Disgraced Italian surgeon convicted of criminal harm to stem cell patient | Science

A surgeon who just a decade ago was celebrated around the globe as a pioneer in stem cell transplants has been convicted of one count of “causing bodily harm,” a felony, in a Swedish court. The district court in Solna today found Paolo Macchiarini not guilty on other charges, including aggravated assault, that could have carried prison sentences of up to 4 years, relating to three patients he treated while working for the famed Karolinska Institute (KI). The court said the penalty was “a suspended sentence,” but did not specify how long the sentence would be if imposed.

The verdict is the latest development in Macchiarini’s stunning fall from grace. In 2010, the Italian surgeon was recruited by KI—home of the committee that awards the Nobel Prize in Physiology or Medicine. A year later, he began to implant synthetic windpipes seeded with stem cells isolated from the patients’ own bone marrow, claiming the cells would grow and integrate with the patients’ tissue. The operations were hailed at the time as a breakthrough in regenerative medicine, although some observers remained skeptical. Macchiarini was fired in 2016 amid allegations of fraud and scientific misconduct after many of his transplant recipients died.

Macchiarini has consistently claimed he is innocent. In court testimony, he defended himself as only trying to help desperately ill patients, and said he had the full support of KI and his colleagues. His lawyer did not respond to emails from Science today.

The mild sentence comes as a disappointment to Macchiarini’s critics. Cardiothoracic surgeon Matthias Corbascio, one of Macchiarini’s former colleagues at KI who first raised questions about the work, describes it as “terrible” and “insane.” “The court basically gave him a slap on the wrist,” says Corbascio, who is now at the University of Copenhagen. “There are people who go to jail for 5 years for not paying their taxes. This guy mutilated people.”

Severe complications

Between 2011 and 2014, Macchiarini implanted artificial windpipes in at least eight patients in Sweden, the United States, and Russia. All but one died following severe complications with the implants. (The patient who survived had the implant removed.)

Four of Macchiarini’s colleagues at KI, including Corbascio, filed official complaints in 2014 charging that several papers describing the surgeries deliberately left out serious complications in the patients. They also questioned whether Macchiarini had obtained proper ethical permission for the surgeries and challenged a paper describing animal experiments with the technique.

KI commissioned surgeon Bengt Gerdin, a professor emeritus at Uppsala University, to investigate the issue. Gerdin’s report, released in May 2015, concluded Macchiarini was guilty of misconduct, but university administrators rejected that conclusion 3 months later, arguing Macchinarini and his co-authors had “satisfactorily countered” the issues Gerdin raised. They allowed Macchiarini to continue his work as a visiting professor with a research lab.

However, Swedish TV reporters also decided to take a close look at Macchiarini’s work. Their devastating documentary, which aired in January 2016, led KI officials to reopen the investigation. Around the same time, an article in Vanity Fair described how Macchiarini had misled a girlfriend—an NBC news producer working on a flattering documentary about his surgeries—into thinking they would be married in a ceremony attended by the Clintons and Obamas and officiated by the pope. The story portrayed Macchiarini, who was already married at the time, as a serial fabulist who exaggerated or lied about degrees, academic appointments, and personal accomplishments.

KI fired Macchiarini in March 2016, 2 months after the Swedish documentary came out. In 2018, KI finally released the findings of its second investigation, which confirmed he had committed misconduct.

Manslaughter charges

In 2017, prosecutors in Sweden charged Macchiarini with manslaughter in connection with the three patients who had received transplants at KI in 2011 and 2012, all of whom had died: Andemariam Teklesenbet Beyene, a graduate student from Eritrea with a slow-growing cancer obstructing his windpipe; Christopher Lyles, a 30-year-old American with tracheal cancer; and Yesim Cetir, a teenager from Turkey whose trachea had been accidentally damaged during a previous surgery. Prosecutors dropped the case a few months later, however, saying they didn’t have sufficient evidence to prove manslaughter.

They reopened the case in 2020, this time charging Macchiarini on lesser counts of aggravated assault and severe bodily harm. The court heard testimony in the case between 27 April and 12 May.

At the trial, Macchiarini and his lawyer argued that the patients, with no other options, had been treated under compassionate care standards. Other witnesses contradicted that, arguing that with Andemariam’s slow-growing cancer, minor surgeries and other treatments could have kept him alive. “Every patient had another, nonlethal option,” Pierre Delaere, a trachea expert at KU Leuven and an early critic of Macchiarini, said in an email to Science.

A panel of judges unanimously ruled that “the interventions were not in accordance with science and proven experience,” according to a statement released today. But the judges decided that, because the initial prognoses for Andemariam and Lyles were so grim without surgery, Macchiarini could not be held criminally responsible in those cases. In the case of Cetir, he should have known the risk of complications was higher than the expected benefit, the judges ruled. But they found prosecutors didn’t prove Macchiarini was “indifferent” to the injuries or suffering that the surgeries might cause, the standard required for aggravated assault. Instead, they found him guilty of negligence and the lesser charge of causing bodily harm.

In Sweden, both the defense and the prosecution can appeal rulings, and senior prosecutor Karin Lundström-Kron says she and her colleagues will decide in the coming weeks. They will especially examine the judges’ decision that Macchiarini couldn’t be held responsible for what happened to Andemariam and Lyles “because he acted in distress,” according to the court’s statement. “That’s something that was new to us, so we need to analyze that,” Lundström-Kron says. She says it may mean the judges thought he and the patients believed time was short and options were few. Macchiarini’s lawyer declined to comment to Swedish media today about whether his client would appeal.

Delaere feels the sentence is too light for what he considers a serious crime. He says prosecutors should have pressed for manslaughter charges because Macchiarini had no evidence that the tracheas he implanted would develop into normally functioning organs. “When you implant a synthetic trachea you have one certainty, and that is that the patient will die as a result of it,” Delaere says in the email. “Acquittal is therefore difficult to defend.”

But Gerdin says the verdict is not unexpected. The court had to apply the “intentional indifference” standard for the assault charges, he says, which is difficult to prove. Macchiarini’s argument that KI fully supported and encouraged the surgeries likely swayed the judges as well, he says. KI officials “let him do this. It relieved a little bit of burden from him.”

Gerdin says the conviction on one count still shows “that health care doesn’t stand above the law. If as a doctor you do stupid things, then you can be charged.” But the not-guilty verdicts on the other two cases highlight how the law can leave vulnerable people unprotected, he says, for example when they are facing life-and-death decisions and holding less information than their doctor.

The felony conviction means Macchiarini would have a hard time finding employment again in Sweden, Gerdin says. But because Macchiarini is apparently living in Spain, it’s unlikely to have much effect. “It’s actually meaningless for him,” Gerdin says. “But he’s lost his reputation, and that’s more important.”

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