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NCCIH Director's Statement for the Appropriations Committee Regarding the FY 2019 Budget Request

Prepared Statement of David Shurtleff, Ph.D.
Acting Director, National Center for Complementary and Integrative Health

May 17, 2018

Mr. Chairman and Members of the Committee:

I am pleased to present the President’s Fiscal Year (FY) 2019 budget request for the National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health (NIH).

The mission of NCCIH is to define, through rigorous scientific investigation, the safety and effectiveness of complementary and integrative health approaches, which are a group of practices and products that originate outside of conventional medicine. This diverse group of health practices includes natural products such as dietary supplements, plant-based products, and probiotics, as well as mind-body approaches such as yoga, massage therapy, meditation, mindfulness-based stress reduction, spinal manipulation, and acupuncture. According to a 2012 National Health Interview Survey (NHIS), Americans are spending approximately $30.2 billion a year on complementary approaches to improve their overall health, manage symptoms of chronic diseases, and/or counter the side effects of conventional medicine. However, the scientific research base surrounding the safety and efficacy of these practices is limited. Therefore, NCCIH is committed to providing the American public with valuable information about these practices, while also investigating how specific complementary approaches can be integrated into conventional medical care.

Exploring Nonpharmacologic Approaches for Pain Management

NCCIH is devoting significant resources to understand the basis of pain and how complementary and integrative health approaches can be utilized in pain management. Pain is a major public health problem and is the most common reason Americans turn to complementary and integrative health practices. Data from the 2012 NHIS found that an estimated 25.3 million adults in the U.S. (11.2 percent) experience daily pain with nearly 40 million adults (17.6 percent) experiencing severe levels of pain. The use of highly addictive opioids as a primary pain management strategy in the U.S. is helping to fuel the growing opioid misuse epidemic. Improved strategies for pain management may lead to a decreased reliance on opioids for patients suffering from pain. NCCIH supports research to better understand the biologic mechanisms of pain and to identify effective nonpharmacologic approaches to reduce the duration and intensity of pain.

Research supported at NCCIH is focused on understanding the role of the brain in perceiving, modifying, and managing pain, with the long-term goal of improving clinical management of chronic pain through the integration of pharmacologic and nonpharmacologic approaches. Recently, scientists discovered a new class of sensory nerve cells that respond to high-threshold (intense) mechanical stimuli, such as hair pulling. This work provides insights into how our bodies encode and transmit pain sensations. Another study mapped the regions of the brain activated during pain to establish a “pain signature” and found that specific regions of the brain respond to pain intensity, while other regions mediate the psychological effect, and yet another region showed increased activity related to pain relief. This work not only provides insights into how pain is interpreted, but could lead to the development of new methods to detect, quantify, or target pain.

NCCIH-supported research is also advancing understanding of the mechanisms of action of mind and body interventions and determining their effectiveness for treating pain. One study investigated the effect of acupuncture on carpal tunnel syndrome and found that it affected activity within brain pain centers, decreased associated pain symptoms, and improved overall wrist function. Mindfulness meditation is another promising area of research. Numerous studies have shown that mindfulness meditation helps relieve pain, but the mechanism through which meditation exerts this effect is not well known. New study results demonstrate that mindfulness meditation activates the same region of the brain as opioids; however, it reduces pain independently of opioid neurotransmitter mechanisms. These results suggest that greater pain control could be achieved through the combination of mindfulness meditation and opioid-signaling-induced pharmacologic approaches. NCCIH-supported research has also shown that mindfulness-based stress reduction and cognitive behavioral therapy can improve functioning and reduce chronic low back pain in young and middle-aged adults and may provide patients with skills for long-term management of pain. Studies have demonstrated that these approaches resulted in substantial cost savings over usual care.

Based on these and other promising results, NCCIH is leading a new multi-agency partnership between the NIH, Department of Defense (DoD) and Department of Veterans Affairs (VA). This initiative, called the NIH DoD-VA Pain Management Collaboratory (PMC), addresses the need to focus on “advancing better practices for pain management,” which is outlined in HHS’s five-point strategy to combat the opioid crisis. The PMC will focus on developing, implementing, and testing cost-effective, large-scale, real-world research on nondrug approaches for pain management and related conditions in military and veteran health care delivery organizations. The PMC launched in FY2017 and the agencies plan to fund 11 two-year UG3 (Planning Phase) awards, and up to 10 four-year subsequent UH3 (Implementation Phase) Demonstration Projects, contingent upon successful completion of the short-term pilot and feasibility studies In addition, a PMC Coordinating Center has been established at Yale University and the Veteran’s Administration Hospital in Connecticut to provide leadership and serve as a resource for the projects by providing innovative tools and best practices. Types of approaches being studied include mindfulness/meditative interventions, movement interventions (e.g., structured exercise, tai chi, yoga), manual therapies (e.g., spinal manipulation, massage, acupuncture), psychological and behavioral interventions (e.g., cognitive behavioral therapy), integrative approaches that involve more than one intervention, and integrated models of multi-modal care. The results of these studies may inform new pain management practices within the DoD and VA and support the use of nondrug approaches for pain management in the general population.

Advancing Research on Natural Products

According to the 2012 NHIS, nearly one in five U.S. adults use botanical supplements and other non-vitamin, non-mineral dietary supplements, such as fish oil/omega-3 fatty acids and probiotics. Adverse events related to dietary supplements are estimated to contribute to 23,000 emergency department visits in the U.S. each year. To better inform consumers and their health care providers, NCCIH supports rigorous research on the biological mechanisms of the benefits and potential harmful effects of natural products with the goal of improving the body of knowledge available to health care providers and patients.

NCCIH is supporting a Center of Excellence to determine how best to study potential adverse interactions between natural products and conventional medications. The goal is to develop a definitive approach to determine the clinical relevance of supplement-drug interactions to inform design of future research and, ultimately, decision-making about using natural products and medications together.

In FY2015, NCCIH partnered with NIH’s Office of Dietary Supplements (ODS) to establish the Centers for Advancing Research on Botanical and Other Natural Products (CARBON) Program. Through this program, researchers recently identified two chemicals found in grapes that could significantly reduce depression-like behaviors in mice. The systems targeted by these compounds are not the same as current pharmaceutical antidepressants and may provide novel insights into the biology of depression and could lead to new therapeutic agents. The program is also developing new methods for chemical characterization of natural product mixtures, biological profiling assays, and creating new informatic tools to rigorously analyze and share data.

NCCIH is also supporting research on cytisine, a natural product for smoking cessation. Despite promising results from clinical trials conducted outside the U.S., cytisine has not yet been approved for use in the U.S. NCCIH supported a series of pre-clinical studies on cytisine through a strategic collaboration with Achieve Life Sciences, Inc., OncoGenex Pharmaceutical, Inc., other NIH ICs, and private research organizations. Recently, the FDA accepted an Investigational New Drug application that permits phase 2 clinical studies to further assess cytisine as a smoking cessation treatment. This continuing public-private partnership may lead to the wide availability of a new option to address the major public health issues associated with tobacco use.

Conclusion

As a responsible steward of resources, NCCIH supports scientifically meritorious basic, mechanistic, clinical, and translational research. The Center focuses on areas with the greatest potential impact by prioritizing research topics that show scientific promise and are amenable to rigorous scientific inquiry. We leverage strategic partnerships to build the scientific evidence needed on the safety and efficacy of complementary health approaches and disseminate evidence-based information to the American public.


David Shurtleff, Ph.D.

Acting Director, National Center for Complementary and Integrative Health

David Shurtleff, Ph.D., is Acting Director of the National Center for Complementary and Integrative Health (NCCIH), performing a wide range of activities aimed toward directing and implementing a program of research that builds a scientific evidence base about complementary and integrative health approaches that advances fundamental knowledge, and informs decision making by the public, health care professionals, and health policymakers. Dr. Shurtleff’s 23-year career at the National Institutes of Health (NIH) has focused on providing leadership and fostering an extensive research portfolio in the basic behavioral and neurosciences—cognitive studies, behavioral economics, decision theory, and risk-taking—and a broad spectrum of research that has contributed to cutting-edge research related to drug abuse, addiction, and their treatment. Prior to becoming Acting Director, NCCIH, Dr. Shurtleff served as the Deputy Director of NCCIH. Prior to joining NCCIH he served as the Acting Deputy Director of the National Institute on Drug Abuse (NIDA). At NIDA, he helped develop, implement, and manage the Institute’s broad grant portfolio covering basic cellular, molecular, and systems neurobiology as well as behavior, treatment, medication development, clinical neuroscience, clinical trials, prevention, and health services research. Prior to joining NIDA, Dr. Shurtleff was a research psychologist at the Naval Medical Research Institute in Bethesda, Maryland, where he conducted basic behavioral, electrophysiological, cognitive, and field research on a variety of issues related to cognitive performance, environmental stress, and peripheral neuropathy. He also served as a research fellow at the Walter Reed Army Institute of Research in the Department of Medical Neurosciences. Dr. Shurtleff holds a B.S. degree from the University of Massachusetts. He received his M.A. and Ph.D. degrees in experimental psychology from American University.

He has received various honors and awards including several NIH Director’s Awards. One of these awards recognized his outstanding contributions to the 2014 President’s BRAIN Initiative.