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. (...)
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.”
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. (...)
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.”
by Stephen S. Hall, New York Magazine | Read more:
Image: Bobby Doherty
