Some states are restricting the use of the new painkiller Zohydro, "setting up a showdown with the federal government over who gets to decide the best way to protect public health," Michael Ollove reports for Stateline.
Though millions of chronic pain sufferers could benefit from the drug, some officials worry that abusers will crush and inject it for a big high, will significantly worsen the painkiller abuse crisis they have been battling. Combating prescription drug abuse has been a focus in Kentucky for the past few years. U.S. Reps. Hal Rogers of Somerset and Stephen Lynch of Massachusetts have introduced a bill to withdraw the Food and Drug Administration's approval, done though an advisory board voted 11-2 against it.
|Rogers (Herald-Leader photo)|
A federal judge told Massachusetts officials that they cannot ban a drug that the FDA has declared safe and effective, but Gov. Deval Patrick is restricting its use. Vermont Gov. Peter Shumlin has taken similar measures, and the Ohio legislature is debating similar action. Twenty-nine state attorneys general, including Kentucky's Jack Conway, have requested that the FDA rethink its approval of Zohydro.
"We're in the context of a very serious epidemic of opioid drug addictions and opioid deaths, and that's a public health crisis that has been growing over the last decade and half," said Michael Carome, director of the Health Research Group at the consumer organization Public Citizen. "The last thing we needed was another extended release opioid for treating chronic pain."
According to Trust for America's Health's 2013 report, "6.1 million Americans abuse or misuse prescription drugs," and "Overdose deaths involving prescription painkillers have quadrupled since 1999, and now outnumber those from heroin and cocaine combined, Ollove reports. Zohydro is an opioid, and opioids are not only easily abused but are also unfortunately gateway drugs, influencing people to use heroin, which isn't as expensive. One advantage to Zohydro is that it is a single-ingredient, long-acting product, unlike other painkillers that were combined with acetaminophen, which can be injurious to the liver.
Opponents are frustrated that the FDA not only approved the drug but also did not force the manufacturer, Zogenix, to create a version that isn't so easy to abuse. The company has said it is making such a version. "In the meantime, it said it has implemented other safeguards, such as compensating sales representatives for educating doctors, pharmacists and patients on the risks and benefits of extended-release opioids," Ollove writes.
Sherry Green, chief operating officer of The National Alliance for Model State Drug Laws, agreed withZohydro maker Zogenix "that taking action against selective prescription drugs is the wrong approach," Ollove reports. Green said, "When we focus almost solely on an individual drug, we tend not to put as much attention on the underlying problem, which is the abuse and addiction. Obstructing illicit routes to one medication only creates pathways to another one." (Read more)