Why the FDA Can't Fix the Opioid Crisis

Illustration: Angelica Alzona/Gizmodo
Illustration: Angelica Alzona/Gizmodo
We may earn a commission from links on this page.

Opana was a painkiller twice as strong as Oxycontin. Like most opioids sold in the US it was easy to snort, until one day it wasn’t: Its manufacturers, Endo Pharmaceuticals, rigged it with crush-resistant technology in 2012. Within months the largest HIV outbreak in Indiana’s history was underway—addicts had taken to injecting it.

The non-snortable Opana was an abuse-deterrent formulation, or ‘ADF’—an opioid painkiller designed to minimize abuse and prevent addiction. It backfired so disastrously that, in early June, the FDA asked Endo to pull it from the market. It was the first time the agency had pulled a painkiller on the basis of its abuse potential.

Opana’s wake was held in Silver Spring, Maryland, in a Sheraton conference room rented out by the FDA for two 90-degree days this past July. There, doctors, statisticians, addiction specialists and Big Pharma consultants sat around a conference table mulling the ADF market’s open secret—namely, the near-total absence of information on whether or not these drugs actually work.

At present, only 3-5 percent of opioids prescribed in the US contain abuse-deterrent properties; they’re a fireproofed pantry in a vast, burning mansion. The job of the twenty-odd independent “thought leaders” assembled by the FDA was to stand at some distance from that mansion and, iced coffees in hand, help the agency figure out whether the pantry’s on fire, too.

“Patients,” “abusers,” and “legitimate users”

Despite the Sheraton’s sealed-in placelessness (opaque beige curtains, noiseless A/C) the summer heat seemed to wither the room, on the meeting’s first day. Experts slumped in their seats, or scrolled iPhones under the table; at least two discreetly napped. A moderator’s question was met with room-tone, and a lone echoing cough.

That silence suited the stunningly bleak landscape of ADF analysis. To circumvent ADFs addicts will sometimes soak their pills in vinegar or lemon juice, corrupting most of the opiate in the process. Distill an addict to a datapoint and the same thing happens: Context melts away, leaving behind dregs of questionable value. It’s almost impossible to tell, from the data, what specific opioid a person was abusing, let alone whether that opioid had abuse-deterrent properties (which, again, virtually no opioids do). However hole-filled, though, this data is better than nothing, and nothing is mostly what we’re dealing with: Addicts rarely interact with the treatment and Poison Control centers used to monitor opioids after they’ve been approved.

Before it can tighten its research methods, the FDA will need to determine who, exactly, it’s trying to study. This question was destabilized early on by Dr. Sidney Schnoll, a former opioid hype-man (years ago he lobbied editorial boards to publish pro-opioid articles) and abuse-research guru, and current VP of Pinney Associates, which helps drug companies get their ADFs through the FDA’s approval process.

Schnoll repeatedly insisted on the need to distinguish “patients”—i.e., those legally prescribed the drug—from black-market abusers. But when the FDA’s Judy Staffa proposed adopting Schnoll’s distinction half the panel appeared to revolt.

“It’s not patient versus abuser,” said Dr. Erin Krebs, a researcher at the US Department of Veteran Affairs. “If you say a ‘patient’ is anyone ever treated with opioids, then we could be talking about the whole US population, because we’ve so blanketed our society with at least short-term opioid therapy it would be hard to exclude anyone.”

Another panelist edged us closer to the epistemological void by pointing out that “even the distinction between legitimate and non-legitimate users is problematic,” as plenty of people who might be using the pills illegitimately (via snorting, injecting, etc.) are nonetheless legitimately prescribed those pills for severe pain problems.

In lieu of clarifying this issue Staffa opted to muddle it beyond comprehension, expanding the definition of “patient” to include those patients’ hypothetical teen sons; and the subject was soon after dropped entirely when a doctor who’d been nodding off throughout the discussion (clearly a veteran panel-napper, able to look straight-backed and alert with his eyes fully closed) said with perfect obliviousness that one interesting thing to consider might be the distinction between “patients” and “non-patients.”

Big pharma at the table

It is worth lingering on Dr. Schnoll, and on the rest of what I came to think of as the Schnoll Corridor—a collegial network of pro-ADFers spread across a couple of Schnoll-adjacent rows. Dan Cohen was one of them: Head of the Abuse Deterrent Coalition, an ADF lobbying firm, he spent much of the meeting in Schnoll’s orbit, passing him notes and at times hovering behind his seat like a boxing coach or defense attorney. Most visible of the bunch was Paul Coplan, an impressively-cheekboned, South African-accented epidemiologist at Purdue Pharmaceuticals, the company that gave the world Oxycontin.

The meeting’s audience participation sessions were open to the public but this public consisted almost exclusively of Paul Coplan, whose unflagging appearances at the podium became a kind of running joke around the Sheraton. (By far the meeting’s biggest laugh-line came from Staffa, when an audience-participation session was called and no one came to the podium: “I take it this means Mr. Coplan has left the building?”) Of the four or five other audience participants, two were other Purdue employees, and one represented yet another pro-ADF consulting firm. Schnoll himself spent years at Purdue, and seemed to be on good terms with Coplan: “I’m trying to get them to understand,” I overheard him saying to Coplan.

It is easy to write off the drug industry as a pack of price-gouging Shkrelis unswervingly devoted to impoverishing cancer patients and clinical depressives and all the other mentally and/or physically unwell Americans struggling to pay for their pills. It is also, often, correct. But in the interest of fairness, it’s worth casting an unjaundiced eye on the motives of the Schnoll Corridor, and the painkiller industry as a whole, as it ramps up its efforts to develop and lobby for ADFs.

There is no reason to doubt Dr. Schnoll’s sincerity when he speaks of how he’s witnessed opioids transform patients’ lives. That is partly what’s at issue, in the broader opioid debate: These drugs really do work, in some cases, and very few legitimately prescribed patients end up addicted to them. From pharma’s perspective, the strict prescribing limits passed by or inching through state legislatures imperil the health and happiness of countless upstanding pain sufferers who’d never think to sniff their supply. ADFs, in this context, would seem a perfect solution: Patients are helped, addicts are foiled, and teens rummaging medicine cabinets never get the rush which starts so many down the path to dependence.

The problems with this approach are manifold, and grow clearer with each skeptical study, like the one published this month by the Institute for Clinical and Economic Review, which concluded that there is “very little evidence on the impact of ADFs on abuse in clinical practice.” (In fact, of the ten ADF opioids presently approved by the FDA, Oxycontin is the only one with any kind of real-world evidence to show for itself, positive or negative.) Like, say, charter schools, ADFs would seem at best a band-aid, at worst a money-making scheme, and either way a poor substitute for real systemic reform. One argument along these lines, published recently in the New England Journal of Medicine, contends that ADFs might serve to distract doctors and lawmakers from the value of multidisciplinary (that is, not exclusively pill-based) therapy as well as from the scant evidence for the long-term effectiveness of all opioids, ADF or otherwise.

There is also the issue of their cost: Insurance companies often refuse to cover the pills, which can be up to 10 times costlier than regular opioids, and while six states have so far mandated their coverage by insurance companies many others—New Jersey, for instance—have had their initial interest dampened by sky-high cost estimates. However nobly-intentioned Schnoll, Coplan, et. al. might be, the fact is they and their employers stand to earn or expand whole multi-generational fortunes if and when the ADF market really does take off, given the drugs’ higher price—and this time, they might not have to deal with all that nasty press, if they can avoid another Opana-style debacle.

Weird science

Given the scarcity of hard data on ADFs, it made sense that the meeting’s most energized interlude was almost totally untethered from reality. It all started when Dr. Edward Boyer floated the possibility of implanting micro-tracking devices into some ADF pills, to see whether they’re reaching (and remaining at) their intended destinations, a daydream not too far removed from work he’d apparently done with Bluetooth-enabled Naloxone syringes.

After two days of granular, stubbornly earthbound analyses Dr. Boyer’s remarks struck a nerve. One by one, and with a nod to the tangent’s outlandishness (“since we’re in the stratosphere...,” “to hop on the crazy-train...,” “I’ll get up in the ionosphere, from an analytical toxicologist’s perspective...”) the panelists launched their own Boyerian riffs. Staffa tried to halt the tangent’s momentum (“I just want to throw in a little reality check, from back here on the ground,” she said) but by then it’d taken on a life of its own: Ideas put forward included pills that send signals when they’re crushed, “white-hat” hackers for premarket ADFs, ADFs which, if snorted or shot, would leave chemical traces in the body, the potential benefits of gathering and testing discarded syringes, etc.

This is not to suggest that no plausible solutions were proposed in the meeting’s two days. We’re a long way from knowing with any certainty whether or not these drugs actually curb abuse, but the assembled panelists did point to some promising routes, some of them fascinating—for instance, Nabarun Dasgupta’s bit on studying opioid abuse via the Deep Web (apparently, you can learn a lot from the customer reviews).

But as Schnoll pointed out, when I spoke to him on the phone a few days after the meeting, “the FDA is one piece in a very large and complicated puzzle.” Key to that puzzle are treatment and community outreach programs (funding for which might’ve been slashed by 95 percent had bipartisan outrage not persuaded Trump’s White House to rethink its budget). There is only so much an agency devoted to approving and monitoring new drugs can do, at this point.

“They like them.”

As far as the addiction crisis, Schnoll has a confounding concept of responsibility. “People are always trying to cast blame on somebody for their problems,” Schnoll told me, when I asked if the FDA might bear any responsibility for the opioid crisis as it presently stands. “There’s no one to blame. Should we blame fast foods for diabetes and obesity in this country? We could do that—but the fact is people eat these fast foods. They like them. Yeah, they’re heavily marketed. But if people didn’t eat them, they wouldn’t be there.”

In December 1995, Purdue received FDA approval for Oxycontin, an opioid which was itself supposed to deter abuse, through its allegedly rush-curbing, time-release formulation. Purdue lacked anything in the way of persuasive evidence for this claim at the time, and later studies would debunk it entirely, but, as detailed in Barry Meier’s Pain Killer, that didn’t stop the FDA from allowing them to include it in the drug’s labeling—an unprecedented decision which, in Meier’s words, “threw open the door to the drug’s widespread marketing,” and in turn generated precisely the catastrophic conditions which brought us there, to that Sheraton, in the first place.