The Macchiarini case: The story so far

Published 2016-02-22 20:30. Updated 2016-09-13 18:53Denna sida på svenska

Misrecruitment, scientific fraud and failing implants that should never have been implanted in patients – serious allegations have been levelled for a long time against visiting professor Paolo Macchiarini and KI’s conduct in connection with his activities.

Autumn 2010. Paolo Macchiarini is recruited by Karolinska Institutet (KI) as a visiting professor conducting basic research in the field of regenerative medicine/stem cell biology. At the same time, he is employed on a part-time contract as a consultant and surgeon at Karolinska University Hospital.

2011–2012. Paolo Macchiarini performs three transplantations of synthetic tracheas coated with stem cells at Karolinska University Hospital. The hospital decides to perform the operations as care interventions on the basis of a so-called vital indication (i.e. as an attempt to save the patients’ lives).

2012. One of the patients operated on at Karolinska University Hospital dies a few months after the operation, the second survives for two and a half years, while the third is alive but still in hospital in the USA.

2013. Karolinska University Hospital decides to stop all future operations with syntethic trachea and not to extend Paolo Macchiarini’s contract as surgeon.

December 2013. Paolo Macchiarini commences clinical studies in Krasnodar, Russia, where patients are to be operated on for research purposes.
Macchiarini informs KI that he has an extra-mural occupation at Kuban Medical State University (KMSU) and the extra-mural occupation is approved by Paolo Macchiarini’s department at KI.

June 2014. A Belgian researcher reports Paolo Macchiarini for scientific misconduct. The case is investigated by KI’s Ethics Council, which clears him of the allegations. Ethics Council’s statement.

June–August 2014. Two separate reports of scientific misconduct are filed against Paolo Macchiarini by four doctors at Karolinska University Hospital, according to whom research results have been described in overly positive terms in seven of Paolo Macchiarini’s scientific papers, which they argue incorrectly describe the postoperative status of the patients and the functionality of the implants. The four doctors are also researchers at KI and three of them are co-authors on some of the papers.

August 2014. Paolo Macchiarini submits his response to the first complaint, which relates to an article in Nature Communications.

November 2014. KI assignes Bengt Gerdin, professor emeritus at Uppsala University, to examine the material and issuing a statement.

April 2015. Paolo Macchiarini submits his response to the second complaint, which relates to six different articles.

April 2015. KI clears Paolo Macchiarini of scientific misconduct in the case of the complaint levelled against him by the Belgian researcher. KI’s Ethics Council also pronounces on the matter

May 2015. Bengt Gerdin submits his official statement of opinion to Karolinska Institutet. He concludes that many of the points constitute scientific misconduct.

June 2015. Paolo Macchiarini and his co-authors submit their comments on the content of Bengt Gerdin’s statement of opinion.

August 2015. KI issues its overall verdict acquitting Paolo Macchiarini of all allegations of scientific misconduct, but states that his research fails to meet the standards of quality set by KI and the scientific community. KI’s judgement on the matter is made with reference to the new information that has emerged from the comments submitted by Paolo Macchiarini and his co-authors on Bengt Gerdin’s official statement of opinion.

November 2015. Paolo Macchiarini has his contract extended with KI as a researcher up until 30 November.

December 2015. Bengt Gerdin stands by his conclusion after having, on his own initiative, reviewed KI’s acquittal and the material that arrived in after he had submitted his own report. Gerdin emails his conclusions to Vice-Chancellor Anders Hamsten.

January 2016. Vanity Fair publishes an article in which Paolo Macchiarini is accused of having lied on his CV. KI opens an inquiry into the veracity of the CV with which Paolo Macchiarini furnished KI in connection with his employment.

13, 20 and 27 January 2016. The 3-part documentary series Experimenten is broadcasted on SVT. The documentaries, which closely track Paolo Macchiarini and his work, show how patients have suffered and died in connection with failed operations, and raise numerous issues concerning care and research ethics. The fierce public response to the series causes a crisis of confidence in KI.

1 February 2016. KI’s first investigation into Paolo Macchiarini’s CV concludes that it contains several falsehoods, although none so serious as to justify his dismissal or resignation. The definitive examination is yet to be concluded.

4 February 2016. Vice-Chancellor Anders Hamsten decides that Paolo Macchiarini’s contract with Karolinska Institutet will not be extended.

4 February 2016. An external inquiry is mounted by the Karolinska Institutet University Board into Karolinska Institutet’s handling of the entire case, from Paolo Macchiarini’s recruitment to the present. It is to be led by lawyer Sten Hecksher. The University Board also decides to give Vice-Chancellor Anders Hamsten their continuing confidence for the duration of the inquiry.

 7 February 2016. Urban Lendahl, secretary of the Nobel Committee at Karolinska Institutet announces that he is resigning from his post at his own request. He cites “concern for the Nobel Prize” as his reason, as he understands that he will be part of the external investigation.

 13 February 2016. Vice-Chancellor Anders Hamsten announces his resignation and that KI will be mounting a new inquiry into scientific misconduct against Paolo Macchiarini after having received information that presents a different account of the first patient from Iceland, whose case forms the basis of some of Macchiarini’s articles.

13 February 2016. Pro-Vice-Chancellor Karin Dahlman-Wright takes up office as stand-in Vice-Chancellor.

13 February 2016. Four professors from the Nobel Assembly at Karolinska Institutet decline to participate in the work of the assembly while the Macchiarini case is being investigated since they themselves will be under examination: former vice-chancellor Anders Hamsten, Dean of Research Hans-Gustaf Ljunggren, Katarina Le Blanc and Urban Lendahl.

17 February. The KI University Board decides to request the government to appoint Karin Dahlman-Wright as stand-in vice-chancellor for Karolinska Institutet after Anders Hamsten.

18 February. The government decides to appoint Karin Dahlman-Wright as stand-in vice-chancellor of Karolinska Institutet. Dahlman-Wright was made pro-vice-chancellor on 1 January 2016 and has been a professor of molecular endocrinology since 2009.

February 2016. Acting Vice-Chancellor Karin Dahlman-Wright decides to reopen the case of scientific misconduct concerning Paolo Macchiarini and to have the seven scientific papers to be examined by the expert group for misconduct at the Central Ethical Review Board (CEPN).

19 February 2016. KI’s Recruitment Committee tightens up and clarifies procedures for reviewing job applications.

22 February. Dean Hans-Gustaf Ljunggren requests to step down from his position as Dean of Research.

March 2016. KI’s acting vice-chancellor asks the acting pro-vice-chancellor to carry out a systematic inventory at KI to identify any faults or failings that need rectifying, and to make recommendations where necessary.

March 2016. Karin Dahlman-Wright decides that Paolo Macchiarini’s scientific articles are to be re-examined, this time by the expert group for misconduct at the Central Ethical Review Board (CEPN). The new examination concerns the seven scientific articles that were previously examined by Professor Bengt Gerdin, which led to Macchiarini being cleared of scientific misconduct by Vice-Chancellor Anders Hamsten.

3 March 2016. The government has announced its decision today to task a nomination committee with submitting proposals for new members of the Karolinska Institutet University Board.

23 March 2016. The Staff Disciplinary Board at KI decides to relieve Paolo Macchiarini of his duties as a researcher at KI. He is to be informed immediately that his contract has been rescinded.

1 April 2016. The government receives proposals for the members of the KI University Board (konsistoriet) whom it is to appoint.

21 April 2016. Government decides on a new KI board on the basis of a proposal submitted by the nomination committee County Governor Christ Heister, former University Chancellor Lars Haikola and a student representative.

22 April 2016. Karolinska Institutet re-examines the case of a scientific article co-written by Paolo Macchiarini. The case was uncovered in an inventory conducted by the university to uncover scientific misconduct.

May 2016. The four doctors that reported Paolo Macchiarini in 2014 submit another report of scientific misconduct concerning an article that already forms part of the ongoing inquiry.

22 June 2016. The prosecutor officially serves a write against Paolo Macchiarini informing him that he is suspected of gross negligent manslaughter and bodily harm.

21 June 2016. Professor Anders Gustafsson is appointed new dean of research at Karolinska Institutet.

30 August 2016. Karolinska Institutet receives another report of scientific misconduct, this one concerning a poster used to present Paolo Macchiarini’s research at a scientific conference in 2012.

31 August 2016. Presentation of Kjell Asplund’s report, “The Macchiarini Case”, which has examined the circumstances surrounding Paolo Macchiarini’s activities at Karolinska University Hospital. The report is fiercely critical of the hospital as well as of Karolinska Institutet and notes, amongst other things, that the operations constituted research and not healthcare, and that KI was proactive in the hiring of Macchiarini, who was initially employed at both institutions.

2 September 2016. Lars Leijonborg resigns as KI board chairman.

5 September 2016. Sten Heckscher submits his external report, “Karolinska Institutet and the Macchiarini Case”, which he conducted on behalf of the KI University Board. KI is criticised on several counts, including the recruitment of Macchiarini in 2010 and the decision to extend his contract in 2013, which was taken in breach of proper procedure.

6 September 2016. The Karolinska Institutet board taskes the vice-chancellor with drafting a plan of action for how the university will remedy the serious failings identified within the Heckscher report.

9 September 2016. A statement issued by the expert group for misconduct at the Central Ethical Review Board (CEPN) finds Paolo Macchiarini guilty of scientific misconduct.

This article will be kept updated.