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The Abuse‐​Deterrent Folly

Summary:
On September 11 a Food and Drug Administration Advisory Committee recommended rejecting Purdue Pharma’s request to add to the label of the abuse‐​deterrent formulation (ADF) of its drug OxyContin the claim that it reduces the incidence of non‐​medical use and overdose from opioids. In the early part of this century law enforcement officials reported that many non‐​medical users of the diverted prescription drug OxyContin, a concentrated, slow‐​release formulation of oxycodone, would crush the pills and snort them, or dissolve them in liquid and inject them. In 2010, as its patent for OxyContin was about to expire and cheaper generic competitors were waiting in the wings, Purdue Pharma received FDA approval to release its reformulated ADF OxyContin. This reformulation made the pills

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On September 11 a Food and Drug Administration Advisory Committee recommended rejecting Purdue Pharma’s request to add to the label of the abuse‐​deterrent formulation (ADF) of its drug OxyContin the claim that it reduces the incidence of non‐​medical use and overdose from opioids.

In the early part of this century law enforcement officials reported that many non‐​medical users of the diverted prescription drug OxyContin, a concentrated, slow‐​release formulation of oxycodone, would crush the pills and snort them, or dissolve them in liquid and inject them. In 2010, as its patent for OxyContin was about to expire and cheaper generic competitors were waiting in the wings, Purdue Pharma received FDA approval to release its reformulated ADF OxyContin. This reformulation made the pills uncrushable and insoluble in liquid. The reformulation approval meant Purdue Pharma could extend its patent—and its monopoly—over the production and sale of OxyContin. Extending drug patents by reformulating drugs in a meaningful way—a process known as “evergreening”—is a common practice in the pharmaceutical industry.

In an ironic twist, the pharmaceutical company that was, by then, the opiophobia‐​driven scapegoat for the overdose crisis sought to profit from further stoking opiophobia. The FDA didn’t just approve the ADF of OxyContin–it encouraged drug makers to develop ADFs of all opioid pain relievers, with the ultimate goal being that all opioids available on the market would be abuse‐​deterrent formulations.

As I explained in my 2018 policy analysis, non‐​medical users of OxyContin can still swallow the ADF OxyContin to get the desired effect. And if the non‐​medical users preferred the effect of snorting or injecting the drug, they can readily shift to cheaper and more available heroin (and now also fentanyl). In fact, the evidence shows that is exactly what happened. The ADF formulation had the unintended consequence of driving non‐​medical users to more dangerous opioids easily obtainable in the black market. If anything, ADFs grow the overdose rate this way. It took until September of 2020 for an FDA advisory committee to reach the same conclusion.

Unfortunately, policymakers are still addicted to the idea that the overdose crisis is the result of physicians “overprescribing” opioids to their patients in pain and turning them into addicts—despite the fact that government data show there is no correlation between prescription volume and non‐​medical use of opioids, or opioid use disorder, in persons over age 12. There is also no clearly established understanding of just what constitutes “overprescribing.”

The overdose death rate has been on a steady, exponential increase since at least the late 1970s, and will continue along that path until policymakers finally conclude that its ultimate cause is drug prohibition. The continuing focus on prescription pain killers is not just a fool’s errand. It is killing people.

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