Once-Celebrated Surgeon Investigated for Manslaughter

June 24, 2016

A surgeon who once wowed the medical world with trachea transplants built with a patient's own stem cells is being investigated by Swedish prosecutors for possible involuntary manslaughter in the deaths of two patients.

The probe of 57-year-old Paolo Macchiarini, MD, PhD, extends to two possible counts of causing bodily harm to two other patients who survived their operations, said Swedish prosecutor Anders Tordai in an interview with Medscape Medical News.

Tordai said the investigation will look into whether Dr Macchiarini's experimental procedures were based on legitimate research and, to a lesser extent, whether he obtained proper informed consent from patients.

The decision to investigate Dr Macchiarini follows his dismissal in March from the prestigious Karolinska Institute medical school in Stockholm, Sweden, where he worked as a visiting professor conducting research in regenerative medicine. The Karolinska Institute, which awards the Nobel Prize in Physiology or Medicine, said it fired him because, among other things, he had "demonstrated scientific negligence," supplied false or misleading information about academic posts in a resume submitted to the institute, and damaged its reputation.

Similar allegations appeared recently in a story by investigative reporter Adam Ciralsky in the magazine Vanity Fair. It portrayed Dr Macchiarini as a globe-trotting scam artist who romanced an NBC news producer making a documentary about him, convincing her that Pope Francis would officiate their wedding. Guests were to include President Barack Obama and his wife Michelle along with Russia Federation President Vladimir Putin and his wife. The producer cancelled their wedding once she discovered that Dr Macchiarini apparently was already married. NBC aired the 2-hour documentary titled "A Leap of Faith" in 2014, but pulled it from its website in February 2016.

"A Wild Animal That Does Not Need to Be in a Cage"

Born in Switzerland of Italian parents, Dr Macchiarini once compared himself in a 2012 Lancet article to "a wild animal that does not need to be in a cage. I need to express my convictions that I can help a patient with innovative things."

He won acclaim for innovation in 2008 when he led a medical team in Barcelona, Spain, that performed the first airway transplant relying on the patient's stem cells to help grow the organ. As described in the Lancet, the patient was a 30-year-old woman whose left bronchus collapsed on account of tuberculosis.

The physicians obtained a trachea segment from an organ donor and removed tissue that, if transplanted, would have triggered a host rejection. Adult stem cells and other cells from the healthy right bronchus of the patient were then grafted onto the stripped-down trachea segment so it would rebuild itself. Eventually, the trachea segment was transplanted to serve as a new left bronchus. The patient did not need immunosuppressant drugs afterward.

Dr Macchiarini altered his transplant approach by making a synthetic trachea scaffold from a nanocomposite polymer and coating it with the patient's stem cells. He performed this procedure for the first time in 2011 at Karolinska University Hospital in Stockholm, where two more would follow.

Dr Macchiarini became in-demand. Surgeons at Children's Hospital of Peoria, Illinois, invited him in 2011 to give Hannah Warren, a baby born without a trachea, a synthetic one. Newspaper headlines described the April 2013 operation as "ground-breaking" and "revolutionary," but the toddler died that summer from postoperative complications.

Five other patients of Dr Macchiarini who received a synthetic trachea also have died, although some lived 1 or 2 years after their procedure, according to published reports. Two of these patients had their surgery at Karolinska University Hospital. In 2013, the hospital decided to stop all future synthetic trachea transplants and not extend its surgical contract with Dr Macchiarini, according to a chronology of events produced by Karolinska Institute.

The following year, Dr Macchiarini faced three separate charges of scientific misconduct, including two submitted by fellow physicians at Karolinska University Hospital, who said that seven of the surgeon's research papers exaggerated the postoperative recovery of his patients and the functionality of the transplants. Some of his accusers had coauthored some of those studies.

Karolinska Institute eventually acquitted Dr Marchiarini of all charges of scientific misconduct in separate decisions in 2014 and 2015, overriding the conclusions of special investigator Bengt Gerdin, MD, a Swedish surgeon and researcher. However, the institute chided Dr Macchiarini for research that fell short of quality standards. Dr Gerdin continued to press his case that Dr Macchiarini had crossed the line.

Dr Macchiarini's credibility took more blows in January 2016. That month, Vanity Fair published the story by Adam Ciralsky, who wrote that not all the academic degrees and positions on the surgeon's resume panned out. At the same time, a three-part documentary on Swedish television about Dr Macchiarini's medical career suggested that some of his patients were not fully informed of the procedure's risks. It featured one patient who did not appear to be terminally ill when she received the first of two synthetic trachea (she died a year after receiving her second one). The Karolinska Institute has stressed that Dr Macchiarini's three transplant patients at the Karolinska University Hospital had been terminally ill, justifying the experimental procedure.

"If what the [Swedish] programme claims about patients being tricked or talked into undergoing surgery on dubious grounds is true, it is naturally altogether unacceptable," Karolinska Institute Vice Chancellor Anders Hamsten, MD, said in a February news release.

In response, the Karolinska Institute reopened its investigation of Dr Macchiarini, leading to his dismissal, and took a hard look at itself. Dr Hamsten resigned, as did the secretary of its Nobel Prize committee, to protect the prize's reputation. The dean of research also stepped down.

Was Dr Macchiarini Reckless?

Of the four patients that figure into the Swedish criminal investigation of Dr Macchiarini, three received a synthetic trachea, and two of them died, according to Anders Tordai. The fourth patient survived a procedure that Tordai declined to identify.

A patient death could rise from the level of a bad outcome or malpractice to involuntary manslaughter, suggested Tordai, "if you take a chance and use methods that are not perhaps evaluated, and it's not a valid procedure, and if you haven't made enough research and you still carry on with the operation."

At this point, Swedish prosecutors have not filed formal changes against Dr Macchiarini. Rather, authorities are investigating suspected crimes, according to Tordai.

His office is attempting to collect medical records from other countries where Dr Macchiarini has worked as a surgeon, as well as interview individuals there. The dragnet extends to the United States. Tordai said he wants to see the documentation that Dr Macchiarini and others submitted to the US Food and Drug Administration when they sought permission to use an experimental synthetic trachea in Hannah Warren. Prosecutors also are awaiting a review of the case by a judiciary council of Sweden's National Board of Health and Welfare.

If Dr Macchiarini is charged with involuntary manslaughter and convicted, he faces as many as 6 years in prison.

Tordai said Dr Macchiarini has been cooperating with the investigation.

In a brief conversation with Medscape Medical News, Dr Macchiarini deferred all questions to his attorney, Björn Hurtig, who once represented WikiLeaks founder Julian Assange regarding allegations of sexual assault.

Hurtig told Medscape Medical News in an email that the accusations against his client originated with an ex-colleague at the Karolinska Institute who was found guilty of plagiarizing research conducted by Dr Macchiarini's team.

"An internal investigation at Karolinska [Institute] found that [the accusations] were false, but because of the seriousness of the allegations, it is entirely appropriate that the prosecutor has to investigate them," Hurtig said. "Legally, I cannot see that Dr Macchiarini has any case to answer. He was working as one of a large team within the Karolinska University Hospital, where large discussions were had about the best healthcare options for these terminally ill patients, and the hospital authorities dealt with all the ethical permissions and consent for those patients.

"There has never been any question of Paolo's exceptional surgical skills, and he continues to practice around the world saving patients who present extremely complex and difficult cases."


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