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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.'"

14 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, Interesting

      Posting anonymously for obvious reasons: I actually participated in the drug study of this medication as a patient. I thought it was terribly ineffective for me. I will say up-front that I do not think that my body metabolizes hydro or oxycodone properly. Here was my experience:

      I was on a duragesic patch (25 micrograms of fentanyl transdermally, patch is worn for 72 hours). For some reason the patch did not last the full 72 hours so I was on a 48 hour dosing schedule. I felt relatively good. My pain level was manageable and I was not drowsy or loopy. I felt like a normal human being again. I was very content with my treatment. The big issue was that both that medication and my arthritis medication were not covered by my insurance and I was paying $200 a month for my meds. So when I heard about the trial I decided to give it a go.

      They started me on 20mg of the med, which was slightly less than the equivalent dose from my patch. I could not get out of bed for three days I was in so much pain (turns out it was partial withdrawal symptoms that was amplifying my pain). The medication was not delivering what my body considered to be an equivalent dose. I stepped up after 3 days. I was still in a lot of pain. I stepped up again, and again all the way up to 120mg doses. At that point it was the equivalent dose of the highest duragesic patch and still I was miserable. At that point I requested that I be released from the study and returned to my pain management doctor's care. At that point, the 25microgram patch was no longer sufficient and I had to step up to the next dose. But again I felt like a normal human being with manageable pain.

      In my opinion the fentanyl patch was much more convenient, stable, and provided exponentially better relief. This medicine was garbage for me. However, that does not mean that it can't be useful to some. If they formulate it like the oxycodone ER, in a way that helps prevent crushing, chewing, or other abuse then it may have pharmacological value.

      I will say that I believe that fentanyl can be a terrible, terrible drug. I had a procedure that brought my pain levels down to the point that I was in no pain with the fentanyl. I decided to stop the medication. That was hell on earth. I thought I was going to lose my job. I could not sleep, I had no appetite. I felt like a zombie. The doctor gave me oxycodone to help me step down from the last patch and at 2x the dosing the doctor recommended I had no relief from the withdrawal symptoms. I ached for relief so badly that I had to destroy all of the oxycodone to prevent myself from taking too much. I went cold turkey. It took almost a year for my body to return to normal. Without the medication I still have pain but I refuse to go back on. My doctor just writes me a script for a very small monthly supply of oxycodone that I use in case of emergency.

    3. 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.

    4. Re: It's just a tool I guess by parrini · · Score: 5, Interesting

      Are you shure you were not in the control group?

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

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

      Just look at the current refer madness - that's at least starting to somewhat abate. There was just a story yesterday about the Annapolis police chief, who quoted a DailyCurrant article to a State committee about a coroner who had to put five college students in body bags before breakfast (due to marijuana overdose). The Chief later apologized, half heartedly, but the level of rank incompetence is astonishing - he doesn't even know enough about the topic to spot satire, but he's happy to cage people for it anyway.

      Meanwhile, suffering patients often can't even get a little bit of pain relief (without facing criminal charges).

      --
      My God, it's Full of Source!
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    6. 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.

    7. 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.

    8. 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. Well, duh by Rik+Sweeney · · Score: 5, Funny

    Of course a pain pill is going to frighten people, who the hell is going to take something that causes them discomfort?

    (It's worth noting that I may have only read the title of this article)

  3. 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.

  4. 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.

  5. Probably current best treatment by Anonymous Coward · · Score: 5, Informative

    I don't know for this specific instance, but generally for studies like this, the control is not a placebo but current best treatment.

  6. 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