- há 15 horas
Titulo Original: Trachea transplanters without borders
Canal Autor (Nome): Leonid Schneider
Canal Autor (Link): https://www.youtube.com/@leonidschneider2983
Fonte do Video (Link): https://www.youtube.com/watch?v=TGhe66_c1eQ
Licenca: Este conteúdo é reutilizado sob a Licença Creative Commons Atribuição 4.0 Internacional (https://creativecommons.org/licenses/by/4.0/).
Note: The original content has not been modified. / O conteúdo original foi mantido integralmente.
Canal Autor (Nome): Leonid Schneider
Canal Autor (Link): https://www.youtube.com/@leonidschneider2983
Fonte do Video (Link): https://www.youtube.com/watch?v=TGhe66_c1eQ
Licenca: Este conteúdo é reutilizado sob a Licença Creative Commons Atribuição 4.0 Internacional (https://creativecommons.org/licenses/by/4.0/).
Note: The original content has not been modified. / O conteúdo original foi mantido integralmente.
Categoria
📺
TVTranscrição
00:01Okay, so that's recording.
00:04Thank you very much Trish for inviting me again
00:06and thanks all of you for coming.
00:10So, this will be the main character in the story I'm going to tell you.
00:16It's Paolo Macchiarini.
00:18He's an Italian, a thoracic surgeon
00:21who used to be an honorary professor at UCL
00:23and of the Karolinska Institute
00:26where the scandal actually exploded
00:29and in the picture, the photograph shows him in a German TV studio
00:33where the whole scandal was known
00:36but he was still celebrated as a hero
00:38because in Germany we don't have medical scandals
00:40We have purely liberal law.
00:44So, sorry.
00:46Oh, alright.
00:48OK.
00:49So, here's Macchiarini again
00:51and this is basically summing up.
00:53A thoracic surgeon, stem cell pioneer
00:56and he used to be head of the trachea surgery in Carregi
01:00in Florence, Italy
01:02and Professor Karolinska Institute in Sweden
01:05the institute which gives out Nobel Prize in Medicine.
01:09This was their hope that by recruiting Macchiarini
01:12they will get their share of the Nobel Prize once it all becomes famous.
01:20So, when Macchiarini did, he transplanted a number of patients with artificial tracheas.
01:25Some of them were made from cadaveric trachea, dead patients, not a living trachea
01:31basically a piece of dead tissue
01:34and tracheas made of plastic
01:36and they were seeded with bone marrow cells
01:38and it was supposed to bring them alive
01:41and the top was basically almost everybody dead.
01:45and there were quite a lot of people.
01:50I was a bit, I'm very sorry about it.
01:52So, how did it say, how did it get that bad?
01:57And, those are the institutions that Macchiarini used to do his work.
02:02He has started at Germany medical, Hanover Medical School
02:08and he still has adjunct professorship there by the way.
02:11Then, he moved to Barcelona to the hospital clinic
02:14where he started with trachea transplants.
02:17After that, he went to Florence Hospital, the Carreggio University Hospital
02:24transplanted more patients there, at least five.
02:27And, then he had an honorary professorship at UCL
02:32where one patient was transplanted by him
02:35and he had a success, his partners transplanted even more.
02:38And, then he moved to Karolinska where he became a kind of associate professor.
02:46Transplanted three patients and then he also, in parallel,
02:49while being paid a salary in Karolinska,
02:51he was actually working in Russia where he was transplanted.
02:55In total, it was five patients also, but probably even more.
03:02So, the question is, was it, so the official portrait is that Macchiarini is a horrible person,
03:08which is true.
03:09He is a pathological liar, which is also true.
03:13But, the lessons we learned, well, we sacked Macchiarini,
03:15so everything is fine now, right?
03:19There is a bigger problem, this is actually the system.
03:22Macchiarini never did anything alone.
03:23There were a lot of other people involved who wanted the bit of fame which he promised them.
03:29And, he actually, they actually not only wanted the fame,
03:32they also wanted the technology.
03:34And, this is how it became so bad, not just because he is such a horrible person.
03:40So, what Macchiarini did here, stem cells are extremely hot topic in biology and medicine,
03:49and regenerative medicine is because they, the promise is to cure all the diseases which are
03:55generally, normally not curable.
03:58And the hype is enormous.
04:00There is enormous amount of money in it and this is what Macchiarini took advantage of.
04:04Of course, he has no biological background or regenerative medicine background.
04:08He is a surgeon, but he had big ideas.
04:12And, whenever he ran into problems, he just changed the institution.
04:15I showed you all the many institutions he was working on.
04:17And, this is what also made it continue.
04:20Because, normally, what happens when too many patients start dying,
04:25doctor is asked to stop if he wants to keep, he or she wants to keep the job.
04:31In Macchiarini's case, he was just sick.
04:32He moved somewhere else, told new lies, he operated new patients, and this is how it could develop.
04:40And, this is a very important bit.
04:43There is always assumption that science is self-corrected.
04:46Science is not self-correcting anything.
04:50It takes science decades to correct something, a minor research issue even.
04:59So, in Macchiarini's case, science and medicine failed because they were either part of it or afraid.
05:07The few whistleblowers who reported something were punished and are still being punished.
05:13So, the scandal was only uncovered by some very brave Swedish journalists.
05:18Not just them, actually, Vanity Fair.
05:21You know, the popular genre which tells about celebrity marriages and everything.
05:26They played their part in exposing the Macchiarini scandal.
05:28This is how embarrassing the whole thing is.
05:30That he needed Vanity Fair to expose the scandal.
05:34And, meanwhile, what the university was doing, they're basically doing either damage control
05:39or distancing themselves from Macchiarini in order to use his technology to continue, which is even worse.
05:48So, again, as I said, the scandal had it all.
05:52Of course, it had this hype of stem cell regenerative medicine.
05:57The top journals were involved.
05:58One of the highest journals in medicine, The Lancet, is part of the scandal.
06:02And they're part of the actively covering up the scandal.
06:06Even now, Macchiarini was very well connected politically.
06:12The governor of Tuscany, him, Enrico Rossi, he's still crying about the loss of Macchiarini
06:20and how he should have stayed in Italy and he's such a great surgeon.
06:27And then it is, of course, a scientific problem because Macchiarini's science is not supported by any evidence.
06:38It's just an uneducated guess in his case and it's very simplistic.
06:44It's just basically wishful thinking.
06:45Of course, he also manipulated data and he lied about the results of clinical outcomes.
06:50He committed ethical breach in every step.
06:52One doesn't even know to start, in Macchiarini's case, what he did wrong.
06:57Because he did everything wrong with his patients, everything possible.
07:01He didn't obtain ethical permits here.
07:04He never recorded the patient cases properly, even, to hide his tracks.
07:11The institutions threatened the whistleblowers when they tried to report.
07:15The investigations were suppressed.
07:18Even if something was investigated, the results were suppressed.
07:21And I, myself, was sued by his right-hand man and, unfortunately, lost in court last week completely.
07:29Not because my evidence was not valid, but because the judge decided that my evidence is boring
07:35and they prefer to trust the doctor.
07:37And they declared Macchiarini, actually, to be right.
07:42So, I'll now tell you a bit more in detail what happened.
07:45The cartoons are mine, actually.
07:48And I will upload it online, so if you want to use them for your own talks, feel free.
07:57Why trachea?
07:59Because a trachea is an organ you cannot transplant.
08:02This is a slide made by Pierre Delare, who is a thoracic surgeon, who developed his own method
08:07of transplanting a trachea, which is very complicated.
08:11The problem is that, so, it was a, of course, if you transplant an organ,
08:18it needs to be connected to the blood supply, otherwise it will die immediately, right?
08:24And, well, you know, one can transplant liver, heart, kidney, a lot of other organs.
08:30This is where, those are organs where you can connect the central veins and arteries,
08:34and now they are supplied with blood, and they are sustained, and they will remain alive inside the patient.
08:40This is something you cannot do with the trachea, because the trachea
08:45doesn't have a central blood supply, supplied by tiny capillaries, which surgeons cannot connect
08:50in time while operating, so there is no way to transplant it here like you transplant a kidney,
08:57for example. So Pierre Delare did, he puts it into an arm of the patient, lets it slowly get
09:03vascularized there, and then he transplant it into an airway.
09:09So, this is why it cannot be transplanted normally. So, this is what Maccherini and others proposed,
09:16when we use regenerative medicine. We take a dead scaffold, either desolarized,
09:22so here from a dead person, basically a piece of connective tissue, or we take a piece of plastic.
09:34We put what we call stem cells on them, which were bone marrow cells, which are not really,
09:41not stem cells, but they were declared to be pluripotent stem cells. We put it into a patient,
09:47and we announce that it got immediately vascularized by magic, basically. There is no scientific
09:52explanation. They say, it got vascularized. And of course, you collect funding, awards, fame,
09:57promotions, published papers. When the problems arise, you have to cite those critics, you hide
10:04dead patients, and then you continue as before.
10:11So, the technical aspects of what do you call your stem cells?
10:18The main selling part of Maccherini's method was that you do not need immunosuppressives
10:26to, when you transplant his traitor, like with any other organs. When you transplant from one
10:30patient to another, you need to suppress immune system, system of the organ will be rejected,
10:34the patient will die. So, the main selling point was here that you do not need this,
10:40because you use patients' own cells to grow a betrayal. It's their own betrayal. So, which kind of cells
10:45are you going to use? Obviously, the induced pluripotency didn't exist at that time,
10:51that's well, and anyway, the method is still not very well established. So, basically,
10:57you announce that a certain type of the cells inside the patient is pluripotent and can make
11:02any kind of tissue and can grow to here. And the cells which Maccherini and his partners declared to
11:11be pluripotent and able to grow to here are bone marrow cells. Bone marrow cells have a long history of
11:19research fraud and patient abuse. It started with very bad basic science, and this is a scientist,
11:27one of the scientists behind those claims. This is Kathleen Verfei, who is presently director of the
11:34Stem Cell Research Institute in Leuven, in Belgium, where Pierre de Lara actually, the same university
11:39where Pierre de Lara works, the Maccherini critic. So, her big success story was that in Nature, published
11:47in 2002, where she declared that the cells inside our bone marrow are pluripotent, which means they
11:54can make every kind of cell types, like very early embryonic cells. And this was what kicked off the
12:02whole hive of bone marrow cells, because, of course, when something is published in Nature, it's a
12:07scientific fact, right? It's true, because of Nature. So, the Nobel Prize was almost saved. She was put on a
12:15stamp, even, and in all the media. And then something happened. Turned out someone manipulated data in
12:24those papers. She had a retraction on a related paper, on a related topic, because the data was fake. The
12:30Nature paper was never retracted.
12:32They published an enormous correction of this paper, basically admitting that a lot of data was
12:40manipulated. But the paper was not static. Why? Because by now, everybody knows that the bone marrow cells are
12:48not pluripotent. You do not leave a paper static, even corrected, because if the main results are wrong. But
12:56the Nature did it anyway. And this is why scientists could still claim that bone marrow cells are pluripotent,
13:02because Nature says so. And it's also, eventually, what Macchiarini indirectly based his research on.
13:10So, basically, nobody knows what this bone marrow cells can do. Obviously, they produce blood cells,
13:18right? And there's subtypes of the cells, which are called mesenchymal stem cells. But nobody knows what
13:25they're doing, but they're definitely not pluripotent. You definitely cannot grow. It's a hero,
13:29which doesn't stop people, even now, from trying.
13:37A good slide to stop, because we're obviously in Liverpool here, the University of Liverpool, and
13:44is here? So, this is Anthony Hollander. His current status is Vice Hector.
13:54Vice Chancellor. Well, a very, very senior person in the University. And Anthony Hollander was one of the
14:00scientists who followed this idea that bone marrow cells are pluripotent, because... And he developed a
14:08technology to make cartilage out of them. And he has a company, Azalon, which patented it and marketed it.
14:15And here, this is an important bit. This is from the screenshot from the country university website.
14:22In 2008, Professor Hollander and the team of scientists and surgeons successfully created and
14:27transplanted the first tissue engineered Trahir using patients' own stem cells. And this is where
14:33The Macchiarini story started with the Trahir transplant of 2008. You might have heard of it. It was a huge
14:42news story. Even I remember seeing it, although I wasn't working on exactly on that field.
14:48Macchiarini was, at that time, in Spain, in Barcelona. And this is a patient, Claudio Castillo.
14:56And he didn't replace the Trahir, he replaced the Bronchus. So, Trahir is a wide-formed organ.
15:04And the Bronchus is one of the branches that goes to each of the lungs, right? So, you have to
15:11understand
15:12that the difference between replacing a Trahir, the main part, and replacing a Bronchus is that
15:17if the Bronchus fails, the patient loses the lung, right? If the Trahir fails, the patient loses life.
15:24Because you can't suffocate. If the Bronchus fails, one lung collapses, but the other lung can be used.
15:31So, this was happened in her case. It was published in Lancet in November 2008. By that time,
15:39the graft failed. The patient needed stents to keep it open. Of course, it's not in the paper because
15:44it's not relevant, right? And it got worse and worse and worse. This woman, two years ago, she really went
15:54to the hospital asking to remove her lung and the graft because she had enough of suffering. And after
16:01they did that, she feels great. So, but this, back then and even now, it's being sold as a success
16:10story.
16:11And this is a, so here transplant team. Like, Paolo Macchiarini was obviously his Spanish patient.
16:17He, this is his right hand man, Philip Jungeblut, who was with Macchiarini starting from that very
16:24first operation to the, basically, to the very recently where the boss sacked in Karolinska Institute
16:31and who sued me in court and won because the judge thought he was more trustworthy than anything I say.
16:39Right? And this is Martin Burchell, a professor of laryngology at UCL, in London. Back then, he was in Bristol.
16:49So, he was in charge of preparing the for Claudia using Anthony Hollander's technology.
16:57And, well, the problem was that Martin Burchell at that time was a professor at a veterinary institute
17:06department. So, his lab was a veterinary lab where he was operating on pigs.
17:13He didn't, it didn't stop him to prepare a human graft in a pig lab.
17:18He simply didn't tell it to the authorities that he was doing it.
17:24And, that kind of makes it right because, I mean, if you don't tell the authorities, it's not lying.
17:28Right? So, it's okay. Apparently, this was the logic.
17:33So, they pretend they never had a trachia in the lab, which doesn't make any sense.
17:38So, the principle of trachia regenerations, again, a diagram by Pierre de Lahrin, is that you take this,
17:45it is coupled, you put bone marrow cells, which you call stem cells, on them, and then you say,
17:50well, now it's living trachia, I put it inside, and it miraculously will grow blood supplies out of Norway.
17:58So, this is Claudio Castillo Strachia in the Deutscher's veterinary laboratory in Bristol.
18:04Right? The photograph of it in the lab, which they said was never there.
18:10And, this is not what Deutscher was something he actually never, never, never liked or wanted
18:15to see it had anything to do with plastic trachia. Back then, it was different.
18:23So, again, to discuss some science behind it. Why would bone marrow cells produce cartilage
18:32around this earth stachia? There's no scientific explanation why they would do it, because,
18:38So, well, let us assume it's magic. And why would it survive without blood supply when put in a patient?
18:47Because, also, magic. Magic makes blood vessels grow with light speed towards a dying,
18:53bunch of dying cells sitting on a dead carcass and saves them. So, Maccherini pumps up his patients
19:01with erythropoietin, which has huge side effects, makes blood clot. Probably also led to some of the
19:08deaths because of it. Because he just decided erythropoietin is a blood thing.
19:15So, probably it makes blood vessels grow. So, let's put it into patients. This is how it worked.
19:20And, of course, how can plastic trachia become a living trachia? This makes no sense, right?
19:26But because it wasn't simple plastic, it was nanotechnology plastic.
19:32Nanotechnology is a magic thing. So, people associate a lot, make something which doesn't
19:39make any sense at all. But you put nanotechnology in it, and suddenly it's something great.
19:44So, and then practical considerations. The first patient, Claudio Casio, which I told you about,
19:51this here was regenerating a bioreactor. This little box I showed you before,
19:55in a Bristol lab, this is a bioreactor. As it sits in there and it gets, it swims in the
20:03solution,
20:03it has to be rotated all the time. And that's the bioreactor. And they're very difficult. Of course,
20:11you can't do it in a pig lab. You need a GMP certified laboratory for human use. And you need
20:20a bunch of
20:20approvals. And because he needed too much paperwork, McKinney decided just to skip the bioreactor and said,
20:29human body is the best bioreactor today. So, just put a dead piece of trachea in it, cover it with
20:36stem
20:37cells and say, that's enough. And then just close the patient. That's it. And of course, don't forget
20:45to retropietin too, to make the vascularization. Another problem, McKinney had the extra cadaver here,
20:51a bit of a mess. You need donors, donor approval. The deceleration process takes very long.
20:59And it's very expensive and actually destroys the trachea. It becomes very soft and floppy
21:04after deceleration. Because, of course, he removed all the cartilage. And McKinney noticed it. Hey
21:10noticed that his patients are dying because of an extra cadaver here, because it was collapsing.
21:15And he said, let's take something more rigid, which is plastic, and put it in. And that's how he
21:23switched to plastic trachea. Of course, every surgeon would have told him, and he should have
21:29not, that if you put plastic as a trachea replacement human being, you will kill this
21:34person, because trachea is a moving organ. So it goes from here to here somewhere, and it
21:41moves all the time. Whenever you breathe, it moves. So when you have a plastic tube moving
21:45inside you, it starts tearing apart the other surrounding tissues, like oesophagus, and so
21:50on. And this is exactly what happened. But McKinney's argument, ah, but this is not normal plastic.
21:55It's non-structured plastic with stem cells on it. And this was the argument, because that's
22:01why it eventually got published in Lancet. This is the patient under Marian Bayer. He was the
22:06first patient to respond to the plastic trachea. It was published in Lancet. He died two and a half
22:12years later, and it was a quite slow and horrible death. He didn't need a life-saving operation,
22:20because he was not immediately dying. But McKinney was desperate to use a plastic trachea, and
22:26Karolinska was pushing him to transplant someone with a plastic trachea. So basically the patient
22:33was, I wrote to Karolinska for an examination, but McKinney told me, we're transplanting you.
22:38Come on, sign here. And this is what happened. The outcomes. McKinney had nine patients that we know
22:49who received a plastic trachea. Eight of them are dead. The only survivor was lucky because the
22:56piece he received was high enough that it could be removed, and he's still alive with a tracheostomy.
23:02A Russian patient. At least 12 patients received a cadaver to hear probably much more. From
23:09McKinney and Martin Burchill. They used to be big partners, and they had a huge fight over patents,
23:17so the friendship ended over money, actually. From those patients, maybe two, maximum two or three are alive.
23:25Two we know are alive. It's Claudio Castillo, who is alive, who saved herself by asking to have her
23:31lung removed. And the other patient who is alive is this boy, Kira Lynch. And he was operated in London
23:41eight years ago, and he received a cadaver trachea with stents, and that's why he's still alive.
23:46The interesting thing which I published just yesterday, I think. New evidence came out that Martin
23:56Burchill wanted to be the first man to use a synthetic trachea, a plastic trachea, and his
24:00choice candidate was Kira Lynch. He wanted to fix him in the year 2010 already with a plastic trachea
24:09to be faster than McKinney, I presume. Because UCL was at that time preparing, making plastic grafts,
24:16vascular grafts, and Bertrand had an idea where you can make plastic blood vessels. Let's make plastic trachea.
24:25Kira Lynch was incredibly lucky because the lab which made the plastic trachea was not ready at the
24:30time, so they didn't make it. So he got a cadaver trachea from Italy, delivered by Maccherini from Italy.
24:38Maccherini was a member of the operations team. They installed it. The boys survived. We don't know much
24:45about it. We only have Burchill's own papers. What happened? And two and a half years later,
24:52it was published in Lancet. Oops. Oh, right. Again, I made a mistake. It was supposed to be the other
25:01Lancet paper showing the Kira Lynch story. I'm sorry. Maccherini was removed from the paper because
25:08by then Burchill and him stopped being friends. Okay. And this is very kind of, well, cynical comparison,
25:18I know. But I'm just showing the perspective of doctors like Maccherini. It's not something I know
25:27how it sounds. But it's basically you compare pig versus patient whom you want to do your research on.
25:33So if you imagine you're a person like Maccherini or even Martin Burchill,
25:37because he really said his pigs are stupid. I want to operate a research on humans.
25:44Those are your alternatives, if you want to test trachea transplant. So let's see what you can do
25:48with pigs. Pigs is pig is animal size of a human. So the organs are similar size. But you need
25:56ethics
25:57approval. Animal research needs approvals, especially dangerous animal research which you make. Animals suffer.
26:04It's sometimes difficult to get approved. And they're very, very expensive. So pigs are very
26:09expensive to do research on. You need, of course, controls. You need pigs treated with a plastic trachea
26:15or cadaver to hear pigs treated. Not treated, pigs treated with, I don't know, a different kind of
26:22comparative treatment so you can compare it in between. So it has to be properly scientifically controlled.
26:30And many scientists don't like controls because controls spoil everything.
26:34Well, if you operated 12 pigs and only one survived, you cannot publish just the one pig, right?
26:41And you have to publish the other 11 as well. And then there goes your success story. The media is
26:47not interested. Nobody will write about how you successfully transplanted a trachea. So pigs
26:54Guardian won't write, BBC won't write, nobody. And of course, other labs can do the same. They get their
27:01own pigs and test your matter and say, look, I repeated it and my pigs all died. So how to eat
27:06yours were
27:07alive? How do you plan? And this is where the beauty of patient research is beauty.
27:17Because you don't need ethical support for patients. You think you need them. You don't.
27:22Because there's such a thing as a compassionate use. And compassionate use, or hospital exception,
27:27means user treating doctor says this patient is dying. So the only way to save this patient is
27:34to do whatever I think is necessary. And this is where you really, you can get minimal ethical
27:43approval by your own hospital. You can be scripted in this because you are in a hurry. I'll show you
27:48examples where it really happened in Germany. Where absolutely no ethical approval was made and it was
27:53Still cool, apparently. You don't need contrast or whether you just have one patient. If the patient survives,
28:00it's successful. You don't have to explain why the patients are. If the patients died, they never
28:06existed. Nobody forces you to report dead patients, right? And this is what also happened in Makirini
28:12case. Because whenever you, whenever they applied for funding, out of the 12 patients I told you about,
28:18only two existed, Claudio Castillo and Kiran-Lich. Everybody else actually never existed. Or they
28:23intend to, because they were dead. So actually you only announce those to the, in papers and also funds,
28:31not just media, but also funds. And of course you go on media. And nobody can challenge you because
28:36of course they can't, only you have access to the patient. Unlike with, with animal experiments where
28:43you have to eventually release all the data, if someone insists, with patients. It's all patient
28:50. Another trick is to put, when you do such crazy things with religious medicine,
28:55you have to put it where it can't be seen. And this is Harold Oth, another great hero of
29:01religion of medicine in the U.S. And he can make all kinds of organs. He claims to. At least
29:08he never
29:08tells it to one patient. One of his claims that he can grow a leg. He just takes a leg
29:14of a red,
29:15cuts it off of a dead red, removes all the cells of it, puts bone marrow cells on it, and
29:21he says it
29:22becomes a living leg. It was reported by what new scientists and other media as if it was a proper
29:29science, which is not. But imagine if he really transplanted it on a red. And he would, everybody,
29:36everybody would ridicule him because you can see that it's a rotting piece of dead leg hanging on a red,
29:43right? And this is a beauty. When you put a rotting piece of dead trait in a patient,
29:48nobody can see it. So nobody can prove to you that you are actually cheating.
29:55So this is something which Pierre Delare exemplified with a thumb. Basically, he used the model of a
30:01thumb. This is a measure you take, you take a patient without a thumb, and you
30:10take a dead donor's thumb, remove all the cells, and just suture it on. Imagine how it will look,
30:17right? You cannot sell this as a success. But with trahi, you can, because it can be seen.
30:23And this is another argument. Can you say that I want to do it? Because obviously I have a patient
30:28without a thumb or a leg. There is no medical way to grow a thumb or a leg, right? The
30:33patient
30:33is uncurable, right? This is the logic we've heard. And this is how you can get your hospital
30:38exemption, because obviously there is no therapy for replacing a leg or replacing a thumb. So you
30:45make one in this method and put it onto a patient. This is exactly the same logic with a trahi
30:50transplant.
30:51A number of these patients were not dying at all. They were in a situation where they could not be
30:56treated because they had a hole in their throat, a tracheostomy, which is a stable situation.
31:03As long as you don't go swimming, you're safe, right? It's very inconvenient for patients, and that's
31:10why they agreed to have this transplant. But the point is they were not dying. Their lives were not in
31:16danger. But the argument was that they can't be helped, right? So let's test it on them. Only,
31:29you have to publish very quickly before you run into trouble. And this is what they did in Lancet.
31:33So this is the paper which is about the Stephen Lynch two and a half year follow-up study. THE
31:39lot of
31:40authors, not a single one of them is Macchiarini, although he was one of the surgeons who brought it here.
31:45He operates and who brought it here. So this is how it sometimes works. And this is a paper about
31:51about Claudio Castillo. And this is a five year follow-up paper which is just basically a fairy tale
31:56by Macchiarini where he was just inventing things as he went along. Lancet knows it. They know exactly
32:05what happened. But for the Lancet, Paul Macchiarini is not guilty of scientific misconduct. This is
32:12the editorial issued by Richard Horton. He never retracted his editorial or corrected it. I put in
32:18different ones and said, I'm sorry, I was wrong. Macchiarini is guilty of scientific misconduct and
32:22maybe I should retract his paper. No. Not a single Macchiarini paper in Lancet was retracted yet.
32:32Okay. And sometimes you just need to blame the patient. So this is what Macchiarini did. So he at some
32:45point assumed that if he operated on cancer patients, they were not, by the pretense of saying their lives,
32:55they were too weak to profit from his great technology, which was obviously nonsense. And besides,
33:02Those patients were not even dying. They had a very slow growing form of cancer. But anyway,
33:06This was Macchiarini's logic. So I have a method which is great, but my patients are not good enough
33:11for it. So what I need are healthy patients. And this is where he switched to patients we had,
33:18which had no life-threatening disease, which were victims of a car accident where they had
33:24left with a hole in their throat, with a tracheostomy, the damaged trachea. They could have gotten
33:29very old if he didn't operate there. But this is what he did. This was Yulia Tulik. If you saw
33:34the
33:35Swedish documentary, she was teaching prominently in it. And this is David Green from the Harvard
33:42operators talking her into accepting a piece of plastic as a trachea replacement. This is
33:49Yersin Chetty, a young woman from Turkey, who also, didn't even have a tracheostomy.
33:57She had damaged trachea and she needed a lung drainage from time to time, but she didn't even
34:05have a tracheostomy. And still, Macchiarini replaced her trachea with a piece of plastic,
34:12and it got worse and worse and worse. Both patients received the trachea collapse,
34:17they got a second piece of plastic and put it in them, it collapsed again. And eventually,
34:22Yulia Tulik died alone at home. And Yersin Chetty was brought to Philadelphia, where they
34:30replaced trachea, ozophagos, and I think even one lung, and still didn't help her. She died in 2016,
34:37I think, or 17, early 2017. And now her family is suing the company of this guy
34:45for making the materials and associating with Macchiarini.
34:52So this is the perverse logic. When you say, instead of thinking that my technology is killing
34:58my patients, you say, now my patients are sabotaging my technology by dying.
35:04So I need healthier patients. This was Macchiarini's logic.
35:12So, yeah, so, and he still says that we are all very, very sick and dying. Actually,
35:18he saved them. And all the accusations of his users are jealousy.
35:22Yes, they get eight of nine are dead with plastic to heal sequence. The ones with cadaver trachea,
35:29we don't even know how many they are. I'm still trying to find it out. We only know the ones
35:35which,
35:35which he himself will have records about. Maybe two or three are survived. This woman is one of the
35:42survivors, but she is not doing very well. So, we don't know how it will develop. And, yeah,
35:51meanwhile, old Martin Burchill had even his post in the parliament, celebrating his success stories,
35:59while the patients were dying already there. So that's why you have to control the effects of
36:05the past, to control the future of your regenerative medicine project. And when the scandal broke,
36:13Martin Burchill and also his partner Martin Elliott, who is a pediatric surgeon who transplanted
36:20Kiran Lynch, and also this girl, they say that everything was Macchiarini's fault,
36:28and they were always against plastic to heal. And the problem is, of course,
36:33Burchill wanted to be the first one, apparently, who transplanted plastic to heal on the child.
36:37You never test unproven medicines on children. It's just a very sick thing for a doctor to try.
36:45But that was the idea. And, of course, this patient, this girl was basically experimented upon in every
36:57possible way. They just wanted to test several things in the same time. They wanted to test
37:06to transplant without a stent, because to sell their technology later on, they wanted to say
37:12that the patients don't need a stent. They knew that every single patient needed a stent,
37:17because the tracheas were collapsing. But they wanted to prove that it works without a stent,
37:23so they didn't put a stent when it was planted. They wanted to prove that the tracheas can be frozen.
37:32Why is it important? Because if you want to do a clinical trial on, like, 50 patients,
37:37you need a stock of tracheas, right? And you keep them in the fridge, in the freezer.
37:44So for that, you have to defrost them, and then put in your patient. For this girl,
37:51a fresh trachea was frozen and defrosted to prove that it's possible to use defrosted trachea.
37:59So both things, defrosted trachea, although they knew it weakens the integrity of the graft. They knew it
38:05from the lab test. But they had to prove it from the clinical trial. It was Martin Berger and also
38:11Martin, because he was in charge of this patient. Another thing, they didn't want to put a stent,
38:16because if they put a stent in, they will be told, well, there's no benefit, right? Why should we need
38:22anyone to pay up to here? They want to prove we don't need a stent for this patient. They do
38:28all
38:29these things to Shona Davison. Two weeks later, she was dead. And after that, she ceased to exist.
38:35Nobody mentions her anymore, except when occasionally they passed a lie in this publication,
38:42where they said, well, she was dying, actually, and we saved her life. Unfortunately, she died from
38:48unknown causes. We don't know what killed her, but her life quality was incredibly improved.
38:54And the thing is, there's a BBC documentary about this girl, where you can see her, how relatively
39:00well she was. And two weeks later, after the transplant, she was dead. Which kind of quality
39:07of life and life extension it was. But, yeah, but the idea is that, of course, the cadaver
39:17trachea, the one which killed Shona Davison, and one which also killed Keziah Shorten before
39:22Shona. Basically, Shona was operated while, let me see if I get the dates right, while Keziah
39:32was dying already, already dead, from the same technology. And Keziah died because they removed
39:39the stent. So, basically, the logic is we killed one patient by removing a stent from a cadaver
39:45picture here. So, let's do it again. Maybe it works this time, right? Keziah Shorten also
39:54is in this paper, declared that she was saved, and her quality of life was extended. She was
40:01Operated in Italy by Macchiarini. What I found out, that UCL was involved. She was a UCL patient
40:09while she was treated by Macchiarini in Italy, operated by Macchiarini in Italy. NHS paid for
40:15it. The transplant, the operation was organized by UCL. But after it completely became a complete
40:23disaster, where a young girl was tortured to death, basically, UCL intended they had absolutely
40:29nothing to do with this transplant. They even went to the land. In a Swedish documentary about
40:34Macchiarini, when you watch it, Keziah's story is being told. Because she received, when she was
40:40almost, when she was dying, they put a plastic trash into her, apparently to save her as a
40:45palliative measure. But it actually looks like they were saying, well, she's going to die anyway.
40:49Let's test the plastic trahirino. So, they managed to make it look like it was Macchiarini who put a
40:56plastic trahirino into her. When you watch the documentary, the association is in this way. Basically,
41:01they played the journalist by telling them bullshit. In fact, Macchiarini was against putting a plastic
41:08Trahirino into her because he knew it will kill her. Macchiarini knew that very weak patients should
41:14do not receive plastic trahirino because it will kill them. UCL did it anyway. So, this is basically a team
41:21of UCL. This is Martin Burchill. This is Mark Laudle. He's a man of charge of making a career for UCL.
41:28And this is Martin Elio, who was responsible for this patient. And also, Kieran Lynch.
41:36Okay. 2007, 17, I swished a lecture to you. Just when I was giving my talk in Liverpool,
41:45before that, I was at UCL invited as a witness. And I gave a testimony in front of this commission.
41:54And I really, at that time, I thought they did it seriously. But I can't read people, I admit. Only,
41:59I really fell for it. It was a escaping non-investigation. What they did, they just,
42:06it was a white-watering exercise to protect Burchill and others. And they blamed Alexander
42:11Cephalian. This is him. This virtual student. And then they're holding up plastic trahirino.
42:18Of course, what Cephalian did was not right. But the point is that Cephalian is not qualified to
42:23decides about such things. He is not a doctor. He is not a biologist. He is a physicist. He was
42:28making
42:28plastic material. They blamed him for failing to provide, to obtain the certificate, to verify the ethics
42:36permits for operations in Sweden, and things like that. So, here, a bit more details. This was a
42:47Guardian article, which was published, which made Guardian look like a PR agency of UCL,
42:56where they basically, Burchill was not mentioned even once in this article. Like, he has nothing to do
43:03with it. In fact, the entire report protected him and the others, Martin Elliott and Paul de Koppi also,
43:09from any negative association. They didn't publish certain information to obtain some records of this
43:19investigation. And it turned out the investigators knew that Martin Burchill planned to use a plastic
43:25trahirino in December 2009 on Kiran Lynch to be the first man who transplanted a plastic trahirino.
43:31I would think it is a bit of a relevant bit of information if you have a trahirino transplant
43:35investigation going on at UCL, right? No. It's a bit boring. You don't want to bore your audience.
43:42It's nowhere in the report. Nowhere. And they knew it.
43:49So, there are other things that are omitted. So, for example, yeah, the main finding was that Alexander
43:57Cephalin manufactured the plastic trahirino and also vascular grafts in a non-GMP-certified laboratory,
44:04as if it matters. Of course, it is supposed to be a GMP-certified laboratory, but the point is UCL
44:10I knew it.
44:11They didn't care. They have pulled the export of the trahirino. The cadaveric traitor were not
44:17made in GMP-certified labs. It doesn't, nobody bothered about it. And the bit is, well, they cannot,
44:24they, you know, the head of the investigation said it was something frightening finding that we found
44:30out that he was doing plastic trahirino and sending them to Sweden or to, to, and vascular grafts and
44:37send them to India or Iran. Behind everybody's back, nobody knew. Do you know what? The investigators
44:43were discussing with Cephalin about a plastic nose he made, which was implanted a patient in UCL.
44:51So, basically, everybody knew in UCL, the investigators knew, that they were making plastic
44:58grafts, plastic organ replacements, using them at UCL, and they were not GMP-certified.
45:04So, how can you blame Cephalin for doing something which he was told to do by his superiors at UCL?
45:11But, of course, they did it, and he was denied the right of appeal. Normally, if you're found guilty
45:16in a misconduct investigation of something, you have to, you can appeal, and it goes back,
45:20and before the report published, your right of appeal has to be exhausted. But because it wasn't
45:26official in misconduct investigation, do you know what they did? Like two hours, one or two hours,
45:32before they published the report online, they sent Cephalin an email telling him, Alex, can you,
45:38you can come to our office and have a look at the report. They gave him half an hour time.
45:44I mean,
45:44I don't think he will ever read it. It's 70 pages. But this, the time frame he was getting, the time
45:50when the
45:50email was sent, at the time when the report was published, it was like two hours. Because,
45:55uh, yeah. And the worst bit, they concluded that we need more experiments. Because obviously,
46:03yeah, there are patients, too many patients died. Uh, so we need to operate more to see if the method
46:09works. It's a strange logic, but yeah, they decide to do it. So, and this is actually what happens.
46:24There are already, there were three clinical trials. Um, uh, I think I have to hurry up,
46:30so I'm very sorry. Um, INSPIRE, which was supposed to be for, so here transplant patients,
46:37the phase one trial, phase two trial funded by the European Union, and, uh, another phase one trial
46:43on 10 patients to replace larynx. And there's a Liverpool-based company, VIDEVEJ, uh, which
46:51organized all these trials. Uh, and this is their SEO, and this is their technology.
46:59How the current status is, they're all delayed. INSPIRE and Terrain Inbox trials were suspended,
47:06also because of my reporting. I'm so happy about it. And TETS were carried away anyway,
47:10because it's a phase two trial. And even European bureaucrats understand that you can start
47:15phase two without results from phase one. So, basically, money will be just wasted,
47:20but the patients are almost safe. Not entirely safe. Even if those trials are not going anywhere,
47:26they are still compassionate use, right? And this is why UCL, and that almost, with hope,
47:31that transplanted their child in May last year, with a cadaver here, under compassionate use.
47:38It only came out in the investigative report. We still haven't heard of the results. Not published,
47:44nothing. We don't know how the child is doing. If it was a success, they would probably have told us,
47:48but they are not. Well, on the other side, we understand that this is not happening. There's no...
47:56So, they put an announcement where they seek partners in Asia and the United States
48:03for their to hear transport technology. And here's an important bit. This is Trish. And what she did,
48:10she formed the Parliament Science and Technology Committee. And there was a big letter and a follow-up,
48:20and what Trish and Rafael Levy asked that there should be a proper investigation, not this joke,
48:26which UCL did. And it should, of course, stop all clinical trials and also compassionate use cases
48:34before they figure out what actually happened. And a very elementary thing that you don't test on
48:40humans before you tested it in the lab, like an animal. And finally, the United Kingdom should
48:46reform its research integrity oversight, because normally it's university investigating themselves,
48:52and we know from UCL what turns out if they do it. So, the results of the trials were officially
48:58suspended,
49:00and Trish even appeared in Science. So, there's an article reporting about the
49:06the stop of these two clinical trials of Burschel and his partners. And, of course, Trish is being
49:14excited there. It's strange that the University of Liverpool didn't make a press release about it.
49:19Should have, right?
49:20Okay. So, it's kind of summing up how Macchiarini can stop afterwards, depending on the time you have to say.
49:35So, these are the countries where Macchiarini did his work. So, in Spain, there was no investigation.
49:40Nobody knows how many patients he transplanted there. And very exactly, because apparently there
49:45were other hospitals he was using. In Italy, in the investigation in Carregi, where he was transplanted
49:54at least five patients. He is still supported by the politicians. He might even be still working in
49:58Italy, because I heard some rumors. But, at least there were some good journalists who exposed his
50:05deeds already early on. It was Correa Fiorentino did it. In Sweden, it was actually the only country
50:13where media did a good job of exposing the scandal. It started with a Swedish TV documentary and then it
50:19grew. The newspapers went on it. So, actually, all Swedes are informed about the Macchiarini scandal.
50:25Some people had to step down. There was even criminal prosecutions which began to investigate the
50:32cartoons of manslaughter. Unfortunately, it just really shows how legal experts think. And this is
50:41really... So, we are investigating someone who abused patients by unethical tracheal transplants. And we
50:48need some expert advice on it. That's what the Swedish procedure... So, who shall we ask? Let's ask someone
50:54who also did unethical tracheal transplants and was found guilty of misconduct. This is what they did.
51:01They really asked two surgeons who themselves were found guilty of misconduct of transplanting
51:07a tracheal with the same technology. Patient died afterwards. And what kind of advice? Of course,
51:13they said that, yeah, based on their advice, the charges were dropped. So, even in Sweden, such
51:20things happen. In Russia, very interesting, Russians did a Russian thing. They learned from Macchiarini
51:29the technology of tracheal regeneration, fired him, and set up their own business. They announced in the
51:36biggest Russian medical newspaper that they have a cadaric tracheal technology ready to be used to the
51:41patient. No mention of Macchiarini at all. So, in Germany, Germany is really where Macchiarini is a hero.
51:53He's still an adjunct professor at Hanover Medical School. Nobody knows why.
52:01He's still unpaid, but he still carries a professor degree because of it.
52:06If you search German news about Macchiarini and his partner, Jungeblut, who sued me,
52:13almost everything is positive. Jungeblut is never mentioned in any negative context because obviously
52:19they watched what's being done to me in courts and they decided, well, let's leave it.
52:23So, this doctor is practicing. So, this is the situation and the court case was completely bizarre.
52:34Shall I continue? Sorry I went so much over time.
52:43Okay. So, do you know what? I'll put it online. Basically, all the information will be on the slides.
52:50And the story is about motor heat transplants other than Macchiarini. And you can maybe read it after
52:55also. I'm very sorry, but I went so much over time. Okay.
53:05It's my contact date. Thank you very much.
53:08Okay. So, we have time for a few questions.
53:25Yeah. This was Yasin Chetty, the girl from Turkey. And so, yeah, um, so there was no media reporting about
53:33This. It was just one.
53:36Actually, no. Yeah. There was basically no media reporting about the story. And, um,
53:40her family is suing the company which produced the bioreactors for Macchiarini.
53:44And they might be also suing Macchiarini as well, but it's not like he is going to appear in front
53:49of the court in the U.S.
53:52Okay. So, I think it might be good to stop for lunch now. And we can have a broader discussion
53:58afterwards.
53:59But just, you know, one thing for you to think about before we go to lunch. So, after, you know,
54:04the operation, I'm sure,
54:05one of the days and she died shortly afterwards. Um, the team then undertook some studies on pigs and rabbits
54:12and 100% mortality.
54:15But it was, you know, in all of those experiments, despite that, as Leena mentioned, they operated on
54:22and they were tired last night and nobody knows how that child could. But that's something we can come back
54:27to a bit later.
54:28So, we can stop now for lunch, which is going to be downstairs by the reception. And then, if I
54:34can ask everyone to be back for a half past one.
54:45So, let me stop now.
54:46So, let me stop now.
54:47It's okay.
54:48Thank you.
Comentários