One year ago Cato published my policy analysis, “Abuse-Deterrent Opioids and the Law of Unintended Consequences,” which provided strong evidence that reformulating opioids, so that they could not be crushed for snorting or dissolved for injecting by nonmedical users, only served to drive nonmedical users to more dangerous, readily available, and cheaper heroin provided by the efficient black market.
The evidence included a RAND study that found “a substantial share of the dramatic increase in heroin deaths since 2010 can be attributed to the reformulation of OxyContin” which replaced regular OxyContin in 2010. It also included a study from researchers at Notre Dame and Boston Universities that found:
When we combine heroin and opioid deaths together, we find no evidence that total heroin and opioid deaths fell at all after the reformulation—there appears to have been one-for-one substitution of heroin deaths for opioid deaths.
Now comes a new RAND study that finds the abuse-deterrent reformulation of OxyContin led to an increase in cases of hepatitis C from IV drug use. As nonmedical users switched from OxyContin to injectable heroin, more became exposed to hepatitis C, transmitted by needle sharing.
The study compared states with above-median misuse rates of OxyContin to states with below-median misuse rates before and after the drug’s reformulation—from 2004 to 2015. Prior to the reformulation there was almost no difference in hepatitis C infection rates between the states. After the reformulation, states with above-median misuse rates saw a 222 percent increase in hepatitis C infections, while the below-median states saw a 75 percent increase during the same period.
Add hepatitis C to the list of unintended consequences from abuse-deterrent reformulation of opioids.
Despite mounting evidence that abuse-deterrent reformulation of opioids has done nothing to reduce overdoses but may in fact be adding to them, the Food and Drug Administration continues to encourage pharmaceutical manufacturers to bring more abuse-deterrent formulations to market. As was the case with OxyContin, reformulation often results in extension of existing patents, reducing competition from generics and allowing patent holders to charge and profit more from their product. So opioid manufacturers are answering the FDA’s call for more abuse-deterrent reformulations.
Now that we have strong evidence that abuse-deterrent formulations spread disease as well as death, perhaps the FDA will reconsider this ill-advised policy.