Purdue Pharma is testing OxyContin on children six and up. Oxy's gonna go out of patent some day, and shut down Purdue's gravy train. But if they test it on kids -- even it's never approved for use on kids! -- the folks at the FDA will extend their patent by another six months. "Dr. Elliot Krane, director of pain management at Lucile Packard Children’s Hospital at Stanford University" says "They are doing (the pediatric trial) for patent exclusivity, there’s no doubt about it in my mind.... That’s important for their bottom line." (via Techdirt)

38 Responses to “Big Pharma gives Oxy to kids, gets an extra six months of patent monopoly”

  1. Andrew Singleton says:

    Scum. Pure criminal sociopathic scum that hs  no thought or care for people.

  2. Mantissa128 says:

    So what would happen, exactly, if pharmaceutical research were de-privatized and handed over to universities and the fed? All research paid for with public funds, all research developed available to the public. It wouldn’t cost anything more than it does now, and there would be no direct advertising/selling to doctors, no money spent on P&R instead of R&D, and treatments for Alzheimer’s would get more funding than Viagra.

    Just a thought.

    • Jenonymous says:

       It’s a great idea, and one that there is a teeny tiny sliver of that going on in the field of oncology.

      However, for-profit pharmaceutical cos always love to point out that every major drug invented in the last 50 years or so was done by for-profit companies in the US.  The argument is that the rest of the commie socialist free-healthcare-loving moochy world is benefiting from all of the US markets’ hard work.

      • I’m pretty sure the huge global pharmaceutical industry would disagree about the US bit, but I could be wrong.

        Ultimately it’s because each drug that comes to market cots millions to get on to a shelf, researching/making drugs is an expensive business.

        If we relied on our governments to pay for it then it would just be one more thing to cut in favour of the military budget.

        I’d like our governments to have better control over pharmaceutical companies, but you only have to look at the NHS I. The UK and their hideously crippled budget to see why making it a public industry is a flawed idea.

        • digi_owl says:

          “I’m pretty sure the huge global pharmaceutical industry would disagree about the US bit, but I could be wrong.”

          Meh, they are the same companies. They just wrap themselves in whatever flag is convenient for what they hope to achieve.

  3. Jenonymous says:

    I used to work for a Big Pharma Company that did this sort of thing every chance they got.  Even for drugs that were long OUT of patent, they tried crap like toying with the dosage (ie making something that was 3x/day a “one a day/extended release” caplet) just to see if it stuck to the wall.

    I have no doubt that Purdue saw Pfizer implode after the Lipitor fiasco (actually also largely due to gross incompetence and corporate bloat) and are trying to buy themselves some time–ANY time.

    As noted above, disgusting.

  4. Mister44 says:

    On one hand I see how you have to milk every successful drug to pay for the dozens that don’t pan out. On the other hand I can’t afford name brand oxycontin and would really, really, REALLY like to see it in generic form. Sooner better than later.

  5. JonS says:

    I find it kind of strange that the patents or drugs are so comparatively short. I mean, drugs cost a LOT to get to market, and they actually do some deomnstrable, measurable good. Yet the makers have a comparatively short monopoly.

    Compare that to copyright; life+70yrs (or whatever it is now). For something that is relatively cheap to make, and ‘only’ makes people smile or cry or laugh.

    Weird.

    disclaimer: I don’t think drug patents should be longer, bigp harma bad, blah blah.

    • digi_owl says:

      This is because patents started out as something physical, a patent on a machine or production process. Note btw that while the patent term may look short on medicine, it is huge when applied to software.

      Also, the original US copyright was some 20 years plus one extension. And the author (it was only about books back then) had to register. In Europe however there was the Bern convention that merged the various national copyrights, most of them variants of the French but also included the British that the US was based on, and gave rise to life+50 (later 70). This largely due to the French, as they wanted to cover more than simply the economic rights that the UK/US covered. The French included the social aspects, like how a third parties use of a work may color the social standing of the author. So they set a long period to allow a author to nix any use, like say political, that he did not agree with.

      Note btw that USA only really signed on to the Bern convention in the 1980s. And was only really ratified recently. And that was why there was this hoopla about works originally published in Europe being taken out of the US public domain.

  6. hipdadiddy says:

    Man, if I were in Purdue University’s PR dept., I’d be burning through my entire budget making sure the world knows my school is NOT affiliated with these scumbags.  Is it?

  7. Joshua Ochs says:

    There’s not really anything scummy here – it’s business as usual. Drug patents are deliberately short to ensure generics reach the market relatively quickly, and then the pharmaceutical companies are given patent extensions to run clinical trials in populations that otherwise wouldn’t have been tested. Frequently that’s tests on children, as running trials on kids tends to be more difficult and the market is usually smaller so it’s less profitable. However, if you never run those tests, then you never find out if the drugs are safe in smaller doses, how it interacts with growing bodies awash in hormones, etc. It’s actually one of the better policies, tying the carrot of extended patent protection to the societal benefit of additional testing.

    Sure, the idea of Oxycontin for kids may sound terrible on the face of it due to the abuse of the drug by adults, but is it really a terrible thing if they discover it’s effective pain relief for pediatric oncology?

    • Andrew Singleton says:

      Just because it’s business as usual does not mean that it is morally bankrupt or not needing to be changed. If anything it means we need to take a long hard look at ‘normal’ and redefine it. 

      If this were Apple I wouldn’t be as outraged. Not life-dependent or quality elevating medication. Pharmacudicals and other areas of medicine need to be treated differently because people depend on these things either to live, or to have a quality of living that makes being productive, or even just keeping from blowing your brains out either from the physical pain or the mental torment.

      That is why I feel strongly about this. These people are profiteering off the suffering of others. They are not, in my eyes, allowed to look luxery goods as an example to follow.\

      And At this point they would have to do an industry wide shakedown of Everything and rebuild from scratch then show off that they are a different industry that I will not see headlines that have anything to do with pharma and think by default they are bottom feeding leeches.

      • Joshua Ochs says:

        I see this simply as providing useful trials that otherwise would not be done, for a very short-term additional profit. Six months of additional patent protection won’t mean anything in the long term, but those additional studies may relieve quite a bit of suffering.

        Perhaps if you didn’t go in looking for ways to view it as “bottom feeding leeches” you’d find they aren’t necessarily. Big Pharma is an easy target for the uncritical eye – their products are expensive, they protect them with patents, and people need them – they *must* be bad, right? Well, let’s look at this a bit more.

        Safe drug development is both time consuming and expensive. Running multiple phases of clinical trials across a large population is not trivial, it is not cheap, and it is not quick. There are huge numbers of people involved, from scientists, doctors, statisticians, etc – and that doesn’t even get into the patient populations! It’s complex – you have to control for sometimes massive variability and outside factors, and despite all of the unknowns, still do your best to treat patients, gather data, and keep them alive. And ultimately, the drug may not work, either due to lack of efficacy, side effects, or interactions, and this is frequently discovered very late in trials, after enormous sums of money have been spent.

        So – you have a process that requires large numbers of extremely skilled people, long time horizons, and a large amount of capital – and commonly fails. A company may have dozens of drugs in the pipeline and none of them pan out. When they do come across one that does work, they use the profit from that to fund all the ones that don’t. I’m sure many people get rich in the process, but that process results in massive advancements in drugs, therapies, and research, all of which becomes public domain in *very* short order compared to any other industry. Look at the drug therapies today and compare them to 40 years ago – the advancement is utterly astounding.

        People fail to realize just how expensive drug development is, and how often it fails. Either that or it’s just another inconvenient truth.

        • lafave says:

          Drug companies aren’t evil by virtue of their patents.

           The problem isn’t that research and development costs a lot so much as, the drug companies spend twice as much on marketing as they do on R&D.  And then they bribe US legislators to make it illegal for Medicare to negotiate lower drug prices (which would fix Medicare’s budget issues all by itself).

    • CH says:

      Yea, I didn’t get the “even it’s never approved for use on kids”. Um… that’s the point… it needs to be tested before it can be approved.

      As far as I have understood, the problem is that very few medicines are tested on children (or women, for that matter, as it is easier to test on men as they don’t have that monthly varying whacky hormone thingy… again, if I have understood correctly). One reason is the reaction shown above “OMG… they are testing it on _children_!!!!!”… and that doing tests on all the different demographics (age & sex) costs a lot. So, if it is enough to do a study on population X, why do it also on Y and Z? But kids will still need to use the drug, so… um… just hope that it won’t have any surprises?

  8. Jenonymous says:

     Josh–that’s  not how drug testing works.  First of all, doctors can prescribe almost anything “off label”–classic case is birth control pills for PMS, not contraception.

    Secondly, painkillers are a crap example here RE ped testing because in fact it’s one of the few kinds of medicine where it’s EXTREMELY easy to titrate doses up/down based on body weight.  They also generally are not affected  by hormones and other meds.  ESPECIALLY brute-force opiates like Oxy.  Anything from the poppy is very very flexible on dosing (due to various respiratory and structural damage I have a lifetime of experience with codeine cough suppressants–first life-threatening cough and infection was at 11 months).

    This is just a naked grab for a patent extension for no good reason. 

    • feetleet says:

      So you’re advising AGAINST testing….  

      “ it’s one of the few kinds of medicine where it’s EXTREMELY easy to titrate doses up/down based on body weight.  They also generally are not affected  by hormones and other meds.”  

      Very very very unscientific method, if you ask me.  

      • Jenonymous says:

         well, go read a ped onc treatment plan then.  I have.  Just reporting what I’ve seen.

        • feetleet says:

          I’ve read every page of the bible.  Seriously.  Ok, not seriously, but that’s what you’re doing there.  Please address why titration of doses  makes testing obsolete?  Net immediate efficacy/toxicity are very different from long term effects, especially with something that crosses the blood-brain barrier.  It sounds to me like you’re ready to give kids the Oxy right now.  I don’t care if this is a callous ploy to extend a patent ad infinitum.  That ploy is yesterday’s news.  At the bare minimum, INFORMATION, even from a poison control perspective, is not a bad thing.  Sucks that it’s such a callous gambit, but this can’t be the first.  

    • CH says:

      So… um… just assume that it’s ok… or should we perhaps do the scientific thingy of actually testing that it is doing what we assume it is doing?

      Perhaps the doctors in your country can prescribe anything “off label”. The ones in my country mostly can’t (and are you sure birth control pills for PMS is “off label”?). Or well… I’m not a doc, so I don’t know exactly what the rules are, but I have at least got a couple of times the “well… this medicine could help, but it is not approved for use in x, so I cannot prescribe it”, and yes, once the “x” was “for children under the age of…”.

  9. feetleet says:

    Pihkal-mindedness gets a nice rubdown on this site often.  But this nimby-ism when it comes to your own kids seems CRAZY hypocritical.  I’m certainly not going to give oxy  to to my children for no reason.  But I WILL get t them Adderall irrespective of their grades/needs.  Having (abused) it often in my adult life, I shudder to think how productive I could have been.  Especially in the non-academic metric that matters going forward.  In my adult life – I watch less porn, I eat fewer burgers, I write more music when I’m on adderall. My unborn children WILL have ADD on paper.  They may or may not get cancer.  But if they do happen to have legitimate chronic pain, from whatever source, damn you for condescending to the people who safety tested a pain medication for them.  You can’t have it every which way.  

    • The Rizz says:

      The point here is not that they’re testing it on kids – the point is that the ONLY reason they’re testing it on kids is to get a patent extension.

      • feetleet says:

        That’s why I brought up Adderalll  You can’t this conflate this with White-People-Problems drugs like Adderall or Viagra.  Even if it’s a cynical sell, what they’re “selling” isn’t an off-brand use (esp. after Glaxo Kline this week), a lifestyle, or – because it would hypothetically be fed to children by their parents- something that is likely to be abused by the actual patient.  
        The management of pain and  the ease of life and death, I think, are seminal to the goals of medicine, if not, I don’t know, alphabets.  This story contains all the right buzz words to get people riled up.  But you want to talk about a cynical ploy?  Exploiting a mundane and mandatory best-interest-of-investors move on behalf of pharma that might lead to  to advances in pain management for – get this – infants! in order to advance a political agenda regarding intellectual property.  
        THAT’s cynical.  

      • Joshua Ochs says:

        So they make some more money. It’s short term (six months – it’s not like it’s a decade!), we’ll likely get some useful data from it, and with any luck kids who do need this will have safe and tested access to it.

  10. What the hell do you tell parents to get them to sign the papers for this?

  11. feetleet says:

    Why aren’t people more upset about this in the way that I am?  IP law, as fascinating and/or outmoded as you think it is – should bow out –  at least – to baby-cancer-pain.  You cannot co-opt this as an IP talking point.  You simply cannot.  

    • Antinous / Moderator says:

      If it’s meaningful, the drug companies should have done the studies earlier. Health care professionals have historically been reluctant to provide adequate pain control for children for a number of reasons, mostly founded on incorrect assumptions. Testing pain meds for peds patients early on would help to promote better pain control for children.

      In other words, the skeezy behavior around IP and the continuation of poor pain control are both results of drug company greed.

      • feetleet says:

        Now THAT is an explanation I can get behind.  Thank you.  But if treating infant pain is always going to be a lower priority than hard-ons and hairlines, then why throw out the baby with the bathwater?  Didn’t patent, in a very real sense, incentivize drug companies to do something positive that wouldn’t normally figure into their bottom line?  

      • Tynam says:

        If this were about controlling pain in children, the company would have done the paediatric tests some time in 1996.

        If IP law (and pharma law) were more intelligently written, drug companies might have motivation to do these studies earlier, and *help patients* earlier.  That this is being done now *as a patent extension measure* is exactly what *makes* this an IP talking point.

        (For a start, it’s an argument against extending patents.  If patents were five years longer, under the current rules… Purdue wouldn’t be bothering to see if they can treat children until 2017.)

        • feetleet says:

          To my understanding, patents, like copyrights, in the U.S. are more than mere monopolies.  They’re supposed to incentivize innovation.  I know so little about pharma law, but what new (or more ‘intelligently written’)law could accomplish this?  We can’t command pharma to innovate.  Like I said, the directors of these companies are beholden to their investors.  No one is making a crappy decision, it’s just a lot of sticks and carrots.  Directors MUST pursue the bottom line, or be fired.  If that’s the case, then a law that requires companies to at least ‘improve on’ or ‘broaden’ their existing bunker of bought innovations to keep them might occasionally result in a windfall for non-customers.  And that’s a good thing.  This is nothing like the Mickey Mouse copyright extensions.  This is new testing, and hopefully, new innovation, or at least new information.  The fact that pharma is brazenly courting the bottom line here is nothing new.  If it results in something more substantial than mere money changing hands, then I’m all for it.  This IS incentivized innovation, just not the way we always dreamt.  

          • Antinous / Moderator says:

            To my understanding, patents, like copyrights, in the U.S. are more than mere monopolies. They’re supposed to incentivize innovation.

            100 mg of meperidine kills the pain; 1,000 mg of meperidine kills the patient. Extrapolate.

  12. CognitiveDissident says:

    My theory:
    Younger Oxy use
    = younger Oxy addicts
    = younger, more agile Oxy thiefs
    = more pharmacy Oxy stockpiles successfully stolen
    = more pharmacy Oxy stockpiles replaced with insurance money
    = Big Pharma Win!

    (Also, it wouldn’t hurt for Big Pharma to buy stock in Big Prison, either.)

  13. Xanthomonas says:

    My 11 year old son ends up on Oxy- contin several times a year to manage acute neuropathic pain crises. I don’t understand what is evil or strange about this story. The government uses patent exclusivity to encourage private companies to undertake research that would otherwise not create a return. Similarly the Orphan Drug program invents companies like Genzyme to deliver meds for rare diseases by creating a short term monopoly.

  14. Maeg says:

    How long did the original patent last?  Why didn’t they bother to do the peds testing until now?   It’s the timing, along with the excuse, that is so suspect.

    Lilly just did the same thing with Cymbalta in the same week.  This, just as my brother was prescribed it, hoping for the generic to be released soon. $250 a month, out of pocket, or staying depressed and listless and in pain?

    He chose the latter, and it sucks.

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