The Lancet has tagged an expression of concern onto a seminal 2011 paper by Paolo Macchiarini, the Italian surgeon whose work and conduct outside the operating room has earned months of heavy criticism that recently culminated in his dismissal from the Karolinska Institutet.
“Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study,” which described the first case of a transplant using an artificial trachea seeded with the patient’s own stem cells, now bears an expression of concern from The Lancet editors, citing ongoing investigations. The journal has also removed three more authors from the paper, upon their request.
The expression of concern essentially presents the timeline of the controversy that led the journal to make this move:
On Nov 24, 2011, The Lancet published a research article on tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite. 3 years later, several of the authors, together with others, raised concerns about the validity of this work. The Karolinska Institute launched an investigation led by Professor Bengt Gerdin into papers on the development of the technique. Gerdin’s report was followed by a second evaluation that largely cleared concerns regarding The Lancet paper. More recently, a documentary series on Swedish television again cast doubt on this work and precipitated public uncertainty about the research from Karolinska. There are now several new investigations into various aspects of the research carried out at Karolinska and the outcomes of the investigation pertinent to The Lancet paper are awaited. Meanwhile, several authors have now distanced themselves from the work to which they originally assigned their names. In view of the ongoing uncertainty about the integrity of the work reported in this paper, and after discussion with the lead author of the research article, Dr Paolo Macchiarini, we now issue an expression of concern about the paper, while reserving a final decision for when current investigations are completed.
In short: After some KI doctors raised concerns about Macchiarini’s work, KI launched an investigation but ultimately cleared Macchiarini of misconduct. More recently, a series of documentary films raised new allegations, and KI has reopened its inquiry.
The journal has also issued a new erratum about the paper, removing three names from the author list:
The Lancet has been contacted by Dr Nilsson, Dr Le Blanc, and Dr Teixeira, who no longer wish to be associated with this paper and ask for their names to be removed. This correction has been made to the online version as of March 31, 2016.
Just a few weeks ago, the journal removed another author from the list.
The paper has been cited 192 cites, according to Thomson Reuters Web of Science, earning it a “highly cited” designation.
Earlier this year, The Lancet published a commentary from Macchiarini, defending the ethical oversight in the paper, after reports that the man it described died — and, according to a 2014 story in the New York Times, signed a consent form dated two weeks after the procedure. In the commentary, Macchiarini writes:
We hope that this note will reassure any concerned readers that such an extensive and experimental treatment, carried out by a large, international, and multidisciplinary team at a prestigious university hospital, was not done without appropriate ethical consideration and consultation.
Earlier this month, the journal published another correspondence from The Royal Swedish Academy of Sciences, expressing its concerns about the paper:
Available information shows that the paper does not present the condition of the patient in a correct way.
It is evident from biopsies and bronchoscopy data that epithelialisation of the graft was incomplete, that the patient suffered serious complications, and that he eventually died. The published report states that “there were no major complications, and the patient was asymptomatic and tumour free 5 months after transplantation”. According to an independent expert, Professor Bengt Gerdin (Uppsala University, Uppsala, Sweden), who evaluated the paper in an investigation into possible scientific misconduct by its senior author Professor Paolo Macchiarini, this is a severe misrepresentation of the hospital records describing the patient’s condition after the operation.
For a recap, you can consult our ever-updating timeline of events in this case.
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