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Research to pinpoint the biological underpinnings of what causes pain could help drug companies develop better pain medications and replace the health-care industry’s reliance on opioids.
The National Institutes of Health will soon invite scientists to apply for grants to discover and validate biological indicators, or biomarkers, to show that a response to the pain treatment has occurred. If successful, these biomarkers could improve clinical trials and potentially lead to better therapies for the 25 million Americans who are suffering from chronic pain.
“The lack of biomarkers has hampered research, particularly in drug development. We have very few, really effective drugs for chronic pain,” Cindy Steinberg, a Boston-based patient advocate and the national director of policy and advocacy for the U.S. Pain Foundation, told Bloomberg Law. “Opioids are one of them, and they obviously come with a lot of downsides.”
The NIH work on pain biomarkers is part of the HEAL Initiative, an agency-wide effort to combat the opioid crisis while finding better pain treatments. HEAL, which stands for Helping to End Addiction Long-term, builds on a public-private partnership between the Foundation for the NIH and more than 30 biopharmaceutical companies.
An Eli Lilly and Co. executive told Bloomberg Law he is hopeful biomarkers for patients with chronic pain conditions will be developed and validated. “Ideally, these biomarkers may help stratify the best patients for clinical trials and monitor the impact of a pain medicine in a clinical trial on a patient’s experience or function,” Mark Mintun, Eli Lilly’s vice president of pain and neurodegeneration, said in an Aug. 3 email.
Congress gave the NIH $500 million over two years for the HEAL initiative in response to the opioid epidemic, a public health emergency linked to 116 deaths per day.
The NIH agency would like to receive applications by the end of the year and has already has published an initial notice, said Michael Oshinsky, who is the program director of pain and migraine in the NIH’s National Institute of Neurological Disorders and Stroke.
The biomarkers initiative aims to change the assessment of pain in the patient, in the context of developing new therapeutics, or for determining whether a treatment is working for a patient, Oshinksy told Bloomberg Law.
“One of the things that we really believe is that the HEAL money can galvanize the community to put more effort in this area,” Oshinksy said. Acceleration of new therapeutics can “replace the very strong reliance for the health-care industry on the use of opioids to treat pain.”
The NIH defines a biomarker as a “defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.”
Clinical trials for pain intervention typically have relatively high levels of placebo response, Oshinksy said. A biomarker would allow researchers to determine whether the treatment being testing actually works by measuring the direct effects of a drug compound, instead of relying patient responses.
“It could really change the paradigm of how we do these clinical studies if you’re looking for a physiological response and not a cognitive response to the pain that’s subjective,” he added.
Identifying the biological mechanisms causing pain might provide clues about what treatments will be most effective, Roger B. Fillingim, who’s been researching pain for more than 25 years, told Bloomberg Law.
“It’s trying to find more specific remedies that target the mechanism that’s responsible for their pain,” Fillingim said, “as opposed to maybe a more generic approach where we give people what we have on hand that we believe helps people to feel better.”
Low back pain, for example, could be due to any number of causes, such as structural damage in the spine or an alteration in the compounds regulating the nervous system. “If we’re going to effectively diagnose and treat these different conditions, we need to have some markers of those different mechanisms,” said Fillingim, who’s a professor at the University of Florida and a former president of the American Pain Society. “And our current diagnostic systems don’t support that.”
Chronic pain patients usually get grouped based on where pain is occurring, but, Fillingim said, if researchers can target a biological process associated with a treatment, “it ceases to matter where their pain is. It’s much more important why their pain is. Because the ‘why’ is what we try to target with our treatments.”
With an abundance of scientific literature, Fillingim said, “it seems conceivable that we’re maybe a few years away, not decades away” from using biomarkers.
Patients also could prove more easily they qualify for disability and other services with biomarkers, Steinberg said. Right now, somebody in horrible pain will “be questioned about whether this treatment is really necessary because it costs money.”
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