Introduction
Part 1 of this interview with Josephine Briggs, MD, the director of the National Center for Complementary and Integrative Health (NCCIH) at the USA National Institutes of Health, ran in the September 2016 edition of The Journal of Alternative and Complementary Medicine. The conversation was stimulated by NCCIH's recently issued 2016 Strategic Plan. This article, Part 2, speaks to the Center's natural products agenda, including the whole herb; challenges of antibiotic overuse and mounting interest in the microbiome; the shift in some toward health enhancement as a means of diminishing the impact of disease; and interventions engaged with employers and in communities. Part 1 focused on such topics as the influence of the value-based medicine movement on NCCIH planning, patient-centeredness, prioritizing pain, researching whole systems, and the impacts of whole disciplines.
As I read the Strategic Plan, I felt like there was a renewed and shifted focus relative to natural products. I am wondering what your comments are in this area.
Dr. Briggs: This is an important topic. Certainly, one area where there is enormous scientific activity in the natural product arena is in probiotics and in the microbiome. This is clearly an area of enormous scientific excitement. As you know, we have a very powerful voice on our council, Martin Blaser [Martin Blaser, MD, director, Human Microbiome Program, New York University Langone Medical Center]. He is a real advocate for exploring the possibility that excessive use of antibiotics and other interventions may have diminished the diversity of our microbiome and could be having adverse effects on human health. I consider this one of the most exciting parts of our natural product portfolio. This is an area where our work is just starting. I think that we can do much more in terms of prebiotics, probiotics, and really understanding the ways in which plant-derived products, natural foods, change the gut composition. In general, we are very interested in the various interventions that can help preserve the diversity of the microbiome. That is one area of excitement. In a more general area, together with the Office of Dietary Supplements we are reshaping the botanical centers a bit. We cofund these with the Office of Dietary Supplements. We are increasingly funding those with a structure that creates a center with expertise in genomic and other high-throughput methods for studying natural products. I think the team that is running that center, which includes some of the traditional natural product investigators, but also some very innovative young scientists, has real potential for making natural product research move into the 21st century. This will make the work livelier and more interesting. As you know, I became a little disillusioned with the large-scale randomized clinical trials for dietary supplements. It is not inappropriate to run a large-scale randomized trial like the gingko trial to see if it changes cognitive function. But it is frustrating to run big-scale trials and at the end find no evidence of benefit. While each of those studies was very well implemented and they did influence use, I have felt that there was still nothing immediately pressing that justified the investment on that scale.
Then where are you preferring to place new natural products research investment?
Dr. Briggs: There are still some very important unsolved micronutrient issues. I was just talking with Paul Coates [Paul Coates, MD, director of the Office of Dietary Supplements] yesterday about iodine and iron supplementation for pregnant women. These areas are still inadequately investigated. There are still quite a number of unanswered questions about whether or not supplementation is indicated for specific populations. Any sense that we have retreated from this area is not exactly correct. We continue to invite investigator-initiated projects in this area and welcome good studies.
I know an area of interest of some in the botanical community is trying to understand more clearly some of the complexity of the whole herb and the way that it might work in multiple ways with the human body. That is, of course, the philosophy of the herb community. It looks like you are thinking, “Well, maybe we have a chance now with some of the emerging technologies to be spending a little bit more time and energy to understand that.”
Dr. Briggs: Absolutely. I think some of the complexity is going to arrive from impact on the microbiome. This has made me aware that the strategies for dealing with complexity have just been too simplistic. This gives me added confidence that there really is something to the complexity hypothesis and that we can turn it into some testable ideas.
I was very interested in reading of NCCIH's new strategic look at these products and practices in people's efforts to enhance their health. I think it has really grown out of Richard Nahin's work looking at use patterns with the CDC [Centers for Disease Control and Prevention]. [Dr. Richard Nahin, NCCIH's lead epidemiologist, collaborates with various partners to provide reliable estimates of the use of complementary health approaches.] Now you are taking seriously your findings that many people are using these methods for self-care reasons and for health-promoting reasons and have built that into your strategic plan in a way that has not been before. I would love to have you just speak to that and where you see it is going to go.
Dr. Briggs: The increased emphasis on lifestyle choices and on use of these approaches to promote health, as opposed to treat conditions, is indeed something that we are very aware of from the [National Health Interview Survey]. We are thinking about the best research approaches to capture this. People make many lifestyle choices. How do we develop evidence that will help people understand the choices they make and develop evidence that will contribute to approaches that truly promote resilience and a broader sense of health than the view that health is just freedom from disease? It is clear that the best complementary practitioners talk to their patients about lifestyle changes. The traditional disciplines emphasize healthy eating, sleep, avoiding stress, and other aspects of promoting health. I do struggle with what are the right research approaches to show that these practices make people live longer or avoid chronic disease. It is not something we have the scale or, in fact, patience to do. I am not interested in only 30-year-long studies. I do feel like we need a continued dialogue about research approaches for understanding what promotes wellness.
I have an observation that I think is useful but that may confound this distinction between the populations of people who are using these therapies and approaches for health outcomes versus to attack some condition or disease. I know that naturopathic doctors for instance speak of “treating disease by restoring health.” This is pretty much the thinking across integrative practice. Part of the process for patients in this paradigm is to come to see their health care this way. So, there may be some confounding of language in the survey. They may be responding that they are doing something to enhance their health when it is also their way to manage a disease. This wouldn't be captured in the survey.
Dr. Briggs: Yes. As a conventional-trained physician, one is educated to think of one's job as finding disease—what are the diagnostic tests you should employ in this situation in order to find out whether your patient is hypothyroid or your patient has X. It is a different mindset. Of course, one of the areas where this blurring between creating health and treating disease gets into a lot of problems is with conditions, like chronic pain or fibromyalgia, that are defined by the healthcare system. The person does not feel well, but it is not always clear to me that labeling somebody as having a disease like that is helpful to the patient.
It locks people in.
Dr. Briggs: I think sometimes the symptom complex is disabling. Is that an explanation that really helps people develop strategies for optimizing their function?
It struck me that perhaps the language of the survey is not capturing some of what is going on in an actual paradigm shift in the way some people are beginning to think about the whole process of their relationship with these sorts of relatively new kinds of doctors—these retrained approaches.
Dr. Briggs: Agree. We should rethink this issue as we formulate the next survey. These surveys take a long time to put together, and the questions are field tested to develop them. We are already worrying about the next one. We are analyzing 2012, but 2016 is soon upon us. We have not thought about whether those questions need to be rethought a little. I will discuss it with Richard.
Well, good. It really struck me in seeing the health-disease distinction that you are making that maybe it is a little murkier. On a not unrelated note—I just did some writing on the Benson-Henry Institute work on mindfulness that showed a rather remarkable 43% less utilization of medical services [in the population that participated in the program]. It was a retrospective analysis of about 4000 of their participants. They ended it with a policy recommendation in bold terms that perhaps we need to be looking at mindfulness in the way that we look at vaccination and driver's education, which was, I thought, a beautiful choice of language.
Dr. Briggs: I did not see that analysis. We are putting together this summer a small working group to talk about mindfulness with children and adolescents. It is a little like vaccination. It probably is an intervention that you should start before puberty. But just to return to the natural product area, I remain intrigued by the clear impact that complex, vegetable-derived diets have on health. There is incredibly more to learn, and maybe part of that will be how various compounds in a complex varied diet contribute to an intestinal flora that promotes health. The natural product portfolio I think is still almost half of what we fund.
Yes, it is huge and I suppose backed by the relatively high level of consumer use relative to other agents, modalities, or practitioners.
Dr. Briggs: In no sense have we retreated from a strong interest in natural products. I am very proud of the RCTs [randomized controlled trials] we did. They were really rigorous. They were careful and they did impact use. They did tend to look at one natural product at a time and a single preparation. They have left us with unsolved questions. I do my best to eat a very varied diet, but I do not take any herbal supplements, although when I have a sore throat I go for an herbal lozenge. But I do not think we have evidence yet that says herbal supplementation is an answer. We have learned that these compounds tend to be safe, but there are many unanswered questions, and the investments we are making, both the large trials and the more mechanistic work, are important.
One perspective on the high investment in natural products is that the surveys show high utilization of supplements. But another perspective on the high investment in looking at these products is perhaps less friendly towards NCCIH. This is that it is a comfort zone. It is perceived to be a comfort zone at NIH to be working with those things that are most drug-like and can potentially, depending on how you are looking at it, have benefits for drug manufacturers, that you are learning things that people can synthesize and create drugs around. I am just wondering—45% of your research investment is a big number, particularly given the broad kinds of explorations that you do.
Dr. Briggs: A chunk of that is the investment in the botanical centers, and then it is investigator-initiated grants. Of course, the use pattern and the large amount that people spend on dietary supplements is an important driver of our thinking about research priorities. But the work that we support does emphasize, and I think this is clear in the strategic plan, the complexities and the interactions that these compounds have. We are by and large not supporting work that tries to isolate an active substance, for example, to turn into a drug. That is not the direction we are going in. On the other hand, science is science, and understanding if a particular component of a natural product, one that is metabolized by the gut bacteria, you know, getting to a molecular understanding may be pretty useful.
You are learning things that could be useful. That is still a high number, given all the different ways laid out in the plan where you can be asking research questions and sending your research dollars.
Dr. Briggs: Right. It has evolved. This is a slowly steered ship. It is just, perhaps, slightly less slow than it was 5 years ago, but there is not a drastic change.
I wanted to back up. The drift of my statement about the Benson-Henry mind–body cost-savings was really to get into your new initiative in the plan to look at partnering with employers, partnering with communities and schools as locales potentially for research. I wonder if you could comment on that?
Dr. Briggs: It is actually something that we have talked about for a while. We have a member of our Council, Reed Tuckson [Reed Tuckson, MD, managing director, Tuckson Health Connections, LLC, Sandy Springs, Georgia], who is very interested in employee and community-based wellness approaches. Wendy Weber [Wendy Weber, ND, PhD, MPH, branch chief, Clinical Research in Complementary and Integrative Health Branch, Division of Extramural Research, NCCIH] is acting as the lead for this. She is a quite effective and energetic person. She has and is giving a number of talks on this. I really hope we see grant applications that will address this area because it is an important one. We are aware how much public presence this topic has right now. This question of the use of mindfulness in adolescents and children is one piece of how we are exploring this general topic. ■
