Dopesick (2021) s01e07 Episode Script
Black Box Warning
1
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 shot.
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 higherâups? We start charging individuals with felonies, we need the kill shot.
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 drugs 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 feltââ 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, 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.
Uhâhuh.
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, soââ Excuse me.
IââIââI 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.
Fuck.
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 war 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 investedââ We can try.
But I think our best bet is to see if we can work out new language with them.
Lâlike 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 killed 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, coâwriting 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? Didââ 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 itââ was it seniorâlevel 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 drugs.
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.
IââI 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 meanââand 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 war 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 usââ 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'llââI'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 killed 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'tââ 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 pamphletââ 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? Someââsome 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 shit.
That'sââ 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? Myââmy employee.
And, um, and my boyfriend.
Are youââare you joking? No.
It's tough being a girl.
You know, you fuck a guy enough and then you start to get attached.
Ugh, it's the worst.
Is that, umââ 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 pussy.
Sounds kind of magical, doesn't it? Does sound kind of magical.
Well, you've seemed a little burned out.
Change is exactly what you need.
We'll make a fortune there.
It's a booming market.
Châch, châch, châch.
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 medicationâassisted 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 shot.
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 canââ 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? Mmâhmm.
Well, enough of the Sacklers for tonight.
Come to bed.
Hey.
Come here.
I'm sorry this case has been so timeâconsuming.
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.
Canââcan 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 allââ 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 wasââ 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 McCloskyââ 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 prisonââ 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'sââit'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'sââhe'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 drugs in the bathroom.
And that was a grotesque aberration of our trust.
But if you take these soâcalled medications, you're not placing your trust in a higher power.
You're just putting it into more drugs.
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 isââit'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 killing 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'tââ Okay, we'll take you to the clinic and give it a try.
Here he comes.
Sir.
Thank you.
Mmâhmm.
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 fucked.
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 fuck 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.
Fuck 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 fuck 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 OxyContinâverified deaths since the toxicology reports usually do not list exact levels of the other drugs at the time of death.
The DEA marked a death as OxyContinâverified 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 antiâdepressants, drugs 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 thoroughconservative.
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 fucking believe it.
Oh, I justââI 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 thoughtââ 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 shot 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 beenââ 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 drugs 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 pointsââit'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 decisionâmaking 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'mââI'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 umââ it's like Oz for country queers.
I'dââI'd love to come by sometime.
Oh, yeah, you should.
Ah, it'd be great to see you.
Hey, uh do you think thatââ 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.
Iââ 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.
Sogive 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.
Thatââ 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.
Have you thought about methadone? It's worth a shot.
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 higherâups? We start charging individuals with felonies, we need the kill shot.
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 drugs 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 feltââ 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, 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.
Uhâhuh.
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, soââ Excuse me.
IââIââI 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.
Fuck.
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 war 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 investedââ We can try.
But I think our best bet is to see if we can work out new language with them.
Lâlike 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 killed 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, coâwriting 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? Didââ 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 itââ was it seniorâlevel 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 drugs.
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.
IââI 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 meanââand 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 war 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 usââ 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'llââI'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 killed 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'tââ 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 pamphletââ 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? Someââsome 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 shit.
That'sââ 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? Myââmy employee.
And, um, and my boyfriend.
Are youââare you joking? No.
It's tough being a girl.
You know, you fuck a guy enough and then you start to get attached.
Ugh, it's the worst.
Is that, umââ 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 pussy.
Sounds kind of magical, doesn't it? Does sound kind of magical.
Well, you've seemed a little burned out.
Change is exactly what you need.
We'll make a fortune there.
It's a booming market.
Châch, châch, châch.
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 medicationâassisted 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 shot.
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 canââ 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? Mmâhmm.
Well, enough of the Sacklers for tonight.
Come to bed.
Hey.
Come here.
I'm sorry this case has been so timeâconsuming.
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.
Canââcan 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 allââ 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 wasââ 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 McCloskyââ 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 prisonââ 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'sââit'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'sââhe'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 drugs in the bathroom.
And that was a grotesque aberration of our trust.
But if you take these soâcalled medications, you're not placing your trust in a higher power.
You're just putting it into more drugs.
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 isââit'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 killing 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'tââ Okay, we'll take you to the clinic and give it a try.
Here he comes.
Sir.
Thank you.
Mmâhmm.
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 fucked.
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 fuck 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.
Fuck 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 fuck 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 OxyContinâverified deaths since the toxicology reports usually do not list exact levels of the other drugs at the time of death.
The DEA marked a death as OxyContinâverified 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 antiâdepressants, drugs 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 thoroughconservative.
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 fucking believe it.
Oh, I justââI 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 thoughtââ 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 shot 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 beenââ 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 drugs 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 pointsââit'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 decisionâmaking 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'mââI'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 umââ it's like Oz for country queers.
I'dââI'd love to come by sometime.
Oh, yeah, you should.
Ah, it'd be great to see you.
Hey, uh do you think thatââ 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.
Iââ 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.
Sogive 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.
Thatââ 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.