Transplant surgeon sentenced to prison for failed stem cell treatments | Science

Surgeon Paolo Macchiarini, who was once hailed as a pioneer of stem cell medicine, was found guilty of gross assault against three of his patients today and sentenced to 2 years and 6 months in prison by an appeals court in Stockholm. The ruling comes a year after a Swedish district court found Macchiarini guilty of bodily harm in two of the cases and gave him a suspended sentence. After both the prosecution and Macchiarini appealed that ruling, the Svea Court of Appeal heard the case in April and May. Today’s ruling from the five-judge panel is largely a win for the prosecution—it had asked for a 5-year sentence whereas Macchiarini’s lawyer urged the appeals court to acquit him of all charges.

Macchiarini performed experimental surgeries on the three patients in 2011 and 2012 while working at the renowned Karolinska Institute. He implanted synthetic windpipes seeded with stem cells from the patients’ own bone marrow, with the hope the cells would multiply over time and provide an enduring replacement. All three patients died when the implants failed. One patient died suddenly when the implant caused massive bleeding just 4 months after it was implanted; the two others survived for 2.5 and nearly 5 years, respectively, but suffered painful and debilitating complications before their deaths.

In the ruling released today, the appeals judges disagreed with the district court’s decision that the first two patients were treated under “emergency” conditions. Both patients could have survived for a significant length of time without the surgeries, they said. The third case was an “emergency,” the court ruled, but the treatment was still indefensible because by then Macchiarini was well aware of the problems with the technique. (One patient had already died and the other had suffered severe complications.)

The judges ruled that Macchiarini “acted with criminal intent,” even though he hoped the technique would work. They were persuaded by the evidence that he was fully aware “of the risk that the procedures would cause the patients physical injuries and suffering and that he was indifferent to the realization of these risks.” Viveka Lång, one of the appeals judges who heard the case, says Swedish law recognizes three levels of intent, and the court found Macchiarini guilty of the lowest level. Even if it was not his purpose to harm the patients, she says, “was he aware of the potential risk, and did he do [the surgeries] anyway?”

The court’s decision is “logically argued” and the 2.5-year sentence is reasonable, says Bengt Gerdin, a surgeon and professor emeritus at Uppsala University who investigated some of the initial misconduct claims against Macchiarini. Once the patient’s own trachea was removed, Gerdin says, Macchiarini “knew if he couldn’t replace it, the patient would die. And he had no evidence that he could replace them, other than his sort of divine or magical belief” that the stem cell technique should work.

“I think this is a fair verdict,” says Pierre Delaere, a trachea expert at KU Leuven who has long been a strong critic of Macchiarini. “He used people as guinea pigs not to help them, but to promote his name and fame in the scientific community and beyond.” Delaere adds that Macchiarini’s remaining papers on tracheal regeneration should now be retracted.

Macchiarini’s lead lawyer, Björn Hurtig, says the defense team will appeal the verdict to Sweden’s high court. Based on an initial reading of the verdict, he and his colleagues will question the appeals court’s ruling that Macchiarini acted with intent and that two of the cases were not emergencies. The team, he says, will also ask whether the sentence is reasonable, “for things that happened in the context of health care and were more than 10 years ago.”

At a press conference today with his lawyers, Macchiarini denied he had any intent to harm the patients and claimed he had wanted to help those who had no other treatment options. “The intention of harming is the most awful accusation that you can make to a doctor,” he said. His colleagues and supervisors all approved of the surgeries, he said: “In the operating room we were 20, 25 people. What surprises me is, why I am here alone?” He said his only regret was accepting Karolinska’s job offer, and that he is now “jobless” and does not expect to be able to work again.

The prosecutor’s office has not said whether it will appeal for the longer sentence it had requested. Director of Public Prosecution Mikael Björk issued a short statement saying, “It is satisfactory that the Court of Appeal shares our view that two of the three injured parties were not in danger within the meaning of the Penal Code” and that the surgeries were research, not compassionate care for desperate patients.

Macchiarini does not have to report to prison as long as an appeals process is underway. It isn’t clear when the high court will decide whether to hear the case. Some cases are taken up within days, Hurtig says, others can take more than 2 years. If the sentence is ultimately upheld, Lång says, Macchiarini is likely to serve two-thirds of his sentence, in line with Swedish standards.

Surgeon Paolo Macchiarini, who was once hailed as a pioneer of stem cell medicine, was found guilty of gross assault against three of his patients today and sentenced to 2 years and 6 months in prison by an appeals court in Stockholm. The ruling comes a year after a Swedish district court found Macchiarini guilty of bodily harm in two of the cases and gave him a suspended sentence. After both the prosecution and Macchiarini appealed that ruling, the Svea Court of Appeal heard the case in April and May. Today’s ruling from the five-judge panel is largely a win for the prosecution—it had asked for a 5-year sentence whereas Macchiarini’s lawyer urged the appeals court to acquit him of all charges.

Macchiarini performed experimental surgeries on the three patients in 2011 and 2012 while working at the renowned Karolinska Institute. He implanted synthetic windpipes seeded with stem cells from the patients’ own bone marrow, with the hope the cells would multiply over time and provide an enduring replacement. All three patients died when the implants failed. One patient died suddenly when the implant caused massive bleeding just 4 months after it was implanted; the two others survived for 2.5 and nearly 5 years, respectively, but suffered painful and debilitating complications before their deaths.

In the ruling released today, the appeals judges disagreed with the district court’s decision that the first two patients were treated under “emergency” conditions. Both patients could have survived for a significant length of time without the surgeries, they said. The third case was an “emergency,” the court ruled, but the treatment was still indefensible because by then Macchiarini was well aware of the problems with the technique. (One patient had already died and the other had suffered severe complications.)

The judges ruled that Macchiarini “acted with criminal intent,” even though he hoped the technique would work. They were persuaded by the evidence that he was fully aware “of the risk that the procedures would cause the patients physical injuries and suffering and that he was indifferent to the realization of these risks.” Viveka Lång, one of the appeals judges who heard the case, says Swedish law recognizes three levels of intent, and the court found Macchiarini guilty of the lowest level. Even if it was not his purpose to harm the patients, she says, “was he aware of the potential risk, and did he do [the surgeries] anyway?”

The court’s decision is “logically argued” and the 2.5-year sentence is reasonable, says Bengt Gerdin, a surgeon and professor emeritus at Uppsala University who investigated some of the initial misconduct claims against Macchiarini. Once the patient’s own trachea was removed, Gerdin says, Macchiarini “knew if he couldn’t replace it, the patient would die. And he had no evidence that he could replace them, other than his sort of divine or magical belief” that the stem cell technique should work.

“I think this is a fair verdict,” says Pierre Delaere, a trachea expert at KU Leuven who has long been a strong critic of Macchiarini. “He used people as guinea pigs not to help them, but to promote his name and fame in the scientific community and beyond.” Delaere adds that Macchiarini’s remaining papers on tracheal regeneration should now be retracted.

Macchiarini’s lead lawyer, Björn Hurtig, says the defense team will appeal the verdict to Sweden’s high court. Based on an initial reading of the verdict, he and his colleagues will question the appeals court’s ruling that Macchiarini acted with intent and that two of the cases were not emergencies. The team, he says, will also ask whether the sentence is reasonable, “for things that happened in the context of health care and were more than 10 years ago.”

At a press conference today with his lawyers, Macchiarini denied he had any intent to harm the patients and claimed he had wanted to help those who had no other treatment options. “The intention of harming is the most awful accusation that you can make to a doctor,” he said. His colleagues and supervisors all approved of the surgeries, he said: “In the operating room we were 20, 25 people. What surprises me is, why I am here alone?” He said his only regret was accepting Karolinska’s job offer, and that he is now “jobless” and does not expect to be able to work again.

The prosecutor’s office has not said whether it will appeal for the longer sentence it had requested. Director of Public Prosecution Mikael Björk issued a short statement saying, “It is satisfactory that the Court of Appeal shares our view that two of the three injured parties were not in danger within the meaning of the Penal Code” and that the surgeries were research, not compassionate care for desperate patients.

Macchiarini does not have to report to prison as long as an appeals process is underway. It isn’t clear when the high court will decide whether to hear the case. Some cases are taken up within days, Hurtig says, others can take more than 2 years. If the sentence is ultimately upheld, Lång says, Macchiarini is likely to serve two-thirds of his sentence, in line with Swedish standards.