Remember when computers took up entire rooms and were exclusive to big companies and the government? Now we carry them in our pockets.
But what changed between the days of Space Odyssey and selfies isn’t just technology. It’s access. The software boom that defined the 90s and early 00s would not have happened if it weren’t for the pioneers behind the open source software movement.
Now, a similar revolution is happening, but not in software. So-called Do-it-yourself biologists, inspired by the same principles that made software collaborative, want to change the future of medicine. They’re assembling in low-budget laboratories, teaching people how to build their own EpiPen’s on YouTube, and trying to change the future of pharmaceuticals.
Late last year we explored how these ‘biohacked’ medicines might fit into the existing infrastructures for producing, regulating, and distributing pharmaceuticals. We describe our findings in a paper published by Trends in Biotechnology and in a follow-up story for The Conversation.
Our paper focuses on The Open Insulin Project. Run by a collective of patients, computer scientists, and hobby biologists in a lab in Oakland California, the original goal of the Open insulin Project was to develop a protocol for making insulin and release it “open-source”, so that it could be picked up by generic drug manufacturers to get around patents. Our paper explains why this model would not fit within the current regulatory framework in the United States, and it’s gotten a lot of attention.
Our Conversation story has been read over 55,000 times and was reprinted by dozens of news organizations including Live Science, Discover Magazine, and Salon. We have also been interviewed for blog posts, news segments, and, recently, the podcast, An Arm and a Leg.
The Podcast is titled “The insane, surprising history behind insulin’s crazy price (and some hopeful signs in the wild)”, and the host opens by explaining that 1 in 4 diabetic patients rations their insulin.
The severity of the insulin affordability model is what makes The Open Insulin project in particular so interesting among biohacking initiatives. The desperation with which the patients depend on it is also what makes patients more likely to try “home-brewing” the drug.
The host explains that The Open Insulin Project is more focused on a micro-brewery model than home brewing per se. They want to produce affordable insulin for patients in small scales. But Jing Luo, a Harvard professor who’s also a guest in the podcast doesn’t think the FDA will go for it.
Although it’s noted that The Open Insulin Project considers our lab an ally in their efforts, and the podcast presents our perspective as opposed to Luo’s, we have to agree. The argument we make clearly in our Trends in Biotech paper is that no model for small scale insulin production is going to fly under current regulations.
No model, that is, except home brew. “There is nothing that prevents a patient from manufacturing a drug for himself,” says Dr. Peccoud in the podcast. For better or for worse, that is still the only model that we believe fits in the current regulatory structure.
As for The Open Insulin Project’s Perspective, “we’re awaiting the opinions from our legal council,” says project lead Anthony Di Franco. And the host reminds us of the gruesome truth of the situation, “meanwhile diabetics die rationing their insulin every year.”
With the rising costs of health care, price gauging on essential drugs, and unprecedented medical technologies on the horizon, the pharmaceutical industry is ripe for change. It’s not yet clear what form that change will take.
We are hopeful that the creative thinkers of the Do-It-Yourself biology space will help facilitate change. They’ve at least attracted some headlines, and for the diabetic residents in our home state of Colorado, that’s lead to some good news: The price for insulin is now capped at $100 per month for insured patients.