The Karolinska University Hospital and the Karolinska Institute (KI) in Stockholm ignored warning signs when they hired surgeon Paolo Macchiarini in 2010, an independent panel concluded this week. The investigation was commissioned by the hospital’s director in the wake of an ongoing misconduct scandal surrounding Macchiarini and the artificial tracheae he implanted in three patients at the hospital. Two of the patients died, and a third has been hospitalized since receiving an implant in 2012. “Macchiarini’s transplant activities have damaged clinical research not only at Karolinska University Hospital, but also in Sweden in general,” the panel noted.
The procedures did not have proper ethical approval, were not based on adequate science, and failed to follow Swedish regulations regarding new medical products, the panel says in its 31 August report. (An English summary is here. The full report in Swedish is here.) The investigation was led by Kjell Asplund, professor emeritus in medicine at Umeå University in Sweden, chairman of the Swedish National Council on Medical Ethics in Stockholm, and former director general of the Swedish National Board of Health and Welfare, also in Stockholm.
The report highlights mistakes made during Macchiarini’s tenure at the hospital. But it also notes that the hospital terminated Macchiarini’s employment in late 2013, successfully resisting pressure from KI, where Macchiarini remained a senior researcher until March. Whistleblowers raised questions about Macchiarini’s work in 2014, but KI stood by the surgeon, extending his contract even after an independent investigator found that the allegations had merit. He was dismissed after a television documentary in January raised additional questions about the surgeon and his work.
Managers from KI and the hospital recruited Macchiarini, according to the report, based on favorable publicity surrounding his work on trachea transplants and the technical skills he demonstrated during a “test operation” in Stockholm. KI managers took the lead, and the hospital did not collect independent information on Macchiarini’s clinical qualifications until late in the recruitment process. “The warning signs that arose then were suppressed,” the panel writes.
Once Macchiarini took up the dual appointments, the report says, it was not always clear who was supervising his activities. At the hospital, he was officially part of the ear-nose-throat clinic, but he performed the surgeries in the thoracic clinic, located at a different campus. The report says this left ambiguous who was responsible for the “independent” and “difficult-to-manage” Macchiarini and gave him “an opportunity to move between the two clinics too freely.” Macchiarini also failed to provide adequate follow-up care when the implant recipients developed complications, the report says.
The hospital and Macchiarini have argued that the surgeries did not require ethical review because they were not clinical research but were performed as life-saving measures on patients with no other treatment options. But the panel said the patients who received the transplants did not have life-threatening conditions and that the surgeries should have been subject to ethical review as clinical research. There were no animal studies that had tested the specific combination of materials Macchiarini used on the patients at the time of the transplants, the report says.
“We find it to be very unlikely that the transplants would have been approved by an ethical review board based on the scientific information that was available in 2011,” the panel writes. The panel warns that continuing to argue that the surgeries were not clinical research risks undermining future research at the hospital.
The report recommends that the hospital implement a range of measures to address the problems the panel identified. It notes that the hospital has already set up a procedure for whistleblowers to express concerns and established a task force to address the overlap between patient care and clinical research. It calls for the hospital to be more independent from KI, especially in hiring decisions, and recommends additional training for staff on regulations surrounding ethics approval and new medical products.