Aegis Compliance and Ethics Center, LLP
Clinical Research in the Age of Opioid Addiction
Opioid addiction remains a serious problem in the United States. Deaths from overdose, both from prescription pain killers and narcotics, such as heroin, amounted to about 64,000 in 2016, according to the Center for Disease Control. That’s twice the rate of deaths caused by firearms in a single year; same for automobile accidents. With opioid use and access increasing, the world of health care needs innovative ideas to prevent future overdoses and meet pain management needs.
A Public Health Emergency
The category of opioids includes substances intended for medical use—such as oxycodone, morphine, and codeine—and illegal drugs—such as heroine. These substances act on opioid receptors in the brain and can relieve pain or create euphoric effects. Whether a user starts opioids with a doctor’s prescription or recreationally, users may become addicted and with continued use, are more susceptible to overdose.
In October 2016 President Donald Trump declared the country’s opioid addiction epidemic a public health emergency. The official designation aims to raise awareness of drug abuse, expand access to counseling and allow for the use of some federal funds to combat the crisis. For some policy and law-makers, however, Mr. Trump’s declaration is just the start; critics argue that without significant federal funding and directives, overdose-related deaths will still remain high. The Trump Administration has indicated that more guidelines will be released soon.
For now, at least, local and state governments, health care providers and drug manufacturers search for creative resolutions to the opioid crisis. The city of Seattle looks to open “safe-consumption sites” to prevent heroin overdose deaths. A New York addiction center allows users to test if their heroin supply is cut with potentially lethal fentanyl. The lobbying group Pharmaceutical Research and Manufacturers of America advocates for new policies to reduce the duration of new prescriptions and bolster the Drug Enforcement Agency’s ability to monitor suspect drug shipments.
The Food and Drug Administration (“FDA”) also looks to take a leading role in combatting the emergency. The department works to protect consumers by ensuring the safety, quality, and effectiveness of existing and new medical drugs and devices. Scott Gottlieb, Commissioner of the FDA, announced a review of packaging and dispensing of prescription opioids and issued a statement promoting medication-assisted treatment that combines medication with behavioral counseling to combat addiction.
Perhaps the biggest opportunity both to curb the present rise of opioid use and provide better care to medical patients and opioid users will come in the form of innovation—new drugs, procedures, and treatment plans that serve patients better. Researchers can aim to reduce the medical community’s reliance on prescription painkillers and improve intervention and treatment for addicted users.
Rethinking Clinical Research
New ideas in healthcare and medicine are practically limitless. For common surgeries, investigators can test less-invasive procedures that do not require as long of recovery times, thereby reducing the amount of prescription pain medication a patient may need. Sponsors can develop and evaluate new drug offerings that provide less-addictive pain relief or lower-dose formulations of known medicines that last longer. As with any novel medical hypothesis, these solutions rely on sound science and robust clinical research to demonstrate their safety and effectiveness.
Gottlieb defends the empirical standards of clinical research in demonstrating the quality of medicine, but he argues the process from development to FDA-approval is unnecessarily burdensome. In his tenure as head of the FDA Gottlieb hopes to make clinical trials more efficient. In an interview with Washington Post, Gottlieb suggested the FDA can clarify for sponsors and investigators what evidence can be used in an approval application, such as pre-clinical studies in assays and animals and statistical modeling of trial data. He explained further that sponsors can create enriched trial designs and develop master protocols that explore multiple scientific outcomes in the same study. For Gottlieb “this isn’t a binary choice where if we reduce development timelines on average, we’re going to have less safe drugs. I think you can actually reduce development timelines and have a higher assurance of safety and efficacy if what you’re doing is scientifically sound and you’re incorporating better methodologies.”
Specifically relating to prescription opioids, the FDA may also consider new data methodologies when evaluating a currently available drug. An article from BioCentury explains how the FDA could examine the overall effect of a drug on a total population, rather than the clinical benefit for an individual patient and could use side-by-side comparisons of various treatments to remove unsafe drug options from the market.
The Future of Innovation
Given the present opioid emergency, new clinical trials are slated to begin. Last July the New England Journal of Medicine described the National Institute of Health’s (“NIH”) three-pronged approach to tackle the crisis. NIH hopes to partner with drug manufacturers and researchers to improve overdose intervention, treat addiction and manage chronic pain. So far through research, development and testing, NIH and their partners developed a naloxone nasal spray to prevent overdose-related deaths and a buprenorphine implant that pain relief over a six-month period. Other clinical trials aim to compare the effectiveness of opioid-addiction treatments against one another, to identify a better standard of care.
The health care world needs revolutionary thinking to respond to the opioid crisis. Clinical research can pave the way to a variety of solutions. Hopefully with the FDA’s renewed focus on trial efficiency and scientific interest in the current epidemic, researchers can swiftly and effectively develop improved treatment options for all patients.