Swedish prosecutor won’t pursue criminal case against Macchiarini


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Paolo Macchiarini

A Swedish prosecutor has announced she won’t continue investigating a former star surgeon who has since fallen from grace.

Paolo Macchiarini made a name for himself by transplanting synthetic tracheas. After multiple patients died, however, allegations against the researcher have continued to swirl. He was dismissed from the Karolinska Institutet last year, after it reopened its misconduct investigation. The Swedish prosecutor was investigating Macchiarini’s role in the deaths of three out of four patients he operated on five times between 2011-2013.

Although the prosecution concluded that most of the operations proceeded “negligently,” it could not conclude Macchiarini was criminally responsible.

According to the public prosecutor Jennie Nordin:

We have reached the conclusion that four of the five operations were negligently carried out, as the surgeon performed the operations using synthetic tracheas, which is in conflict with science and tried-and-tested practice. However, we have been unable to prove that any crimes have been committed. We cannot prove that the effects of his actions, with sufficient degree of probability, would not have occurred had another method been used. Regarding the fourth individual, we are not of the opinion that the surgeon’s actions were negligent. Expert medical opinion is not unanimous regarding what should have been done instead for these seriously ill individuals, which therefore has made the suspicions difficult to prove…

Macchiarini’s lawyer Bjorn Hurtig previously acted as a lawyer for Wikileaks founder Julian Assange.

As part of the investigation, Nordin and two other prosecutors conducted approximately 80 interviews in Sweden and abroad.

You can read the prosecutor’s statement https://www.aklagare.se/globalassets/dokument/ovriga-dokument/decision-1-3.pdf about three patients here. In an excerpt, it states:

The actual treatment method was unproven and there was a lack of sufficient scientific support. As mentioned, animal studies had not been performed. PM had good information about the research situation. Furthermore, the investigation has shown that it was not entirely evident to any of the persons in what way the transplanted synthetic tracheas were actually going to be developed. The fact that there was faith and hope in that this method would work cannot motivate that it was clinically used at such an early stage…There is no doubt that the use of synthetic tracheas has been negligent and that is has entailed a deliberate risk-taking of a serious nature. This is negligence that throughout a series of operations has also increased along with the continued absence of positive results, in part with the occurrence of negative findings.

Criminal sanctions for misconduct are rare: Recently, we found only 39 science researchers from seven countries had been criminally sanctioned for research misconduct since 1979. Among the more than 250 researchers sanctioned for misconduct by the U.S. Office of Research Integrity over the same period, less than 2% also faced criminal sanctions. We presented the findings of our survey at this year’s World Conference on Research Integrity. http://www.wcri2017.org/images/Abstract-Book-5th-WCRI-2017.pdf

For more details on the Macchiarini case, check out our timeline. http://retractionwatch.com/2016/02/12/reading-about-embattled-trachea-surgeon-paolo-macchiarini-heres-what-you-need-to-know/

Click for more embedded links: http://retractionwatch.com/2017/10/12/swedish-prosecutor-wont-pursue-criminal-case-macchiarini/


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I'm not convinced that he hasn't been made a scapegoat as others seem to have been actively involved in this as well. I guess they just get to say they regret it and then on to the next experiment.

University College London Releases Investigation into Macchiarini Ties
Laboratory Equipment
by Seth Augenstein - Senior Science Writer - @SethAugenstein

University College London
A special inquiry concluded that University College London provided some experimental implants to a now-disgraced surgeon, leading to a handful of deaths, according to a report released Sept 29.

The wide-spanning look into the regenerative medicine research at UCL had a particular focus: its ties to Paolo Macchiarini and his work at the Karolinska Institute in Sweden.

Some of the biological materials were supplied from UCL personnel – and that should not have happened, according to the investigatory report.

“We deeply regret that materials (known as POSS-PCU constructs) that had not undergone rigorous pre-clinical assessment and which were not made to GMP standards, were manufactured and supplied by Professor Alexander Seifalian’s research laboratory for direct clinical use,” the school writes, in response to the lengthy report.

“Our governance systems should have prevented that. We also regret the wider-negative impact that this work had on the field of regenerative medicine research,” they add.

The UCL-suppled materials included an artificial trachea and a graft for an artery.

Macchiarini and his work was the main focus of the investigation. The Italian-born surgeon had first reached prominence with the transplant of a cadaver trachea into a Spanish woman’s throat, using the patient’s own stem cells to prevent rejection, in 2008. Macchiarini parlayed his notoriety into a job at the prestigious Karolinska Institute in 2010. Headlines and acclaim followed.

However, a series of his patients died after the procedures involving trachea implantations. As the death toll increased, Macchiarini’s work became scrutinized for claims of fraud.

The UCL investigation focused on the ties to Macchiarini, who was named an honorary professor at the school. The plastic scaffold used in one operation by Macchiarini was constructed by Seifalian, as was a blood vessel graft used for another procedure, according to the report. The latter patient died, though the first one’s ultimate outcome remains unclear.

Seifalian was dismissed last year due to unrelated financial accusations – though he does still face two research misconduct investigations.

Seifalian told various media outlets since the release of the report last week that he was being made into a “scapegoat” for school-supported work.

The inquiry recommended that UCL further codify its approval of experimental, life-saving treatments beyond the ad-hoc “three wise men” panel of informal decision making.

“The Inquiry believes that whilst occasional compassionate use is unavoidable, the development of the field is contingent upon rigorous scientific evidence, good manufacturing practices, robust non-clinical evaluation and properly structured clinical trials,” they concluded.

Macchiarini was fired from Karolinska last year, and began a job at the Russian Science Foundation, where he was focused on the esophagus, and not the trachea. But after a retracted paper, he lost his job there, as well.