FDA

FDA Commissioner Scott Gottlieb Goes to Bat For Evidence-Based Opioid Policies

Gottlieb isn't a perfect harm reduction advocate, but he's a hell of a lot better than the D.C. status quo.

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FDA Commissioner Scott Gottlieb. Photo source: Douliery Olivier/Sipa USA/Newscom

Food and Drug Administration Commissioner Scott Gottlieb is now the highest-ranking member of the Trump administration to say in plain language that America can't address the opioid crisis by relying on outdated prevention campaigns or forcing dependent and addicted users to quit cold turkey.

"[G]iven the scale of the epidemic, with millions of Americans already affected, prevention is not enough," Gottlieb said in a statement to the House Committee on Energy and Commerce this week. He also pledged his agency would do everything in its power to "break the stigma associated with medications used for addiction treatment."

A physician and former resident fellow at the American Enterprise Institute, Gottlieb's testimony provided a dramatic and welcome contrast to the blunt and shallow statements of other Trump administration officials.

Whereas former Health and Human Services Secretary Tom Price said that methadone and buprenorphine therapy—which can reduce opioid-related mortality by 50 percent—amount to "just substituting one opioid for another," Gottlieb acknowledged this week that some people with opioid use disorders will need "a lifetime of treatment." His agency, he added, is "revising the labels of these medical products to reflect this fact."

He has also instructed Food and Drug Administration staff to develop more extensive guidelines for "non-abstinence-based" products that "address a fuller range of the symptoms of addiction such as craving."

Lastly, Gottlieb delivered a rousing rebuttal to the idea that addiction and dependence are no different:

Because of the biology of the human body, everyone who uses opioids for any length of time develops a physical dependence—meaning there are withdrawal symptoms after the use stops. Even a cancer patient requiring long-term treatment for the adequate treatment of metastatic pain develops a physical dependence to the opioid medication.

That's very different than being addicted.

Addiction requires the continued use of opioids despite harmful consequences. Addiction involves a psychological craving above and beyond a physical dependence.

Someone who neglects his family, has trouble holding a job, or commits crimes to obtain opioids has an addiction.

But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving more or harming themselves or others is not addicted.

The same principle applies to medications used to treat opioid addiction. Someone who requires long-term treatment for opioid addiction with medications—including those that cause a physical dependence—is not addicted to those medications.

Here's the bottom line:

We should not consider people who hold jobs, re-engage with their families, and regain control over their lives through treatment that uses medications to be addicted.

Rather, we should consider them to be role models in the fight against the opioid epidemic.

Others have drawn this distinction before, so I hesitate to applaud Gottlieb for acknowledging what his peers have said for years. But this is Washington, a place where drug policy experts are often drowned out by quacks, drug cops, and prosecutors. Gottlieb is not the most progressive reformer in this debate—he may end up calling for the removal of still more opioids from the market, which will hurt legitimate pain patients and likely drive non-medical users to the black market—but his perspective on using opioid therapy to treat opioid addiction puts him head and shoulders above the D.C. status quo.