17 September 2015

"A head transplant now is complete nonsense"

Surgeon Paolo Macchiarini on head transplant,
accusations against yourself and medical science in Russia




Paolo Macchiarini, a surgeon working in Russia, told the newspaper.Ru" about the accusations against himself and his rehabilitation, about the development of medical science in Russia and why a head transplant operation is impossible.

The famous surgeon Paolo Macchiarini, who was repeatedly accused by colleagues of violating ethical norms, misinformation and falsifying the results of scientific research, was cleared of all charges a few weeks ago. This was reported by the authoritative scientific journals Nature and Lancet.

Paolo Macchiarini, professor of regenerative medicine at the Karolinska Institute, created the technology of bioengineered trachea transplantation. Now he is also working in Russia – in Krasnodar, where a Center for Regenerative Medicine was created with the funds of a megagrant received in 2011. 

"Newspaper.Ru" has repeatedly written about the achievements of Paolo Macchiarini: about the first tracheal transplant operation performed in Russia on a megagrant; about the first transplant of a bioengineered trachea "tailored for growth" to a child; about the creation of the first bioengineered esophagus. However, at the beginning of last year, the surgeon's reputation was under threat: colleagues accused him of violating ethical standards and falsifying the results of operations. In particular, it was about the death of patients who had a trachea transplanted from a polymer frame seeded with stem cells. In May of this year, a report was published by an independent expert, Professor Bengdt Gerdin, who stated that Macchiarini was guilty. 

However, this report was an inconclusive conclusion, and the investigation was continued by a specially assembled commission of doctors. 

A few weeks ago, the leadership of the Karolinska Institute, having studied all the materials, announced that the scientist did not violate ethical standards, and his activities were fully justified. The correspondent of the science department managed to meet with the surgeon and talk to him about how the story of the accusations actually began and how it ended.

– Professor Macchiarini, first of all, let me congratulate you on the fact that all charges against you have been dropped… 

– Thank you very much. 

– ...and ask: the accusations against you were quite loud and widely replicated by the media. However, the refutation came out quite modestly – it cannot be said that it was actively distributed. How can this situation be explained? 

– In July last year – when all these accusations appeared – I said that I would not give comments and interviews until the investigation was completed. This is my principled position: I have not declared anything, I have not announced anything, and I have given the leadership of the Karolinska Institute a chance to speak on my behalf. On the other hand, everyone knows that the media loves scandals and does not like to admit that they were wrong. Now that the truth that I am innocent has finally been confirmed, journalists may feel uncomfortable. Therefore, I am not surprised by this situation.

The Lancet magazine proved to be quite an emotional publication: a week after the decision on my innocence was made, they criticized both the Karolinska University, Professor Gerdin, and his statements to the media, and how he conducted the investigation. You know, it's very easy for a famous person to ruin a reputation, but it's difficult to restore it. However, my colleagues did not see a single proof of my guilt. 

– However, you were accused of not being interested in the condition of your patients after operations, of publishing data on people's health 5 and 12 months after trachea transplantation, but you did not actually collect them. Is it all made up? 

– I would like to tell you how this whole story began – few people know about it. Initially, all the charges were brought by a group of German scientists who worked in the laboratory next to mine. In February 2014, they received a grant from the Swedish government for the implementation of a scientific project, the author of which was actually me. They received 5 million Swedish kronor. When I found out that they had received money for my scientific work, I declared it, declared their violation of ethical norms, caught them in plagiarism. A commission was created that proved the fact of plagiarism. After that, they accused me. I don't think it's revenge – it's a backlash. Of course, the university had to launch an investigation and instructed Professor Gerdin to look into the situation. He had every opportunity to conduct the investigation the way he wants. He said that I was guilty of violating scientific ethics. At the same time, he did not talk to me or my immediate colleagues (he stated that he did not consider it necessary to do this). In addition, he said that I did not provide him with all the documentation about the operations. This is not true – in fact, he looked through only part of the documents. 

The Karolinska Institute provided him with materials for studying on more than 7 thousand pages of printed text – including such data to which I myself did not have access. Professor Gerdin stated that he read them in less than eight hours. Do you think it's possible? What kind of professionalism can we talk about?

Nevertheless, Professor Gerdin talked to the press – with the New York Times, with you, after all – and called me a criminal. Professor Gerdin's report was only part of the investigation. He did not wait for the official verdict of the commission and accused me. I didn't expect this. I started studying the documents myself. It took me and my two assistants eight days to do this.

– However, your methods of treatment are still experimental today? 

– Yes, of course. We are still at the experimental stage. We cannot use my methods as a routine way of treating such diseases. We have to prove that they work by such trial operations. After several operations, side effects were revealed – now work is underway to eliminate them. Because of this, operations have been suspended for the time being and will resume next year, possibly in July. We are really doing very serious work and trying to fix all the shortcomings. My methods are used only when the patient has no other chance. We inform patients about this, and they understand it. For my patients, this operation is already the fifth or sixth in a row, when all the previous ones could not help. The last time I operated on a person for whom this procedure was the thirteenth. 

– In 2013, you operated on a 32-month-old girl, Hannah, from South Korea. Then you said that the trachea transplanted to her would grow for several years, and then another operation would be required to correct the connection between the trachea and the larynx. How is she doing now? 

– Unfortunately, she died three months after the operation. She died due to postoperative complications related to problems with the functioning of the esophagus. 

– How many tracheal transplants have you performed in total? 

– We use different techniques: bionic skeletons, artificial skeletons... there were 19 operations in total. 

– And how many patients survived? 

– It's better if I write to you about it later – I don't remember the exact figure. However, you can find this information in the journal Nature, in an article by David Chiranoski. It was released about a year ago, since then the figures have not changed. You see, it's not the numbers that matter. If this technology saves at least one life, it will already be fine. Let's remember how liver or heart transplant operations began – patients died. The most important thing is progress, development and following the rules. (The Department of Science managed to find an article by the author indicated by the professor – it was published on November 28, 2014. It says that since 2008, Paolo Macchiarini has performed 17 tracheal transplant operations. Of the eight patients to whom an organ with an artificial frame was transplanted, six died, having lived from 3 to 31 months after the operation. The remaining nine people received a trachea from a donor, four of them died. Elena Kokurina, coordinator of the project "Regeneration of the respiratory tract and lung", said that another patient from the Crimea was not taken into account in Nature. The operation was performed on him in 2014, and he is now alive – "Newspaper.Ru»).

– And can you say something about the tracheal transplant operation, which was carried out in the summer of this year at the Institute of Oncology. Petrov by the method of Professor Yevgeny Levchenko? It was reported that the trachea he developed consists of 5% synthetic material and 95% of the patient's cells. 

– No, I can't comment on it, since I haven't heard anything about it. 

– Could you tell us more about your work in Russia? 

– My Russian colleagues and I are still working on the creation of bioengineered organs, creating them from scratch, trying to better understand how stem cells and artificial skeletons work and interact with each other. We work in different fields and with different bodies. In animals, these are – in addition to the trachea – the heart, lungs, diaphragm, esophagus. I plan to continue working in Russia. 

– Does the political situation interfere? 

– No, not at all. I don't see a connection between science and politics. We have an excellent laboratory in Krasnodar, it fully meets all international standards. The Russian government encourages us to conduct research and teach. There is also significant progress on our part, and I see no reason why I could stop working in your country. In recent years, Russia has made a huge leap forward in this area, and this is significantly helped by mega-grants. Of course, there are problems in our laboratory – for example, it takes a lot of time to obtain reagents – but it's all solvable. I believe that science has no borders, and that your country deserves the development of science. I'm glad I'm here and that I'm helping this. 

A few years ago there was nothing in Krasnodar – and now we have a laboratory, projects, scientists – very young people, many of them are not even 30 years old yet – they speak English, can independently conduct serious research at such a level that some of the work cannot be implemented in Europe or the USA.

Perhaps I can only judge about one rather narrow niche, and not about the whole of Russian science, but I am sure that this is just the beginning. I see how young scientists are developing – the future of your country – and I am happy to observe this process. Believe me, they don't care about politics – they want to teach and learn. 

– And why was your laboratory created in Krasnodar? 

– I was in Moscow, St. Petersburg… And in Krasnodar. It was there that I saw the greatest opportunities to combine research, teaching and medical activities. There I found administrative opportunities for my work, and met with enthusiasm. You don't need to be in the heart of the country to do something important, you can do it in a small town. 

In your country, thanks to Krasnodar, I really understood how interpersonal communication should be built, I saw how passionate the desire to learn can be. Of course, there are problems, but, once again, they are all solvable. 

– Did you have any problems with working in the Krasnodar laboratory after these accusations were made against you? 

— no. People who know me– as a professional– have never believed these accusations. Even in the most difficult period for me – after the publications in Nature and Science – they supported me (I am now talking not only about Russian colleagues, but also about foreign ones). In Russia, I felt one hundred percent trust and support, so no, there were no difficulties. 

– Professor Macchiarini, thank you so much for your time and attention. Let me ask you one last question – despite the fact that it does not concern your work, it would be interesting to hear your opinion as a surgeon and scientist. 

– I think I know what you want to ask. About an Italian who is going to have a head transplant operation? 

– Yes, exactly. Do you think this operation is possible? 

– My medical students in Krasnodar have already asked me this question. How can such an operation be imagined at all? Personally, I think he's a criminal. 

Firstly, there is no scientific basis for this. Secondly, this is already something from the field of transhumanism… How in general can one person's brain suddenly start functioning, being attached to another body? Even if we imagine that he has learned to restore the severed connections between parts of the spinal cord and the nervous system, why is this technique not yet used to treat paralyzed patients, for example? I first heard about this operation when I was in Germany, and I read about it in the yellow press. There was a photo of him, he was smiling, talking: "I'll do this, this, and then this." And then I found out that the Russian was going to become his patient, and I thought, "Either he's a complete idiot, or he doesn't realize the danger." I think it is impossible to allow this operation, it is ethically unacceptable. In 100 years, maybe, but now it's complete nonsense.

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17.09.2015
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