Karolinska Institutet comments on Asplund’s “Macchiarini case” inquiry

Commentary: On 31 August, Kjell Asplund presented results of the inquiry into circumstances surrounding the trachea operations performed by Paolo Macchiarini on three patients at Karolinska University Hospital. The inquiry is heavily critical not only of the hospital, but also of Karolinska Institutet.

Two of the conclusions drawn by Asplund are that the operations constituted acts of research rather than healthcare, and that Karolinska Institutet was proactive in the recruitment of Macchiarini, who was initially employed at both institutions.

“It would be extremely regrettable if Karolinska Institutet had exerted any kind of pressure in the recruitment of Paolo Macchiarini,” says Karin Dahlman-Wright, Acting Vice-Chancellor of KI. “That kind of thing must naturally not happen. It is important to raise these issues, and I’m grateful that Kjell Asplund and his investigation also covered KI’s responsibility so that we can take the appropriate steps to ensure this doesn’t happen again.”

Dahlman-Wright says that the investigation indicates a need for a clearer division of responsibilities in joint projects, including recruitments. Asplund’s report also shows that KI wanted to retain Macchiarini, while the hospital wanted to terminate his contract. Macchiarini left the hospital in 2013, but remained a visiting professor and researcher at KI until 2016.

The investigation also concludes that the operations should be considered clinical research and not healthcare on the basis of a so-called “vital indication” (i.e. in the interest of saving patients’ lives), as both the hospital and the former KI management had maintained. This means that the proposed operations should have undergone an ethical review.

According to Asplund, it is difficult to ascertain whether the three patients’ lives were in danger or not and whether the operations shortened or prolonged their lives.

“It cannot be ruled out that the operations led to premature deaths. We take Karolinska Institutet researchers’ involvement in this matter very seriously and deeply regret the unnecessary suffering caused to the patients,” says Professor Dahlman-Wright. “We sincerely apologise to them and their families and pledge to do all we can to prevent this from ever happening again.”