- 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!