The Vice-Chancellor of Karolinska Institutet, Anders Hamsten, has concluded after a long investigation that while on some points Visiting Professor Paolo Macchiarini did act without due care, it does not qualify as scientific misconduct.
The high-profile case was file against Professor Macchiarini after complaints were lodged by four physicians at Karolinska University Hospital who were themselves part of the research environment and, in some cases, co-authors of the articles that were reported for scientific misconduct.
The complaints were submitted in June, August and September 2014, prompting an inquiry by Karolinska Institutet’s Vice-Chancellor in accordance with the provisions of the Higher Education Ordinance and the university’s own rules for dealing with cases of alleged scientific misconduct.
The first complaint involved a paper that describes the manufacture of a synthetic oesophageal prosthesis and its functionality on transplantation into a rat. Complainants raised their concerns on the conclusions of the functionality of this prosthesis and the interpretation of CT scans.
In another complaint, the complainants pointed out that the results concerning the three patients who were given synthetic trachea coated with their own bone-marrow derived stem cells at Karolinska University Hospital and described in six papers didn’t have patients’ medical records as kept at Karolinska University Hospital. Also, the complainants said that there was no evidence that a synthetic tracheal transplant can develop into a functional airway.
Further the complainants also questioned the claim that the first patient had suffered a relapse of his tracheal cancer and that surgery was therefore necessary.
As part of the inquiry, a statement of opinion was requested from Professor emeritus Bengt Gerdin, who, on examining the documents and information included in the complaint, Professor Macchiarini’s initial response and the medical records from Karolinska University Hospital, submitted his conclusion in mid-May that the accused was indeed guilty of scientific misconduct.
Following the detailed report submitted by Professor Gerdin, Professor Macchiarini and his co-authors submitted over 1,000 pages of comments and documents, including medical records from the first patient’s doctors in Iceland, showing that on the crucial points, the description of his condition given in the articles is correct.
“Now that we have examined the allegations of scientific misconduct in all seven indicted articles, we have found that they contain certain flaws but nothing that can be considered scientific misconduct,” says Vice-Chancellor Anders Hamsten.
The inquiry shows that the interaction between Karolinska Institutet and Karolinska University Hospital has not functioned satisfactorily, and the Vice-Chancellor’s decision promises improvements to procedures, regulations and support structures for clinical trials and clinical therapy research. The line between clinical application and research when it comes to experimental therapy will need to be better defined, and clearer guidelines for academic research and academic healthcare will be drafted.
Professor Macchiarini has also been instructed to submit errata to the journals that published some of the scientific papers to clarify and rectify the failings that the inquiry has brought to light.
“Some aspects of Paolo Macchiarini’s research do not meet our high quality standards,” says Professor Hamsten. “We will now be remedying the deficiencies our inquiry uncovered with him, the heads of his department and representatives from Karolinska University Hospital.”