Paolo Macchiarini indicted for aggravated assault in Sweden

The scandal surgeon Paolo Macchiarini is now officially indicted for aggravated assault in Sweden, over three deadly plastic trachea transplants performed at the hospital of the Karolinska Institutet (KI). This was the public announcement by the Swedish Prosecution Authority yesterday, I publish below the full indictment letter which I received directly from the prosecutor, Mikael Björk.

As a brief recap: Macchiarini invented the method of trachea transplants using patient’s own bone marrow cells, seeded on top of scaffolds either from plastic or decellurised grafts from deceased donors, which he applied it in six different countries. Almost all of his trachea transplant recipients (totalling up to 20, referenced only on my site) died, the known operations took place between 2008 and 2014. There was also lots of other patient abuse, not transplant related, last year an Italian court sentenced Macchiarini to 1 year 4 months prison (on parole) for extortion of his terminally-ill patients and their families). Having left a trail of death and suffering in Spain and Italy, Macchiarini was recruited to KI in 2011 with the hope to obtain governmental stem cell funding and to bring home the Nobel Prize for medicine.

At KI, Macchiarini performed in 2011-2012 three transplants with a plastic trachea, all 3 patients died, for which he was supposed to be charged with manslaughter, but the prosecutor failed there 3 years ago having recruited as experts Macchiarini’s collaborating trachea transplanters from Gothenburg, who were guily of misconduct and patient abuse themselves. Now is a new attempt, thanks to the efforts of the deceased patients’ families, and this time Macchiarini is charged with aggravated assault. This time, there are better expert witnesses: the stem cell researcher and biomedical regulatory and ethics expert Patricia Murray from University of Liverpool, and the airway transplant surgeon Pierre Delaere of KU Leuven.

Before presenting the Swedish indictment letter, I would like to remind you that Sweden is the only country which raised criminal charges against Macchiarini over the trachea transplants. Sweden is also the only country where any research misconduct findings were made against Macchiarini and his partners in this regard (although KI somehow did manage to blame whistleblowers also).

Spanish and Italian authorities are absolutely not interested in investigating the trachea transplant affair, for them the case is buried together with the patients (2-3 decellurised trachea transplants in Spain, 5 in Italy, all but one patient are dead). Russian universities, where one decellurised and 4-6 plastic trachea transplants were performed, sacked Macchiarini twice, but retained his technology and now parade it as their own, some even continue with trachea transplants. The Russian doctors are probably inspired by the United Kingdom, where Macchiarini’s former colleagues in London managed to achieve exactly same, but more successfully. Not for patients (at least two died), but for themselves, the governmental cash is flowing even now. The UCL scientists were also involved n one trachea transplant in KI which is the subject of current criminal charges, but the investigation whitewashed Martin Birchall and other important English people, and blamed the foreigners alone. In USA, where a child died after a plastic trachea transplant, Macchiarini’s partner Mark Holterman (mentioned here) continues in his academic job while rumours go he still is doing business with Macchiarini, wherever in the world that might be.

Macchiarini first began studies into airway transplants with decellurised cadaveric grafts at the Hannover Medical School (MHH) in Germany, the human research was led by the former ethics council member Heike Walles and her surgeon husband Thorsten. It is thanks to MHH that Macchiarini can still call himself professor, the university is not inclined to revoke his adjunct professorship. Also at that MHH, Macchiarini met his student and right-hand man Philipp Jungebluth, who was one way or another involved in almost all of Macchiarini’s research with trachea transplants (in particular those now under criminal charges in Sweden), and who had me sued and sentenced in a German court over the transplants Macchiarini performed in Italy, with Macchiarini himself acting as court witness. Jungebluth is now completing his surgeon training not far from Hannover, even though he was previously kicked out by KI in Sweden for research misconduct, carrying a made-up PhD degree and practising medicine without a licence.

Again, the full list of Macchiarini’s trachea transplant victims is here and nowhere else. Now, the Swedish prosecutor Mikael Björk, with added links for additional information.

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AGGRAVATED ASSAULT (5000-K675951-15) 

Plaintiff 

Andemarian Beyene, Chris Lyles and Yesim Cetir (all deceased) 

Plaintiff’s Assistant (appointed for some of the plaintiffs’ survivors) Attorney Sabina Saidi 

Offences 

Paolo Macchiarini has been employed at Karolinska Institutet and Karolinska University Hospital (hereinafter KS). In his employment as a doctor at KS, Paolo Macchiarini has performed surgery on three patients, namely Andemarian Beyene, Chris Lyles and Yesim Cetir. During the procedures, the patients’ trachea has been removed and replaced with synthetic trachea. These  synthetic windpipes have been completely or partially lined or seeded with each patient’s own cells. 

Paolo Macchiarini has – as main operator and chief physician – on  June 9, 2011 at KS in Huddinge removed Andemarian Beyene’s trachea and replaced it with a synthetic trachea [read Beyene’s case here, -LS]. Paolo Macchiarini has performed the procedure totally contrary to science and proven experience. The procedure has been unlawful because it was not part of any form of healthcare or licensed research study. Through his actions, Paolo Macchiarini has inflicted severe bodily injuries on Andemarian Beyene, which have led to long-term suffering. 

Furthermore, Paolo Macchiarini – in his capacity as main operator and chief physician – on November 17, 2011 at KS in Solna, removed Chris Lyle’s trachea and replaced it with a synthetic trachea [Chris’ case mentioned here, -LS]. Paolo Macchiarini has performed the procedure completely contrary to science and proven experience. The procedure has been unlawful because it was not part of any form of healthcare or licensed research study. Through his actions, Paolo Macchiarini has inflicted severe bodily injuries on Chris Lyle. 

Finally, Paolo Macchiarini – as main operator and chief physician – on 7 August 2012 at KS in Solna removed Yesim Cetir’s trachea and replaced it with a synthetic trachea [read Yesim’s case here, -LS]. Paolo Macchiarini has performed the procedure completely contrary to science and proven experience. The procedure has been unlawful because it was not part of any form of healthcare or licensed research study. Paolo Macchiarini has also, as part of the planned transplant, on 24 July 2012 at KS in Solna carried out a preparatory operation on Yesim Cetir, which led to the need for one of her lungs to be operated on. Through his actions, Paolo Macchiarini inflicted severe bodily injuries on Yesim Cetir, which have led to long-term and severe suffering.  

Paolo Macchiarini has committed the acts with intent. 

The acts are to be judged as grave because Paolo Macchiarini has inflicted severe bodily injuries and very severe suffering on Andemarian Beyene, Chris Lyles and Yesim Cetir. In addition, Paolo Macchiarini has shown particular ruthlessness and callousness.  

Subsequent claims 

Secondarily, it is asserted that the three acts are to be judged as causing bodily injury, serious crime, since Paolo Macchiarini has caused Andemarian Beyene, Chris Lyles and Yesim Cetir at least through negligence bodily injuries, which were not minor. The crimes are to be judged as serious because they involved a deliberate risk-taking of a serious nature and when Paolo Macchiarini was guilty of serious negligence, which resulted in serious suffering for the patients. 

Law 

3 Chapter § 6 of the Criminal Code in its wording before 1 July 2017, secondarily 3 Chapter § 8 of the Criminal Code  

Evidence 

Oral evidence 

1. Interrogation of the accused Paolo Macchiarini, who denies any wrongdoing. 

2. Witness interrogation with Kjell Asplund regarding the investigation he carried out and the conclusions he drew in “The Macchiarini Case” [read details here, with full report for download, -LS], to show that the interventions were carried out in violation of science and proven experience and thus are not to be judged as any form of medical care, that it there was no so-called vital indication for the interventions under accusation, that the interventions could not be defended with so-called compassionate use, that the procedures were to be assessed as experimental and part of licensing research and development, that a permit was required from the Ethics Review Board and the Medical Products Agency before carrying out the procedures, that the procedures resulted in significantly increased suffering for the patients and that Paolo Macchiarini performed the procedures with great risks without taking into account the patient safety, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences.  

3. Witness interrogation with Bengt Gerdin regarding the question of possible misconduct in research on an study and seven articles (a study on animal experiments in the journal Nature Communication and six articles in the journal Lancet regarding the results of the operations performed by Paolo Macchiarini) [Nature Comms report here, Gerdin’s investigation discussed here, -LS], to show that there were a number of inaccuracies in the article in Nature Communications and that the three interventions were not part of any form of medical care but instead constituted research on humans, that a permit was required under the Ethics Review Act to carry out the interventions, that Paolo Macchiarini was not unaware of the results of the operations and of the research findings made in the  aftermath of the interventions; that articles incorrectly stated that ethical status existed despite the lack of such, that patients’ conditions were described incorrectly (by describing examination findings in a beautifying way and complications withheld) and that Paolo Macchiarini was primarily responsible for the inaccuracies published in the articles, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences.  

4. Witness interrogation with Thomas Fux regarding both the conclusions- after a long-term follow-up of the three interventions – in his and a number of co – authors’ report “Synthetic tracheal grafts seeded with bone marrow cells fail to generate functional tracheae: First long-term follow-up study” [KI whistleblowers’ paper Fux et al 2020 here, -LS] and also his knowledge of the complications that arose after the three procedures (especially with regard to Yesim Cetir) to show that the method used by Paolo Macchiarini did not work in any way but on the contrary, caused serious complications and suffering for the patients, that Yesim Cetir had been inflicted with severe suffering and serious bodily injuries as a result of the procedures and that Paolo Macchiarini was well aware that the method did not work and that Yesim Cetir was operated on despite ongoing inflammation (which made the operations very risky), all in support of the fact that Paolo Macchiarini has behaved in the manner stated in the description of the offences. 

5. Witness interrogation with Oskar Simonsson regarding both the conclusions drawn (especially in relation to the complications that arose after the procedures) – after a long-term follow-up of the three procedures – in his and a number of co-authors’ report “Synthetic tracheal grafts seeded with bone marrow cells fail to generate functional tracheae: First long-term follow-up study” [KI whistleblowers’ paper Fux et al 2020 here, -LS], as well as his knowledge of the animal experiments (on rats) performed with the method by Paolo Macchiarini used to show that the animal experiments performed showed that the method did not work, that the method is not based on science and proven experience, that the procedures were not preceded by necessary experiments in the laboratory (preclinical studies) or even experiments on animals and that Paolo Macchiarini was reached by information regarding the complications that occurred after the operations, all to prove that Paolo Macchiarini has behaved in the manner described in the description of the offences. 

6. Witness interrogation by Lennart Åkerblom, Medical Products Agency, regarding the conditions and forms for obtaining a permit under the Medicines Act, his contacts with Paolo Macchiarini (and Rickard Kuylenstierna) and his assessment of whether a permit could have been granted at all for the three interventions to show that permit requires extensive clinical studies and animal experiments, that a permit would not have been granted if a formal application had been received by the Medical Products Agency and that he had not provided any oral information that it would be permitted to carry out the current procedures without a permit. 

7. Witness interrogation of Professor Pierre Delaere (who needs an English interpreter) regarding his assessment of the method used by Paolo Macchiarini  and the procedures performed by Paolo Macchiarini on the three patients [Delaere’s guest post here, and his book about the affair here, -LS], to show that the method is not based on science and reliable experience, that there are no medical conditions for the method to work and that there have been no published preclinical or animal experiments before the procedures, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences. The prosecutor has no objection to the interrogation being held by audio and video transmission from Belgium. 

8. Witness interrogation with Professor Patricia Murray (who needs an English interpreter) regarding her assessment of the method used by Paolo Macchiarini  and the interventions performed by Paolo Macchiarini on the three patients [Murray’s guest post here, her other relevant contributions here], to show that the method is not based on science and proven experience, that there are no medical conditions for the surgical method to work, that there were no published preclinical trials or animal trials before the operations, that the operations can not be defended with so-called compassionate use, all to prove that Paolo Macchiarini has behaved in the manner specified in the description of the offences. The prosecutor has no objection to the interrogation being held by audio and video transmission from England. 

9. Witness interrogation with Jed Johnson (who needs an English interpreter) [Johnson and his company Nanofiber Solutions mentioned here, -LS], regarding the contacts he had in connection with his manufacture of synthetic throats used by Paolo Macchiarini, to show that the synthetic windpipes were manufactured at a very short notice and without further development and tests, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences. The prosecutor has no objection to the interrogation being held through audio and video transmission from the United States of America. 

10. Witness interrogation with Merhawit Baryamikael Tesfaslase (who was married to the late Andemarian Beyene and needs a Tigrinya interpreter), regarding Andemarian Beyene’s state of health [Beyene’s personal story here and here, -LS] and their contacts Healthcare in Sweden and Iceland, to show that Andemarian Beyene has been hesitant to have the procedure but was also persuaded by Paolo Macchiarini and that Andemarian Beyene’s health condition deteriorated sharply after the procedure, etc., all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences. 

11. Witness interrogation with Nuguse Ghirmai Dirrar, regarding Andemarian Beyene’s health condition and their medical contacts in Sweden and  Iceland, to show that Andemarian Beyene has been hesitant to have the operation carried out but was persuaded by Paolo Macchiarini and that Andemarian Beyne’s health condition deteriorated sharply after the procedure,  etc., all in support of the fact that Paolo Macchiarini has behaved in the manner stated in the description of the offences. 

12. Witness interrogation with Veera Karoliina Männikkö, regarding the multidisciplinary conference that took place on 27 May 2011 with a view surgery on Andemarian Beyene, to show that there was no vital indication that it was highly inappropriate to operate on Andemarian Beyene due to previous interventions on him and the major risks involved and that Paolo Macchiarini stated that he could cure Beyene with the current method despite the fact that no previous intervention of the type in question has taken place, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences. 

13. Witness interrogation with Tomas Gudbjartsson, [who narrowly managed to escape misconduct findings himself, read here, -LS] regarding the information about Andemarian Beyene’s condition (including information about the complications which arose after the that procedure) which Paolo Macchiarini received, to show that Paolo Macchiarini had knowledge of and continuously received information in various ways and from various sources concerning Andemarian Beyene’s condition after the operation, that Paolo Macchiarini was thus aware that the method used by him did not work and that Paolo Macchiarini before the operation (incorrectly) indicated that an application for an ethical permit was being prepared, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences.  The prosecutor has no objection to the interrogation being held by audio and video transmission from Iceland. 

14. Witness interrogation with Ann-Charlotte Orre regarding the preparatory operation on Yesim Cetir and her condition before and after the procedures, etc., to show that the purpose of the preparatory operation was to check possible the presence of infections and to clean up the replacement of the natural windpipe with a synthetic one, that other alternatives to treatment were not considered, that it was unclear how long Yesim Cetir could live without the current procedure with the help of proven medical care and that it was not a question of any form of vital indication, that she and others remained unaware of how unproven the method used by Paolo Macchiarini was and whether the necessary permits had been obtained and that Yesim Cetir had been inflicted with extremely severe and long suffering after the procedures, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences.

15. Witness interrogation with Jan Liska regarding his observations during the procedures on the three patients, his professional assessment of Paolo Macchiarini and possibly conditions for obtaining a permit from the Medical Products Agency to carry out the current type of procedure, to show that the synthetic windpipes used were badly fitted, made of too hard or too soft material, did not appear to be approved and were difficult at suturing (resulting in the riskier stitch used), that at the multidisciplinary conference before the intervention on Andemarian Beyene, only Paolo Macchiarini had the overall knowledge of the method and that the patients’ respective conditions were not such that there was a vital indication, all in support of the fact that Paolo Macchiarini has behaved in the manner specified in the description of the offences. 

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Other evidence gathered by the prosecutor include the police and prosecution reports, Macchiarini’s history of recruitment based on a falsified CV and his sacking at KI, the investigative reports and decisions by KI, KS and Central Ethics Review Board (CEPN) on Macchiarini’s research misconduct and medical ethics breaches, opinions by Swedish health authorities, patients’ medical files and even a video of Beyene’s operation. Read here the full document in Swedish:

Macchiarini is now requested to submit a statement to decide if the court procedure can be shortened. I assume the prosecutor wants to know if he wants to plead guilty (no chance at all).

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