Innovation in treating chronic pain requires new measures

Christine Lemke is co-founder and president of Evidation Health, a health and measurement company that provides technology and guidance to understand how everyday behavior and health interact.

As a second state pursues legal action against makers and distributors of opioid painkillers, the focus has continued to be on overdose deaths from prescription opioids, now averaging 46 per day. Often overlooked in this conversation is the broader epidemic—the 50M U.S. adults who suffer from chronic pain, of which, more than 19.6M Americans are thought to have high-impact chronic pain (i.e., pain that frequently limits life or work activities).

With one in three U.S. adults living and silently suffering with their chronic pain (count me as one, thanks to a rare genetic condition that causes inflammation between my spinal joints), there is a desperate need for responsible, ethical treatment of chronic pain.

In spite of this need and overreliance on prescription opioids to treat pain, only five novel drugs have been approved by the FDA to treat pain in the last 10 years. Three of those are indicated for migraines and were only approved last year. This shouldn’t be a surprise to anyone looking at the leading indicators—BIO found there were 10 times as many active clinical programs in oncology relative to pain, and that pain had received 17 times less venture funding than oncology.

Developing novel analgesics is a challenging endeavor, in part because pain is a subjective condition. Doctors ask patients to rate pain severity on a numeric scale or point to the faces on the Wong-Baker FACES chart, even though it is commonly understood that the measurement may not be the same given different patient contexts. Additionally, chronic pain can come and go over weeks; in my case, I cannot perfectly predict when my next flare is coming, creating an additional hurdle for developers of novel treatments or a doctor seeking to understand the severity of the complaint.

Innovation in the way we measure chronic pain is critical to unlocking innovation in the way we treat chronic pain. Measurement today has largely been limited to capturing information patients provide when they visit the clinic or pause to record how they feel. And existing approaches to track self-reported outcomes are not easily used to develop a personalized treatment plan, as they typically lack important behavioral or contextual factors.

Despite the innate subjectivity of pain, there is an unprecedented amount of objective data available, enabling a combined view of pain that could lead to a more discrete understanding of individual experiences and the best approaches to treatment.

The pathway forward on measurement must include both a push toward higher frequency, closer to real-time capture of patient experience (versus point in time capture at the doctor’s office that is prone to recall bias) and the use of objective data that can help better measure and quantify severity, triggers for flares, and quality of life (versus only subjective data).

One example is the use of advanced neuroimaging to understand pain perception and analgesia, such as the research work being done at the Pain Analgesia/Anaesthesia Imaging Neuroscience (P.A.I.N.) Group based at Oxford. Another example is the Digital Signals in Chronic Pain (DiSCover Program). For full disclosure, DiSCover was initiated, designed, and funded by the company I co-founded, Evidation Health. Launched in 2018, it is the largest nationwide study of chronic pain ever undertaken and includes high-scale digital data collection.

DiSCover has enrolled more than 10,000 individuals from all 50 states, and study participants are helping to create a novel set of data that provides visibility into the day-to-day life of individuals living with chronic pain, utilizing smartphones, wearables, connected sensors, health apps, voice and speech, genetics, traditional blood-based biomarkers, direct patient reports, and more. The primary research objective is to develop novel digital measures that quantify chronic pain severity, flares, and quality of life.

This data set is enabling researchers to take an in-depth look at how an individual’s subjectively reported daily experience with pain relates to objective data such as genetics, blood-based biomarkers, physical activity, heart rate, sleep, and voice and speech. Researchers are gaining an unprecedented level of visibility into what is happening with an individual when they experience (and don’t experience) pain, instead of relying solely on infrequent and potentially unreliable self-reporting.

Developing a new class of treatments to treat chronic pain is an area fraught with a high degree of scientific and technical risk and significant unknowns. What we do know is that we cannot reduce the use of opioids and help people suffering from chronic pain without fully understanding the problem. And that is an undertaking that will require new sources of data and investment in research that bridges underfunded efforts fragmented across academia, condition-specific foundations, life sciences companies, and others in the private sector.

Innovation hinges on first developing personalized and objective ways to measure pain. More than 10,000 Americans have committed to help us in this pursuit and we welcome the collaboration of research partners who are equally passionate about this endeavor.