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Karolinska orders new investigation of trachea surgeon Macchiarini

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Paolo Macchiarini

Paolo Macchiarini

The Karolinska Institutet University Board announced today it was issuing a new external investigation of trachea surgeon Paolo Macchiarini, looking into questions about his recruitment and the handling of previous allegations of misconduct.

According to a press release:

The University Board deems such an inquiry to be an important part of restoring the confidence of the public, the scientific community, staff and students in the university.

The board hopes to appoint the investigative team, which will not consider “matters of a medical-scientific nature,” next week. The goal is to conclude the investigation by the summer.

There were many signs this was coming: Last week, KI announced it may reopen its previous misconduct inquiry, after a series of recent documentaries aired in Sweden raised a number of new allegations, such as suggesting Macchiarini operated on patients in Russia whose conditions were not life-threatening enough to warrant such a risky procedure.

During the previous inquiry, an external review concluded that Macchiarini had committed misconduct in seven papers; ultimately, KI’s vice-chancellor, Anders Hamsten, concluded that Macchiarini acted in some cases “without due care,” but that his behavior “does not qualify as scientific misconduct.”

Yesterday, Karolinska announced it would not extend Macchiarini’s current one-year research contract.

Macchiarini is world-renowned for performing a breakthrough surgery, creating tracheas from cadavers and patients’ own stem cells. However, some Karolinska surgeons eventually filed a complaint — alleging, for instance, Macchiarini had downplayed the risks of the procedure and not obtained proper consent.

Today’s release included some details about the nature of the investigation:

The investigation will be led by a highly experienced lawyer, who will subsequently be writing the final report. Well-qualified medical researchers, ideally not from Sweden, should assist in this work. The person tasked with leading the work will decide on who is to take part in the investigation and on what resources will be needed to bring the inquiry to a satisfactory conclusion. KI’s internal audit office, which answers direct to the University Board, will also be a resource available to the investigation.

It included the specific questions that will be considered:

The investigation will cover that which falls within the University Board’s sphere of responsibility, and will thus not be examining matters of a medical-scientific nature. Issues that that external investigation should consider are:

-Was any law broken or other formal transgression committed on Macchiarini’s recruitment or later during his period of employment at KI?

-Were adequate inquiries made in connection with his recruitment?

-Was sufficient effort made at a departmental and university management level to ensure that Macchiarini’s activities were conducted in a proper scientific manner with due respect to research ethics?

-Has his research been documented in a manner consistent with the rules and praxis in effect at KI?

-Has the division of responsibility between KI and Karolinska University Hospital been sufficiently clear, and has their collaboration been adequate from a research and clinical perspective?

-Has the chain of responsibility from department to Vice-Chancellor and the University Board been sufficiently effective?

-Was anything – or enough – done to ensure that Macchiarini’s extramural activities complied with KI’s scientific and ethical requirements?

-Were the allegations of scientific misconduct levelled against Macchiarini handled correctly?

-Why was Macchiarini’s employment contract extended in 2015 in spite of the obvious doubts there were about his activities?

The release concluded by reaffirming the board’s support for Vice Chancellor Anders Hamsten, who has been under pressure following the earlier decision:

The University Board has full confidence in Vice Chancellor Anders Hamsten and has urged him to remain in office during the investigation. Whether the outcome of the investigation will lead the board to change its stance in this respect is not a matter for speculation at present.

Hamsten said he appreciated the support:

I intend to continue as vice-chancellor of Karolinska Institutet with full force and energy, and to execute my responsibility in this situation in the best possible way….The decisions taken by the board are fully in line with what I myself believe must be done now.

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Written by Alison McCook

February 5th, 2016 at 8:30 am

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