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Διαβάστε τι συμβαίνει σήμερα στις ΗΠΑ με το Zohydro
Who’s Afraid of Zohydro?
If a good politician is somebody who, to paraphrase Winston Churchill, never lets a serious crisis go to waste, then Deval Patrick, the governor of Massachusetts, is an excellent politician. In March, responding to the nation’s truly horrific epidemic of prescription-drug abuse, he announced that Massachusetts would ban the drug Zohydro, despite the fact that it had already been approved by the Food and Drug Administration.
Patrick said that the powerful new opioid posed “a significant risk” to the public, and that the state would “immediately prohibit” its distribution until “adequate measures are in place to safeguard against the potential for diversion, overdose, and misuse.’’ Two courts have since overturned Patrick’s ban, but he has promised to press on, and more than two dozen state attorneys general have joined the effort to revoke or ignore Zohydro’s approval. Patrick is indeed dealing with a serious crisis, and so are the rest of us: prescription-drug abuse is the nation’s fasting-growing drug problem. Between 1999 and 2010, the number of drug-poisoning deaths in the United States involving an opioid analgesic went from forty-three hundred to almost seventeen thousand. Prescription medications now kill more people than heroin and cocaine combined.
Zohydro, a pure, extended-release form of the painkiller hydrocodone, was approved by the F.D.A. last October, and it went on sale in March. The reaction in Congress, and among addiction specialists, has been overwhelmingly negative. “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,’’ Andrew Kolodny, the president of the advocacy group Physicians for Responsible Opioid Prescribing, said before the drug was released. “It will kill people as soon as it’s released.”
Fortunately, Kolodny appears to be wrong about that. But why would any agency approve another version of a painkiller with hydrocodone in it when addiction to Vicodin is already so severe a problem? Every other drug in Vicodin’s class contains acetaminophen, which has become the leading cause of liver toxicity in the United States. (Those who regularly take the painkiller three times a day, for example, may consume as much as three hundred and sixty thousand milligrams of acetaminophen a year.) Zohydro has no acetaminophen. It lasts between eight and twelve hours—at least three times as long as drugs like Vicodin—which may well lessen the effect of withdrawal for the many people who need to take a pill every few hours.
Zohydro is highly controlled and difficult to obtain, and it comes with a warning label that reads like a guide to nuclear warfare. To prescribe it, physicians have to do more than fill out special forms; they need an additional license. None of that changes the fact that it is a dangerous and powerful drug. But you can’t talk about the risks of a medicine without also considering its benefits. And almost nobody has done that with Zohydro. Remarkably, through all the coverage of the drug’s potential for addiction and abuse, little has been said about its usefulness in managing chronic pain. There have been reports that Zohydro is ten times stronger than Vicodin (it’s the same strength), and that it’s more powerful than anything else on the market (it’s the least powerful opioid in its class).
There are reasons to fear Zohydro, certainly, but the same is true of all such addictive drugs. Narcotics are not controlled or dispensed properly, and they are often abused. Programs designed to train and monitor physicians who prescribe serious narcotics are largely inadequate—and a disturbing number of prescriptions are dispensed by a tiny minority of doctors. There isn’t a good way to be sure that a patient isn’t wandering from doctor to doctor, shopping for prescriptions. (Health-care providers wrote two hundred and fifty-nine million prescriptions for painkillers in 2012, enough for every American adult to have a bottle of pills.) If I travel—whether it’s to Chicago, Hong Kong, or Aurangabad—all I need to do to get money is slide a piece of plastic into an A.T.M. The banking system knows who I am and what funds might be available to me. Is it outrageous to hope that, faced with a growing medical emergency, the United States could develop a similarly comprehensive and instantaneous system?
“Prescription opioid abuse and addiction is a very serious public-health problem in this country, and it needs to be addressed,” Margaret A. Hamburg, the commissioner of the F.D.A., told me. “However, this issue is not about one drug. Our focus and attention should be on identifying ways to address the inappropriate prescribing of all opioids, which is driving the tragic increase in abuse and overdose deaths we have experienced in the past decade.” In its first four months on the market, there has been one Zohydro prescription for every eleven thousand eight hundred prescriptions for other narcotics. Which of those two numbers should we pay the most attention to?
Bashing the F.D.A. is never a bad idea for a politician, unless he thinks about it for five minutes. Patrick might have considered the implications of a single state deciding to ban a federally approved medication. Patrick is a liberal, and a strong supporter of women’s rights. Surely he is aware that other governors have other agendas. It seems reasonable to guess that he would be unhappy to see the emergency contraceptive Plan B banned from Massachusetts pharmacies. But if Patrick can ban a painkiller he doesn’t like, what is to stop somebody else from banning a different drug? (Perhaps next Deval Patrick will decide to issue Massachusetts currency.) Prescription-drug abuse is a terrible problem in the United States, but one that can never be solved through the fiat of a single governor. For that, it’s going to take a village—and then some.