Karolinska Institutet may reopen its misconduct investigation into acclaimed surgeon Paolo Macchiarini following new allegations revealed during a documentary series by Swedish Television.
According to a recent statement from KI:
The programmes contained information that was unknown to the university management, which means that the inquiry into suspected scientific misconduct might be reopened against Professor Macchiarini.
“My conclusion is that we need to examine and evaluate the claims made in the documentary, and will be reopening the inquiry if there is reason to do so,” says Karolinska Institutet’s vice-chancellor, Anders Hamsten.
Macchiarini is currently in the midst of a one-year research contract with KI. He is famous for creating tracheas from cadavers and patients’ own stem cells. However, the glow of his success was diminished somewhat after some Karolinska surgeons filed a complaint — alleging, for instance, Macchiarini had downplayed the risks of the procedure and not obtained proper consent.
Last May, an external review by Bengt Gerdin of Uppsala University concluded that visiting professor Macchiarini had committed misconduct in seven papers. The university gave co-authors on all papers time to respond, after which Hamsten would reach an official decision.
A series of recent documentaries aired in Sweden, however, have 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.
The series has provoked Hamsten to revisit KI’s handling of the case. In KI’s statement, Hamsten says:
We’ve seen footage in SVT’s documentary that is truly alarming, and I empathise deeply with the patients and their relatives. Many of the circumstances, as portrayed in the programme, are wholly irreconcilable with KI’s values and with what we expect of our employees. If what the programme claims about patients being tricked or talked into undergoing surgery on dubious grounds is true, it is naturally altogether inacceptable.
The primary concerns apparently stem from operations Macchiarini performed in Russia:
Professor Macchiarini was on a part-time contract at Karolinska Institutet from 2010 to 2015, and had approved extra-occupational activities in Krasnodar, Russia. Although the university management knew that he had operated and researched there, the information that has emerged in the documentaries on the ethical nature of these operations is new to Professor Hamsten.
“The three patients on whom Paolo Macchiarini operated at Karolinska University Hospital in 2011 and 2012 were seriously ill and judged to have little time left to live. We assumed that the same was true for the patients operated on in Krasnodar.”
Karolinska Institutet does not allow secondary occupations that are undermining confidence, and given the way Macchiarini’s activities in Russia have been described in the documentary, they would never have been approved, explains Anders Hamsten.
“KI will now see if the way secondary occupations are reported at the university needs revising so that we may more readily judge the potential harm they can do to our reputation.”
Another statement KI released last week explains that as a KI employee, Macchiarini had to ensure the operations in Russia met the same ethical demands as in Sweden:
SVT’s documentary series “Experimenten” [lit: The Experiments] described the transplantation of synthetic trachea into four patients in Krasnodar, Russia. Responsibility for these operations, which patients were to be operated upon, the conditions under which the operations were to be performed and the ethical issues surrounding the operations lay, and lies with those in charge of the research project in Krasnodar, of which Paolo Macchiarini was part. As an employee of KI as well, Prof. Macchiarini is also required to ensure that his research in Krasnodar meets the same ethical demands as would be made in Sweden.
Macchiarini told us legal action is being pursued against SVT over the series (although not by him personally):
…there are already legal cases raised against SVT with regard to the content of the series. Their repeating and compounding of the allegations made against me is something I take very seriously, as well as the way that they approached patients and their families. It is entirely right that the Vice Chancellor of KI is looking closely at these allegations, and also the content of the documentary and conduct of the production team, and I am in constant contact with him and others.
There were multi-disciplinary and international video-conference discussions about the best healthcare pathways for many patients with severe tracheal injuries in 2012, which included patients later operated on as part of the clinical trial based in Russia. In addition, the proposed treatment of each of those patients was submitted to an ethical permissions process (on top of the umbrella ethical permission covering the trial). These are among the documents that I am currently in the process of collating in order to demonstrate that the accusations made by SVT are entirely baseless.
As ever the welfare of our patients is the foremost priority, not only for me but for all the healthcare providers involved in these difficult cases. All decisions are discussed by a large number of people, assessed by those specialised in ethics, and never taken lightly. For a TV documentary to suggest otherwise, for their own purposes, is extremely unprofessional and damaging and not something to be tolerated.
The release also notes KI is investigating allegations from last month’s Vanity Fair article that Macchiarini lied on his CV during his recruitment to KI. A spokesperson for KI told us:
This coming week KI will make a couple of decision: One of them is about Macchiarini’s future at KI which will be based upon KI’s investigation into his credentials from former employers and institutions. It has been somewhat hard to retrieve original documentation as some of the institutions KI has been in contact with so far has not responded. KI will also look into the circumstances surrounding his work in Krasnodar. The documentary claims he operated on patients who were not life threathingly ill.
Another decision to be taken is whether or not KI shall reopen the investigation about scientific misconduct. The documentary broadcasted by SVT, Swedish public television, has shown some new information about the transplant of the first patient who had surgery in Sweden that needs to be scrutinized. Here it’s important to remember that KI’s investigation about misconduct was about if the articles were correct or not by the time they were published. Health care ethics is not a matter for the investigation on scientific misconduct.
The whole case is evolving from day to day now and the KI leaders are continuously trying to inform the public and employees in the best possible way.
For instance, last week, Hamsten sent a long letter to KI professors about his reaction to the documentary:
I felt great unease at what I saw. Many of you and our colleagues, not least those who have collaborated with Paolo Macchiarini, have also come to me and reacted with dismay in the way that is shown and expressed in the programme. But let me at the same time point out that at present we do not have a comprehensive picture of the activities in Krasnodar but only the slice of reality shown in the documentary…In light of what has emerged in the two TV programmes, Dean of Research HansGustaf Ljunggren and I will soon meet with Paolo Macchiarini to hear his side of the story.
That letter to professors appears to dispute the documentary’s claim that Swedish experts help select the patients who received the procedure in Russia:
In the second episode of “Dokument inifrån”, it was mentioned that “Karolinska in Stockholm had helped with the final selection [of patients to receive surgery in Russia]”. This is information that the documentary makers obtained from the Russian project’s website. There are memoranda from an international video conference that took place in February 2012, attended by a number of employees of KI and Karolinska University Hospital. The Swedish participants have a completely different view. According to them, the purpose was to try to see if it was possible to meet over continents with the aid of video technology (in this case Russia, Sweden, Italy and the USA). At this video conference, experiences from previous and current patient cases were shared, which is also the view that emerges when going through the memoranda from the meeting. The claim that patients would have been selected for transplantation in Russia in this context is something that the Swedish participants do not confirm. This was also the only video conference arranged as it was established that the current technology did not enable the displaying of x-ray images, for example.
Simultaneously, Hamsten told the professors that KI is taking a second look at how it handles such “secondary employment” as Macchiarini’s in Russia:
We do not allow secondary employment that may undermine confidence in KI, and considering the way that Macchiarini’s activities in Russia are described in the programme, the secondary employment would not have been approved. At the same time we are looking into whether KI’s secondary occupation reports need to be developed further in order to improve the possibility of assessing the potential danger of secondary employment undermining confidence.
That Vanity Fair article mentioned by KI also described how Macchiarini had seduced a producer for NBC News under false pretenses while the outlet was preparing a special about his work.
Update: 2/1/16 11:47 a.m. eastern: We’ve updated our text since a careful reader informed us that the statement from Macchiarini doesn’t explicitly say whether or not he is personally pursuing legal action against SVT. We contacted him to follow up on this question, and Macchiarini confirmed that he personally is not pursuing the legal action.
Update 2/2/16 1:28 p.m. eastern: A representative of SVT told us there is no legal action against them for the series, although they have been contacted by lawyers who represent a German production company that filmed a surgery in 2012.
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