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How Much Does It Hurt?

Zohydro is the new FDA-approved painkiller that some doctors think the FDA had no business approving. And in ERs across America, they’re anxiously awaiting the fallout.


Even before a single doctor in the United States had written a prescription for Zohydro, the controversial long-acting painkiller approved by the Food and Drug Administration last October, potential users were already dreaming up possible street names. “How many times will this be said in the future,” someone posted on Opiophile, an online forum for people who like to share their drug experiences and expertise. “Got any of dem Zoh’s?” There were other possibilities: Zs, Zodros, and Zorros.

Another voiced chimed in: “I like Zorros … Yeah, has a ring to it.” This was on October 26, 2013, less than 24 hours after the FDA announced its decision.

And in April, even before Nima Majlesi, an emergency-room physician at Staten Island University Hospital, had seen a single report of an overdose or death related to Zohydro in the borough, he and his fellow doctor Amit Gupta were searching websites for the first anecdotal, and decidedly unofficial, accounts of its recreational use. Majlesi logged on to another well-known drug-use site to see if anyone had posted an opening-night review.

“How do you spell it again?” he asked Gupta, with whom he shares an unadorned office a few feet from the emergency room.

“Z-O-H-Y-D-R-O,” Gupta said, and Majlesi repeated the letters aloud as he typed them into a site called Erowid.

If the prescription-painkiller epidemic in America is a heartland phenomenon, as is often said, the heartland begins just beyond the toll plaza of the Verrazano-Narrows Bridge. As New York City Department of Health epidemiologists have helplessly documented over the past ten years, opioid abuse has skyrocketed on Staten Island, with three times the rate of overdose deaths of the rest of the city. In a borough where police have busted illegal prescription-drug-selling operations in everything from a neighborhood deli to an ice-cream truck, Majlesi and Gupta have seen and heard it all: the urgent calls of EMS teams phoning in reports of suspected overdoses as ambulance crews race to the hospital, lethargic or comatose patients (often young adults in their 20s and 30s) wheeled into the ER. Sometimes the overdose is accidental. Often there’s nothing to do because first responders didn’t arrive in time.

“No user experiences yet,” Majlesi announced, scrolling through the Erowid site. He tried checking Opiophile, but the site was blocked at the hospital. As far as he was concerned, it was only a matter of time. “I’m sure Staten Island will be among the first to see it,” he said glumly.

In the annals of new-drug rollouts, Zohydro seems to be in a class by itself. It has become a political nightmare for the drug’s manufacturer, Zogenix, Inc., and for the FDA—Massachusetts tried to ban it; the attorneys general of 28 states excoriated the FDA for approving the drug without “tamper-­resistant” features, a decision Senator Charles Schumer of New York has called “baffling”; and Senator Joe Manchin of West Virginia has introduced legislation to roll back the approval. It has inspired apocalyptic warnings, mostly because Zohydro belongs to a class of drugs that the Centers for Disease Control and Prevention said in 2011 has created a nationwide, doctor-­driven epidemic of addiction, death (roughly 16,000 a year), and unquantifiable familial devastation. And yet, so far, it has been nearly invisible—as of March 31, the company reported exactly 1,141 prescriptions filled nationwide.

“Watchful waiting” is a time-honored term in medicine, and it is the perfect phrase to describe the collective sense of anxiety, dread, and fatalism playing out as Zohydro slowly makes its way to pharmacies and ultimately into medicine cabinets. Zohydro is neither the first long-acting opioid painkiller nor, milligram per milligram, the most potent, so why all the fuss? Part of the concern is that because the drug is an extended-release formulation, it packs up to 50 milligrams of hydrocodone in a single capsule (Vicodin, the more familiar, instant-release version of hydrocodone, tops out at 10 milligrams per pill). And since it does not come in a tamper-resistant formulation, addicts can theoretically crush and snort or inject it to get an instant high from all 50 milligrams at once. OxyContin, the most infamous of prescription opioids and the main protagonist in the painkiller epidemic, did not come in a tamper-resistant formulation until 2010. By then, it had been implicated in thousands of overdose deaths since it hit the market in 1996.

It was precisely those fears that unnerved a panel of pain experts convened by the FDA to consider Zohydro 18 months ago. “Are we really, in the long run, helping people, or are we creating an epidemic?” asked one. As another briskly put it, “There are too many deaths already.”

Each year, the Drug Enforcement Administration, which tightly controls the amount of narcotic painkillers made in the U.S., sets the overall amount of opioid drugs that pharmaceutical manufacturers can churn out. In 2014, for example, the DEA total is 326,000 kilograms of opioids, including just under 100,000 kilos of hydrocodone. Put another way, that’s about 700,000 pounds of ersatz heroin usually doled out in 5 milligram or 10 milligram doses. Not all of that goes into domestic prescription medicine (some is used for research, some is shipped overseas), but since 2004, total amounts for oxycodone, hydrocodone, hydromorphone, and oxymorphone have basically tripled.

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