FILE – Mass. Gov. Deval Patrick last week ordered an outright ban on prescribing and dispensing Zohydro until it is marketed in a form that is difficult to abuse. Zohydro belongs to a family of medicines known as opiates or opioids. Others include morphine, heroin and oxycodone, the painkiller in OxyContin. (AP Photo/Charles Krupa, File)
BOSTON (AP) — Drug abuse prevention groups, state lawmakers and organized labor leaders rallied outside the Massachusetts Statehouse yesterday to call for more restrictions on a powerful new painkiller.
The rally, which drew more than 150 people, comes as Governor Deval Patrick’s latest attempt at restricting the drug faces a legal challenge and a top federal drug regulator suggests that state policy makers’ almost singular focus on restricting Zohydro will not be effective in combating the scourge of prescription drug abuse.
In a federal lawsuit filed Monday, Zogenix, the drug’s San Diego-based maker, argues that Massachusetts’ new restrictions impose “draconian” mandates on doctors and “amount to an effective ban of the drug” that is unconstitutional. The company wants the federal court to vacate any actions the state has taken to restrict access to the drug.
Speakers at yesterday’s rally, organized by Learn to Cope and the Massachusetts Organization for Addiction Recovery, voiced support for Patrick’s efforts. They also called on Congress and federal officials to reconsider approval of Zohydro, which public health officials say comes in dosages of hydrocodone higher than those found in other painkillers and in pills that can be easily abused.
“We don’t need any more opiates! We don’t need any more addiction!” shouted Steven Tolman, president of the Massachusetts AFL-CIO. “Yes, we know that people need pain medication, but they need the right type of medication. And it needs to be monitored.”
Patrick announced new restrictions on Zohydro last week after a federal judge said his previous attempt to ban the drug outright was unconstitutional.
Under the new state requirements, doctors must, among other things, evaluate a patient’s substance abuse history and other current medications, provide a “letter of medical necessity” to the pharmacy and enter a “pain management treatment agreement” with the patient.
Doctors must also use the state’s online Prescription Monitoring Program, which tracks prescriptions of controlled substances, before prescribing drugs like Zohydro that are extended-release medications containing only hydrocodone and do not come in an “abuse-deterrent form.”
At yesterday’s rally, people wore white T-shirts saying “Stay Strong” while others held signs calling Zohydro “heroin in a capsule” or accusing “Big Pharma” of “killing kids.”
Massachusetts Senate President Therese Murray said battling the state’s drug abuse problem, which Patrick has declared a public health emergency, is not limited to Zohydro. She said Senate leaders are working on a comprehensive bill dealing with all aspects of addiction, from education to prevention to treatment.
“We will take action,” Murray said. “Now is the time not to back down …Too many opioids are being prescribed. Too many families are being destroyed.”
Zogenix said in a statement yesterday it is willing to work with states to develop restrictions on prescription opioid medications, but said it is “unjustifiable” to single out one medication over others.
The company has said it is working on an abuse-deterrent form of the drug.
Zogenix maintains that Zohydro, which was approved by the U.S. Food and Drug Administration in October, is no more potent, per milligram, than other hydrocodone pills on the market. It also says the drug is appropriate for people who suffer from severe chronic pain and need an alternative to acetaminophen.
FDA Commissioner Margaret Hamburg, in a message posted yesterday on the FDA’s blog, said policy makers need to focus on “comprehensive and science-based” solutions addressing “key drivers” of the prescription drug abuse problem, such as excessive prescribing, improper disposal of unused medications, and inadequate prescriber and patient education.
