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Jul 17 2012

Ethicists don’t necessarily know what they’re talking about

Purdue Pharma is currently running trials of the opioid painkiller OxyContin on 150 patients aged 6 to 16, after previously discontinuing expensive youth trials in order to redirect their resources to developing an abuse-resistant form of the drug. All of these children were already on other opioid painkillers to manage pain from cancer, severe burns and sickle cell anemia.  Doctors have already been prescribing OxyContin, but without the benefit of any studies showing its effects on children specifically, and the FDA’s offer of a six-month patent extension on the drug in exchange for conducting trials on children was enough to get Purdue to resume testing.

Ethicist Dr. Arthur Caplan has a problem with this:

“It looks to me like a raw, crass, last-gasp exploitation of a drug that has been synonymous with misuse, abuse and harm to patients,” said Dr. Arthur Caplan, the head of the division of medical ethics at NYU Langone Medical Center.

Putting aside Purdue’s possible motives, I’m not sure why OxyContin should necessarily be considered uniquely “synonymous with misuse, abuse and harm to patients”, or why this is a reason not to acquire data about its possible effects in children who would already be taking other opioid painkillers anyway. Does OxyContin possess some property which presents a much higher risk of addiction than all other opioids in common use as painkillers? When used properly, is it still more harmful than other opioid painkillers? Are these same objections somehow inapplicable to other opioids, which also pose a risk of addiction and can be harmful when abused?

Or does Dr. Caplan believe that OxyContin itself now inherently possesses some kind of Aura of Badness just because of the widespread trend of people abusing it? If OxyContin did pose any sort of elevated risk to people beyond that of any other opioids they may be taking for pain management, then this argument should be made on the basis of relevant evidence – and OxyContin being a trendy street drug is not relevant evidence here. And even if it did carry additional risks, those risks should be weighed against its effectiveness as a painkiller, and viewed in light of the need these children have for pain relief. This isn’t as simple as “everyone is focusing on people abusing this one drug, therefore it can have no legitimate medical use.” If OxyContin itself is really so ethically objectionable, why not just pull it from the market entirely?

 

30 comments

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  1. 1
    BrianX

    As far as I can tell, the only thing special about Oxycontin is that there’s no other drugs in it. With Vicodin and Percocet, you have opiates mixed with acetaminophen, which will wreck your liver.

    What I’m curious about is why this study is being done in the first place. It seems to me that the mechanism of action of opiates is intimately connected to the mechanism that makes it addictive. So far as I know the only significant opiate that isn’t addictive is loperamide, which can’t cross the blood-brain barrier without major assistance and therefore is useless as a painkiller, but does just fine as a diarrhea drug.

    1. 1.1
      Rory

      It’s being done for two reasons, but really only one.

      1) Currently, without studies supporting pediatric usage, some doctors are still prescribing it to kids who need chronic pain management. So it behooves Purdue to do the studies that allow doctors to do this safely.

      2) Probably more important is the fact that an approval in a pediatric population means a six month extension of exclusivity on all indications, which translates into a boatload of money for Purdue–almost certainly far more than the pediatric studies will cost them.

    2. 1.2
      Tsu Dho Nimh

      Children don’t process opiates exactly like adults … actually testing the half life and duration of effectiveness in them is needed so it can be effectively prescribed.

  2. 2
    internetpal2012

    From the many horror stories Ive heard about OxyContin it’s best to be avoided at all costs.Where there’s smoke there’s fire,but I’m sure some people just won’t believe it.If someone is told enough times not to try something because it might very well have harmful side effects,if the person taking it has a family and that they might suffer if things go wrong people don’t care they do it anyway.

    The most important thing in people’s lives is their happiness like making kids they can’t support or running up the credit card to it’s limit without caring if they can pay it off or not.Or getting a bunch of tattoo’s on their body as long as it looks “cool” not taking a minute to think that some jobs they apply for may not hire them because of their “body art”.

    The main thing is their Happiness at all costs,that’s why this country is going down like the Roman Empire right now.

    1. 2.1
      dab

      Great unrelated ramble with abysmal punctuation. Assuming that’s what you were going for.

      1. internetpal2012

        What an educated snob you are.Please use your college degree that you must have for toliet paper,you know that’s the only thing it’s good for?

        1. Lucy

          Great ad hominem response, not answering any of the points about your post or clarifying in any way.

    2. 2.2
      Dean Austin

      internetpal2012: Many people have kids and credit card debt that they can afford just fine, but then lose their jobs and can’t afford them any longer, just as some people are seriously injured and take a painkiller that then turns into an addiction, but thank goodness there are superior, judgmental assholes like you around to put them in their place.

      1. internetpal2012

        Yes because it’s very wrong to judge people at all(people do it everyday all over the internet).When you use a curse word at someone they must have made you very angry,did they make you think as well?You sound like you hardly ever do such a thing.And by cursing you show you have no manners,and no class at all,I pity you,really I do.

        1. Ms. Daisy Cutter, General Manager for the Cleveland Steamers

          Of course, it’s a tone troll. “Cussing” is so much worse than victim blaming or threadjacking.

    3. 2.3
      Zily_Popygaj

      internetpal2012 says: “From the many horror stories Ive heard about OxyContin…”

      Well, as someone who actually *took* it for severe post-operative pain, I can say that, Yes, it is effective, and Yes, like any opioid, it is physically habit-forming. I also say, however, that most of the “horror stories” could be avoided with adequate patient counseling prior to prescribing them. For myself, having taken other opioids following surgeries, I was well aware that there is a point where one is watching the clock, not because the pain is bad but because one is eager for the next dose. And that is exactly when one has to stop oneself, even if three are doses left. I switched to ibuprofin at that point, and appropriately discarded the remaining doses. The problem is that, for non-protracted pain, this sort of patient education, *and* patient monitoring, is not done; patients also need to be switched over to medications using decreasing doses of the opioid, and then shifted onto non-opioids.

      This is a matter of patient education, and has nothing whatsoever to do with “getting tattoos” or “credit card debt” or having sex. When pain is severe enough to require strong medications, OF COURSE it’s useless to command them not to take it because of potential side effects! The solution is to educate patients before prescribing the medication, not pass unrelated moralistic judgements about their character if they do take the medication they’ve been prescribed.

    4. 2.4
      Setár, Elvenkitty

      The most important thing in people’s lives is their happiness

      That goes for you, too, you know. And besides, why shouldn’t it be? Why the fuck would one not want to be happy?

      like making kids they can’t support or running up the credit card to it’s limit without caring if they can pay it off or not.

      Or getting injured and being unable to support said kids or pay said credit card bill because the United States is the only developed country whose citizens still have to pay for their own healthcare or grovel at the feet of an insurance company, unless they’re either old or poor enough to qualify for benefits.

      Please check your class privilege.

      Or getting a bunch of tattoo’s on their body as long as it looks “cool” not taking a minute to think that some jobs they apply for may not hire them because of their “body art”.

      Nobody is the fucking body police, asshole.

      -sigh- Where are all these reasonable arguments for conservatism, neoliberalism and the current system that I keep hearing about? I haven’t seen one; all I can see is a sea of privilege.

    5. 2.5
      Onamission5

      If that happiness (note: no capital letters) has to do with a child needing management for debiliating pain, why is that a problem for you? Surely you did not seriously just compare pain management for chronically ill or injuired children to the more frivilous issue of an individual’s choice in skin art, because it sure seems like you did.

  3. 3
    johnhines jr

    My problem with this study is the timing. They were asked in 2004 to conduct it, but they canceled it for “lack of resources.” Now that the patent is about to expire, they suddenly have the resources to complete it. And, hey, look, they get six more months of patent protection for testing it with children. The cynic in me is convinced they waited on the trial solely to see if the sales were high enough to warrant the investment in the trial.

    1. 3.1
      Rory

      Nothing cynical about it at all. I guarantee you that the decision was financial in nature. Maybe they were waiting to see how the market would develop, or they might have been haggling with the FDA over how big the pediatric trial would need to be (in terms of patients and length of follow up), but at the end of the day of course it’s about money.

    2. 3.2
      kagerato

      When did Congress give the FDA authority to extend medicinal patents, anyway? I had never heard of this before.

      1. Rory

        It’s not a patent extension. Under the FDA Modernization Act of 1997, the FDA can incentivize the study of drugs in pediatric populations by offering data exclusivity–basically this means that generic companies which want to produce Drug X after the patent on it expires can’t use the original patent holder’s clinical data to support their approval application for a certain amount of time past patent expiry. So data exclusivity delays the entry of generic companies into the market.

        FiercePharma says that while Purdue probably won’t greatly increase pediatric utilization with this move, they’ll likely net an additional $1.4 billion by extending the life of the other indications. Not a bad chunk of change considering that the additional trials needed will probably cost in the tens of millions.

        1. kagerato

          Interesting. Thanks for the details.

  4. 4
    didgen

    I’m going to speak here as someone who has worked as an RN both in ER’s with extensive contact with addicts and with nine years experience in liver transplant. Sure, Oxycontin has potential for addiction as does any medication that relieves pain. The problem is that some MD’s prescribe it inappropriately, some write scripts for profit, and some people are prone to addiction. What is the replacement for it if it is banned? Or do we just ignore the people who need it to live reasonably comfortable lives. All that aside, I believe the manufacturer would do anything to extend their patent. It’s all about money for them, for it to go generic would seriously hurt the bottom line.

    1. 4.1
      F [i'm not here, i'm gone]

      Thank you.

      There are a lot of people with severe pain, acute or chronic, who simply cannot get pain medication because parts of the medical establishment and the government have an agenda to not give people real and appropriate pain medication which actually works for the patient. And their methods have done nothing to cut down on abuse, so they are irresponsibly, ineffectively, and expensively going about dealing with that issue the wrong way.

  5. 5
    Buffy

    Does OxyContin possess some property which presents a much higher risk of addiction than all other opioids in common use as painkillers?

    What sets OxyContin apart from other painkillers, if I’m not mistaken, is its formulation. It comes in a 12-hour time-release tablet. People like to abuse it by crushing it so they get the full dose immediately rather than steadily over the 12-hour time period.

    1. 5.1
      didgen

      That doesn’t really set it apart, people quite happily take inappropriate doses of non-time release meds, or use it in an inappropriate way such as crushing and snorting or injecting it. People are amazingly innovative. It’s amazing how many people that use meth are bitten by “spiders” they are also afflicted by what we often referred to as pediculosis hallucinocis.

      1. Setár, Elvenkitty

        I believe this was actually shown on an episode of House, where Wilson once walked in on him chopping up and snorting antihistamines* because “it’s more effective that way”.

        * – I remember him claiming it was that, but I know it was probably his Vicodin

    2. 5.2
      Midnight Rambler

      Except that that formulation makes users of it (somewhat) less prone to addiction if they’re just taking it normally. That was, in fact, the whole point of it – you didn’t get a big rush and then a decline.

  6. 6
    left0ver1under

    I’m no expert and have never used such drugs, so I have no opinion.

    However, two recent articles from Raw Story tell me to avoid oxycontin and other such drugs altogether.

    http://www.rawstory.com/rs/2012/07/11/in-u-s-painkiller-abusers-turning-to-heroin-research/

    http://www.rawstory.com/rs/2012/07/13/scientist-pushing-oxycontin-addicts-to-heroin-reveals-utter-failure-of-drug-war/

  7. 7
    BecomingJulie

    Every µ-receptor agonist has the potential both to be abused, and to cause addiction. This is a limitation of the universe, not a limitation of present technology; in humans, the pain and reward systems are one and the same. The body releases endorphins (naturally occurring opiate drugs) in response to pain, or as a reward for (hopefully) evolutionarily-desirable behaviour. Similar chemicals, which bind to the same receptor, occur in poppies.

    Any bioavailable µ-receptor agonist will have pain-relieving and “feelgood” effects. The two cannot be separated, because they are one and the same.

    1. 7.1
      BecomingJulie

      Bother, posted too soon. The mechanism of addiction is simply that endorphin production is regulated by negative feedback. The introduction of exogenous µ-receptor agonists cause the body to cut back on endorphin manufacture, and it takes some time from the discontinuation of opiate administration for the body to resume full production — during which time, it is possible to feel all sorts of unpleasant sensations which are normally masked by a background level of endorphins, and reaching for the tinfoil again only restarts the cycle.

  8. 8
    mimi

    I have an acquaintance who became addicted to the stuff when she was given it long term as a child after severe injury.

    But yeah, if the kids are receiving opioids anyway, what is the difference? The problem with the drugs is misuse, and that can’t really happen here.

  9. 9
    anon

    Oxycontin was the first high-potency opioid available as an extended release pill. Immediate release opioids generally last about 4-6 hours, so patients take 3-4 doses per day. “Oxy” holds a higher dose in each pill, to be released slowly in the gut. So a dose lasts 12 hours. At the time it was first released, it was unique.

    This means that if an abuser crushes a pill, he/she can release the whole hit all at once. That made oxy uniquely (back then) dangerous. Oxycontin powered the astronomic rise in opioid abuse, misuse and diversion starting about 10-15 years ago, and remains a leading cause of death in teens and young adults.

    Now there are other extended release high-potency opioids, but Oxycontin remains the most extractable, and most abused, of the lot. Purdue has tried to re-engineer the pill to make it harder to extract the oxycodone contained within, but it’s unclear this new formulation has made, or will make, much impact.

    That’s why Oxycontin has a unique place on the list of abusable opioids.

    disclaimer: I work for a pharma company, but not one that has any opioid or related product on the market or in development.

  10. 10
    Azkyroth Drinked the Grammar Too :)

    Does OxyContin possess some property which presents a much higher risk of addiction than all other opioids in common use as painkillers?

    Name recognition.

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