-Pharma executives, all of you that are here today
are here because the way you've been doing business
is unacceptable.
-Drug company executives were recently called to testify
about what has led to America's
skyrocketing prescription drug costs.
-Let me just say I think that you
charge more here because you can.
-One drug they focused on was Revlimid.
-Today, it sells for about $18,000 for a 21-day supply.
-Revlimid is a derivative of a drug called thalidomide
and, long before it became a poster child
for rising drug costs,
thalidomide was a cautionary tale for drug safety.
That story begins in the 1960s,
with a warning from the president.
-Every doctor, every hospital, every nurse, have been notified.
Every woman in this country, I think,
must be aware that it's most important
that they check their medicine cabinet
and that they do not take this drug.
-Only two years earlier,
thalidomide, a sedative billed
as the latest pharmaceutical marvel,
had been set to arrive on American shores.
-A hypnotic, as the doctors call it,
that was the answer to a prayer.
-The hallmark, defining quality of thalidomide was its safety.
So safe that, in Germany,
there was no prescription needed.
-The German company that developed thalidomide,
Chemie Grunenthal,
claimed that even pregnant women could take it.
-The drug company had handed out samples of this drug
all over the place,
starting with employees of its own company.
On Christmas Day in 1956,
a baby girl was born in Germany without ears.
And she was the daughter
of an employee of the drug company Grunenthal.
-No immediate connection was made to thalidomide,
which soon sold almost as well as aspirin
in some European countries.
-We received it in quantities of like 1,000 pills.
There was tremendous pressure all over the world
to get this wonderful new drug on the market.
-They had two million tablets ready to go
the moment the FDA approved the drug,
which was almost a foregone conclusion,
until one doctor came along and began working at the FDA.
-It just so happened that my first application was
for the drug thalidomide.
I got this because I was new
and they thought I should have
an easy one to start on.
-But Dr. Kelsey was uneasy with what she saw
as the lack of rigorous scientific studies.
-The best thing that could be said about thalidomide
at the time was simply that you could not kill a rat,
no matter how much thalidomide the rat ate.
-With thalidomide being prescribed
for morning sickness in other countries,
Kelsey became particularly concerned
with what effect it might have on a developing fetus.
In June of 1961,
an article appeared,
promoting its safety during late pregnancy.
-It was allegedly written by a Dr. Ray Nulsen,
but, in fact, the article was written
by the medical director of the drug company.
-About six months later,
long ignored evidence became public in Germany,
linking thalidomide to a rash of birth defects.
Although hundreds of thousands of pre-market samples
had been provided to American doctors,
Dr. Kelsey's stubborn delay
of the drug's approval for more than a year
had prevented a similar scale of tragedy
from unfolding in the United States.
-Dr. Kelsey was absolutely a unique hero
in American history.
-But thalidomide's reach continued to be felt
across the rest of the world,
including in Trinidad and Tobago,
where Giselle Cole was born.
-When I came along, I'm a firstborn,
and they were a young, married couple.
I mean, I was never unloved
or not wanted or anything like that,
but I would be foolish to think that it was easy for them.
My disability is, uh --
the official term is phocomelia,
coming from the Greek, meaning "shorter arms"
or "flipper-like."
I think people always expect that I would've been angry
and I'm certainly not angry, and never have been.
-Long discussed, but seldom implemented,
major regulatory reforms were finally forced
on the pharmaceutical industry
following the thalidomide scandal.
-For some time, President Kennedy has tried
to get Congress to approve new controls,
but without much success.
Now, with the thalidomide scare,
most of the opposition has melted.
-Largely, the same FDA guidelines
that we live under today were created in the immediate wake.
-These regulations were too late for thalidomide's thousands
of surviving victims across the world,
[ Melancholy tune plays ] who soon became the story.
-Philippa Bradbourne is one example.
Her mother rejected her.
-10-year-old Carl Davies leads a relatively normal life
for a boy without arms.
-One other young mother, her husband, her sister,
and her doctor are charged
with the mercy killing of her deformed infant.
-I'm one of the lucky ones in that my parents were adamant
that I was their daughter and their daughter first,
before anything else, and it was treated as such.
♪♪
Many were put in homes
because they just didn't know what to do.
Some families battled with doctors
to have amputation of fingers and toes or whatnot
to accommodate these prosthetics.
Many families were broken, irrevocably.
-Instead of quickly settling, the drug companies dug in,
with Grunenthal originally arguing
that the children's deformities were caused by everything
from nuclear fallout to botched home abortions,
anything but thalidomide.
-It was a very long and difficult process.
-British thalidomide children, so far, have not received
any compensation from the rich company
that made the drug which crippled them so brutally.
-Most cases were eventually settled,
but litigation continues,
with some survivors saying the original settlements
cannot cover the cost of their specialized care.
Grunenthal didn't apologize to its victims until 2012,
50 years after the tragedy unfolded.
-They issued a statement saying that
it has taken them the 50 years to come forward,
to say anything, because they were shocked.
They don't have a right to be shocked.
The shock doesn't belong to them.
-Despite all that the thalidomide's victims
endured over the decades,
they could long take solace in one simple fact.
-Thalidomide is now banned everywhere.
-The now banned thalidomide.
-The drug was banned in 1962.
-And I would have liked to have seen it never used again.
♪♪
-There's a tremendous amount of luck in science.
It's almost like an Easter egg hunt.
-In 1992,
while conducting research into macular degeneration,
ophthalmologist Robert D'Amato began his own hunt,
this one, to find a pill
that might restrict blood vessel growth.
-I started searching for drugs
that cause some sort of damage to a fetus, a birth defect,
and at the top of this list was thalidomide.
-After much trial and error,
Dr. D'Amato finally had a breakthrough
when he demonstrated that thalidomide
could starve blood flow to cells,
a discovery that held the potential
for treating cancerous tumors.
-The people that really understood the results
were excited because we had a tool
that we didn't have before.
But the knee-jerk reaction was, "This is a dangerous drug.
No one would ever want to use it."
There's thousands of victims that still remain.
There had been a promise that thalidomide
would never be developed again.
-We had to make a decision: what position we were going to take.
Many would have thought and expected
that we would have been screaming, "No, no, no, no, no!"
-But, following a surge of reports
about promising studies,
that's not what happened.
-We are nervous.
We are, of course, frightened and dismayed,
but we realize that this is not a perfect world.
-Thalidomide is back.
-The Food and Drug Administration says
thalidomide will be
the most restricted drug ever distributed.
-Female patients taking the drug
will even have to submit to pregnancy tests.
-Since then, thalidomide has gone on
to combat a surprising variety of diseases,
from tuberculosis and Crohn's disease
to multiple sclerosis and leprosy.
And D'Amato's hunch about the drug's effect
on cancerous tumors paid off in a groundbreaking treatment
for certain types of the disease.
-Thalidomide and its derivatives have become
the primary treatment for multiple myeloma.
-It's a very fine line that I walk, and many of us walk,
when we think about thalidomide in today's world.
Clearly, you can see what it has done
to the thousands of us who are still on this Earth.
But if it provides some kind of assistance, help,
relief of suffering,
then I cannot, in good conscience, be opposed.
-Brynner, who saw thalidomide's curative powers firsthand
after being prescribed it for a deadly skin disease,
says that the drug's circuitous history tells us a great deal
about the accidental nature of drug discovery.
-It's kind of surprising, I think, to most people,
to learn that drugs are, in fact, developed
and then become, as they're called,
a drug in search of a disease.
-But, for all its benefits, the scientific rehabilitation
of thalidomide has come with a heavy cost.
-We were told this could never happen again.
-In Brazil, where the drug
is used extensively to treat leprosy,
researchers have documented
that new thalidomide children have been born.
-Alan, who's eight, has been terribly damaged by thalidomide,
which his mother took by accident
when she was pregnant.
-Fifty years down the road, I would like to think
that there's no such thing as thalidomide,
that we have created something, we have developed something,
that would allow us to bury thalidomide, literally.
Destroy it, get rid of it,
so that there are no further discussions,
other than a note in history.
♪♪