Ole Petter Ottersen, president of the Karolinska Institute, acknowledges that how to judge the whistleblowers was “the major difficulty" for him.

Erik Cronberg/Karolinska Institute (CC-BY-NC-ND)

Macchiarini guilty of misconduct, but whistleblowers share blame, new Karolinska Institute verdict finds

The Karolinska Institute (KI) in Stockholm has finally, officially, found disgraced surgeon Paolo Macchiarini guilty of scientific misconduct. Macchiarini was widely hailed as a pioneer in regenerative medicine for his technique of implanting artificial tracheae seeded with a patient’s own stem cells into patients, but KI fired him in 2016 amid allegations of fraud and other types of misconduct.

However, the verdict is a bitter pill for the four people who raised the alarm about Macchiarini’s fraud. In a report issued yesterday, KI President Ole Petter Ottersen finds one of them, Karl-Henrik Grinnemo, a surgeon and stem cell researcher at KI and Uppsala University in Sweden, guilty of misconduct as well, based on his involvement in a paper he and others co-authored with Macchiarini in The Lancet in 2011. And the report says two others are “blameworthy” for their roles in a 2013 paper in Biomaterials that describes data from a patient for whom there was no ethical approval in place.

“This sends the message that whistleblowers in research will be punished. That’s a serious problem for research,” says cardiothoracic surgeon Oscar Simonson, one of the whistleblowers, who now works at Uppsala University Hospital. He and his colleagues “spent thousands of hours over 5 years” uncovering and documenting the problems with Macchiarini’s research and the papers in question. (The report says Simonson is “blameworthy,” but not responsible for misconduct for his role in the 2013 paper.) 

The verdict is “a continuation of the harassment by Karolinska leadership” of the whistleblowers, Grinnemo says. “They used our own investigation against us, to find things we should have done differently.”

Ottersen acknowledges that how to judge the whistleblowers “has been the major difficulty with this decision.” The university wanted to send two clear messages, he says. First, that “we commend these four people for their role” in uncovering the scandal. “Any organization needs whistleblowers, because it is essential that flaws and misconduct be brought to the attention of society.” At the same time, he says, “The other signal that is also important is that you cannot absolve yourself of responsibility [for misconduct] by blowing the whistle after the fact.”

The decision says six papers authored by Macchiarini should be retracted. It is KI’s official response to an earlier evaluation by the Swedish Central Ethical Review Board, published in October 2017. That report recommended that the same six papers be retracted and said its 46 authors were all guilty of misconduct, although it did acknowledge that some authors bore more responsibility than others.

KI regulations allowed those involved to respond to the report before Ottersen decided on a final verdict. After reviewing the responses, he decided to differentiate between authors who were responsible for misconduct, those who were “blameworthy” but not directly responsible, and those who could be cleared of blame. 

This sends the message that whistleblowers in research will be punished. That’s a serious problem for research.

Oscar Simonson, Uppsala University

Grinnemo and three colleagues filed detailed complaints to the university in August 2014, describing how clinical records of the three patients who received implants at KI did not match descriptions of their conditions in published papers. The university ignored the complaints for several months but finally asked an external reviewer to investigate. KI initially overruled the reviewer’s decision that Macchiarini committed misconduct, but in January 2016 a troubling documentary on Swedish television raised additional questions about Macchiarini’s work, which prompted KI to reopen the investigation and eventually fire Macchiarini.

The 2011 Lancet paper, about the first artificial trachea implant, claimed the recipient had no complications 5 months after the surgery. That wasn’t true, and given his role in the original surgery and in referring patient biopsies afterward, Grinnemo had to know this, the report says. Although “all credit must go … to the four whistleblowers for submitting a thoroughly grounded complaint and thus triggering this investigation,” that doesn’t clear Grinnemo, the report says.

Grinnemo says he was not working at the hospitals where the patient was being treated after surgery—he was at a different campus and at the time he had no reason not to trust his co-authors’ description of the patient’s condition. The biopsy referral was a purely bureaucratic procedure, he says, because Macchiarini was in a different department from the pathologist. Grinnemo says he never handled the samples directly. In fact, he and his colleagues later pieced together how the samples were mislabeled as part of their original complaint to KI.

Ottersen says the university hopes to reach a decision soon about what, if any, sanctions to impose on Grinnemo and other current employees. “We have a responsibility to those who have been singled out. We don’t want to leave them in limbo,” he says.

Grinnemo and Simonson say a number of researchers from across Sweden are preparing a formal complaint about the verdict, disputing the decision to cast blame on the whistleblowers. “This is not the end of the story,” Simonson says.

It isn’t clear whether Macchiarini will face any additional sanctions based on the KI decision. He and several co-authors recently published a new paper on an artificial esophagus seeded with stem cells.