79 votes

An open letter to Johnson & Johnson regarding its strategy to extend its patent on bedaquiline leading to a predicted six million lives lost over four years

32 comments

  1. [11]
    Interesting
    Link
    Evergreening patents for drugs should be illegal. Once you've gotten a medication past the approval process, as a part of that process it should trigger a mandatory sharing of all processes needed...

    Evergreening patents for drugs should be illegal. Once you've gotten a medication past the approval process, as a part of that process it should trigger a mandatory sharing of all processes needed to create that drug. In exchange, you get market exclusivity for a given period. Once that period ends, you should have no right to sue a company that uses any method to reproduce your medication.

    One protection end date for every medication, no matter when the first or last patent was written.

    And hell, maybe not just drugs, but anything safety related. I recall a similar effort by SawStop, which invented a saw that self destructs to stop when it touches flesh.

    58 votes
    1. NinjaSky
      Link Parent
      Right just like Volvo did the right thing for 3 point safety belt CarandDriver . There should be both a business ethics responsibility to share when lives are at risk, but also as we've seen...

      Right just like Volvo did the right thing for 3 point safety belt CarandDriver . There should be both a business ethics responsibility to share when lives are at risk, but also as we've seen business ethics sucks it needs to be regulated.

      I'm excited how California disrupted insulin and hope States start doing similarly.

      31 votes
    2. [6]
      owyn_merrilin
      Link Parent
      Fixed the sentence for you. IP law in general retards the progress of science and the useful arts (as opposed to the verbiage in the US constitution that says the only reason for any of this it to...

      Patents for drugs should be illegal.

      Fixed the sentence for you. IP law in general retards the progress of science and the useful arts (as opposed to the verbiage in the US constitution that says the only reason for any of this it to promote that progress), and medical patents in particular are especially heinous. A patent today is basically a way to stake a claim and say "I've done all the science that can be done in this area for the next 20 years. Now get off my property before I sic my (legal) dogs on you!"

      When it's something frivolous like a software patent on minigames you can play in a loading screen, you might keep the innovation from ever being used while it's still relevant, but at least you aren't literally killing people by holding progress back.

      The same cannot be said for medical patents.

      15 votes
      1. [4]
        pbmonster
        Link Parent
        The problem I see is that many drugs are trivially easy to (re-)produce once you (1) know they work and (2) have acceptable side effects - but finding if those two are true frequently costs...

        Patents for drugs should be illegal.

        The problem I see is that many drugs are trivially easy to (re-)produce once you (1) know they work and (2) have acceptable side effects - but finding if those two are true frequently costs billions of dollars.

        If you can't patent drugs, you cannot stop pharma companies from taking every new drug hitting the market, running cheap analysis on the chemical compounds it contains and mass-producing the same compounds for a few cents per dose. Which means those same pharma companies are now not investing in costly research and year-long trails anymore, they can just wait for someone else to do that.

        Which is fine, I completely agree with your statement, but it also means that this "someone else" needs to step up. Which probably means Government-funded institutes. Which need to be given lots (really, unbelievable amounts) of taxpayer money for bio-medical research.

        Research, which foreign pharma companies hugely would profit from. Which everybody needs to be fine with.

        I would be, but I also know many others would not.

        12 votes
        1. [2]
          AAA1374
          Link Parent
          It's weird to me that people look at that and say, "No way, Jose, I'm not willing to pay a penny to save lives in Kazakhstan! I don't even know where that is, is it near Timbuktu?" For so many...

          It's weird to me that people look at that and say, "No way, Jose, I'm not willing to pay a penny to save lives in Kazakhstan! I don't even know where that is, is it near Timbuktu?"

          For so many reasons you should be wanting to spend that money. It's better for your country if you need the medicine (cheaper), it's better for other countries (altruism), and it makes your country look really good for pursuing this and making the world a legitimately better place.

          Crowd sourcing expensive things makes it substantially cheaper, too, and people don't realize how little it actually costs to pay up your portion. Something may cost $1b and that is a fuck lode of money, but the population of the US that pays taxes is roughly 170m, and that's like, $6 a person a year if they were all even having to pay the same amount, which they don't. I've lost more money than that and never thought about it or got upset. It's really not that big a deal.

          It's the same frustration that I have with people who hate the idea of universal healthcare in the US. I hate that I can be sick and my insurance that I pay hundreds of dollars to a month can just say, "Nah, we don't want to cover it," and that's that. It's comparatively cheap to subsidize it across the country - but that wouldn't be in the insurance shareholders' interests so good luck I guess.

          16 votes
          1. pbmonster
            Link Parent
            Yeah, and for the very same reason I'm a big open source software and open hardware advocate. It would be a powerful force for good if those things would be cheap and easy to use for everybody....

            Yeah, and for the very same reason I'm a big open source software and open hardware advocate. It would be a powerful force for good if those things would be cheap and easy to use for everybody.

            But sure, that would cut down on the ability of some people to create large personal fortunes. Which for me, is a feature, but others see themselves robbed of the opportunity to create such a fortune...

            4 votes
        2. MimicSquid
          Link Parent
          I would personally be very much in favor of the USA being known for spreading valuable medical tech free of charge than most of the current things that come to mind. Some paths to soft power are...

          I would personally be very much in favor of the USA being known for spreading valuable medical tech free of charge than most of the current things that come to mind. Some paths to soft power are way more moral than others.

          7 votes
      2. Grzmot
        Link Parent
        From my time at uni I took a course on patents for engineers and the prof did dip into pharma patents as well; the gist being that it takes approx 10 years and 1 milliard EUR to bring something to...

        From my time at uni I took a course on patents for engineers and the prof did dip into pharma patents as well; the gist being that it takes approx 10 years and 1 milliard EUR to bring something to the market, which is why pharma patents are extended to 24 years (standard patent maximum is 20). i haven't watched the video cause I'm on the road but it's my understanding that patents specifically are never evergreen. They expire because the entire social contract underpinning them is "We give you exclusivity for 20 years to make a shitton of money, but after this the knowledge goes back to society."

    3. [2]
      ThePandaManWhoLaughs
      Link Parent
      My only critique on the US patent system is that the clock starts when the patent is accepted and not when the product hits the market. For high regulated products, that could mean you only get a...

      My only critique on the US patent system is that the clock starts when the patent is accepted and not when the product hits the market. For high regulated products, that could mean you only get a 5-10 year window to sell the product after you do your due diligence in fulfilling testing, clinical studies, etc.

      If things were to change to addrss that, they should probably include limits on how long it takes you to bring the product to market before you start your 20 year on market window.

      14 votes
      1. Interesting
        Link Parent
        Yeah, that sounds reasonable, I don't know if this new window should be 20 years, but I think the idea is that you still have the patents as well, you're just basically licensing them to anyone...

        Yeah, that sounds reasonable, I don't know if this new window should be 20 years, but I think the idea is that you still have the patents as well, you're just basically licensing them to anyone who is making that exact product. You can refuse to license the patent for other products, you've just already granted a license for that particular case.

        So basically, it would be a maximum amount of time you can prevent someone else from making a particular medication. So, to use an EpiPen as an example, once the exclusivity period ends, anyone can make that auto-injector with epinephrine in it, down to the shape of the plastic (but minus branding), but they couldn't sell, say, glucagon in the same injector. No trade secrets or biosimilar nonsense either. You must share all information relevant to creating the medication

        I'm not a lawyer, doctor, or pharmaceutical expert, so this is mostly just me spitballing ideas. I just think we need a clear last day for every vital medicine's protection, and then a path towards getting it available to everyone who needs it.

        4 votes
    4. DeepThought
      Link Parent
      I think we should also give the government a mechanism to buy out a patent and encourage it's use when an invention is too important to keep from the market. For example, SawStop holds the patent...

      I think we should also give the government a mechanism to buy out a patent and encourage it's use when an invention is too important to keep from the market. For example, SawStop holds the patent for table saws that stop when the blade makes contact with skin. They however refuse to license this tech to anyone else and as a result the feature of not being able to cut off your fingers remains locked away in only the most expensive of saws. I am a strong proponent that the government should step in in these situations and buy out the parents for a reasonable price and make them free to use for all manufacturers.

      5 votes
  2. [13]
    Comment deleted by author
    Link
    1. [5]
      TheWizard
      Link Parent
      If it weren't for this open letter, I wouldn't have known about this issue at all.

      If it weren't for this open letter, I wouldn't have known about this issue at all.

      51 votes
      1. [4]
        sunset
        Link Parent
        And now that you know about the issue, what actions are you taking to stop it? That's the problem with slacktivism, it confuses raising awareness with actually doing something. If you don't...

        And now that you know about the issue, what actions are you taking to stop it?

        That's the problem with slacktivism, it confuses raising awareness with actually doing something. If you don't actually do anything, you knowing about the problem is identical in practice to you not knowing about the problem. Nothing changed now that you were made aware.

        5 votes
        1. [3]
          zykirion
          Link Parent
          I think in the future we're going to find links between the rise of slacktivism and decline in mental health. I've been more informed about all the problems in the world, yet simultaneously felt...

          I think in the future we're going to find links between the rise of slacktivism and decline in mental health. I've been more informed about all the problems in the world, yet simultaneously felt so helpless, or worse, like I'm part of the problem by not being part of some online awareness campaign

          12 votes
          1. snakesnakewhale
            Link Parent
            To your point, and sort of to the point of the guy calling this virtue signaling, you can think of "open letters" like these as a form of mass marketing, like a flyer. Yes, the direct address to...

            To your point, and sort of to the point of the guy calling this virtue signaling, you can think of "open letters" like these as a form of mass marketing, like a flyer. Yes, the direct address to the company is dramatic and feels like it's supposed to lead to some Frank Capra mass action, but really the high visibility just makes it more likely to be seen by people who are in a relevant position to act.

            The fact that you may not be a relevant actor here doesn't make you a slacktivist, nor does reading about something that you do have a feeling about, but aren't starting a campaign for.

            8 votes
          2. CosmicDefect
            Link Parent
            I highly recommend two short vlogbrothers videos (funny considering this thread is about a vlogbrothers video) on this very topic with a practical answer on how to overcome this sort of...

            I've been more informed about all the problems in the world, yet simultaneously felt so helpless, or worse, like I'm part of the problem by not being part of some online awareness campaign

            I highly recommend two short vlogbrothers videos (funny considering this thread is about a vlogbrothers video) on this very topic with a practical answer on how to overcome this sort of understandable thinking:

            In case you can't watch: The answer is to pick a problem, even just one, and decide to go deep in helping fight that problem. You will not be able to fight all the world's problems, but you can make a small but valuable dent in a single problem you focus your attention on it whether it be local or global.

            5 votes
    2. [2]
      Kenny
      Link Parent
      Not sure how bringing attention to the problem is virtue signaling. They make a specific call to action that is within their ability to make. The company that the vlogbrothers run actually donates...

      Not sure how bringing attention to the problem is virtue signaling. They make a specific call to action that is within their ability to make.

      The company that the vlogbrothers run actually donates its profits to Sierra Leone, which is why they're particularly interested in this drug. If it's virtue signaling to raise awareness about things that affect your interests how are we suppose to learn about these things as laypeople? I know I don't have the capacity myself.

      28 votes
      1. [2]
        Comment deleted by author
        Link Parent
        1. sparksbet
          Link Parent
          I don't see how you could possibly think this is exclusively directed at J&J rather than for awareness when the bulk of the video is explaining the situation to their regular viewers. The video is...

          I don't see how you could possibly think this is exclusively directed at J&J rather than for awareness when the bulk of the video is explaining the situation to their regular viewers. The video is clearly a call to action for regular vlogbrothers viewers (their fanbase is generally very devoted and care about issues like this) to bombard J&J through various channels to raise visibility on this issue and convince the company that it's not worth the negative press to enforce their secondary patent. Most of that is explicitly stated in the video itself.

          It's honestly kind of ridiculous to call someone pointing out the horrible effects of something a big company is doing "virtue signaling". Is it possible to point out anything wrong with the world without it being virtue signaling in that case? John Green is already raising and spending a lot of money on healthcare in Sierra Leone, so the money is clearly where his mouth is. And I fail to see what more effective action he could take regarding this secondary patent other than raising awareness and directing people to make a big stink about it to J&J the way he does in this video.

          21 votes
    3. CosmicDefect
      (edited )
      Link Parent
      John Green isn't one to virtue signal. He's been advocating for various issues in global healthcare for years now and has some reason successes under his belt with Partners In Health. As an...

      I mean I'm getting kind of sick of these open letters. It's basically virtue signaling at this point, it's not like anyone takes these seriously.

      John Green isn't one to virtue signal. He's been advocating for various issues in global healthcare for years now and has some reason successes under his belt with Partners In Health. As an example, improving maternity health in Sierra Leone is one of their big projects which is really taking off. If you follow him at all, you'd know that tuberculosis has also been a personal project of his for a while now and advocating for bedaquiline treatments to become more accessible in a variety of ways. This video is just one of his latest pitches to generate awareness and move the needle. (This video was basically an adaptation of an op-ed he wrote for the Washington Post a few weeks back, though honestly the op-ed is worth the read by itself.)

      I understand your frustration with videos like this, it seems like a fad to pick a topic of woe in the world, "bring awareness" and then basically do nothing else or never return to it. That's not what's happening here. John will likely do other things, make more videos, write articles or organize groups or donations on this same issue in the years to come. I respect the guy incredibly.

      19 votes
    4. Melvincible
      Link Parent
      I am also having a real hard time. I agree with you that we are being manipulated into being too peaceful. I am not advocating violence, but I acknowledge that lasting change in power structures...

      I am also having a real hard time. I agree with you that we are being manipulated into being too peaceful. I am not advocating violence, but I acknowledge that lasting change in power structures has never occurred without the presence of violence. Whether from the side of the oppressed, or the side of the oppressors.

      Think of the civil rights movement in the US... Those were extremely effective peaceful protests, but think of how much violence they had to endure. They were peaceful, but it was not a peaceful time. It is not ineffective if it is persistent, loud, and in everyone's face as much as possible. But we are all still convinced that we have something to lose (when in reality most of us don't own our homes, our cars, our media, the ability to repair our devices, access to information is basically a tech monopoly... we own less than we think). We have to accept that these things aren't just "happening to someone else" and stop numbing out.

      We are being absolutely flooded with coping mechanisms. Limitless streaming of entertainment, food is not scarce, clothing is cheaper than ever, and drugs of all kinds are pervasive. Did you know you can get lexapro for free from the manufacturer if you are poor? Sure lexapro would reduce my anxiety, but so would not being one medical bill away from destitution.

      I don't know what the answer is. But the trajectory scares me a lot. Peaceful doesn't have to mean passive. I hope that we can be louder than the coping mechanisms one day.

      4 votes
    5. Tigress
      Link Parent
      True... but at the same time violent revolution is usually more palatable and startable by people who are more motivated and in general shouldn't be leaders either. Notice most revolutions don't...

      True... but at the same time violent revolution is usually more palatable and startable by people who are more motivated and in general shouldn't be leaders either. Notice most revolutions don't really end up with things being better for the people, particularly if it isn't one born out of desperation (mainly people have nothing left to lose). Most people can't be convinced to risk everything when they have stuff to lose. And when they can it's not usually the people you really want leading.

      I'm not sure what the solution is. I personally think the 1 percent protests if they were better organized and people didn't have short memories might have worked. Maybe something in between where we don't violently force the leadership to change but we make it so we are in the way unless they agree to change (like the recent train protests I was pissed Biden forced them to keep working. Yes, it would have hurt economically but how do you expect them to have leverage without being able to tell the companies, negotiate with us in actual good faith or suffer consequences). Something has to hurt and we have to be in the way to stop that hurting to motivate "them" into change.

      3 votes
    6. CosmicDefect
      Link Parent
      I reread your comment on noticed this part: This hits me hard because I often feel the same way, and don't want to. I want to direct you to this comment written I wrote in response to another user...

      I reread your comment on noticed this part:

      I'm being vague on purpose, but honestly I'm having a hard time coping with how much the world keeps trending downward worse and worse, and what the endgame is for this trajectory.

      This hits me hard because I often feel the same way, and don't want to. I want to direct you to this comment written I wrote in response to another user here feeling the same way. As an aside, I recommend the vlogbrothers's YouTube channel immensely. It's probably the best anti-nihilism content on the internet without dripping in saccharin or reeking of false optimism but operating in a thoughtful genuine way.

      3 votes
    7. idrumgood
      Link Parent
      I generally view these as "I have a platform with modest reach and no real direct contact at these mega-corps so this is my best bet at both drawing some attention to the issue and from the...

      I generally view these as "I have a platform with modest reach and no real direct contact at these mega-corps so this is my best bet at both drawing some attention to the issue and from the mega-corp". But yea, I hear ya.

      2 votes
  3. cdb
    (edited )
    Link
    As someone who works closely with formulation development, I find the 'pen cap' analogy oversimplified and a little bit insulting. A pen can be used without the cap. A drug cannot be used without...

    As someone who works closely with formulation development, I find the 'pen cap' analogy oversimplified and a little bit insulting. A pen can be used without the cap. A drug cannot be used without the formulation. Oftentimes the formulation makes the drug. The active pharmaceutical ingredient (API) is the star of the show, but if you can't find a formulation with good properties, it will kill the drug as a candidate.

    Also, there's a lot of work that goes into formulation such as screening, stability, and animal studies. It's just not worth it to put in the resources until you have a drug that has enough data behind it to advance, since the vast majority of drugs don't make it past phase 1. Although there are some predictive stability techniques, if you want to be sure the formulation is stable for a year, you have to actually wait a year to find out. Then you have to get all that data together to file a patent, then wait for it to be approved, which can take years.

    Edited to add: If the suggestion is to move the formulation development work earlier in the process, that means more studies on candidates that aren't going anywhere. Financially, that's hard to justify because it increases development costs, leading to higher prices or reduced investment in drugs without high profit potential (like this one). Ethically, it's hard to justify as well, since we'd be sacrificing more animals for studies on failed candidates. Thinking about animal studies makes me a bit sad, but we justify it by saying that it's to save human lives. We can't expand these activities frivolously; we have to be very careful about what studies we consider to be worthwhile. (End of added section)

    That said, I just work in research. I don't want people to die, but I don't know how to solve this problem in terms of economics (although I have no influence on the business side of these things anyway). According to J&J, they've invested about $500 million. This article says that public investment was 1.6-2.2 times that amount though. I'd be interested in knowing if there were any strings tied to that money, and how that's played out.

    J&J had its patent granted in 2003 and it's expiring this month after 20 years. The drug was approved in the US in Dec. 2012, Europe in 2014, and India in 2015, so they've had ~8-10 years to sell it without competition. Looks like India, the country with nearly 1/3 of the world's TB cases, didn't find the formulation to be a substantial change and rejected the patent extension, so maybe they'll be producing the generic there.

    14 votes
  4. [4]
    Tigress
    Link
    I remember when the drug companies patented a new way to deliver albuterol (the drug itself wasn't patented but the delivery device was) just to make it expensive again to buy ventolin.

    I remember when the drug companies patented a new way to deliver albuterol (the drug itself wasn't patented but the delivery device was) just to make it expensive again to buy ventolin.

    7 votes
    1. Kenny
      Link Parent
      I just used this as an example in a conversation today. That directly impacted me, too. Nothing I can do about it, unforunately. This seems like I can at least make a small impact given the...

      I just used this as an example in a conversation today. That directly impacted me, too. Nothing I can do about it, unforunately. This seems like I can at least make a small impact given the situation. A four-year extension with the negative PR that could possibly ensue. Perhaps J&J will consider it too costly.

      2 votes
    2. [2]
      just_another_guy
      Link Parent
      THAT'S why the cost for ventolin is so high? And here I thought it was because the concentration of albuterol per dose was greater than others, such as ProAir (which, anecdotally, I will swear is...

      THAT'S why the cost for ventolin is so high? And here I thought it was because the concentration of albuterol per dose was greater than others, such as ProAir (which, anecdotally, I will swear is the equivalent of a vial of air that has been homeopathically treated to contain the memory of albuterol).

      1 vote
      1. Tigress
        Link Parent
        To be fair that happened a while ago and the cost for generic has gone down again (cause there is generic). Ventolin is so high cause it is the name brand one. Albuterol is the actual drug so you...

        To be fair that happened a while ago and the cost for generic has gone down again (cause there is generic). Ventolin is so high cause it is the name brand one. Albuterol is the actual drug so you can find generics of it. But for a time you couldn't again cause of that patent.

        1 vote
  5. Rocket_Man
    Link
    IMO, it sounds like the drug has been artificially restricted for 8-10 years. We've already let millions of people die so that J&J can privately make a profit. It was mentioned elsewhere they...

    IMO, it sounds like the drug has been artificially restricted for 8-10 years. We've already let millions of people die so that J&J can privately make a profit. It was mentioned elsewhere they spent 500 million on the drug. It would have been reasonable for governments to buy out the patent from J&J if society considered the price of their monopoly too high. The actual mechanism of their extension, and allowing millions more to die is worth talking about. But the problem is these incredibly important drugs not being bought out for the betterment of society.

    7 votes
  6. [3]
    Tynted
    Link
    I just saw this video today and also just read and appreciate cdb's perspective on this issue. There is a lot more that goes into drug development than just the "pen cap" analogy. However, given...

    I just saw this video today and also just read and appreciate cdb's perspective on this issue. There is a lot more that goes into drug development than just the "pen cap" analogy. However, given the publicly available numbers, I think it's safe to say J&J has made definitive profit on their investment and it's now in the best interest of the public to reap the rewards of generic formulation. Drug-resistant TB is a risk of becoming a much bigger problem if we do not make available the currently available resources to keep it in check in underdeveloped countries.

    I sent emails to their investor & media relations email addresses (investor-relations@its.jnj.com & media-relations@its.jnj.com) voicing my opinion that they should not enforce this secondary patent, citing their credo and letting them know I'll be avoiding their products such as Band-Aids and soaps in the future because of this decision. I am aware that basically all competing pharmaceutical companies have done similarly awful things, but you must pick your battles in this world to achieve change.

    6 votes
    1. [2]
      CosmicDefect
      (edited )
      Link Parent
      Looks like J&J got the message! https://www.stoptb.org/news/global-drug-facility-update-access-to-bedaquiline Edit; discussion here:...
      5 votes
      1. Tynted
        Link Parent
        Hell yes, that's great news! Thanks for posting this!

        Hell yes, that's great news! Thanks for posting this!

        2 votes