FDA Chief on Opioid Epidemic
Scott Gottlieb vows not to repeat the mistakes of the past
Dr. Scott Gottlieb says the fight against opioid abuse must involve tackling the stigma around addiction treatment.
Scott Gottlieb vows not to repeat the mistakes of the past
Opinion Oct 27, 2017

With drug overdose deaths seeing a sharp increase of over 22 percent in 2016, the state of opioid epidemic of the United States continues to exacerbate. As per a National Institute on Drug Abuse (NIDA) estimate, drug overdose claimed 64,070 lives last year as compared to 52,404 in 2015. And this time, the main culprit was strong synthetic opioid fentanyl and its analogs. The grave situation has compelled the authorities to take note of this national emergency and act rather proactively.

Shedding light on these numbers while addressing media persons at the National Academy of Medicine recently, the U.S. Food and Drug Administration’s (FDA’s) new chief, Dr. Scott Gottlieb, was candid in accepting recently that when he was at the agency in the 2000s, it failed to make a mark with respect to regulation of opioids. He acknowledged that during his previous stints at the FDA, opioid abuse was growing as a menace and prescription drugs were marketed inappropriately.

Dr. Gottlieb said that being a former fellow of the conservative American Enterprise Institute, he spent years lamenting the growing federal intrusion into the practice of medicine but also felt that with respect to controlled substances things were different. The very fact that the FDA commissioner shared such details and has been quick in taking steps to tackle the opioid menace since his swearing-in in May 2017, seems indicative of a reform the nation has been waiting to see for quite some time.

Through this post, the Hooked Sober brings to you excerpts from the message of the FDA chief and how he plans not to repeat the mistakes of the past. Read on.

Emphasis on MAT, tackling stigma

Even as the White House geared up to declare the prescription drug and heroin crisis a national emergency, Dr. Gottlieb said recently that the fight against opioid abuse must involve tackling the stigma around treatment. “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 mentioned in the 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. 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 didn’t get ahead of it. Nobody got ahead of it… The type of action we need to take to finally (address) this crisis is going to be far more dramatic than we would have had to do had we made certain decisions years ago,” the FDA chief said, adding that in order to make up for the opportunity that has been lost, his agency is on the verge of rolling out plans to promote less-or-non-addictive pain treatments as well as medications to help people who have an addiction wean themselves off the drugs.

He also talked about the ways to lessen the damage caused so far, including increased use of addiction-treatment medications, mandatory opioid training for doctors, shorter duration of opioid prescriptions, regulation of immediate-release (IR) opioids, tightening the requirements for abuse-deterrent formulas, and more. Highlighting the advantages of medication-assisted treatment (MAT), Dr. Gottlieb said the FDA is exploring the possibility of label changes that would permit the drugs to be prescribed to anyone who experiences an overdose as well as help promote better use of such treatments.

“Since becoming FDA Commissioner, I’ve made it one of my highest priorities to work on multiple fronts to reduce the scope of the opioid epidemic that’s devastating our nation and destroying individual lives and families,” Dr. Gottlieb said in a statement, adding, “In particular, we believe the FDA has a vital role to play in curbing new addiction, reframing how we look at the benefits and risks of opioids as part of our pre- and post-market efforts, and keeping as many people as possible from experiencing the serious adverse effects associated with these medications.”

The future of opioid epidemic

At a time when the opioid epidemic is proving to be one of the biggest killers in the American history and the dangerous drugs are flooding the market, Dr. Gottlieb’s ideas and initiatives seem to be a big ray of hope for the nation. With various high-profile bills passed to expand the scope of treatment options and the use of overdose reversing drugs along with several new policies since he stepped in, we can hope for a gradual end to the opioid epidemic. Yet, the truth cannot be negated that a lot more needs to be done to be able to reach that phase, and without the combined efforts of the people, federal and state governments and the regulatory bodies, being an addiction-free nation will remain a far-fetched dream.

About the FDA chief

Dr. Scott Gottlieb, a senior physician who has been a medical policy expert and public health advocate, had earlier served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and as a senior advisor to the FDA Commissioner. He was sworn in as the 23rd Commissioner of the FDA on May 11, 2017. He also worked on implementation of the Medicare drug benefit as a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services. In 2013, Dr. Gottlieb was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on health care IT.


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