In 1985, Dr. Briggs moved to the University of Michigan where she held several academic positions, including associate chair for research in the Department of Internal Medicine and professorships in the Division of Nephrology, Department of Internal Medicine and the Department of Physiology. Dr. Briggs joined the National Institutes of Health in 1997 as director of the Division of Kidney, Urologic, and Hematologic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases where she oversaw extramural research activities. While at NIDDK, she co-chaired an NIH Roadmap Committee on Translational Core Resources.

Dr. Briggs’ research interests include the renin-angiotensin system, diabetic nephropathy, circadian regulation of blood pressure, and the effect of antioxidants in kidney disease. She has published more than 130 research articles, has served on the editorial boards of several journals and was deputy editor for the Journal of Clinical Investigation. She is an elected member of the American Association of Physicians and the American Society of Clinical Investigation and a fellow of the American Association for the Advancement of Science.

What is the mission of the National Center for Complementary and Alternative Medicine?

It is to bring rigorous science to the wide range of complementary and alternative health practices being used by the American public. We also want to make sure the public gets good information about this and to make sure that we’ve got a good research workforce who can do the kind of rigorous science that’s needed. Those are the three parts of our mission. My predecessor laid that out and I think it’s a good statement of the mission.

Complementary and alternative medicine (CAM) is defined quite broadly and incorporates a somewhat odd mixture of methods. It includes everything from single agent therapies like St. John’s wort for depression or ginger for nausea to wide-ranging healing systems like Chinese medicine, chiropractic and naturopathy. This must lead to challenging questions about where to allocate the substantial funds available through NCCAM. How do you determine where the money should be spent?

First of all, we operate within classic NIH systems. That means that we are highly dependent on expert review panels for the evaluation of ideas submitted by investigators across the country. In the chiropractic colleges, we have had some very strong research communities developing and lots of good grant submissions. The grants that come in from across the country are reviewed by panels that include CAM practitioners and experts that have the right scientific skills to evaluate the proposals and they rank them.

It’s very tough to get a grant from us—we only fund about 12 percent of the grants that are submitted. And the bulk of the priority setting is done by these expert review panels. The NIH peer review process has what’s called first- and second-level review. The first level is these expert peer review panels. The second level is review by our own scientific staff and then our advisory council. Our staff read very carefully, listen to the opinions of the expert peer review panels and then bring summaries and discussion of things that are on the border to our advisory council. The advisory council then advises me and I’m responsible for signing off on the recommendations.

To what extent is there turnover on these expert panels and the advisory board, to avoid entrenched patterns of power?

I think there’s a fair amount of turnover. Members of our advisory council have three or four year terms. We have 18 members, so each year we’re naming three or four new people. So that’s one aspect of turnover. The peer review panels are set up by a different part of the NIH, either by our own review branch or by the Center for Scientific Review. They pull in experts, partly determined by the grant flow. So if there are a lot of grant applications coming in on acupuncture, they would turn to acupuncture experts to review those grants. The composition of the panels changes depending on the grant submissions.

About how many studies has NCCAM funded in the past couple of years and how broad a range of topics is covered? You’ve mentioned chiropractic and acupuncture. Can you give us a broader sense of the areas addressed?

At any one time, we have about 300 active projects. Our investigators have published approximately 3300 papers and the projects are about half and half, with a little more on human subjects than basic science. They cover an incredibly wide range of projects, everything from individual natural products to Traditional Chinese Medicine to back pain management. We have a very strong portfolio in back pain management and we’re very proud of the back pain management area. This is an area where our research is really having an impact on practice.

NCCAM provides support for medical schools and CAM training institutions to develop centers of excellence. What does this involve? How important is building research infrastructure?

The Centers of Excellence program supports collaborative grants, typically three or four projects, and provides support for the investigators in those projects. We have centers of this sort, usually funded as program projects, in both CAM institutions and conventional institutions. I think it’s been incredibly important in building the research community. Actually, a pretty sizable part of our budget goes into program projects and centers, over 15 percent.

What is your overall budget for the coming year?

It’ll be 128.8 million dollars. Our grants are for four years on average, so each year we’re awarding new grants for about a quarter of that.

To what extent does current NCCAM-funded research involve studying the effects of a single intervention and to what extent are you funding whole systems research, which looks at health effects more comprehensively?

This is an important area that we’re working to strengthen as part of an effort across the NIH to do more research that falls in the category of what’s being called comparative effectiveness research. All of us recognize that assessing how modalities work in the real world is a very important area to strengthen in our research portfolio. And we are sponsoring several areas where we will be expanding the comparative effectiveness research.

Comparative effectiveness research is very important and some of the breakthrough studies involving chiropractic, for example, have involved head-to-head comparisons with conventional medical approaches to back pain or headaches. But comparative effectiveness research often involves comparing the effects of two single-agent therapies, with the sought-after effects very tightly defined.

It is, by its nature, real world research. It would be asking, “How well does this work?” in the real world. You know, NCCAM has invested, over the past several years, fairly sizably (nearly 10 percent of its budget) in clinical trials of herbals, plants, and other botanicals. And we just saw the completion of one of those recently, the study on ginkgo for cognitive decline in elderly people, for early dementia.

That’s the one that showed that ginkgo was not particularly effective.

Right. At this point, we are not initiating any new major studies of this sort. That was a big study that was funded together with the National Institute of Aging. It was one of the biggest longitudinal studies on the development of Alzheimer’s ever done. We’re pretty proud of the study, not only because of information about ginkgo per se, but also because of the important information it gave us about Alzheimer’s disease and its development.

Right now, we are not thinking about developing new studies of this sort in herbals but we are talking about how to look at things like pain management, particularly back pain management.

I want to ask again about whole systems research. Are you open to, and are you seeking out, research projects that involve integrative multi-factorial interventions, such as approaches that combine changes in nutrition, exercise and stress reduction rather than limiting the intervention to one specific therapy?

We are talking about how to do that kind of research in a way that will ensure that it can actually be rigorously defined. There are two questions implicit in your discussion. One is, “What is the intervention?” The other is, “What is the outcome you’re after?” It is important, in thinking about this kind of research, to figure out both how to define with the kind of precision that will result in rigor, what kind of interventions are useful to couple together, and then what kind of measures you want to use to see if it works.

We’re very impressed with the idea that some of the CAM practitioner approaches may have particular promise for promoting healthy behaviors, like promoting healthy eating and promoting more physical activity. We’re interested in seeing people develop grant proposals on the impact of integrative health approaches and complementary practitioner approaches to the promotion of health behaviors. That’s something we’re going to be talking with the advisory council about. We think it’s an important area for us to strengthen the research in.

Do you feel that NCCAM research is a success when a study shows a benefit from a CAM approach and a failure when a study shows no benefit? And do you find yourself personally happier with one that shows a positive effect rather than no effect?

Oh, absolutely! We’re always happy when we can demonstrate benefit. We try to go into this work really neutral and to maintain neutrality, but like all health care providers, we’re interested in helping people. So we are very pleased when, as we’ve seen in pain management, data comes together showing that some of the CAM approaches are really helping in pain management. That’s very satisfactory. The ginkgo results were very disappointing to the investigators and to us. The study was very rigorously done, very careful, and it’s still of enormous value, but certainly this result isn’t what people hoped for.

I want to ask you about the role of placebos and controls in clinical research because this is a real challenge for non-pharmaceutical, or non-substance based, therapies …

I totally agree with you. The notion that you can have double-blinded studies with a placebo control works in a drug study, but is really un-doable when you have an intervention where the context and the interaction with the practitioner is part of the benefit. We struggle with this problem a lot.

It seems to me that it is impossible to construct a true, effective placebo intervention for studies on physical medicine — chiropractic, massage therapy, acupuncture, physical therapy and so on. And yet we find our research community challenged to live up to the so-called “gold standard” of a placebo-controlled, randomized trial.

Right. We are holding a workshop on just this problem later this spring. I totally agree with you. It is also important to have some clarity on what the question is. So if the question is, “Does massage therapy get people back to work faster than standard care?” then the placebo may not be relevant. If the question is, “Do needles on the meridians have a different effect than needles that aren’t on the meridians?” then you may be able to develop an appropriate sham. But I know that within the chiropractic community, we’ve had a number of grant applications, and in fact have funded some, on sham controls for spinal manipulation. But I’m not at all sure that this is making total sense. Because the patient who has experienced these kinds of therapies before may know what’s happening and the subjective experience may be an important part of the way these interventions are working.

Every so often, usually when budgets are being considered, I read an opinion piece in the Washington Post urging that NCCAM be completely defunded because none of its research has proven to be of any value. On your website, however, I see reports of NCCAM-funded studies, as well as other CAM research, which show positive results from CAM procedures. Among those currently highlighted are positive studies on acupuncture for low back pain and for arthritis of the knee. Do you personally have to spend much time fending off those who want this research shut down?

It’s a hard question. We are, of course, unhappy when we hear critical comments about us. I am more worried about the criticism, which I view as unjustified, that the research isn’t rigorous scientifically. Sometimes it’s positive and sometimes it’s negative — that’s the way science is. And I think that these [CAM] practices are important, people are finding them to be of benefit and we’ve got to learn more about how they work and in what settings they’re most useful. So I don’t worry as much about the criticism that the research isn’t always turning out positive. I do worry a little about the perception, which I consider incorrect, that the work isn’t rigorous. We worry about that and we do our best to counter it.

In terms of being trained in rigorous scientific methods, can you share with us something of your background before your appointment to NCCAM?

I’m a kidney doctor and I have spent a lot of my career taking care of people with chronic kidney disease. They’re people with very substantial illness. A number of our patients are either on dialysis or transplant-dependent. High-tech medicine often leaves people feeling pretty unsupported by the health care system. Before I took on this job, I worked a lot with my predecessor, Steve Straus. We co-chaired a conference on the placebo and I was struck by how impressive the effects of reassurance and a placebo pill were on a lot of symptoms. It’s a fascinating area of medicine. So I came to this with both interest in the science and with a real feeling that high-tech medicine didn’t have all the answers. And I am finding this to be a very interesting responsibility. I’m learning a lot from the CAM practitioners I talk to, a number of whom seem to be very committed clinicians who are working very hard to take care of their patients.

What can you tell us about plans for NCCAM’s future? I know that you are now in the process of formulating a five-year plan.

It’s our third strategic plan, for the next five years. We are very much in the middle of it. We anticipate that it will be published at the end of 2010, with all of the spring months being devoted to getting further input from the community. We’ve had a lot of response to the preliminary documents we’ve posted. We’re digesting that and we’re presenting that to our council.

I guess if I had to point to some of the areas we’ll be emphasizing, one is the role of CAM in symptom management. Back pain and pain in general are among the main reasons that people are turning to CAM practitioners and CAM modalities. I think this is an area which is really important. One of our critics criticized some comments I made, and said that CAM modalities are only good for things like hot flashes and back pain. I responded pretty adamantly to that by saying, “No, symptoms really matter.” And if we can help people with common discomforts, that’s really important.

If the complaint that “CAM only treats symptoms” is presented to the patient whose life is significantly thrown out of kilter by hot flashes or low back pain, it’s really rather offensive.

Correct.

Anything else about future plans?

I also think that in the area of herbal products and other natural products, we really need to build some good basic science understanding of how these compounds work. Take Echinacea as an example. Echinacea is thought by some people to suppress the immune system (which would cut down on the symptoms you get from colds) while others think it stimulates the immune system (which would be why you don’t get colds as often). We’ve really got to get to the basic science before we do the next round of clinical studies. I think that building the mechanistic understanding of herbals is really important. We’re also quite interested in probiotics, which is an exciting area for NCCAM. Probiotics have some very beneficial effects in certain settings and we’re eager to see more work on this.

I recently read about an NCCAM-funded study that sounded quite intriguing to me. This is the one where Elizabeth Blackburn, winner of the 2009 Nobel Prize for Medicine, received NCCAM funding to study cell aging in the context of the metabolic and immunologic effects of meditation. Is there more you can tell us about that study?

That’s an example of how modern science is creating methods to detect benefits that are very subtle. What she found was effects on the telomeres [structures at the end of chromosomes that are involved with cell aging] from the relaxation techniques of meditation. Now this was a small study and it needs to be replicated in a larger group. But it’s plausible that the relaxation and the resetting of stress that occurs with meditation, may also affect these subtle measures of how the cell controls its aging. But this is an example of a very sensitive measure that comes out of modern genomic methods.

So high-tech methods are being used to objectively measure the effects of low-tech, traditional approaches.

Right, exactly.

Is there anything else you would like to add, to share with our readers.

We certainly will be welcoming comments from your readers on our investment in chiropractic research, which is sizable and really important for us.

Thank you, Dr. Briggs.

Daniel Redwood, DC, the interviewer, is Associate Professor at Cleveland Chiropractic College–Kansas City and Editor-in-Chief of Health Insights Today and The Daily HIT.