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Medicine

Doctors Say New Pain Pill Is "Genuinely Frightening" 294

Posted by samzenpus
from the take-your-medicine dept.
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.'"
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Doctors Say New Pain Pill Is "Genuinely Frightening"

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  • by dimko (1166489) on Thursday February 27, 2014 @08:08AM (#46356089)
    Can be used for good, can be used for bad. Just regulate the hell out of it. Let it be.
    • by SJHillman (1966756) on Thursday February 27, 2014 @08:13AM (#46356113)

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

      • by Anonymous Coward on Thursday February 27, 2014 @08:32AM (#46356237)

        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.

        • by SJHillman (1966756) on Thursday February 27, 2014 @08:41AM (#46356313)

          It's pretty rare that "self-harm" only harms the person doing it, especially with addictive substances. They may be the only one suffering the physical effects, but there's emotional, financial, social, etc, etc effects that radiate out to their family, friends, co-workers and more. It's not as obvious as second-hand smoke from cigarettes, but the detrimental effects are still there.

          • by kilfarsnar (561956) on Thursday February 27, 2014 @08:51AM (#46356425)

            It's pretty rare that "self-harm" only harms the person doing it, especially with addictive substances. They may be the only one suffering the physical effects, but there's emotional, financial, social, etc, etc effects that radiate out to their family, friends, co-workers and more. It's not as obvious as second-hand smoke from cigarettes, but the detrimental effects are still there.

            That's true and good to recognize, but not an argument for continuing the war on drugs. The answer to the question of how to deal with such people is not to throw them in jail, compounding the problem, but to actually help them with the aim of getting them to a healthy mental and physical state. Unfortunately, out society seems more interested in punishing people than helping them.

            • Re: (Score:3, Insightful)

              by rmdingler (1955220)
              I don't presume to know how close you've ever been to full-on drug addiction,

              but in my own admittedly small sampling,

              many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.

              • by Mashdar (876825) on Thursday February 27, 2014 @09:30AM (#46356803)

                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.

                • by Anonymous Coward on Thursday February 27, 2014 @09:48AM (#46356979)

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

                  • They often need more than medical help. They often need counseling and help to get back on track. But what they don't need is punishment for being addicts.

                    (Punishment for committing drug related crimes is a different matter.)

              • by Zero__Kelvin (151819) on Thursday February 27, 2014 @09:56AM (#46357053) Homepage
                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.
                • I know of people who specifically get arrested just to smuggle drugs into jail, so yeah...and several of the "rehab centers" in my town are awash with pills...even crooked staff. On top of this is 4-6% population is genetically inclined for opiod addiction. Some of these "severe pain" patients may someday find themselves; after surgery and recovery, puking up for days on end, hot / cold flashes, massive mood swings, extreme agitation at everything, inability to remember where they just "put down something
              • by kilfarsnar (561956) on Thursday February 27, 2014 @10:17AM (#46357293)

                I don't presume to know how close you've ever been to full-on drug addiction,

                but in my own admittedly small sampling,

                many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.

                I have been very close to addiction. I have watched a good friend put heroin into his arm, and had another die of "massive organ failure" after many years of drug use. There was a time when at least half of my friends were in AA. I agree that some people need confinement to stop using, at least temporarily. But I think that's what we have inpatient rehab for. Confine someone if you must, but don't put them in jail. Prison is not an environment conducive to improving one's mental and physical health; it just makes things worse.

              • by jamstar7 (694492) on Thursday February 27, 2014 @10:31AM (#46357525)

                I don't presume to know how close you've ever been to full-on drug addiction,

                but in my own admittedly small sampling,

                many an addict's confinement is the only time in their adult lives they're not using. A great friend passed last year at the ripe old age of 48, but his life was probably extended a decade by frequent periods of abstinence as a guest of the County and State.

                Problem with simple confinement is, it doesn't fix the problems, just delays the next dose. And don't think for a minute that jails and prisons are drug-free. They're not. Drugs are available, just at insanely high prices due to scarcity.

                Speaking as a recovering addict, you need to fix the cause, not the symptoms. Incarceration does neither, and tags the 'offender' with a felony rap, making it that much harder for them to reintegrate to society by blocking employment opportunities when they get back to the streets. End results? The 'offender' ends up back in jail.

                • by ediron2 (246908)

                  While I agree that having a felony record is cruel baggage to a recovering addict, being stripped of rights for a time is effective when other things fail. My state has a program that is only open to 'use' type drug prisoners. It's hard to get into, it's strict, it focuses on changing habits, breaking away from toxic relationships, and skills needed to hold down a job, plus the usual drug treatment and 12-step program. It has helped a few people I know.

                  Back before Reagan, institutionalization was similar

              • by coolsnowmen (695297) on Thursday February 27, 2014 @11:27AM (#46358419)
                As other people have noted there is a difference between detox in confinement and putting them in jail as a criminal. Getting out of prison is not like getting out of detox. You are a criminal now, and can't get a job, and in some places can't vote, get certain types of public assistance... basically, you get fucked.
            • by SJHillman (1966756) on Thursday February 27, 2014 @09:17AM (#46356711)

              I agree that the war on drugs is stupid and causes more harm than good. However, the counter argument that "people should be allowed to do things that only hurts themselves" is pretty poor in the case of most addictions (including but definitely not limited to drugs). Personally, I think people should be allowed to do whatever they want as long as there's no adverse affects to those around them. Unfortunately, most people only think of the immediate physical effects (e.g. secondhand smoke) and don't think of the more long-term effects, especially those which are harder to quantify.

              • by causality (777677)

                I agree that the war on drugs is stupid and causes more harm than good. However, the counter argument that "people should be allowed to do things that only hurts themselves" is pretty poor in the case of most addictions (including but definitely not limited to drugs).

                The question is whether jail is an environment that will make them better people and help them overcome these problems. A related question is whether armed police, not doctors/therapists, should be the ones we send to deal with people who have not used fraud or violence against another person.

                Unfortunately, most people only think of the immediate physical effects (e.g. secondhand smoke) and don't think of the more long-term effects, especially those which are harder to quantify.

                It's hard to think of a more damaging long-term effect than expanding the definition of "crime" to include "something other than using force/fraud to harm another human being", the subsequent mutilation of the Fourth

              • by Kjella (173770)

                I agree that the war on drugs is stupid and causes more harm than good. However, the counter argument that "people should be allowed to do things that only hurts themselves" is pretty poor in the case of most addictions (including but definitely not limited to drugs). Personally, I think people should be allowed to do whatever they want as long as there's no adverse affects to those around them. Unfortunately, most people only think of the immediate physical effects (e.g. secondhand smoke) and don't think of the more long-term effects, especially those which are harder to quantify.

                If you just make it broad and vague enough practically everything will have some adverse effect on something. Or if not with certainty then with for some of the people some of the time and the increased risk meaning an increased risk. Or it's not by itself harmful but is somehow a gateway or stepping stone to something which might have adverse effects.

                For example, take alcohol and let's forget all the health effects. Alcohol drinking is probably the leading cause of public urination which is clearly some fo

            • Re: (Score:3, Interesting)

              by ehiris (214677)

              No one wants to punish people for victim-less crimes. We just fall prey as a society for the giant enforcement and correction industry and can no longer differentiate between what is actual crime and what is a money-making scheme.

              Class extermination is the only true vice of the war on drugs. Which is why Meth has the worst reputation at the moment. Meth has brought lawlessness to predominantly white communities and turned them into drug-based ghettos. And heroin use increase in white communities is a result

        • Re: (Score:2, Interesting)

          by Anonymous Coward

          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.

          If society is going to be on the hook for providing food stamps, welfare, and "free" health care to people who turn themselves into total derelicts through drug abuse, damn right drug abuse should be illegal.

          If you want drug use to be legal, then you damn well shouldn't be protected from the consequences of drug abuse. You wanna put that crap into yourself? Then if you turn into a derelict addict, no health care, no food stamps, no methadone, NOTHING.

          You did it to yourself, you deal with it. ALL of it.

          • by EzInKy (115248)

            Which puts society on the hook for their room and board when they get put in jail, numnuts! Understand and fix the root of the problem, which might be human being's natural tendency to avoid pain and other stressors such as hunger and poverty.

      • by bill_mcgonigle (4333) * on Thursday February 27, 2014 @09:05AM (#46356557) Homepage Journal

        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 [wikipedia.org] for it anyway.

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

      • by Derec01 (1668942)

        This seems a little better than that, if I'm understanding it correctly. The drug would never be mass-produced if its approval is revoked, and it's doubtful that the company would let its production method out AND that it would come to someone with the capabilities of producing it illicitly.

        It's hard to have a black market if no one makes the drug for any legal use.

    • by Anonymous Coward on Thursday February 27, 2014 @08:26AM (#46356195)

      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.

      • You are not the only one. I got some oxycodone for a neck issue from my doctor and I ended up shitcanning it. Advil worked better and the oxycodone just made me itch, disturbed my sleep, and did not much for pain relief. I do feel for addicts, but I could be addicted to hitting my thumb with a hammer easier than the *codones. My cat got a fentanyl patch after cancer surgery and he was out there. He would just pass out in random places.
        • Interesting. I had the same experience with one of the oxycodone + NSAID combos. I forget which one. Might have been vicodin. Anyway, I had a severe toothache that was going to be a Monday morning root canal. Oxycodone over the weekend was the pain management plan. I found it was less effective than the 600 mg of ibuprofin, so I quit using the oxycodone and went back to the IB. I was still in pain, but less pain.

      • by parrini (840878) on Thursday February 27, 2014 @08:39AM (#46356301)
        Are you shure you were not in the control group?
        • by Anonymous Coward on Thursday February 27, 2014 @09:21AM (#46356745)

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

        • by jonnythan (79727) on Thursday February 27, 2014 @09:29AM (#46356791) Homepage

          The control group in a drug study would not place someone currently on strong medication onto no medication. That would violate the ethical principle of equipoise. The subjects in the control group wouldn't be given a placebo; that would be horrendously unethical. They would be given either the current gold standard of care or the new drug/procedure being tested. The researchers and subjects would both be blinded to which they were receiving. For instance, an RCT comparing hydrocodone to a new med would have both arms take a new pill, but both pills look identical. One would contain the medication they've been taking and the other would contain the new drug. That's not what the OP is talking about though.

          I'm not super experienced in clincal trials, but the study the OP was a part of doesn't sound like a double-blinded RCT; it sounds more like a limited-rollout experimental kind of clinical trial, where certain people are allowed to elect to try out the drug. This is not really a scientific experiment that would have a control group, but a limited opt-in rollout of the drug.

          • But putting them on a placebo is far safer than putting them on these new untested drugs. Often the placebo will actually also do better at curing/treating the patient, as well as avoiding the nasty, often deadly, side-effects. There are prescription drugs out there right now that have been clinically prove to do a less good job at their purpose than a placebo, so some random untested drug that in all likelihood has serious side effects, and has yet to be proven to be even minimally more effective than a pl

            • by jonnythan (79727)

              Do some reading on "clinical equipoise" and you'll start to get it.

            • by u38cg (607297)
              I hope you never have to go on opiates to manage chronic pain, but one positive side effect is you would realise how damn stupid you sound right now.
          • by flynt (248848)

            The Phase III study "Study 801" of the compound under discussion did have an open-label run-in period, *and* was placebo controlled.

            I believe the ct.gov link below is the study under consideration. Regardless, the press release mentions the placebo control.

            http://clinicaltrials.gov/ct2/... [clinicaltrials.gov]

            http://ir.zogenix.com/phoenix.... [zogenix.com]

            From the last link:

            Zohydro ER was studied in over 1,100 people living with chronic pain who participated in the pivotal Phase 3 efficacy study or an open-label Phase 3 long-term safety stud

    • by sunderland56 (621843) on Thursday February 27, 2014 @08:34AM (#46356253)

      Can be used for good, can be used for bad.

      Both heroin and cocaine were originally developed as medicine. Turns out that their potential for misuse far, far outweighs any medical benefit.

      As far as new pain medicines go - why not just go back to using heroin? Cheap to make, easily available in generic form, and it's side effects are well known.

      • by jovius (974690)

        Heroin is used as a medicine in some countries; in UK for example [wikipedia.org].

      • Re: (Score:2, Informative)

        by Anonymous Coward

        Cocaine is schedule two in the United States; it's used most commonly in nasal surgery. There's nothing else that really provides its combination of local analgesia and vasoconstriction. Herion is still available for medical use outside of the US as Paramorphan.

        All opiate narcotics essentially work the same way, and there are many in use in the US that are far more potent than morphine or dihydromorphine. Look up "fentanyl" or "sufentanil". Potency just tells you the amount of dose you need to achieve a

      • Re: (Score:3, Interesting)

        by Eunuchswear (210685)

        My mum was given Heroin while in hospital recovering from surgery(*). Best thing she'd ever had for pain.

        ((*) they tell you it's "diamorphine" :-))

      • by sribe (304414) on Thursday February 27, 2014 @09:16AM (#46356695)

        Both heroin and cocaine were originally developed as medicine. Turns out that their potential for misuse far, far outweighs any medical benefit.

        And yet they both are still used in medicine (http://www.medicinenet.com/cocaine_hydrochloride-topical/article.htm). While marijuana is classified by the US feds as having no medical use. Go figure.

        • by causality (777677) on Thursday February 27, 2014 @09:47AM (#46356957)

          Both heroin and cocaine were originally developed as medicine. Turns out that their potential for misuse far, far outweighs any medical benefit.

          And yet they both are still used in medicine (http://www.medicinenet.com/cocaine_hydrochloride-topical/article.htm). While marijuana is classified by the US feds as having no medical use. Go figure.

          The cannabis plant is too easy to cultivate and has too many non-drug uses that threaten several powerful industries with lots of lobbyists. That's why something with demonstrated medical use that is practically impossible to overdose on is listed as a Schedule I. That's the only reason why.

          • by sribe (304414)

            That's the only reason why.

            No it's not; you're forgetting Richard Nixon's white-hot hatred of hippies ;-)

      • "Turns out that their potential for misuse far, far outweighs any medical benefit."

        That doesn't "turn out" to be true at all. It "turns out" that when society is confronted with a choice between the truth and their highly biased propoganda induced viewpoint, they form absurd conclusions like: "Turns out that their potential for misuse far, far outweighs any medical benefit."

        Let's start with the ridiculous term "mis-use". Who the hell are you to tell me what "mis-use" is for me? If I want to use cocaine

  • Well, duh (Score:5, Funny)

    by Rik Sweeney (471717) on Thursday February 27, 2014 @08:09AM (#46356099) Homepage

    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)

  • 'There's a lot of misinformation being put out there by people who don't have all the facts,'

    I wish I knew how often this was actually true and relevant compared to all the times it isn't.

    • This is just a stronger formulation of hydrocodone than what was previously available. The summary makes it sound like a new type of opiate.

      A new opiate could, depending on its characteristics, be a most welcome addition. Existing opiates have a lot of drawbacks.

      But this? Not nearly as significant as the summary would indicate. On either side of the argument.
  • by jratcliffe (208809) on Thursday February 27, 2014 @08:23AM (#46356177)

    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.

    • The articles. (Score:5, Insightful)

      by Anonymous Coward on Thursday February 27, 2014 @08:40AM (#46356309)

      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.

    • by ILongForDarkness (1134931) on Thursday February 27, 2014 @09:13AM (#46356663)

      The same war on drugs crowd are the ones that say ACA has death panels and push to prevent any tolerance for euthanasia. They simply don't care if the patient is in pain as long as their moral sensibilities don't get offended.

    • The problem isn't the people that OD, it's the people that become long-term addicts. Cause they can be anyone -- your neighbor, your kid's teacher, some guy driving behind you. You create an entire underclass of people that are continually addicted to pain pills, no different than those addicted to meth, who will do anything for their next fix. These people are far more dangerous than those that just OD and die.

  • Higher potency? (Score:4, Insightful)

    by Hrrrg (565259) on Thursday February 27, 2014 @08:28AM (#46356211)

    As a physician, I am not sure I understand the concern after reading the article. After all, if a drug is higher potency, you just prescribe less of it. Higher potency does not equal higher efficacy (efficacy if the maximum effect that a drug can produce, potency refers to how much of the drug it takes to get that effect). We already have a ton of highly addictive opioids on the market, and hydrocodone is hardly one of the most effective narcotics. If the main ingredient is hydrocodone, how can it be more potent than other hydrocodone containing drugs? Maybe the concern is that it will be easier to get than other narcotics, but hydrocodone is being switched to the more-restrictive Schedule II drug class like oxycodone. Maybe this pill provides a higher dose of hydrocodone than existing medications? The article doesn't say. No doubt people will abuse this new pill, but it is not clear to me why it is thought that this will cause more addiction than already exists...

    • I think the issue is that this drug doesn't have acetaminophen, so someone in chronic pain and a high tolerance can take a lot of it without destroying their liver. This also means that it's safer for recreational usage, which theoretically is a concern since they've removed a consequence of addiction.
      • by weave (48069)

        I take Vicoprofen (for migraine pain). It's mixed with Ibuprofen instead of Tylenol. It still makes me sick all day after taking it. No idea why people abuse it.

        For me it comes down to a choice between being in horrible agony all day or having no pain but stuck in bed feeling dizzy and like shit all day. I'll take that over the pain.

        Now there may be some anti-nausea I can take to counteract some of the negative affects, but I haven't asked my doctor about that because the effects now ensure I won't ab

        • by Sipper (462582)

          I take Vicoprofen (for migraine pain). It's mixed with Ibuprofen instead of Tylenol. It still makes me sick all day after taking it. No idea why people abuse it.

          For me it comes down to a choice between being in horrible agony all day or having no pain but stuck in bed feeling dizzy and like shit all day. I'll take that over the pain.

          Now there may be some anti-nausea I can take to counteract some of the negative affects, but I haven't asked my doctor about that because the effects now ensure I won't abuse it and I don't want to know otherwise I guess.

          I ended up having temporary facial palsy (i.e. half my face drooped and didn't work) after taking Ibuprofin for a week for severe headache pain related to heat stroke. I also felt dizzy and sick while taking the Ibuprofin, but the headache pain without meds was unbearable. After the headache pain from effects of heat stroke passed I was able to stop taking Ibuprofin, and a week later the facal palsy went away. I can't know for sure that the Ibuprofin caused the palsy, but some number of people that take

          • by weave (48069)

            Thanks for the warning. I don't take it often enough to probably hit that. The ibuprofen dose is only 200mg, which is one OTC pill.

            I pretty much take maybe 1 or 2 a week at most as needed, but they keep me out of the hospital or urgent care place so it's worth it.

            (Annoys me that pain pills are hard to get for people who really need them because some people abuse them...)

    • by geogob (569250)

      I had at first trouble as well understanding the concern, which I have initially related back to me not being a physician. But if I put my engineer hat back on, I start to understand what the issue is (I deal all the time with people having issues, they can't correctly describe or explain). My believe, and I hope someone here can confirm or infirm this, is that the potency is not that much the issue, but rather the variance of the potency. In order word how different is the potency of the drug for different

      • Not quite. There are two main problems. One, missing Acetaminophen (like Vicoden). so many long-term addicts who WERE staying away from stuff because of liver toxicity now don't have to worry about it, and new "abusers" will see that as a "good thing" to go find it for illicit use; that's just the way an addict's brains is logically. Two, it's crushable...meaning it can be snorted or shot up easily. THIS is what's going to kill people...especially missing the acetaminophen. Of course, an enterprising a
    • People don't understand drugs. They don't understand that drugs have a window of pharmacological effectiveness, where you need a dose of X to get the desired effect but T is toxic. There's T1 T2 T3 etc, some drugs are really short-window or complex: T1 may be less than X, and the drug may have constant side effects--prednizone does this, it makes a LOT of people psychotic at normal doses that aren't even high enough to function as a viable treatment for some of its use cases. T2 may be something like e

  • This is not as "genuinely frightening" as the number of people that die of liver failure due to overdose or overuse of acetaminophen. The only difference between this "new" drug and the ones currently on the market is that this one does not contain acetaminophen. Old drug = hydrocodone + acetaminophen. This drug = hydrocodone only.
  • by wisnoskij (1206448) on Thursday February 27, 2014 @08:36AM (#46356271) Homepage

    It sounds like there are many use cases where it is basically necessary. Their are people out their who need more powerful drugs, and this is simply safer than taking 20 Tylenol a day.

    It would seem extremely reactionary and short sited of healthcare professionals ban this drug because it might increase the risk to abusers over the short term.

  • The reason everybody is so up in arms is that the opiate is not mixed with acetominophen. The only purpose of putting acetominophen in an opiate painkiller is to make it so it will fry your liver if you take more of it than it was designed for. Basically, such drugs are designed to be deliberately fatal to addicts. So much for "do no harm".
    • by CastrTroy (595695)
      It can be more dangerous to more than just addicts. They put acetaminophen/Tylenol in a lot of medications. If patients don't pay attention to which medications contain acetaminophen then they could overdose by accident. The difference between the maximum daily dose and fatal dose is not that big. People who don't realized their opiates contain acetaminophen could also be taking cold medicine or tylenol (you know, for the pain), and end up doing a lot of damage to their body.
      • They put acetaminophen/Tylenol in a lot of medications

        This is so bad to the point that I've found it necessary to order some of the constituent ingredients of various cold remedies off Amazon because I can only get them locally compounded with acetaminophen (paracetamol for our overseas folks) in the big name brands and their store-brand copycats. Fortunately, you can get a couple hundred doses of, say, expectorant, for the cost of a dozen doses of compounded gelcaps. Mix and match in the others as needed

    • The acetaminophen supposedly has an advantage in pain treatment, but if that were the sole purpose, you could just advise them to take some Tylenol in addition to their pain pill. That would almost certainly work out better, and would be far easier to scale for chronic pain patients.

      Another bizarre thing done to prevent abuse is the inclusion of dangerous chemicals in otherwise fairly safe recreational substances, such as canned air.or nitrous oxide.
      • I hate acetominophen, and ibuprofen gives me headaches. Naproxin works best but I rarely take it because dosing NSAIDs is ridiculous. For naproxen you need 8 hour spaced 100mg doses, but usually you need 200mg on the first dose to get it to work. Don't take more than 300mg/day. How the fuck do I keep this running for 24 hours without overdosing? Fortunately the first dose usually solves the problem: the inflammation goes away, so the pain stops, and the irritation causing inflammation stops (i.e. infl
        • by compro01 (777531)

          For naproxen...Don't take more than 300mg/day.

          Huh? The typical prescription naproxen dosing I see is 500mg every 12 hours or 325mg every 8.

          • Naproxen Sodium comes in 100mg doses, blue tablets, with the standard directions of "Take one every 8 hours, you may take two for the first dose, do not exceed three per day." I've never seen it prescription, but this seems silly: you can just buy naproxin and take 5 of them at once instead of a prescription 500mg.
      • Or methanol to rubbing alcohol as a preventative measure. Admittedly drinking alcohol itself is a poison but there is little reason to add impurities to research grade alcohol other than to protect the interests of distillers (and government tax revenue). Because: someone working in a lab wouldn't know to add ~2 units of water for each 1 unit of alcohol.

    • Interesting. Citation?

    • Mod parent up (Score:4, Interesting)

      by Medievalist (16032) on Thursday February 27, 2014 @12:17PM (#46359241)

      The reason everybody is so up in arms is that the opiate is not mixed with acetominophen. The only purpose of putting acetominophen in an opiate painkiller is to make it so it will fry your liver if you take more of it than it was designed for. Basically, such drugs are designed to be deliberately fatal to addicts. So much for "do no harm".

      I don't know why you got modded "flamebait". My current doctor and my previous one both told me exactly the same thing. They said they can't prescribe opiates without acetaminophen or their practices will systematically harassed by the government's drug warriors, and they can't help people if they are driven out of business.

      Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, says "Zogenix is working on an abuse-deterrent version of Zohydro that should become available in three years."

      To me, that says as soon as they add toxicity it'll be acceptable. Because in the USA, the goal of punishing addicts has become more important than the goal of helping people in pain. Authoritarianism is ascendant over compassion.

  • think of the children!

  • Just give the patient a fear pill.

  • Therefore I'm in favor ot it.

  • your lack of pain frightens me. Cut it out.

  • by p00kiethebear (569781) on Thursday February 27, 2014 @09:13AM (#46356669)

    It's only five times the dose of other hydrocodone tablets available. Doctors are going to always over prescribe opioids. If this one wasn't available then it would be a different one. I will say though that hydrocodone has a much more euphoric high. It might make it more desirable over existing oxycodone options. It should be noted that doctors already prescribe hydrocodone in these doses. This just means that chronic pain patients will only need to take 1 pill instead of five.

    Just because one new tablet becomes available doesn't mean there is going to be a sudden mass explosion in the number of pain pills available on the street. If people weren't ODing on this drug then they'd be ODing on one that's already available. But somehow we interpret people dying from overdose on a new pain killer as being 'added' deaths. When statistically the death would have happened on one pill or the other.

  • The problem with this drug isn't the potency. It's that it's time released like Oxycontin. Oxycontin was billed the same way this drug is... the same arguments. Doctors didn't think much of it at the time and used it. What we found out however is that opiates that are time released are orders of magnitude more addictive than just getting a "hit" by taking an immediate release.

    Now, I'm pretty libertarian, and feel that people should be able to destroy their lives in any such way they feel. But lets at least

  • last thing? (Score:5, Insightful)

    by nitehawk214 (222219) on Thursday February 27, 2014 @09:43AM (#46356923)

    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 think there is a classification for drugs that can only be administered in tightly-controlled, supervised settings.

    Perhaps this drug should be classified this way, at least for the first year or two.

  • Getting all these poor people addicted to your high-potency opioids is SURELY going to make their lives better! Oh, and fatten your wallet. The latter being the most important part.

  • You mean from the FDA-appointed scientific advisory panel which voted against its approval.....hmmm.....
  • I'll just have to try some before I make up my mind about it.
  • by Anonymous Coward on Thursday February 27, 2014 @10:26AM (#46357441)

    So, some doctors want their patients to suffer only because some people might abuse the drug? Assholes.

  • by ErichTheRed (39327) on Thursday February 27, 2014 @10:29AM (#46357489)

    I know "drugs are evil" and all, but I genuinely don't understand why people are so panicked about people abusing prescription pain killers. The reality is that there's a huge demand for pain medication, both for legitimate and abuse purposes. Just like the other wars on drugs, it's impossible to stop. Therefore, I'm of the mind that we shouldn't do anything...and that's coming from a very left-wing, big-government type. We should focus on providing abusers safe drugs, and spend the money we save on enforcement on treatment for the people who really want to get off drugs. I've never touched drugs, but I can't blame someone who has a crappy life and no prospects of it getting better from doing so.

    Providing pain medication addicts with a preparation that won't destroy their liver (due to the included acetaminophen in other meds) would be a start. There's no fix for the demand problem, and reducing supply just drives up the price.

    The reality is that the future is looking pretty bleak -- unemployment is going to be incredibly high as even safe middle class jobs are automated. Unless we want a revolution, it might be time to start loosening the restrictions on controlled substances. When unemployment goes up past 30, 40% and higher, governments are going to have angry mobs on their hands unless they have something to keep them occupied...

  • by un4given (114183) <bvoltz@gmai[ ]om ['l.c' in gap]> on Thursday February 27, 2014 @11:29AM (#46358461)

    From my view of this "new" drug, it looks to me like it's just hydrocodone in a time-release form, without any acetaminophen in it. The intention of this drug company is take a medication that is now generic and produce a novel, patented form that can be sold at a premium. The fear that some doctors have is that each pill contains a large amount of hydrocodone, so if your intent was to abuse, you could crush it and get the full dose all at once, without the liver-poisoning acetaminophen. I don't really see how it's any different from plain oxycodone in that regard.

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