The NIH is pulling out all the stops to make President Donald Trump’s Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand a reality. And older Americans are likely to benefit every bit as much as young people.
Learning about fatal opioid overdoses changes prescribing behavior. That was the headline on an announcement today from the National Institutes of Health (NIH) outlining a study the nation's medical research agency did to see if putting an individual face on the opioid epidemic could alter prescribers’ behavior. As it turns out, it did just that.
Researchers first identified 170 people who had a fatal prescription opioid overdose over a year in one California county. They then located 861 clinicians who'd written at least one prescription to one of the deceased and sent them letters from the county’s medical examiner notifying the doctors of their patient's overdose death, along with that patient’s name, address and age.
The team found that opioid prescribing was almost 10% lower among the clinicians who received the letters compared to the control group over a three-month period beginning a month after the letters were mailed. Moreover, clinicians who received the letters were 7% less likely to start a new patient on opioids and wrote fewer prescriptions for high-dose opioids.
In keeping with its daunting pursuit of curbing the nation’s opioid crisis, the NIH also announced today that it has launched the Acute to Chronic Pain Signatures (A2CPS) program to investigate the biological characteristics underlying the transition in some people from acute to chronic pain.
Part of the NIH’s HEAL (Helping to End Addiction Long-term) Initiative—an aggressive, trans-NIH effort to bolster research to speed up the discovery of scientific solutions that could stem the national opioid public health crisis—the effort will also seek to determine the mechanisms that make some people susceptible and others resilient to the development of chronic pain.
According to the NIH, the high prevalence of chronic pain in the United States, and the reliance on opioids for its management, has created an urgent need for safer, more effective pain control. “Though A2CPS is part of the HEAL Initiative, its anticipated $40.4 million four-year budget is supplied by the NIH Common Fund, and is an additional investment to enhance research on pain and opioid addiction beyond funds already allocated to HEAL.”
In most cases, pain dissipates as an injury heals. But for some people, pain can last a long time if not for the rest of their lives—transforming from acute pain to chronic pain. This creates a major challenge in pain care. With the A2CPS initiative, scientists want to find out what changes occur in the body and brain during the development of chronic pain so that they might find new therapies to treat them.
“Our lack of understanding of how acute pain becomes chronic pain has limited our ability to target effective preventive and treatment strategies to patients,” said NIH Director Francis S. Collins, M.D. Ph.D. in a statement.
“The ability to identify those at risk will increase our understanding of pain, accelerate therapy development, and ultimately may guide chronic pain prevention strategies tailored for those at risk for chronic pain.”
The NIH says the A2CPS program will collect data from patients with acute pain associated with a surgical procedure and patients with acute pain from a musculoskeletal trauma such as a broken bone. The large number of traumatic events and surgeries performed annually makes the results of the studies more likely to be meaningful to a significant number of patients, according to A2CPS program staff. “The predictive signatures in these populations will help us find signatures in other pain conditions,” they said.
“Neuroimaging, high-throughput biomedical measurements, sensory testing and psychosocial assessments collected periodically after the acute pain event will form a comprehensive data set to help predict which patients will develop chronic pain,” the NIH contends.
This information will hopefully help researchers identify individual patient features that together will provide clinically meaningful, predictive “signatures” of transition or resilience to chronic pain. Additional studies that include patients with other acute pain events could also be considered if the data pans out. Researchers hope that these biological signatures can predict who might be at risk for developing chronic pain as these would be valuable in guiding precision medicine approaches to prevent chronic pain, and by doing so, reduce reliance on opioids.
Francis S. Collins, M.D., Ph.D., NIH director, announced the launch of HEAL at the 2018 National Rx Drug Abuse and Heroin Summit in April. With the program and through a financial boost by Congress, the NIH nearly doubled funding for research on opioid misuse, addiction and pain from approximately $600 million in fiscal year 2016 to $1.1 billion in fiscal year 2018.
“Every day, more than 115 Americans die after overdosing on opioids” such as oxycodone and fentanyl, Collins said. “That is a four-fold increase since 2000, and the numbers continue to climb. NIH has been deeply invested in efforts to counter this crisis through research, but we are determined to do even more.”
And America’s opioid crisis is certainly not owned by the young. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), in its Resources List: Opioid Use in The Older Adult Population, nearly half of older Americans suffer from a chronic pain disorder, and the population of older adults who misuse opioids is projected to double from 2004 to 2020.
“As the baby boomer generation ages and the population of older adults in the United States grows, opioid misuse among older Americans is becoming an increasingly urgent public health concern,” the document states. “An analysis of Medicare Part D data by the Office of the Inspector General revealed that more than 500,000 Medicare Part D beneficiaries received high amounts of opioids in 2016, with the average dose far exceeding the manufacturer’s recommended amount.”
And opioid abuse in older adults poses unique problems of its own, the document states. “Beyond the threat of addiction, opioid use can also pose health risks such as breathing complications, confusion, drug interaction problems and increased risk of falls…”
Still the SAMHSA acknowledges that even with the risks, opioids can be a valuable tool in treating pain and improving quality of life in older adults and that physicians have an important responsibility in monitoring them. “Nearly half of older Americans suffer from a chronic pain disorder, and the incidence of chronic pain increases with age,” its resource document says. “Opioids can help older adults maintain their independence, which is a key predictor of health, and can treat debilitating pain that might otherwise leave individuals immobilized and homebound. Prescribers serve a critical role in weighing the benefits and risks of opioid use in the older adult population and treating individuals through responsible prescribing practices.”
According to A2CPS staff, the next step for the NIH is to wait for researchers to apply for funding through the program. The NIH is currently seeking applications for multisite clinical centers for the surgical and musculoskeletal pain studies, a clinical coordination center, omics data generation centers, and a data integration and resource center. Funding Opportunity Announcements for researchers to apply to participate in the A2CPS program are now available, and applications are due October 24, 2018.
“The earliest we expect research funds to be issued is in June of 2019. Once the researchers are selected, the program will enter a planning year to organize its clinical studies,” a spokesperson for A2CPS said. Studies could start recruitment for the approximately 1,800 participants needed per study as early as Fall 2019, though until researchers are selected to conduct the studies, program organizers will not know with whom. More information about the clinical sites will be posted to here once researchers are selected.
The A2CPS program is supported by the NIH Common Fund and is managed by a trans‐NIH working group representing multiple NIH Institutes and Centers, led by the Office of the Director, the National Institute on Drug Abuse (NIDA), and the National Institute of Neurological Disorders and Stroke (NINDS).
The nation's medical research agency, the NIH includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services (HHS). It is also the primary federal agency conducting and supporting basic, clinical and translational medical research, and is investigating the causes, treatments and cures for both common and rare diseases.