Michael Abrams, MPH, PhD, senior health researcher at Public Citizen’s Health Research Group, discusses actions needed to help manage the opioid epidemic in the country.
Pharmacy Times interviewed Michael Abrams, MPH, PhD, senior health researcher at Public Citizen’s Health Research Group, to discuss his petition to the DEA and FDA regarding the classification of gabapentin and the closely related drug, gabapentin enacarbil, as schedule V controlled substances.
Alana Hippensteele: What are your hopes for the future following the submission of the petition to the FDA and DEA?
Michael Abrams: Yeah, so, the word hope is kind of emotional. So, we're trying to stay away from the emotions and stick with the facts here. So, we really think this one is straightforward. Petition to DEA and FDA, what we expect they'll do and what they need to do is to initiate proceedings to schedule it. That means it's already on the register because we put it there. They should encourage and solicit comments, they should study our petition—35 pages, well-referenced.
They should add to it and convene whatever additional public input they need to to rule once and for all. If this drug poses the risks and is diverted the way that we say it is, and if it doesn't, then they need to own up to it and accept responsibility that we think has been long neglected by them just by quirk of timing, as I say, because 1993 was before people were worried about overdose deaths as much as they do now and that's obviously a key driver for it.
But there are other problems with gabapentin, too. So, we're cautious. But we think that there's plenty of evidence for DEA and FDA both to attend to this efficiently.
Alana Hippensteele: What else is needed to help manage the opioid epidemic in the country?
Michael Abrams: So big question, lot of public health attention to that. We thought we were in the third wave 2 years ago, before COVID-19, and we had figured it out that it was prescription drugs, followed by illicit fentanyl, and we were sort of figuring that out.
Then COVID-19 hit and we see that this is a more complicated problem than we thought, and it has many dimensions to address it. Prevention is important. And how do you prevent drug abuse? Well, social determinants of health, right?
So, I mean, I could wax poetic about this a lot. There are many experts out there more knowledgeable than me trying to figure this stuff out. There are excellent treatments—pharmacologic, especially buprenorphine, methadone, so forth, but the trick is getting people connected to them. So, it's a wide array of issues that surround this whole thing. So that was that big context.
Now, let's zoom back in on this little petition that we're doing, which we think is important. And you might say, well, this is a trivial tangential connection. As it turns out, in the Morbidity and Mortality Weekly Report, there was a publication just in December, I think, looking at fentanyl overdoses going through 2020. They really got us good recently, and we're back sort of in the full throes of this epidemic—in the reports, they were able to discern that like 3% to 5% of those were gathered in the blood of the deceased. That's a pretty big proportion of the variants potentially.
Keep in mind that gabapentin often is an ignored substance when people are doing this sort of forensic review. So, it could even be higher than that. As I said previously, we know gabapentin’s use, we know it's used by opioid users to promote their high, etc., and we know that it causes respiratory depression, we know that's the key reason that when people take opioids, they often don't wake up. So, there is a connection here.
It’s sort of a reminder of the complexity of the epidemic, but also a particular note, again, that we think our petition lays out and encourages FDA and DEA to do the right thing here and to not just keep their eye on the full picture, not just be distracted by specific trees instead of the whole forest.
Alana Hippensteele: Absolutely. Any closing thoughts?
Michael Abrams: We think our petition and the action that I suggest to the FDA and DEA is long overdue to control gabapentin. So, it's our expectation that they'll probably act quickly on this. We hope that they will sort of admit, especially FDA, to past failures regarding oversight of this, the FDA and any agency, any human being for that matter, hates to admit that they miss something in the past.
So, we hope that they will rise to the occasion and regulate this drug. We think it represents a small step, but a substantive step that may save lives and further spare many people, thousands of people, pain and morbidity that too often persists around a prescription medication like gabapentin.