Open Insulin Project Could Help Save Thousands Of Lives And Billions Of Dollars

from the public-health,-public-domain dept

Techdirt has written a few times about the pharmaceutical industry's use of "evergreening", whereby small, sometimes trivial, changes are made to drugs in order to extend their effective patent life. It turns out the technique is applied to one of the most widely-used drugs of all, insulin:

There are currently about 387 million people worldwide living with diabetes. Meanwhile, as discussed by Jeremy A. Greene and Kevin R. Riggs in their March 2015 article in the New England Journal of Medicine, there is no generic insulin available on the market despite great demand in poorer communities and regions of the world. As a result, many go without insulin and suffer complications including blindness, cardiovascular disease, amputations, nerve and kidney damage, and even death. Pharmaceutical companies patent small modifications to previous insulins while withdrawing those previous versions from the market to keep prices up.
The obvious solution is to produce a generic version of insulin that can be sold cheaply enough that nobody dies or suffers complications simply because they cannot afford Big Pharma's hefty price tags. That's just what the Open Insulin project, with its crowdfunding page, aims to do:
A team of biohackers is developing the first open source protocol to produce insulin simply and economically. Our work may serve as a basis for generic production of this life-saving drug and provide a firmer foundation for continued research into improved versions of insulin.
As well as making insulin more readily available to those in the poorer communities, the Open Insulin project could save Western countries huge sums too. As an article in Popular Science explains:
Since there are no generic versions available in the United States, insulin is very expensive -- that cost was likely a large proportion of the $176 billion in medical expenditures incurred by diabetes patients in 2012 alone.
Any project that could help save thousands of lives and billions of dollars would be noteworthy. What makes Open Insulin even more remarkable is that it is operating on a shoestring -- the initial crowdsourcing target was just $6,000, already surpassed -- and that it intends to put all its results in the open:
All protocols we develop and discoveries generated by our research will be freely available in the public domain. We will also be proactively investigating strategies to protect the open status of our work.
However, it's important to keep those exciting prospects in perspective. The Popular Science article includes a comment from the Kevin Riggs mentioned in the Open Insulin quotation above. He doesn't believe that Open Insulin on its own will be enough to bring a generic insulin drug to the market:
"I don't think the major hurdle is that the companies don't know how to make insulin, because that part is reasonably straightforward," he says. "The real hurdles are getting the drug approved by the FDA (and since insulin is a biologic drug, it requires a lot more original data than an application for a small-molecule generic would), and then upfront manufacturing costs (because making a biologic drug is different, so it requires different equipment)." He suspects that it will take "an altruistic entity with a lot of start-up money" to make generic insulin commercially available.
That may be so, but at least the Open Insulin project is doing something in an attempt to change the status quo that sees huge numbers of people suffering unnecessarily. In any case, Open Insulin is a wonderful demonstration of how much biohacking has advanced, allowing suitably-skilled people to make potentially important contributions to global health. Let's hope it does eventually lead to a generic insulin that can be made available around the world very cheaply.

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  • identicon
    Anonymous Coward, 1 Dec 2015 @ 1:00am

    I don't understand how the FDA process would impact insulin.
    It's already in existence, already used by our own bodies, surely all that's needed is proof that you are making the correct compound?

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

    • identicon
      Anonymous Coward, 1 Dec 2015 @ 1:15am

      Re:

      You obviously do not understand bureaucracies, and how they maintain and exercise their power. Their processes are designed to ensure that they keep their power, and any simplifying of processes reduces their power.

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

  • icon
    That One Guy (profile), 1 Dec 2015 @ 1:12am

    Let the roadblock building commence

    With billions on the line, you can be sure that the major pharmaceutical companies are going to be doing everything they can think of to derail and/or destroy this. If they actually have to compete on price, they stand to lose a hefty sum, much easier to kill the competition to keep it from ever reaching that point.

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

    • identicon
      Anonymous Coward, 1 Dec 2015 @ 1:40am

      Re: Let the roadblock building commence

      Well, in that case, the Open Insulin project should tell those companies to go fuck themselves, and ignore any regulations not directly requested by the FDA, and question those that do come down.

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

    • identicon
      Anonymous Coward, 1 Dec 2015 @ 2:45am

      Re: Let the roadblock building commence

      are the potential loses high enough to start nailgunning, defenestrating and suiciding biohackers?

      we will see the feedback soon...

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

  • identicon
    Anonymous Coward, 1 Dec 2015 @ 2:47am

    Articles like this could push someone over the edge. The truth about the U.S today is a very bitter pill that many can't stomach. Don't believe it? Ask Ed Snowden, he prefers life in Russia. I guess one could douse themselves in petroleum distillate and light up. That would make a few take notice. American Dream? Quit blowing smoke up our collective assholes.

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

  • icon
    Bt Garner (profile), 1 Dec 2015 @ 4:28am

    Contrary to what the article says, there are two kinds of generic insulin widely available in the US: Novolin N (a long acting [12-14 hour]) insulin and Novolin (a short term [4-5 hour] insulin). Both of these are available in WalMart pharmacies for about $25/bottle. By contrast, the Novalin N that I buy at CVS through my insurance is about $280/bottle. Unfortunately neither of these insulins are in wide use, most diabetics use a rapid acting insulin (Novolog, 45 minutes), and a longer acting insulin (like Lantus), that have a duration of closer to 24 hours. It woudl be absolutely fantastic to see a wider variety of insulins available at reasonable prices, but I fully agree with what Kevin Riggs said, that the generic part is not the problem, it's the manufacturing cost (et al). What this effort needs is a Bill Gates sort of benefactor to kick start the whole thing (as a lost cost start up), then operate a company as a non profit to provide the generics at cost. But then you have another issue, who will sell them? Do you honestly think that CVS would prefer to sell you a bottle for $25, when they can instead sell one for 10 times that? Keeping in mind that their markup is probably 10X as well.

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

    • identicon
      Anonymous Coward, 1 Dec 2015 @ 4:41am

      Re:

      american sheeple: "What this effort needs is a BILL GATES sort of benefactor to kick start the whole thing"

      I am pretty shure Gates, Buffet, Rockefeller and friends are heavily invested in BIG PHARMA
      http://youtu.be/X6J_7PvWoMw

      specially in "fertility vaccines"
      http://apps.who.int/iris/bitstream/10665/61301/1/WHO_HRP_WHO_93.1.pdf

      if you are not born from the eugenicist tribe, then Bill Gates is not your friend, you can research that by yourself

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

    • icon
      Machin Shin (profile), 1 Dec 2015 @ 5:35am

      Re:

      "Do you honestly think that CVS would prefer to sell you a bottle for $25, when they can instead sell one for 10 times that? Keeping in mind that their markup is probably 10X as well."

      Yes, I honestly do think they would want to do this. I have never understood why someone would rather charge large amounts and make a few sales verses selling for cheaper and making lots of smaller sales. In the end it is often more profitable to sell at the lower price. Also, you seem to assume CVS is a monopoly. You think CVS would choose not to sell the lower price one and risk Walgreens stealing that market?

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

      • identicon
        Anonymous Coward, 1 Dec 2015 @ 5:39am

        Re: Re:

        "I have never understood why someone would rather charge large amounts and make a few sales verses selling for cheaper and making lots of smaller sales."

        common big pharma medicine is part of the MANDATORY Obamacare (Clintoncare?), that is not a price free market but enforced monopoly

        do your math

        http://youtu.be/X6J_7PvWoMw

        walmart is broke, that famous turing kid is not

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

        • identicon
          Wendy Cockcroft, 2 Dec 2015 @ 6:08am

          Re: Re: Re:

          All the more reason to get the profit motive out of healthcare altogether. Run it as a tax-funded program and let private companies compete on service like we do over here. Bear in mind that a for-profit enterprise makes more money from sick people needing regular treatment than from healthy people who don't need any. The market will NOT sort this out. That's not its job.

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

      • icon
        Bt Garner (profile), 1 Dec 2015 @ 6:51am

        Re: Re:

        Then you do not understand diabetes. Insulin is not optional. Yes, there are soem Type 2s for which it is, but for every Type 1 out there, and many Type 2, it is mandatory. It does not matter whether it is $25 a bottle, $250 a bottle or $2500 a bottle. If you need 3 bottles a month, you need 3 bottles a month, regardless of the price.

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

      • icon
        scotts13 (profile), 1 Dec 2015 @ 6:51am

        Re: Re:

        "I have never understood why someone would rather charge large amounts and make a few sales verses selling for cheaper and making lots of smaller sales."

        Really? There's a cost associated with shipping, storing, and selling a product, and it doesn't vary much with the price of the item. MUCH more economical to sell a single million-dollar item than a million $1 items.

        If you can sell a million $1,000,000 items... better still.

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

      • identicon
        Anonymous Coward, 1 Dec 2015 @ 9:14am

        Re: Re:

        check how much car companies make selling high end cars compared to selling shitcars for the masses?
        You know Porsche bought VW ?

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

        • identicon
          Anonymous Coward, 1 Dec 2015 @ 9:16am

          Re: Re: Re:

          car companies are "forced" via huge subsidies to sell cheap shitcars for the masses so that the riots and guillotines
          are postponed indefinitely

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

    • identicon
      Joe Glucose, 1 Dec 2015 @ 8:40am

      Re:

      Unfortunately neither of these insulins are in wide use, most diabetics use a rapid acting insulin (Novolog, 45 minutes

      Just to add, insulin pumps, which are incredible for managing blood glucose, are built around use of rapid acting insulin like Humalog or Novolog. A low-cost rapid acting insulin would definitely be a big help, since as was mentioned elsewhere, pumps are expensive enough. I wish this project the best.

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

    • identicon
      Maria Chavez, 1 Dec 2015 @ 1:06pm

      Re:

      These aren't generics, just low-cost downmarket products that address some but not all of the price gap. Negotiated price between big distributor and manufacturer which also addresses some but not all of the market service gap.

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

    • identicon
      Anonymous Coward, 9 Dec 2015 @ 8:54pm

      Re:

      Novolin is a product of Novo Nordisk, and therefor not generic. Am I mistaken?

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

  • identicon
    Quiet Lurcker, 1 Dec 2015 @ 5:04am

    Big Pharma(tm) won't have to lift a finger to put a stop to this.

    The FDA approval process will bankrupt any person/company who makes the attempt.

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

  • identicon
    Anonymous Coward, 1 Dec 2015 @ 5:15am

    are not FDA and BIG PHARMA heads of the same monster?
    they randomly change employees don't they?

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

  • identicon
    Anonymous Coward, 1 Dec 2015 @ 5:29am

    "Could Help Save Thousands Of Lives And Billions Of Dollars"

    Well - that will certainly not happen.

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

  • icon
    Machin Shin (profile), 1 Dec 2015 @ 5:39am

    It kind of makes me feel sick, well actually, it makes me down right disgusted with this country to say, but I think a project like this really should start overseas. Sadly there is little chance of making it through FDA and other groups without a large amount of money. They could go somewhere without such groups though and start production of cheap insulin for those people who really need it.

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

  • identicon
    Anonymous Coward, 1 Dec 2015 @ 5:42am

    you americans are aware that for the price you get a new tooth in the us
    you can get a new healthy body transplant everywhere else...
    don`t you?

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

  • identicon
    Anonymous Coward, 1 Dec 2015 @ 5:43am

    this cheap insulin project is terrorism against the nature and the sustainability of the country

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

  • icon
    Chris ODonnell (profile), 1 Dec 2015 @ 6:31am

    With the advances in pumps and insulin and so forth there is no doubt that diabetics that can afford the treatment are better off today than they were 30 years ago. However, since the advent of the insulin pump over 20 years ago, nothing has gotten less expensive. Insulin pumps still cost about $5000 retail, the insulin for a pump is going to be at least $100 per vial, blood sugar test strips are about $1 each, and the typically Type I diabetic will use 8-10 a day. These prices haven't changed in 20 years, except to go up as lower cost generic alternatives were sued out of existence. My wife is convinced that if a sure is found, it'll be held up for 1o+ years as the diabetes treatment companies sue for criminal interference with their business plans.

    Diabetes is a multi-billion dollar market run almost like a cartel, with very few players. There is zero incentive for any of them to make things cheaper.

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

    • identicon
      Anonymous Coward, 1 Dec 2015 @ 7:56am

      Re:

      "Diabetes is a multi-billion dollar market run almost like a cartel"

      ALMOST?
      either she is pregnant or she is not, she cannot be "almost" pregnant

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

    • icon
      Josh in CharlotteNC (profile), 1 Dec 2015 @ 9:01am

      Re:

      These prices haven't changed in 20 years

      And they never will, unless we get serious about stopping price gouging of sick people. When people only have the choice between buying something at an inflated price and dying, the price cannot be left up to a private company only beholden to it's shareholders.

      My sister was diagnosed with Type 1 diabetes when she was 7 years old. She's been through insurance companies forcing changes in the type of insulin she could have after they decided to no longer cover certain types. She's been stuck without insurance between jobs before the ACA went into effect, and even when she did have insurance, been unable to afford care she needed and nearly lost vision in both eyes (only lost most in 1, so at least she can function).

      To be clear: I have no problem with pharma companies making reasonable profits when they are acting ethically. But ethically does not include evergreening of patents, buying out competition from generics or suing them into the ground, spending exorbitantly on advertising and lobbying or to buy and influence doctors, and raising rates even though the actual costs to make and sell their products are stable or decreasing.

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

      • identicon
        Anonymous Coward, 1 Dec 2015 @ 9:20am

        Re: Re:

        "To be clear: I have no problem with pharma companies making reasonable profits when they are acting ethically."

        reasonable profits or ethical behaviour are NEVER going to pay for yuge Lürssen Yachts

        and CEOs love their Yachts

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

  • identicon
    Anonymous Coward, 1 Dec 2015 @ 7:33am

    The issue isn't just (or mostly) about the cost here in the US. Yes, it is bad, but stop being so self centered and think about 3rd world countries that have to try to pay for this..

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

    • identicon
      Anonymous Coward, 1 Dec 2015 @ 7:59am

      Re:

      don`t 3rd world countries just ignore pharma patents and pricing that can kill their citizens?

      That of course is been reverted via FTAs

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

  • identicon
    Anonymous Coward, 1 Dec 2015 @ 8:02am

    ...The issue isn't just (or mostly) about the cost here in the US. Yes, it is bad, but stop being so self centered and think about 3rd world countries that have to try to pay for this...

    One of the biggest costs in the US that 3rd world countries don't have is liability insurance. Most other countries have limits on lawsuits and awarded damages; the US does not, and the few state level limits are inadequate. Those countries with nationalized health care include some form of sovereign immunity. And there are countries where health care is NOT allowed to operate on a for-profit basis.

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

  • icon
    blogagog (profile), 1 Dec 2015 @ 9:26am

    yeah but

    "Open Insulin Project Could Help Save Thousands Of Lives And Billions Of Dollars"

    Yeah, but what if all of those thousands of people saved turn out to be reincarnated Hitlers, and the $billions are spent on creating the Fourth Reich? Are we sure we want to risk this?

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

  • icon
    GEMont (profile), 1 Dec 2015 @ 11:16am

    No signs of intelligent life on the thrid rock from the sun.

    The obvious solution is to stop feeding sucrose - white refined cane sugar - to children.

    Honest studies would show plainly that sucrose is detrimental to every organ in the human body, from heart to head.

    Of course, honest studies are about as rare as honest politicians.

    The simple truth however, is that the obvious solution is never the solution that is chosen. Such solutions are not profitable.

    Instead, we will seek an expensive medical/chemical method of masking the symptoms, so that the malady might generate income forever, for the makers of symptom masks, while the number of addicts whose bodies have begun to fail will continue to rise.

    That's the profitable solution.

    ---

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

    • identicon
      Wendy Cockcroft, 2 Dec 2015 @ 6:14am

      Re: No signs of intelligent life on the thrid rock from the sun.

      We've had diabetes since before white refined sugar showed up. Your solution would almost certainly help to ameliorate this problem — and the dental caries problem, among others — but it wouldn't completely resolve it.

      We need generic drug solutions for diabetes NOW as well as healthy eating promotion programs.

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

      • icon
        GEMont (profile), 2 Dec 2015 @ 11:55am

        Re: Re: No signs of intelligent life on the thrid rock from the sun.

        You might want to read a book titled Sugar Blues, by William Dufty, and perhaps rethink "We've had diabetes since before white refined sugar showed up."

        While I suppose it is possible that there were indeed cases of diabetes prior to the introduction of sucrose as a food, those cases will have been extremely rare and extremely few, worldwide.

        It is always possible that other things might combine to cause a person to become diabetic, such as birth defects or exposure to, or contamination by other chemicals that act in the same way as sugar to destroy a person's body functions.

        However, Diabetes' touted "Genetic Cause" is 100% pure commercial propaganda, paid for by the Sugar Industry, who had the medical name Sugar Diabetes changed to Diabetes through simple pay-offs to typical politicians.

        Refined white sugar from sugar cane was once a pharmaceutical drug, for instance, before it was used popularly as a sweetener.

        The book Sugar Blues (which is often difficult to find) follows the spread of the popular use of sugar as a food, across the planet and notes the maladies that follow in its wake.

        ---

        "We need generic drug solutions for diabetes NOW as well as healthy eating promotion programs."

        While I would love to agree with this statement, especially the first part "we need", the word "solutions" completely invalidates the meaning you intended to convey.

        Pharmaceutical concoctions developed for use by diabetics are not solutions, unless they actually cure the malady.

        Instead, due entirely to the lucrative nature of the pharmaceutical business, all developed "drugs" for use by diabetics, will be, as I noted above, symptom masks that insure the malady remain profitably intact and happily generating income forever for the pharmaceutical industry.

        Medical Science no longer seeks cures because cures eliminate a source of income - the disease - and deprive medical industry corporations of what they feel is their right to make money.

        Regardless of their product or service, all corporations have a single goal in their mandate - greater profits year after year. They have no other purpose, drive or desire, and no corporation on earth has a mandate that includes anything remotely akin to a humane motive.

        While the medical industry may legally (lie) claim publicly to be working towards the betterment of humanity, or seeking to eliminate ill-health, the actual activities of that industry are always 100% profit driven and cures are considered to be diametrically opposed to the mandate of all medical industry corporations.

        ---

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

  • identicon
    Anonymous Coward, 2 Dec 2015 @ 9:42pm

    Insulin producer Novo Nordisk

    One of the world's largest producers of insulin is Novo Nordisk.

    The company was founded after some people from Denmark went to the US and found out how insulin was extracted from pigs. Knowing that US patents could not be enforced in Europe they went home and started a company to duplicate the effort. Of course they immediately patented what they were doing in Europe so they had a local monopoly.

    Later research on gene manipulation made a breakthrough: They were able to engineer a micro-organism that produced insulin which could be cultivated in tanks. This was of course also patented.

    Patents are monopolies. Lots of revenue, making this the largest company in my country by market cap. The market cap got so large that our stock exchange had to change their leading index from C20 to C20CAP, limiting the size of any single stock in the index to 1/5 of the index. Owners of this company got really rich.

    But I wonder how many had to suffer because they could not get their insulin at affordable prices because of the monopoly.

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

  • identicon
    Marg Ewen, 14 Dec 2015 @ 2:46am

    Improving access to insulin

    In January 2015, HAI launched a three year study Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS). You can read about the study on http://haiweb.org/what-we-do/acciss/

    This year we landscaped the global insulin market from various angles, including looking at who makes insulin across the world. In addition to the big three (Novo Nordisk, Lilly and Sanofi), we found a further 39 potentially independent insulin manufacturers (in India, China, Mexico, UAE, Egypt, Bangladesh etc.) making biosimilar (generic) human insulins. The majority only market in their country of manufacture. Next year we intend asking these companies about the barriers they face in getting marketing approvals in other countries.
    For analogue insulins, earlier this year the EMA gave marketing approval to Lilly for a biosimilar glargine product so perhaps next year we will see this biosimilar on the market. It will be interesting to see how it is priced compared to Lantus!

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


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