150 Milligrams (2016) - full transcript

Irène Frachon, a doctor who lives in the Breton town of Brest, dares to stand up to the French health and pharmaceutical industry, helping to uncover the media scandal surrounding the commercialization of a controversial medicine whose side effects have caused the death of hundreds of people.

250, yes please.

Then aim for 350.

Heparin injection please.

There's a bit of bleeding there.

Start ECC bypass.

OK, ECC bypass.

- Say cheese!
- Stop acting the goat for once!

Good... are we ready?

- Ready for cardioplegia?
- Yes.

- Go ahead.
- Starting.

Here are the syringes, Jean-Yves.



- 500.
- 500, right.

Aorta clamp.

Fix it.

Done.

Cardioplegia.

OK... heart to stop.

Heart stopped.

- Fine.
- See Irene, the heart is stopping.

Gently... gently...

It'll take a few more seconds.

I'm at 150.

Clamp.

- OK, it's clamped.
- Stopped completely?

Yes, it's good.



It's good.

Lean over here, Irene.

Look.

The heart valve and the sub-valvular device
have thickened.

I need to replace it.

Sandrine, put it on here.

Stitch.

Very good... hand-stitch it.

Stitch the valve.

- This bit to pathology?
- Yes.

Goodbye... thanks very much.

Goodbye, Irene.

It looks like rheumatism.

That's what she thinks.

You can see it clearly here.

It's not closing as it should.

And there it's leaking heavily.

See that?

It is similar to what the Americans
have described when using Isomeride.

Looks the same.

The name of the drug is different.

Show me that before treatment.

I have her endocrinological
report from 2005.

Doesn't this seem normal?

Completely...
It's going like this.

Looks at this now.

You see the blood flowing in,
but there's no leak.

She's taken in it late 2006.

That makes 11 cases...
and this one's iron-clad.

It's time to act.

French Health Products
Safety Agency

We have a large number of cases
for a medium-size university hospital.

In the light of these worrying clinical
and pharmacological factors...

...we should consider the question
of withdrawing 'Mediator' from the market.

You can't recall a drug
that's been approved, just like that!

There is a toxicity
that is deeply disturbing.

This medication is used extensively.
It should?

Madame, we cannot take
personal opinions into account.

Thank you, but we shall
discuss this between ourselves...

...and move on to the next matter,
one that is of major concern.

The swine-flu epidemic.

Please take a copy of the latest report
from the Ministry of Health.

Another presentation is to be given
in the adjoining room.

It is recommended that we consider
a comprehensive Tamiflu vaccination...

Catherine Haynes.

Hello.

Do you have 5 minutes?

- Yes. Coffee?
- No.

An inquiry is in progress.
I slipped out for a minute.

Is it always like that?

It was like talking
to a brick wall.

Your presentation was excellent.

Especially when the symptoms
are very specific.

I will bring the matter
to the Medical Safety Council.

They're not ones to judge
on superficialities.

They're the real experts experts.

We'll stay in touch by e-mail.

Continue with your research.
I'll be pushing from my side.

You have to get
straight to the point.

It's best. Otherwise
you'll wait for ages.

You know Bihan?

Passed him in the corridor.

Do not act too friendly.

- I won't embarrass you, boss.
- These guys are the heavyweights.

'Isomeride'.
'Mediator.'

Same molecule... Norfenfluramine.

Not mentioned on the label.

This is a heart valve that has
been exposed to 'Mediator'.

The effect is clear.

What does AFSSAPS say?

No reaction.
As if brain-dead.

It's a Breton case, Breton doctors...

Brest Uni Hospital?
Nothing to interest them.

Except for the epidemiologist
at the Gustave Roussy Institute?

Who? Catherine Haynes?

Yes.

You know her?

I did her course at uni.

Impressive lady?!

Apparently she's some sort of
rock-star in her field.

You could say that, yes.

When she said that she agreed they were
a serious indication, I was very pleased.

I'd been looking at
so many heart valves?

...I felt I was going nuts.

So...

Sir...

What did Catherine recommend?

To do a study... and quickly.

It seems experts fear Big Pharma
more than toxic side effects.

To get them to move, you have to stick
a maxi-firecracker up their arses.

The problem...

...is that I'm not a scientist and I don't
have the money to pay to have it done.

I'm not good enough
to do it myself.

I need the backup
of some real professionals.

If a patient of mine had this valve
I would have come across it.

And I'm sure we shall.

However, in order to get
the right numbers...

...you need two case-control patients
for each case, or even three.

We can easily find plenty of the
same age, sex and hospitalisation.

This would enable us
to make the strongest case.

But we can't do it with case-control patients
who have healthy heart valves.

I know there'll be
some problems...

but I believe it can work.

And patients with an aortic valve condition
are easy to come by.

A simple procedure
that will spit out a quick result.

Is there any reason
not to bring in other hospitals?

Yes?

- I'd say we've not the time.
- Not the time?

This drug's been around for 30 years.
That's nonsense.

We could say...
"Starting tomorrow, we'll see what happens"

But that'd take forever.

What do you think, David?

A case-control study
can still be a bit of a trap.

- It can be a poor-man's solution.
- Or an urgent one.

Seeing the pharma we're up against...
it's better to avoid approximations.

That being said...

It'd be was like when diethylstilbestrol
was recalled in the US in 1974

A small case-control study.

Let's not get jumpy!

It's just a company like any other
with a few skeletons in the closet.

It's not Darth Vader.

And after Isomeride...

...if they don't want a second scandal,
they won't bring it back.

Patoche...

...get out all the cardio-valve case-files
we have here, and sort them?

?between "known causes"
and "likely cause unknown".

Are you going to do all this
in overtime?

I don't have a husband
complaining at home.

The kids are with him,
so I have some free time.

- But we can be "Tu" can't we?
- Oh, sure.

Fine.

Still a bit of a whistle.
And your new valve is noisy.

I sleep with the TV on
so I don't hear it.

And I have bronchitis again.

I noticed that.

I'm going to up your treatment
with a budesonide inhaler.

- That's cortisone, isn't it?
- Yes.

Why, is it a problem?

- It'll make me even fatter.
- Oh no!

It's a cortisone inhaler.

In that form,
it can't make you any bigger.

I'm putting on weight anyway.
I went up 7 kilos this month.

Since the operation, I've been
too tired to ever move.

And controlling your appetite
is not easy.

My Mediator prescription is out,
which is a shame, as it helped.

No...

It never helped anyone.

It may be the cause
of your heart trouble.

No...

I've always been OK with it.
I've never had any worries.

Madame Zacharria, I assure you.

It is?

...not recommended.

Out with Mediator.

Feed it to the rats.

You've already taken Mediator?

By tablet or with insulin?

Why did you have it prescribed?

Could a doctor or pharmacist
confirm that to us?

Cholesterol problem.

I'm reviving your pain with my call?
I'm very sorry.

Insulin treatment?

How many capsules?

Hello, I'm calling from the hospital.
May I speak with your mother?

She is still feeling weak,
and with respiratory problems.

I'm booking outpatient care...

...for the immediate future,
before sending her to Guervenan.

If I could have just a moment...
I have a patient...

Catherine says her pressure tactics
have borne fruit.

The Medical Safety Council
is going to see me.

When?

Next Tuesday at AFSSAPS.

- That's no good.
- Why?

It's too soon.

- I beeped you. Don't you reply?
- You beeped me?

No technicians are available.
Everything's at a standstill.

This little case-control study
has created havoc.

Hello!

I have the boss's authorisation
for this study.

I committed myself...
we're almost there.

Do I have to spell it out?

We're a team here...
stop fooling around.

Do you think a small outfit like ours
have the means to upset the balance?

War on Big Bad Pharma?
Is that it?

You'll never make it,
and it'll cost you dearly.

Without their financing,
no research is possible.

In our case, it's not partnership.

It's compromise.
There is a difference.

She's right.

I'm doing this to benefit patients?

She has nothing to lose.
You have everything.

You'll just make
a fool of yourself.

When we've nothing left,
you can join the alter-globalisationists.

You can destroy yourself,
but leave us out of it .

- And reply when I beep you!
- Thanks for the support.

Good conversation.

- Very constructive.
- You want the truth or my support?

I'm no alter-globalisationist.

I also work with pharma companies.

And I believe in therapeutic innovation.

- It's Tuesday, isn't it?
- What?

- Your meeting with AFSSAPS.
- Yes.

Don't say anything
about the case studies.

Why?

Never leak a study
before it's completed.

So what more do I have
to talk about?

I regret that it's premature.

Good, I'll play the flute...

...a Danish flute.

Good morning, I'm a medical researcher
from Brest...

Do you have Mediator
as a medication?

Mr Aubert, Director of Drug Safety
for Servier Laboratories.

Two easily verifiable facts could have
alleviated your fears, Dr Frachon...

...and saved you
the long trip from Brest.

The first is that our product,
Mediator,

...treats diabetes in more than
2 million French people.

With very satisfying results.

The second is, that in 30 years
on the market...

...it has never been associated
with any cardiovascular effects.

Assessing such a risk, just based
on a local survey, seems unwise.

In our eyes, these are
just simple coincidences.

Why not a Breton gene?

In regards to those patient-types
that you have identified...

...obese, diabetic, elderly...

Heart-valve problems are a frequent,
even common occurrence.

With natural causes,
in multiple-disease cases.

Imputing this pathology to our medication,
proves a lack of knowledge of the question.

This is not a criticism.

You are a lung-,
not a heart-specialist.

But in this case you could
also incriminate aspirin.

You understand?

I am neither a researcher
nor a cardiologist, that's true...

But I spent my last year of internship
in a pneumology department...

...where I saw young women die after
exposure to another of your drugs...

Isomeride.

There were?

...many young mothers...

...girls of my age...

...who'd taken it because?

...they felt a bit...

...ugly after pregnancy,
they wanted...

...to get their figure back.

I can still see the faces
of every single one of them.

Young women who died...

...a dreadful death.

Without redress, without justice,
without anything!

Killed by that filthy norfenfluramine!

Unfortunately, madam...

...as you would surely know...

...no drug is perfectly safe.

We have to examine
the risk-benefit balance.

The risk-benefit balance?

We are talking about an
appetite suppressant.

Not a cancer treatment.

Morbid obesity, madam, is one of
the great plagues of our western society.

Denial doesn't protect patients from risk,
as far as a I'm aware.

Denial?

Yes, denial!

That of the anorectic properties
of your molecule, for example...

...not mentioned on the label.

Or Norfenfluramine which enters the body
at a concentration rate...

...near that of Isomeride.

Madam, your allegations
leave me speechless.

The labeling of our products
is in total compliance.

If there had been anything harmful
about Mediator in the 30 years...

...of doctors prescribing it,
and it being reimbursed?

...we would have known about it.

In addition, we would like to know...

?what evidence...
on what evidence do you base...

...this unreasonable obstinacy?

The case-control study
that started in Brest, first of all.

...which should soon confirm
a very strong trend.

A case-control study?

Really?

Do not take me amiss,
Mrs Frachon, but...

...do you have a competent
epidemiological research Centre in Brest?

Yes.

The Centre for Clinical Research.

I asked Professor Le Bihan's team
for help.

Professor Le Bihan?

To sum up...The Breton "Dream Team"!

Well then. Since we are now
talking about Mediator studies...

So what about "Regulate"...

...the international clinical study,
begun in?

In 2000...
That's 9 years ago.

The preliminary results
are being validated.

But definite results could take
another year or two, or so.

Real research, when done
in a rigorous way...

...always takes a bit longer.

Don't take too long.

We always do our best, Sir.

Good.

Now we'll take a vote.

Thank you gentlemen... madam.

Stay there, madam.

To the question, are you in favour...

...of waiting for the results of current
or planned studies, namely...

...those of Servier Laboratories...

...and of CIC-Brest,
before any proposed action?

You can't wait!

People are dying.

Of the 11 cases presented,
one is already dead..

Madam, if you please...
the debate has been concluded.

Those for...

Raise your hands
so you can be counted.

Sixteen.

Thank you.

Those against?

Two.

Abstaining?

- Five.
- Very good.

You've shot yourself in the foot.

I haven't given away
any figures or results.

No study has any significance
without publication.

But Antoine is on it.

What if they can impound the data,
before you're able to have it published?

Which is not a certainty, anyway.

They have the right to do that?

AFSSAPS represents the state.

If it wants something
to fulfill its purpose...

...it can pull out all the stops
to get it.

And major publications hate stale results.
Ask Antoine.

They only want exclusives.

It's obvious that you have to
complete your article in record time.

We ready?

It's coming up.

70 per cent.

Fucking hell!

She was right.

You mean this shit is responsible for
70 per cent of valve problems of this type?

It's totally insane!

Well, guys...

We hit the jackpot.

Now it's official

French cardios have been blind
for 30 years.

You don't always find
only what you're looking for.

Nobody's going to accept it.

They'll say "banana republic
election results".

With a surprising result,
you have to ask yourself...

"What if it IS true?"

Are statistics easily doctored?

Are you kidding?!

What now?

Calm down, nobody's doctored any stats.

Well, the article...
When can we have it?

Tomorrow?

You're joking?

No.

You know me...
Patience is not my thing.

Shit!

Two minutes !

Wow! You're a Rolls Royce!

I write English,
but speaking?

Let me hear you.

"Exposure to fenfluramine
and dexfenfluramine has been

"associated with the occurrence
of cardiovascular side effects?"

Get a load of the bodywork!

Molene is there
and Ouessant on the right side.

That's Ouessant there!

You're not going to teach me
my islands!

Stop with that shit!

You're a pain in the arse!

I can't even share it with you.

Want to share something with me?

- Yeah, something cool for a change.
- Something cool?

Yeah.

Something cool?

Here you are, sweetie-pie!

Well...

Well, back to work?

Good morning.

Hi, Irene.

Hi, Sylvie.

Now, Mr Grall, take a deep breath!

Both lungs, that's right.

Deep breath.

Very good...
you can sit down again.

Well, your lungs are in great shape.

So why do I need glasses?

This isn't the optometrist, Dad.

I'm Dr Frachon,
the lung specialist.

We've met before.

Irene ?

Yes, Irene.

I get so confused.

Behave yourself!

I have a husband
who doesn't get jealous.

So much the better!

Would you like a chocolate?

August 2009

We said no phone for 2 hours.

- Yes, but it's Antoine.
- Doesn't matter!

OK, if it means saving the world.

No, this is the one I want.

But I also want to find one
that I choose for you.

Here we are...
"A Woman's Guide to Men".

Whatever.

Stop it, you sex maniac.

Antoine, I'm with the kids.

It's Amelie's birthday.

Can I call you back?

They know about our case-control study.

How did that get out?

They didn't care about
anything put to them.

They treated me
like some hillbilly bitch.

I had no choice.

Are you sure?
Or was your pride pricked?

Let's not argue now.

We put the article together
in record time.

- For good reason.
- Isn't that what counts?!

Save your energy
for the next round.

You'll be served.

We've been summoned
by the public health authority...

...to present our results
by the 29th of September.

That's how you knew?

Yes, that's right.

If no review publishes
prior to their kangaroo court...

...what then?

You've told me yourself,
that all your articles get published.

Yes, but I work by the rules.

Let's not panic.

We've got a month?

There's time to get a grip on it.

No, because in a fortnight
I've been summoned to a debate

with the experts from Servier Laboratories.

In front of you,
they'll crumble.

We don't have
the data-protection commission.

We don't have a review.

They're just formalities.

What would YOU know about it?!

You've no experience in this!

We'll be ground down
by the methodology freaks

We'll be chopped to pieces!

Do you want this drug
to be recalled?

Say "yes" or "shit",
but leave out the dramatics.

For the umpteenth time,
this is not a normal situation.

This is battlefront surgery...
no anaesthetics, no gloves.

If we have to cut corners,
it's to save patients' lives...

For fuck's sake!

We're only doing the right thing!

We'll never be able to forgive ourselves
if we don't do this. Right?

Antoine ?

Yes, yes.

Yes, I'm still here.

I couldn't help myself.
I pleaded with your wife to let me come.

The firing squad.

I was totally picked to pieces
like you wouldn't imagine.

Look at this.

'PLUS One'... they'll publish.

- A close call, eh?
- Fuckin' hell!

- You're tops.
- You bet.

Yes?

My pericarditis case?

I'm coming.

- What?
- It's Corinne.

I'm going to put my hand
on yours.

Squeeze my hand,
Mrs Zacharria.

Squeeze the left hand.

I've replaced he aortic valve.

What happened?

We'd stopped the medication, though.

It seems, the attending physician,
reassured by a letter from Servier...

...has renewed her prescription.

She was taking 6 capsules a day.

I have to see that letter.

I've asked for it.
I knew you'd be interested.

This can't be true!

Hi, everybody!

How are things?

Christophe's just arrived.

Come on, Yannick!

Let's go.

So, did you sleep well?

Oh no!

Isn't there a button?

Good start!... problem
with the automatic door.

- Go ahead.
- No, no!

- Yes!
- It's no use.

Let the poor things in!

They haven't come for nothing.

It's working. Come on.

This should be entertaining.

Professor Le Bihan?

Eminent specialist?

From Brittany.

- That's Servier's team?
- Yes.

Although the control-group outcome can
be questioned because of so few cases...

...another control
group had difficulty...

...changing the outcome.

We now wish to give the floor to
one of our 3 university consultants here...

...Professor Launay
from Paris University 15.

The protocol... two pages.

...seems very succinct and unsupervised
by a proper epidemiologist.

The odds ratio of the outcome
is very high and simply uncommon.

The adopted methodology is flawed.

The individual cases are classified
without objectivity...

...as if the controllers are selected
to influence the outcome.

So the validity of this study
is at the very least doubtful...

...like the level of scientific evidence
in these results.

The likelihood that the relative risk
is not correct...

...is less than a billion.

One in a billion?

Let's be serious, and honest, Mr Le Bihan.
I'm sorry... Professor.

Listen?

The data speaks for itself.

The data is there.

Yes, yes, of course!

This is going to finish up
in a lawsuit.

Mr Chairman?

We must intervene.

Please... your attention...

Can you please stay
in your seats.

Si pas de quorum, pas de vote.

I know some of you
have trains to catch.

So let us move quickly
to finish this debate. Thank you

It is now indisputable that Mediator
causes severe heart valve problems....

...and we think it
a matter of urgency?

Good... our thanks to Professor Launay.

To sum up,

this study from Brest is a fabrication,
created to discredit our product.

It displays major biases...

...that are highly suspect, and so
must be excluded.

He heard the word "lawsuit".
He's in there.

You OK, Antoine?

We have to go back in.
They're waiting for us.

No.

I'm not going back in there...

Not to that slaughterhouse.

I'm stuffed.

You don't have a choice,
my friend.

We're together on this,
and you're the brains.

So pull yourself together
and get in there.

We're fighting for those who are sick,
not for ourselves...

We're on target, so stop
feeling sorry for yourself.

- He's a mess!
- What are you saying?

That we give up now?

He'll slam them with rules,
like that idiot did to us.

That's what he's here for.
I can't do it for him.

We can take him back in
on a stretcher.

[Danish]

The controlled the study that follows
the best international guidelines...

...supervised for "Cardiac Safety"
by Professor Chataignier...

...shows, for its part, that there is
a trivial risk of heart valve damage...

...in only 15 per cent of cases, and, so to speak,
without pathological signs.

So let's not get carried away,
dear colleagues.

The recommendation of our laboratory,
considered as adequate by those consulted...

...is to modify the package leaflet
as a precautionary measure.

And obviously, keep the product
on the market.

- Mr Chairman, may I...?
- Go ahead.

Professor Chataignier,
Professor Launay...

Has your sponsor,
Servier Laboratories...

...warned the patients who acted as
guinea pigs for 10 years in that study,

...about the risk to their heart valves?

Let's move on now.

The next point is swine flu pandemic.
We have 10 minutes for debate. Thanks.

The health authorities gave us
all necessary permits.

We note that, in any case,
this risk was not proven.

Really?
You found it to be 15 per cent.

It's difficult for me not to see that
as a significant indication.

Mr Chairman...

Go ahead.

When one finds a case of valvulopathy
without an obvious known cause...

...but one knows that the patient
has been taking Mediator for years...

...it is difficult not to establish
a relationship of cause and effect...

...especially with the precedence
of Isomeride.

All you need is a pocket calculator.

- May I have a word?
- Go ahead.

15 per cent?

Over 8 years of study...

...look at the marketing of the drug,
and the study is fair...

Hundreds of thousands of people
have been exposed...

...inducing tens of thousands
of cases of valvulopathy.

And you dismiss it as
an insignificant thing.

Finally, your randomised
double-blind study...

...says even more than our little
retrospective case-control one.

Thank you.

- It's a matter of urgency.
- Not right now.

How is it possible,
that for 8 years...

...when the same toxicity was demonstrated
over ten years ago...

...in one of your similar products,
Isomeride...

...you've done nothing?

...to protect the lives
of your patients?

So who's won?

That academic idiot...
He looked like this...

In 1945 they called him the butcher.

The guy was freaking out.

I came home...
I was scared.

They've acknowledged a risk
for heart-valve disease!

According to Catherine,
withdrawal is imminent!

Antoine was sure.

Can you hear me?

That's him singing.

Hear him?

The prof's lost his inhibitions.

Yeah... end of story.

Tomorrow it's back to shopping,
washing and ironing.

Real life.

I'll call you back later.
Everybody's waiting for me.

Won't it stink?

Why would it stink?

Sick people stink.

You talk like that, Amelie?

You mustn't think like that!

Wait in the car, if you'd rather.

Corinne?

What?

It's me... Irene.

I hadn't caught up with you,
so I thought I'd drop in.

Deep breath.

Your feet are quite swollen.

They've got to carry me!

I'll prescribe you support stockings...
that will help.

I don't leave the couch.

Things will get better.

After the withdrawal of the Mediator,
users will be registered.

I'm sure that they'll
cover certain costs.

You really think so?

For people like me?

Yes.

I can promise that.

Well don't get your hopes up...

...for an American-style jackpot...

But I'm aiming
for high compensation.

Given the handicaps
generated by this toxicity...

Aren't you a bit young
for combat of this sort?

No.

No. Listen?

In this case,
nothing or nobody intimidates me.

My clients will be well-defended.

Do you know how many victims
have been indemnified for Isomeride?

Two?

One only.

Still!

After 10 years of proceedings,
relentless psychological torture...

...inflicted by villainous law firms.

So in your place,
I?d play it low-key.

What do you specialise in?

Bank and finance law.

White-collar crime
is a whole other ballgame.

As a matter of fact?

It's not long since I was sworn in.

I had a period of doubt
and almost ended with the law...

Then my aunt told me
about this case...

About all these poor people
who were poisoned for years...

...by an amphetamine
made up in an anti-diabetic...

...that was fully covered by Medicare.

I thought it was totally insane.

I want to fight for real things
like this.

I know I can defend these women,
and I want to do it.

- Do you have a cat?
- A cat?

No... nothing.

I'm mad about cabinetmaking.
There are the scars.

It is necessary to begin by deconstructing
everything, assimilating everything.

A hell of a job, I warn you.

But otherwise you can't
get your teeth into the case.

Servier know that, and are spending
the whole time...

...shrouding the case
in a technical smokescreen.

Bless you.

Look what those shits
say about the recall.

Hello.

Hello.

Irene Frachon, Flore Michelet.
Flora is a pharma student in Rennes.

Excuse me.

Do you realize it's the only
information that doctors have?

We did our job. It's up to
others to take responsibility.

They don't give a damn!

You think they'll call the patients
in for a screening?

At the Landevennec pharmacy,
they're still selling their stock.

It's madness!

So what do we do?
Drop bombs?

We're talking about
a crime going on!

And the victims are unaware!

Thank you.

I've done what I can.

But now I have a team
to lead on thrombosis.

I've got a scientific report
to present.

Don't you see?

Wake up, for fuck's sake!

We're looking at
a criminal case here!

These characters stuff their pockets
at the expense of the victims!

If the system is rotten...

...it's up to us, the doctors,
to fight for change!

Whose side are you on?

To hell with all those bastards.

The tobacco industry...
and alcohol as well....

...because it's always on sale.

I'm a traitor.
That's right, a traitor.

Do you take me for an idiot?

We did our job...
It concerns us more.

If people don't know
they're being exposed to a poison...

...certainly it's our concern.

What about your patients?

Your children, you husband,
do they concern you?

[Danish].

What?

"Limp dick!"
Is that what you say?

It's people like you
that make it all possible.

"Oh, alright then..."

"I wouldn't know...
I never saw a thing..."

"I think I read something
about it..."

"Oh, no, it's..."
Watch out!

"You mean people die?"
Really?

"I'm busy knitting at the moment."

It's easiest to sweep everything
under the carpet, right?.

You think it's enough
to have a big mouth?

You could never manage things
by yourself...

...because you're incompetent.

So you get yourself a prick, Irene Frachon,
and see how you manage.

Thanks, and goodbye!

That was Irene Frachon.

You wanted to meet her.
Now you have.

Yes, the subject deserves
to be examined...

...but not in a doctoral dissertation.

I don't know?

Does "Study of placebos
in smoking reduction" sound interesting?

It's confidential, isn't it?

Can I really take it home?

If you want to dive into it head first...
this is what you need.

Photocopy them and return me
the originals as soon as you can.

Hello!

Good evening, sweetheart.

Adele.

Flore...
Flore, Adele.

Flore is doing her last year of pharmacy
and had a great idea for her thesis...

To investigate
the spatio-temporal weaknesses...

...in the French
pharmaceutical safety system...

...taking Mediator
as a prime example.

Well, it's not quite that,
but we have the histology to review.

Are you doing medicine?

- Yeah... first year.
- Good luck!

Thanks.

Are you OK to go?

Oh yeah...
my brain's in top shape.

I don't need a prick or a rifle.

Bye bye.

Start without me...
I'll be back soon.

I'd rather stay anonymous.

I do analysis work for CNAM.

I met Mrs Haynes
at a symposium on another topic.

We had a bit of a chat.

It was she who gave me
your number.

I'm proposing
I take a look at the problem.

Quantify the figures.

I can work on week-ends,
keep it under wraps.

Can you send me any documents?

Can I give you my address?

Sorry!

Can you send me the study-
and coding-terminology today?

Yes, I'll send you that.

Can you delete my call?

OK.

Goodbye.

This guy's Santa Claus.

What are you sending him?

The study and the coding
that was used.

He can compare across the CNAM database
patients who received "Mediator"...

...with patients
who haven't received it...

...throughout the whole of France.

What if this guy's works for Servier,
and is pretending to be a friend?

- You need to find yourself a guy.
- I'm serious.

I don't know.
It feels right.

Is he from AFSSAPS?

No, from a health insurance office.

And if it comes out a figure that hurts,
they'll lose their shirts.

All OK?

The stress tests frighten me.

That won't be the hardest thing.

They'll come on hard...
asking disturbing questions.

Loaded, I was told.

You'll be called a liar,
a manipulator?

They'll make out your problems
have nothing to do with the product...

...that you invented it all
to make money.

Don't let them rile you.

Look at me.

You were a little too heavy-handed
with the rouge, Corinne.

You look lovely.

As my daughter told me...
"They can't take away your smile."

This case is rock-solid.

Rock-solid!
Forget about the heart-beats.

No other cause possible?
Understood?

Don't let them drag in obesity
and acute renal failure.

If it starts to get
out of hand...

You jump in and protect her...

Tooth and claw!

- OK.

OK.

It'll be alright.

She was absolutely...
totally stressed out.

She didn't even make it
to the medical examination.

I wish I'd never dragged her into it.

When did you take her out?
She's ice-cold.

But I did take her out
at 7 o'clock.

OK.

Can you do your side now?

They're tough.

That's good.

Can you suck out that liquid?

I'll take a bit...

There's scum there.

Left lung... quite heavy...
congestion... there's scum...

...in the bronchial stump.
And weight?

Left lung... 880.

That's a lot.
Right lung?

1025 grams.

We'll do the heart.

Elisabeth, are you noting?

The heart is large...
it seems heavy...

There are post-operative adhesions.

I think we have
the cause of death here.

So, what's it weigh?

- Heart 515 grams.
- Yeah, that's heavy.

Irene, will you open the heart here,
or send it to pathology?

We'll do the liver.

- Hello, Hafida.
- Hello, Professor.

MEDIATOR 150 MG
HOW MANY DEAD?

- Charles Kermarec ?

- Yes?
- Here...

Read that, and tell me
if it interests you.

- For??
- To publish.

I've only got a small
local publication.

I need a stubborn Breton.

This story was born in Brest.

- And you?
- Me?

Yes, where were YOU born?

Avoid feelings.

Use neutral terms.

I've suggested some cuts
to the body of the text.

How do we title it?

The question seems justified.

No judge could question it.

In the case of a problem...
so that Bruno is not concerned...

Oh no, Irene!

Shouldn't we change
our marriage-settlement terms?

- Something wrong?
- I have a bad feeling.

But doctor...

Patoche told me of
the descent into hell

of a doctor who attacked
an anti-depressant.

The company who produced it,
ruined him.

Sentenced to pay 850,000 euros.

850,000!
The risks are limited!

In the end,
he lost everything.

He started drinking.

- He got cancer?
- Stay off the booze.

What about your life insurance?

- Stop it!
- No, but?

You OK?

No.

I don't know?

My office was open, the light on...
I'm sure I locked up.

Irene... your book.

It's a bombshell.

You know that you can't publish?

I don't want to argue about it.

I just want to give the victims and
their lawyers the scientific evidence...

...that will allow them
to demand compensation.

You'll burn all your bridges.

If I don't do it, nobody else will.

Somebody has to say to them...

"You have to accept responsibility."

You've done enough.
You're becoming irrational...

...becoming extreme.

If you prefer,
I'll remove your name.

What pseudonym
would you like?

HOW MANY DEAD?

"This book is also available..."

Amelie !

Hang on to that.

Excuse us.

Irene.

Irene.

Servier is taking us to court...

They're attacking us
because of the subtitle.

It's annoying, but good.

No big drama, really.

No big drama.

Yes?

Do you know Irene Frachon?

Irene who?

Frachon.

No.

So you're not Santa Claus?

Who?

Santa Claus?

After accidents and attacks

you count the victims.
This is omerta.

If he's here,
you'll smell him.

I'll get you a sandwich.

This is straight out of Kafka.

Totally irrational.

The judge found for Servier,
and against us.

The book's shot down.

We have to remove
"How many deaths?"

He defends tainted blood, growth hormone
and we lose for a subtitle?

[Danish].

Take it easy... calm down...

Listen to me.

You wanted someone
who was rock solid, right?

All this is just intimidation,
and I don't like it.

And censorship, never!

I've got Honnorat.
We're going to appeal.

- And get another slap in the face?
- It was an interim judgment.

Now we'll have top arbitrator.

According to Honnorat, the judge didn't
believe a band of Breton bumpkins...

...couldn't know better than
the second largest pharma in France.

So we've just got to appeal.

Does he realize that it's discredited me
and put you in the poo financially?

He thinks, on the contrary,
that the censorship might pay off.

In what way?

You need to sit down with him,
but in brief...

...he thinks your best defense is the press.

Start a media storm and get started
pending the appeal.

But I'm a doctor,
not a cheerleader!

I know, but?

You have to get personally involved
to make the impact.

You have to stick
your neck out.

Show your indignation
about the censorship?

This is not about censorship!

It's about the message in the book..

...informing and protecting
the victims.

And the fact that after that judgment
I've become illegitimate.

Irene, you don't risk anything.

You'll bet on that?!

I've made enemies everywhere.

And I'm the only one
in their sights.

There are a lot of them.

I see it in my database.

But most of all I see the people?

...behind the figures.

How many?

I'm stuck until someone asks me..

Someone from high up.

They have to ask me.

I'm stuck too,
because of the judgment.

See if you can come up
with the right question.

There's no right question
without an answer.

We must get those figures.

If you have them,
get them out.

I can't do it without an order.

This is all unofficial.

Hell of a job!

Take a low range,
over 30 years of marketing...

That gives?

4,800.

Then...

...estimating mortality of valvulopathies
at 20 per cent?

My Santa Claus has counted up deaths
on his night-shifts for six months...

And it takes you 10 minutes?

- Santa Claus?
- Code name.

A guy at CNAM.

For the whole of France...

Should I add to it?

Put everything as conditional.

Dear colleagues,
I have examined Mr Yvon Giuyou...

...born 5 March 1952...

...following up on a pulmonary
hypertension diagnosis...

...made in...

...2007...

...and treated
with combination therapy...

Subject -
Exchanges between Afssaps and Servier

I'm showing you some of the ridiculous
assertions from the experts...

...who would be doing better
to clean up their own backyards.

Subject: Book on Mediator
Dear Michel

finally, on the subject of Mediator,
there are three aspects...

the articles, the book, the author.

...reminds me of little soldiers...

(that are necessary during a war)

...the book is a narcissistic project...

...it is her life's work...

If we find the book defamatory,
we have two options...

...through the courts...

...or the Medical Association.

- What's happening?
- You were right.

Sit down.

It's a nasty wound.
You're bleeding.

What did you do?

- I'm bleeding?
- Yes, you're bleeding.

I don't know.

Lie down.

Hold it firmly.

I have the whole pack
against me.

Who? What pack?

AFSSAPS, Servier.

They want to attack me before the appeal.
Get me struck off.

You were right.

Lie still.
You need stitches.

Don't move.

It's not the personal attacks
that matter.

What kills me. is their contempt
for the victims.

They mean nothing
to them.

What personal attacks?

They say that?

my book is just an ego-trip...

...that I'm blowing my own trumpet.

Calm down.

Do you think I'm narcissistic?

- Where is this crap from?
- From emails...

...which they exchange,
bad-mouthing me.

All fixed.

You lie still...
I'm on call until tonight.

- Would you have a Valium?
- You want one?

I'm scared.

There's no true combat
without fear.

All the real resistance fighters
got scared.

You know what?

Don't worry,
it'll be fine.

Where are the kids?

- You're injured?
- I hit my head.

- Where are the kids?
- In their room.

Are you sure?

Where's your car?

I left it at CHU.

Why?

It was safer.

I'll put it in the garage tomorrow.

To have the brakes checked.

This is France, 2010.

Not southern Italy, or Russia.

I'm not worried.

Oh, Irene.

I give up.

You're not serious.

I'm quite serious.

I give up. It's all over.

No, Irene, no, no!

I just can't do any more.

I'm exhausted.

I'm not tough enough.

I was only trying to help.
I didn't want to go?

...waging war
in the courts and the media.

It's just not who I am!

If you give up,
who can they turn to?

Hear me out...

If you don't do it for them,
do it for me.

I don't want to see you like this,
because THIS is not you.

Do it for Adele,
who admires you so much.

Do it for Amelie who's tired
of you forgetting her at gym...

...and of being tucked in by her father...

...who has to brush her hair
in the morning.

Do it because we're all
expecting you to do it.

And you'll never be with us completely
if you haven't taken it to the finish.

Can I propose marriage again?

But only with a marriage treaty.

Have you changed your glasses?

Yes.

The kids gave them to me
for my birthday.

I've been wearing them
for 3 months.

Kermarec has been
ringing continuously...

I said you were on duty,
and not contactable.

I'd better call him.

Charles? Hi, it?s Irene.

Yes, fine.

Not too late?

Sub-title censored.

Chairman of the Investigative Committee
on Minors in Sects.

Chairman of the French-Tunisian
Friendship Association.

- Yes?
- Yes.

Yeah.

So?

Gerard Bapt.

Gerard Bapt? so...

Gerard Bapt, member of the Socialist Party
and heart specialist.

M.P. for the 2nd District
of Haute-Garonne since...

Mum... I'm hungry!

Five minutes, sweetie.

I'm going to have
a hypoglycemia attack!

The article's tops!

The photograph, though?

- Not very inviting.
- I'm not a model.

Wow, you look ugly.

Looks like Auntie Greta.

People will be stoning you.

This article will really stir things up.

If I saw that face there,
I wouldn't want to read it.

Arnaud?
Hold it closer to you.

Not too much?
You're angry!

It has to show, anyway!

- Not too much.
- We say "no"!

Truth will out!

Don't move.

It's good when she shakes it!

- Better expression.
- I like that one.

Oh, you're so cute!

Will that do it?

- You look like a kitten.
- You're all nuts.

Looking determined,
but gentle?

That's great!

It's great!
You look lovely. Stop laughing!

Seriously, Mum...

That looks great.

She'd going to look really good.

Smile.

That's perfect.

Jacky Henin.

H, E acute, N, I, N.

Jacky and Michel.

- Eva Joly. J, O, L, Y.

This Irene Frachon again...

The pulmonologist who sent you
the book about Mediator.

Sorry to bombard you
with these messages...

...but I'd very much
like to meet you.

Good afternoon, Sir.
Irene Frachon, here.

We never seem to catch each other.
I had a patient.

I thought this might be a subject
of great interest to your magazine.

It's not all in my book.

Feel free to call me
day or night.

I hope you've received it
and maybe have read it.

To put it all succinctly?

...it's a national scandal.

A few more balls to exchange.
Which referee to ask the score?
It's worse than I thought.

Thesis for Doctorate of Pharmacology

National Assembly

- Gerard Bapt?
- Irene Frachon.

Delighted to meet you.

I'll ask you the unanswered question...
how many killed?

Deaths that can
really be proven.

How many deaths do you need,
in order to be interested?

I've held one of
them in my arms..

. and as far as I'm
concerned, one is enough.

Get off your high horse,
or you'll get nowhere.

What?

I read your unbearable book,
I'm sorry to say.

Probably the only Paris journalist
who did.

You flood my answering-machine
with your messages of doom...

I guess you want more
than a footnote from me.

For an hour now, you've hit me
with stories?

...of poisoned valves,
case-control patients...

Turn-offs like I've never seen.

I write for Le Figaro.

If I get anything more,
I'm going home to bed.

It's difficult to know exactly.

A student has calculated a figure
for her thesis on Mediator, but?

...it remains to be verified.

- 500 ?

It remains to be verified.

Dear Doctor...

I now understand, thanks to you, why
there are so many things I can no longer do.

Look after my grand-kids, do little jobs,
walk more that 150 metres...

I do not believe doctors any more,
we cannot trust them anymore.

Happily, people like you?

Look at this.

From every corner of France.

We were right, damn it!

"Why not a Breton gene?" he said.

This woman lost her sister who
wanted to come in her wedding dress.

Here's the photo.

Why didn't you tell me?

Didn't tell you?

About what?

Flore Michelet's thesis.

What about it?

When are you going to stop treating me
like your pet nerd on your leash?

Antoine, what is it you?

You knew I'd advised her
against touching that.

But you're paranoid.
How would I know?

She was the one
who came to see me.

The pharmas are her future employers.

Meanwhile she graduated
with flying colours.

This is your personal crusade.

You ignore the consequences
it might have for others, eh?

Has Inserm dumped you?

Yeah. Heavily.

Has the academic committee
been infiltrated by pharmas?

I've hunted Inserm certification
for ten years.

And there's a whole team behind me.

I've lost all my research credits.
All of them!

It's over for me here.

I'm going to try Canada.

I'm truly sorry, Antoine,
I don't know what to say.

Best you say nothing.

Just get out of my life.

Anne Jouan. Want it?

No.

Isn't it the journalist
who was helping you?

Samuel, I said "no".

Shortness of breath
may be due many things...

There's smoking?

I'm not out of breath at all...
My doctor heard...

Yes... it's whistling a bit.

Sometimes it whistles.

You've got ticklish bronchi,
I'd say.

Alright?

When you have an asthma attack
it goes like that...

The air doesn't come in anymore.

And with Ventolin,

...it goes like that...

Then I can breathe.

You can breathe
and you can do everything.

You can even take her
to the playground, carefully.

Well what?

I have bronchitis.

I have a scoop.

Oh yeah?

AFSSAPS have asked CNAM
to count the number of deaths.

They're freaking out.

Flore's estimate has leaked...
They want to demolish you.

Who's told you this?

I don't reveal my sources.

I have a contact at CNAM...
who works for us.

A mole, it's called.

It's been radio silence
with him for a while.

I was able to get onto his wife.

I asked if her husband was well.

She said...

"He knows what he has to do."
and hung up.

What if he's the one
that AFSSAPS are using?

He's probably scared stiff.

I received your request.

I'm not sure I understand.

You want me to evaluate the risk
of valvulopathy in those on Mediator ?

Being essentially a calculation
of the number of deaths.

Yes, that's something
quite different.

You'll need to send me an e-mail
stating precisely your requirements.

So we know what we're talking about
and what we are looking for

As an indication,
yes, obviously.

Nevertheless the calculations
will be done by the book.

Numbers don't deviate.

That's what I like about them.

It's an essential dimension
in terms of public health...

Irene!

What?

Your MP!

...was banned in France
only last November.

This molecule has been proscribed
in the USA since 1996.

Your MP!

"My" MP?...
I've seen him once.

The lung-doctor from Brest
has sounded the alert...

..and has done battle
with the pharmaceutical company...

...and with the health authorities...

...to have the medication recalled.

I was thunderstruck to hear
that her book title had been censored...

Because it posed the the question
the company disliked so much...

"Mediator, how many deaths?"

A question that the brilliant thesis...

How good is this!

It's good alright!

Are you afraid of pharmaceutical companies,
Mrs Luciani?

How many deaths will it take
to stop this insanity?

Institutions are not ones
to be afraid.

Our decisions are only taken
on a solid legal grounds...

...so that they are in tune with
the needs of public health.

Who do you want
to protect, Madam?

The French people,
or your government department?

I'll return to the subject
without getting into controversy.

Yet once again...

...I'm trying to get back
to the issue.

You're on the wrong side!

? a decision that's fraught
with consequences?

Fraught with consequences
for whom?

The pharmaceutical company!

It wasn't the evidence that was weak,
it was you!.

You, who are supposed to defend
the interests of the sick...

...but instead shut your eyes...

...on the criminal acts of a pharma,
with total cynicism.

You can't be policeman and gangster
at the same time, madam.

You have to pick a side.

Stop... Sam's going to be sick.

Each time Irene Frachon was met
with distrust, it's amazing.

No... if you'll allow me...

That's just her
emotional interpretation.

You don't agree?

Once again, I'm here
to contextualize...

...not to revisit the emotional
and subjective...

...interpretations of Mrs Frachon.

We obviously see things
very differently.

Why don't you come and see a victim
of Mediator at the morgue...

..and then go and explain
to her children...

...and her husband...

...the importance of contextualisation.

Thank you, Irene Frachon
and thank you, Mrs Luciani.

A very polarised debate
as we have seen.

Goodbye.

What a stupid cow!

Did you hear her?

That bitch?!

This could go on
for a long time, Mr Jaffredo.

It could be?

...5 or 6 years.

With chances to succeed still?

What are the chances?

The chances depend
on the medical report.

A very thorough medical report.

Extremely thorough.

My heart's opened up anyway.

Yes.

I wish that...

...everyone who took
this human time bomb...

Corinne's ultra-sounds
were done here, right?

Yes.

And this is the pair
that started it all.

I'd've got nowhere without him.

I didn't do so much.

He seems a bit awkward, but ...

Here we have my manager, Laugier,
who really saved the day.

Here's two more of the gang!

Professor Le Bihan...

Patricia Brize,
a member of the team.

Mr Oudin will be defending
the victims in court.

Pleased to meet you.

Are we still having lunch?

Laugier!

- What?
- Laugier.

MEDIATOR HEART-VALVE DEATHS

That was quick.

I thought it was
a matter of urgency.

So... the number?

Page 4.

They're reluctant to publish the article
without the CNAM number.

But three of my sources have read it.
I'm sure of it.

What are they afraid of?

Fake numbers
that will screw us up.

What if I get kicked
off this paper.

"Much obliged, Franchon!"

If it's all correct, they'll be hell-bent
on grabbing the story.

Be sure I can reach you around 7.30

Why toot!?

Everyone's aggressive tonight.

Go on!

2 minutes until the bomb drops.

Really?

Is it still happening?

Approved, but hasn't
gone to press yet.

Let's hope it's not pulled.

What I wouldn't give
for a stiff drink!

Hiroshima, here we come!

Stop it!
You're freaking me out!

This is no time for second thoughts.

Oh boy oh boy oh boy!

Anne, keep it down!

In six seconds it'll be
on the web page.

Are you at home?

No!

Park and turn on the radio.

It'll be on all the 8 o'clock
news flashes.

Oh boy oh boy!

Oh boy oh boy!

News on the Mediator story...

...the medication that was
withdrawn from sale in November.

A medication for overweight diabetics...

...then prescribed for other patients
wanting to lose weight.

When it was withdrawn
from sale...

...more than 300,000 people
had been prescribed it

Mediator is accused
of being a cause of death.

How many? An official report
gives the figures.

Up until now we have
only had estimates.

According to a secret CNAM study revealed
by 'Le Figaro'...

...Mediator was responsible for
500 to 1000 deaths in France...

...due to heart-function complications.

...having valvulopathy is not required...

...but in case of doubt...

...he will prescribe
a cardiological consultation...

...to be sure that
you've not been affected.

...Dr Frachon and the university team
at Brest...

...should be recognised for revealing
these harmful effects.

We cannot forget that
the government agency responsible...

...worked to delay the withdrawal
of Mediator from the market.

She had started to have
signs of asthma...

...later diagnosed as a valvulopathy.

She was dead 6 months later.

Yes?

Servier says these are figures
from a thesis...

AFSSAPS says there were no deaths...

CNAM is ducking for cover.

They've got no balls.

We won't sell them ours.

I'll be getting on to Ms Luciani...

If anyone questions you,
say no comment.

Protect yourself from attack.

Patoche, get yourself ready
for a chaotic life.

Your article won't change anything.
We aren't the only ones to refute.

Nobody believes
your girl from Brest.

To base things on a doctoral thesis
is quite dubious.

If even 'Figaro' is reducing it's rigour?

Our figures do not come
from a thesis.

So where are they from?

They're from CNAM's study.

Still sure of no deaths?

I'm unaware of such a study.

Your office has had it
since September 28.

Maybe you swept it
under the carpet.

Listen?

There is one, but it still needs
to be refined.

Refined how? We're talking about
over 500 deaths, not a couple.

Irene Frachon...
You wanted to speak to me?

What's it about?
Let me write that down.

4pm.

She can't speak to you just now.

The toxicity has been known
for 10 years.

Sorry... we're getting so many calls
and I feel I'm drowning.

I do not agree with
AFSSAPS' conclusions.

June 2006?

Mediator, is a drug in the same family
as Isomeride which was withdrawn in 2007?

Irene Frachon...

...when you talk about being pressured,
what is it exactly?

Is it basically because the pharma
is a French company?

The interests of big business
and of the sick, are never to be confused.

There must be complete separation...

...between those whose interests
lie with the sick...

...and the people negotiating
with pharmaceutical companies.

Is she used to being
in front of a camera?

No, she doesn't even have
a TV at home.

...you denounce
the existing health links.

You're a lung specialist
at the university hospital in Brest...

Are you aware that through this case
you've became a whistle-blower?

I never set out to become one.

My vocation is to care
for my patients as best I can.

I succeed, to varying degrees.
But it is with them...

...my patients...
that my true interests lie.

In recent times,
with the Mediator affair...

I can declare the links
that I have with...

I won't give their surnames,
but it is important.

Joelle,

Anna,

Nicole,

Jacqueline,

Yvon,

Mireille,

Michel,

Monique,

Marie-Claude,

Yves,

Auguste,

Therese,

Renee,

Corinne.

These are the people I know best.

Five of them are dead.

The others are in fear of dying.

Somebody has to look after them.

- That went so well!
- She's just so calm!

Are the Beatles here, or something?

There she is!

Are you now more convinced
that this medication kills?

I've been sure of it
for quite a while now...

...since I saw the first case...

...an extremely serious
heart-valve case, in 2008.

When your book came out,
nobody wanted to listen.

People doubted your propositions.

Is that situation reversed now?

Yes, but?

It's all been tipped completely, but...

...only after a proven
major public health issue...

...had been rejected by the authorities...

...who shut their eyes
and ears to the catastrophe.

What do you expect Servier
to do next?

This company, past masters
in driving people insane...

...and getting feedback from my patients
on their evaluations...

...are going to act like a rapist,
saying they were willing...

The girl from Brest?

...and accusing the victim
of asking for it.

Will the scandal be as serious
as that of the contaminated blood?

There were refusals
to listen to you?

Refusals to listen to me? Yes!

I felt I was made to feel unwelcome
before I'd opened my mouth.

That was a problem.

And then, various pressures,
certainly.

It was very disagreeable.

My work was greatly denigrated.

You said that you've been afraid.

Yes.

I HAVE been afraid.

Ministry of Health
January 15

I.D.?

Show yours.

Show me your card.

Irene?

Yes?

I'm Arsene Weber.

My Santa Claus!

I'm so glad to meet you.

Me too.

Know him?
No.

Now that its work is done
the Commission...

...before presenting?

Minister... please!

...wants to highlight the major elements,
the important points in this report.

The course of events
reported in this report...

...is largely related to the behavior and
strategy of Servier Laboratories...

...who, for 35 years,
have played with the lives...

...of those involved
in this chain of events...

...in order to continue marketing...

...Mediator, and have it recognised...

...in the treatment of diabetes.

To use an expression one often sees
in the testimony we have gathered...

...this company...

...this firm did not just
anesthetize those involved...

...it lied to them.

The commission has been informed
of the pressures...

...exercised by people
from Servier...

...or others
with special interests...

...on those involved in proving
the toxicity of Mediator.

The safety oversight body
failed in its purpose...

...which is to identify and instruct...

...in a timely manner,
and to illuminate...

...the decision of those responsible...

...in cases of serious side effects...

...related to the use of the drug.

The main reason
for this collective failure...

...is to be found in the inadequacy
of public health culture...

...especially in a principle of
letting precaution run backwards.

So, it's no wonder that
this alert came from outside...

...from the journal 'Prescribe'...

...from Dr Irene Frachon...

...Catherine Haynes,
Dr Arsene Weber...

...whose concern for the danger
of this drug has resulted in its withdrawal.

As well as Flore Michelet
and Dr Gerard Bapt...

...regarding the impact
in terms of mortality.

Their mission never lost sight
of the dramatic human element...

...of both the sick
and the deceased.

They will be our guiding star
in the upcoming debate.

Incredible!

Although the next phase will be defining
and present guidelines...

...for a reform of safety surveillance...

...we wish to emphasize
some of the most important lessons.

What do you think
of the report's conclusions?

This is a great day for us,
as finally it's all in black and white...

...what we suspected,
and sought to understand...

...and it's all gone further
than we could have imagined.

But what pressure,
what influence...

...what lobbying allowed,
so many times...

...in front of so many danger signals
for a useless medication...

...and I'm not alone in saying this...

...to have all the warning lights
switched off?

- Do you still smoke?
- Oh yes.

But a lot less.

Cutie-pie!

The intrepid big-head!

Where are all
of your photographers?

Going off on your own?

Gail and the kids
are going to join me in a week.

I always hate saying
au revoir, but?

I don't know, it's impossible...

...to not say...

Limp dick?

Hello? Yes!

Thanks for calling back.
You got my letter?

I have the paperwork in my car...

I'll call you back in minutes.

Yes.

They suffer a lot of physical,
mental and economic needs...

...and psychological...
and material as well.

So that's it.

In private practice, it'll be head to head,
with specialist fees up front.

That was the gist of my question.

We must find a quick way
to compensate them.

I had the minister this morning and...

Yes, I'll send it straight away.

I'm nearly at my car.

Sure, sure.

Thanks a lot.

That's terrific,

Terrific.

I don't know
what's happening to me.

No, I'm in a lift.

There, I'm going out of it.

Xavier Bertrand is hesitant about
accepting a proposal from Servier...

...which suggests setting up
a compensation fund itself.

I have the first reports...
they're chilling, sinister.

Antoine works in Canada,
where he lives with his family.

He is still working together
with the University of Brest.

The Mediator was judged in a civil court
to be a defective product.

A criminal procedure is underway.
No judgments have yet been issued.

July 29, 2011 a law passed
current mediator victims.

On January 25, 2011, approved
appeals court in Rennes...

Subtitle: "How many killed?"

AFSSAPS was reformed for increased security.

Two laws gave new administration
and financing...

...for increased transparency and enhanced ethics.

Subtitles by FatPlank for KG