Paolo Macchiarini, Star Surgeon, Loses Court Ruling in Sweden

Source: www.nytimes.com : 2022-06-17 15:39:53 : Euan Ward and Christina Anderson

LONDON — It sounded like real-life science fiction — a 3-D printed organ, a groundbreaking artificial windpipe, built in a laboratory and made to order. The charismatic Italian surgeon who designed it foresaw a future where hearts and lungs could be made from plastic, and organ donations became a thing of the past. Almost overnight, he became a superstar.

But on Thursday, the surgeon, Dr. Paolo Macchiarini, was found criminally liable by a Swedish court for causing felony bodily injury to a patient he had fitted with one of the windpipes at a medical university in Sweden.

Dr. Macchiarini received a “conditional,” or suspended, sentence, and was acquitted of assault charges related to two other patients who had also received the artificial organs from him at the Swedish facility. Although all three patients eventually died, Dr. Macchiarini was not directly accused of killing them.

While many in Sweden expressed disappointment at what they saw as the leniency of the sentence, given that prosecutors had asked for five years in prison, the verdict nonetheless represented the culmination of a stunning fall from grace for a once high-flying surgeon.

In 2011, Dr. Macchiarini, a renowned leader in the field of regenerative medicine, took the medical world by storm when he built and implanted the world’s first “bioartificial” windpipe.

The procedure involved replacing a damaged trachea with a plastic replica that had been soaked in the patient’s stem cells. The theory was simple: let the body do most of the work. By using a patient’s own cells, Dr. Macchiarini sought to rectify an age-old problem with transplants involving donated organs, which the body sometimes rejects as foreign tissue.

The operation, performed at one of the world’s most prestigious medical universities, part of the Karolinska Institute in Stockholm, was hailed as revolutionary. It won Dr. Macchiarini international news coverage and cemented his place as a celebrity scientist.

However, behind closed doors, Dr. Macchiarini was hiding a secret — the procedures were not working.

Colleagues accused him of manipulating his results, even warning of the harm caused by these so-called regenerative windpipes. Allegations also emerged that the risky procedure was performed on at least one person who was not critically ill at the time. But it was already too late.

One biomedical researcher has documented a total of 20 tracheal regeneration procedures by Macchiarini — in Russia, Spain, Britain, and the United States, as well as Sweden. Nearly all of those patients have died.

“The law is supposed to protect individuals from all types of assault, especially when they are powerless,” said Dr. Bengt Gerdin, an independent investigator who was hired by the Karolinska Institute in 2015 to look into Dr. Macchiarini’s work.

His findings at the time concluded that Dr. Macchiarini had committed scientific misconduct, but this was ultimately ignored by the university’s leadership who chose to clear the Italian surgeon.

“No one is more powerless than a patient with a disease,” said Dr. Gerdin.

The court ruling Thursday was in a case involving a Turkish woman named Yesim Cetir, who was the longest surviving of his patients at Karolinska.

Almost immediately after she was fitted with a synthetic trachea in August 2012, Ms. Cetir’s condition began to rapidly deteriorate, according to the court’s written judgment. She remained in intensive care for more than three years at Karolinska University Hospital and underwent more than 200 surgical procedures.

According to hospital staff, she had roughly 40 “near-death experiences” during this time, the judgment said. She remained conscious and awake throughout most of them, but unable to breathe.

“The plastic trachea that Yesim Cetir received disfigured her and made her last three years in life basically like torture,” said Bosse Lindquist, a documentarian who broke the story in Sweden about Dr. Macchiarini in a television series, “The Experiment.”

Dr. Gerdin said Dr. Macchiarini was allowed to continue his procedures for so long because the Karolinska Institute and its hospital allowed him to do so.

“The Karolinska Institute was seduced by Macchiarini,” said Dr. Gerdin. “He was one of the best con-men I have ever come across,” he added. “He convinced the Karolinska Institute that this could make them famous, and they just let him do it. Not only that, they later covered it up.”

Two investigations, one by the Karolinska Institute and one by Karolinska University Hospital, both found that problems with Dr. Macchiarini’s work had been covered up.

The Karolinska Institute declined to comment for this article, noting only that Dr. Macchiarini’s sentence may be appealed. The surgeon’s defense attorney, Björn Hurtig, said his client was considering an appeal. The Karolinska University Hospital suspended Dr. Macchiarini’s contract as a surgeon in 2013, but the affiliated Karolinska Institute kept him on until 2016 even as the scandal over his work spread, according to a timeline on the institute’s website.

It is unclear whether Dr. Macchiarini is still practicing medicine, but his lawyer said in May that he had no income. On Friday Mr. Hurtig declined to comment on “Paolo’s private affairs.”

It is also unclear whether the verdict Thursday will have an impact in other jurisdictions where Dr. Macchiarini conducted windpipe operations. So far he has not been prosecuted in any of those countries.

Euan Ward reported from London, and Christina Anderson from Bastad, Sweden.

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