0:00:02 > 0:00:04- And how are you?- I am fine.
0:00:04 > 0:00:05That's very good.
0:00:05 > 0:00:12This programme contains scenes which some viewers may find upsetting.
0:00:12 > 0:00:15Paolo Macchiarini had created headlines
0:00:15 > 0:00:16all over the world
0:00:16 > 0:00:20when he implanted the first plastic trachea into a human being.
0:00:20 > 0:00:23- REPORTERS:- What seems like the plot from a science-fiction novel...
0:00:23 > 0:00:26We're just a few years away from this happening -
0:00:26 > 0:00:27all new organs being built in a lab.
0:00:27 > 0:00:31Karolinska's star surgeon seemed to be about to solve
0:00:31 > 0:00:33one of the great challenges of the medical world.
0:00:33 > 0:00:36- REPORTER:- Ground-breaking surgery gave a man back his trachea...
0:00:36 > 0:00:38But something was wrong.
0:00:38 > 0:00:40It is not collapsing.
0:00:41 > 0:00:44The plastic tracheas were not working as they should.
0:00:51 > 0:00:54When patient after patient died,
0:00:54 > 0:00:57doctors began to wonder what was going on.
0:01:08 > 0:01:10By 2015,
0:01:10 > 0:01:14Macchiarini's operations were under investigation by the police.
0:01:15 > 0:01:19The management at the world-famous Karolinska in Stockholm, Sweden
0:01:19 > 0:01:24had already been alerted to evidence that their star employee,
0:01:24 > 0:01:28Macchiarini, had been falsifying scientific reports
0:01:28 > 0:01:29and risking patients' lives.
0:01:36 > 0:01:40I had come to realise that this story is about so much more
0:01:40 > 0:01:42than just Paolo Macchiarini.
0:01:43 > 0:01:47How valued is a human life at the cutting edge of research?
0:02:11 > 0:02:12Does a human life have a price?
0:02:15 > 0:02:17I didn't do anything wrong.
0:02:31 > 0:02:33I just did my job.
0:03:09 > 0:03:13I had been following Paolo for almost a year
0:03:13 > 0:03:15and, still, so many questions remained unanswered.
0:03:22 > 0:03:26It seemed Paolo had been performing deadly experiments on human beings.
0:03:28 > 0:03:31But would he really have intentionally endangered
0:03:31 > 0:03:32his patients' lives?
0:03:36 > 0:03:40During my year of filming, I followed him all over the world.
0:03:42 > 0:03:44On one of his journeys,
0:03:44 > 0:03:46he met an old friend and fellow surgeon.
0:03:51 > 0:03:54I was contemplating the criticism against Paolo...
0:03:55 > 0:03:57..that the risks he'd taken had been too big...
0:03:59 > 0:04:01..that he hadn't been sufficiently prepared...
0:04:01 > 0:04:03See? Just on time.
0:04:03 > 0:04:05..and that he hadn't told the truth afterwards.
0:04:07 > 0:04:08Paolo remained quiet.
0:04:10 > 0:04:12But his colleague, Gebitekin,
0:04:12 > 0:04:15gave his thoughts on what made a good surgeon.
0:05:10 > 0:05:13A good surgeon makes careful preparations in advance...
0:05:14 > 0:05:17..leaving as few unforeseen problems as possible.
0:05:20 > 0:05:24But was this the case with Paolo's plastic trachea patients?
0:05:25 > 0:05:27Most of them were dead.
0:05:34 > 0:05:36It was at the Karolinska Institute
0:05:36 > 0:05:39where Paolo's plastic trachea method had been created.
0:06:03 > 0:06:07Grinnemo and Corbascio had been collaborating
0:06:07 > 0:06:10with Macchiarini's team for years.
0:06:10 > 0:06:14Both had made contributions to Macchiarini's scientific studies.
0:06:19 > 0:06:21But after a while, a conflict arose,
0:06:21 > 0:06:23concerning applications and grants...
0:06:24 > 0:06:26..and the collaboration ended.
0:06:28 > 0:06:30During 2013,
0:06:30 > 0:06:34more and more people at the hospital realised that Paolo's patients
0:06:34 > 0:06:35weren't in a good condition.
0:06:39 > 0:06:43Grinnemo and three of his colleagues became convinced
0:06:43 > 0:06:46that there were serious issues with the plastic trachea.
0:06:59 > 0:07:01But Paolo portrayed his method as successful.
0:07:03 > 0:07:07There was a risk that it would still be attempted in other countries.
0:07:15 > 0:07:18Paolo was reported for alleged
0:07:18 > 0:07:22scientific falsification. His entire credibility was at stake.
0:07:23 > 0:07:25He could end up in prison.
0:07:25 > 0:07:28I was attacked brutally and, er...
0:07:28 > 0:07:30vehemently,
0:07:30 > 0:07:31with unfounded...
0:07:33 > 0:07:37..allegations, that they involved them myself, so...
0:07:39 > 0:07:41..we need to clear the name of everybody.
0:07:41 > 0:07:44And that's why I'm fighting for it.
0:07:44 > 0:07:47The hospital seemed to be taking Paolo's side.
0:07:47 > 0:07:51A police report was filed and one of the doctors was questioned.
0:07:53 > 0:07:57He and his three colleagues who had made the complaint were threatened
0:07:57 > 0:07:59with an official warning from the hospital.
0:08:02 > 0:08:07The Karolinska Institute responded with silence but, eventually,
0:08:07 > 0:08:09they appointed an independent investigator.
0:08:14 > 0:08:19Bengt Gerdin was commissioned to assess Paolo's scientific papers.
0:08:32 > 0:08:35Bengt Gerdin compared Macchiarini's scientific papers
0:08:35 > 0:08:38with Karolinska's patient records.
0:08:41 > 0:08:44By May 2015, Gerdin's work was complete.
0:09:02 > 0:09:05Gerdin concluded that Macchiarini
0:09:05 > 0:09:08was guilty of scientific falsification.
0:09:09 > 0:09:11The news made global headlines.
0:09:27 > 0:09:29If Paolo was found guilty,
0:09:29 > 0:09:32his research papers would probably be retracted.
0:09:32 > 0:09:36It could spell the end of his research work round the world.
0:09:38 > 0:09:40I have been depicted on the one angle,
0:09:40 > 0:09:42which is the angle of the media,
0:09:42 > 0:09:44as you said, as a criminal,
0:09:44 > 0:09:47as one that doesn't care about anything and so forth,
0:09:47 > 0:09:48which is totally untrue -
0:09:48 > 0:09:51not according to me, but according to the facts -
0:09:51 > 0:09:54and people have this perception.
0:10:02 > 0:10:03But it hadn't been settled yet.
0:10:05 > 0:10:09The Karolinska Institute still hadn't taken an official decision
0:10:09 > 0:10:12as to whether or not they would act on Gerdin's recommendations.
0:10:14 > 0:10:17Paolo's only chance was to prove to the Vice Chancellor
0:10:17 > 0:10:19that he hadn't falsified his results.
0:10:23 > 0:10:26I don't have that much time, so we need to hurry up.
0:10:33 > 0:10:36In the last year, I have been attacked so many times.
0:10:36 > 0:10:39My conversations with patients have been recorded,
0:10:39 > 0:10:42my finances have been investigated,
0:10:42 > 0:10:47My animal logbooks have been scrutinised
0:10:47 > 0:10:51and my research data re-evaluated.
0:10:51 > 0:10:56It's difficult. It's difficult to be attacked and be on the front pages.
0:10:58 > 0:11:00At least we would have done something wrong,
0:11:00 > 0:11:02then I would understand it,
0:11:02 > 0:11:07but I believe we didn't, so let's wait tomorrow.
0:11:14 > 0:11:15August, 2015.
0:11:16 > 0:11:18The day for the decision had arrived.
0:11:19 > 0:11:21A lot was at stake.
0:11:23 > 0:11:27Karolinska Hospital had approved his method of surgery...
0:11:28 > 0:11:31..and the Karolinska Institute had vouched scientifically
0:11:31 > 0:11:32for his research.
0:11:33 > 0:11:35If Paolo fell,
0:11:35 > 0:11:38the whole of Karolinska was at risk of falling with him.
0:12:18 > 0:12:20I couldn't quite believe what I heard.
0:12:20 > 0:12:25The Vice Chancellor had cleared Paolo of almost all the accusations.
0:12:42 > 0:12:47The Vice Chancellor stated that this decision was based on new evidence
0:12:47 > 0:12:50submitted by Paolo and his collaborators.
0:12:51 > 0:12:54But these additions had only been assessed internally,
0:12:54 > 0:12:56by Karolinska's management.
0:12:56 > 0:13:00The independent investigator, Bengt Gerdin,
0:13:00 > 0:13:02had not been asked to examine them.
0:13:04 > 0:13:06As I read through the new documents,
0:13:06 > 0:13:11I found no real explanation to the Vice Chancellor's decision.
0:13:13 > 0:13:16I had now followed Paolo over an extended period
0:13:16 > 0:13:19and I had seen far too much.
0:13:19 > 0:13:23Out of all of Paolo's plastic trachea patients,
0:13:23 > 0:13:24only two were still alive.
0:13:26 > 0:13:29Dmitri Onogda's plastic trachea never functioned...
0:13:30 > 0:13:32..but it was removed and he survived.
0:13:34 > 0:13:37Yasim Cetir had been close to dying many times.
0:13:38 > 0:13:43In order to survive, she now needed constant intensive care.
0:13:44 > 0:13:46The other patients had died.
0:13:47 > 0:13:49Andemariam Beyene.
0:13:49 > 0:13:52Christopher Lyles.
0:13:52 > 0:13:53Alexandra Zozulya.
0:13:54 > 0:13:56Sadiq Kanaan.
0:13:56 > 0:13:57Hannah Warren.
0:13:58 > 0:14:00And Julia Tuulik.
0:14:02 > 0:14:06It was as if nothing had been learnt from their deaths
0:14:06 > 0:14:09and Paolo was allowed to carry on his work.
0:14:09 > 0:14:12I very much enjoy the fact that now...
0:14:14 > 0:14:19..we are, again, back to science and clinic...
0:14:20 > 0:14:22..and not
0:14:22 > 0:14:25lawyer stuff and so forth.
0:14:25 > 0:14:27So, that's a good thing.
0:14:29 > 0:14:32Interesting. How fast do you think you can be moving, for example,
0:14:32 > 0:14:35with the trachea now? What's your time?
0:14:35 > 0:14:37Well, the timeline is that...
0:14:38 > 0:14:41..we would like to wait the six months...
0:14:42 > 0:14:47..follow-up time, which would end probably in March,
0:14:47 > 0:14:51if everything goes well. And then, immediately start with the...
0:14:52 > 0:14:53..non-human primates.
0:14:53 > 0:14:55Probably by the end of next year...
0:14:57 > 0:15:01..it would be reasonable to think to restart the feasibility
0:15:01 > 0:15:03and then the clinical trial.
0:15:04 > 0:15:07Only a few weeks had passed since the acquittal...
0:15:08 > 0:15:11..and Paolo was already planning new operations on humans.
0:15:13 > 0:15:16When I began to film Paolo nearly a year earlier,
0:15:16 > 0:15:18he had made a demand...
0:15:20 > 0:15:23..that I wouldn't ask about the accusations
0:15:23 > 0:15:25until Karolinska had made a decision.
0:15:25 > 0:15:28Interesting. Something you can talk about?
0:15:28 > 0:15:31No, because the deal was that we would not talk about this.
0:15:31 > 0:15:33You remember that?
0:15:35 > 0:15:36The day had finally come.
0:15:38 > 0:15:41I had gone over everything I knew about Paolo and his operations.
0:15:42 > 0:15:44How are you?
0:15:44 > 0:15:46I am...fine.
0:15:46 > 0:15:47That's good.
0:15:49 > 0:15:52I knew that this was likely to be the last interview
0:15:52 > 0:15:54I would ever get with Paolo.
0:15:55 > 0:15:57I needed answers.
0:15:58 > 0:16:02Had Paolo intentionally risked the lives of his patients?
0:16:07 > 0:16:09A few months earlier,
0:16:09 > 0:16:12I had met a doctor who had prepared Paolo's tracheas,
0:16:12 > 0:16:13ahead of the operations.
0:16:17 > 0:16:21Philipp Jungebluth had had Paolo as his mentor during medical school...
0:16:22 > 0:16:25..and he was now Paolo's closest colleague.
0:16:27 > 0:16:31Philipp Jungebluth is... almost a son of mine.
0:16:31 > 0:16:36Probably he is, right now, the most hard-working man that I have,
0:16:36 > 0:16:38so thank you, Philipp.
0:16:38 > 0:16:42Philipp explained how they'd been thinking at the start.
0:16:43 > 0:16:46But it took some time before I really understood
0:16:46 > 0:16:48what he was saying.
0:16:48 > 0:16:52I mean, of course, this system cannot be perfect
0:16:52 > 0:16:56at the early years, in the early moment of this new technology,
0:16:56 > 0:17:02and you can just learn it in the clinic.
0:17:02 > 0:17:03Some parts of it, at least.
0:17:04 > 0:17:07It seemed as though they had decided, early on,
0:17:07 > 0:17:11to develop the method, in part, on the operating table,
0:17:11 > 0:17:14instead of thoroughly testing it,
0:17:14 > 0:17:17as one normally would with new and dangerous methods of treatment.
0:17:19 > 0:17:24The first plastic trachea was a big step into the unknown.
0:17:25 > 0:17:29We did not test it prior to transplantation,
0:17:29 > 0:17:33prior the first transplantation, because there was no time.
0:17:33 > 0:17:37We had this patient, we had this scenario, this acute scenario,
0:17:37 > 0:17:40where we know that, OK, we cannot wait half a year.
0:17:41 > 0:17:44So, the plastic trachea hadn't been implanted in animals
0:17:44 > 0:17:47before testing it on the first human being.
0:17:49 > 0:17:53Therefore, it was a gamble when they put a plastic trachea
0:17:53 > 0:17:54into Andemariam Beyene.
0:17:55 > 0:17:58And they would continue to gamble.
0:17:58 > 0:18:01At least three, probably four, more patients
0:18:01 > 0:18:02would receive plastic tracheas
0:18:02 > 0:18:06before they had been tested on a single rat.
0:18:07 > 0:18:11There were a couple of tests of plastic tracheas on rats,
0:18:11 > 0:18:15here at the KI, that were started sometime...
0:18:15 > 0:18:18August 2012 or something like that.
0:18:18 > 0:18:22Is that the animal work on synthetic tracheas that you've been doing?
0:18:22 > 0:18:26We did animal studies pre-clinically in rats, with bio-deficent scaffold.
0:18:26 > 0:18:31They are not published yet and we started before.
0:18:33 > 0:18:35So, you have unpublished studies before that?
0:18:35 > 0:18:36Yeah.
0:18:38 > 0:18:39And that was at KI or..?
0:18:40 > 0:18:41It was at KI, yeah.
0:18:43 > 0:18:47'But I couldn't find any such animal tests,'
0:18:47 > 0:18:49nor could I find any approvals.
0:18:52 > 0:18:54Because if you just look at what is published
0:18:54 > 0:18:58- and what has been approved of, for experimentation...- Mm-hm.
0:18:58 > 0:19:00..it's only those two rat...
0:19:02 > 0:19:05- ..rat experiments.- OK, so what?
0:19:05 > 0:19:07- What do you want to say? - Because, before the rats,
0:19:07 > 0:19:12you put the synthetic scaffold into five patients.
0:19:16 > 0:19:18To me, that seems extraordinary.
0:19:18 > 0:19:19Before the rats, I put...
0:19:22 > 0:19:24That's a wrong statement.
0:19:27 > 0:19:29But if I just look at the chronology,
0:19:29 > 0:19:31I see five surgeries,
0:19:31 > 0:19:33no rats,
0:19:33 > 0:19:38- no pigs, no animal experiments. And, then, animal experiments.- Uh-huh.
0:19:38 > 0:19:40I mean, should I not ask that?
0:19:40 > 0:19:42Are you sure about this? Are you sure about this?
0:19:42 > 0:19:45Why you don't go to the lab and you look at data in a lab book?
0:19:47 > 0:19:48Here or in Russia?
0:19:48 > 0:19:51How do you know that we didn't do animal studies in Russia?
0:19:53 > 0:19:56When I confronted Paolo, he simply changed his story.
0:19:58 > 0:20:02He had no longer carried out these unknown animal studies in Sweden,
0:20:02 > 0:20:03but somewhere in Russia.
0:20:06 > 0:20:09But, despite not having tested the trachea on animals
0:20:09 > 0:20:12before implanting it in the first humans,
0:20:12 > 0:20:15the management at the Karolinska Institute still claimed this
0:20:15 > 0:20:17to be the case.
0:20:18 > 0:20:21In a document from autumn 2013,
0:20:21 > 0:20:25they wrote that all surgeries were preceded by all the necessary lab
0:20:25 > 0:20:27and animal tests.
0:21:05 > 0:21:07'Johan Bratt doesn't want to explain how they had
0:21:07 > 0:21:11'skipped over the animal tests.'
0:21:11 > 0:21:15'And to Paolo, the question only seemed to provoke annoyance.'
0:21:15 > 0:21:20I've been scouring the published field for synthetic rat tracheas...
0:21:20 > 0:21:23We didn't do any animal study that involves large animal,
0:21:23 > 0:21:27of course not. We didn't have the time.
0:21:27 > 0:21:30But the material was proven, the material was studied.
0:21:30 > 0:21:33We used fibres that were approved by the FDA.
0:21:34 > 0:21:37And now, all the studies are coming.
0:21:43 > 0:21:47If you have a clinical situation where you are...
0:21:49 > 0:21:51..forced to take a risk, then you take it,
0:21:51 > 0:21:54if you see any chance to help the patient.
0:21:56 > 0:22:00Paolo's point seemed to be that he had been forced to take shortcuts,
0:22:00 > 0:22:03as his patients had been so seriously ill.
0:22:03 > 0:22:05His employers agreed with him.
0:22:34 > 0:22:38The hospital and the Institute claimed the same thing...
0:22:39 > 0:22:41..that Macchiarini's plastic tracheas
0:22:41 > 0:22:45saved the lives of those who were acutely ill and dying.
0:22:47 > 0:22:51But how short should life expectancy be for any hospital to resort
0:22:51 > 0:22:54to unknown and untried methods?
0:22:56 > 0:22:59What was really the case with the first plastic trachea patient,
0:22:59 > 0:23:01Andemariam?
0:23:02 > 0:23:04How ill was he when he underwent surgery?
0:23:11 > 0:23:15Andemariam had previously had a slow-growing cancer in his trachea.
0:23:17 > 0:23:21He'd been operated on and received radiotherapy and, at first,
0:23:21 > 0:23:22it had seemed successful.
0:23:22 > 0:23:25But at a routine examination,
0:23:25 > 0:23:29his doctor had discovered a growth in Andemariam's throat.
0:23:30 > 0:23:34The doctors felt they were not able to handle his case in Iceland
0:23:34 > 0:23:37and began to look for specialist help.
0:23:37 > 0:23:40Karolinska Hospital suggested Paolo Macchiarini.
0:23:41 > 0:23:44From this point, the stories begin to differ.
0:23:46 > 0:23:49One patient was referred from Iceland
0:23:49 > 0:23:52that was given a life expectancy of six months.
0:23:52 > 0:23:56We decided that there was a risk of suffocation.
0:23:56 > 0:24:00He was very short of breath when he arrived in Stockholm.
0:24:00 > 0:24:03He could not really speak one sentence without stopping...
0:24:05 > 0:24:07He had this... HE MAKES RATTLING BREATHING SOUND
0:24:09 > 0:24:13We were in need of something now and not tomorrow.
0:24:13 > 0:24:16Jungebluth, Macchiarini, Hamsten and Bratt
0:24:16 > 0:24:19describe his condition as acute.
0:24:20 > 0:24:22But this wasn't Andemariam's view of it.
0:24:24 > 0:24:27When he wasn't busy with examinations,
0:24:27 > 0:24:28he often left the hospital.
0:24:30 > 0:24:33He met friends and went for long walks.
0:24:35 > 0:24:37They went to cafes and restaurants.
0:24:39 > 0:24:42And Andemariam was well enough to travel to some friends,
0:24:42 > 0:24:43up in Sundsvall.
0:24:47 > 0:24:50When he spoke to Icelandic television, he didn't seem
0:24:50 > 0:24:55to believe that his condition had needed urgent treatment.
0:24:55 > 0:25:02When I was going from Iceland to Sweden, I didn't know that it would
0:25:02 > 0:25:04be such a big operation.
0:25:04 > 0:25:08But then, when I met the doctor, the Italian -
0:25:08 > 0:25:11Dr Paolo - then, he said...
0:25:14 > 0:25:17.."It will be removed at the throat
0:25:17 > 0:25:20"and we will put another one, but this will be synthetic."
0:25:22 > 0:25:26At the press conference, one year after the operation,
0:25:26 > 0:25:27Paolo remembered their meeting.
0:25:29 > 0:25:33The first reaction was just to look at me, to say, you are crazy.
0:25:33 > 0:25:36And he said, "Well..." and I said, "Yes, I am."
0:25:36 > 0:25:40I was very scared, very terrified.
0:25:40 > 0:25:45And the other thing which made me a bit scared was that...
0:25:46 > 0:25:48..this was happening for the first time.
0:25:48 > 0:25:51"How much is the success rate?"
0:25:51 > 0:25:52And I said, "I don't know."
0:25:52 > 0:25:54"Why?" "I never did it before."
0:25:57 > 0:25:59I said, no. I just said, no.
0:25:59 > 0:26:02"But this is your only chance you have right now."
0:26:02 > 0:26:06Andemariam had not seen his condition as acute
0:26:06 > 0:26:09and he'd been terrified of the operation -
0:26:09 > 0:26:12the first one of its kind in the world.
0:26:12 > 0:26:14And yet, he agreed to it.
0:26:14 > 0:26:19He told me straight, you know, "We did not try this to a human being.
0:26:19 > 0:26:21"We tried this into pigs and animals",
0:26:21 > 0:26:25so maybe it was working for the animals, so...
0:26:29 > 0:26:34Andemariam had believed the tracheas had already been tried on animals,
0:26:34 > 0:26:37even though this wasn't the case.
0:26:37 > 0:26:41And this is also what his widow, Merhawit, believed for a long time.
0:27:09 > 0:27:12Paolo had given Andemariam a certificate to sign.
0:27:14 > 0:27:17It said that the surgery was his only chance of survival.
0:27:22 > 0:27:24He was very confident.
0:27:24 > 0:27:28Enough to make me persuaded,
0:27:28 > 0:27:29to make me believe in this.
0:27:52 > 0:27:57Andemariam lived for two and a half years with the plastic trachea.
0:27:57 > 0:28:01We know for sure that Andemariam's cancer was a very relatively
0:28:01 > 0:28:03slow-growing type.
0:28:03 > 0:28:06No-one knows how long he would have lived
0:28:06 > 0:28:09if he had declined the plastic trachea.
0:28:15 > 0:28:17I don't see that there was a clear-cut...
0:28:19 > 0:28:23- ..acute...- You are insinuating that we took a decision,
0:28:23 > 0:28:29we doctors, or whoever, that was not necessary,
0:28:29 > 0:28:30above the line.
0:28:31 > 0:28:35That's a huge accusation.
0:28:35 > 0:28:37And what would your reply be?
0:28:37 > 0:28:39I don't reply to this accusation.
0:28:41 > 0:28:43Why you don't ask all these
0:28:43 > 0:28:47health care providers that are here at KI?
0:28:47 > 0:28:48Because you didn't.
0:28:49 > 0:28:52Obviously, I will, I will. But you are...
0:28:52 > 0:28:53I think that's courtesy to ask you.
0:28:53 > 0:28:57I am, I am, I am, I am. I mean, I'm not God, I'm not above the line.
0:28:57 > 0:29:01I am a man, a human being, that does...
0:29:02 > 0:29:04..mistakes all the time.
0:29:10 > 0:29:12But do you see why I ask you?
0:29:12 > 0:29:15- I mean... - No, I don't see it. It's...
0:29:17 > 0:29:19That's a visit from you that I didn't expect.
0:29:21 > 0:29:25Andemariam's operation became Paolo's most important.
0:29:25 > 0:29:29It was through this surgery that his technique became known to the world.
0:29:29 > 0:29:32- REPORTER:- In Sweden, they've carried out the world's first transplant
0:29:32 > 0:29:34of a synthetic organ...
0:29:34 > 0:29:37And in the articles from the first year's outcome,
0:29:37 > 0:29:41it says that the plastic trachea was functioning better and better.
0:29:42 > 0:29:47But Andemariam's autopsy report had shown that the trachea
0:29:47 > 0:29:50was actually heavily inflamed,
0:29:50 > 0:29:55full of dead tissue and that it had become almost completely loose.
0:29:56 > 0:29:59Could something that had ended so badly
0:29:59 > 0:30:02really be as positive as Paolo had depicted?
0:30:04 > 0:30:07Or did Paolo not describe the whole truth in his articles?
0:30:12 > 0:30:16In August 2011, Andemariam was examined in Iceland.
0:30:18 > 0:30:20The work carried out there makes up an important part
0:30:20 > 0:30:25of the scientific base for the first article on his plastic trachea.
0:30:26 > 0:30:31This is two months after the operation and the Icelandic doctors
0:30:31 > 0:30:34were about to examine Andemariam's plastic trachea.
0:30:42 > 0:30:44With a little pair of forceps,
0:30:44 > 0:30:47they attempted to cut small fragments
0:30:47 > 0:30:48from the surface of the plastic,
0:30:48 > 0:30:50in a so-called biopsy.
0:30:58 > 0:31:02But it seemed difficult to cut any tissue samples from the plastic.
0:31:26 > 0:31:30In the end, they only managed to cut off a few tiny pieces of plastic.
0:31:45 > 0:31:47When the pieces were analysed,
0:31:47 > 0:31:49individual cells were found.
0:31:51 > 0:31:54They were not healthy trachea cells but, in theory,
0:31:54 > 0:31:56could possibly generate them.
0:31:59 > 0:32:01Most of the tissue was dead,
0:32:01 > 0:32:03infected and covered in fungus.
0:32:27 > 0:32:32But in his article, Paolo exaggerated the few positives,
0:32:32 > 0:32:36claiming that large portions of tissue seemed to be on their way
0:32:36 > 0:32:38to develop into a healthy trachea.
0:32:40 > 0:32:44He also wrongly stated that the plastic trachea was completely free
0:32:44 > 0:32:46from fungus and bacteria.
0:33:30 > 0:33:34Since the Vice Chancellor had himself exonerated Macchiarini
0:33:34 > 0:33:37from dishonesty in his reports,
0:33:37 > 0:33:39he ought to have been able to answer this.
0:33:40 > 0:33:42But Hamsten still seemed convinced
0:33:42 > 0:33:46that the discrepancies were mere details
0:33:46 > 0:33:48and believed that the surgery had been a success.
0:34:05 > 0:34:09But Andemariam's wife, Merhawit, has a very different view.
0:34:11 > 0:34:16She says that, even if Andemariam had only lived a few more months
0:34:16 > 0:34:18without the operation,
0:34:18 > 0:34:21it would still have been better than suffering for two and a half years.
0:34:38 > 0:34:40Merhawit's side of the story isn't represented
0:34:40 > 0:34:42in Paolo's scientific works.
0:34:44 > 0:34:46In one of his articles,
0:34:46 > 0:34:49he describes the state of Andemariam's plastic trachea
0:34:49 > 0:34:51after one year.
0:34:51 > 0:34:54In the article, Macchiarini claims that his patient
0:34:54 > 0:34:57had "an almost normal airway".
0:35:01 > 0:35:03This is how a normal airway should look.
0:35:05 > 0:35:09Here you see lots of small blood vessels -
0:35:09 > 0:35:12they are keeping the trachea alive.
0:35:12 > 0:35:15Everything is covered by fine pinkish membrane,
0:35:16 > 0:35:19but when I see a film from Andemariam's examination
0:35:19 > 0:35:21shortly before the anniversary,
0:35:21 > 0:35:26I wonder how anyone could say that he had an almost normal airway.
0:35:29 > 0:35:32The camera is on its way down through a tube
0:35:32 > 0:35:33in Andemariam's throat.
0:35:35 > 0:35:38Deep down, you can see something white,
0:35:38 > 0:35:40the edge of the plastic trachea.
0:35:44 > 0:35:47Down in the plastic part, you can see mucus,
0:35:47 > 0:35:50which Andemariam is unable to cough up.
0:35:54 > 0:35:58And to the left, where the plastic meets the natural trachea,
0:35:58 > 0:36:00it's bleeding and pulsating.
0:36:01 > 0:36:05And there is a hole, a hole directly into the rest of the body -
0:36:05 > 0:36:07a so-called fistula.
0:36:09 > 0:36:12This is what a healthy airway looks like.
0:36:16 > 0:36:20And this is how the same area looks down towards Andemariam's lungs.
0:36:22 > 0:36:25The little black dot near the middle of the picture
0:36:25 > 0:36:28is all that remains of Andemariam's airway.
0:36:30 > 0:36:32The rest is clogged up by scar tissue.
0:36:34 > 0:36:36The right lung is more or less cut off.
0:36:38 > 0:36:42The doctors are forced to pull off large bits of scar tissue,
0:36:42 > 0:36:43in order for it to open up.
0:36:45 > 0:36:48They also need to insert a metal net, to keep the airway open.
0:36:54 > 0:36:57There is nothing about this in Paolo's article.
0:36:59 > 0:37:03The only thing it says is that the airway is almost normal...
0:37:04 > 0:37:07..and that his lung function has improved.
0:37:09 > 0:37:12I've been going through these articles so many times
0:37:12 > 0:37:17about the first operation and the biopsies, the broker's copies,
0:37:17 > 0:37:25everything, and the article doesn't seem to reflect the real situation
0:37:25 > 0:37:26with the patient.
0:37:26 > 0:37:29OK, then why you don't ask the commission that has evaluated
0:37:29 > 0:37:30all the documents?
0:37:30 > 0:37:33No, but I have to ask you, because you are the main author.
0:37:33 > 0:37:38- Yes.- And it's your work. - I am the senior author and I have
0:37:38 > 0:37:41provided written, compelling evidence
0:37:41 > 0:37:43that contrasts what you're saying,
0:37:43 > 0:37:48so I don't need to restate this very bad episode of my life, please.
0:37:48 > 0:37:51I hope that you understand.
0:37:51 > 0:37:54In your statement, I don't see that you actually refuting
0:37:54 > 0:37:59the actual faults from the records.
0:37:59 > 0:38:02I don't see that you're showing the opposite.
0:38:02 > 0:38:05Yeah, it was actually vascularised,
0:38:05 > 0:38:07it was actually covered by epithelial...
0:38:07 > 0:38:12Why you don't complain to the Ethical Commission or to the KI?
0:38:12 > 0:38:14I don't know what you're arguing here.
0:38:24 > 0:38:27When Hamsten and his colleagues cleared Macchiarini,
0:38:27 > 0:38:30they sent an important message to the rest of the world.
0:38:31 > 0:38:34What had been written in Macchiarini's articles
0:38:34 > 0:38:35was substantially true.
0:38:45 > 0:38:48Hence, they supported Macchiarini's claims
0:38:48 > 0:38:49that Andemariam's plastic trachea
0:38:49 > 0:38:52was about to develop into a normal airway.
0:39:23 > 0:39:26But the film from the examination has clearly shown
0:39:26 > 0:39:30that one of Andemariam's airways was almost completely closed off.
0:39:32 > 0:39:33And that they'd had to remove
0:39:33 > 0:39:36scar tissue and insert a metal net.
0:40:08 > 0:40:12These discrepancies in Macchiarini's articles are just two of many
0:40:12 > 0:40:16that were discovered and reported to the Karolinska Institute
0:40:16 > 0:40:17by the four doctors.
0:40:58 > 0:41:02Karolinska Hospital and Institute received several warnings
0:41:02 > 0:41:04but failed to raise the alarm.
0:41:36 > 0:41:39And at this time, Karolinska was still fully supportive
0:41:39 > 0:41:42of Macchiarini and his research.
0:41:42 > 0:41:44Research which had made Macchiarini's method
0:41:44 > 0:41:46known around the world.
0:41:46 > 0:41:48- NEWSREADER:- ..gave a man back his trachea and his life.
0:41:48 > 0:41:51We're just a few years away from this all happening -
0:41:51 > 0:41:52all the organs being built in a lab.
0:41:52 > 0:41:56This is a major achievement for every other patient
0:41:56 > 0:41:59that would need this type of transplantation.
0:42:00 > 0:42:03We have now a clinical trial authorisation in Russia,
0:42:03 > 0:42:05another one in...
0:42:05 > 0:42:09The events at Karolinska had repercussions outside of Sweden.
0:42:11 > 0:42:14For patients who were almost completely healthy...
0:42:15 > 0:42:16..patients like Julia.
0:42:25 > 0:42:27She might have had a long life ahead of her...
0:42:29 > 0:42:32..and still she agreed to a potentially fatal operation.
0:42:35 > 0:42:38She was hoping Paolo would conjure up her old self...
0:42:39 > 0:42:42..but she seemed unaware of the enormous risks
0:42:42 > 0:42:44the surgery posed to her.
0:42:45 > 0:42:48It's the same plastic that this bottle is made from.
0:42:48 > 0:42:50This is medical grade.
0:42:50 > 0:42:52So, we know this material is very safe.
0:42:54 > 0:42:56Nor did Julia seem aware
0:42:56 > 0:42:59of how badly it had turned out for her predecessors.
0:43:00 > 0:43:02And that there was a risk she might die.
0:43:04 > 0:43:07You're in very good hands. Paolo is the best surgeon in the world.
0:43:07 > 0:43:09- I know.- You know?
0:43:09 > 0:43:10You're right.
0:43:46 > 0:43:50Paolo has published hardly any facts from Julia's operation.
0:44:02 > 0:44:04But in interviews after the operation,
0:44:04 > 0:44:07he was quick to claim it was a success.
0:44:07 > 0:44:10And I still do not believe that, a few days ago,
0:44:10 > 0:44:13she couldn't breathe and talk normally.
0:44:25 > 0:44:30After the surgery, Julia had a long struggle ahead of her -
0:44:30 > 0:44:31one that she couldn't win.
0:44:33 > 0:44:35Slowly, her condition worsened.
0:44:37 > 0:44:39The plastic trachea didn't work...
0:44:42 > 0:44:45..and Macchiarini implanted a new plastic trachea in Julia.
0:45:01 > 0:45:04When Julia had only months to live,
0:45:04 > 0:45:06Paolo appeared on German television...
0:45:08 > 0:45:10..and he gave a very different picture of Julia's condition.
0:45:44 > 0:45:46Five months later,
0:45:46 > 0:45:48Julia died.
0:45:51 > 0:45:53Two months after her death,
0:45:53 > 0:45:55Macchiarini wrote to the journal Nature.
0:45:57 > 0:46:01He said that Julia's trachea had been examined weeks before death
0:46:01 > 0:46:04and claimed that there was nothing wrong with it.
0:46:08 > 0:46:10You can live a long life with a tracheostomy.
0:46:12 > 0:46:14I wondered what Paolo's thoughts were on this.
0:46:16 > 0:46:18Had he informed Julia of all the risks?
0:46:21 > 0:46:24The patient may say, "Yes, that's fine,"
0:46:24 > 0:46:26- but the responsibility... - Patients are not idiots,
0:46:26 > 0:46:30they are very intelligent, you need to respect that.
0:46:30 > 0:46:32That's not nice what you're saying.
0:46:32 > 0:46:35Patients understand very well,
0:46:35 > 0:46:39because they are told what to do and what not to do...
0:46:40 > 0:46:42..that you can stay with a hole...
0:46:43 > 0:46:46..that you might have a trachea that works or not,
0:46:46 > 0:46:49that there might be complications and so forth.
0:46:49 > 0:46:52Absolutely, but you feel, you personally,
0:46:52 > 0:46:53you feel no doubts?
0:46:53 > 0:46:58You don't feel regret or maybe, "I shouldn't have done this"?
0:46:58 > 0:47:00Of course, I have doubt. All the time, I have doubts.
0:47:00 > 0:47:03Even if I'm going out, I have doubts I should have done
0:47:03 > 0:47:05this interview or not.
0:47:05 > 0:47:10Come on, I mean, we are doing such very complex innovative things
0:47:10 > 0:47:14that I'm struggling and thinking, 'Should we do it really or not?
0:47:14 > 0:47:18'Is she or he the best candidate or an appropriate candidate?'
0:47:19 > 0:47:22You really think that we are beasts?
0:47:24 > 0:47:26I began to realise that Paolo
0:47:26 > 0:47:29was not going to give me any more answers.
0:47:29 > 0:47:34If you feel I wasn't safe, then I accept your opinion.
0:47:34 > 0:47:36What's your opinion?
0:47:36 > 0:47:38I already said what was my opinion.
0:47:39 > 0:47:41The most I got were counter-questions.
0:47:43 > 0:47:45- I've seen all...- Did you?
0:47:45 > 0:47:48Sorry to insist, now I am the journalist.
0:47:48 > 0:47:51- Did you see that?- Or perhaps, he just didn't want to answer me.
0:47:51 > 0:47:53There's no reference.
0:47:53 > 0:47:57But maybe, they are stored in a different compartment. Ask KI.
0:47:57 > 0:47:59But I just couldn't understand
0:47:59 > 0:48:03how Paolo can implant a plastic trachea in Julia
0:48:03 > 0:48:06without first having tested it on one single animal.
0:48:08 > 0:48:09So, your profession is?
0:48:11 > 0:48:13- How do you mean? - What are you doing as job?
0:48:16 > 0:48:18You have to explain what you mean.
0:48:18 > 0:48:20You are producer?
0:48:20 > 0:48:21TV producer?
0:48:21 > 0:48:24How can you possibly understand all the details
0:48:24 > 0:48:26of a medical evaluation?
0:48:27 > 0:48:30And you know all the details of a medical evaluation.
0:48:30 > 0:48:31No, of course not.
0:48:31 > 0:48:34So if there were, I don't know,
0:48:34 > 0:48:36about 10 to 20 health care professionals,
0:48:36 > 0:48:38health care providers, that decided
0:48:38 > 0:48:41that this was the most appropriate procedure for her...
0:48:42 > 0:48:44..then I believe we can trust them.
0:48:52 > 0:48:56Perhaps Paolo actually believes he hasn't committed any mistakes
0:48:56 > 0:49:02and that in order to progress, you have to experiments on humans.
0:49:02 > 0:49:05Jungebluth's view was that certain things could only be learned
0:49:05 > 0:49:06on the operating table.
0:49:11 > 0:49:17But if I understood you correctly, your assessment is also that the...
0:49:19 > 0:49:22..synthetic scaffold don't really work at the moment.
0:49:22 > 0:49:26Of course, this is the reason why we stopped the clinical trial
0:49:26 > 0:49:29and we are on hold to have a better scaffold.
0:49:37 > 0:49:42But you see no problems with the road to coming to that conclusion?
0:49:44 > 0:49:47- What? - You see no problems with, with...
0:49:49 > 0:49:53Listen, if you don't do things, then you probably will never have...
0:49:55 > 0:49:57..such conclusions, right?
0:49:59 > 0:50:03If you just do reporting without doing it,
0:50:03 > 0:50:06you will not report, so,
0:50:06 > 0:50:09of course, we have experienced...
0:50:10 > 0:50:14..complications but we have learned a lot from them, as well,
0:50:14 > 0:50:17so that possibly the next patients,
0:50:17 > 0:50:20everything will be better, much better.
0:50:22 > 0:50:27So, Paolo has learned that the plastic tracheas don't work
0:50:27 > 0:50:28but to him, it's been worth it.
0:50:29 > 0:50:33And at the time, it seemed as if representatives from Karolinska
0:50:33 > 0:50:34were of the same opinion.
0:50:36 > 0:50:40Richard Kuylenstierna was one of those who authorised
0:50:40 > 0:50:42the first operation on Andemariam.
0:51:13 > 0:51:16In Russia, they were also initially enthusiastic
0:51:16 > 0:51:18about the plastic tracheas.
0:51:26 > 0:51:30Igor Polyakov operated on Julia, together with Macchiarini.
0:51:30 > 0:51:33He really believed that it would work,
0:51:33 > 0:51:35since Macchiarini had the stamp of approval
0:51:35 > 0:51:37from the Karolinska Institute.
0:51:37 > 0:51:41Without that, the Russian trials might never have taken place.
0:52:03 > 0:52:08In Russia, they now know that everything went wrong,
0:52:08 > 0:52:09not least in Julia's case...
0:52:10 > 0:52:12..and they dare to admit it.
0:52:37 > 0:52:40While in early 2016 at Karolinska,
0:52:40 > 0:52:42it was almost as if nothing had happened.
0:52:44 > 0:52:46Perhaps because at the time,
0:52:46 > 0:52:49the hospital still hadn't fully investigated
0:52:49 > 0:52:52how they could put patients through treatment methods
0:52:52 > 0:52:54that hadn't even been tested on animals.
0:52:56 > 0:52:59Perhaps because, at the time, the Karolinska Institute
0:52:59 > 0:53:02was still standing by Macchiarini's research work.
0:54:37 > 0:54:40After this interview in February 2016,
0:54:40 > 0:54:44Hamsten would distance himself from Paolo's work in Russia...
0:54:45 > 0:54:48..and he maintained that Karolinska was not responsible
0:54:48 > 0:54:51for the way Paolo's methods had been adopted there.
0:54:54 > 0:54:58You're insinuating that everybody in the group has lied,
0:54:58 > 0:54:59which is very bad from your side.
0:54:59 > 0:55:02I didn't expect that. Wow.
0:55:03 > 0:55:07And even the president has lied, even the commission has lied,
0:55:07 > 0:55:09everybody has lied.
0:55:09 > 0:55:11Maybe something is wrong in your assumption
0:55:11 > 0:55:15or in your statement.
0:55:15 > 0:55:18But I'm just using my brainpower
0:55:18 > 0:55:23- and I'm trying to find the facts that show...- Well, then,
0:55:23 > 0:55:26maybe you should look and search more before doing this interview.
0:55:27 > 0:55:31Think so. So, please, let's stop here now.
0:56:17 > 0:56:21Ever since I first met Paolo, I've been curious about him.
0:56:22 > 0:56:24Everything he described sounded so good.
0:56:28 > 0:56:29Almost too good to be true.
0:56:31 > 0:56:33Welcome to this session.
0:56:38 > 0:56:41After this series was first broadcast in Sweden,
0:56:41 > 0:56:44it created intense pressure on the Karolinska Institute
0:56:44 > 0:56:46and the University Hospital.
0:56:51 > 0:56:53After an initial period of denial,
0:56:53 > 0:56:56the Vice Chancellor Hamsten resigned.
0:56:59 > 0:57:02The board of the Karolinska Institute, as well as Lendahl,
0:57:02 > 0:57:05the permanent secretary of the Nobel Committee,
0:57:05 > 0:57:06have now also stepped down.
0:57:11 > 0:57:15Paolo Macchiarini had his contract and research group terminated.
0:57:18 > 0:57:22Internationally, more than ten inquiries have been opened
0:57:22 > 0:57:24and Swedish prosecutors are investigating
0:57:24 > 0:57:27whether to press Macchiarini with charges
0:57:27 > 0:57:29for involuntary manslaughter.
0:57:30 > 0:57:35But the most important question of all remains unanswered.
0:57:35 > 0:57:37How could top universities and hospitals
0:57:37 > 0:57:40support everything that happened for so long?
0:58:08 > 0:58:10I can't help wondering...
0:58:11 > 0:58:14..is the reputation of the medical establishment
0:58:14 > 0:58:16worth more than a human life?