a big mistake…

Posted on Friday 25 April 2014

by Michael McCarthy
British Medical Journal. 2014 348:g2939

Margaret Hamburg, commissioner of the US Food and Drug Administration, has defended her agency’s decision to approve the potent long acting opioid Zohydro ER, arguing that the FDA had to balance the risks of opioid prescription abuse with “the very real medical needs of the estimated 100 million Americans living with severe chronic pain or coping with pain at the end of life, which is also a major public health problem in this country.” In an address to the National Rx Drug Abuse Summit being held in Atlanta, Georgia, Hamburg said that the drug—an extended release formulation of hydrocodone bitartrate—offered an effective option to patients who required around-the-clock opioid treatment and for whom alternative treatments were inadequate. She also said that because Zohydro did not contain paracetamol (acetaminophen), it did not pose the threat of liver toxicity seen with combination hydrocodone products, such as Vicodin, which did contain paracetamol.

Hamburg’s comments came as several state governors moved to severely restrict the use of Zohydro in their states, citing concerns that the drug, which can be easily crushed for sniffing or injection, would exacerbate prescription opioid abuse in their states. On Tuesday 22 April Deval Patrick, the Massachusetts governor, issued orders to require prescribers to complete a risk assessment and agreements on pain management treatment before prescribing Zohydro. Rules issued by the Massachusetts Board of Registration in Medicine say that these agreements must address drug screening, pill counts, and safe storage and disposal.

Patrick said, “We are in the midst of a public health emergency around opioid abuse and we need to do everything in our power to prevent it from getting worse.” His order came after a court lifted an outright ban on the drug, which Patrick imposed in March. In that ruling District Court Judge Rya W. Zobel cited the Supremacy Clause of the US Constitution, which establishes that federal law supersedes state law if they conflict. Zobel wrote, “If Commonwealth [of Massachusetts] were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health. The Commonwealth’s emergency order thus stands in the way of ‘the accomplishment and execution of’ an important federal objective”…

The FDA’s decision to approve Zohydro last October, despite an 11-2 vote by the agency’s advisory board against approval, triggered a storm of protests from state officials and politicians in Washington. Late last year attorneys general from 29 states wrote a letter to Hamburg, calling for her to either revoke the drug’s approval or require the manufacturer to quickly produce a formulation that deterred misuse. And earlier this year Joe Manchin, a Democrat senator from West Virginia—a state that has been hard hit by the opioid abuse epidemic—introduced a bill that would force the FDA to withdraw its approval of the drug.
Somebody is making a big mistake here. I think it’s Margaret Hamburg of the FDA. I live in the lower part of Appalachia, continuous with the culture of West Virginia mentioned above. Opioid abuse has replaced the "white lightning" of old and the "meth" of more recent times. It’s endemic. We need a potent long acting new narcotic here like we need more poverty or extra tornados – which is not at all. There’s no problem with end of life care around here. There’s no problem with the current pain management either. Our problem is narcotic abuse, plain and simple. I’ve dropped the hard drugs from my own DEA License. I only rarely needed to prescribe them, but my DEA number has been purloined several times, so I decided to make that part of it unusable. I refer all requests elsewhere. Narcotics are essential for the practice of medicine, sure enough, but building versions like this that are as well designed for abuse as they are for use is just wrong, and this decision should be dogged for the mistake it is. Over-riding her own advisory committee and the wishes of the States just makes no sense at all…
    Steve Lucas
    April 25, 2014 | 8:23 AM

    Up here in the heart of the rust belt, with ties to WV, we have seen an epidemic of heroin use. High unemployment, underemployment, with few job opportunities, and a lack of any options people become bored and cheap drugs fill their time.

    I remember the great idea of pain medication in the form of a lollypop, until people started becoming addicted, and small children died thinking it was candy.

    Today the elderly live in fear that they will be injured, or worse, as drug seekers break into their homes in search of their pain medications. Children and grandchildren take medications to use or sell and the elderly fearing to report this ask for ever larger numbers of pills.

    I am old enough to remember the wasted lives of “recreational” drug use of past times.

    Interestingly the Dutch are beginning to enforce their drug laws, shutting down “cafes” and other drug providers along with tighter restrictions on other vices. They, being oh so liberal, have found that drug use, prostitution, and other vices carry a price society does not want to pay.

    Steve Lucas

    April 25, 2014 | 11:11 AM

    100 million Americans needing opiate care. Give me a damn break!

    I could see close to 100 million Americans dealing with anxiety, but that doesn’t justify a benzodiazepine for all of them either.

    What does “FDA” stand for these days? For Drug Abuse?!

    April 25, 2014 | 3:02 PM

    So, what other options do people with chronic and severe pain have? I’m sure that if there was something non-narcotic that doctors at the V.A. would prescribe that, but maybe I’m missing something. When I hear the panic about prescription narcotics, I don’t hear about alternatives. Is there some reason why no more narcotic medications should be manufactured, aside from the issue of abuse? I can see the manufacturer being required to use medium that isn’t so easy to crush, but if it’s a more effective pain reliever then shouldn’t people suffering with chronic and severe pain have that option?

    I read an article recently about the number of opiates prescribed by the V.A., and some people are taking up to 1000 mg of morphine a day! Gee, take morphine long enough and you need higher doses because you develop a tolerance. If, for instance, someone has chronic pain as a result of battle wounds, should he/she be denied pain medications because of other people’s abuse? Morphine just “takes the edge off”. Surely people with pain that make their lives not worth living without some relief aren’t getting opiates because there are better options, are they?

    If a person has a medical condition that causes pain, should they be punished for problems addicts have? Ritalin is abused as well and I’m not seeing a moral panic about the number of college students who suddenly have ADD and seeing references to the numbers of deaths caused by speed— and prescription speed has been a street drug since the seventies, at least.

    I can see taking issue with over prescribing and failures to sufficiently police the high-volume prescribers and the tricks abusers use to get refills that have already been filled, but vilifying opiates as if they were otherwise worthless drugs is a little bit much.

    April 25, 2014 | 3:27 PM

    100 million need opiates like 100 million suffering anxiety need benzo’s?

    Beyond doubtful, ludicrous more likely.

    April 25, 2014 | 3:38 PM

    Under pressure of overcrowding, it’s the subconscious urge of humans to off their own species. Why should fatal overdoses be a concern?

    April 25, 2014 | 4:19 PM

    100 million needing opiates is like expecting 100 million struggling with anxiety needing benzos. Both pathetic and ridiculous to assume.

    But, as I am personally witnessing at my current locum assignment, the lie becomes truth, eh?

    Hope this comment takes, the last two were stricken?

    April 25, 2014 | 4:20 PM

    So I am banned, eh? Have a good life, you could have at least told me so!

    Joel Hassman, MD

    James O'Brien, M.D.
    April 25, 2014 | 5:01 PM

    3-4% of the world’s population and we consume 80% of prescription opioids. USA number one!

    Therefore we need another stronger one. We never learn.

    “When I hear the panic about prescription narcotics, I don’t hear about alternatives.”

    No one is asking Americans to train as Shaolin monks. I think you are missing the point…more opioids will in time make the pain worse…and there are plenty of alternatives to opioids which should always be a last resort for chronic pain (with a few exceptions like cancer). I’m not going to list them all but there are thousands of Internet articles on this if you are interested.

    April 25, 2014 | 5:38 PM

    The point isn’t “better.” Zohydro isn’t “better.” It’s longer acting. The problem is that to make it longer acting, it has much more in it and is easily deconstructed. This is not a pain management issue. It’s only value is convenience, not greater pain relief.

    PS: I have a request [FOIA] submitted to the FDA about Zohydro’s Approval to see if I’m right about what I said above, but they are notoriously slow with the reports on new drugs. So we’ll see [someday]…

    James O'Brien, M.D.
    April 25, 2014 | 6:42 PM

    Let’s not forget the role that pain management KOLs played in creating this problem:


    April 25, 2014 | 8:27 PM

    Benzo addiction is not rare, either, and it doesn’t take a lot over a long time. Following doctor’s orders is no protection against physiological dependency upon any of these drugs.

    Joseph Arpaia, MD
    April 25, 2014 | 9:05 PM

    The issue of whether Zohydro (who comes up with these names?) should have been approved is separate from the issue of whether states can prevent an approved drug from being prescribed.

    For example, if state had a legislature which was arch conservative and wanted to ban the prescriptions of approved oral contraceptives, or “morning-after” pills would we accept that as OK?

    I think people need to think carefully about what legal precedents are being set and the unintended consequences thereof.

    April 25, 2014 | 9:12 PM

    the clean needles initiative is really bothersome, especially after i’ve learned how the american health care system works wrt acquiring prescriptions.

    again i could be wrong, but i’ve read a wsj article where covenant health stated that a doctor wasn’t necessary for prescriptions (http://online.wsj.com/news/articles/SB10001424052702304819004579487412385359986
    “No appointments are needed at the clinics and most insurance is accepted. Most locations offer care to patients 18 months and older and are open seven days a week with evening hours, making convenience a big part of their lure. Services are usually provided by nurse practitioners or physician assistants, who are qualified to write prescriptions, according to the Convenient Care Association, a national trade association. Many clinics collaborate with local physicians who can be called upon for consultations, if necessary.

    the 11-2 vote sure sounded like a board who wanted to “do right” for once, but it’s too late.

    i hate to sound so cynical but it seems the entire system is set up to allow regular people to acquire powerful drugs easily, which, combined with free/clean intravenous paraphernalia, is a lethal marriage (i believe).

    that benzo, opiate, or whatever, is the abuser’s “outlet” from the terrible state of today’s world. this pill feels like a last gasp in a “market” that, i believe, will be shrinking in the near future.

    we can’t get anywhere without clear heads, and pills like this are the antithesis of that.

    April 25, 2014 | 9:43 PM

    Joseph Arpaia, MD

    Excellent point…

    April 26, 2014 | 2:41 AM

    “… more opioids will in time make the pain worse…”

    More opiods can, in time, make the pain worse. Most people don’t have the paradoxical reaction. I trust my neurologist, my primary care physician, and a pain management specialist I’ve worked with on pain management for MS.

    April 26, 2014 | 1:08 PM

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