Macchiarini investigations outcome: the Karolinska Institutet

Macchiarini investigations outcome: the Karolinska Institutet

The second main investigation into lethal patient abuse by the thorax surgeon and regenerative medicine “pioneer” Paolo Macchiarini is now concluded in Stockholm. After the Karolinska University Hospital (Karolinska Universitetssjukhuset, KS) published their investigative report on August 31st (see my coverage here), the Karolinska Insitutet (KI) now followed suit on September 5th.

This KI investigation was led by the former president of the Supreme Administrative Court of Sweden Sten Heckscher, who was assisted by the journalist Ingrid Carlberg and the Finnish biochemistry professor Carl Gahmberg. Interestingly, the very person who appointed Heckscher in February 2016 as external investigator, the Chairman of the KI University Board (Konsistoriet) Lars Leijonborg, surprisingly resigned just last Friday.

Given the professional specialisation of Heckscher as lawyer and policeman, his investigation focused on the administrative aspects, and not on science or medicine (which possibly was supposed to be covered by the KS investigation).

These are the results, according to the English-language summary and the translated Swedish full report.

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Macchiarini investigations outcome: Karolinska University Hospital

Macchiarini investigations outcome: Karolinska University Hospital

Investigations into lethal patient abuse by the thorax surgeon and regenerative medicine “pioneer” Paolo Macchiarini are now concluded in Stockholm. The Karolinska University Hospital (Karolinska Universitetssjukhuset, KS) published their investigative report on August 31st, the Karolinska Insitutet (KI) will follow with theirs on September 5th.

The KS investigation was chaired by Kjell Asplund, emeritus professor in medicine at Umeå University, who is also chairman of the Swedish Council on Medical Ethics (Smer) and former director-general of the National Board of Health and Welfare (Socialstyrelsen). The Asplund report found gross violations of medical ethics, patient right, even recruitment processes when analysing the history of the scandal around the Italian surgeon. Unlike repeatedly declared by both KI and KS, Macchiarini’s trachea transplants were not medical emergencies and not compassionate care cases:

“There was no immediate threat to the life of any of the three transplant patients before the operations”.

Unethical research, not humanitarian care

These interventions were now determined as clinical research and as such were supposed to be subject to ethics vote and medicinal product approval.  This in stark contrast to previous declarations by KI and KS leadership, namely that Macchiarini’s trachea transplants were merely humanitarian care and medical emergencies. Now the Asplund workgroup rebukes in their Swedish-language report:

“We question the hospital’s stubborn position in defence of transplants’ clean health care initiatives”.

Continue reading “Macchiarini investigations outcome: Karolinska University Hospital”