One of Paolo Macchiarini’s co-authors on a 2011 Lancet paper describing an allegedly groundbreaking procedure to transplant an artificial trachea seeded with stem cells is objecting to a recent investigation that concluded Macchiarini had committed misconduct.
Ola Hermanson, who studies neural stem cells at Karolinska Institutet, argued in a report dated June 29 that the investigation contained “serious flaws and formal errors.”
Hermanson’s lengthy response (uploaded here except for supporting emails) is to the findings of an external review of allegations about Macchiarini’s work, conducted by Bengt Gerdin, of Uppsala University. In regards to the 2011 Lancet paper, Gerdin’s investigation found:
To describe a clinical result after five months without conducting any examination of the patient at this point in time is significant; it is inconsistent with accepted scientific practice and therefore qualifies as misconduct.
To explicitly state that an ethical permit exists despite the absence of one is a false claim that affects the reliability of the research; this is a serious departure from accepted scientific practice and therefore qualifies as misconduct.
Hermanson argued that Gerdin has gotten his facts wrong:
As the investigator Bengt Gerdin failed to talk to or contact any of the main authors or any of the co-authors, there are serious flaws and formal errors in the investigation. Concerning the two main points regarding the Jungebluth et al. publication in Lancet 2011, 1) there were continuous investigations on Iceland of the status of the patient that were made transparent through regular emails to the co-authors, and 2) ethical approvals for the stem cell part of the aspiration [of bone marrow], expansion [of MSCs] and transplantation were in place, the hospital granted the surgery, and the post-operative care and analysis was cleared by an informed consent.
The accusations of scientific misconduct are thus completely unwarranted.
Hermanson, who is also a member of the Karolinska ethics committee, told Retraction Watch he had “nothing to add to” the statement.
According to the Gerdin report, the patient featured in the Lancet paper died in 2014:
Postoperatively, the patient contracted a fungal infection and miliary tuberculosis. After a lengthy and complicated postoperative process, he received a full dose of radiation, after which his condition improved. Early in 2011 a clinically suspicious recurrence in the form of a bronchial stricture was noticed on the right-hand side. This necessitated contact with Paolo Macchiarini and Karolinska. After an administrative process, he was operated on at Karolinska on 9 June 2011, upon which the bottom of the trachea and its subdivision into two main bronchi were removed and replaced by a synthetic tracheal prosthesis which had apparently been manufactured by University College, London, and then imported to Sweden for seeding with the patient’s own stem cells in a bioreactor. A month following the operation, he was returned to Iceland for further observation. He returned regularly to Karolinska for check-ups, however, and for treatment of a growing fistula system that eventually developed into a life-threatening oesophagotracheal fistula. Following increasingly aggressive attempts to operate, he died on 30 January 2014, 30 months after having received his synthetic tracheal prognosis.
Hermanson submitted his rejoinder to the report as part of KI’s response to the allegations of misconduct against Macchiarini. Last week, a spokesperson updated us on the status of KI’s response:
24 June was the deadline for comments on Professor Emeritus Bengt Gerdin’s report on suspected scientific misconduct.
Karolinska Institutet has received 31 replies from the co-authors of the criticized articles. All together the recently submitted material consists of circa 1.000 pages.
The final process leading to a decision of the case has now begun, in which the comments from the co-authors will be taken into consideration. Because of the vast amount of material it is today not possible to set a date for when Karolinska Institutet’s decision will be made.
Hopefully we will be able to give more information in a couple of weeks or so.
In response to a request for comment, Gerdin told us:
This affected document is part of the dramaturgy of the present drama at KI. It does not contain any information that invalidates any of my conclusions. Apart from that I will avoid giving any detailed comments before the verdict from the Vice Chancellor of Karolinska Institutet. It is expected [any] day.
The Gerdin review was one of two reviews commissioned by KI. The other cleared him of different misconduct allegations brought by Pierre Delaere. An investigation in Italy has also cleared him of most charges.
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