NIH Announces HEAL Initiative to Combat Opioid Crisis

Pain research gets a boost in funding as part of the effort. Image credit: Lydia Polimeni, National Institutes of Health.

Editor’s Note: This article originally appeared on the IASP Pain Research Forum, and has been lightly adapted for RELIEF.

Pain researchers and advocates are cheering the announcement of the HEAL (Helping to End Addiction Long-term) Initiative, which promises to roughly double US National Institutes of Health (NIH) funding for addiction and pain research from about $600 million in fiscal year 2016 to $1.1 billion in fiscal year 2018.

NIH director Francis Collins announced the initiative April 4, 2018 at the National Rx Drug Abuse and Heroin Summit. HEAL was developed in response to a call to action from the White House for the US Department of Health and Human Services (HHS) to address the opioid addiction and overdose crisis.

American Pain Society president William Maixner said of the initiative in a press release, “The APS applauds NIH for significantly increasing funds earmarked for pain research and for taking meaningful steps forward in implementing a key recommendation of the National Pain Strategy. Inadequate pain research funding has stalled innovation in finding new therapies. Now the barrier at last has been lowered, and we look forward to participating in a pain research renaissance to finally end the opioids scourge that plagues our nation.”

Robert Gereau, director of the Washington University Pain Center, St. Louis, US, has long advocated for more NIH funding for basic science pain research (that is, for laboratory research in cells and animals that investigates the fundamental workings of the pain system). Is this the package he has been asking for?

“It sure looks like it,” he says. “This is the funding we desperately need. Pain research has been woefully underfunded for years, and this is what we’ve been asking for.”

Focus on addiction
As its name indicates, the HEAL initiative is primarily focused on the opioid addiction epidemic. As such, the initiative’s pain research aim falls under a heading titled “Prevent Addiction through Enhanced Pain Management.”

“These two epidemics of overdose and chronic pain are inextricably linked,” Gereau says, so the initiative is appropriately targeting both problems together. “It’s a little frustrating” that pain research is only getting a boost in funding because of the opioid crisis, he says, “but from a practical point of view, we’ll take it. It will be interesting to see how much of the funding goes to pain research.”

HEAL will not fund pain research across the board, said Linda Porter, director of the Office of Pain Policy at the National Institute of Neurological Disorders and Stroke (NINDS), which coordinates pain research across the NIH. “HEAL does not cover the entire spectrum of pain research, but it will be more targeted to what we think can get out to the clinic rapidly.”

HEAL projects will make use of technologies developed through the NIH’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative and Stimulating Peripheral Activity to Relieve Conditions (SPARC) program. BRAIN is a collaborative project across many agencies to better understand brain function, while SPARC is aimed at understanding nerve-organ interactions.

“We can capitalize on BRAIN and SPARC, take those innovations and apply them to study pain mechanisms,” says David Shurtleff, acting director of the National Center for Complementary and Integrative Health (NCCIH) at the NIH. The technology will also be used to identify pain-related biomarkers—indicators that could identify people more or less likely to respond to a given treatment, or who might be more prone to side effects.

The HEAL initiative also contains a more discovery-oriented aim, which is to understand what happens in the nervous system in the transition from acute to chronic pain, and to be better able to predict who will be affected and why.

“That will take longer to get to the clinic, but I’m excited about this project, because it could transform how we treat chronic pain—we could go from management to prevention,” Porter said. “This is a big, complicated study that we have wanted to do for years, but it needs to be done well and broadly, and we will need to rely on a big swath of the research community to help.” The HEAL funds and networks will finally allow it.

Public-private partners
In 2017, the NIH held meetings with experts in pain research, including basic scientists and representatives from the pharmaceutical industry. “HEAL is based on those conversations,” Porter said.

William Schmidt, a pharmaceutical consultant at NorthStar Consulting, Davis, California, US, attended several of those meetings. A key element of HEAL is that it aims to establish public-private partnerships between pharmaceutical companies and researchers at academic institutions, Schmidt said. And within pharma, he said, “the idea is to share data among companies rather than compete with one another.”

Schmidt said that Francis Collins challenged the group to speed the drug development process. He laid down a bold challenge: to reduce the time it takes to develop new analgesic drugs (pain relievers) by half or more. “We discussed the lack of new products coming into the pipeline, so one aim of HEAL is to take a second look at drugs that have been passed over for reasons other than safety and bring them back into the pipeline.”

HEAL recommends establishing a clinical trials network for pain medications, which would be housed at academic centers around the country but would be used by both academic and industry researchers, Schmidt said.

“Testing abandoned or repurposed compounds might be ideally suited to going into this sort of clinical trials network,” he said. “Pharma companies developing a new compound would be reluctant to use the network, but for drugs that maybe didn’t show efficacy [to relieve pain], or maybe the trial wasn’t designed properly—this would be a way to get them back into a uniform flow.”

“The idea of developing reformulated drugs is particularly exciting because of the potential for shorter-term outcomes,” Porter said. “There are compounds out there that have already been tested, they’re safe, they’ve gone through years of development, so the whole process would be accelerated. So that’s very exciting in the short term.”

As for the public-private partnership, Porter said, “We wanted to bring in industry where we can benefit from their expertise and they can benefit from, for example, the clinical trials network. It’s an important partnership. Their knowledge and expertise are incredibly valuable, and they really know how to do early drug development.”

Gereau, who also attended the 2017 meetings, is somewhat skeptical that pharma companies will put their business interests at risk, but, he said, “I am really hopeful that their stated dedication and renewed commitment results in real change and brings groups to the table, because the assets they have are incredible, and it would be a waste not to leverage those.”

Patients are waiting
Cindy Steinberg is an advocate for people with pain as National Director of Policy and Advocacy at the U.S. Pain Foundation, a non-profit organization based in Middletown, Connecticut, US, that connects, empowers, supports and serves those living with chronic pain. Steinberg said of the HEAL initiative, “It’s fantastic; I am thrilled.”

She praised the new funds for pain research, saying that “a root cause of the inadequate treatment of chronic pain is a lack of understanding of pain in the human body; we still don’t understand the basic neurobiological mechanisms of pain.” Steinberg is also an appointed member of the Interagency Pain Research Coordinating Committee (IPRCC), an NIH advisory group, and a chronic pain sufferer herself.

Steinberg is concerned, however, that despite the initiative’s potential for leading to future pain treatments, “it won’t help in the short term. There are not a lot of truly effective treatment options for people who are suffering now.” Improving pain treatment in the short term would require improving clinical care, she said, including making more non-drug treatments available and affordable. “Care could be better if it were coordinated better, and if doctors were compensated for spending more time with patients. That demands a different model of care from what we’re using now.”

HEAL does recommend studying non-drug modalities of care, building on a collaborative research effort already underway between HHS, the Department of Defense (DoD) and the Veterans Administration (VA).

“That’s our flagship program,” said NCCIH’s Shurtleff, which is slated to fund research to the tune of $81 million over the next six years to develop and test non-drug treatments for pain. “Part of that is going to be pragmatic research, on implementation—how can we quickly accelerate these findings not only to the VA and the DoD but beyond as well.”

“There is a real focus here that I like, a practical sense about things,” Gereau said. “What are the real-world best practices? What non-drug and integrative therapies can we use? There are a lot of studies on these already, but more data will drive changes in practices and hopefully will move insurance companies and payers to support them.”

The HEAL initiative is still in the formative stages, Shurtleff said. “These are the big ideas, but there will be more specific and very detailed programs coming out in the coming months.” An additional $500 million will be allocated to the National Institute on Drug Abuse (NIDA) and NINDS and distributed between pain and addiction research, but Shurtleff says those funds may also be shared across other institutes as well.

“It has a nice mix of discovery and the practical, and I’m hopeful for meaningful outcomes,” Gereau said. “Frankly I hope the funding brings more people to this game. We need more people working on the problem.”

Stephani Sutherland, PhD, is a neuroscientist, yogi, and freelance writer in Southern California.