Insulin should be cheap. Here’s why it’s not.

Insulin should be cheap. Here’s why it’s not.

November 21, 2019 100 By Jose Scott


– I have type one diabetes. My body doesn’t process glucose properly, which it needs to power muscle tissue and other pretty critical
things, like my brain. What I don’t have is insulin. A hormone secreted by the pancreas that helps cells take
up glucose in the blood. That means for the past 15 years, I’ve had to give myself
prescription insulin every single day. Without it, I’d die and
so would millions of other type one diabetics around the world. But luckily for me in the past decade, diabetes management has
undergone a complete overhaul. Instead of pricking my finger every day, I now wear a glucose sensor
to track my blood sugar. And rather than giving myself
multiple daily injections, I can now just dial my
insulin dosage into my pump. But one thing hasn’t changed. I’ve been using basically the
same insulin for 15 years. Unfortunately, the price has changed. In 2013, patients spent more
than three times as much on insulin as they did in 2002. And the problem hasn’t
gone away since then. Now, there’s a whole
mess of finger pointing around who is to blame. But the key to solving the insulin crisis might be in understanding
the protein insulin itself. What it is, how it’s made today, and how it could be made in the future. The first effective treatment for diabetes leveraged the fact that any
normally-functioning pancreas produces insulin, and not
just the human pancreas. So the earliest manufactured insulin was made by grabbing
a cow or pig pancreas, grinding it up and purifying
the extracted insulin. Pretty crude, but it worked. Animal-based insulins weren’t ideal because they could lead
to allergic reactions or theoretically even mad cow disease. That changed in 1978 when
scientists figured out a way to create insulin in a lab without the need for pigs or cows. That technology, known as recombinant DNA took insulin to a whole new level. To make lab-grown
insulin, scientists start with the human gene that
encodes insulin production. Next, the insert the
insulin gene into a plasmid, a small loop of DNA
commonly found in bacteria and other microorganisms. Then they dropped the plasmid into a living bacterium, or yeast. The result is a microscopic
insulin factory. The altered microbes
multiply in a nice warm vat, producing insulin. Manufacturers can then
harvest the insulin cells from the bacteria and purify it into the insulin we use today. So, with this technology,
all a lab has to do is brew large volumes of
insulin-producing microbes and in return, they get a
virtually unlimited supply of insulin using very
cost-effective ingredients. But if that’s the case,
why aren’t more companies manufacturing insulin today. (phone ringing) – [Mike] Mike Carrier. – [Cory Voiceover] Hi Mike, it’s Cory. – [Mike] How are you Cory? – [Cory Voiceover] Good, how are you? – [Mike] So a patent is
designed to promote innovation. In the pharmaceutical industry, it typically takes a lot of
research and development, it’s very costly. – I’m speaking with Michael Carrier, a professor of law at Rutgers University. And yes, we’ve got to talk
about patents for just a minute. Basically, a patent grants an inventor exclusive rights to market
and sell their product for a limited period of time. It gives inventors a
head start to make money, but the system can get stretched. – [Mike] Insulin has been known about for at least a century. It was patented back in the 1920s. Nonetheless, companies keep
getting patents on insulin. Sanofi has 74 patents on insulin. They last 37 years in total. – Today, just three pharma companies, Sanofi, Eli Lilly and Novo Nordisk, control nearly 96 percent of
the world’s insulin supply. For years they’ve stacked
patent on top of patent to extend their head start
and prevent competitors from entering the market. Often, the new patents don’t even change the therapeutic elements of the drug, they’re just smaller tweaks
to extend the patent’s life. It’s a tactic known as evergreening. With less competition,
there’s less pressure to keep prices low, which Michael says defeats the purpose of
patents in the first place. – [Mike] It seems like this really isn’t about innovation, but rather about making as much money as possible. – Even so, some important insulin patents have started expiring,
including those for Humalog, the insulin I’ve been using for 15 years. So you’d think that would open
up the door for competitors, but there’s a second road block. When you think of generic drugs, you might picture Advil versus ibuprofen. These are small-molecule drugs that are relatively easy
to produce in a lab. And it’s easier to convince the FDA that they are carbon
copies of the original. – [Mike] They have the
same active ingredients. They’re absorbed into the body at just about the same rates. – [Cory] But insulin is different. It’s a compound called a Biologic. – [Mike] Biologic drugs
are more complicated. They involve living organisms and with a Biologic drug, it’s harder to come up with an exact replica. – That mean it’s nearly impossible for a competitor to
create a generic insulin. Instead, the FDA has begun
approving biosimilar drugs, compounds that are
deemed to be close enough to the original, but they have
the same therapeutic value. But the process is more stringent. In the past decade, only 24 biosimilars have been approved by the FDA. In roughly that same span of time, thousands of generic drugs were approved. In short, the insulin market
is paralyzed by patents and legal hurdles, so it’s overwhelming for any newcomer to
challenge the big players. But competing with big
pharma on their own terms might not be the only way. (gentle music) Here in this discreet lab
in Oakland, California, a group known as the Open Insulin Project is working on an entirely
open-source insulin. A version of the drug that would be free for anyone to copy and develop
themselves, zero patents. Their founder, Anthony Difranco, started the project in 2015. – I just looked at a technical reality and I saw that something
was technically feasible and that there was a big need for it. And decided to try to pursue it and some people have joined me in that. – [Cory] The team is
working on the early steps of insulin production. Getting those microbes to
take up the insulin genes. It’s the same technology that
those big manufacturers use, just on a much smaller scale. – Scale up is possible, it’s just question of time, resource and establishing the good process. – [Cory] At this stage, the
work feels a bit random. It’s hard enough getting the microbes to take up the altered plasmids and that’s without other variables like temperature and fermentation time. – We’re at the part right now where you just have to keep trying and see which ones are producing the best. So it’s kind of a, almost
artificial evolutionary process and we’re relying on some amount of luck. But right now at the moment it’s just Yann and a couple other folks slinging the pipettes in the lab. So that takes some time. – It’s a pretty striking sight. A volunteer-driven team in a cluttered lab trying to shake up a 22
billion dollar annual market. Massive scale isn’t in their near future, but that’s kind of the point. Anthony says just liters of viable culture could help thousands of diabetics. With enough DIY labs on board, the whole industry could
become decentralized. – What we’re working on is setting up a microbrewery model
for insulin production where you could have several
small-scale factories in every city instead of
just a handful of factories that supply the entire world. This would mean a lot
more direct involvement, potentially, from the people
who are using the insulin in the business of making it. (gentle chimes) – The idea of insulin
microbreweries is exciting, but we shouldn’t hold our breath. Anthony and his team haven’t
made any viable insulin yet. And even if they do, experts we talked to described a long road ahead. Bringing a biosimilar to market can cost as much as 250 million dollars. And money aside, winning FDA approval means proving the safety of a complex and finicky compound. Here is one researchers gut reaction to what open insulin is attempting. – [Irl] I mean, people can do it, you can do your DIY, but I gotta tell you, this is not like making an omelet. This is really tough to do and you make any mistakes
and you can kill people. My opinion is stay away. – Meanwhile though, the
problems surrounding insulin are only getting worse. Demand is expected to rise by
more than 20 percent by 2030. That’s at least 100 million
more vials of insulin per year. Biosimilar insulin production
is starting to ramp up in other countries, notably India. And here in the U.S., the
FDA is planning to streamline the biosimilar approval process. But today, right now, half of all patients who need insulin worldwide,
don’t have proper access to it. So the very fact that wild,
out-of-the-box experiments like Open Insulin exist,
it means things have gotten much worse than they ever should have. (gentle chime) So today is National
Diabetes Day, November 14th, and in downtown Manhattan, just outside of the New York Stock Exchange, the group Insulin for All has gathered with the main message,
patients over profits. – [Insulin For All Group]
Patients over profits! Patients over profits!