01x07 - Black Box Warning

[bunniefuu]

How many times
have y'all been to rehab?

I'm just worried
maybe it doesn't work.

Have you thought about
methadone? It's worth a sh*t.

The FDA would take action
against OxyContin

if the drug was shown
to be unsafe

when used as prescribed.

You think we'll be shut down
by the higher‐ups?

We start charging individuals
with felonies,

we need the k*ll sh*t.

Have you spoken to Curtis?

Is he still
the review officer?

Two years after
the drug hits the market,

Curtis Wright
ends up at Purdue Pharma.

You're kidding me.

"Time Magazine's"
Man of the Year,

Mayor Rudy Giuliani.

I just started a new firm
and I represent Purdue Pharma.

I'm not obsessed with work,

I'm just trying to prevent
mass deaths

from occurring
across the country.

You got any Oxy?
I'm in real bad shape.

I got some H.

It's way cheaper
and it's way better.

♪ ♪

Do you,
Arthur Sackler, solemnly swear

the testimony you give
for this Finnix Committee

will be the whole truth

and nothing but the truth,
so help you God?

I do.

The Sackler empire
is completely integrated.

It can devise a new drug
in its development enterprise,

have the drug
clinically tested,

then secure favorable reports
on it from various hospitals

where they have connections.

Your company makes false
and grandiose claims

about products you advertise

using quotes from doctors

that are, in actuality,
on your own payroll,

hidden through a series
of shell companies

you or your family members
secretly control.

Senator, my company

is an ethical pharmaceutical
advertising organization

working in prescription dr*gs

and materials produced
primarily for physicians.

We continue to operate
on the basis

that good, ethical
pharmaceutical advertising

plays a positive role

in advancing the health
of the community.

♪ ♪

I have a very, very high regard
for Purdue Pharma

and its employees
from my district

who work very, very hard
to produce quality products.

Now, the drug OxyContin
has become vital

to people suffering with
chronic and debilitating pain.

Now, let me ask Dr. Van Zee,
and I quote here,

"Conventional wisdom says that
if a drug is widely available,

it will become widely abused."

Is there any more to this
than that?

Senator Dodd,
that is an old medical adage.

One of
those Appalachian things?

Uh, no,
it's a national adage.

I would say by extension,
if you have an abuseable drug

that is widely available,
it will be widely abused.

In the 25 years
I have practiced medicine

in my small Appalachian town,

there has never been anything
to compare

to the epidemic of drug abuse
and addiction like OxyContin.

♪ ♪

If you see this girl,

just give a call
at that number below.

There's a reward.

Excuse me.

I'm trying to find my daughter,
Betsy Mallum.

Have you seen her?

♪ ♪

Please, tell her we're not mad,
we're just real worried.

I know where she is.

♪ ♪

♪ ♪

♪ ♪

Betsy.

Betsy.

Betsy, Betsy.
It's Mama.

Hon.
Mom.

I'm here, I'm here.
Betsy?

I want to go home.
Okay.

I never hated myself more

than when I agreed
to get arrest reports.

Some of my former patients.

Some of them I had delivered
as babies.

The shame
and the guilt I felt‐‐

Okay, you know what,

I'm gonna stop you
right there, Sam.

Sam, can you tell me
how many babies you delivered

over the years?

214.

214, wow.
Yep, 214.

In those days, you know,
you had to do it all.

Well,
that must've been wonderful.

Yeah.
Right?

Helping all those parents?
All the pain and anxiety?

Yeah.

Delivering their children.

And unlike most city doctors,

you get to watch them grow up.

Yep.
Yep.

Uh‐huh.

You've made some mistakes.

But you've done
some wonderful things, too.

Next session,
I want you to journal about,

uh, what it feels like
to deliver a baby.

Yeah?

And I want you to focus on the
positive things that you did.

We already know
about all your regrets.

I want to hear
about these births.

Samuel?

Yeah.

♪ ♪

The Sackler Center
for Arts Education

is one of the most
satisfying things

that our family
has been part of.

I want to thank my brother,
Raymond,

for being here tonight
to celebrate the great work

and the next generation
of artists.

What's the status
with the children's OxyContin?

Still in development,
but coming along nicely.

Hey, cuz.

Hey, congratulations
on another great year.

Sales keep going up.

Yes, David, it's going well.

So a few of us were thinking
of buying a ski resort company.

They've got amazing slopes
all over the country.

And I know how much
you love to ski, so‐‐

Excuse me.

I‐‐I‐‐I have to take this, but
yes, yes, I'm very interested.

Curtis?
Tell me.

It's bad, Dr. Richards.

My intel is from
inside the FDA

and they plan on reviewing

the wording
of the OxyContin label.

And it's very likely
they're gonna change it.

f*ck.
Oh, my God.

But why would the FDA

change our warning label
out of the blue?

Oh, please.
That's enough.

Your son is the only one

unaware that his drug
is a national punching bag.

God damn it, Curtis,
we brought you in from the FDA

to make sure things like this
didn't happen.

That's right.
Look, look, Rich.

Dr. Richard.

The press w*r
that woman at the DEA started

has had some effect.

There's just too much
bad publicity about the drug

and the FDA
needs to take action.

Curtis, are there
any concessions we can offer

that will prevent them
from changing the label?

Here's an idea.

What if we tell them
we'll pull the 160?

We have invested‐‐
We can try.

But I think our best bet
is to see if we can work out

new language with them.

L‐like the first time.

The wording may
not be as beneficial,

but hopefully
will minimize the damage.

If we have to give up
"addiction is rare,"

sales will plummet.

Let's send a delegation
to meet with the FDA.

I'm sure there are ways
we can aid them

in rewriting this new label.

The good news is
the misbranding case

is open and shut.

Everything we've compiled shows

that Purdue systemically
oversold the benefits

and trivialized
the risks of OxyContin.

But it doesn't put us
over the finish line

'cause we still haven't
charged individuals at the top,

and putting executives
into jail

is truly the most effective way

of deterring companies
from this type of behavior.

You can fine a company,
but you can't put it in jail.

Because a company
feels no pain.

I want Purdue
to feel some pain,

so let's make a final push.

Let's shake every tree.

Financial records, call notes,

applications,
marketing materials.

See if we can find
some hard evidence

against top executives.

Let's go out there and do it.
All right.

Morning, Ms. Moles.

It's Randy Ramseyer, U.S.
Attorney's Office Abingdon.

We talked about four years ago.

Sorry, I'm late for work.

Oh, should we talk
at the FDA instead?

I had a couple questions
about Curtis Wright,

specifically the OxyContin
label that he approved.

You know, actually,

we got a bunch
of unanswered questions

and we're not afraid
to open up our investigation

to individuals
beyond Curtis Wright.

You're referring to me?

I'm referring to anybody
at the FDA

who played a part in that
approval process, ma'am.

We got Purdue sales reps
using that warning label

to sell OxyContin
as basically nonaddictive.

And the guy that approved it
went from working at the FDA

to working for Purdue Pharma
for $379,000 a year.

I mean, it looks to me like

he sold out the health
of the nation.

And I just need to know

if he was promised a job
for that approval.

I have no idea.
I wasn't part of that process.

Now, I have to go to work.

A few years ago,
I had cancer.

And I'm fine now,
but at the time,

when I was in the hospital,

well, I very easily could've
become addicted to Oxy.

And it wouldn't have been
the disease that k*lled me,

it would've been my medication.

I got lucky.

I just want you to think
of all the kids

that are not getting lucky.

My, uh,
neighbor's kid got hooked.

Please just tell me what you
know about that warning label.

We both know there's
something rotten going on here.

I heard that

about a year
before the drug was approved,

Purdue rented out a hotel suite
in Rockville

down the road from the FDA,

where they meet
with Curtis Wright in private.

Supposedly, Curtis
and the Purdue executives

spent three days together,

working out the wording
of the medical review,

co‐writing the summary
of safety and efficacy.

An FDA employee

literally helped Purdue
write their own review.

Did Curtis Wright pen
the OxyContin warning label

for Purdue?
Did‐‐

did he actually write it?

There is more than one person
that believes that he did.

Do you know who from Purdue
was in that hotel room

with Curtis Wright?
Was it‐‐

was it senior‐level executives?

I'm sorry,
I honestly don't know.

Because if I did,
I would tell you.

Got to go to work.

Have you told any of this
to anybody else before?

No.

Why not?

'Cause it wouldn't matter
if I did.

♪ ♪

There's these flyers
all over town.

A big meeting tomorrow night.

About OxyContin, hmm?
I think we should go.

I don't want people
to see me there.

Then they'll know, Mom.
No.

I don't care what they know.

There might be
some helpful information.

We got to find a way
to get you better, honey.

The real you is still in there.
I just know it.

I don't know
where she's gone.

Well, we got to
find her again, then.

Well?

Okay, Mama.
Okay.

What you got there?

It's for a meeting
about all these dr*gs.

I know what you're gonna say,

but I don't care
if people know our business.

There's nothing that you
can say to keep me from going.

I‐‐I don't want to stop you
from doing anything, Diane.

You do whatever you need to do.

♪ ♪

My name
is Sister Beth Davies.

I want to thank you all
for coming down here.

It's not easy,
as so many of you

are carrying the heavy burden
of a loved one

suffering from this
chronic disease of addiction.

With that said,
I want to introduce you

to the most dedicated
recovery doctor in Appalachia,

Dr. Art Van Zee.

♪ ♪

Thank you, Sister Beth.

I know it wasn't easy
for you all to come tonight,

as this addiction
has shame attached to it,

but I hope you all see by this
turnout that you're not alone.

This drug doesn't care
if you're rich or poor,

man or woman,
white, Black, or brown.

Once you've taken too much,
it changes your brain chemistry

so you're in so much pain
without it,

you think you're going to die.

I brought you here tonight
to sign a petition

to ask the FDA to
pull OxyContin from the market

till it can be reformulated
to be resistant to abuse.

It's been done before.

So, after the meeting,
we have tables set up over here

for you
all to sign the petition

so we can try to bring an end
to this nightmare.

♪ ♪

I couldn't believe
these results

when I first saw them either,
sir.

I mean‐‐and this is rock solid.

See, the autopsy report proves
overdoses can occur in people

who are taking the drug
exactly as prescribed.

It's not just drug abusers
who are dying.

It's everyday
pain patients, too.

You can't just send out
a press release

without discussing this
with the FDA first.

Okay, but, sir, the press w*r
I orchestrated last year

is what got the FDA
to take action

against Purdue's warning label.

But if you act without
discussing this with us‐‐

Sir,
with all due respect,

the public needs to have access
to this data ASAP

for their own personal safety.

When do you plan on sharing
your report with the FDA?

I've already set up a meeting
next week

and I've requested Purdue
to be there.

Are you giving Purdue the
report ahead of the meeting?

No.

So you're jamming them
into a fast rebuttal

without being able
to review the report first?

Maybe.

You know you're just going
to piss everyone off.

My goal is to stop
a dangerous drug

from being diverted and abused.

I'm not looking
to make friends.

Excuse me.

Uh, if you don't mind.

If you soak that
in some Epsom salts

and cut the nails
straight across,

that should help that.

Thank you, sir.
I'll‐‐I'll do that.

Sure.
Give it a try.

When you're holding a newborn

and it lets out
the first cry of its life,

your heart can't help
but jump a little.

That's a language
that's as old as those hills.

♪ ♪

Bravo.

You know, I'd like
to have you journal next

about, uh, three other people
that you have helped.

Your three proudest moments
as a doctor.

All right.

You know, it sounds crazy,
maybe,

but, uh...

I think a lot about

being a doctor again.

You've never not been
a doctor, Sam,

it's who you will always be.

It's just you need to take
the time to heal yourself.

Right?
It's what I had to do.

I nearly k*lled a woman and
her young son drunk driving.

Sam, those people walked away
from the wreck that I caused,

but I couldn't walk away
for a long time.

It took me a long time
to forgive myself.

Yeah. I feel like what I did
isn't even forgivable.

I don't‐‐
No. Look.

A way to make amends...

for the pain that we have
caused others is to give back.

And when you're ready,

the greatest thing you can do
is heal others.

So, yes,

begin the process of getting
your medical license back.

Paperwork looks good.

Soon as you've completed
the term of your probation,

we'll get the ball rolling.

Good, good.

It's going to take at least
a year, but it'll be worth it.

There is only one issue I see.

They won't reinstate
your medical license

if you're on methadone.

There's no medical board
in America that would allow it.

Any chance that you'd be done
in a year?

I don't know, to be honest.
Maybe, maybe not.

Well, then you shouldn't
turn in this application

till you're off it.

It's the only thing
keeping me clean.

Well, technically,
you're not.

It's a narcotic.

It's protective.

It protects the way
insulin protects diabetics.

It's banned by physician
plans across the board.

These maintenance medications,
they affect cognition.

That's bullshit.

My thinking hasn't been
this clear in years.

Sir, you can appeal
the decision,

but we've never had
an appeal like this go through.

Good day.

♪ ♪

Dr. Cutler, if your patients
report breakthrough pain,

all you have to do
is double their dose

to get them
a full night's sleep.

♪ ♪

Isn't, um, breakthrough pain

just a way for you
to sell more Oxy?

Um, not necessarily.

Um, if you look
in the pamphlet‐‐

I heard more milligrams
you write,

bigger your bonus check.

So isn't all this just bullshit
so you can make more money?

I haven't heard of half
the terms in this paper.

Okay, tell you what,
let's take a quick break,

uh, grab some coffee,
be back in ten.

♪ ♪

Come on, Miles.

♪ ♪

You've seemed unhappy
for a while now.

Yeah, I've been going through
a tough time, you know?

Some‐‐some personal stuff.

Is it girl trouble?
Yeah, yeah.

I'm seeing this chick who's
driving my head in circles.

All right.
Look.

♪ ♪

You have got to get your head
back in the game.

You are one of
my best sellers, man.

You're family here.

So whatever you need,
you let me know.

Thanks, Barn.
I appreciate that.

♪ ♪

Something interesting
came up.

I've been asked to be
the regional manager

in Louisiana
out of New Orleans.

Wow, holy sh*t.
That's‐‐

congratulations.
That's great.

New Orleans is a great city.
Thanks.

Um...

and I was thinking
maybe you could come with me?

Uh, how would that work?

I mean, like, as what?

My‐‐my employee.

And, um,

and my boyfriend.

Are you‐‐are you joking?

No.

It's tough being a girl.

You know,
you f*ck a guy enough

and then you start
to get attached.

Ugh, it's the worst.

Is that, um‐‐
is that you being sweet?

Fine.

I have feelings for you.

Okay?
You happy now?

I have feelings for you, too.

Wow, I had no idea.

Come to New Orleans.

I'll be the regional manager,

you'll be my star employee.

We can eat beignets,

then you can eat my p*ssy.

Sounds kind of magical,
doesn't it?

Does sound kind of magical.

Well, you've seemed
a little b*rned out.

Change is exactly
what you need.

We'll make a fortune there.

It's a booming market.

Ch‐ch, ch‐ch, ch‐ch.

Money, money, money, money.

♪ ♪

♪ ♪

I'm sorry about the wait.
I'm one of the only doctors

that treats opioid use disorder
in the region.

I'm just grateful
you could see me.

Sister Beth
speaks real highly of you.

And I her.

I believe medication‐assisted
treatment combined with therapy

is the best path to recovery.

I couldn't do this without her.

It's extraordinary
what this drug does.

I still can't get it
out of my mind.

That's because your brain
has been rewired.

And it can take two years for
the frontal lobe to fully heal.

As I understood it,
it wouldn't take that long.

Two years?

I'm afraid that's what
the most recent studies show.

And that's after you stop.

There's a new drug
called Suboxone

that's similar to methadone,
but it's easier to take

because you don't have to go
to a clinic every day.

I can write a prescription.

Is it classified
as a narcotic?

It is, but you might be more
successful in weaning off it.

It can't be done quickly
and the truth is,

some patients will need
to take it

the rest of their lives.

And you don't know that
I'll ever really be off of it?

I don't.

But we can certainly try.

♪ ♪

Okay.

♪ ♪

Let's give it a sh*t.

Newt Gingrich has
expressed interest

in running for president.

Certainly a very
interesting guy.

Rudy Giuliani, in fact,

when we look
at the "USA Today"/CNN poll

comes out actually first.

Giuliani would be
the strongest candidate

against Hillary Clinton
because he can‐‐

Bedtime, honey. I want you
to get some sleep tonight.

Yeah, I'll be up in
about 30 minutes.

♪ ♪

Look at all
these lovely white people.

Mm.

These the Sacklers?
Mm‐hmm.

Well, enough of the Sacklers
for tonight.

Come to bed.

Hey.

Come here.

I'm sorry this case
has been so time‐consuming.

How about you come home
for dinner tomorrow

and play with the kids?

I can't tomorrow.

An opioid abuse doctor is
giving a public presentation.

I need to go it.

Okay, well.

Can‐‐can I go?

Hmm?

Tomorrow, you want to come?

Yeah. I would like
to understand a bit more.

Then you can take me to dinner
afterwards for date night.

All right. You got a deal.

All right.

Five years ago,
when I came to this very gym,

I was naive.

I believed that once Purdue
saw our 10,000 signatures,

they'd reformulate the drug.

But they not only refused,

they pushed even harder
on their marketing.

When I testified in front
of Congress about OxyContin,

I was so nervous,

but I felt I had to personally
warn our government

about what was happening.

And, sadly, they didn't
seem to care, either.

Neither did
the Purdue executives

that were also testifying.

Some senators pushed back
against me, others were bored.

I have to make
a quick phone call.

That's when I knew
this crisis wasn't going

to end anytime soon.
That we all‐‐

Hey, it's me.
When did we last look

at Purdue's
congressional testimony?

That was one of the first
things we did four years ago.

It was all the usual
talking points.

They had no idea of abuse,
all that BS.

Well,
now that we spent years

going through their
internal documents,

maybe it's possible to prove
they were lying to Congress.

Well, Mr. McClosky,

who was the U.S. Attorney
in Maine at the time,

told us when he started
to see problems,

at the very earliest was
the beginning was 2000.

It was in early April
of 2000 that Purdue was‐‐

We didn't learn of the abuse
until March of 2000.

So we have Purdue's
top three executives

all proclaiming to Congress
under oath

that they didn't know the drug
was being abused until 2000,

when US Attorney from Maine,
Jay McClosky‐‐

Who now works for Purdue.

Informs them
that it's being abused.

Okay, got it, so the year
2000 is their official marker?

Yeah.
So what?

Oh, my good God.

Is Rick Mountcastle smiling?
This ought to be good.

So we got numerous
newspaper articles

and emails sent
to these exact guys

that shows that
they were informed of abuse

as early as 1997.

Contradicting
their congressional testimony.

♪ ♪

We can charge Purdue's
top three executives

with lying to Congress
and conspiracy to defraud.

♪ ♪

Okay.

Let's indict these assholes.

My gut is they're going
to be so scared shitless

of going to prison‐‐

They just might flip
on the Sacklers.

Think they just might.

Well, congratulations, boys.
You just made your case.

♪ ♪

I asked you here because
there have been rampant tales

of abuse and diversion
across the country.

The FDA feels
it's time to intervene.

We understand there's been
some diversion,

but changing our warning label
is overly punitive.

It's not the drug
that's the problem,

it's‐‐it's the addicts
who are abusing it.

And, Cynthia, it is not fair
to single us out on this issue.

Endo, Jansen, Teva
are all selling opioids.

You're not changing
their warning labels.

That's because their sales
reps aren't telling doctors

to prescribe
a dangerous narcotic

for wisdom teeth surgery,
or headaches.

Perhaps there are other
actions to be taken

besides something as drastic
as a label change.

There are concessions
we're willing to make.

Like what?

For starters, we'll be taking
the 160 off the market.

I think
you absolutely should.

Right.

But that won't shift
our position

on the warning label.
It will be changed.

We're seriously considering

giving you
the black box warning.

They what?

They might add a black box
warning to the new label.

That's the worst thing
that could happen

except for a recall.

I know, I know, Dad.
Okay? I know.

♪ ♪

Well, you finally did it.

You flew too close to the sun.

Yeah.
I bet you're happy now.

Excuse me?

Oh,
it must've been difficult,

see your son more successful
than you ever were.

You only had this company
because of Arthur.

Everything anyone has in this
family is because of Arthur.

It all came from his brain.

And all you could ever do
is sell Betadine.

Then I finally did something.
Me.

And it was bigger than anything
you or Arthur ever dreamed of.

Oh, but you seem to be
missing a key difference

between you and Arthur.

What's that?

He never would've gotten
a black box warning.

♪ ♪

Dr. Sackler,

the "Journal of the
American Medical Association"

thought you misstated the facts

by overstating
the effectiveness of the drug

and understating
the side effects.

You complied with their request

by making edits
on the advertisement

which then got the ad approved,

but then you went on
and printed the original ad

with the misstated facts
in other journals.

Senator, the
"Annals of Internal Medicine,"

with an eminent board,
accepted these opinions.

"The Journal of the American
Medical Association,"

with an equally prominent
board, did not accept them.

Therefore, what we were
dealing with here

was a difference of opinion,
not a misstatement of facts.

♪ ♪

Perhaps...

this could potentially create

an opportunity for us.

Why not ask
if the label could say

the drug can be used

for an extended period
of time?

You really think the FDA
would allow that?

Come on.

I'm worried that they're going
to pull all the language

about the drug
being less addictive.

Yeah, I am too.

Fighting to keep
"less addictive" is crucial,

but we need to give
a little to do it.

Right now, the label says
"addiction is rare,"

so maybe we offer, "addiction
is reported to be rare."

That's not bad.

We need to be able to keep
prescribing for moderate pain.

What about
"extended period of time"?

That could turn
this whole fiasco

into a financial win because

patients will be on it
for longer periods.

Perhaps indefinitely.
Mm.

I just think it'll be
a bridge too far for the FDA.

But it's possible
they won't be aware

of exactly
what they'd be giving us.

And if they're going to slap us
with a black box warning,

they should at least
give us something.

♪ ♪

Hello?

Hey, Bets,
this is Sam Finnix.

I thought you were dead.

No, no.
I'm still fighting this thing.

Me, too.

Bets...

I'm so sorry I ever
prescribed that drug for you.

I never would've done it
if I thought it would hurt you.

I promise you I didn't know.

Of course you didn't.

That company's been lying
to everybody.

Listen, I'm going to tell
you why I called you.

I've been seeing this doctor
in a clinic in Jonesville.

He's‐‐he's started me on
this new drug

that, uh, has helped me.

I mean, my cravings are
way, way down.

Well, what is it?

It's called Suboxone.

It's like methadone,
which also helped,

but this, for me,
is way, way better.

I've heard about them.
And they really work?

Well, it does for me.
It's just, you know,

it's damn hard to get off
this junk without medicine.

Yeah.

It's been impossible.

And I've been really trying.

I know you have, Betsy.

And listen to this.

I want to drive you
to this clinic.

It's about an hour
from your place.

I will drive you there
and back every week.

What do you think?

Um.

♪ ♪

Let me think about it.

Hey.

I'm just so damn sorry, Betsy.

♪ ♪

Hey, Doc?
Yeah?

♪ ♪

I love you.

♪ ♪

I love you, too.

♪ ♪

They're narcotics.

You're just trading in one drug
for another one.

They're dangerous and addictive
in their own way.

Nothing has worked
for my girl.

We brought her here and people
sold her dr*gs in the bathroom.

And that was a grotesque
aberration of our trust.

But if you take
these so‐called medications,

you're not placing your trust
in a higher power.

You're just putting it
into more dr*gs.

So they don't work?

No, they don't.
I'm sorry.

♪ ♪

Mom.

I don't believe
in a higher power.

I only believe in heroin.

Bets, don't say that!

Now, you heard the man.

These medications could be
just as dangerous

as the one that got you hooked
in the first place.

I've got to try something.

I miss who I was.

This is‐‐it's not me.

All right?

It never has been.

I heard you that night,

when you told me
you liked girls.

And I've been k*lling myself
for years I didn't say nothing.

I feel like this all happened

because I stayed quiet
that night.

It didn't.

I promise you.

I think maybe it did.

Even just a little.

And I want you to know
that when you're better,

I want you
to have a girlfriend.

And I'll cook you both dinner
and breakfast

and anything you two want.

That sounds real nice.

I got to get better first.

I want to do this.

Okay, Betsy.
I don't‐‐

Okay, we'll take you to
the clinic and give it a try.

♪ ♪

Here he comes.

♪ ♪

Sir.
Thank you.

Mm‐hmm.
Okay. Thanks.

♪ ♪

As we suspected...

the FDA ordered a label change

and that label will have
a black box warning on it.

We're so f*cked.

Not necessarily.

There are a few surprises here.

It says on page three

the label is approved to say,

"addiction is reported
to be rare."

Really?
That's huge.

And we're still allowed to
keep selling for moderate pain.

Thank God.

It would've ended us if we
were restricted to severe pain.

Oh, 100%.

There's one more
big surprise.

The FDA has agreed
to let us say...

the drug can be used
for an extended period of time.

You gotta be kidding.
No, I'm not.

What?

We can now tell doctors

OxyContin is safe to use
indefinitely.

Well done, son.
Well done.

How the f*ck
did we pull this off?

Yeah, when we discussed it
with the FDA,

they seemed open to it.

I mean, Dr. Richard was right.

I don't think
they fully understood

the true ramifications of,

you know, what this wording
would do.

Oh, my God, I can't believe
how lucky we got.

It's luck
with a little bit of a push.

Marketing has
already run numbers

and with this new language,

they think we can triple
our sales in two years.

♪ ♪

Look, with this new language,

it's not even
really a black box warning,

it's more like black box lite,

and that is exactly

what you need to be telling
your doctors.

I don't understand that.
What?

A black box label indicates
the drug is much more dangerous

than we've been telling doctors
for years.

Absolutely not.

The new label itself says
that it can be used

for extended periods of time.

How dangerous can it be?

And as far as the black box
itself goes,

if it comes up,
you tell your doctors

that it is an "exercise
in graphic design."

Yeah.

I may be mistaken here,
but this new label

gives us leeway
to be even more aggressive now.

f*ck yeah it does!

The bosses think
that we can double,

maybe triple sales
with this new wording.

♪ ♪

What are you doing?

Hey, I, uh, came to find you.

I'm not feeling too good.

I was going to ask you
if I can take off.

That thing we talked
about earlier?

Yeah, yeah.

Okay.
Thanks.

Billy?
Yeah.

Don't let a piece of ass
f*ck up a career

that's about to get
a lot more lucrative.

Thank you.
I won't.

Okay.

♪ ♪

This is an exhaustive
DEA autopsy study

that demonstrates
the dangers of OxyContin

when taken as prescribed.

I've asked Deborah Leiderman,

the FDA's controlled
substances director,

to join us since we didn't get
the report ahead of time.

I thought her expertise
would be necessary.

Of course.
Thank you.

DEA pharmacologist
David Govin

will now take you
through the data

which was derived
from 1,304 autopsies.

To start off,

we uncovered that 98% of our
verified OxyContin user deaths

were not drug abusers

who crushed and then snorted
or injected the drug.

They had simply swallowed it,
as approved by the FDA.

We know this to be true because
we had photographs of the pills

intact in their stomachs
at the time of autopsy.

It's not possible
to determine

OxyContin‐verified deaths

since the toxicology reports
usually do not list

exact levels of the other dr*gs
at the time of death.

The DEA marked a death
as OxyContin‐verified

only if the level of OxyContin
in the bloodstream

was high enough to be deadly
on its own.

Assuming the measurements
were accurate,

how do we know that?

Why would they be inaccurate?

The data came directly
from the autopsy reports.

And we only counted
drug combinations

with tranquilizers
and anti‐depressants,

dr*gs commonly prescribed
with OxyContin

to reduce anxiety
amongst pain patients.

In all likelihood,

we undercounted the number
of OxyContin overdoses

out of an abundance of caution
for accuracy.

Okay, okay.
First of all,

Purdue had not been given
access to this data in advance,

making it impossible for us
to uncover errors

made by
these medical examiners.

And at first glance,
the science appears to me

as rudimentary
and overly simplistic.

If we had more time to respond,

we could make crystal clear
how far off they are.

Absolutely.

This study is exhaustive...

thorough...conservative.

Deborah?

♪ ♪

I tend to agree
with Purdue on this.

These autopsy reports
are inconclusive at this point.

Or at least not as definitive
as the DEA has presented them.

And our own data does not
underscore the DEA's analysis,

which to be honest,
I also find ambiguous.

Based on this study alone,

I don't find
any cause for panic.

Great, great.

So you're just going
to ignore the results?

I'm not ignoring them.
I'm disagreeing with them.

The FDA changed
the warning label a year ago

and gave it
a black box warning,

which was a harsh rebuke.
And appropriate.

Yes.

But on this autopsy issue,
I side with Purdue.

And we completely agree.
Thank you, Doctor.

Cynthia. Thank you.
Thank you, Cynthia.

♪ ♪

Can't f*cking believe it.

Oh, I just‐‐I can't believe it.

Do you think that she was
on the take?

That she intentionally
sabotaged our investigation?

Well, maybe she just
doesn't like you.

Are you kidding?
No, I'm not.

You shouldn't have gone
to the press first.

You should've given them all
the report before the meeting.

Yeah, and then they would've
coordinated a response.

Bridget, Bridget.

Leiderman and McCormick
don't need to be on the take

to side with Purdue.

You don't have to look
any further

than Curtis Wright's new salary

to know why the FDA
almost always sides with them.

♪ ♪

They're just being friendly
to a potential future employer.

♪ ♪

That's all this is, isn't it?

♪ ♪

Hey.

I thought‐‐
I thought we'd celebrate.

I lost.

The FDA sided with Purdue.

Are you serious?

They said our data wasn't
conclusive, which it was.

The FDA just blew their sh*t
to end the opioid crisis.

Oh, my God, oh, my God,
oh, my God, oh, my God,

I'm so sorry.
Oh, honey.

Come here.
Come on, let's sit down.

Look, this has been‐‐

this has been on my mind
for a long time.

And this just confirms
what I've been thinking.

Your job's
destroying your life.

And I don't think that
they even appreciate it.

I know that this is hard,

but have you thought maybe
about doing something else?

In an unrelated field.

Just get away
from these people.

Okay, uh,
this isn't destroying my life.

It is my life.
I love what I do.

We can't go on together
living like this.

♪ ♪

My goal in life is...

not just to be your wife.

♪ ♪

You know what, I know
that your work is important.

I know that what you do
is important.

I just want to be important
to you as well.

We got married
kind of late in life.

And it was supposed
to make us happy.

♪ ♪

I don't think
either of us is happy.

♪ ♪

Hi, Alice.

Hi, John.

This is Rick Mountcastle
and Randy Ramseyer.

They've been running point
on this case.

This is Alice Fisher,
head of the criminal division.

A pleasure. I hear you've
been doing great work.

Nice to meet you.
So, I'm curious.

If anyone hires Rudy Giuliani,
Howard Shapiro,

and Mary Jo White,

do they get a special audience
with the DOJ

to plead their case

or is that just billionaires
with their names on museums?

That's cute, John.

♪ ♪

No, it is total bullshit

that we're even
taking this meeting.

And I hear Giuliani is lobbying
everyone in the building

not to charge these guys
with felonies.

Okay, the former mayor
does not influence the DOJ.

Let's just hear what they have
to say and go from there.

♪ ♪

We can provide hundreds
of internal emails

to show how surprised
these executives were

if there had been abuse
prior to the year 2000.

Yes, there had been
random incidences,

but all narcotic
prescription dr*gs

get abused to a certain extent.
And there were no warning signs

that OxyContin
had reached unusual levels.

And it would be highly
inappropriate and overzealous

to charge individual executives
with felonies

for the actions
of a few rogue sales reps.

♪ ♪

Well, it's been
about a few hours.

I'd hate to get
too overzealous.

Why don't we take
a quick break?

♪ ♪

Come to my office.

♪ ♪

They have a legitimate defense.

No.
No, they don't.

Those are just their standard
talking points‐‐it's bullshit.

That doesn't mean
they won't sway a jury.

Look, these guys dropped
this drug in my community,

they addicted
thousands of people,

and then they walked away
with billions.

They will either plead guilty

or they'll be convicted
by a jury.

I've got a great case here.

It's a case
that still has risks.

Come in.

♪ ♪

I don't think you're gonna
find main Justice

will support felony charges
against these executives.

Well, it's not your call.

And I don't report to you,
so I'll make my own decisions.

I know it's not my call.

And you're correct.

I have no decision‐making power
over charging.

Sorry, are you saying that

this is coming from
the deputy attorney general?

I don't believe you will
find support at main Justice

for felony charges
against these individuals.

♪ ♪

Excuse me,
ladies and gentlemen,

if I could have your attention.

Thank you so much
for your lengthy presentation.

After careful consideration,

I have decided to indict
Michael Friedman,

Paul Goldenheim, and
Howard Udell on felony charges.

Have a great day.

♪ ♪

So how is this going to work
if they won't let us indict?

♪ ♪

I have no idea.

Hello?

Hey, Grace, it's Betsy.

Hey.
How are you doing?

Oh, I'm‐‐I'm good.

I think I'm finally getting
a handle on all this mess.

Well, that's great.

How's Eureka Springs?
Oh, you'd love it.

It's um‐‐

it's like Oz
for country queers.

I'd‐‐I'd love
to come by sometime.

Oh, yeah, you should.

Ah, it'd be great to see you.

Hey, uh...

do you think that‐‐
maybe that when I'm better...

we could, uh...

try again?

Start over?

Um...

I don't think
that would work.

But, uh,
I'd sure love to be friends.

Yeah.
I‐‐

I understand.

Be real nice to be friends.

♪ ♪

Uh...

take care, Grace.

You too, Bets.

♪ ♪

It's been a while
since I've seen you.

Yeah, well, I'm starting
Suboxone tomorrow.

So...give me one hell
of a sendoff.

You got it.

♪ ♪

♪ ♪

♪ ♪

♪ ♪

I'm so sorry, Diane.
I'm so sorry.

♪ ♪

♪ ♪

♪ ♪

♪ ♪

♪ ♪

♪ ♪

Hello?

Hey, Diane, it's Sam Finnix.
I'm just waiting here.

You and Betsy
are still coming, right?

I'm sorry,
but Betsy's in heaven now.

My girl is finally out
of her pain.

That‐‐

♪ ♪

New medicines
are changing the world.

They can cure diseases
once thought incurable.

They can bring joy...

where there was
once only pain.

It has truly been an honor to
testify before this committee

on a subject that means
so much to me and my family.

And I'd like to leave you with
one very important thought.

♪ ♪

No laws or regulations

will ever be able
to stop the miracle

that is modern pharmaceuticals.

♪ ♪

Thank you.

♪ ♪

The record speaks for itself.

♪ ♪