The NIH HEAL initiative

The NIH HEAL initiative

As the Nation’s medical research agency, one of NIH’s most important roles is leveraging our resources to respond to emerging public health crises. In my many years as a physician, and in the decade I have served in the federal government, the opioid epidemic is one of the most troubling problems I have ever witnessed. In February, at the behest of Congressman Evan Jenkins, I led a team from NINDS who traveled to Huntington, West Virginia to get a first-hand look at how this hard-hit community is addressing the issue on the ground. Huntington is dedicating incredible energy and valuable resources to provide addiction and overdose treatment and social services to people of all ages. Of key concern is evidence-based care for babies born with drug withdrawal symptoms. Every 25 minutes, a baby is born suffering from opioid withdrawal. The large number of babies born with Neonatal Opioid Withdrawal Syndrome at Cabell Huntington Hospital led to the opening of special units for their care, both in the hospital and a community supported facility – Lily’s Place  – to provide extended care for recovering babies. While I was inspired by the response mounted by this single town, our visit underscored the scale of the opioid crisis and its effects on Americans of all ages and from all walks of life. 

CDC statistic stating that 115 Americans die every day from an opioid overdose including illegal prescription opioids.
Poster reflecting the most recent CDC data that 115 Americans die every day from an opioid overdose. CDC Source: CDC

For millenia, our most potent treatments for pain have been opiate-based drugs, which have a high risk for addiction. The dramatic increase in prescription opioids starting in the 1990s, along with easier access to heroin and other illicit opioids such as fentanyl— has spiraled into the epidemic of addiction we face today. From the CDC’s most recent data, 115 Americans die every day from an opioid overdose, and the rate continues to rise. To turn the tide, we need better ways to prevent and treat addiction, a goal long-championed by our colleagues at NIDA. However, there is still a great need to treat people in pain in a safe way. With 25 million people experiencing daily chronic pain in the U.S., it is imperative that we support research to advance both our understanding of the underlying condition and develop better treatments for those suffering.

Congress recognizes this need as a priority and recently provided a boost in funding for “targeted research related to opioid addiction, development of opioid alternatives, pain management, and addiction treatment.” NINDS is dedicated to enhancing research into the underlying causes of pain and preventing addiction through the development of better pain therapies. To this end, and as part of the NIH HEAL (Helping to End Addiction Long-term) Initiative that Dr. Collins recently announced, we are introducing programs for which we will call on the expertise of the pain research community. A forthcoming webpage will detail all of the HEAL funding announcements, as I will only touch on several here.

First, with NINDS and NIDA at the helm, the NIH Common Fund program recently approved a large scale study to identify “biosignatures” that can predict the development of chronic pain following an initial acute injury. The study will focus on two different populations: people who are undergoing surgery and those with a musculoskeletal injury. We hope to find biological and psychological features related to the likelihood that an individual will recover from the acute pain event, or conversely, will go on to suffer from lasting chronic pain. What are the differences between such individuals? Based on their biosignatures, can we predict who is more likely to suffer from chronic pain? Answering questions like these could lead to more effective, personalized treatment of acute pain and prevent it from becoming chronic.

One of the other challenges of clinical trials for pain therapies is knowing whether a treatment is working. For many years, the standard way to measure pain has been a 1 to 10 pain severity scale. This scale can be incredibly subjective, making it difficult to distinguish a real response to treatment from a placebo effect. For this, we need objective biological indicators, or biomarkers, to show that a response to the pain treatment has occurred. NINDS recently initiated a biomarker program for neurological disorders that takes a three-pronged approach:  1) promoting rigorous biomarker validation, 2) collecting all information about existing NIH biomarkers (tissues and data) and making it available to researchers, and 3) helping to develop future resources to fill gaps in the biomarker development pipeline. To date, the NINDS biomarker program has published funding opportunity announcements that encourage the validation of biomarkers for neurological conditions, and we issued a notice of special interest in projects to develop and validate biomarkers for pain and pain therapies through this program. To further enhance this program, we are planning a workshop in early 2019, focused on best practices for biomarker discovery.

Graph displaying the 3 Waves of the Rise in Opioid Overdose deaths. Wave 1: Rise in Prescription Opioid Overdose deaths (purple line); Wave 2: Rise in Heroin Overdose deaths (gold line); Wave 3: Rise in Synthetic Opioid Overdose deaths (dark blue line).

Graph displaying the 3 Waves of the Rise in Opioid Overdose deaths. Wave 1: Rise in Prescription Opioid Overdose deaths (purple line); Wave 2: Rise in Heroin Overdose deaths (gold line); Wave 3: Rise in Synthetic Opioid Overdose deaths (dark blue line).
Source: National Vital Statistics System Mortality File

 

We envision that the signature effort of the initiative will focus on building a powerful Clinical Trials Network (CTN) for studies on novel treatments for pain. The primary goal of this CTN will be to accelerate new drug and device testing in early clinical trials for safety and efficacy. Running a clinical trial for pain is very complex due to the many different kinds of pain conditions that exist and frequent co-occurrence with other health issues, such as depression, anxiety, and sleep disturbances. In response, NIH will work with the academic, industry and patient community to develop and incorporate useful biomarkers to improve the ability to determine whether a treatment is hitting its biologic target.  The CTN will integrate data and establish clinical coordinating centers and centers of excellence to study well-phenotyped populations with specific types of pain conditions. We anticipate the CTN will be a learning environment making clinical trials to test pain treatments ever faster and more efficient.  

On top of these three new initiatives, we will look for opportunities through other NINDS programs to fund excellent pain research. One such opportunity is to leverage the strides made in neural technology development through the NIH BRAIN Initiative. We have issued a notice to researchers that we welcome BRAIN Initiative grant applications with a focus on nociceptive and pain circuitry. I will also continue to lead the collaborative efforts of pain research within NIH and the Department of Health and Human Services through the NIH Pain Consortium and the Interagency Pain Research Coordinating Committee (IPRCC), respectively. We will be working closely with the pain research community in the coming months to get the word out about these initiatives with the ultimate goal of effectively treating people with pain and preventing addiction by using safer treatments. When I think about the babies at Lily’s Place, or the patients suffering every day in chronic pain, or the 115 people dying every day from overdose, I am heartened by the potential of neuroscientists worldwide to contribute solutions to a very hard problem. I would encourage scientists of all kinds to consider if there are ways your work can combat the terrible problems of chronic pain and addiction; NIH is here to support you.

Wednesday, May 2, 2018