BARRE, VERMONT — State officials around the country are rebelling over a powerful new painkiller that law enforcement and public health authorities fear could worsen the nation's deadly scourge of heroin and prescription drug abuse.
On Thursday, Vermont Gov. Peter Shumlin announced an emergency order that would make it harder for doctors to prescribe Zohydro, an extended-release drug that contains up to five times the amount of narcotic hydrocodone previously available in pills. Massachusetts Gov. Deval Patrick went even further last week, ordering an outright ban on prescribing and dispensing Zohydro until it is marketed in a form that is difficult to abuse.
The Food and Drug Administration approved Zohydro last fall, and it hit the market last month. Some public health authorities say abusers can too easily crush the pills and then snort or inject the drug.
"It's not like we don't have painkillers in America," Shumlin said. "We're just saying, 'Hey, we understand we don't control the FDA, but we do have some influence in Vermont.'"
Prescription drug abuse is the nation's fastest-growing drug problem, with more than 4.5 million Americans abusing pain relievers, according to a 2013 Drug Enforcement Administration report. Law enforcement and public health officials say that for many people, prescription painkiller abuse can pave the way to heroin addiction. In January, Shumlin devoted the bulk of his State of the State address to Vermont's "full-blown heroin crisis."
The backlash against Zohydro has been growing since the FDA approved the drug against the recommendation of an internal advisory committee. Late last year, 28 state attorneys general signed a letter asking the FDA to revoke the drug's approval or require the manufacturer to reformulate the drug to make it harder to crush. Also, Sen. Joe Manchin, D-W.Va., and Rep. Stephen Lynch, D-Mass., introduced legislation that would compel the FDA to withdraw the drug.
San Diego-based Zogenix, which makes Zohydro, said the drug is no more potent, per milligram, than other hydrocodone medications. The company also said that it set up a board of experts to guard against abuse and that its sales representatives are not being paid based on volume, but rather on their efforts to ensure prescribers, pharmacists and patients understand the medication's risks and benefits.
Zohydro belongs to a family of medicines known as opiates or opioids. Others include morphine, heroin and oxycodone, the painkiller in OxyContin. Its painkilling power comes from hydrocodone. Other medications, such as Vicodin, contain the same narcotic but also include acetaminophen, the active ingredient in Tylenol.
The FDA said Zohydro meets its standards and provides an important option for patients with chronic pain. The agency, which in 2010 approved a crush-resistant version of OxyContin to discourage abuse, said abuse-deterring formulations of Zohydro are in the early stages of development. Shumlin said he chose strict regulation over an outright ban, at least in part to avoid what could be expensive litigation.
"I expect that Massachusetts is likely to confront that and we really wanted to get something done quickly," Shumlin said.
Vermont's emergency rule to prescribe Zohydro includes requirements that prescribers conduct a thorough medical evaluation and risk assessment.
April 5th, 2014, By Beth Garbitelli, The Associated Press
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