- The Washington Times - Wednesday, October 25, 2017

FDA Commissioner Scott Gottlieb on Wednesday said no one should face stigma for using certain drugs to fight an addiction to opioids, as the White House gears up to declare the prescription drug and heroin crisis a national emergency.

Dr. Gottlieb said his agency is rolling out plans to promote pain treatments that aren’t addictive and medications that help addicts wean themselves off opioids.

He said patients who avail themselves of drugs like methadone and buprenorphine shouldn’t feel shame for trying to beat a physical dependence dictated by biology.

“The stigma reflects a view some have — that a patient is still suffering from addiction even when they’re in full recovery, just because they require medication to treat their illness,” he said in testimony to the Energy and Commerce Committee. “This attitude reveals a flawed interpretation of science. It stems from a key misunderstanding many of us have of the difference between a physical dependence and an addiction.”

Even cancer patients who use opioids for long-term treatment will develop this dependence, he noted.

He said medication-assisted treatment has a successful track record. For instance, Massachusetts recorded a more than 50 percent reductions in the risk of death from an overdose among those who were treated with methadone or buprenorphine after a nonfatal overdose.

“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,” Dr. Gottlieb said. “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.”

Dr. Gottlieb’s comments offered a more full-throated endorsement of using medications, such as methadone or buprenorphine, of Health and Human Services Secretary Tom Price, who was quoted in May as saying, “If we’re just substituting one opioid for another, we’re not moving the dial much.”

HHS later clarified that Mr. Price supported across-the-board efforts to fight addiction, including medication-assisted treatment.

Dr. Gottlieb said the FDA is exploring label changes that would allow the drugs to be prescribed to anyone who experiences an overdose.

“We believe that granting such an indication in labeling can help promote more widespread use of, and coverage for these treatments,” he said.

He also said the labels might reflect the fact that some patients may require a lifetime of medication-associated treatment. Already, the government expanded the roster of patients that each licensed doctor can treat with drugs like buprenorphine.

Dr. Gottlieb’s testimony precedes a major opioids speech from Mr. Trump on Thursday, when he is expected to declare a national emergency around the epidemic.

The long-awaited declaration, first proposed by the White House opioids commission led by New Jersey Gov. Chris Christie, should allow the administration to waiver certain federal rules to expand treatment and direct more resources to the fight.

Committee Chairman Greg Walden said 91 Americans die each day from overdoses. In last year alone, the epidemic claimed more Americans than the Vietnam War, as deadly synthetics like fentanyl flood the heroin market.

“It is one of the few public health problems that is getting worse instead of better,” said Dr. Anne Schuchat, principal deputy director at the Centers for Disease Control and Prevention.

Neil Doherty, a deputy assistant administrator at the Drug Enforcement Administration, said the U.S. is seeing a “fundamental shift” from prescription-driven addiction to cheaper-to-buy heroin, exacerbating the problem.

Congress tried to get its arms around the opioids problem by passing a pair of high-profile bills that expanded treatment options and the use of overdose-reversing drugs, while doling out $1 billion in state grants to combat the issue.

Rep. Frank Pallone, New Jersey Democrat, said the money is being put to good use in his home state but amounts to a “down payment” on what’s needed to stamp out the scourge.

“There just needs to be a lot more,” Mr. Pallone said.

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