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The final verdict on Paolo Macchiarini: guilty of misconduct

2018; Elsevier BV; Volume: 392; Issue: 10141 Linguagem: Inglês

10.1016/s0140-6736(18)31484-3

1474-547X

The Lancet,

Ethics in Clinical Research

In this issue, we are retracting two papers by Paolo Macchiarini and co-authors after receiving requests to do so from the new President of the Karolinska Institute (KI), Ole Petter Ottersen. In its final decision, the KI finds that the research reported in the 2011 Lancet paper and elements of a Review published in 2012 “constitutes scientific misconduct”. In his request for retraction, Ottersen states that ”no ethical permit had been obtained for the underlying research. The research was carried out without sufficient support by preclinical data, and the paper presents its data in a way that is unduly positive and uncritical. The clinical findings reported are not supported by source data.” This final verdict comes after years of uncertainty and turmoil at the KI with differing pronouncements on misconduct, which eventually led The Lancet to issue an Expression of Concern for the research paper on April 2, 2016. This final KI investigation report follows the conclusion by the Central Ethical Review Board's expert group on Oct 2, 2017, that six papers, including the two Lancet papers, contained material constituting scientific misconduct and that all authors were guilty of misconduct. After giving all authors the opportunity to respond and examining each author's contribution, conduct, and responsibility in detail, the KI came to a different conclusion on the authors' culpability. It divided author responsibility into three different categories: “responsible for misconduct”, “blameworthy or not beyond criticism”, and “not responsible for scientific misconduct and not blameworthy”. For the Lancet papers, Paolo Macchiarini, Philipp Jungebluth, Karl-Henrik Grinnemo, Jan Erik Juto, Alexander Seifalian, Tomas Gudbjartsson, and Katarina Le Blanc were found guilty of misconduct. This judgment was based on their intention to deceive at the time of publication, or their negligence in obtaining information or permits that were required. All other authors of the research paper—apart from Claire Crowley, who only became an author late in the process and was a student—were deemed blameworthy. The three co-authors of the Review paper were found not blameworthy and not guilty of misconduct. We welcome this thoughtful and clear conclusion of an extraordinary case. Retraction—Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept studyFollowing our Expression of Concern1 we have now received further information about the conduct of the study by Philipp Jungebluth and colleagues.2 In letters to The Lancet, the President of the Karolinska Institute has sent the results and conclusions of the final investigation that has identified serious flaws in the conduct and reporting of this study. The report concludes there was scientific and ethical misconduct and requests retraction of the paper. The Lancet is therefore retracting this research article from the scientific record. Full-Text PDF Retraction—Engineered whole organs and complex tissuesIn letters to The Lancet, the President of the Karolinska Institute has sent the results and conclusions of the final investigation that has identified serious flaws in the conduct and reporting of the study by Philipp Jungebluth and colleagues.1 The report concludes that part of the series paper by Stephen Badylak and colleagues2 referring to the Jungebluth and colleagues' research article is therefore misleading. In accordance with a request from the Karolinska Institute, The Lancet is retracting the series paper from the scientific record. Full-Text PDF RETRACTED: Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept studyTailor-made bioartificial scaffolds can be used to replace complex airway defects. The bioreactor reseeding process and pharmacological-induced site-specific and graft-specific regeneration and tissue protection are key factors for successful clinical outcome. Full-Text PDF RETRACTED: Engineered whole organs and complex tissuesEnd-stage organ failure is a key challenge for the medical community because of the ageing population and the severe shortage of suitable donor organs available. Equally, injuries to or congenital absence of complex tissues such as the trachea, oesophagus, or skeletal muscle have few therapeutic options. A new approach to treatment involves the use of three-dimensional biological scaffolds made of allogeneic or xenogeneic extracellular matrix derived from non-autologous sources. These scaffolds can act as an inductive template for functional tissue and organ reconstruction after recellularisation with autologous stem cells or differentiated cells. Full-Text PDF