Any life cut short is a tragedy, but the opioid crisis in particular is staggering in the number of lives it has claimed. Opioids—a class of drug that includes everything from heroin to commonly-prescribed pain medications like oxycodone—killed more than 42,249 Americans last year. That’s 115 lives lost each day.

The scope of the opioid crisis is so enormous that it’s a major reason why average life expectancy in the United States declined for the second year in a row, and some experts fear opioid deaths could top 500,000 over the next decade. It is a crisis that spans all demographics. An addiction specialist at Stanford University speculates that the problem may be even worse than it looks—research has shown official figures are likely undercounting the true number of opioid deaths by at least 20 percent, meaning that even if we ignored deaths from all other drugs, the opioid epidemic alone is deadlier than the AIDS epidemic was at its peak.

The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

History of Opioid Misuse

The opioid crisis in America is primarily tied to two issues. The first issue is the significant rise in opioid analgesic prescriptions that began in the mid-to-late 1990s following FDA approval of Oxycontin in 1995 and Fentanyl in 1998. Not only did the volume of opioids prescribed increase, but well-intentioned healthcare providers began to prescribe opioids to treat pain by prescribing high doses for longer durations, protocols we now know to be high-risk and have been associated with abuse, addiction, and overdose.

The second issue is a health system and healthcare provider incapacity to identify, engage, and provide those abusing opiates with high-quality, evidence-based opioid addiction treatment. It is well-documented that the majority of people with opioid addiction do not receive treatment, and among those who do, most do not receive evidence-based care.
Accounting for these factors is vital to the development of a successful strategy to combat the opioid crisis. Further, there is a need for more rigorous research to better understand how existing programs or policies might be contributing to or mitigating the opioid epidemic.

What’s Being Done?

Agencies across the country are working on strategies to curb the opioid crisis. The U.S. Department of Health and Human Services (HHS) is focusing its efforts on five major priorities:

  1. Improving access to treatment and recovery services.
  2. Promoting use of overdose-reversing drugs.
  3. Strengthening our understanding of the epidemic through better public health surveillance.
  4. Providing support for cutting-edge research on pain and addiction.
  5. Advancing better practices for pain management.

In the summer of 2017, the FDA and NIH met with pharmaceutical companies and academic research centers to discuss safe, effective, and non-addictive strategies to manage chronic pain along with innovative medications and technologies to treat opioid use disorders. Further, in April of 2018 the NIH Director, Francis S. Collins, launched HEAL (Helping to End Addiction Long-Term) which is an aggressive inter-agency effort to speed scientific solutions for the national opioid public health crisis. Lastly, the FDA has stated their commitment to the development of non-addictive pain management therapies via the Fast Track and Breakthrough Therapy Designations that are intended to facilitate development and to expedite review of products that, for example, are intended to treat a serious condition for which there is an unmet medical need.

What Can We Do? Sponsors and IRBs working together

Consistent with the stated goals of the FDA and NIH, IRBs should be prepared to provide quick and thorough review of new and innovative treatments for pain and opioid use disorders. We know that developing non-opioid and non-addictive pain medicines is challenging for many reasons, and at the same time as we are prioritizing work on non-opioid and non-addictive pain management therapies we should all be taking steps to facilitate the development of treatments that can help patients with addiction recover, as well as promoting overdose reversal drugs.

As new pain management medications and treatments are being developed we need to be cognizant of preventing a future epidemic. Both Sponsors and IRBs should have assurance that protocols include or have considered preclinical drug abuse paradigms to assess abuse potential of novel compounds (i.e., self-administration, microdialysis etc.). We should also be limiting uncontrolled access to study drugs by storing them in pharmacy or behind double-locked doors with limited access by study staff. We should be assessing the amount of study drug dispensed at a given time, for example, participants are only dispensed weekly doses or have more frequent visits to limit the amount of drug available. Study drug could be dispensed in bubble or popout containers to reduce the likelihood of overdose and improved medication compliance.

Ending the opioid crisis will require better coordination of care, community involvement in finding solutions, and more consistent use of improved pain-control options. Combating this epidemic requires urgent, evidence-based approaches that address clinical, research, and education issues.

Stay tuned for a Quorum-produced whitepaper that examines these issues in greater depth.

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