How important is the issue of opioids? Well, important enough that it was the very first panel offered at the 2014 BIO Convention’s regulatory affairs track. And it didn’t disappoint.
Moderated by yours truly, I was joined by three experts (Douglas Throckmorton, MD, Deputy Director of Regulatory Programs, FDA’s Center for Drug Evaluation and Research, Richard C. Dart, MD, PhD, Director of the Rocky Mountain Poison and Drug Center, and J. David Haddox, DDS, MD, Vice President of Health Policy for Purdue Pharma, L.P.) and a room full of engaged and inquisitive attendees. The session began with a question – Who lost opioids?
I reminded the audience of the old public relations maxim that, “Everything you read in the newspaper is true – except for those things you know about personally.” And today that means the preeminence of social media. Google “opioid abuse deterrence” and you’ll find a lot of hits from lawyers and elected officials in the mainstream media -- but you have to know where to look (or who to ask) to access expert thinking from the FDA.
There’s certainly no dearth of verbiage and suggested solutions from the law enforcement community. Alas, those fixes rely on the general philosophy that the only good opioid is a recalled opioid. And that results in strategies that require strict prescribing limitations, and severely limited access. Punishing the legitimate pain patient, all the panelists agreed, is the wrong way to go.
Then there’s the legislative solution – but what this really means is allowing politics to drive the agenda. The posturing and hyperbole that has surrounded the issue of opioids pain medicines hasn’t resulted in a single workable solution. And the premature promptitude of many attorneys general and chief executives such as Massachusetts Governor Deval Patrick has led to numerous headlines but, in the end, nothing but fruitless lawsuits.
As Mark Twain quipped, “For every complex problem there is usually a simple answer – and it is usually wrong.” What those seeking to solve the problem with one-shot solutions have ignored is that pain in America is a medical problem of enormous proportion.
100 million Americans are now living with chronic pain. That’s a third of the U.S. population. Ten million of those have pain so severe that the pain disables them. Pain costs the US economy about $600 billion dollars a year in lost productivity and healthcare cost. And lawsuits, recalls, and police actions won’t change those dire statistics.
But just as opioids aren’t the problem, neither are they a panacea. Yet payers often implement barriers to the use of branded, on-label non-opioid pain medicines, relegating these treatments to second line options. 52% of patients diagnosed with osteoarthritis receive an opioid pain medicine as first line treatment, as do 43% of patients diagnosed with fibromyalgia, and 42% of patients with diabetic peripheral neuropathy.
Aren’t abuse deterrent opioids the magic bullet we’ve all been looking for? Not really. First of all, what does “abuse deterrence” even mean? As FDA Commissioner Peggy Hamburg testified to Congress, “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.” Abuse deterrence is a goal. And at present, it’s an elusive one.
Abuse deterrence also raises some very important and difficult regulatory questions for the FDA. What type of 21st regulatory science will be required to review abuse deterrent applications? How will the agency approach the approval of non-abuse deterrent generics? What about more sophisticated pharmacovigilance programs? And, last but not least, how can the FDA better protect the public health while simultaneously preserving innovative development programs?
Dr. Throckmorton’s presentation noted that both FDA and other government epidemiologists are working to improve the surveillance databases and tools used to assess impact of abuse deterrent formulations in US market. He specifically mentioned the “DAWN” (Drug Abuse Warning Network) database replacement, measuring appropriate access to opioids by pain patients. The development and broad adoption of successful abuse-deterrent formulation remains an important priority for FDA. But we’re in the early days of the science, with much important work to be done.
But what else can be done?
As former Canadian Prime Minister Pierre Trudeau once said, “There's no place for the state in the bedrooms of the nation.” But what’s the appropriate place for the state in our nation’s pharmacies and medicine chests – particularly for opioids? As CDER Deputy Director (and the FDA’s point-man on opioids) Dr. Douglas Throckmorton said, “We are challenged with determining how to best balance the need to ensure continued access to patients who need these medications while addressing concerns about abuse and misuse.”
While scene-stealing members of Congress, some governors, and a gaggle of state attorneys general are trying to run roughshod over science-based regulation to great attention from the media, the FDA has been quietly doing the right thing without anybody noticing. In the immortal words of Don Draper, “If you don't like what is being said, then change the conversation.
The FDA must play a lead role in facilitating physician education, not only through labeling language but physician education. The FDA has, of late, repeatedly discussed enhancing continuing medical education (CME) and working to develop (with a broad constituency) validated tools for physicians to use in determining which patients may be more prone to slide into abuse so they can choose their therapeutic recommendations more precisely.
In the words of FDA Commissioner Hamburg, “It all comes back to provider education.” Amen.
Provider education – the Hamburg Manifesto.
That’s not regulatory mission creep; it’s the appropriate application of the agency’s Safe Use of Drugs initiative. The way you make a drug “safer” is to ensure that it is used by the right patient in the proper manner.
Abuse deterrence is a worthy goal and will evolve when all the players work together in a more regular and synchronistic fashion. Fortunately, all panelists agreed this was the reality.
As the Japanese proverb goes, “Don’t fix the blame, fix the problem.”