we don’t have $200 million to look at these things from a population based or a public health vantage point, and I know that is the song you sing.

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine PARTICIPANT: Unfortunately, many of the other agencies don’t receive that level of funding to pursue those agendas. DR. YATES: I am Allison Yates, the director of the Food and Nutrition Board at IOM. It is interesting to see the diet supplements and then look at integrative and complementary medicine. One aspect Dr. Woteki brought out was the specifics of the law in 1994 of the Dietary Supplement Health and Education Act, which essentially said dietary supplements are foods. One component that might be useful to discuss is the other aspect of that enactment, which limited dietary supplements to only being discussed in terms of structure and function. Perhaps Cathie and Dr. Eisenberg want to talk about their role in treating disease. DR. WOTEKI: When dealing with an extract or a concentrate, in my mind, that takes it into the realm of drugs and out of the realm of foods. Secondly, the idea that those marketing these supplements are only marketing them for the effects they will have on structure and function is kind of winking, to put it mildly, at the implicit message surrounding so many of these products that they do have a direct disease prevention or disease treatment intent or purpose. Both of those things are inherent weaknesses in this regulatory approach, but they are ones that no leading members of Congress want to take on to revise legislation. The end result is this enormous dilemma of a product that can only be regulated on safety, for which the labeling claims can be made for structure and function effects, but everything surrounding them, with respect to books and articles and advice from sales people, does have a direct medical implication to it. DR. YATES: I thought Dr. Eisenberg might want to address whether these are medicines? Then, when one uses them to treat Parkinson’s? DR. EISENBERG: There is no clear delineating line between food and medicine as supplement and over the counter substances. Certainly, the line is terribly blurred for somebody who walks into Osco, CVS, or any drug store in the country. Where does the aisle begin and end? I didn’t show two slides of an article published in the Archives of Internal Medicine this summer by Robert Blendon on his survey of adults’ perceptions on dietary supplements. One of the more remarkable findings really points to a perception disconnect, if you will. When asked whether individuals would want their dietary supplements to be proven safe and

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine effective before being given permission to be placed on the shelf, I forget the number, but it must be higher than 70 percent. I think the American public is not aware of the facts that have been presented tonight, of the absence of teeth in the law that demand efficacy or safety prior to putting them on the shelves. The language is unclear. If you speak to an audience of clinicians, doctors in white coats, and PharmDs and nurse practitioners, they are quite frustrated with the inadequacy of what is available by way of information and labeling. When a patient says, does saw palmetto help with my benign prostatic hypertrophy? The label says: it improves urinary health. What do we have here? Speaking only for myself, I think we should, as a nation, rally support from additional congressmen and women to revisit this. I personally think it is not working in the service of the patient or the healthcare practitioners who are very frustrated. I do not think we have properly incentivized the private sector to make the investment to improve the quality or do the science. If they could regain some of the investment, they might help us discover what the active ingredient or ingredients are and help promote scientific discovery. That is where I stand on it. DR. HARAMATI: I’m Adi Haramati from Georgetown University. David, this is for you. You have presented a vision of integrative health care and listed the stakeholders and the progress, and also a series of key issues. I wonder if you could prioritize or give us a sense, in the short term, of what barriers we have to overcome to get there, to try to give us some short-term goals. Perhaps we can eventually focus on the long-term goals, but more importantly, we can leave this room with a sense of the immediate things we need to do in the next year or two. DR. EISENBERG: I think it depends where you sit. You know, the notion that if you are a hammer, everything looks like a nail? If I were in a board room of Fortune 500 employers and their groups, I would say: you should invest in health service research to figure out which, if any, of these things should be in your benefit package or your cafeteria plan. If I were with the pharmaceutical companies, I would say what I said five minutes ago. If I were with FDA, we would have a different conversation. You know, as an academic, and you in particular, in the basic sciences, we both participate in the consortium where we are working with the deans of medical schools and colleagues in the medical community where we can say, this is our problem. We must lead, and we as members

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine of academic medical centers and universities have to do the hard work of distinguishing useful from useless, pursuing scientific discovery, following all the guidelines we follow for everything else we do when we wear white coats. I guess I go back to that stakeholders chart and say that we have to methodically, with the help of all the stakeholders, state that each one of those groups needs its own priority list. If you are in the private sector, it may be credentialing or patent protection with input from the government. It depends where you sit. I wish I could prioritize it. In fact, I am glad I can’t. By not prioritizing it, it means that they are all equally important. I don’t think the field will develop in a satisfactory way in the absence of any one of those components. I am sorry to slice up your question. MS. BEATTY: Hi, my name is Margaret Beatty, and I am actually an acupuncturist practicing here in D.C. I have three questions for Dr.Eisenberg. First, are you familiar with the Japanese acupuncture tradition of Toyohari? DR. EISENBERG: Just by its name, but I have not practiced this. MS. BEATTY: It is a tradition of acupuncture where the acupuncture needles are just placed on the skin or maybe placed above the skin. I just toss that out as another method of acupuncture, which seems to complicate your life a little bit more. Also, I am intrigued by this whole idea of research, since acupuncture comes from a medical tradition that has a totally different paradigm than allopathic medicine and has a much longer tradition and history. One question is: how do you study something that comes from such a totally different view of the world with something that comes from a competing kind of culture? DR. EISENBERG: First of all, I very much appreciate the question and let me answer it in two ways. One, I have mentioned already that it makes no sense to design a trial without input from the actual practitioners. So, the practitioners have been helpful in figuring out the different credible shams. That is on one extreme. On another extreme, the practitioners have been very helpful in the following experiment. It is known in Chinese medicine that 10 people with pneumococcal pneumonia or migraine headache on the western side might have five or 10 different diagnoses.

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine There are now NIH-funded trials to take a group of people with a homogeneous diagnosis by western terms and stratify them by Chinese or Japanese diagnoses. So, you can imagine 1,000 people with migraine headaches, only 100 of whom have one particular Japanese or Chinese diagnosis, and randomize those to either real acupuncture, sham acupuncture, or conventional medicine. My point is, these are all attempts to honor the tradition from which the therapy comes and simultaneously acknowledge that there are rules of evidence that we believe and hold dear, and believe can be beneficial in helping us understand where the most benefit is gained. This isn’t an either/or, but rather a call for collaboration between scholars and practitioners of some of these therapies and our most openminded skeptical clinical epidemiologists. I just want to conclude my response by saying I understand it. The 20 clinician researchers with me who do this work understand it. The NIH is increasing understanding of it. It is not an attempt to just put a round plug in a square hole and figure it out: does it work or not? MS. BEATTY: There are just two other things I am curious about. DR. EISENBERG: How about you and I talk about your question afterwards, because I think we are over time. Let’s have one other question. I am here afterward, and maybe I could answer yours offline. MS. BEATTY: I am curious about your partnerships with, for instance, acupuncture schools or chiropractor schools. I didn’t see them on your list of integrative medicine stakeholders. There seems to be a lot of emphasis on allopathic medical schools and that also brings up the issue of doctors who are able to practice acupuncture by taking a 300-hour acupuncture course, as opposed to acupuncturists who have a much more substantial training. I think that is a concern. DR. EISENBERG: I think my diagram needs to have another box of important stakeholders, and I thank you for that. MS. BEATTY: I am just wondering, is anybody looking at a definition of health and looking at how we do work with people from medicine, coming from a definition of health perspective? DR. BULGER: Could I suggest you pursue that offline? We are going to have some dietary supplements soon, be they either too warm, or too cold, or whatever. The last question.

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine DR. MARION: My name is Phil Marion. I am a medical director of rehab medicine at The George Washington University, up the street. A question for Dr. Eisenberg and perhaps an observation. I am one of those allopathic physicians, who is also a medical acupuncturist, and I have noticed that patients, who come in; are not insured; and are going to pay cash, have a different enthusiasm, if you will, toward the treatment of acupuncture than someone who receives it from their managed care companies. As a matter of fact, patients are a bit suspect if they are going to be covered by their managed care companies, and sometimes that has an effect on the results of their treatment. The second point I wanted to make was that very often with patients, especially if you look at stakeholders for patients covered by their insurance companies, they try to fit an eastern traditional medicine into western medicine. For example, they will give you four visits and they will say, get them better in three months or they have to get another referral. You then have to fight the battle with the insurance company, if you will. In many ways, it turns out that having them covered by their insurance company is actually a detriment to their actual treatment. I am using acupuncture as an example, but for others as well, and I wanted your comments and experience on that. DR. EISENBERG: I think these are excellent points. There is a large literature, much of it out of RAND, looking at how patients perceive and behave in health systems where health care is free, partially covered, or self paid, and I think that translates across the modalities used. It is clearly a very important aspect of care, as to whether (a) you choose it, (b) you have access to it, and (c) how much you pay for it. In the same way, trying to do a randomized trial of people who have an injury and are seeking worker’s compensation is very different from a population trying to get its life back and is very motivated to participate and pay any amount just to salvage a life. I think these are factors that can and are being incorporated into some of the health service research. In all the studies I mentioned, these are some of the variables that need to be tested, not just the choice of a therapy, but the co-payment and the percentage of co-payment. I think these are part of the future of health service research in this area and your points are very well taken. Thank you. DR. BULGER: I want to thank everybody. I will have an interesting e-mail for our members based on what we have learned tonight. I heard from Cathie Woteki that we all need to explore the financial records of Osama Bin Laden and see whether he is in the herbal supplying

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The Richard and Hinda Rosenthal Lectures 2001: Exploring Complementary and Alternative Medicine business. Perhaps that would help FDA and the academic centers who formed these 11 centers to somehow get together with the entrepreneurial divisions of the universities and allocate funds to post an authoritative internet site. I think you have raised a tremendously important set of points. Please join me in thanking them once more.