'Scientifically, By Definition, It Is An Opioid': FDA Commissioner Makary Discusses Synthetic Drug

Forbes Breaking News

At a press briefing on Tuesday, FDA Commissioner Marty Makary spoke about synthetic opioids.

Transcript

00:00It's great to be here.

00:037-OH is not just like an opioid.

00:07It does not just have opioid binding properties.

00:117-OH binds to the mu receptor,

00:14which means scientifically, by definition, it is an opioid.

00:18And yet it is sold in vape stores, in smoke shops,

00:22in convenience stores, in gas stations

00:24that are popping up all over the United States,

00:27and nobody knows what it is.

00:30It is a synthetic concentrated byproduct of kratom.

00:36Our focus is not on kratom.

00:38Our focus is on 7-OH,

00:40which, according to the Journal of Medical Chemistry,

00:44is 13 times more potent than morphine.

00:48We have a history in public health

00:49of being asleep at the wheel.

00:5230 years after cigarettes were widely used,

00:57then we started raising public health concerns.

01:02After heroin, crack, cocaine, and other street drugs became popular,

01:07about 10 years later,

01:09the medical establishment and public health community responded.

01:1218 years after the approval of OxyContin by the FDA,

01:17we woke up to a terrible crisis that may have killed almost a million Americans.

01:22And then again, right afterwards, with fentanyl.

01:24We have a history of being asleep at the wheel.

01:28For the sake of our nation's children, let's not get caught flat-footed again.

01:34Public health is supposed to prevent disasters,

01:39not just clean them up after they killed thousands and thousands of people.

01:43Why do we get caught flat-footed time and time again?

01:50In my opinion, it's because of a disconnect between the ivory towers and the streets.

01:59Have experts been to the vape stores?

02:01It affects what we see in the operating room.

02:07I learned from living and working in inner-city Baltimore

02:11that you have to be proximate to a problem to understand it.

02:16We can't just talk about it on panels, at medical conferences,

02:20and in the ivory towers of the medical establishment.

02:24I saw on the streets of Baltimore how some of my patients that I would bump into

02:29switched from the prescription opioid that I would prescribe to heroin

02:33because they couldn't afford the copay.

02:39I've been surprised going to these vape stores at what I'm seeing.

02:42First of all, roughly 85% of the vape products are illegal vape products.

02:49We know that because the FDA publishes a list of legal vape products

02:53and no cutesy, fruity flavor designed to appeal to children

02:57or a video game vape product device is legal or approved by the FDA.

03:03I've been surprised at the candies and gummies and drinks and ice cream cones.

03:09Here's one drink with 7-OH in it.

03:12There are other products that get added to drinks.

03:17Do we understand what 7-OH is at public health scale?

03:23Let's not get caught flat-footed again.

03:27We're not targeting the kratom leaf or ground-up kratom.

03:30We are targeting the concentrated synthetic byproduct that is an opioid.

03:35The Trump administration is deeply committed to preventing another wave of the opioid epidemic.

03:42And this is deeply personal for many people.

03:46It's deeply personal for the Secretary of Health and Human Services,

03:49who will share how, at a young age, he struggled with addiction.

03:54It's personal for a family friend, a good family with a good kid who is addicted,

04:02knows they're addicted, wants to stop their addiction, but can't stop.

04:06That story is going on all across the United States,

04:09and we don't have research or numbers or statistics on the scale of that problem.

04:14Let's not allow another wave of the opioid epidemic to catch us blindsided again.

04:23I've met some of these families.

04:25Let's be honest.

04:26There's also a lot we don't know.

04:29This may be the calm before the storm.

04:32It may be the tip of the iceberg.

04:34But let's be aggressive and proactive.

04:36Today, the FDA is announcing that we are initiating action to recommend scheduling of 7-OH as a controlled substance by the DEA.

04:48We are also releasing a report on 7-OH to educate the public, including the other names it goes by.

04:56And finally, we need to educate the public, including the medical community.

05:01I've talked to many doctors who don't know what 7-OH is.

05:03We need to be proactive so we don't get caught blindsided again.

05:08Thank you very much.

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