The controversial trachea transplantations by the notorious surgeon Paolo Macchiarini created a storm in the scientific world. It initiated a debate on the intersection between research and healthcare and the importance of a distinct ethical compass for the patient’s safety.
At first the world was in awe about the groundbreaking news. Paolo Macchiarini, a well-renowned thoracic surgeon and guest professor at the Karolinska Institute (KI) in Stockholm, had implanted the world’s first artificial trachea. He had replaced missing or damaged windpipes with an artificial trachea made of a polymer scaffold “seeded” with the patient’s own stem cells, which were supposed to grow into living tissue. A 36-year old patient, an Eritrean man with tracheal cancer had undergone a successful transplantation and – at the time – seemed to be recovering and in good health, according to the reports that the surgeon himself gave. Two more patients underwent surgery and Paolo Macchiarini also tested the technique in Krasnodar, Russia. Macchiarini received international tributes and his transplantations of artificial trachea were perceived as pioneering. Finally there was a new possibility that had opened up that could solve the problem of the lack of donated organs. These could now be built in the laboratory and a new era of regenerative medicine could begin.
Alas the development took a dramatic turn, with devastating consequences. The transplants had not been as successful as had been hoped for. The artificial tracheas did not integrate with the patients’ own tissue resulting in severe complications, and tragically to lethal consequences. Most of the patients who had been treated by Macchiarini passed away some time after their operations. The focus of the media attention took on a more sinister character as also other revelations were made. Colleagues at KI alleged that Macchiarini’s papers made his transplants seem more successful than they were, omitting the serious complications. He was also criticized for persuading patients to undergo surgery, performing it without proper clinical trials in animals first and performing operations while knowing that the implants were not in a good condition. The scandal was a fact. The world of science was now stunned at what had been going on at Sweden’s most esteemed institution and hospital. It has raised questions of morality and ethics, of institutional transparency and responsibility. The Macchiarini story also became a legal matter. Sometime later it emerged that the transplantations had not been performed in accordance with legislation, as they had been done without the proper permits. In April 2015 the Medical Products Agency filed a complaint with the police and the public prosecutor. The operations performed by Paolo Macchiarini were a breach of the Medicinal Products Act as no permit had been issued. Gunilla Andrew-Nielsen at the Medical Products Agency explains,
“The agency did neither receive an application for a permit for a clinical trial of a medicinal product, nor an application for a permit to manufacture it. The transplantations of the synthetic tracheas are categorized as advanced therapy …