An historic victory over a dread disease…
When Jonas Salk developed the polio vaccine…
The Salk vaccine against crippling polio has proved to be a sensational success.
…he famously opposed the idea of patenting and profiting off the discovery.
They weren't in this for making money.
It just didn't interest him.
Today, patents and profits have become central to the development of innovative drugs.
Without patents companies wouldn’t have the incentive to bring a medicine to market.
But with skyrocketing drug prices making headlines…
In recent months the price shot up almost 5000%.
They are priced disastrously, almost criminally, too high.
Has the system designed to bring innovative drugs to market shortchanged the very people
it’s supposed to help?
I think the public is not aware of all the stuff that goes on.
It's not right.
It's not fair.
When the polio vaccine was rolled-out in 1955, Dr. Jonas Salk, the scientist who developed
the drug with funding from the March of Dimes, became an overnight celebrity.
And the entire world heralded the discovery, which assured an end to one of mankind’s
most dreaded diseases.
Following that, Ed Murrow, who had a television program interviewed my father and one of the
questions he asked was: Who owns the patent on this vaccine?
Well, the people I would say.
There is no patent.
If you look at the original tape of that interview, there's a moment where there's sort of a little
bit of pausing.
And he thought for a moment, and then you could see the expression on his face just-just
light up.
He said: Could you patent the sun?
He just saw this as, this was just a natural evolution of science.
The results belong to the people.
Well that's the way it was in those days.
Scientists had the view that you could either do well or do good but that it was tough to
do both.
AIDS is the most serious epidemic to strike this country since the polio epidemic of the
1950s.
By the time another public health crisis hit America, three decades later…
The often dreaded disease was unknown five years ago.
Doctors now say it’s a national epidemic.
…the pharmaceutical industry had changed dramatically.
The costs of research and development had soared, and drug development, with expensive
clinical trials, had become increasingly reliant on investment.
Jonas Salk was interested in trying to develop an AIDS vaccine when he was approached by
a venture capitalist and asked to collaborate and form a biotech company.
My job was to finance the company.
To start on an ambitious effort like the one we did with Dr. Salk, to get the best people
working on this, you need to give them the opportunity that this is not going to just
be a puff of smoke or a tumbleweed that's just going to blow away.
Salk began to experiment with a vaccine using the AIDS virus itself.
Patents are fundamental to that process.
This was not a charity.
And so, Jonas Salk’s company ended up filing several patents on a potential AIDS vaccine.
It's not what my father would've chosen.
Different world, a different reality.
Today, the pharmaceutical industry has evolved into a trillion-dollar business.
It’s clear any for-profit company has to answer to both investors and it has to answer,
in our case, to patients, as well.
In 2004, Barbara Hiser was diagnosed with a rare form of cancer called chronicmyeloid
leukemia.
When my oncologist told me what the diagnosis was, my first question to him was, "How long
am I going to live?"
And he said, "Up until about three years ago, you would've had three to five years to live,
but," he said, "now we have this new drug and," he said, "you're not going to die from
leukemia.”
Gleevec has been hailed as a real life cancer-fighting miracle.
But this pharmaceutical marvel has a drawback that is becoming increasingly important in
the worsening economy.
Gleevec had a list price of around $26,000 a year when the drug came on the market in
2001.
Hiser was getting a deep discount from the manufacturer Novartis.
But in 2012, after she changed insurance companies, her costs went up.
So I called to renew my drugs and the operator said I'm going to charge your credit card
$5,000.
And I said "What?
At that time, I said to my husband—I said, "You know, I feel like I'm being faced with
the choice of either keep our house and keep the lifestyle that we have, or stay on Gleevec."
We couldn't do both.
Today, the price of the drug can run to more than $100,000 a year, earning Novartis around
$4.7 billion in sales in 2015.
Hiser says the price is outrageous, especially considering that some of the cost of researching
and developing Gleevec was paid for with federal funds.
When my money goes to help fund the development of it, and then they're going to turn around
and charge me exorbitant prices that I can't afford, then there is something wrong with
that.
I think it’s important to look at the advancements that we’ve gotten and ask whether or not
those advancements would have occurred without a for-profit industry.
But over the past few decades, innovative drugs have increasingly stemmed from federally-funded
research.
That's because of a little known law called the Bayh Dole Act.
This law changed everything.
This 1980 law allowed researchers who made discoveries funded by public institutions
like the National Institutes of Health to license their patents to private companies
who could develop and market new drugs.
Despite the fact that America was investing a significant amount in research and development
dollars, only five percent of patents were ever getting used by the private sector because
there was uncertainty around those patents.
What the Bayh-Dole Act really did was cause a transformation in terms of the ability of
the private sector to utilize that research in the hopes of bringing in new product to
market.
That one law said to the big drug companies: you can market drugs, but you don't have to
come up with your own, original, innovative drugs.
That will be done with NIH dollars.
And that's exactly what has happened.
But do they have a right to be rewarded as though they were the innovators?
And, she says, the problem with pharmaceutical pricing today extends beyond drugs.
A growing firestorm about the soaring cost of the potentially life-saving EpiPens.
The price of EpiPens has skyrocketed.
Mylan Pharmaceuticals licenses the patent on EpiPen – a special syringe whose precursor
was originally developed with public funds at the Department of Defense – that injects
epinephrine, or adrenaline, to treat life-threatening allergic reactions.
Over 10 years, the EpiPen has gone from $100 to $600.
The drug itself isn't expensive.
It's the delivery method which is.
So Jim Duren led a team at King County Emergency Medical Services that developed a less expensive
way of administering the drug.
It would only take about $10 worth of equipment, plus $5 worth of epinephrine to put a package
together.
We developed a kit what we call the "Check and Inject" kit.
So, inside the kit we have our little check sheet, two safety syringes and then your bottle
of adrenaline.
King County’s emergency services are saving more than $300,000 a year with this alternative
kit.
And emergency services around the country are now buying kits or learning how to make
their own as an alternative to Mylan’s EpiPen.
We are going to continue to run a business and we are going to continue to meet the supply
and demand of what’s out there.
The complaints against high prices have risen...
It’s not funny, Mr. Shkreli.
People are dying.
And they’re getting sicker and sicker.
… particularly with some drug companies making record profit margins...
We've seen these prices creep up and up every single year for so many drugs.
...and some have pointed to another provision of that 1980 Bayh-Dole law, which allows federal
authorities to “march in”… and take over the patent of a publicly-funded drug
in extenuating circumstances.
The Bayh-Dole Act says the patent has to be made available to the public on reasonable
terms.
If the patent, drug, or whatever else it was, wasn't sold at a reasonable price to the public
the government could march in and lower the price.
There’s no history at all that it was intended to address drug prices.
I would argue that if march-in rights are used to address drug prices and the government
could come in and, and either give license to someone else or try and control the price,
it would undo the positive influence and the positive aspects of the Bayh-Dole Act.
The NIH has declined to use the march-in rule for drug pricing, despite six petitions to
apply it to high-priced drugs for such diseases as AIDS and cancer.
Barbara Hiser says she is not waiting for the government to solve her drug price problem.
I’ll be honest with you the drug that I take has a generic that comes out of India,
but that generic is not legal in this country.
Since the Indian version costs a small fraction of the drug price in the US, Barbara has started
ordering her pills directly.
When I get my shipment, I almost feel like I'm looking over my shoulder to open it up.
I feel like a law-abiding citizen has become a drug importer.
And that doesn't feel very good.
But she says she risks it, since it’s the only way she could afford her life-saving
medication.
If I were doing it the traditional route, I would pay $1,300 out of pocket.
Going through India it comes to about $250 for a month’s worth.
We have to remember that there are people on the other end of this, and that we not
end up depriving people of life saving medications.
The reasons that I can't get it at a reasonable price from my neighborhood drug store, are
all political.
And that stuff needs to be fixed.
There was a phrase that my father used: “Which is more important, the human value of the
dollar, or the dollar value of the human?”
Somehow in this complex world we have to find the mix between the two.