Part 3 Storyville

-And how are you?

-I am fine.

That's very good.

This programme contains scenes which some viewers may find upsetting.

Paolo Macchiarini had created headlines

all over the world

when he implanted the first plastic trachea into a human being.

-REPORTERS:

-What seems like the plot from a science-fiction novel...

We're just a few years away from this happening -

all new organs being built in a lab.

Karolinska's star surgeon seemed to be about to solve

one of the great challenges of the medical world.

-REPORTER:

-Ground-breaking surgery gave a man back his trachea...

But something was wrong.

It is not collapsing.

The plastic tracheas were not working as they should.

When patient after patient died,

doctors began to wonder what was going on.

By 2015,

Macchiarini's operations were under investigation by the police.

The management at the world-famous Karolinska in Stockholm, Sweden

had already been alerted to evidence that their star employee,

Macchiarini, had been falsifying scientific reports

and risking patients' lives.

I had come to realise that this story is about so much more

than just Paolo Macchiarini.

How valued is a human life at the cutting edge of research?

Does a human life have a price?

I didn't do anything wrong.

I just did my job.

I had been following Paolo for almost a year

and, still, so many questions remained unanswered.

It seemed Paolo had been performing deadly experiments on human beings.

But would he really have intentionally endangered

his patients' lives?

During my year of filming, I followed him all over the world.

On one of his journeys,

he met an old friend and fellow surgeon.

I was contemplating the criticism against Paolo...

..that the risks he'd taken had been too big...

..that he hadn't been sufficiently prepared...

See? Just on time.

..and that he hadn't told the truth afterwards.

Paolo remained quiet.

But his colleague, Gebitekin,

gave his thoughts on what made a good surgeon.

A good surgeon makes careful preparations in advance...

..leaving as few unforeseen problems as possible.

But was this the case with Paolo's plastic trachea patients?

Most of them were dead.

It was at the Karolinska Institute

where Paolo's plastic trachea method had been created.

Grinnemo and Corbascio had been collaborating

with Macchiarini's team for years.

Both had made contributions to Macchiarini's scientific studies.

But after a while, a conflict arose,

concerning applications and grants...

..and the collaboration ended.

During 2013,

more and more people at the hospital realised that Paolo's patients

weren't in a good condition.

Grinnemo and three of his colleagues became convinced

that there were serious issues with the plastic trachea.

But Paolo portrayed his method as successful.

There was a risk that it would still be attempted in other countries.

Paolo was reported for alleged

scientific falsification. His entire credibility was at stake.

He could end up in prison.

I was attacked brutally and, er...

vehemently,

with unfounded...

..allegations, that they involved them myself, so...

..we need to clear the name of everybody.

And that's why I'm fighting for it.

The hospital seemed to be taking Paolo's side.

A police report was filed and one of the doctors was questioned.

He and his three colleagues who had made the complaint were threatened

with an official warning from the hospital.

The Karolinska Institute responded with silence but, eventually,

they appointed an independent investigator.

Bengt Gerdin was commissioned to assess Paolo's scientific papers.

Bengt Gerdin compared Macchiarini's scientific papers

with Karolinska's patient records.

By May 2015, Gerdin's work was complete.

Gerdin concluded that Macchiarini

was guilty of scientific falsification.

The news made global headlines.

If Paolo was found guilty,

his research papers would probably be retracted.

It could spell the end of his research work round the world.

I have been depicted on the one angle,

which is the angle of the media,

as you said, as a criminal,

as one that doesn't care about anything and so forth,

which is totally untrue -

not according to me, but according to the facts -

and people have this perception.

But it hadn't been settled yet.

The Karolinska Institute still hadn't taken an official decision

as to whether or not they would act on Gerdin's recommendations.

Paolo's only chance was to prove to the Vice Chancellor

that he hadn't falsified his results.

I don't have that much time, so we need to hurry up.

In the last year, I have been attacked so many times.

My conversations with patients have been recorded,

my finances have been investigated,

My animal logbooks have been scrutinised

and my research data re-evaluated.

It's difficult. It's difficult to be attacked and be on the front pages.

At least we would have done something wrong,

then I would understand it,

but I believe we didn't, so let's wait tomorrow.

August, 2015.

The day for the decision had arrived.

A lot was at stake.

Karolinska Hospital had approved his method of surgery...

..and the Karolinska Institute had vouched scientifically

for his research.

If Paolo fell,

the whole of Karolinska was at risk of falling with him.

I couldn't quite believe what I heard.

The Vice Chancellor had cleared Paolo of almost all the accusations.

The Vice Chancellor stated that this decision was based on new evidence

submitted by Paolo and his collaborators.

But these additions had only been assessed internally,

by Karolinska's management.

The independent investigator, Bengt Gerdin,

had not been asked to examine them.

As I read through the new documents,

I found no real explanation to the Vice Chancellor's decision.

I had now followed Paolo over an extended period

and I had seen far too much.

Out of all of Paolo's plastic trachea patients,

only two were still alive.

Dmitri Onogda's plastic trachea never functioned...

..but it was removed and he survived.

Yasim Cetir had been close to dying many times.

In order to survive, she now needed constant intensive care.

The other patients had died.

Andemariam Beyene.

Christopher Lyles.

Alexandra Zozulya.

Sadiq Kanaan.

Hannah Warren.

And Julia Tuulik.

It was as if nothing had been learnt from their deaths

and Paolo was allowed to carry on his work.

I very much enjoy the fact that now...

..we are, again, back to science and clinic...

..and not

lawyer stuff and so forth.

So, that's a good thing.

Interesting. How fast do you think you can be moving, for example,

with the trachea now? What's your time?

Well, the timeline is that...

..we would like to wait the six months...

..follow-up time, which would end probably in March,

if everything goes well. And then, immediately start with the...

..non-human primates.

Probably by the end of next year...

..it would be reasonable to think to restart the feasibility

and then the clinical trial.

Only a few weeks had passed since the acquittal...

..and Paolo was already planning new operations on humans.

When I began to film Paolo nearly a year earlier,

he had made a demand...

..that I wouldn't ask about the accusations

until Karolinska had made a decision.

Interesting. Something you can talk about?

No, because the deal was that we would not talk about this.

You remember that?

The day had finally come.

I had gone over everything I knew about Paolo and his operations.

How are you?

I am...fine.

That's good.

I knew that this was likely to be the last interview

I would ever get with Paolo.

I needed answers.

Had Paolo intentionally risked the lives of his patients?

A few months earlier,

I had met a doctor who had prepared Paolo's tracheas,

ahead of the operations.

Philipp Jungebluth had had Paolo as his mentor during medical school...

..and he was now Paolo's closest colleague.

Philipp Jungebluth is... almost a son of mine.

Probably he is, right now, the most hard-working man that I have,

so thank you, Philipp.

Philipp explained how they'd been thinking at the start.

But it took some time before I really understood

what he was saying.

I mean, of course, this system cannot be perfect

at the early years, in the early moment of this new technology,

and you can just learn it in the clinic.

Some parts of it, at least.

It seemed as though they had decided, early on,

to develop the method, in part, on the operating table,

instead of thoroughly testing it,

as one normally would with new and dangerous methods of treatment.

The first plastic trachea was a big step into the unknown.

We did not test it prior to transplantation,

prior the first transplantation, because there was no time.

We had this patient, we had this scenario, this acute scenario,

where we know that, OK, we cannot wait half a year.

So, the plastic trachea hadn't been implanted in animals

before testing it on the first human being.

Therefore, it was a gamble when they put a plastic trachea

into Andemariam Beyene.

And they would continue to gamble.

At least three, probably four, more patients

would receive plastic tracheas

before they had been tested on a single rat.

There were a couple of tests of plastic tracheas on rats,

here at the KI, that were started sometime...

August 2012 or something like that.

Is that the animal work on synthetic tracheas that you've been doing?

We did animal studies pre-clinically in rats, with bio-deficent scaffold.

They are not published yet and we started before.

So, you have unpublished studies before that?

Yeah.

And that was at KI or..?

It was at KI, yeah.

'But I couldn't find any such animal tests,'

nor could I find any approvals.

Because if you just look at what is published

-and what has been approved of, for experimentation...

-Mm-hm.

..it's only those two rat...

-..rat experiments.

-OK, so what?

-What do you want to say?

-Because, before the rats,

you put the synthetic scaffold into five patients.

To me, that seems extraordinary.

Before the rats, I put...

That's a wrong statement.

But if I just look at the chronology,

I see five surgeries,

no rats,

-no pigs, no animal experiments. And, then, animal experiments.

-Uh-huh.

I mean, should I not ask that?

Are you sure about this? Are you sure about this?

Why you don't go to the lab and you look at data in a lab book?

Here or in Russia?

How do you know that we didn't do animal studies in Russia?

When I confronted Paolo, he simply changed his story.

He had no longer carried out these unknown animal studies in Sweden,

but somewhere in Russia.

But, despite not having tested the trachea on animals

before implanting it in the first humans,

the management at the Karolinska Institute still claimed this

to be the case.

In a document from autumn 2013,

they wrote that all surgeries were preceded by all the necessary lab

and animal tests.

'Johan Bratt doesn't want to explain how they had

'skipped over the animal tests.'

'And to Paolo, the question only seemed to provoke annoyance.'

I've been scouring the published field for synthetic rat tracheas...

We didn't do any animal study that involves large animal,

of course not. We didn't have the time.

But the material was proven, the material was studied.

We used fibres that were approved by the FDA.

And now, all the studies are coming.

If you have a clinical situation where you are...

..forced to take a risk, then you take it,

if you see any chance to help the patient.

Paolo's point seemed to be that he had been forced to take shortcuts,

as his patients had been so seriously ill.

His employers agreed with him.

The hospital and the Institute claimed the same thing...

..that Macchiarini's plastic tracheas

saved the lives of those who were acutely ill and dying.

But how short should life expectancy be for any hospital to resort

to unknown and untried methods?

What was really the case with the first plastic trachea patient,

Andemariam?

How ill was he when he underwent surgery?

Andemariam had previously had a slow-growing cancer in his trachea.

He'd been operated on and received radiotherapy and, at first,

it had seemed successful.

But at a routine examination,

his doctor had discovered a growth in Andemariam's throat.

The doctors felt they were not able to handle his case in Iceland

and began to look for specialist help.

Karolinska Hospital suggested Paolo Macchiarini.

From this point, the stories begin to differ.

One patient was referred from Iceland

that was given a life expectancy of six months.

We decided that there was a risk of suffocation.

He was very short of breath when he arrived in Stockholm.

He could not really speak one sentence without stopping...

He had this... HE MAKES RATTLING BREATHING SOUND

We were in need of something now and not tomorrow.

Jungebluth, Macchiarini, Hamsten and Bratt

describe his condition as acute.

But this wasn't Andemariam's view of it.

When he wasn't busy with examinations,

he often left the hospital.

He met friends and went for long walks.

They went to cafes and restaurants.

And Andemariam was well enough to travel to some friends,

up in Sundsvall.

When he spoke to Icelandic television, he didn't seem

to believe that his condition had needed urgent treatment.

When I was going from Iceland to Sweden, I didn't know that it would

be such a big operation.

But then, when I met the doctor, the Italian -

Dr Paolo - then, he said...

.."It will be removed at the throat

"and we will put another one, but this will be synthetic."

At the press conference, one year after the operation,

Paolo remembered their meeting.

The first reaction was just to look at me, to say, you are crazy.

And he said, "Well..." and I said, "Yes, I am."

I was very scared, very terrified.

And the other thing which made me a bit scared was that...

..this was happening for the first time.

"How much is the success rate?"

And I said, "I don't know."

"Why?" "I never did it before."

I said, no. I just said, no.

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

Andemariam had not seen his condition as acute

and he'd been terrified of the operation -

the first one of its kind in the world.

And yet, he agreed to it.

He told me straight, you know, "We did not try this to a human being.

"We tried this into pigs and animals",

so maybe it was working for the animals, so...

Andemariam had believed the tracheas had already been tried on animals,

even though this wasn't the case.

And this is also what his widow, Merhawit, believed for a long time.

Paolo had given Andemariam a certificate to sign.

It said that the surgery was his only chance of survival.

He was very confident.

Enough to make me persuaded,

to make me believe in this.

Andemariam lived for two and a half years with the plastic trachea.

We know for sure that Andemariam's cancer was a very relatively

slow-growing type.

No-one knows how long he would have lived

if he had declined the plastic trachea.

I don't see that there was a clear-cut...

-..acute...

-You are insinuating that we took a decision,

we doctors, or whoever, that was not necessary,

above the line.

That's a huge accusation.

And what would your reply be?

I don't reply to this accusation.

Why you don't ask all these

health care providers that are here at KI?

Because you didn't.

Obviously, I will, I will. But you are...

I think that's courtesy to ask you.

I am, I am, I am, I am. I mean, I'm not God, I'm not above the line.

I am a man, a human being, that does...

..mistakes all the time.

But do you see why I ask you?

-I mean...

-No, I don't see it. It's...

That's a visit from you that I didn't expect.

Andemariam's operation became Paolo's most important.

It was through this surgery that his technique became known to the world.

-REPORTER:

-In Sweden, they've carried out the world's first transplant

of a synthetic organ...

And in the articles from the first year's outcome,

it says that the plastic trachea was functioning better and better.

But Andemariam's autopsy report had shown that the trachea

was actually heavily inflamed,

full of dead tissue and that it had become almost completely loose.

Could something that had ended so badly

really be as positive as Paolo had depicted?

Or did Paolo not describe the whole truth in his articles?

In August 2011, Andemariam was examined in Iceland.

The work carried out there makes up an important part

of the scientific base for the first article on his plastic trachea.

This is two months after the operation and the Icelandic doctors

were about to examine Andemariam's plastic trachea.

With a little pair of forceps,

they attempted to cut small fragments

from the surface of the plastic,

in a so-called biopsy.

But it seemed difficult to cut any tissue samples from the plastic.

In the end, they only managed to cut off a few tiny pieces of plastic.

When the pieces were analysed,

individual cells were found.

They were not healthy trachea cells but, in theory,

could possibly generate them.

Most of the tissue was dead,

infected and covered in fungus.

But in his article, Paolo exaggerated the few positives,

claiming that large portions of tissue seemed to be on their way

to develop into a healthy trachea.

He also wrongly stated that the plastic trachea was completely free

from fungus and bacteria.

Since the Vice Chancellor had himself exonerated Macchiarini

from dishonesty in his reports,

he ought to have been able to answer this.

But Hamsten still seemed convinced

that the discrepancies were mere details

and believed that the surgery had been a success.

But Andemariam's wife, Merhawit, has a very different view.

She says that, even if Andemariam had only lived a few more months

without the operation,

it would still have been better than suffering for two and a half years.

Merhawit's side of the story isn't represented

in Paolo's scientific works.

In one of his articles,

he describes the state of Andemariam's plastic trachea

after one year.

In the article, Macchiarini claims that his patient

had "an almost normal airway".

This is how a normal airway should look.

Here you see lots of small blood vessels -

they are keeping the trachea alive.

Everything is covered by fine pinkish membrane,

but when I see a film from Andemariam's examination

shortly before the anniversary,

I wonder how anyone could say that he had an almost normal airway.

The camera is on its way down through a tube

in Andemariam's throat.

Deep down, you can see something white,

the edge of the plastic trachea.

Down in the plastic part, you can see mucus,

which Andemariam is unable to cough up.

And to the left, where the plastic meets the natural trachea,

it's bleeding and pulsating.

And there is a hole, a hole directly into the rest of the body -

a so-called fistula.

This is what a healthy airway looks like.

And this is how the same area looks down towards Andemariam's lungs.

The little black dot near the middle of the picture

is all that remains of Andemariam's airway.

The rest is clogged up by scar tissue.

The right lung is more or less cut off.

The doctors are forced to pull off large bits of scar tissue,

in order for it to open up.

They also need to insert a metal net, to keep the airway open.

There is nothing about this in Paolo's article.

The only thing it says is that the airway is almost normal...

..and that his lung function has improved.

I've been going through these articles so many times

about the first operation and the biopsies, the broker's copies,

everything, and the article doesn't seem to reflect the real situation

with the patient.

OK, then why you don't ask the commission that has evaluated

all the documents?

No, but I have to ask you, because you are the main author.

-Yes.

-And it's your work.

-I am the senior author and I have

provided written, compelling evidence

that contrasts what you're saying,

so I don't need to restate this very bad episode of my life, please.

I hope that you understand.

In your statement, I don't see that you actually refuting

the actual faults from the records.

I don't see that you're showing the opposite.

Yeah, it was actually vascularised,

it was actually covered by epithelial...

Why you don't complain to the Ethical Commission or to the KI?

I don't know what you're arguing here.

When Hamsten and his colleagues cleared Macchiarini,

they sent an important message to the rest of the world.

What had been written in Macchiarini's articles

was substantially true.

Hence, they supported Macchiarini's claims

that Andemariam's plastic trachea

was about to develop into a normal airway.

But the film from the examination has clearly shown

that one of Andemariam's airways was almost completely closed off.

And that they'd had to remove

scar tissue and insert a metal net.

These discrepancies in Macchiarini's articles are just two of many

that were discovered and reported to the Karolinska Institute

by the four doctors.

Karolinska Hospital and Institute received several warnings

but failed to raise the alarm.

And at this time, Karolinska was still fully supportive

of Macchiarini and his research.

Research which had made Macchiarini's method

known around the world.

-NEWSREADER:

-..gave a man back his trachea and his life.

We're just a few years away from this all happening -

all the organs being built in a lab.

This is a major achievement for every other patient

that would need this type of transplantation.

We have now a clinical trial authorisation in Russia,

another one in...

The events at Karolinska had repercussions outside of Sweden.

For patients who were almost completely healthy...

..patients like Julia.

She might have had a long life ahead of her...

..and still she agreed to a potentially fatal operation.

She was hoping Paolo would conjure up her old self...

..but she seemed unaware of the enormous risks

the surgery posed to her.

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

This is medical grade.

So, we know this material is very safe.

Nor did Julia seem aware

of how badly it had turned out for her predecessors.

And that there was a risk she might die.

You're in very good hands. Paolo is the best surgeon in the world.

-I know.

-You know?

You're right.

Paolo has published hardly any facts from Julia's operation.

But in interviews after the operation,

he was quick to claim it was a success.

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

she couldn't breathe and talk normally.

After the surgery, Julia had a long struggle ahead of her -

one that she couldn't win.

Slowly, her condition worsened.

The plastic trachea didn't work...

..and Macchiarini implanted a new plastic trachea in Julia.

When Julia had only months to live,

Paolo appeared on German television...

..and he gave a very different picture of Julia's condition.

Five months later,

Julia died.

Two months after her death,

Macchiarini wrote to the journal Nature.

He said that Julia's trachea had been examined weeks before death

and claimed that there was nothing wrong with it.

You can live a long life with a tracheostomy.

I wondered what Paolo's thoughts were on this.

Had he informed Julia of all the risks?

The patient may say, "Yes, that's fine,"

-but the responsibility...

-Patients are not idiots,

they are very intelligent, you need to respect that.

That's not nice what you're saying.

Patients understand very well,

because they are told what to do and what not to do...

..that you can stay with a hole...

..that you might have a trachea that works or not,

that there might be complications and so forth.

Absolutely, but you feel, you personally,

you feel no doubts?

You don't feel regret or maybe, "I shouldn't have done this"?

Of course, I have doubt. All the time, I have doubts.

Even if I'm going out, I have doubts I should have done

this interview or not.

Come on, I mean, we are doing such very complex innovative things

that I'm struggling and thinking, 'Should we do it really or not?

'Is she or he the best candidate or an appropriate candidate?'

You really think that we are beasts?

I began to realise that Paolo

was not going to give me any more answers.

If you feel I wasn't safe, then I accept your opinion.

What's your opinion?

I already said what was my opinion.

The most I got were counter-questions.

-I've seen all...

-Did you?

Sorry to insist, now I am the journalist.

-Did you see that?

-Or perhaps, he just didn't want to answer me.

There's no reference.

But maybe, they are stored in a different compartment. Ask KI.

But I just couldn't understand

how Paolo can implant a plastic trachea in Julia

without first having tested it on one single animal.

So, your profession is?

-How do you mean?

-What are you doing as job?

You have to explain what you mean.

You are producer?

TV producer?

How can you possibly understand all the details

of a medical evaluation?

And you know all the details of a medical evaluation.

No, of course not.

So if there were, I don't know,

about 10 to 20 health care professionals,

health care providers, that decided

that this was the most appropriate procedure for her...

..then I believe we can trust them.

Perhaps Paolo actually believes he hasn't committed any mistakes

and that in order to progress, you have to experiments on humans.

Jungebluth's view was that certain things could only be learned

on the operating table.

But if I understood you correctly, your assessment is also that the...

..synthetic scaffold don't really work at the moment.

Of course, this is the reason why we stopped the clinical trial

and we are on hold to have a better scaffold.

But you see no problems with the road to coming to that conclusion?

-What?

-You see no problems with, with...

Listen, if you don't do things, then you probably will never have...

..such conclusions, right?

If you just do reporting without doing it,

you will not report, so,

of course, we have experienced...

..complications but we have learned a lot from them, as well,

so that possibly the next patients,

everything will be better, much better.

So, Paolo has learned that the plastic tracheas don't work

but to him, it's been worth it.

And at the time, it seemed as if representatives from Karolinska

were of the same opinion.

Richard Kuylenstierna was one of those who authorised

the first operation on Andemariam.

In Russia, they were also initially enthusiastic

about the plastic tracheas.

Igor Polyakov operated on Julia, together with Macchiarini.

He really believed that it would work,

since Macchiarini had the stamp of approval

from the Karolinska Institute.

Without that, the Russian trials might never have taken place.

In Russia, they now know that everything went wrong,

not least in Julia's case...

..and they dare to admit it.

While in early 2016 at Karolinska,

it was almost as if nothing had happened.

Perhaps because at the time,

the hospital still hadn't fully investigated

how they could put patients through treatment methods

that hadn't even been tested on animals.

Perhaps because, at the time, the Karolinska Institute

was still standing by Macchiarini's research work.

After this interview in February 2016,

Hamsten would distance himself from Paolo's work in Russia...

..and he maintained that Karolinska was not responsible

for the way Paolo's methods had been adopted there.

You're insinuating that everybody in the group has lied,

which is very bad from your side.

I didn't expect that. Wow.

And even the president has lied, even the commission has lied,

everybody has lied.

Maybe something is wrong in your assumption

or in your statement.

But I'm just using my brainpower

-and I'm trying to find the facts that show...

-Well, then,

maybe you should look and search more before doing this interview.

Think so. So, please, let's stop here now.

Ever since I first met Paolo, I've been curious about him.

Everything he described sounded so good.

Almost too good to be true.

Welcome to this session.

After this series was first broadcast in Sweden,

it created intense pressure on the Karolinska Institute

and the University Hospital.

After an initial period of denial,

the Vice Chancellor Hamsten resigned.

The board of the Karolinska Institute, as well as Lendahl,

the permanent secretary of the Nobel Committee,

have now also stepped down.

Paolo Macchiarini had his contract and research group terminated.

Internationally, more than ten inquiries have been opened

and Swedish prosecutors are investigating

whether to press Macchiarini with charges

for involuntary manslaughter.

But the most important question of all remains unanswered.

How could top universities and hospitals

support everything that happened for so long?

I can't help wondering...

..is the reputation of the medical establishment

worth more than a human life?