Natalie Bravo is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.
Brief History of Insulin
In 1921, Dr. Frederick Banting, Charles Best, and James Collip successfully isolated the hormone insulin, discovering a new life-saving treatment for managing diabetes in humans. The first human injected with insulin was a 14-year-old boy in 1922. By 1923, insulin was widely-produced and available to the general public.
Dr. Banting and research facilitator Dr. Macleod, refused to put their names on the patent for the drug, with Banting stating “as a physician who had taken the Hippocratic oath he could not be party to any patenting of a discovery.” Thus, the first patent application for an insulin patent was filed under Best and Collip’s names. However, as all the co-inventors believed that the medicine should be widely available and not restricted by costs, they sold their intellectual property rights to the University of Toronto for just $1. Today, contrary to the co-inventors’ intentions, insulin is highly unaffordable for individuals around the world who rely on the lifesaving treatment, including in the United States.
Insulin Price Rise
Over 30 million people in the U.S. live with diabetes and around a third of them require insulin to survive. From 1960 – 2019, the price of a vial increased from 75 cents to $250, over forty times the rate of U.S. inflation. Soaring prices have left many with few options besides rationing or skipping doses altogether, a practice that has harmful and sometimes fatal consequences. To put it in perspective, a carton of insulin costs $20 in Canada but can cost $300 across the border. Many researchers and doctors attribute these price hikes to lax regulatory measures on drug-pricing in the U.S. How do patents play into this? Only a handful of companies control the market and those companies are increasingly modifying their insulin products, improving them, and typically protecting them with additional patents. It’s a practice that some call the “cost of innovation”. However it is unclear if these modifications are always worth the additional costs for the consumer. Most patients are prescribed the newer, modified formulations, instead of the older ones. Unfortunately, no true affordable generic is currently available. Enter bio-hackers: a group of individuals who hope to make insulin more accessible for everyone.
Insulin Bio-hackers
Bio-hacking is essentially a do-it-yourself (DIY) approach to biology. The Open Insulin Project works to create insulin that is open-source, easily replicable, and most importantly, affordable. The group is comprised of volunteer scientists and community advocates. The not-for-profit project was started in 2015 by Anthony Di Franco. Di Franco himself lives with Type-1 diabetes and was motivated to create the project after witnessing the rising prices of insulin in the U.S.
The project is not limited to the U.S. and, if successful, seeks to provide insulin to other parts of the world where patients similarly struggle to access insulin. To date, the project has made some strides in their discoveries. They announced their first major milestone at the end of 2018, genetically engineered yeast cells to create a precursor to insulin. Open Insulin estimates that they may be able to develop a version of insulin that only costs $7 per vial to produce– a stark difference in price from what is currently available. While optimistic, the project faces various regulatory obstacles. The group will not be able to produce market insulin without the Food and Drug Administration’s (FDA) approval. They may, however, publish their findings to help support other biohackers around the globe.
Even if they are unable to release generic insulin to market, their innovative research and goals are making waves, increasing awareness, and inspiring others to push for solutions to the insulin cost problem. Check them out at https://openinsulin.org!