Google “opioid abuse deterrence” and you’ll find a lot of hits from lawyers and elected officials. What you won’t find is a lot of expert thinking from the FDA.
That needs to change.
FDA Commissioner Hamburg’s recent comments (and, in particular, her testimony in front of the Senate HELP Committee) hopefully represent a more aggressive stance by the agency. That’s good. But there needs to be more. The FDA must be the leading voice on the issue of abuse deterrence and the safe use of opioids.
At present, politicians and pundits (not to mention trial lawyers) own the conversation. They're the ones talking about it. They're the ones the media goes to when they write about it. Have a look at a sampling of the press coverage surrounding Zohydro and see who's quoted and what they're saying.
The struggle over control of the opioid abuse deterrence story is, shall say, not going the right way for the agency.
Peggy got it right when she testified that (per Zohydro), “We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy.”
In short – not all opioids are the same and not all patients respond to all opioids in the same way. Further, it’s important to remember that “safe” doesn’t mean 100% safe. Never has. Never will. Not for any medicine. It’s always about the benefit/risk balance.
This is not a new topic. Americans woke up the morning after the Vioxx recall and were amazed to discover that drugs have risks. Good lord. Who let that happen! Avandia, in that respect, was Son of Vioxx. And, like any sequel, new actors were brought in to spice up the story. Now it’s about opioids.
Relative safety is an important conversation. It’s an opportunity for the FDA to help educate the public about the safe use of drugs.
(The foundational proposition of the FDA’s “Safe Use” initiative is that the way to make a drug “safer” is to better educate prescriber, dispenser, and user about the product.) And nowhere is “safe use” a more important issue than opioids.
Dr. Hamburg’s testimony continued, “It doesn’t do any good to label something as abuse deterrent if it isn’t actually abuse deterrent, and right now, unfortunately, the technology is poor.”
As with safety, “abuse deterrent” doesn’t mean that an opioid can’t be abused. “AD” doesn’t mean “100% abuse deterrent” just as “safe” doesn’t mean 100% safe.
Who does that and how it is done is where the rubber meets the road. After all, as the saying goes, everything you read in the paper is true except for those things you know about personally. Such is the case for the drug safety imbroglio currently surrounding opioids.
The FDA must take the lead. And that means more than finessing the label. It means working with CME providers to develop better curricula. It means more targeted REMS. It means enhanced and validated reporting tools for post-marketing surveillance. It means better tools for using that data for better social science in developing tools that can assist prescribers in determining which patients are likely to abuse. “Abuse deterrence” isn’t just a formulation question – it’s a systems question.
Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines. And when Bloomberg reporter Drew Armstrong notes that “FDA pain drug czar Bob Rappaport has already said the agency would consider jerking Zohydro from the market if an abuse-resistant version become available,” it reinforces the erroneous concept of “100% abuse deterrence.” Dr. Rappaport certainly knows better. The general public does not.
There’s an apt Japanese proverb that bears repeating, “Don’t fix the blame. Fix the problem.” Unfortunately, the recent bashing of opioids (and the FDA’s regulatory decision-making and oversight thereof) isn’t helping. It's time for the grown-ups to step forward and take charge of the debate on drug safety.
