Review excoriates work of Paolo Macchiarini
The three operations carried out by throat surgeon Paolo Macchiarini have damaged the public's confidence in Swedish clinical research, according to an external investigation ordered by the Karolinska University Hospital.
Initially hailed as a pioneer in his field, Macchiarini carried out eight operations to give patients artificial windpipes (tracheae) coated in their own stem cells. Three of them were performed at Karolinska, five abroad. Only two of the patients have survived, but with serious complications.
Following an official complaint filed against Macchiarini, the hospital had an investigation conducted, which found a series of procedural and ethical breaches.
The investigation concluded that Macchiarini should never have been hired in the first place. But the recruitment went ahead in spite of negative references from the surgeon's previous colleagues, partly because of Macchiarini's work having received positive media attention.
“The hospital and the Karolinska Institute together had a vision of building up an airway institute, with international background. And Paolo Macchiarini fit very well into that vision. He had a very good reputation at that time," Kjell Asplund, who the hospital appointed to lead the external investigation, and who is the chairman of the Swedish National Council on Medical Ethics, told Radio Sweden.
The investigation also found that there were many shortcomings before, during and after the transplants, and that Paolo Macchiarini's scientific foundation for performing them was inadequate. The transplants had not been subjected to ethical review, and there were multiple issues concerning patient safety. It was not until some time after the transplants had been performed that some of his colleagues and others raised alarm.
Melvin Samsom, CEO at Karolinska University Hospital, admitted the institution failed to see the problems with Macchairini's work until it was too late. He added that two clinical managers who were involved with Macchairini's work will take a timeout from their positions until further notice.
"What has happened is totally unacceptable," Samson said in a statement. "And in very many ways also exceptional. The review shows a sequence of events where Paolo Macchiarini was able to implement three transplants completely outside the hospital's regular rules and procedures, without any alarm bells going off."
The Karolinska Institute has carried out its own investigation into how they had handled allegations that the surgeon had committed scientific fraud. It will release its findings on Monday.