Sweden could witness a repeat of the Macchiarini medical scandal without a major rethink of research ethics, despite the conviction of the surgeon at the heart of the case, scientists have warned.
Paolo Macchiarini’s transplantations of tracheas coated with stem cells at Karolinska University Hospital became one the worst scientific scandals of recent years after several of his patients died and investigations found institutional failings and Macchiarini guilty of scientific misconduct.
In 2020, Swedish prosecutors indicted Macchiarini for aggravated assault over three of his surgeries in 2011 and 2012. On 16 June, judges ruled that none of the procedures had been sufficiently grounded in evidence or experience, but that the first two were justifiable because of the patients’ serious illnesses.
However, they said, by the time of the third surgery, Macchiarini should have learned from the experience of the previous two and not gone through with the transplant. On this count, the judges found him guilty of the lesser charge of bodily injury and handed down a suspended sentence.
The verdict was a milestone in a decade-long reckoning for Swedish research, but experts have said more work will be needed to prevent history repeating itself.
“We need to look at the laws we have today and see if they are good enough, and if we really want this to happen again. If the answer is ‘no’, we have to change the laws because in two cases out of three the court found he did something which was not blameworthy,” Nils-Eric Sahlin, head of medical ethics at Lund University, told Times Higher Education.
Professor Sahlin, who is also chair of the Swedish Research Council’s expert group on ethics, said the country’s scientists also needed to examine their own attitudes.
“Not only could it happen again, it will happen again,” Professor Sahlin said. “It’s not enough to have stricter laws, but we have to make sure there’s a cultural change here – that we promote ethics, that we discuss value conflicts in healthcare on a regular basis.”
The Karolinska Institute investigated and cleared Macchiarini three times in the years after the surgeries, but external investigations later found that he had committed misconduct, and an independent commission found that the institute’s procedures were flawed.
Details of Macchiarini’s clinical practices and lies on his CV caused a public outcry, leading to a slew of resignations at the Karolinska and to Macchiarini’s dismissal.
In 2020, the Swedish government set up a National Board for Assessment of Research Misconduct to handle all such allegations. The Karolinska Institute and its hospital developed new guidelines for research and recruitment, and set up a system for anonymous reporting of “irregular or unlawful” incidents.
Jonas Åkerman, research integrity and ethics coordinator at Stockholm University and secretary of the Association of Swedish Higher Education Institutions’ expert group on ethics, said that while many universities had introduced organisational or procedural changes as a result of the scandal, it was too soon to know if these would prevent a recurrence.
“I don’t think we should ever expect to come up with a foolproof solution or preventive measures where we can be really confident this will never happen again, because the research system is based on mutual trust, which makes it inherently vulnerable to exploitation by manipulative people,” he said.
Dr Åkerman said Macchiarini’s actions highlighted issues with research incentives. “You don’t want researchers to feel pressured to reach sensational results and prestigious publications. You don’t want that pressure to be such that they feel inclined to cut corners,” he said.
