Surgeon Paolo Macchiarini, who is under investigation for allegedly downplaying dangers of an experimental surgery, has been cleared of some misconduct allegations by the Karolinska Institutet in Stockholm.
Macchiarini, a thoracic surgeon, has made headlines for repairing damaged airways using tracheas from cadavers and even synthetic tracheas, both treated with the patients’ own stem cells to assist in the transplant.
In a letter to Vice-Chancellor Anders Hamsten dated last month, KI’s Ethics Council refuted a number of accusations leveled against Macchiarini by Pierre Delaere at KU Leuven in Belgium, who had suggested the surgeon had engaged in scientific misconduct, including fabricating data.
The Ethics Council, however, disagreed:
The Ethics Council’s general conclusion is that apart from the clinical outcome of the transplanted patients – whose medical records we have not examined and which are being examined in another investigation – we find that the issues raised by Professor Delaere are of a philosophy-of-science kind rather than of a research-ethical kind. Accordingly, the Ethics Council concludes that, on the backdrop of the examined issues, Professor Delaere’s allegations of scientific misconduct are unfounded.
You can read the entire statement here. Delaere also suggested The Lancet, which published the first paper describing the synthetic trachea transplant, had issues with its peer review. The Ethics Council refuted that accusation, as well.
Professor Macchiarini has allowed the Ethics Council to see the correspondence between the authors and The Lancet. The Ethics Council can confirm that the paper was critically reviewed by four reviewers in The Lancet. The authors revised the paper in accordance with the reviewers’ comments. We have also seen the changes made in the original version. The Ethics Council’s conclusion is that the review process has been correct.
Macchiarini told us he was pleased with the outcome:
As I have emphatically stated all along that the allegations from Dr. Delaere are unfounded, I am pleased that the Ethics Council has now also affirmed their lack of substance.
Delaere also received a letter from Hamsten saying the Vice-Chancellor will uphold the Ethics Council’s conclusion, a decision taken “in the presence of University Director Per Bengtsson.”
Delaere is not happy with the Ethics Council’s decision:
I am stunned about such outright injustice.
Macchiarini has also been accused of failing to obtain proper consent from patients before performing the experimental procedures, as well as downplaying the dangers of the surgery, including minimizing the complications. In filing documents to support these accusations, doctors revealed information about the patients who underwent the procedure; the Karolinska hospital has now filed a complaint with the police against the unnamed person who passed these documents onto “an English-language blog on research fraud and retracted scientific papers,” which we believe is us (based on our translation of the link in Swedish).
Update 1:50 p.m. eastern 4/16/15: Claes Keisu, press officer at Karolinska, told us that the Swedish version of the decision by the Ethics Council included information about conflicts of interest among council members, which was left out of the English version. We have uploaded the new version. Here is the additional text:
In the discussion of and decision on the matter, the following members of the Ethics Council participated: Gert Helgesson, Marie Arsenian-Henriksson, Göran Lambertz, Patricia De Palma, Nina Rehnqvist och Niels Lynöe. The other members, Anders Ekbom, Ola Hermanson and Annika Tibell have a conflict of interest and therefore did not participate in the discussion or decision.
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