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.