Paolo Macchiarini

A new KI investigation concluded that several papers contained fabricated or distorted descriptions of patients' conditions, a lack of justification for emergency intervention, and insufficient animal experimentation, ethical approvals and consent. KI requested six retractions.

State of the evidence

Confirmed

The Lancet retracted the 2011 paper presented as proof of concept for bioartificial tracheal transplantation, which had become one of the symbols of the scandal.

The Swedish expert group concluded that Macchiarini had misleadingly presented and interpreted results from an animal study, with withheld raw data and questions surrounding ethical approval. The Nature Communications article was subsequently retracted.

KI dismissed Macchiarini on several grounds: false or misleading CV information, incomplete disclosure of external activities, conduct in Russia incompatible with the institute's values and scientific negligence.

Attribution

Directly implicated

Independent investigations concluded that Macchiarini should not have been recruited and that KI and Karolinska Hospital had committed serious errors in governance, allocation of responsibilities and monitoring of the procedures.

Attribution

Institutional responsibility

Clinicians who had treated the patients compared medical records with published articles and reported serious inconsistencies, particularly the omission of complications and unsupported claims about graft function.

Attribution

Directly implicated

In 2015, KI's Vice-Chancellor decided not to find scientific misconduct against Macchiarini despite the criticisms and external opinion. This decision was subsequently strongly challenged, and several cases were reopened in 2016.

Macchiarini had a relationship with NBC producer Benita Alexander and described a lavish wedding in Rome, supposedly officiated by Pope Francis and attended by numerous heads of state. A Vanity Fair investigation demonstrated that these central claims were false.

Attribution

Directly implicated

In Krasnodar, Macchiarini implanted a synthetic trachea in Yulia Tuulik, who had undergone a tracheotomy following an accident but was described as not facing a life-threatening condition. The implant collapsed, was replaced, and she died in 2014.

State of the evidence

Documented

Alexander Zozulya also received a synthetic prosthesis in Krasnodar, although his condition was not described as immediately life-threatening. Following complications, he underwent further surgery in 2013 and died in February 2014.

State of the evidence

Documented

In Peoria, Macchiarini participated in an experimental tracheal transplant on two-year-old Hannah Warren. The child died less than three months later from postoperative complications.

State of the evidence

Documented

Subsequent external investigations concluded that Macchiarini's recruitment to Karolinska had been pushed through with insufficient checks. KI subsequently stated that he had supplied false or misleading information in his CV.

Attribution

Directly implicated