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Doctors Say New Pain Pill Is "Genuinely Frightening"

Hugh Pickens DOT Com writes "Stephanie Smith reports at CNN that a coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the new prescription pain drug Zohydro, a hydrocodone-based drug set to become available to patients in March. 'You're talking about a drug that's somewhere in the neighborhood of five times more potent than what we're dealing with now,' says Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. 'I'm five times more concerned, solely based on potency.' The concerns echoed by all groups are broadly about the drug's potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers. 'In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid (PDF),' the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.

Zohydro's maker, Zogenix, and the FDA say the drug's benefits outweigh its risks and in their petition to the FDA for approval, Zogenix representatives say the drug fills a critical need for people suffering from chronic pain who are at risk for liver toxicity and cited examples of patients who might benefit from Zohydro: a 46-year-old male with chronic back and leg pain who had two failed back surgeries; a 52-year-old female with metastatic breast cancer experiencing diffuse pain; a 32-year-old woman with multiple orthopedic fractures. 'There's a lot of misinformation being put out there by people who don't have all the facts,' says Dr. Brad Galer, executive vice president and chief medical officer at Zogenix. 'We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones — it's a very significant medical health problem that is being ignored.'"

9 of 294 comments (clear)

  1. It's just a tool I guess by dimko · · Score: 5, Insightful

    Can be used for good, can be used for bad. Just regulate the hell out of it. Let it be.

    1. Re:It's just a tool I guess by SJHillman · · Score: 5, Insightful

      Sometimes regulating the hell out of things decreases its availability for good use and jump starts the black market for bad use.

    2. Re:It's just a tool I guess by Anonymous Coward · · Score: 5, Insightful

      But in this case preventing "bad use" actually means trying to prevent people from harming themselves. Stopping self-harm can be morally good, but isn't really morally required. However, when an effort to prevent self-harm actually causes harm, that effort is purely immoral. The war on drugs is immoral.

    3. Re:It's just a tool I guess by Mashdar · · Score: 5, Insightful

      Confinement is certainly a good thing for some, but jails/prisons seem like the wrong setting for non-violent addiction-related issues. The focus of prisons (from my limited observation) is rarely to rehabilitate.

    4. Re:It's just a tool I guess by Anonymous Coward · · Score: 5, Insightful

      Exactly. Drug addicts should be sent to rehabilitation centers, not prisons. They need medical help, not punitive justice.

    5. Re:It's just a tool I guess by Zero__Kelvin · · Score: 5, Insightful

      You seem to be under the mistaken impression that jail is drug free, and that the "confinement" of which you speak can only be acheived with prison. There are plenty of lock-in treatment facilities. Prison / Jail is never the answer, and every single claim that they make that your loved one will get "help" in prison is a straight bullshit lie. Anyone who gets clean in jail and stays that way when they leave does so in spite of, and not because of, the prison system.

      --
      Guns don't kill people; Physics kills people! - John Lithgow as Dick Solomon on Third Rock From The Sun
  2. Problem is, they're probably both right by jratcliffe · · Score: 5, Insightful

    Put it on the market, and some people will abuse it and OD on it. Keep it off the market, and some people will suffer extreme pain needlessly. Honestly, I don't envy the FDA team that has to make this call.

  3. The articles. by Anonymous Coward · · Score: 5, Insightful

    The articles give a lot of voice to the critics.

    But do they talk to folks who are suffering from pain so much that they'd rather die?

    Hardly. They're mentioned in passing.

    Everybody is so afraid of the criminals and the occasional overdose, folks who could realy benefit from this drug may be screwed.

    But do any of these physcians, law enforement, attourney generals, and every other critic offer a solution to this "opioid addiction epidemic"? Nope.

    Do they suggest that possibly there's something going on in our society that gives folks the desire to abuse? Nope!

    Addiction is considered a character flaw in our society - lack of willpower - even by most medical professionals.

    When you actually talk to these addicted folks, you hear the same stories over and over: child abuse, sexual abuse, violence, care givers that had their own addictions, neglect, etc ...

    And it's not just the poor. I've seen some really screwed up kids because their parents were worshipping the bitch Goddess Success and pretty much left the kids to babysitters and then left to their own devices. And they wonder why the kid blows through his trust buying drugs.

    We're a shallow and cruel society that eats up its kids and then they turn into fucked up adults.

    Oh, and not all are drug addicts or alcoholics. Gambling, over eating, buying shit, ... there is plenty of addictive behavior in this society.

  4. last thing? by nitehawk214 · · Score: 5, Insightful

    the very last thing the country needs is a new, dangerous, high-dose opioid

    Unless, of course, you are in serious chronic pain. Then, according to Dr. Stephen Anderson and friends, fuck you. You are obviously faking it because if they can't imagine needing this drug in the emergency room, then it must be useless to everyone.

    --
    I'm a good cook. I'm a fantastic eater. - Steven Brust