NCCIH Director's Statement for the Senate Appropriations Subcommittee Regarding the FY 2017 Budget Request

Prepared Statement of Josephine P. Briggs, M.D.
Director, National Center for Complementary and Integrative Health

April 7, 2016

Mr. Chairman and Members of the Committee:

I am pleased to present the President’s Fiscal Year (FY) 2017 budget request for the National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health (NIH).

The NCCIH is the lead Federal agency for scientific research on the usefulness and safety of complementary and integrative health practices. Complementary health approaches include mind and body interventions, such as massage, acupuncture, yoga, and meditation, and natural products, such as dietary supplements and probiotics. To address the need for objective evidence as to the safety and efficacy of many of these approaches, NCCIH supports rigorous scientific investigation to better understand how these interventions work, for whom, and the optimal method of practice and delivery.

The 2012 National Health Interview Survey (NHIS), conducted by the Centers for Disease Control and Prevention (CDC) with support from NCCIH, showed that one-third of U.S. adults use complementary and integrative health approaches. Many of these individuals seek these approaches to improve their health and well-being or to manage symptoms of chronic diseases or the side effects of conventional medicine. Natural products (dietary supplements other than vitamins and minerals) are the most commonly used complementary health approach, followed by deep breathing exercises and yoga.

Reducing Pain and Improving Symptom 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 United States (11.2 percent) experience daily pain. In addition, nearly 40 million adults (17.6 percent) experience severe levels of pain and are likely to have worse health status than the general public.¹

CDC has classified fatal overdoses involving opioid analgesics, medications used to treat pain, as an epidemic. To help address this crisis, we need improved strategies for pain management so that healthcare providers are less reliant on prescribing opioids. NCCIH supports research to better understand pain and to identify effective nonpharmacologic approaches to reduce the duration and intensity of pain. For example, our intramural research program studies the role of the brain in perceiving, modifying, and managing pain. Specifically, scientists are investigating the role of the brain in pain processing and how emotion, environment, and genetics affect its perception.

Recent results from NCCIH’s extramural research program are advancing our understanding of the mechanisms of action of mind and body interventions and helping determine their effectiveness for treating pain. For example, previous research showed that mindfulness meditation helps relieve pain, but the mechanism through which meditation exerts this effect is not well understood. New study results, funded in part by NCCIH, demonstrate that mindfulness meditation may work on a different pain pathway in the brain than opioid pain relievers. Since opioid and non-opioid mechanisms of pain relief interact synergistically, the results suggest that combining mindfulness-based and other pain-relieving approaches that rely on opioid signaling may be particularly effective.

Furthermore, study results published in the Journal of the American Medical Association expand the evidence base for the effectiveness of mind and body interventions. In the first randomized clinical trial to rigorously evaluate mindfulness-based stress reduction (MBSR) for young and middle-aged adults with chronic low-back pain, researchers compared MBSR with usual care (UC) and cognitive-behavioral therapy (CBT). They found that individuals with chronic low-back pain who received training in MBSR and CBT, compared with UC, demonstrated greater improvements in functioning and reductions in chronic low-back pain at six months and one year following treatment. The persistence of these beneficial effects suggests that MBSR and CBT may provide patients with skills for long-term management of pain.

NCCIH is also working with other NIH Institutes and Centers, the Department of Veterans Affairs (VA), and the Department of Defense (DOD) to test improved pain management strategies. Military personnel, veterans, and their families often struggle with pain management and its associated comorbidities including opioid misuse, abuse, and disorder. NCCIH plans to support a clinical trial coordinating center to launch a multi-year program to develop and test the efficacy and effectiveness of nonpharmacologic approaches to pain management and comorbidities for our military and veteran populations. Additionally, NCCIH is collaborating on the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative to accelerate the development and application of technologies to study the brain. NCCIH also is leveraging its resources through the NIH Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program to better understand the mechanisms of action and the development of “electroceuticals” for therapies in which nerves are stimulated to control organ function.

Advancing Research on Natural Products

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, according to the 2012 NHIS. The use of dietary supplements at times poses risks. For example, adverse events related to dietary supplements are estimated to contribute to 23,000 emergency department visits in the United States each year.² To better inform consumers and their health care providers, NCCIH supports research on the biological mechanisms of the benefits and potential harmful effects of natural products, such as their interaction with medications and liver toxicity. In FY 2015, NCCIH established a Center of Excellence for Natural Product-Drug Interaction Research. The Center is systematically examining methods for studying natural product-drug interactions; developing standardized protocols to clarify which interactions have clinical impact; and disseminating its findings and resources broadly. In essence, the Center is developing a roadmap for the study of natural product-drug interactions with the ultimate goal of improving the body of knowledge available to health care providers, patients, and researchers.

To further enhance NCCIH’s natural products portfolio, NCCIH partnered with NIH’s Office of Dietary Supplements (ODS) to fund five research centers in FY 2015. These research centers focus on the safety of natural products, how they work within the body, and the development of innovative research technologies. Specifically, the three Botanical Dietary Supplements Research Centers will advance the understanding of the mechanisms through which complex botanical dietary supplements may affect human health and resilience. The two new Centers for Advancing Natural Products Innovation and Technology aim to propel chemical and biological investigation of natural products. Each is tackling unique research challenges. One center is working to improve the speed, breadth, and precision of the characterization of natural products by developing innovative cell-based screening approaches to uncover bioactive molecules of interest and their corresponding biological targets. The other center is coordinating and disseminating research technologies aimed at mining bioanalytical knowledge of natural products.

Spurring innovation and developing new methodologies may lead to alternative sources of medically relevant compounds. For example, researchers, supported in part by NCCIH, created an innovative method to produce opioid drugs from sugar using genetically modified yeast. Using genes from a variety of plants, mammals, and microorganisms, they created yeast cells that can perform the entire process of manufacturing the opioids thebaine and hydrocodone using sugar as the starting material — a process that involves more than 20 separate steps. This innovation opens the door to additional novel approaches to generating needed medically relevant compounds in diverse settings. The new technique illustrates the potential value of genetically engineered yeast as a platform for producing many complex chemicals and materials and may help lead to better drug development in the future. Given this advance is moving ahead of regulations and policy, open discussions and decisions for the use and application of this technology will be needed.

Assessing Cardiovascular Benefit of Chelation Therapy in Patients with Diabetes

NCCIH is leading a trans-NIH effort (with NHLBI, NIDDK, NIEHS) and funding a planning phase to replicate the previous NIH-funded Trial to Assess Chelation Therapy (TACT) in older heart attack patients with diabetes. “TACT 2” will assess if an intravenous solution, which includes ethylendiaminetetraacetic acid (EDTA) — a chemical used to treat environmental exposure to heavy metal toxicity such as lead or cadmium, will reduce cardiovascular events in diabetics. Its use for treating heart disease was found beneficial in TACT, particularly for diabetic patients over 50 years of age who had a previous heart attack, but needs replication before becoming universally accepted. Additional research to identify the mechanisms by which chelation may affect heavy metal body burden and cardiovascular disease risk is also being planned.

Inspiring Public Trust through Stewardship

NCCIH works diligently to be an efficient steward of the resources entrusted to us. Currently, we are undertaking strategic planning activities focused on prioritizing our future research investments in complementary and integrative health. Additionally, we are ensuring that research workforce needs, especially those of clinician-scientists, are addressed. NCCIH’s new strategic plan is expected to be released this summer.

Due to the self-care nature of these complementary health approaches, the translation and dissemination of unbiased, evidence-based information is of great importance to NCCIH. Therefore, helping consumers, health care providers, researchers, and policymakers be better informed about the safety and effectiveness of complementary interventions continues to be our primary communication goal. NCCIH makes research findings available to the public through multiple platforms, including video, social media, and mobile applications.

Conclusion

NCCIH continues to support research and leverage its strategic partnerships to build the scientific evidence needed by consumers, health care providers, and policymakers regarding the safety and efficacy of complementary health approaches. By catalyzing innovation, NCCIH is advancing research on natural products and mind and body interventions.