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.
Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+
Thank you for reading this Techdirt post. With so many things competing for everyone’s attention these days, we really appreciate you giving us your time. We work hard every day to put quality content out there for our community.
Techdirt is one of the few remaining truly independent media outlets. We do not have a giant corporation behind us, and we rely heavily on our community to support us, in an age when advertisers are increasingly uninterested in sponsoring small, independent sites — especially a site like ours that is unwilling to pull punches in its reporting and analysis.
While other websites have resorted to paywalls, registration requirements, and increasingly annoying/intrusive advertising, we have always kept Techdirt open and available to anyone. But in order to continue doing so, we need your support. We offer a variety of ways for our readers to support us, from direct donations to special subscriptions and cool merchandise — and every little bit helps. Thank you.
–The Techdirt Team
Filed Under: big pharma, diabetes, drug prices, generic insulin, insulin, open insulin, patents, pharmaceutical pricing
Reader Comments
Subscribe: RSS
View by: Time | Thread
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?
[ link to this | view in chronology ]
Re:
[ link to this | view in chronology ]
Let the roadblock building commence
[ link to this | view in chronology ]
Re: Let the roadblock building commence
[ link to this | view in chronology ]
Re: Let the roadblock building commence
we will see the feedback soon...
[ link to this | view in chronology ]
[ link to this | view in chronology ]
Re:
[ link to this | view in chronology ]
Re: Re:
BEFORE Hillaryforprison2016 asked for his brain in a smoothie cocktail
[ link to this | view in chronology ]
[ link to this | view in chronology ]
Re:
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
[ link to this | view in chronology ]
Re:
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?
[ link to this | view in chronology ]
Re: Re:
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
[ link to this | view in chronology ]
Re: Re: Re:
[ link to this | view in chronology ]
Re: Re:
[ link to this | view in chronology ]
Re: Re:
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.
[ link to this | view in chronology ]
Re: Re:
You know Porsche bought VW ?
[ link to this | view in chronology ]
Re: Re: Re:
are postponed indefinitely
[ link to this | view in chronology ]
Re:
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.
[ link to this | view in chronology ]
Re:
[ link to this | view in chronology ]
Re:
[ link to this | view in chronology ]
The FDA approval process will bankrupt any person/company who makes the attempt.
[ link to this | view in chronology ]
they randomly change employees don't they?
[ link to this | view in chronology ]
Well - that will certainly not happen.
[ link to this | view in chronology ]
[ link to this | view in chronology ]
you can get a new healthy body transplant everywhere else...
don`t you?
[ link to this | view in chronology ]
Re:
[ link to this | view in chronology ]
Re: Re:
[ link to this | view in chronology ]
[ link to this | view in chronology ]
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.
[ link to this | view in chronology ]
Re:
ALMOST?
either she is pregnant or she is not, she cannot be "almost" pregnant
[ link to this | view in chronology ]
Re:
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.
[ link to this | view in chronology ]
Re: Re:
reasonable profits or ethical behaviour are NEVER going to pay for yuge Lürssen Yachts
and CEOs love their Yachts
[ link to this | view in chronology ]
[ link to this | view in chronology ]
Re:
That of course is been reverted via FTAs
[ link to this | view in chronology ]
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.
[ link to this | view in chronology ]
yeah but
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?
[ link to this | view in chronology ]
No signs of intelligent life on the thrid rock from the sun.
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.
---
[ link to this | view in chronology ]
Re: No signs of intelligent life on the thrid rock from the sun.
We need generic drug solutions for diabetes NOW as well as healthy eating promotion programs.
[ link to this | view in chronology ]
Re: Re: No signs of intelligent life on the thrid rock from the sun.
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.
---
[ link to this | view in chronology ]
Insulin producer 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.
[ link to this | view in chronology ]
Improving access to insulin
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!
[ link to this | view in chronology ]