Universities chief fired as KI scandal fallout spreads

Minister of Higher Education and Research Helene Hellmark Knutsson has fired the country’s University Chancellor and head of the Swedish Higher Education Authority, Harriet Wallberg, and four members of the board of the Karolinska Institute, or KI, in Stockholm in the wake of the Macchiarini affair.

The minister also said that all remaining board members who were active during Paolo Macchiarini’s tenure as visiting professor at KI would be replaced.

The chairman of the board and former minister for higher education and research, Lars Leijonborg, resigned on 2 September.

A new external inquiry last week damned the institute’s "poor leadership".

Macchiarini, renowned as a surgeon for his pioneering trachea transplants, was hired by both KI and the Karolinska University Hospital in 2010, when Wallberg was vice-chancellor of the Karolinska Institute.

Macchiarini was the first in the world to implant a synthetic trachea on 9 June 2011, on an Eritrean geologist living in Iceland, involving extensive international collaboration, as reported by University World News.

In 2011 Macchiarini reported in The Lancet his implantation of an artificial windpipe (trachea) into a patient at the Karolinska University Hospital, using the patient’s own stem cells. The operation was hailed as a landmark in regenerative medicine. He followed up with implants of tracheas into seven more people, Nature reported.

Three of his operations in which he implanted artificial tracheas that were seeded with stem cells into patients took place at Karolinska University Hospital. Two of the patients died and one has been in intensive care since the surgery in 2012.

In January 2014 a Belgian researcher reported Macchiarini for scientific misconduct, but KI’s Ethics Council, which investigated the case, cleared him in April 2014.

Further concern was raised, however, by experts at KI in 2014, this time about Macchiarini’s over-positive claims of success in seven papers. KI hired a retired surgery professor, Bengt Gerdin, to examine the allegations, who in May 2015 concluded that the surgeon had systematically misrepresented the results of the surgery to an extent that constituted misconduct.

But the then vice-chancellor, Anders Hamsten, who had taken over at KI in January 2013, rejected the finding and in November 2015 renewed Macchiarini’s contract.

Following the broadcast this January of a three-part documentary by Swedish Television exposing several examples of misconduct concerning transplantations performed by Macchiarini, and showing how patients had suffered in connection with failed operations, further investigations began.

Hamsten resigned, but at the same time announced that KI would be conducting a new inquiry into scientific misconduct by Macchiarini based on new information relating to the original operation on the first patient from Iceland.

In March KI fired Macchiarini.

An external inquiry into KI’s handling of the entire case, commissioned by KI, and led by Sten Heckscher, former president and justice of Sweden’s Supreme Administrative Court and under-secretary of state in the Ministry of Justice, published a report last Monday strongly criticising KI’s handling of the affair.

It said Macchiarini’s recruitment in 2010 and the extension of his contract in 2013 were pushed through improperly and found that KI could not be completely absolved of responsibility for the synthetic trachea transplantations performed at Karolinksa University Hospital.

Remarkably negative references

Macchiarini’s recruitment was initiated by the then vice-chancellor – Wallberg – in a way that constituted a breach of delegation of authority creating confusion over who had responsibility for the recruitment. It then went ahead despite the receipt of “remarkably negative references”.

These included “information that Macchiarini had been blocked from a professorship in Italy, that there were doubts surrounding his research and that his CV contained falsehoods”, the report said.

This information was not passed on to file or to the recruitment committee and the vice-chancellor “neglected to request a more thorough report” when closer examination should have been carried out before any decision was taken, the report said.

The investigators concluded that the recruitment was pushed through in an “inappropriate manner and in a way that failed to meet the requirements for documenting and handling such matters”.

They also found that, although the operations took place at the hospital, which unequivocally bears responsibility under the regulations for the decision to carry out the operations as well as how they were carried out, KI also had certain responsibility for the operations.

This was due to many instances of KI employees being involved in the discussions before and following surgery. In addition, KI had cited the transplantations as part of its own activities, for instance quoting them as research successes in KI’s evaluations of how research funding had been used.

In fact, the ambition to create an almost seamless collaboration between his clinical activities and his research at KI had confused the division of responsibilities between the university and the hospital, the report found.

“When it became obvious that the first operation on the basis of so-called vital indication would be followed by others, KI, which took part in the discussions, had a responsibility to ensure that the transplantations were performed in accordance with the regulations,” the report said.

No evaluation

The enquiry also found that KI initiated no real evaluation and assessment of Macchiarini’s work at KI ahead of contract extensions in both 2013 and 2015, when for the 2013 extension there were “countless circumstances that should have warranted such an evaluation”.

This included uncertainty over the reason for legal action taken against the surgeon in Italy in 2012 and the objections raised by the Karolinska University Hospital in 2013 that made the hospital decide to stop further transplantations and terminate its part of Macchiarini’s contract. Instead Macchiarini was asked to describe his work himself and this description was used in the proposal to extend his contract.

Further in 2015, when the situation surrounding Macchiarini was turbulent, with conflicts regarding his work and an ongoing preliminary inquiry, KI did not carry out any independent evaluation of his work ahead of its decision to appoint him as senior researcher.

At the time Macchiarini had been acquitted by the vice-chancellor of all alleged scientific misconduct and was first choice of experts for a prospective permanent professorship.

The report criticised KI for its “nonchalant attitude towards regulations – sometimes enshrined in the constitution – governing how public authorities are to manage their business”. It complained about a lack of registration and tardy registration of public documents and lack of proper compliance with requirements related to the archiving of research data.

“An irresponsible attitude to formalities increases the risk of principal mistakes. Formal requirements, ultimately based on a directive in the Instrument of Government, provide valuable support for a careful and correct decision-making process and legal protection for the individual and the state,” the report said.

Commenting on her decision on 2 September to fire Wallberg and the KI board members, Hellmark Knutsson told Swedish newspaper Expressen: “Scandal is the right word. Several of the patients have suffered [and died]. Karolinska Institute has not understood the responsibilities of being a governmental organisation.”

In a press conference on Tuesday, Heckscher said the affair provides textbook examples of poor leadership and a broken delegation of authority. Both vice-chancellors were inappropriately involved in the case, including Macchiarini’s recruitment.

“Emails were sent that made it clear to a head of department exactly what was to be achieved, while telling her that she was free to decide for herself.”

Damage to reputation

The fallout from the affair includes severe damage to KI’s reputation and also threatens the credibility of science’s top prize.

The Nobel Assembly at KI, which awards the Nobel Prize for physiology or medicine, has asked both former vice-chancellors, Wallberg and Hamsten, to resign their membership of the assembly to prevent damage to the credibility of the world’s most prestigious scientific award, Science magazine reported.

KI’s own website reported last week that an online survey had shown that KI’s public reputation had fallen drastically in the past year due to the Macchiarini scandal. The TNS Sifo survey found KI’s reputation had plummeted to 59 out of 100 compared with 85 last year, representing a drop from fourth most respected higher education institution in Sweden to 12th.

The report said the damage was done by the widespread denigration of the university management’s ethical and moral credentials, its conduct when the Macchiarini case came to light and its handling of the media during the crisis.

“This is extremely serious and we are not at all happy about this, but we have to acknowledge the fact and do our very utmost to improve the situation,” said Karolinska Institute’s Acting Vice-Chancellor Karin Dahlman-Wright to Swedish Television.