The phenomenal Macchiarini
Macchiarini landed not somewhere, but in Kazan Federal University.
A few years ago, Paolo Macchiarini was one of the most famous doctors in the world: his bold method of transplanting an artificial trachea with stem cells seemed to promise a medical revolution – the ability to create any artificial organs for a person, like spare parts for a car. But it was too good to be true: most of the patients operated on by the Italian surgeon died a painful death, the rest survived rather than thanks to, but in spite of the operation. Reputation Macchiarini is destroyed, in Sweden he is accused of manslaughter, and in In Russia, a person who seems to have not only medical talent, but also the talent of an adventurer, is still ready to appoint to enviable posts.
Radio Liberty tells in detail about the phenomenal story Paolo Macchiarini.
The Pope's personal physician
In 2012, the authoritative medical journal The Lancet published a flattering portrait of Paolo Macchiarini entitled "Crossing Borders". The author of the note was clearly very impressed by the meeting with the Italian surgeon: Macchiarini's statements (not so bright, in fact, like "I 'm just a surgeon. I love acting"), he compares with "conversational pearls", and even the voice of the interlocutor seemed to him "in all respects similar" to the voice of the famous actor Javier Bardem.
A few months earlier, in June 2011, Macchiarini performed the first artificial trachea transplant in history – he became a patient 36-year-old Eritrean Andemariam Beyene, a student at the University of Iceland, who suffered from late-stage tracheal cancer. "The patient feels better than great," Macchiarini told The Lancet 9 months after the operation.
The operation performed by Beyene attracted huge attention – both in the professional community and in the media. Macchiarini seemed to have revolutionized regenerative medicine–and medicine in general. The plastic frame of the trachea was created at University College London based on scanned images of the trachea of Beyene himself. Macchiarini planted stem cells taken from the patient's bone marrow on a polymer tube: it was assumed that over time the artificial frame would be covered with new tissues, and, in fact, it would turn into an organ exactly like the real one. Since no donor cells were used in the prosthesis, this would solve one of the main problems of transplantation – the immune response to foreign tissue. "The transplantation of such a "bio–artificial" organ was the first of its kind in the field of regenerative medicine, an area that has been promising for several decades that we will soon learn how to create ready-made organs for transplantation in laboratories: liver, kidneys and even new hearts, " wrote a journalist of The New York Times newspaper, talking about the Italian's achievement.
If the Macchiarini method was successful , an extraordinary prospect would open up to humanity: from a special plastic, you can create (and in the future, simply print on a 3D printer) the skeleton of any organ, and exactly according to the patient's measure, plant stem cells on it and get an ideal prosthesis that will not be rejected by the body. At the time of the publication of the article in the NYT, 15 months had passed after the operation on Beyene, he returned to Iceland, where his wife and two children were waiting for him, he felt better day by day and even began to take short runs. The patient required regular trips to Stockholm for observation, but he hoped that he would soon be able to return to Eritrea in order to work in the specialty received in Iceland – in the field of geothermal energy. "Everything is fine," Beyene assured journalists, "my life has become much better."
Macchiarini could afford the wildest dreams: for example, that over time it would be possible to abandon both stem cells and a plastic frame. Someday, he reasoned, medicines will be created with the help of which the body will be able to patch up organs on its own. In an interview with The Lancet, an Italian surgeon quoted the poet T.S. Eliot: "Only those who risk going too far are able to figure out how far they can go."
The popularity of everything related to stem cells, which in the mass view began to seem almost a panacea, the apparent success of Beyene's transplantation, the medical prospects that he opened – all this launched the popularity of Macchiarini to unprecedented heights. It is not so surprising that the columnist of The Lancet caught every word of his hero, comparing even the most banal statements of the surgeon with pearls. Among other things, everyone who has come across Paolo Macchiarini personally, notes his almost magical charm and ability to fall in love with himself.
In September 2012, an article about Macchiarini in the New York Times caught the eye of NBC anchor Meredith Vieira. The story captured the journalist, and a few months later she was recording the first interview with the surgeon – for the future two-hour TV biopic "Leap of Faith". The film's producer, Benita Alexander, spent a lot of time with Macchiarini, her husband was dying of glioblastoma, one of the rare forms of brain cancer, and she found solace in conversations with the doctor. A romantic relationship began between the surgeon and the producer , and in June 2013 the couple went on a romantic trip to Venice. At Christmas, Macchiarini proposed to Alexander. The Italian could not stay with the bride until the New Year: he explained that he had to urgently perform an operation on a certain high-ranking person.
As Alexander later told Vanity Fair magazine, Macchiarini told her that he was part of a "highly classified international group of doctors" whose services are used by VIPs from all over the world. Allegedly, he performed operations on Bill and Hillary Clinton, the Japanese emperor and Barack Obama. According to Alexander, Macchiarini also claimed to be the personal physician of Pope Francis. In October 2014, the groom told Alexander that during a four-hour meeting in the Vatican, the pope agreed to the marriage of Macchiarini and Alexander, who were both divorced, moreover, offered to personally conduct the ceremony.
The wedding was to take place in Rome in the summer of 2015, and in the presence of Vladimir Putin, Barack Obama, Kofi Annan and Nicolas Sarkozy. Radio Svoboda received an independent confirmation from the person who has a copy of the wedding guest list at his disposal that the named persons were indeed invited to the ceremony, as well as, no matter how difficult it is to imagine, relatives of some of Macchiarini's deceased patients.
Preparations for the celebration were in full swing: a wedding dress Benita Alexander was engaged by the famous designer Matthew Kristofferson, chic invitations to celebrities and politicians – from Putin and Obama to Russell Crowe and Elton John – were prepared and sent out. On May 13, 2015, Alexander resigned from the TV channel due to the upcoming move to Europe. The next day she received a letter from a friend, in the attachment was the official schedule of planned trips of Pope Francis. It followed that on the day of the wedding Alexander and Macchiarini the pope will be in South America. Alexander's dream began to crumble like a house of cards. The head of the Vatican press service said that the pope is not familiar with anyone by the name of Macchiarini. A private detective hired by Alexander found out that almost all the surgeon's stories about the upcoming wedding were not true. Finally discovered by a detective in Italian documents indicated that Paolo Macchiarini had been married to Emanuele Pecchia and never divorced her.
By this time, Paolo Macchiarini's professional reputation had long been cracked for many reasons, and his image as a man who had revolutionized medicine had noticeably dimmed. Andemariam Beyene, the first patient to have a plastic trachea transplanted using the Macchiarini method, died in 2013. In the Swedish television documentary "Documents from the Inside: Experiments", dedicated to Macchiarini, it is said that the student suffered from an increasingly bloody cough, tried several times to get Macchiarini to replace an artificial organ, and the surgeon reluctantly agreed even to meetings. Beyene died in hospital on an artificial respiration machine, an autopsy showed that the plastic tube in his throat, never replaced, almost completely detached from the surrounding tissues.
The way up
In an interview with The Lancet in 2012, Paolo Macchiarini admitted that his career was not easy at first. Macchiarini grew up in the German part of Switzerland, in a family of Italian immigrants, but he went to get higher education in his ancestral homeland, at the University of Pisa. And in He felt uncomfortable in Basel and Pisa, in Switzerland – as the only Italian among his classmates, in Italy – as a person who does not speak Italian well and is not used to local realities. "The Italian system," Macchiarini told The Lancet, "gives preference to people with connections in politics, to someone's relatives, despite their merits. I knew there was no such thing in other countries. And that's why I left." From the late 1980s to the mid-2000s Macchiarini managed to complete an internship in the USA, get a PhD in Paris, and work in Hanover, Germany. The details of Macchiarini's work biography, namely the question of the correspondence of positions in different clinics and universities, which he indicated in his CV of different editions, to the real state of affairs, were repeatedly questioned in the future.
In 2005, the Italian ended up in Barcelona. Here, in At the Barcelona University Hospital, Macchiarini performed the first tracheal transplant – not artificial, but donor. In 2008, a patient named Claudia Castillo was transplanted with a purified donor trachea, on which the patient's own stem cell culture was planted. The operation – the first of its kind in history – was presented as an immediate and unconditional success, and the Italian surgeon turned into an extremely tasty morsel for the best clinics and medical universities in Europe.
In the autobiographical document that Paolo Macchiarini provided Radio Liberty without the right to direct quotation, he says that in 2009 he had job offers from Florence, London and the Karolinska Institute in Stockholm. The surgeon chose Italy: according to Macchiarini, his move to Florence was lobbied by the Minister of Health (and in the near future – the governor) of the Italian province of Tuscany Enrico Rossi. In Florence, Macchiarini combined research work at the University of Florence with clinical work at the Carreggi Hospital, here he created a laboratory in which his team honed the purification of donor tracheas from all cells (the so–called "decellurization") - so that only the naked collagen skeleton of the organ remained, which during transplantation could not cause an immune response.
Macchiarini's work in Florence ended in a scandal: in September 2012, almost on the same days when an article about him in New York The Times was interested in the host of the American NBC channel Meredith Vieira, he was arrested on suspicion of fraud. The doctor was accused of trying to exert pressure on seriously ill patients, to whom, according to the prosecution, he offered to perform the operation not in the Carreggi hospital, but in other medical institutions outside Italy, where the surgeon could count on more favorable financial conditions for himself.
In his autobiographical note, Macchiarini says that he was detained right in the hospital, spent several days under house arrest, after which his lawyers recommended that he resign from all positions at the Carreggi hospital. Macchiarini explains his arrest by being at the center of "political tension" caused by the figure of Enrico of Russia and his lobbying efforts to invite a popular surgeon to Florence. It is worth noting, however, that the politician made these efforts against the background of the ambiguous curriculum vitae of his celebrity protege, which could not but cause discontent of the academic community in Florence.
However, by this time Macchiarini was already holding a position at the Karolinska Institute in Stockholm.
To this part, it remains to add that the transplantation performed by a surgeon in Barcelona in 2008 to Claudia Castillo did not turn out to be as unambiguous a success as it seemed at first. In 2013 , five years after the operation, Macchiarini and his colleagues reported on the long-term effect of the transplant, but there are discrepancies in the assessment of Castillo's further condition . In 2014, Barcelona doctors who observed Castillo reported that in fact only a section of the trachea was transplanted to the patient (and not the entire organ, as Macchiarini claimed) and constant stenting was required to keep it open – the introduction of special biodegradable tubes into the trachea. Doctors did not find epithelial growth, and the patient had to have a mandatory removal of the left lung.
Black Box
The trachea is the organ connecting the larynx and bronchi, in fact, it is just a rigid tube through which air enters the lungs. If the trachea is severely injured or its function is impaired during the course of an illness, such as cancer, doctors do not have many ways to help the patient. Usually in such cases, stenting is performed – placing a special tube in the tracheal cavity . Sometimes the only option is to provide access to air through a small tube that is implanted directly into the throat.
Before Macchiarini, tracheal transplantation seemed almost incredible: although it is not the most complex of human organs, it is riddled with a dense network of thin blood vessels, which during transplantation would have to be stitched with the recipient's vessels literally one by one. In addition, complications associated with the body's immune response to foreign tissues made such an operation ineffective.
The Macchiarini method seems to solve these problems. At him there are two options – transplantation of an artificial tube made of a special polymer , or transplantation of a specially prepared frame, which is obtained by cleaning the donor organ from all cells. Macchiarini and his colleagues assumed that if the patient's stem cells taken from bone marrow and epithelial cells taken, for example, from the nasal mucosa were planted on such skeletons , then over time new tissues – external cartilage and internal, consisting of epithelium, would grow on the skeleton by themselves, and with them recover and the blood supply system. Since the implant initially contains only the patient's own cells, the problem of biocompatibility is automatically removed.
So, according to the Macchiarini method, stem cells are planted on a frame (biological or polymer) (in some cases also epithelial cells), all this is placed in a so-called bioreactor for a few days so that the cell culture develops a little, and then implanted in the patient. Sounds surprisingly simple, almost like magic? Many experts hold the same opinion.
Bengdt Gerdin, former Professor of Surgery at the University Uppsala (he is now retired; Gerdin's connection with the Macchiarini case will be described in detail later), told Radio Liberty that Macchiarini's approach seems initially questionable for several reasons at once.
Firstly, in order for the frame to turn into a full-fledged trachea, new tissues must grow on it, in particular, cartilage on the outside and epithelium inside. And for this, they should be comfortable on the proposed "substrate". If the growth of new tissues on a biological framework is theoretically possible and has been experimentally achieved by other researchers (for example, the Belgian Pierre Delaere, though not in the trachea), then an artificial surface consisting of homogeneous polymer molecules is too unusual, too unnatural a substrate for living cells. "An implant made from a donor organ consists of many types of molecules, this is the optimal structure to which cells can attach, nature guarantees this. No one has yet been able to reliably prove that a synthetic frame can work in this role," explained Gerdin.
The second controversial point is the blood supply. You can't, for example, put a stem cell on a table and hope that something will grow out of it. New tissues can neither develop nor survive without a circulatory system, which is absent in the prosthesis as such. Macchiarini, in his commentary for Radio Liberty, said that during the operation, the implant turns into a so –called large omentum - a fold of the peritoneum rich in blood vessels. "This gives the frame indirect access to vascular tissue at the first stage," says Macchiarini. In the future, the surgeon believes, we can count on angiogenesis – the process of gradual formation of new vessels in the tissue (Macchiarini cited a reference to a 2015 scientific paper, the authors of which claim to have observed angiogenesis in transplanted prostheses in rabbits). But Bengdt Gerdin believes that wrapping the prosthesis with the tissue of the omentum does not make any sense. "This wrapper will be too far from the inner part of the tracheal skeleton, there will be no oxygen access there, and cell growth will not be supported," Gerdin is sure.
Another obstacle is infection. A foreign body, especially an artificial one, may not like the body's own cells, but it is ideal for bacteria to reproduce. That is why artificial grafts are mainly used where the environment is initially sterile – for example, in blood vessels. "Our vast experience suggests that once an infection has started on the transplant, nothing can be done with it. And to hope that the infection will not occur on the site of an artificial prosthesis, which is not protected by anything from numerous microbes inhaled together with the air, is simply naive, " Gerdin is sure. "It's hard to seriously assume that a new epithelium will grow in the trachea right on top of the bacteria."
And what about the magic stem cells that have attracted so much attention to the Macchiarini method? All the specialists with whom Radio Liberty managed to communicate are sure that they will die very quickly and will not be able to turn into any natural tissue for the trachea. "Planting stem cells on a biological or synthetic scaffold will never lead to tissue regeneration if blood supply is not provided," says Pierre Delaere, professor of respiratory surgery at the University of Leuven, Belgium.
"The only effect that stem cells could theoretically have – just in the process of their death (and in the vast majority of cases they die), they secrete some biologically active substances that can enhance the growth of the epithelium. Only such an indirect influence," said Roman Deev, Director of Science at the Institute of Human Stem Cells.
By the way, this was indirectly confirmed by Macchiarini himself, telling the New York Times in 2012 about the results of the operation on Beyene: "I am sure that the cells that we put into the bioreactor die. But when they die, they secrete substances that give the body a signal to send more stem cells to this place, thus contributing to the regeneration process." Today, Macchiarini's statements about the importance of stem cells for his method are still cautious: "Many have studied the advantages of sowing stem cells on prostheses in comparison with using prostheses without stem cells. Both methods may work, but I think the available evidence indicates that stem cell culture increases the chances of success."
Macchiarini's approach looked too bold from the very beginning, too much of it had no theoretical justification and almost no experimental. It was a kind of black box that had to work magically – or at the expense of the notorious inexhaustible possibilities of the human body. "When Macchiarini proposed many years ago its technology, it was quite a romantic period, it seemed that stem cells in medicine were about to start working,– says Roman Deev. – Besides, it was already clear at that time that Macchiarini himself did not really understand what he was talking about. When a surgeon undertakes to talk about molecular or cellular biology, it often does not work out very well. Boots should be sewn by a shoemaker, and pies should be baked by a pie maker, when they change places, it turns out what happens, which turned out in the end. My personal opinion is that the theoretical basis of the Macchiarini method is insufficient. As a basic concept, it is certainly interesting, but its verification and processing are insufficient."
Bengdt Gerdin says that this type of approach may well work someday in the future - for this you will have to cope with a number of difficulties, deal with problems, one after another. "Further progress is possible, but in science it is impossible to move forward with giant leaps, you need to go step by step. Macchiarini violated this research principle, he relied on the will of chance. Can this be called courage? Perhaps this is the form of courage that borders on irresponsibility."
But then, five or six years ago, when Macchiarini was at the zenith of his fame, he attracted many with this very thing - his willingness to make a huge leap to where no one had ever been before. No wonder a note about him in the magazine The The Lancet was called "Crossing Borders" and the film was called "Leap of Faith".
And what does Macchiarini himself think about his approach, today, at the beginning of 2017? He speaks more confidently about biological frameworks: "There is no doubt that this method, properly applied, can become a successful approach to tracheal transplantation in humans, and my team and I are now working on improving it in application to other organs, such as the esophagus." The surgeon's words about synthetic prostheses sound more cautious – there are "many problems of their own", but scientific groups around the world are engaged in the subject. "I think, over time , improved prostheses will be able to be used for tracheal transplantation. Why not?"
Disaster in Sweden
Today, when Paolo Macchiarini's stormy romance with the Karolinska Institute – one of the most authoritative medical universities in the world – has been completed, a timeline can be found on the institute's official website detailing all stages of this romance, from the courtship period to the painful breakup.
It begins in the fall of 2010, when Paolo Macchiarini, who managed to become famous for the operation performed on Claudia in Barcelona Castillo, who still maintained his position in Florence, was hired simultaneously as a visiting professor at the Karolinska Institute and as a surgeon and consultant at the Karolinska University Clinic. Less than in A year ago, in June 2011, Macchiarini performed the first transplant in Stockholm - and the first with an artificial frame. The patient was an Icelandic student of Eritrean origin Andemariam Beyene – as mentioned above, he lived less than three years after the operation. Over the next year and a half , Macchiarini spent in Karolinska Hospital has two more operations, both using an artificial frame. A patient named Christopher Lyles, a thirty-year-old employee of the US Department of Defense, was at an inoperable stage of tracheal cancer, returning home after surgery, he lived only two more months.
Finally, a Turkish student Yasim Chetir, whose trachea was seriously damaged as a result of a medical error in Istanbul, underwent a transplant at the Karolinska Hospital in 2012 and has hardly left the hospital wards since then (at the moment Chetir is in Philadelphia in the USA). The new trachea did not work, the graft was replaced, but the second prosthesis was not better. Chetyr has been in the hospital for more than 1,500 days, she has had more than a hundred additional operations to maintain the tissues around the frame. Medical expenses are paid by the Turkish state, at the beginning of 2015 they amounted to about 6 million euros. According to the scientific journalist Leonid Schneider, who is closely following the history of Macchiarini and his patients, has the plastic frame removed from the throat of the Chetyr.
In 2013, the management of the Karolinska University Hospital decided to stop operations using the Macchiarini method using synthetic frames, in the spring of 2014, a scientific article by Belgian specialist Pierre Delaere "Trachea: the first organ with artificially grown tissues?" was published – it was a sharp criticism of the Macchiarini method. Delaere he became one of the most irreconcilable opponents of the Italian, but Macchiarini believes that Delaere is just an envious competitor. The management of the institute considered Delaere's arguments unconvincing, but a few more months passed – and his own colleagues, doctors of the Karolinska Hospital, spoke out against the Italian.
"For a long time, everyone – or almost everyone –was delighted Macchiarini, you can say, he was considered something like the new Jesus Christ," says Bengdt Gerdin. According to Gerdin, even before 2010 , not everyone in medical circles was crazy about the new star of surgery, someone said that Macchiarini moves from place to place too often, leads an atypical lifestyle for a scientist, because usually a scientist tries to gain a foothold in one university. The management of the Karolinska Institute knew about the doubts that accompanied Macchiarini's CV in Italy, but nevertheless he was hired, and at first there were no complaints against him in Stockholm.
"It all started with the fact that Macchiarini began to notice that he was behaving irresponsibly towards patients,– says Gerdin. – And for a doctor, there should not be a person closer to the patient, and when doctors notice that their colleague is not very attentive to those he treats, to their complaints, this is a very alarming signal. Then people began to notice that the postoperative condition of patients was not at all as good as they expected and as expected Macchiarini.
In the summer of 2014, four of Macchiarini's colleagues at the clinic filed two complaints to the management – in their opinion, the results of transplants described by the Italian surgeon in several scientific papers are presented biased, do not correspond to the actual postoperative condition of patients and inadequately describe the operability of implants. It is worth noting that three of the four doctors who filed complaints worked closely with Macchiarini and were co-authors of some of his articles.
The article published in 2011 was the most criticized year in The Lancet magazine – a description of an allegedly quite successful transplant performed on Andemariam Beyene. "The doctors found that what is written in it does not correspond at all to the real condition of the patient, whom they also observed, including during the frequent departures of Macchiarini," says Bengdt Gerdin.
By the way, Macchiarini, in a comment to Radio Liberty , says that initially he did not plan to use a synthetic frame for Beyene, but the laboratory in which the technique of decellularization of donor organs was mastered was still in Italy at that time. It was not possible to transport the patient to Florence or make a high-quality biological frame in Sweden, and Macchiarini decided to use a plastic prosthesis. The surgeon admits that the technology has not been previously tested even on animals, however, "we were faced with a choice – the death of the patient due to aggressive tracheal cancer or an experimental technique. It was a very difficult and personal choice."
However, the complaints were not only about the clinical activities of Macchiarini, but also about his research work (all complainants worked at the Karolinska Institute), doubts were raised by an article published in the authoritative journal Nature Communications in the same year 2014, it described the current experiments of the Macchiarini group on transplantation of donor esophageal skeletons with stem cultures cages on rats.
In November 2014, the leadership of the Karolinska Institute appointed a retired former professor of surgery at the University Uppsala Bengdt Gerdin to conduct an independent review of the facts presented in the complaints.
"I don't know why they chose me, but I can guess, " says Gerdin. – Firstly, they needed a person who has free time. I was retired, I had it. Secondly, we needed a person with whom no unpleasant rumors were connected. I was a normal scientist, always tried to be honest and earned a good reputation. Finally, they needed a person with broad qualifications who would understand chemistry, clinical research, and animal experiments. I had it all. And of course, they were looking for someone who is not connected with the Karolinska Institute."
Gerdin prepared his report for several months – until May 2014. His conclusion is a significant part of the violations described in the complaints of colleagues Macchiarini, confirmed.
"We usually proceed from the fact that what is recorded in the patient's medical history reflects the real state of affairs," explains Gerdin his conclusions. – The objective condition of the patient and everything that happens to him, all the tests that are taken from him, are entered there every day. I found out that the articles don't say exactly what can be found in medical histories. For example, the article talks about the growth of the epithelium, and there is not even a record in the medical history that an appropriate analysis was performed. The patient was in a bad condition, and the article says that he feels well. You don't even need to be a specialist to detect this, that is, you certainly need clinical experience, but you don't have to be an advanced thoracic surgeon at all."
Gerdin claims that in response to his report, which Macchiarini prepared in June 2015, the surgeon did not give a clear explanation for any of the specific claims. In some cases, he stated that the responsibility lies not with him, but with one of his co-authors who conducted the analyses. In August, three months after the publication of the report, the administration Karolinska Institute issued a verdict: consider the surgeon's response to the Bengdt report Gerdina is convincing and withdraw all charges against Paolo Macchiarini.
Gerdin suggests that financial considerations and a desire to save face could have pushed the management of the institute to this decision. The scandal broke out just at the moment when the decision was being made to extend state funding, under which Macchiarini worked in Stockholm. In addition, according to Gerdin, at the same time, negotiations were underway between the Karolinska Institute and a major Chinese investor to launch a joint project in Hong Kong with a total investment of about $ 50 million. Journalist Leonid Schneider discovered that at the same time Paolo Macchiarini promised the institute's management that an American philanthropist was ready to invest $10 million in a new research center in Stockholm. Is it reasonable at such a moment to catch one of the main stars of the institute on scientific fraud?
"Another circumstance is the special charisma of Macchiarini, thanks to which something like a cult was formed around him," he says Bengdt Gerdin. – Perhaps you will understand the comparison with Grigory Rasputin. People were afraid to ask him uncomfortable questions. One surgeon told me that during Macchiarini's speech at the conference, there was an atmosphere of almost religious worship in the hall. Sometimes he behaved like a psychopath, I don't want to say that he is actually a psychopath, but sometimes he behaved very similarly. Even after Macchiarini was finally exposed, there were plenty of people who are sure that he was treated unfairly, that he was not guilty of anything."
In November 2015, the contract with Paolo Macchiarini was extended for a year. Moreover, despite all the proceedings, it was said that he would be offered a permanent professorship at the Karolinska Institute – a rare success in the modern academic world. But at the beginning of 2016 , thunder broke out. Almost simultaneously, Vanity Fair magazine published a large text about the romance of Macchiarini and Benita Alexander and their failed wedding, and the Swedish national TV channel SVT showed a three-part documentary called "Experiments".
In his autobiographical note, Macchiarini says that the management asked him to cooperate with the film crew, in addition, "we had nothing to hide," the surgeon is sure. Perhaps Macchiarini hoped that the film would turn out to be another laudatory biopic with a pinch of criticism, like the "Leap of Faith" of the American channel NBC. But Swedish journalists Bosse Linqvist and Joannes Hallborm discovered and showed the reverse, scandalous and ambiguous side of the famous surgeon. Here 's how they described her in an interview with the portal Rectaction Watch:
– Let's start with the fact that Macchiarini used people who got into a difficult situation to test his synthetic trachea, actually deceiving them, claiming that this was their only chance to survive, and all this without preliminary animal experiments. In addition, he deliberately disregarded ethical norms and wrote untruths about the results of operations in his scientific articles.
By this point, rumors about possible professional and personal dishonesty of Macchiarini had been circulating in the medical and scientific community for a long time, but now all this has splashed out into the public space. The leadership of the Karolinska Institute, which had just rejected the results of the investigation of Bengdt Gerdin and extended the contract with the Italian, was forced to act, and then everything developed unusually quickly. 1st of February In 2016, three days after the release of the last series of "Experiments", it was officially confirmed that there were some inaccuracies in Paolo Macchiarini's resume . On February 4, the Vice-Chancellor (the equivalent of the vice-rector in the Swedish system) of the Karolinska Institute, Anders Hamsted, decided that the contract with Macchiarini would not be extended in the future. On the same day, the external supervisory board The Karolinska Institute demanded to conduct a trial of all the activities of the Italian at the Institute, starting with the study of the grounds for his hiring. February 7 Urban Lendahl, secretary of the Nobel Committee at the Karolinska Institute, resigned due to "concern for the Nobel Prize." The investigation of scientific dishonesty in Macchiarini's articles has been reopened. On February 13 , Vice-Chancellor Anders Hamsted, the main supporter and defender, resigned Macchiarini at the Karolinska Institute. On February 22, the dean responsible for research, Hans-Gustaf Ljunggren, resigned. On March 3 , the Swedish Government initiated the process of electing new members of the Council Karolinska Institute. On March 23, the disciplinary committee released Paolo Macchiarini from his duties as a researcher at the Karolinska Institute. On April 21 , the Swedish government appointed a new composition of the main governing body Karolinska Institute – Council.
On June 22, 2016, the Swedish prosecutor announced Paolo Macchiarini that the Italian surgeon was suspected of manslaughter and causing bodily harm.
Macchiarini rose to the top of fame largely thanks to journalists who wanted to see him as a bold innovator and revolutionary, but journalists pushed him down. Rolling down the slope like a snowball, the surgeon took with him almost the entire leadership of the famous medical institute and even the general secretary of the Nobel Committee – the man who was to announce the winners of the Nobel Prize in Physiology and Medicine.
However, Paolo Macchiarini himself claims that he was the victim of personal hostility of one of his colleagues and press pressure, which pushed the administration of the Karolinska Institute to biased actions. In an autobiographical document that Macchiarini presented to Radio Liberty without the right to direct quotation, he claims that in 2012, relations between Macchiarini's scientific group and Karl-Henrik Grinnemo's scientific group, who shared a common laboratory and a common budget, began to deteriorate. According to Macchiarini, at the end of 2013, Grinnemo borrowed data from the work of one of the graduate students of an Italian surgeon. The report of the Ethics Council of the Karolinska Institute, which Macchiarini made available to Radio Liberty, partly confirms this. Macchiarini claims that Grinnemo, who turned out to be one of four researchers who filed complaints against the Italian surgeon in 214, thus took revenge on his colleague. Documentary film "Experiments" by Paolo Macchiarini calls it biased, and the events that followed his release are political actions carried out under media pressure.
And what about the accusations of data manipulation in scientific publications? Macchiarini told Radio Liberty that the accusations related to the data published in The Lancet "are serious," but the responsibility lies with others (they made about the same comment several years ago on the Gerdin report), since "the pathologist who performed the biopsy analysis and provided it for the manuscript of the article swore that, as far as he knows, everything is written correctly in the manuscript. (...) I have no reason to doubt the sincerity of the pathologist and the reliability of the data, and in the context of the accusations and the background on which they are made, it is very likely that these accusations will turn out to be groundless." As for doubts about the reliability of the data of the article published in Nature Communications, Macchiarini stated that "after careful study, they were found to be based on nothing." We will have to return to this statement at the very end.
Russia launches into space
The second series of the film "Experiments" tells about the side of Paolo Macchiarini's biography, which we have not touched yet: about his work in Russia.
The surgeon first came to Russia in February 2010. Mikhail Batin, founder and president of the Science for Life Extension Foundation, entrepreneur, told about the circumstances of this visit in a Facebook post in December 2016 . Currently, the recording is hidden, but journalist Leonid Schneider managed to save a copy of it.
According to this version, Batin, passionate about promoting life extension technologies, heard about Macchiarini in the late 2000s. Through Elena Kokurina, an employee of her foundation (scientific journalist, wife of an academician of the Russian Academy of Sciences Svyatoslav Medvedev, who eventually became Macchiarini's right-hand man in Russia and wrote a book about him "Megagrant") Batin invited the Italian to conduct a master class at the Russian Academy of Medical Sciences. Speaking in Moscow in February 2010, Macchiarini talked about his, what was then considered a successful operation on Claudia Castillo. The audience took the lecturer with great interest (although there were also questions – for example, on the blood supply of regenerated tissues), Batin caught fire with the idea of inviting Macchiarini to perform an operation in Russia and even found a basic hospital for this – the Petrovsky Surgery Center. Batin said that the sponsor of the project was also found – it was supposed to be the developer Sergey Polonsky (currently in a pre-trial detention center in a fraud case). Polonsky first agreed to finance the project – it was only about 16 thousand euros, since Macchiarini verbally promised Batin to do the operation for free. A patient was found, a 26-year-old woman from Kazakhstan, Zhadyr Iglikova, whose trachea had been seriously injured in a car accident four years earlier.
According to Batin, Polonsky unexpectedly refused to finance the project (shortly before that, Yuri Luzhkov resigned as mayor of Moscow, and this affected the position of the businessman), moreover, Paolo Macchiarini also unexpectedly announced that his services would cost 110 thousand euros, and a donor tracheal frame for Iglikova – another 30 thousand. The entrepreneur sold his share in the Hundertwasser restaurant and financed the operation (Batin confirmed the Radio Freedom that paid a total of 140 thousand euros). The operation to transplant a donor frame with table cells to Zhadyre Iglikova took place in December 2010, six months before Andemariam Beyene's Stockholm operation. Immediately after her, the patient's condition was good, and numerous Russian media reported on her success, including Channel One, which quoted the words Iglikova: "I can go to work, I want to continue working after getting an education."
Later, Zhadyra Iglikova returned to Kazakhstan. Supporters of Macchiarini said that the girl learned Chinese and got married, but there was no reliable information about the girl's health for a long time. Only in the middle of 2016, Swedish journalists managed to find the parents Iglikova, who said that her daughter uses a silicone tracheostomy tube that prevents the prosthesis from collapsing, is unable to speak and cannot stand. After the operation, she left her parents' home only to visit medical institutions.
But at the beginning of 2011, as it happened more than once in the biography Macchiarini, media and experts praised the Italian surgeon. With the help Elena Kokurina, he submitted documents for a mega-grant as part of a public competition for large-scale funding, which the Russian government conducted for the first time in order to attract leading scientists to Russian universities. Macchiarini became one of the 39 winners, having received a budget of 150 million rubles for the creation of a laboratory of regenerative medicine on the basis of the Kuban State Medical University in Krasnodar, which has a high–quality clinical base – Regional Clinical Hospital number 1. "It was excitement, it 's about like launching a man into space," said the deputy director of the Krasnodar hospital Igor Polyakov on the expectations of working with Paolo Macchiarini.
In Krasnodar, Macchiarini performed four transplants, two of them in June 2012. The first patient was Yulia Tuulik, like Iglikova, a victim of a car accident. Unlike a woman from Kazakhstan, Tuulik had an artificial tracheal frame transplanted. Channel One announced the success again, but Tuulik died two years later, in September 2014. Before that, she had to undergo another transplant. Swedish journalists managed to find the mother Yulia Tuulik, who said that a week after Yulia's transplant it was difficult to breathe, she started coughing up pieces of her own trachea and, according to her mother, "rotted from the inside."
In the same month , Alexander underwent surgery in Krasnodar Zozulya. He died in February 2014 under unknown circumstances, although the newspaper Moskovsky Komsomolets wrote with reference to the head physician of the regional hospital Igor Polyakova said that it happened after a fall from a bicycle. Another patient Macchiarini in Krasnodar was a Jordanian Sadiq Kanaan, the operation was carried out in August In 2013, according to the authors of the film "Experiments", the man also died.
The last patient of Macchiarini, not only in Russia, but in general, was a native of Crimean Kerch Dmitry Onogda, who, like Iglikova and Tuulik, damaged his windpipe in a car accident. In June 2014 , a synthetic trachea was transplanted into him. It is curious that the question of Radio Liberty about the examples of documented growth of new epithelium in patients, Paolo Macchiarini remarked: "It is worth mentioning my last Russian patient. He is alive and in good condition, which means that the growth of the epithelium can be verified by endoscopy and other tests." The surgeon also noted that the Swedish television team wanted to include Onogda in their film, but did not do so because "his condition did not fit the story they told."
In fact, there was little information about Dmitry Onogda's condition, but Radio Liberty managed to track him down on social networks. Dmitry briefly answered the correspondent's questions:
– The operation was successful, but after six months the prosthesis was removed, it began to narrow again and it became difficult for me to breathe. The doctors tried to help, but nothing worked out, now I have a tracheal tube again. Macchiarini himself did not observe me, my doctors Polyakov and Artur Valerievich are observing. At first Macchiarini made a great impression on me, but when the operation failed, all hopes collapsed. No, I don't think it was a mistake, I hoped that everything would work out, but it didn't work out.
In fact, the prosthesis installed by Macchiarini was removed from Dmitry Onogda's throat, and he returned to the same condition in which he was before the unsuccessful transplantation. It is difficult to understand why Macchiarini considers the case They are an example of successful epithelial growth. Judging by social networks, she is fond of computer games and cars and regularly meets with friends. Could Julia Tuulik have had the same life?
In 2013, the Macchiarini megagrant was extended for another two years with additional funding in the amount of 40 million rubles.
Alexander Fradkov, Member of the Grants Council of the Russian Federation In October 2016, he left a comment on the website of the Society of Scientific Workers:
"We took part in the extension of this mega-grant, which was then considered one of the most successful. The leading scientist came to the MES for a meeting of the Council and made a presentation of his work, which made a good impression. Now the megagrant is finished, back in 2015. But the regenerative medicine laboratory is working. Should it be closed? I think not. The accumulated experience, infrastructure and grown-up youth should be protected. After all, regenerative medicine is a promising direction, isn't it? And in general, why should Macchiarini's personal qualities be reflected in the development of sciences in the Kuban? But it is necessary to check the work of the laboratory in connection with the revealed facts, of course , but there is someone to do this without us."
The megagrant project was finally completed in 2015, and at the beginning of 2016, Roszdravnadzor began checking the Krasnodar Clinical Hospital in connection with the Macchiarini scandal. Its results have not yet been made public.
Step back
In December 2016, medical journalist Alla Astakhova discovered that after a deafening scandal in Sweden, back in August, Paolo Macchiarini found a job again in Russia, at the Institute of Fundamental Medicine and Biology of Kazan Federal University, where the Italian headed the laboratory "Bioengineering and Regenerative Medicine". This information Radio Liberty was confirmed both at the university and by Paolo Macchiarini himself.
"I had a grant from the Russian Science Foundation, and I was looking for an opportunity to take the cellular and molecular aspects of our project to a new level. Professor Roman Deev told me about the wonderful infrastructure and equipment of Kazan University," said Macchiarini.
Deev explained to Radio Liberty that even when Macchiarini continued to work in Krasnodar, but the mega-grant came to an end, the Italian managed to get another Russian scientific grant from the Russian Science Foundation, this time for only 20 million rubles for two years. Macchiarini continued to work in Krasnodar, but, as Deev said, "somewhere in the middle of the execution of the state assignment for this grant, it became clear that it would not be possible to fulfill it - for subjective reasons. Because the relations within the scientific group developed in such a way that joint work could not be continued. Therefore, the question arose – either to break the contract and declare that this state task will not be fulfilled, or to complete the research program. In order to continue, it was necessary to find a new team, to find a new platform that is able to implement the tasks formulated in the application."
Kazan Federal University became the new site, where Paolo Macchiarini now works as the head of the laboratory. An important note needs to be made here: the current grant imposes a strict framework on the surgeon. As emphasized by Natalia Doroshkevich, a representative of the KFU press service, "grant The RNF, which Paolo Macchiarini implements at KFU, assumes exclusively preclinical research and is conducted on the topic of creating a tissue -engineered esophagus structure to replace a damaged organ with a model of lower primates. The esophagus is not as complex an organ as the trachea, taken in the past as a model , for such work. Macchiarini himself admits that now a step has been taken back and much remains to be done before technology can be massively useful for people."
So, Macchiarini had to take a step back in order, in the words of Bengdt Gerdin, to move on step by step, without thinking about quick and bold experiments on humans. The Italian surgeon conducted a total of about 14 such experiments, judging by open data, at least seven of them definitely died, although it is difficult to unequivocally blame Macchiarini for at least one death, because his patients had poor medical prognoses before the operation. The survivors are experiencing severe medical problems, tracheal transplantation using the Macchiarini method – donor or plastic – actually did not help anyone.
"Of course, I always believed that my operation could help the patient," Paolo Macchiarini told Radio Liberty. – I am deeply committed to each of my patients who literally put their lives in my hands. I have dedicated my life to finding a way to make patient care even better. There is nothing more important to me."
In December 2016, a group of Swedish doctors published a petition addressed to the Russian authorities with a proposal to conduct an additional investigation of Macchiarini's activities in Russia in light of the circumstances revealed during the Swedish investigation.
"You know, it is very important for any scientist to have trust. And I'm afraid Macchiarini has lost it. Should the Russian society invest money in a scientist whose results no one will believe? Will he be able to repay society with something?" – asks Bengdt Gerdin.
"All of Macchiarini's articles since 2008 are based on lies. I am sure that when applied to it, the word "fraud" is an understatement. Implantation of a foreign body using the Macchiarini method is a medical crime, it cannot be called otherwise," says Pierre Delaere, a "competitor and critic," as Paolo Macchiarini calls him.
Perhaps this opinion is too radical (Delaere calls Macchiarini's operations a kind of "medical torture"). Perhaps Macchiarini's desire to help patients was sincere. In any case, the media should share at least half of his guilt for the deceived expectations.
On the eve of the publication of this text, a source told the Radio Svoboda, that Macchiarini's co-authors according to an article in the journal Nature Communications (claims to which Macchiarini called "not based on anything") received a letter – it is at the disposal of Radio Liberty – from the editors of the magazine. They suggest that they voluntarily withdraw the article from the publication by January 24 , 2017. Otherwise, the article will be withdrawn by the journal itself.
Portal "Eternal youth" http://vechnayamolodost.ru 23.01.2017