Former super-star surgeon Paolo Macchiarini is guilty of misconduct, along with six of his co-authors — including one who initially help alert authorities to problems with Macchiarini’s work, according to an announcement today by his former institution, the Karolinska Institute.
KI is also calling to retract six articles co-authored by Macchiarini and his colleagues, including two highly cited papers in The Lancet. The papers described the procedure and outcomes of transplanting synthetic tracheas into three patients between 2011 and 2013.
KI’s investigation uncovered “serious inaccuracies and misleading information in the reviewed articles:”
The articles contain fabricated and distorted descriptions of the patients’ conditions before and after the operations. Justification is lacking for treatment of the patients on the grounds of so-called vital indication (when a given treatment is the last resort for survival), and one misses reference to relevant animal experiments which must precede human studies that involve unproven methods. Furthermore, ethical approvals are lacking, as are appropriate informed consents.
The finding is a long-time coming. After four researchers raised concerns about Macchiarini’s work, in 2015, KI’s former Vice Chancellor Anders Hamsten concluded that Macchiarini acted in some cases “without due care,” but that his behavior “does not qualify as scientific misconduct.” After Swedish Television aired a series of documentaries about Macchiarini and his work — alleging, in part, that he operated on patients in Russia whose conditions were not life-threatening enough to warrant such a risky procedure — KI agreed to reopen its investigation. Hamsten resigned, and in March 2016, Macchiarini was dismissed from KI. (For more details, check out our timeline.)
In yet another twist in this saga, one of the four whistleblowers who initially alerted experts to the issues with Macchiarini’s work is among the seven KI deemed responsible for scientific misconduct. That whistleblower, Karl-Henrik Grinnemo, told us:
KI and its leadership has during all these years tried to harass me and my whistleblowing colleagues. This decision is just a continuation of five years [of] harassment. We have been very critical [of] the way KI has handled the Macchiarini case and it is ridiculous that KI should have a final word in this case, they are so biased. It is like letting the other [soccer] team coach be the referee in a [soccer] team and decide over the other teams penalties. Me and colleagues have done a fantastic work to uncover the Macchiarini scandal, while KI always have tried to stop us and free Paolo.
Indeed, after Grinnemo and colleagues voice their initial concerns about Macchiarini’s work, Macchiarini retaliated, accusing Grinnemo of misconduct. Although KI initially found Grinnemo guilty of “carelessness” in a grant application to the Swedish Research Council, including plagiarism, he was eventually exonerated (and spoke to us about the roller-coaster last year). Today, Grinnemo says:
After this decision no one will ever make complaints when it comes to research- the consequences are to high!!
According to statement from Ole Petter Ottersen, KI’s president who took office in August 2017:
The investigation points to inaccuracies for which Paolo Macchiarini is ultimately responsible but for which several of the co-authors also bear responsibility. The four whistle blowers are to be commended for their action in this case that has contributed to the investigation. However, it is KI’s firm opinion that a whistle blower who has participated in a scientific study and also as author of a scientific article, despite reporting, cannot be freed from blame or absolved from responsibility.
Besides Macchiarini and Grinnemo, the other researchers KI has declared to have committed scientific misconduct are Philipp Jungebluth, Jan Erik Juto, Alexander Seifalian, Tomas Gudbjartsson, and Katarina Le Blanc. You can read the full report (in Swedish) here. [Note: For an English version, see update below.]
The six articles KI recommends be retracted are:
–Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study, Lancet 2011; 378(9808): 1997–2004. Cited 272 times, according to Clarivate Analytics’ Web of Science. The paper has already been flagged with an expression of concern.
–Engineered whole organs and complex tissues, Lancet 2012; 379(9819): 943–952. Cited 251 times.
–Verification of cell viability in bioengineered tissues and organs before clinical transplantation, Biomaterials 2013; 34(16): 4057–4067. Cited 13 times.
–Are synthetic scaffolds suitable for the development of clinical tissue-engineered tubular organs? Journal of Biomedical Material Research 2014; 102(7): 2427–2447. Cited 9 times.
–Airway transplantation, Thoracic Surgery Clinics 2014; 24(1): 97–106. Cited 18 times.
–Biomechanical and biocompatibility characteristics of electrospun polymeric tracheal scaffolds, Biomaterials 2014; 35(20): 5307–5315. Cited 24 times.
A spokesperson for The Lancet told us:
We welcome the report from the Karolinska Institute. We will study their findings and conclusions carefully and respond as soon as possible.
Today’s release notes:
According to the President’s decision, an additional 31 authors are blameworthy for their contributions to the articles, however not responsible for scientific misconduct. Another five authors are cleared of blame and of responsibility for scientific misconduct. Karolinska Institutet is requesting that the six articles be retracted without undue delay.
KI’s finding appears to mirror a previous one from an ethical review board in Sweden, although today’s release notes:
Today’s decision differs from the report of the Expert group for misconduct in research at the Central Ethical Review Board, CEPN, who considers all authors responsible for scientific misconduct. Karolinska Institutet’s investigation has examined the responsibility of each individual author (a total of 43 researchers).
As Science reported earlier this year, Macchiarini continues to publish research, serving as senior author on a recent paper in Journal of Biomedical Materials Research Part B: Applied Biomaterials that examined artificial esophagi “seeded” with stem cells.
Update June 27, 2018 14:13 UTC: A representative of KI sent us an English version of the full report.
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