Part 2 Storyville

Star surgeon Paolo Macchiarini was the first in the world

to surgically implant a plastic trachea in a human being.

The ground-breaking surgery

gave the man back his trachea and his life.

He promoted a future with more organs made of plastic,

such as hearts and lungs.

..a few years away from this all happening,

all organs being built in a lab.

But privately, Macchiarini started to discover faults

with his tracheas...

So I think that we need to redo everything again.

..and patients were beginning to die.

I didn't do anything wrong.

I...just did my job.

But despite the faults,

Macchiarini made plans for new operations with plastic organs.

If he succeeded, he would be revolutionising the medical world.

But if not, it would be one of the most spectacular falls

in the history of international medicine.

You are crazy.

Does a human life have a price?

I didn't do anything wrong.

I...just did my job.

By spring 2012,

the atmosphere was tense in Macchiarini's lab

at the prestigious Karolinska Institute

in Stockholm, Sweden, home of the Nobel Prize.

It was here, amongst other places,

that Macchiarini tried to solve the problems

that had recently been discovered with the plastic tracheas.

Paolo was now fighting to succeed.

In his view, it wasn't the plastic trachea

which had caused the death of the patient,

but the patient had simply been too ill.

For clearer results,

he wanted to try his method on stronger, healthier subjects.

People who were not fatally ill.

Despite the method having been tested so little,

Paolo had managed to achieve something nearly impossible.

He was granted permission to start a clinical study on humans.

The first trials would take place in Russia.

For some time, they had searched for the right volunteers here.

Many candidates pitched their case for treatment

and the Karolinska Institute in Stockholm

had assisted in making the final selection.

Julia Tuulik had been chosen to be the first experimental subject.

She was asked to record a video,

explaining why she wanted the operation.

Both Julia and Paolo were now heading towards the hospital

in Southern Russia.

At this point, Paolo's international reputation was at its peak.

A German TV crew was recording a documentary about him

and his operation on Julia.

This footage is taken from their unedited material.

The recordings give a unique insight into Paolo's medical experiments.

The more I saw, the more questions I had for Paolo.

But I would have to wait a long time before I could put them to him,

and only after I had looked through all his past experiments.

It all began four years earlier for Julia.

She and her husband at the time were driving

when a truck crashed into them.

Miraculously, they survived.

Julia was pregnant

and she would put up with just about anything to protect her child.

In order to speak,

Julia had to cover the hole in her throat with her hands.

You can live a long life with a tracheostomy.

But the hole in her throat bothered her...

..and she wanted to be her old self again.

During the last leg of the journey,

Julia was interviewed by the interpreter for the German crew.

-Come in.

-Come in.

This is the German physician Philipp Jungebluth -

Macchiarini's right-hand man.

It was he who prepared the plastic tracheas.

First, bone marrow was extracted from Julia's hipbone.

The cells were mixed into liquid,

which was then poured over Julia's new plastic trachea.

The trachea was left to rotate for several days.

A number of tracheas were prepared as extras.

LAUGHTER

With one day to go before the operation,

Paolo arrived.

Let's go.

-Here you go.

-OK.

Do you want something? Cup of tea, coffee, water?

-No, no.

-No?

-I just want to talk to...

-To...?

-Igor.

Igor, OK. Please take a seat.

Igor Polyakov was going to operate together with Macchiarini.

Nice to meet you.

Let's go, then.

This was beginning to sound worrying.

It seemed like all the plastic tracheas

had something wrong with them.

And yet, no-one seemed to consider cancelling the operation.

Instead, everything continued as planned.

Now Julia was going to find out how the plastic trachea works.

David Green, the president of the American company

which made the bioreactor, would explain this to Julia.

-Hello.

-Hello.

-Is it OK to come in?

-Yes.

-Yes?

-I'm David.

-Julia.

David Green. Nice to meet you. Can I sit here?

So, Olga and Victor told me that you would like to see

the trachea scaffold and the bioreactor.

So...

So, these are sterile.

But this is exactly the same as what will go into you tomorrow.

So when the doctors came two months ago...

You can touch it. You can feel it.

When the doctors came two months ago,

they took the scans, the CAT scans of your neck...

..and this is made to the exact dimensions.

But this has no cells.

Your trachea has cells and blood vessels.

So, when this has the cells on it, it will look like normal tissue.

It is plastic.

It is the same plastic that this bottle is made from.

It says on the bottom here, for recycling, it says PET.

This is the same plastic.

But this is food grade.

This is medical grade.

So this is much, much purer.

This is just...

..for industrial use.

So we know this material is very safe.

And this, you cannot get, naturally.

So we have to make it. But I can show you.

So, this is Mr Andemariam Beyene.

Did you hear about this?

He received his trachea one year ago.

Very similar.

Very similar to this.

We all went to Iceland with all the surgeons

to make a celebration,

like, a one-year birthday party for him.

One week earlier, David Green had been to Iceland,

where he took the photo he showed her.

In the photo was Andemariam Beyene,

Paolo's first plastic trachea patient.

Green and Macchiarini's team had travelled there

to celebrate the one-year anniversary of the operation.

It is, of course, a big moment for both us,

the team here in Iceland,

and, of course, the team in Karolinska...

They had held a press conference about the operation.

Back then, nobody knew that we would be here,

one year later, in Iceland, to celebrate this anniversary.

So it's a huge clinical milestone.

When I saw him the first time,

he asked me, "What you want to do with me?"

I explained to him.

His first reaction was just to look at me

and say, "Well, you are crazy."

And he said...

Well, I said, "Yes, I am.

"But this is the only chance you have right now."

But at this point, one week before Green's visit to Julia,

Macchiarini knew there was also a fault with Andemariam's trachea.

He had made this discovery earlier that spring.

But this seriousness of the situation

was covered up during the press conference.

Was there a wish to portray the operation

as a greater success than it really was?

In fact, Andemariam had not been very well at all.

His wife Merhawit remembers that it seemed to have been a success

right after Andemariam had received his new trachea.

But slowly it had become clear that all wasn't as it should be.

These events have been so painful for the family

that Merhawit doesn't want herself or the children

to be shown in this documentary.

COUGHING

Merhawit also remembers the one-year anniversary

and how the operation was portrayed as a success.

In reality, shortly before the press conference,

Andemariam had been forced to fly to Sweden for treatment.

The examination filmed from the Karolinska Hospital

shows inflammation

and an increasingly problematic trachea.

He'd had trouble keeping his airways open,

and he had coughed up blood and mucus.

They had to insert a steel net in order for him to breathe.

Paolo was the responsible consultant at Karolinska.

Surely he couldn't have missed this?

What we saw in Karolinska is that, um...

..after so many hours, the scaffold are very, very...soft,

so they need to be dry before implanting,

because otherwise they will collapse completely.

What did Paolo's team here in Krasnodar know about the problems?

Could they have told Julia about the risks?

You can touch it...

Did Green lead Julia to believe that everything was tried and tested?

So we know this material is very safe.

Could he have focused more on the risks?

So this can turn like this, to turn it around,

and this is mounted in here,

and then the stem cells are poured in here,

and this rotates very slowly.

So they are in the bioreactor for two days.

It is completely sterile and then it's done.

And then tomorrow, they will put this into you,

but after it goes in, it still has no blood supply,

so it takes about seven days

for your body to grow new blood vessels through the scaffold,

and then it will be your new trachea.

It will be just like this -

you'll be sitting in bed, lying in bed.

You are in very good hands for the next seven days.

Paolo is the best surgeon in the world.

There is no-one better who can do this surgery for you.

-I know.

-You know.

You're right.

Very nice meeting you, Julia.

-Bye-bye.

-Bye. Thank you.

You're welcome.

This is the final brainstorming before the transplantation.

Julia, tomorrow, will be the first patient

entering a clinical trial.

We need to go through every single step.

When I watched this, I wonder why it all seemed so rushed.

This distance should be covered.

We need to give credit to Professor Porhanov.

The pressure that he and I have

from different ministry authorities is extremely high.

They want that this will be a success.

And I am confident that we will do the best.

Was it the pressure from ministers and financiers

that made Paolo push on?

If we could do the transplantation

by just doing...through a cervical incision only,

this would be a major achievement.

I mean, she will be going, making interviews

and so forth and so forth, and if...

SPEECH FADES

Shortly before the operation, Paolo and Julia finally met.

-You look beautiful.

-Thank you.

Even if Julia had been informed that this was an experiment

and perhaps also signed a document,

she doesn't seem to have understood the risks she was about to take.

Not even her Russian doctor, Polyakov,

actually seemed to have been informed

of the setbacks Paolo's method had had.

We have to...we have to know their wishes.

OK, so this is the zone...forbidden, OK? OK.

Any scars, but...out of this zone.

The time had finally come.

Paolo would have the opportunity to implant the plastic trachea

in a patient who quite possibly had a long life ahead of her.

Suction.

Stop ventilation.

You just keep it...

Good, good.

Congratulations to everybody. Really.

It's also plastic, so it's really tricky.

Just a few days later, a press conference was called.

APPLAUSE

Julia? Julia...

This is Julia.

Eto Julia.

When I met Julia, she was not able to play with her child.

It was a very emotional moment for me.

RUSSIAN INTERPRETER SPEAKS

And I immediately said, "This is the right patient."

And I still do not believe that a few days ago,

she couldn't breathe and talk normally.

So, um, she's a little bit afraid of you,

so please be very sweet.

INTERPRETER SPEAKS

She can... She can...

She can answer all the questions that you would like.

APPLAUSE

APPLAUSE

It seemed like an all-round success.

Julia was seemingly on the road to complete recovery

and Macchiarini could show off

a ground-breaking plastic trachea transplantation

to the media, ministers and financiers.

Now, he could continue doing research and performing operations.

Igor?

-Cheers.

-Cheers.

LAUGHTER

Borscht, maybe?

Another patient had been operated on almost immediately after Julia.

His name was Alexander Zozulya.

The operation was viewed on TV in an adjacent room.

Here was American paediatric surgeon Mark Holterman.

Together with Paolo,

he would soon implant a plastic trachea in a child.

Parallel with the trials in Russia,

Paolo continued to implant plastic tracheas

in patients who were seriously ill.

The operation took place in the US on two-year-old Hannah Warren,

born without a windpipe.

-It's OK.

-Don't worry about it.

And then there was one more patient-in-waiting.

22-year-old Yesim Cetir from Turkey.

Yesim was not part of the Russian trials

but was operated on at Karolinska Hospital in Stockholm,

where Macchiarini's plastic trachea transplants had first begun.

Yesim's operation to replace her own damaged trachea failed.

The plastic trachea wouldn't take hold

and it lost its shape.

It had to be cleaned every four hours

to prevent her from suffocating.

After a year, Yesim had a new plastic trachea implanted,

but matters didn't improve.

In the end, Yesim stayed in hospital for over three years.

Hannah Warren also remained in intensive care.

She died three months after having received her plastic trachea.

The condition of Andemariam,

Macchiarini's first plastic trachea patient,

also worsened.

He felt that there was something wrong with his trachea,

and he tried to reach Macchiarini.

Not only the patients felt that Paolo wasn't there

when they needed him.

While Macchiarini travelled across the world,

the hospital staff back in Stockholm were left to deal with the patients

and their severe complications.

One of the doctors dealing with Paolo's patient was Thomas Fux.

Now, even the management started to have issues

with Macchiarini's methods.

In October 2013,

his transplantations were stopped at Karolinska Hospital.

But since Paolo's experimental work had been suspended,

his patients were left without specialist help.

Thomas Fux tried to fill the void.

He and his colleagues would now make a very surprising discovery.

Their suspicions about Paolo's reports

were about to be confirmed.

Andemariam returned one last time to Karolinska.

SHE CRIES

Andemariam Teklesenbet Beyene passed away in January 2014.

From the autopsy report,

the doctors now discovered the truth about his plastic trachea.

There were no signs that a new organ had been created -

only inflammation and dead tissue.

The plastic trachea was so loose that it could simply be lifted out.

It was far worse than the doctors had ever imagined.

They decided to compare the test results

of the plastic trachea patients in Sweden

to the way they had been described in Macchiarini's scientific reports.

They soon discovered a pattern.

There is information about certain problems in Macchiarini's work,

but nothing about the many times

Andemariam needed emergency treatment

and nothing about a chronically infected trachea

that eventually came loose,

or about the fact that Yesim had endured

more than 7,000 examinations and operations.

The doctors now alerted their superiors at the Institute

and the University Hospital.

Macchiarini's operations had been stopped in Sweden.

But Fux and his colleagues were worried that the flawed procedures

would still take place in other countries,

placing more lives at risk.

The doctors asked their superiors

to alert the medical world to what had really been going on.

Otherwise, other patients risked receiving Paolo's plastic trachea.

Others like Julia.

She was one of the patients meant to prove that the method worked.

How was her recovery after the operation?

This is something Macchiarini has said very little about publicly.

A few days ago, she couldn't breathe and talk normally.

APPLAUSE

This is the last footage I saw from the German recordings.

Watching this footage

had generated many questions I wanted to put to Paolo.

But first, I had to follow this story to the end.

I suspected that I would only get one more chance to interview Paolo.

When he and his team flew off to the next operation,

everything went back to normal...

..for everybody except for Julia.

Julia spent as much time as she could with her son,

but everything wasn't as it should be.

Julia had to be rushed back to the hospital in Krasnodar

to get help.

Her surgeon told me what had gone wrong.

First, the problem with the scaffold.

It collapsed.

It collapsed over time.

Polyakov had to insert a steel net into Julia's trachea

to prevent her from suffocating.

She remained in Krasnodar for months.

Without the plastic trachea,

Julia might have had a normal lifespan.

But the situation continued to be life-threatening.

Julia was able to return home.

But she was constantly suffering from infections.

Macchiarini's team had no other solution

than to insert a new plastic trachea.

But it didn't help.

It was here in her apartment that Julia spent her last days.

Julia's sister-in-law remembers her final days.

Julia Tuulik died at home alone in September 2014.

It had been seven months

since the doctors of Karolinska had warned their superiors

that Paolo's methods could result in the death of his patients.

One might think that such serious warning signs

would have made the management at Karolinska act a long time ago.

But despite several meetings, e-mails and conversations,

they did not share these warning signs.

And in Russia,

Paolo's trials on almost completely healthy patients continued

with Dmitri Onogda.

The doctors got more and more frustrated

with their superiors' lack of reaction.

Therefore they decided to take drastic action.

They documented all the faults they could find

in a 400-page-long report

and filed it with the Vice Chancellor

at the Karolinska Institute.

Although lives were at stake,

it wasn't until nine months after the doctors' warning

that the Vice Chancellor of the Karolinska Institute

commissioned an independent enquiry.

What was going on in Karolinska Hospital

and the Karolinska Institute?

Were they trying to silence the doctors?

Did they not want to investigate Macchiarini's operations

and his research?

I had seen patient after patient die,

but according to Macchiarini,

the tracheas had nothing to do with the deaths.

He had presented all the facts correctly

and always been there for his patients,

but was this really the case?

In part three, Paolo will get to answer all of my questions.

Perhaps there's something I have missed.

Your profession is...?

Because she had so much...

Answer my question. Your profession is...?

-How do you mean?

-What are you doing as a job?

You have to explain what you mean.

You are... You are a producer, a TV producer, right?

How can you understand, possibly understand,

all the details of a medical evaluation?

-Now, I...

-You know all the details of a medical evaluation?

No, of course not.

But I've read all the documents with the investigation...

This is totally wrong, totally wrong.

You should revise your English.