How Patents Have Contributed To The Opioid Crisis

from the monopolies-make-people-do-fucked-up-things dept

Over at Quartz, there's a very interesting article about how patents may have contributed to the opioid crisis in the US. It's based on a recent paper, May Your Drug Price Be Ever Green, by law professor Robin Feldman (who has done lots of great work about problems in our patent system) and law student Connie Wang.

For many years, we've written about how the pharmaceutical industry has become so overly reliant on patents for their business model, that's it's become destructive. We've argued that the misaligned incentives of the patent system, especially in pharmaceuticals has so distorted incentives that the big drug companies basically have become focused solely on keeping exclusivity that it has lead to a lot of tragic game playing, where the cost has literally been people's lives. This went into overdrive a decade or so ago when big pharma realized that many of their biggest sellers had patents expiring, and their pipeline had failed to come up with new drugs to replace the monopoly rents of the old. This resulted in all sorts of gamesmanship designed to allow big pharma to retain monopoly rights even after a drug should have gone off patent. This included pay for delay schemes, whereby big pharma effectively paid off generic makers to keep them out of the market for longer.

And then there's the trick of making basically the same drug, but with just a slight, non-essential change, and getting a patent on the new drug. Of course, you might wonder why that would stop people from moving to generics. There are all sorts of games played over this, including misrepresenting the "new" drug as somehow better, or even tarnishing the reputation of the old drug for no other reason than to drive people to the new one. Or, a really nefarious trick: stop selling the older drug a little while before it's gone off patent, to effectively force patients who need it onto the new drug, making it much less likely they'll go to the generic copy of the old drug, since there's a big gap in when it was available.

Another trick is Big Pharma threatening doctors for prescribing generics.

Basically, if there's been some sort of sleazy underhanded way to make people pay more for drugs than they really should, Big Pharma companies have probably done it. And that takes us back to Feldman and Wang's study. Basically it puts some numbers to the anecdotes and examples we've talked about over the past few years:

This study examines all drugs on the market between 2005 and 2015, identifying and analyzing every instance in which the company added new patents or exclusivities. The results show a startling departure from the classic conceptualization of intellectual property protection for pharmaceuticals. Key results include: 1) Rather than creating new medicines, pharmaceutical companies are recycling and repurposing old ones. Every year, at least 74% of the drugs associated with new patents in the FDA’s records were not new drugs coming on the market, but existing drugs; 2) Adding new patents and exclusivities to extend the protection cliff is particularly pronounced among blockbuster drugs. Of the roughly 100 best-selling drugs, almost 80% extended their protection at least once, with almost 50% extending the protection cliff more than once; 3) Once a company starts down this road, there is a tendency to keep returning to the well. Looking at the full group, 80% of those who added protections added more than one, with some becoming serial offenders; 4) The problem is growing across time.

And what does that have to do with the opioid crisis? Well, Purdue Pharmaceutical, the makers of OxyContin -- the key drug that's at the heart of the crisis -- has messed with the formulation of OxyContin 13 times to effectively "extend" the patent. Some of these may have good intentions behind the modifications, such as the changing of OxyContin to "abuse proof" pills that are much harder to crush and snort. But, as the Quartz article notes, the constant revamps of the formula and the extending of the patent cliff allowed Purdue to continue promoting the drug. And, famously, Purdue got tons of people hooked on OxyContin by falsely claiming that it was non-addictive. The story of the rise of OxyContin and the false marketing involved in its success is legendary and has been written about in academic papers and the press over and over again. Indeed, the New Yorker just did a giant article on the rise of OxyContin and the dark legacy of Purdue Pharmaceutical's aggressive and misleading marketing. The short summary from that article:

Purdue launched OxyContin with a marketing campaign that attempted to counter this attitude and change the prescribing habits of doctors. The company funded research and paid doctors to make the case that concerns about opioid addiction were overblown, and that OxyContin could safely treat an ever-wider range of maladies. Sales representatives marketed OxyContin as a product “to start with and to stay with.” Millions of patients found the drug to be a vital salve for excruciating pain. But many others grew so hooked on it that, between doses, they experienced debilitating withdrawal.

Since 1999, two hundred thousand Americans have died from overdoses related to OxyContin and other prescription opioids. Many addicts, finding prescription painkillers too expensive or too difficult to obtain, have turned to heroin. According to the American Society of Addiction Medicine, four out of five people who try heroin today started with prescription painkillers. The most recent figures from the Centers for Disease Control and Prevention suggest that a hundred and forty-five Americans now die every day from opioid overdoses.

That part about how it led many to switch to heroin, because OxyContin is too expensive? Well, that all goes back to patents. Obviously Purdue held the key patent on OxyContin for a while, but that expired in 2013. And yet, four years later, there still aren't generics to take its place. As the Quartz article explains:

The company is still profiting off “abuse-deterrent” OxyContin. Though there are currently “authorized generics” of OxyContin available, these are made by manufacturers with licenses to use Purdue’s formula. In other words, Purdue makes money off them. And there are currently no approved abuse-deterrent generics in the US. In September of this year, FDA commissioner Scott Gottlieb said that soon the agency plans to issue guidelines to assist companies who are trying to file applications for these types of generics. No word on when that document will be published, however.

Obviously, this is not the sole reason -- or perhaps even a major reason -- behind the opioid crisis. But it has clearly contributed to it. Purdue Pharma certainly deserves much of the blame for everything its done. And it took doctors way too long to realize the problems and risks of these drugs. But the artificially inflated prices of OxyContin, driven not just by patents, but by the games played by Purdue and other pharma companies, certainly helped keep the prices ridiculously high, often driving people to heroin or other, even more dangerous opioids.


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  • This comment has been flagged by the community. Click here to show it
    identicon
    Anonymous Coward, 28 Nov 2017 @ 9:39am

    Patents and Copyrights make me dissent on Techdirt!

    But I think you already hated them, so no change.

    Is there NOTHING you won't blame on Patents? -- INSTEAD OF ON THE RICH AND THEIR MONEY MANIA?

    reply to this | link to this | view in chronology ]

    • identicon
      I.T. Guy, 28 Nov 2017 @ 9:43am

      Re: Patents and Copyrights make me dissent on Techdirt!

      Oh Jesus Christ just fuk off already. Don't you have diapers you need to go change?

      reply to this | link to this | view in chronology ]

  • This comment has been flagged by the community. Click here to show it
    identicon
    JEDIDIAH, 28 Nov 2017 @ 10:01am

    "You call that a knife?"

    I'm not sure Mike has any real awareness of drug prices, oxy included. He's just happy to jump on someone else's "media narrative" and drag patents (out from left field) and dump them onto the pile.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 28 Nov 2017 @ 10:16am

    Perhaps the biggest shortcoming of the current drug business model is that it hinders the development of badly-needed new antibiotic drugs, because any newly developed antibiotic will not be profitable enough to fight antibiotic-resistant "superbugs" until there is a widespread epidemic and people start dying in droves due to all current antibiotics becoming ineffective.

    reply to this | link to this | view in chronology ]

    • icon
      JoeCool (profile), 28 Nov 2017 @ 11:10am

      Re:

      Antibiotics cure the problem, not treat the symptom, so they're low priority to drug companies who would rather have millions of customers treating symptoms that are never cured.

      reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 28 Nov 2017 @ 11:46am

        Re: Re:

        Kind of like Chiropractic and Homeopathic "medicine" ... if it doesn't cure your ailment then it's because you need to take more of it and keep taking it ever longer.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 28 Nov 2017 @ 12:52pm

        Re: Re:

        So what about Hep C drug that cures the problem and doesn't just treat the symptom.

        You are free to come up with your own drug business model and bring antibiotics to market. Go ahead, be the next Jonas Salk.

        Also, yes, prescription drugs do play a part in the current crisis, but it is only a small part. Over 80% of overdoes in the US happened to people that have never been prescribed painkillers.

        The current crisis is caused by drug use mostly, not by anything the drug industry has done.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 28 Nov 2017 @ 2:29pm

        Re: Re:

        Oh sure, Joe, so low priority are they that they were over-prescribed and over-used to the point that the drug-resistant strains manifested themselves in the first place.

        reply to this | link to this | view in chronology ]

        • identicon
          Wendy Cockcroft, 29 Nov 2017 @ 7:17am

          Re: Re: Re:

          Assume Joe is wrong; if antibiotics are indeed a priority why aren't more varieties being developed?

          The truth is, healthcare is a public good and should not be run solely for profit. I don't have a problem with for-profit healthcare and medicine provision as long as there's a public option. That drug development has mostly been controlled by pharmaceutical companies is the problem. Getting patents off of drugs and of medical equipment and appliance is the solution.

          reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 28 Nov 2017 @ 3:04pm

      Re:

      There are many reasons that for profit health care systems do not work.

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 28 Nov 2017 @ 10:22am

    What ever happened to the Hippocratic Oath and when was it changed to the Hypocritical Oath?

    reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 28 Nov 2017 @ 10:39am

      Re:

      If doctors stayed true to the Hippocratic Oath, plastic surgery would not exist because instead of cutting people up, they'd be referring all their (potential) patients to psychiatrists.

      reply to this | link to this | view in chronology ]

  • icon
    ShadowNinja (profile), 28 Nov 2017 @ 10:52am

    > And, famously, Purdue got tons of people hooked on OxyContin by falsely claiming that it was non-addictive. The story of the rise of OxyContin and the false marketing involved in its success is legendary and has been written about in academic papers and the press over and over again.

    Whatever the fine they got for their false advertising clearly isn't enough. The courts need to strike down much harder on them for false advertising.

    I'd say revoking their patent on the drug would be a strong enough of a deterrent to send a strong message to ALL drug manufacturers that lying to the public about your drugs is not ok, and you'll be punished severely if you do it.

    reply to this | link to this | view in chronology ]

    • This comment has been flagged by the community. Click here to show it
      identicon
      Anonymous Coward, 28 Nov 2017 @ 2:24pm

      Re:

      Dude, what Mike is conveniently not mentioning, in furtherance of his never ending patent bashing is the fact that any false advertising issues with that drug are ancient history. He, and you are trying to imply that they continue with that practice despite the fact they've legally been prohibited from doing that for years on end. Furthermore, you don't seem to mind punishing anyone and everyone who might actually need the drug in the process (but then again, nobody is so important that they can't be thrown under the bus when it comes to idiots bashing patents, eh?).

      reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 28 Nov 2017 @ 3:11pm

        Re: Re:

        I think you are missing the point that the disincentives are not large enough to dissuade further occurrence of the same exact problem.

        Or, possibly you think there is no problem.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 28 Nov 2017 @ 3:21pm

        Re: Re:

        When you start a comment with “dude” I assume it’s absolute dross and not worth the time I spent reading it. Your comment however... has proven my opinion completely right.

        reply to this | link to this | view in chronology ]

    • identicon
      New Mexico Mark, 29 Nov 2017 @ 3:56am

      Re:

      I know I'm dreaming here, but it feels good to say it anyway.

      Striking down one patent would sting a little. Striking that patent and issuing two injunctions (worded slightly differently and running consecutively) on the company against filing for any new patents for, say, two 20 year periods ("we'd make it 'just' 20 like normal drug patents, but you might miss the point about what patent abuse really is") would be both a strong deterrent and message to other companies.

      They could still probably find a way to weasel their way around the injunction by reorganizing as a new company, forming shell companies, or something similar, but it would definitely be painful. The best case scenario is that they would actually learn to compete on merit and value, and set an example for other companies to follow.

      In the best case scenario, they wouldn't even have to fire their lawyers. Instead the lawyers could help fight the legal shenanigans of their competition when they realize that a major drug company selling drugs at competitive prices will fundamentally change the whole big pharma paradigm.

      Again, from a current legal framework, this isn't going to happen. First, we'd have to enact patent abuse laws with real consequences. But I can dream.

      reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 29 Nov 2017 @ 7:53am

        Re: Re:

        How about putting those people in jail, you know - the ones who committed crimes. Last I heard bribery was still illegal as are kickbacks, price fixing and gouging.

        reply to this | link to this | view in chronology ]

    • icon
      PaulT (profile), 29 Nov 2017 @ 4:47am

      Re:

      When Bayer released their drug Heroin on to the market (yes, it was originally a brand name), they made the same claim about it being non-addictive. That was in the late 1800s, and we can all work out what really happened next.

      This is nothing new.

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 28 Nov 2017 @ 2:14pm

    The Opioid Crisis = Andrew Kolodny

    The only thing behind the "opioid crisis" is Andrew Kolodny, and his promotion of the non-existent crisis in furtherance of swapping out the use of existing opioids with his favorite pet opioid buprenorphine, Suboxone specifically. He has absolutely no problem with people using opioids provided it's limited to the one he and his cohorts can control. A turf war and no less. He and his fellow idiots attempt to have you believe that the "scourge of heroin" didn't exist prior to advocacy of Lortab and oxycontin, and that if patients are cut off of said medications, they have no other recourse but to stumble into some alley and fall on a pre-filled syringe of heroin, the only supposed solution to which is buprenorphine/suboxone conveniently prescribed by governmentally backed Pheonix House where he is conveniently head medical director while political mouthpiece the CDC shouts their virtues frequently so same said Pheonix House can make a financial killing along with Reckitt Benckiser thanks to their flat out government sanctioned under the table dope deal..... "as if" other recovery options like methadone maintenance, etc. are "somehow" unheard of and simply haven't existed for the decades that they have and in response to the same "scourge of heroin" that existed long before lortab and oxycontin were even thought of. Heroin sells and promotes itself - and it always has for decades upon decades and it always will forevermore. It is NOT the end result of "over-prescribing" lesser opiates/opioids - period.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 28 Nov 2017 @ 2:25pm

    Most of the things in this article have absolutely nothing to do with patents.

    Just saying.

    reply to this | link to this | view in chronology ]

  • identicon
    Mason Wheeler, 28 Nov 2017 @ 2:37pm

    It's not as if the people without the patents are any better, though.

    One of the principal manufacturers of generic oxycodone is a company called Mallinckrodt. They make tons of money off of it. And then, when people get hooked on it... you know what else Mallinckrodt makes? Methadone, the leading drug for treatment of opioid addiction.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 28 Nov 2017 @ 2:56pm

    Fact: Most people that die of drug overdoses have never been prescribed pain medication.

    Another Fact: Opioids are needed by many people. They allow them to live their lives maybe not pain free, but at least able to live through the pain.

    There are doctors that overprescribe yes, but there are other doctors that worry because of the current environment, people are not receiving the drugs that they should be getting.

    reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 28 Nov 2017 @ 3:15pm

      Re:

      So, you are saying there is no problem.

      Fake news then? ... yeah?

      reply to this | link to this | view in chronology ]

    • icon
      PaulT (profile), 29 Nov 2017 @ 4:51am

      Re:

      "Fact: Most people that die of drug overdoses have never been prescribed pain medication."

      Citation?

      "There are doctors that overprescribe yes, but there are other doctors that worry because of the current environment, people are not receiving the drugs that they should be getting."

      So, we have to decide where the acceptable point is, since whichever way we go it will lead to people being under or over-prescribed.

      Maybe instead of bleating and whining, you guys might actually want to get into an actual debate about these issues?

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 28 Nov 2017 @ 3:31pm

    There is an overdose problem, but to present this problem to the public, they have brought in prescription drug use as the main part of the problem. Why do they do that? Because they know if a bunch of heroin using druggies are dying, quite a few Americans would say "who cares, just a bunch of dirtbags dying." Most of the ads (at least the ones I have heard) talk about prescription drugs, because that can happen to anyone.

    Just like how some groups talked about how AIDS wasn't just a gay problem, even though it mostly was. They knew that a lot of Americans would not care if gays were dying, so they tried to make it seem like everyone was at risk.

    There is a drug use problem, but mostly an illegal drug use problem. Patents have very little to do with this.

    reply to this | link to this | view in chronology ]

  • icon
    MyNameHere (profile), 29 Nov 2017 @ 12:50am

    Wow, talk about blaming the wrong things for the outcome.

    Patents really don't have much to do with it in reality. People are dying of overdoses not because of a patent, but because they are addicted to it and are unable or unwilling to get help for it.

    Moving from Oxy to heroin may be a price issue, but at that point, you are just down the tube of choosing your own pain. Plenty of people OD and die from oxy. Lower the price (or make it generic and even more widely available) and you will just displace heroin as their death of choice.

    Huge numbers of people are taking it without a prescription, mostly though pill mills, prescription diversions, forgeries, and of course armed robberies of drug stores. The number of non-prescription users generally far exceeds the number of legit users.

    Making it generic and even more widely available wouldn't fix the issues.

    The true issues are (a) the US is addicted to legal and illegal opiods, and (b) the US border is so porous that tons of illegal drugs such as heroin are flooding the marketplace.

    Work on B, limit the use of opiods as prescription medication, and work on getting those addicted off the drugs. Then patents aren't even an issue. Worrying about patents in all of this is deck chairs on the Titanic material.

    reply to this | link to this | view in chronology ]

    • icon
      Ninja (profile), 29 Nov 2017 @ 3:52am

      Re:

      "Patents really don't have much to do with it in reality. People are dying of overdoses not because of a patent, but because they are addicted to it and are unable or unwilling to get help for it."

      Addicted out of thin air I suppose? No abuse in prescriptions, no pressure on doctors.

      My mother happens to be a doctor. She has been pressured and threatened, in a veiled way of course, because she refused to prescribe medicine. More than once. Good thing she built a solid reputation and could repeal such threats. On medicine that should be public domain.

      So, personal experience says you are a moron.

      reply to this | link to this | view in chronology ]

      • icon
        PaulT (profile), 29 Nov 2017 @ 4:55am

        Re: Re:

        Overprescription probably has some of its roots in direct to consumer advertising. Not only do prescription drugs not get marketed to consumers anywhere else, it's actually explicitly illegal to do so. Yet, in the US patients are being recruited to pressure them into prescribing what the drug company wants to sell, not what the patient needs. It's bizarre.

        There will be many other factors, but I think this (along with things like patents that encourage such behaviour) has to be a major factor.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 29 Nov 2017 @ 8:44am

        Re: Re:

        So we should base public policy on your mom. Great, check, got it.

        reply to this | link to this | view in chronology ]

        • icon
          Ninja (profile), 30 Nov 2017 @ 5:06am

          Re: Re: Re:

          No, she's just one example of something much bigger. Think of one more in the hundreds of thousands of evidence of abuse by the pharma companies.

          reply to this | link to this | view in chronology ]

    • icon
      PaulT (profile), 29 Nov 2017 @ 5:06am

      Re:

      "Patents really don't have much to do with it in reality."

      Really, patents don't have much to do with the way companies use underhanded tactics to get maximum profit during the patented period? Tactics that have a large amount to do with the current problem. You believe that?

      "Moving from Oxy to heroin may be a price issue, but at that point, you are just down the tube of choosing your own pain."

      Heroin was also a branded drug made by a "respectable" company who claimed it wasn't addictive. Worth thinking about.

      "Huge numbers of people are taking it without a prescription... The number of non-prescription users generally far exceeds the number of legit users."

      "Work on B, limit the use of opiods as prescription medication, and work on getting those addicted off the drugs."

      Most people are taking it without a prescription, and often recreationally so the best fix is to reduce the prescriptions and threat the medical side. Really?

      You should read your own arguments sometimes, it might help you see why they're laughable.

      reply to this | link to this | view in chronology ]

      • icon
        MyNameHere (profile), 30 Nov 2017 @ 12:49am

        Re: Re:

        Tightening prescriptions and distribution would be a big step. Limiting the number of pharmacies that can stock it, limiting it's distribution, and having the product secured in a manner that discourages brute force holdups to steal it would go a long way to getting it off the street.

        Tighter restrictions on it's use would also go a long way to keeping people from getting addicted. The fewer people with marginal issues or issues that could be addressed by non-addicting medication that don't end up taking it would certainly have longer term implications.

        "Really, patents don't have much to do with the way companies use underhanded tactics to get maximum profit during the patented period? Tactics that have a large amount to do with the current problem. You believe that?"

        I think that as a more widely available generic, we might be facing an even greater crisis. Prices would drop, usage would likely go up, and more people would be addicted.

        The truth is that it's a medication that should be stringently controlled. The government(s) have failed.

        reply to this | link to this | view in chronology ]

        • icon
          PaulT (profile), 30 Nov 2017 @ 1:33am

          Re: Re: Re:

          "Tightening prescriptions and distribution would be a big step"

          It will help, but I think the boat has sailed there in terms of it being the major solution. People who are already genuinely addicted will still go to the black market, who are very much capable of producing their own drugs.

          It's currently easier for them to redistribute officially produced drugs, but the people currently producing other opitates and synthetic drugs will most likely be happy to produce these as well, with the lack of quality control that happens in that market causing even more problems.

          It's right that these things have to be done, but it's a folly to suggest that it's the main solution, especially in a profit-driven medical system.

          "I think that as a more widely available generic, we might be facing an even greater crisis"

          Now, this is where I disagree totally, but I admit I'm not fully versed in the US medical system. I think that the issue isn't patent vs generic at heart, but overprescription and the resulting addiction. Uniquely in the US system, corporations pressure both patients and doctors to prescribe their product, even where it's not medically necessary. Making the product generic removes the major profit motive for a single company to push doctors to prescribe their product, since even if the advertising works, they can't guarantee it will be their brand that the pharmacist provides.

          Again, I could be wrong, but in a massively profit-driven medical system (changing that would be the better long-term solution, by the way) removing the profit increase driven by the patent would surely stem some of the overprescription.

          "Prices would drop, usage would likely go up, and more people would be addicted."

          If the only way you can legally obtain a drug is through a doctor's prescription, I don't see why price should be an issue. But, I do say that as someone who has enjoyed public healthcare for most of my life, so I've rarely paid more than a few pounds/euros/dollars for any type of medication. The problem in my mind is the profits due to the drug manufacturers and the doctor, not the cost to the patient.

          "The truth is that it's a medication that should be stringently controlled. The government(s) have failed."

          You can say that about most drugs, medically prescribed or otherwise. Thriving black markets exist for all of them, except those that don't sell enough to be worth the effort.

          But, it is worth noting that the current opiate epidemic is mostly in the US, where 80% of prescribed opiates are consumed. While you want to pluralise the governments there, this does seem to be a largely American problem, and so you have to look at what makes the medical system different there - which usually includes things like for-profit motives, marketing prescription drugs to patients (illegal in most other countries) and so on.

          reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 29 Nov 2017 @ 7:57am

    If the pharma corp had revealed their new drug as being addictive, would it have been granted a patent?

    reply to this | link to this | view in chronology ]


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