• Another drug threat?
    March 16,2014
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    In a week where lawmakers moved Vermont a step closer to a bill designed to get more Vermonters with addiction problems into treatment, a handful of the state’s mayors are eyeing another threat — one that could prove deadly.

    Mayors Thomas Lauzon of Barre, Christopher Louras of Rutland, and Miro Weinberger of Burlington are calling upon state and federal officials to stem the flow of Zohydro, a painkiller approved in December by the U.S. Food and Drug Administration.

    FDA Commissioner Margaret Hamburg recently defended approval of Zogenix Inc.’s Zohydro, saying the powerful prescription opioid offered a “unique option” to help treat pain. It is the first single-ingredient hydrocodone drug ever cleared for U.S. patients, and carries five times as much narcotic in a single, extended-release dose as in a current hydrocodone drug like OxyContin.

    The FDA’s own advisory committee of pain specialists reportedly voted 11-2 against it.

    Hamburg, responding to a query from a U.S. Sen. Joe Manchin, a West Virginia Democrat, said that many hydrocodone drugs contain acetaminophen, which can be toxic to the liver in higher doses. Zohydro does not contain the added pain ingredient.

    However, the extended-release pill contains more of the narcotic pain reliever than older combination pills, such as Vicodin.

    “We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy,” Hamburg said at a hearing of the Senate’s Health, Education, Labor and Pensions Committee.

    But Manchin called on the government’s top health official to overturn the approval of a powerful painkiller, arguing that Zohydro could add to the national epidemic of prescription drug abuse. Manchin asked Health and Human Services Secretary Kathleen Sebelius to overrule the agency’s decision. Nearly 30 attorneys general also signed a letter urging the commissioner of the FDA to reconsider the approval of this drug.

    And more than a half-dozen members of Congress have sent letters to the agency questioning its review of Zohydro.

    “(We) do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed,” the letter from the attorneys general read.

    Lauzon, who has been leading the charge against Zohydro in Vermont, has sought counsel from Health Commissioner Dr. Henry Chen, and has reached out to other Shumlin administration officials, as well as representatives from Vermont’s congressional delegation.

    At a minimum, Lauzon, Louras and Weinberger are in the process of asking the Vermont Mayors Coalition to support a ban on the drug — which became available in some parts of the nation this week — being shipped to Vermont pharmacies, at least for six months.

    The mayors are not alone in their concern.

    The FDA approval surprised many doctors. Chief among the criticisms leveled at the agency is that FDA regulators should have required Zohydro to be formulated in a way that would make it difficult for abusers to crush or dissolve, for snorting or injection.

    To date, the FDA has only approved one medication with such features, a tamper-resistant version of OxyContin launched in 2010.

    “It doesn’t do any good to label something as abuse deterrent if it isn’t actually abuse deterrent, and right now, unfortunately, the technology is poor,” Hamburg told lawmakers in January.

    Meanwhile, Purdue Pharma, the maker of OxyContin, announced recently it would submit an abuse-deterrent version of hydrocodone to the FDA for review later this year. The news sent shares of San Diego-based Zogenix Inc. down more than 20 percent in trading, on expectation that Purdue’s product could derail sales of Zohydro.

    It is courageous and right, on the heels of the governor’s high-profile State of the State address going after opiate addiction, that the mayors of three Vermont communities (each city with known drug problems) would be proactive, rather than adopting a wait-and-see approach to such a dangerous drug. The abuse potential is off the charts, and without the proper abuse-deterrant formula in place, the FDA is putting communities at great risk for a new form of addiction.

    Zogenix is saying patients who might benefit from Zohydro include people suffering from chronic back pain, metastatic breast cancer or a patient with multiple orthopedic fractures. That is a large population of Americans. That is a lot of potential for Zohydro to be accessed, crushed and abused. And once again, it is available over the counter.

    The mayors have every right to be very concerned, and perhaps even outraged that in Vermont’s newly declared war on drugs, the FDA potentially just made any victory that much harder.
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