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Karolinska Institute scandal: systemic failures or individual errors?

Sweden鈥檚 leading university pledges to learn after government intervenes in Macchiarini affair

Published on
September 18, 2016
Last updated
February 16, 2017
Paolo Macchiarini, Karolinska Institute
Source: Alamy

Hiring someone for a job is always a big decision. But the Karolinska Institute鈥檚 2010 decision to appoint as a visiting professor聽Paolo Macchiarini (pictured above), once a world-renowned thoracic surgeon, turned out to be really big.

Following the deaths of two of Dr Macchiarini鈥檚 patients at the Karolinska University Hospital and allegations of research misconduct, a TV documentary on his work shocked the Swedish public and led the Karolinska Institute鈥檚 board to commission an external inquiry into the institution鈥檚 handling of his case.

After the inquiry published on 6 September 鈥 saying the institute had a 鈥渘onchalant attitude towards regulations鈥 鈥 Sweden鈥檚 higher education minister removed the institution鈥檚 board and fired one of its former vice-chancellors, Harriet Wallberg, from her post as head of the Swedish 糖心Vlog Authority and chancellor of all the nation鈥檚 public universities.

Professor Wallberg and another former KI vice-chancellor, Anders Hamsten, have also been removed from the institute鈥檚 Nobel Assembly, which is responsible for awarding the Nobel Prize in Physiology or Medicine.

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The scandal has shaken the Stockholm medical institution, one of Europe鈥檚 most prestigious universities (it was continental Europe鈥檚 second highest placed university in the 2015-2016听糖心Vlog World University Rankings, at 28th).

Were systemic problems at the Karolinska Institute to blame? Or does the affair show how individual errors can have huge consequences for universities?

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Dr Macchiarini鈥檚 recruitment 鈥渨as pushed through inappropriately鈥 and was 鈥渋nitiated by then vice-chancellor鈥 Professor Wallberg, according to the external inquiry into the case, led by Sten Heckscher, a former president of Sweden鈥檚 Supreme Administrative Court.

The institute 鈥渞eceived remarkably negative references, including information that Macchiarini had been blocked from a professorship in Italy, that there were doubts surrounding his research and that his CV contained falsehoods鈥, continues the report.

In a 2011 operation at the Karolinska University Hospital that attracted worldwide headlines, Dr Macchiarini performed the world鈥檚 first synthetic organ transplant by replacing a patient鈥檚 windpipe with a plastic tube coated with stem cells. He went on to conduct a further two such operations.

Of the three patients he operated on, two died and the third developed severe complications that have required continuous hospital treatment.

In 2013, the university hospital stopped any further operations and terminated its part of Dr Macchiarini鈥檚 contract.

But the Karolinska Institute extended his contract in 2013 and 2015 鈥渨ithout any evaluation of his activities鈥, says the external inquiry report.

In August 2014, research misconduct allegations against Dr Macchiarini concerning his publications were reported to Professor Hamsten, who succeeded Professor Wallberg as vice-chancellor in January 2013.

A separate ,聽carried out into Dr Macchiarini鈥檚 operations at the university hospital, says: 鈥淭he vice-chancellor appointed an external investigator [Bengt Gerdin, emeritus professor of surgery at Uppsala University] who found that the accusations against Macchiarini were essentially correct. However, the vice-chancellor decided to acquit Macchiarini of the accusations of research misconduct.鈥

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Swedish public TV station STV broadcast a three-part documentary, The Experiments, concerning Dr Macchiarini鈥檚 transplants in January 2016 鈥 including images of a young woman who died after surgery in Russia.

The Karolinska Institute鈥檚 board launched the inquiry in February and Professor Hamsten resigned. He was replaced by Karin Dahlman-Wright on an interim basis.

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Dr Macchiarini, who has denied all the allegations against him,聽was fired by KI in March. Prosecutors in Sweden said in June that they were investigating him on suspicion of two cases of involuntary manslaughter at Swedish hospitals.

In April, The Lancet added an 鈥渆xpression of concern鈥 to a 2011 paper by Dr Macchiarini.

This month, Sweden鈥檚 Central Ethical Review Board found Dr Macchiarini and his co-authors had committed research misconduct in a 2011 Nature Communications paper.

Hans Wigzell, who was vice-chancellor of the Karolinska Institute between 1995 and 2003, said that at the highest levels of the institute a 鈥渓ack of allowing information to easily come in鈥as been a significant part鈥 of the affair.

But he added that the case tells us 鈥渘othing about the general standard, the quality of research鈥 at the institute.

He continued: 鈥淢y experience from my relatively long life in these kinds of areas is that people think it鈥檚 something wrong with the system. It鈥檚 not the system 鈥 it鈥檚 the individuals.鈥

Professor Gerdin said that 鈥渢his terrible process took place in one single department out of 22 departments鈥.

But he added: 鈥淭he current Karolinska Institute leadership, and the current vice-chancellor, has not yet dismissed any one of those employed internally at KI based on the current investigations. If that will not be the case鈥t is a scandal.鈥

Asked what lessons should be learned from the case, he called for improved processes 鈥渇or documentation of scientific work鈥 by researchers, in employing newcomers who are 鈥渘ot yet full professors at any other respected university鈥, and for handling allegations of research misconduct.

The Heckscher report also says 鈥渟tructural circumstances鈥 may have had an impact, including 鈥渞esearch policy developments and a growing fixation on excellence...and the aspiration to close the gap between research and its application in healthcare鈥.

Professor Dahlman-Wright said in a statement that the Karolinska Institute has 鈥渕uch to learn from what has happened and now we are undertaking extensive work鈥.

The institution has 鈥渟trengthened recruitment processes in terms of review and assessment of CVs, and verification of references鈥, and has 鈥渁ltered the process for handling suspected research fraud鈥, she said.

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She added: 鈥淣ow it is up to us to prove that Karolinska Institutet is so much more than the Macchiarini affair.鈥

john.morgan@tesglobal.com

POSTSCRIPT:

Print headline: Karolinska Institute scandal: the system or the surgeon?

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Reader's comments (1)

In which the TES continues to ignore the UK angle on this shocking abuse of patient trust.

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