By: Marcus J. Hopkins, Blogger
A new report released by the National Academies of Science, Engineering, and Medicine (NASEM) makes several pointed recommendations about the way the United States Food and Drug Administration (FDA) approaches prescription opioid drugs, a class of pain relievers that are highly addictive and serve as a potential gateway to heroin, once supplies and sources of prescription drugs run dry (NASEM, 2017a). The panel, ordered under the Obama Administration’s FDA head in 2016, spent a year looking at the burgeoning opioid and heroin epidemics in the U.S. in an effort to better address these issues at every level of government (Diep, 2017). Among these recommendations are suggested guidelines for how the FDA considers the approval, regulation, and class scheduling of prescription opioid drugs.
Throughout the 1990s and early-2000s, pain advocates and pharmaceutical companies successfully lobbied the FDA to expand the indications (approved usage) for various high-powered opioid pain relievers that had previously been reserved for major surgeries, injuries, and palliative care. Purdue Pharma, in particular, scored a big win with its groundbreaking product, OxyContin, one of the first high-powered opioids to become commercially successful. What Purdue failed to mention while they were handing out free 30-day trial coupons for doctors to give to patients was that the drug was highly addictive. By the late-1990s, however, it became abundantly clear that these drugs had a high rate of addiction.
The recommendations put forth by NASEM as the FDA to adopt a position they term “opioid exceptionalism,” where “…the FDA thinks about opioid drugs differently from other products, …taking a public health approach to drug approvals and to other decisions about postmarket (sic) surveillance” (Servick, 2017). This would require the FDA to take into account the following:
- benefits and risks to individual patients, including pain relief, functional improvement, the impact of off-label use, incident opioid use disorder (OUD), respiratory depression, and death;
- benefits and risks to members of a patient’s household, as well as community health and welfare, such as effects on family well-being, crime, and unemployment;
- effects on the overall market for legal opioids and, to the extent possible, impacts on illicit opioid markets;
- risks associated with existing and potential levels of diversion of all prescription opioids;
- risks associated with the transition to illicit opioids (e.g., heroin), including unsafe routes of administration, injection-related harms (e.g., HIV and hepatitis C virus), and Opioid Use Disorder (OUD); and
- specific subpopulations or geographic areas that may present distinct benefit-risk profiles (NASEM, 2017b)
These recommendations come on the heels of a June recommendation by the FDA that pharmaceutical company, Endo, voluntarily remove its product, Opana ER, from the market in response to the public health crisis it says is in part because of illicit use of the drug by Injection Drug Users (IDUs) (Mandal, 2017). Endo recently complied with that request, despite insisting that it believes the drug to be safe when used properly (Ramsey, 2017).
Opana ER (Extended Release) is a reformulation of the drug in an effort to stem abuse by patients who were crushing the drug in order to snort it. This reformulation involved coating it with a plastic coating that Endo promised would make it “abuse deterrent/resistant.” Opana abusers, however, were quick to find a way around this by melting down the drug and its the plastic coating, filtering out the plastic through mesh, and injecting the drug directly into their bloodstream, resulting in a more intense effect (McEvers, 2016). Rather than alleviate abuse, Opana ER ended up creating a deadlier epidemic, as users were sharing needles to inject the drug, fostering the spread of both HIV and Hepatitis C (HCV). Once supplies of Opana ER dried up, those users often moved directly to heroin, as it is both cheaper and more readily available.
The NASEM recommendations will no doubt result in outcry from both pain advocates and pharmaceutical companies desperate to retain profits. Should they be adopted, the U.S. may finally be able to break its near-thirty-year abusive relationship with opioid pain killers.
- Diep, F. (2017, July 13). THE FDA NEEDS TO COME DOWN HARDER ON OPIOIDS, AN FDA-COMMISSIONED PANEL SAY. Santa Barbara, CA: The Social Justice Foundation: Pacific Standard: News. Retrieved from: https://psmag.com/news/panel-recommends-the-fda-think-bigger
- Mandal, A. (2017, June 09). Opana ER – a long acting opioid painkiller, to be pulled from the markets as per FDA directive. London, UK: AZoNetwork UK Ltd.: News Medical Life Sciences. Retrieved from: http://www.news-medical.net/news/20170609/Opana-ER-e28093-a-long-acting-opioid-painkiller-to-be-pulled-from-the-markets-as-per-FDA-directive.aspx
- McEvers, K. (2016, March 31). Inside A Small Brick House At The Heart Of Indiana’s Opioid Crisis. Washington, DC: National Public Radio: Shots: Podcasts: News & Politics: Embedded. Retrieved from: http://www.npr.org/sections/health-shots/2016/03/31/469525114/inside-a-small-brick-house-at-the-heart-of-indianas-opioid-crisis
- National Academies of Science, Engineering, and Medicine. (2017a, July 13). Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: The National Academies of Science, Engineering, and Medicine: The National Academies Press. doi: https://doi.org/10.17226.24781
- National Academies of Science, Engineering, and Medicine. (2017b, July 13). RECOMMENDATIONS. Washington, DC: The National Academies of Science, Engineering, and Medicine: The National Academies Press.
- Ramsey, L. (2017, July 06). A painkiller at the heart of the opioid epidemic has been taken off the market. New York, NY: Business Insider. Retrieved from: http://www.businessinsider.com/endo-international-removes-opana-er-from-the-market-after-fda-request-2017-7
- Servick, K. (2017, July 13). Expert panel to FDA: time to hold opioids to a new standard. Washington, DC: American Association from the Advancement of Science: Science: News. Retrieved from: http://www.sciencemag.org/news/2017/07/expert-panel-fda-time-hold-opioids-new-standard
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