Below I am publishing the most recent dossier authored by the four whistle-blowers from the Karolinska Institutet (KI) in Sweden: Oscar Simonson, Karl-Henrik Grinnemo, Matthias Corbascio and Thomas Fux. Two of their earlier notifications of research misconduct to KI by their former colleague Paolo Macchiarini are available in full on my site, here and here.
This time it is about Macchiarini’s trachea transplants in Russia, and the so-called Megagrant funding he received from the Russian government for his work at the Kuban State Medical University in Krasnodar. The accusation goes that the KI star surgeon misrepresented the true outcomes of his two first disastrous human experiments with a plastic trachea, performed at KI on the patients Andemariam Beyene and Chris Lyles, both of who died. Also, the whistle-blowers criticise that KI failed to investigate these failed transplants and patient deaths and did not report those to the Russian authorities, which might have helped avoid the unnecessary deaths of at least two Russian patients, Yulia Tuulik and Alexander Zozulya.
The fate of a third plastic trachea recipient in Russia, Dmitri Onogda, is unclear. We only know from Bosse Lindquist’s film “Experimenten” that his plastic transplant was removed, which saved his life back then. Alla Astakhova, a Russian health journalist, reports regularly on the Macchiarini case, her site is a treasure trove of information. She told me:
“I’m not sure that the discussion of the petition by the Swedish doctors with ethics committees or Commission on Pseudoscience will help clarify the fate of patients, who were implanted an artificial trachea in Krasnodar. Elena Kokurina [who manages Macchiarini’s work and also wrote an admiration-filled book about his Russian achievements, “Megagrant”, -LS], for example, could neither confirm nor deny the BBC information that Dmitry Onogda is alive. I’d love to find out where he is and in what condition. “
In her recent article, Astakhova wrote about the whistle-blowers’ new dossier:
“We can expect that the investigation will begin in Russia, when the petition will go to the relevant authorities. Perhaps, in this case questions will arise not only to Paolo Macchiarini. “It seems that those who approved the trachea transplant protocol, approached this very formally, not to say carelessly, – said the Head of the Laboratory of Biomedical Technologies FNKTS Physico-Chemical Medicine, Sergey Kiselev. – There are many things that require a separate serious consideration. It is unclear why it was not done”.
How come Macchiarini received that Megagrant, and that even after all the scandals he still receives fresh Russian funding? The information below might provide some insights.
First, a recent comment by a member of the Grant Council of the President of Russian Federation, the St. Petersburg cybernetics professor Alexander Fradkov:
“The Macchiarini Megagrant was approved by the Grant Council in 2010, the same year when he joined the Karolinska Institute. Our section of the Council did not participate.
We participated in the extension of this Megagrant, which was then considered one of the most successful. The lead scientist [Macchiarini,- LS] came to MON [Ministry of Education and Science, LS] to the Council meeting and made a presentation of his work, which made a good impression. Photographs of patients with artificial trachea were shown. Back then no one has died yet, I believe [in fact, patient Lyles died one year before, in March 2012, -LS]. I remember someone asked whether preliminary tests on animals were performed and Macchiarini replied that, of course, they were.
Now Megagrant is finished, already in 2015. But the laboratory of regenerative medicine is working. Do we have to shut it down? I don’t think so. The accumulated experience, infrastructure and the raised early career researchers should be protected.
Because regenerative medicine – it’s a promising direction, isn’t it? And indeed, why should the personal qualities of Macchiarini be reflected in the development of science in Kuban? But to check out the laboratory work in connection with the discovered facts, is of course necessary, but there are others who can do this, even without us”.
Fradkov, who described Macchiarini as “good surgeon” and “good manager” as well as “adventurer who uses women to achieve career goals” then added in another comment:
“With the [Macchiarini’s Megagrant, -LS] extension in 2013 (it was the 2nd wave, to be precise) all 4 experts who evaluated the reports supported the extension. In cases of doubt, members of the board visited the lab (I went there a few times), but that case was free of suspicion. Members of the Board who were responsible for the area of Sciences, evaluated positively, and so the total vote was also positive. And it is clear: there was a whiff of Nobel Prize (now we know why he went to Karolinska, working, as usual, through the ladies)”.
There was not just a whiff of Nobel Prize in the air, but even alcoholic fumes of it. The Russian businessman Mikhail Batin runs a “Science for Life Extension Foundation” and played a key role in recruiting Macchiarini to work in Russia. Batin told the Megagrant story on Facebook in December 2016 (which he promptly removed as soon as I stuck my nose in it, here a backup), where he also commented that a drunk Macchiarini promised to give him half of his Nobel prize should he receive it. Here Batin’s own (meanwhile deleted, and occasionally profane) words:
“It all started back in 2009, when I was having my family holidays in Spain. […] The whole thing was happening right in Barcelona [see my report about that 2008 trachea transplant operation here, -LS]. Back then I did not know Paolo in person; I knew only that he was a great surgeon. […] I’m leaving Spain, left, and Lena [Elena Kokurina, Batin’s employee, -LS] came calling: “Misha, it’s incredible, everything’s cool, I spoke [with him], pure regenerative medicine”. In short, we decided to invite him to Russia, that he shows our simpletons how all this is done. We organized a large conference in the Academy of Medical Sciences [details here, -LS].
[…] In general, people liked it. There were questions about the vascularization, but Paolo dismissed those, saying, erythropoietin does everything in the best possible way. Look: the epithelium increased, the patient runs about and she had cancer [Claudia Castillo never had cancer, -LS].
So I tell Lena [Kokurina, -LS], let’s also realise in Russia the progress of cellular technologies, let’s grow a trachea. Soon the story told, but not soon deal is done, but we found a hospital, interested in cooperation: the Petrovsky Institute. I paid the visits of their doctors to Italy, so they could watch an operation live. […]
When Paolo was visiting, I asked him how much will the operation cost in Russia? He said: “I will do everything for free “.
– For me, there is nothing more important than children’s health! […]
Nevertheless, money was still needed for the entire project. We found a sponsor, well, yes, it was Polonsky [apparently, the Russian billionaire Sergey Polonsky, Batin then narrates that Polonsky withdrew his funding offer and that he, Batin, decided to pay for the patient himself, -LS].
Pity for the patient, who can hardly walk with a hole in her throat. A Kazakh [the 26-year-old Zhadyra Iglikova, who according to Swedish journalists was in the spring 2016 found dying following that failed operation with a cadaveric trachea transplant, -LS].
Almost everything is ready, the operating table is in place and Paolo says: “Will come to operation in Russia for 110 thousand euros”. And we fucking wasted a year on this project, with the salaries, travels and doctors! […] I sold my shares in the café Hunderwasser and agreed [to finance the operation, LS]. Meanwhile arrived new greetings from Paolo: “The donor trachea frame will cost another 30,000 euros”. I’m trying to understand: what the fuck? […]
The patient looks like she is about to drop dead. It is after a serious accident, she was treated everywhere, with an artificial lung which destroyed her trachea. Well, I say, OK, I will pay for the trachea too. Then Russian doctors came running to me: we too want to be paid also. We told them: “Fuck off, you were already travelling at my expense to holidays. Learn. This is your reward”.
The date was set and Macchiarini operated. As Lena tells, so far the patient is still alive, learned Chinese, married. Well, thank God. […]
Then television, success, we grew a human organ. In America there is nothing like this. So coincidentally they started issuing megagrants here. […] Macchiarini decided to apply together with the Krasnodar Regional Hospital, there ruled a strong grandfather Parkhanov [Vladimir Parkhanov, head of the Krasnodar research hospital, -LS] because back then everyone in Moscow was giving us fucking trouble. In short, we won 5,000,000 $. Well, exactly in which sense us? The money went all to the local university for Paolo. Lena was slaving, writing papers, explaining those in Krasnodar where Italy is located and what regenerative medicine is. I agreed with Paolo in August in the top restaurant in the Ritz-Carlton, that he would employ my people and allocate to them $ 500,000. They would be working in molecular biology and writing follow-up grants. We all agreed”.
Kokurina indeed then started to work with Macchiarini as his project manager, and she apparently even followed him to his new place of work. Because meanwhile, Macchiarini received a fresh new grant in Russia to test artificial oesophagus constructs on monkeys, which he took to his new host institution, the Federal University of Kazan. The university was a bit secretive about this, they kept removing their new professor’s name and photo off their website. The rector however even issued an order to organise a Macchiarini-led conference and pay the travel costs for his international associates (see my report here). Also, the Latvia-based exile-Russian news site Meduza reported that Macchiarini works in Kazan since August 2016. Thus found out, the Kazan University issued a Christmassy press release, where they invited their new professor to refute all accusations against him in an interview. Also the Moscow Medical University head thoracic surgeon Vladimir Parshin, who together with Macchiarini operated the patient Iglikova, as well as Macchiarini’s admirer Roman Deev (who as a studied surgeon, once desribed Macchiarini as “Michelangelo of thoracic surgery”), were interviewed as experts. No faults with Macchiarini’s previous or current work were found by these experts.
“Thus, the data presented in this article confirm the viewpoint of P.R. Delaere and D. Van Raemdonch that the information about creating a “new” bioengineered trachea is not a proven fact. Transplantation of a donor trachea made and used in clinical practice as described by Professor P. Macchiarini eventually led to the graft’s stenosis due to scarring and granulation tissue formation without signs of preservation of native tracheal structure and function”.
The paper has a PS:
“P.S. But life goes on. And recently Professor P. Macchiarini has received a grant from the Russian Science Foundation to create a “bioengineered” esophagus”.
The full document is available here.
This petition concerns the “Tracheal Transplantation Clinical Trial Protocol, Version A” signed by Dr. Paolo Macchiarini (PM) as “Leading Scientist, Karolinska Institutet” on February 5, 2012 (1, 2) which was approved by The Ethical Commission at the State Budgetary Educational Institution for Higher Education “Kuban State Medical University” of the Ministry of Health Care and Social Development of the Russian Federation on February 15, 2012 (protocol 9) (3) and May 29, 2012 (protocol 11) (4).
Together with the ethical approval of the Clinical Trial Protocol (protocol) which was issued by The Local Ethics Committee at GBUZ “Krasnodar Regional Clinical Hospital No. 1, n.a. S.V. Ochapovsky Department of Health Care Krasnodar Krai” on May 31, 2012 (protocol 49) (5) PM received ethical approval to implant synthetic tracheae in humans.
In the 40-page protocol PM refers to the two patients (with special focus on patient nr. 2) who had undergone elective (the two patients’ conditions were not immediately life threatening) synthetic tracheal implantations at Karolinska University Hospital in June and November 2011 (6, 7). In the text clinical findings are presented that PM uses to support the conclusion that these procedures were clinically successful without any negative effects or complications ([1, 2] pp. 6, 8, 9, 15, 17, 26, 27). On the basis of these conclusions from the Karolinska cases PM wishes to continue and expand the program of synthetic tracheal implantations ([1, 2] pp. 25-26) despite the lack of any previous animal data (8, 32), implying potential success of this procedure before starting up these high risk experiments in humans. It must also be pointed out that these two experimental Karolinska implantations by PM were executed without ethical approval (9, 10, 11, 12, 13, 14, 15, 16) and without permission from the Swedish Medical Products Agency (MPA) (17, 18). After the protocol was approved the patients Julia Tuulik and Alexander Zozulya were the first two Russian “patients” transplanted in Krasnodar on June 19 and 21, 2012 respectively (19, 20, 21).
The following review of the Clinical Trial Protocol Version A from February 5, 2012, will prove that the clinical findings presented by PM of the two patients operated at Karolinska have no correlation to their actual clinical outcome as demonstrated in the patient medical records, in the recorded bronchoscopic film material and in the radiological reports. PM has thereby consciously been providing misleading and fraudulent results of the procedure the patients have been subjected to in order to attain approval and multimillion dollar funding (22, 23, 24, 25, 26) of these high risk experiments on humans in Russia.
The text of the protocol where PM presents falsified data and misleading conclusions have been marked in yellow. Under each Russian text section a translation is attached as well as a page reference from the original document. For each statement separate comments are provided with references to hyperlinked documents (pp. 39-45), specific images from bronchoscopic recordings and radiological exams (pp. 18-38) as well as appendices (pp. 46-55) in order to demonstrate evidence of serial fabrication and manipulation.
Translation of the original protocol consists of 29 of the total 40 pages. The untranslated pages consist of images and technical tables which do not change the implications of the translated text. The contents of the documents and page numbers have been preserved between the original and translated versions to simplify comparison.
Along with this petition the following documents are attached:
- Original Russian version of the “Tracheal Transplantation Clinical Trial Protocol, Version A, February 5, 2012” (1).
- Our English translation of the protocol (2).
Original bronchoscopic films will be supplied upon request.