The ”Macchiarini affair” or the ”KI scandal” has substantially shaken confidence in medical research in general and in Karolinska Institutet in particular during the last few weeks. I have had reason to scrutinise both my actions and the decisions I have made concerning the investigation into research irregularities that was the starting point for the media storm which has been raging for the last couple of weeks.

Because of the attention in the media, KI has received new information which definitely gives a modified picture of the charges of irregularity against Paolo Macchiarini. My conclusion is that KI’s investigation into Paolo Macchiarini’s scientific misconduct has to be reopened. Against this backdrop it seems very likely that my decision in this case was wrong.

During the last few days it has become obvious that the information possessed by KI when the matter was investigated was not complete. Last Wednesday we were given a new impression of the period following the operation in Iceland on his first patient, whose case is the basis of some of Macchiarini’s articles. During the last few days KI has also received information that implies serious inaccuracies in an article describing trials with artificial tracheae in rats. This information was totally new for KI. We are now endeavouring to investigate this information thoroughly and arrange an independent examination. But there is much to indicate that the judgement reached by KI last summer should be amended to scientific misconduct, which in plain language means research fraud.

In hindsight I can conclude that I should have looked for these probable inaccuracies during the review that led to the decision KI made on the matter of misconduct in August 2015. We should quite simply have been more thorough. As Vice-Chancellor of KI I am ultimately responsible for this.

Bosse Lindquist has made an important documentary series which pinpoints a number of important questions and reveals misjudgements at Karolinska Institutet. Today I can see that I completely misjudged Paolo Macchiarini and that he and KI should have gone their separate ways far earlier. It was in all probability wrong to employ him in 2010, just over two years before I was appointed Vice-Chancellor.

KI failed to see the warning signs early enough and did not pay enough attention to the warnings that came from doctors working close to Paolo Macchiarini. Nor was KI critical enough of the method of using artificial tracheae that Macchiarini adopted. Many have said that I, as Vice Chancellor, together with the management of Karolinska University Hospital should have acted to draw these warnings to the attention of the research project Paolo Macchiarini was conducting in Russia. With the benefit of hindsight I can of course see that we should have done so. At the same time, one has to remember that the clinical study Macchiarini conducted in Krasnodar was undertaken with permission from the Russian authorities and that, according to information available to KI, there was ethical approval for each single patient. What form these approvals took and what the medical status of the patients was before the operations is known only by those who took part in the study. Patient confidentiality, obviously, also exists in Russia.

In the recent discussion Karolinska Institutet has also been criticised for a culture of self-sufficiency, unhealthy elitism and prestige thinking. This may be true, I don’t know. What is, however, true is that we have high ambitions in our endeavour to use research and education to improve people’s health and at the same time contribute to medical breakthroughs and innovation in the field of life sciences which will benefit the whole of society in Sweden.

Tens of thousands of extraordinarily capable and dedicated employees who have had nothing at all to do with this unfortunate story work at KI and Karolinska University Hospital. All these loyal and dedicated employees deserve our gratitude, support and encouragement.

It is obvious that the picture many people have of KI as a self-sufficient elite university is alarming. Now we must ransack ourselves and get to the bottom of the question of whether an unhealthy academic culture prevails here. KI is reviewing the routines concerning recruitment and employment as well as our control mechanisms. We must introduce and take care of international researchers in a better way. And we must be more explicit with our employees about the ethical framework that is in place for their actions in Sweden as well as abroad. KI will actively encourage dialogue and discussions about values so that they are always inherent in our work.

The fact that Karolinska Institutet’s reputation has been tarnished by the ”Macchiarini affair” is extremely serious and is something for which I am obviously responsible. KI’s board has initiated an investigation into KI’s handling of Paolo Macchiarini from recruitment onwards and, not least, my actions in the misconduct investigation. A similar external investigation of Karolinska University Hospital’s role is being undertaken. This is excellent, as the two autonomous investigations will provide answers about direct errors that have been committed and what can be learned from them.

I am aware that confidence in me as Vice-Chancellor of KI has been impaired, both in the public, the research community and many of KI’s employees and students. The chorus of voices raised to demand my resignation is so multifarious and strident that I realise it will be difficult for me to continue working as Vice Chancellor of Sweden’s most successful university with credibility and effectiveness. That is why I am resigning my position.

http://www.dn.se/debatt/i-am-resigning-my-position-as-vice-chancellor-of-karolinska-institutet/

http://ki.se/en/news/anders-hamsten-steps-down-as-vice-chancellor-of-karolinska-institutet