Paolo Macchiarini, the charismatic star surgeon and stem cell pioneer, once lauded for saving lives of suffocating patients, is now really in trouble. Having described himself once in The Lancet as “a wild animal that does not need to be in a cage”, Macchiarini might soon find himself behind bars for medical malpractice. Six of the eight patients, into whom he transplanted artificial tracheas, without having first tried the method in animal models, have died, while another nanopolymer graft recipient is in permanent critical care. The youngest casualty was a two-year old child in the US. The most recent death was that of a Russian patient in Krasnodar, where Macchiarini works as “leading scientist” at the Kuban State Medical University. Also some of those patients of Macchiarini’s, who received cell-free trachea from cadaver donors, are dead or dependent on stents to be able to breathe. Suppressed evidence turned up that the Italian surgeon committed fraud, clinical and scientific misconduct as well as other crimes, while receiving best possible institutional protection at the Swedish elite university, the Karolinska Institute (KI).

Macchiarini revelations are not really a surprise to KI, the scandal actually began to simmer as soon as the Italian surgeon joined KI.

RetractionWatch kept reporting how Macchiarini was first accused of misconduct, found guilty by an internal investigation, only to be almost immediately publicly rehabilitated by the KI directorate in August 2015. Macchiarini was then officially above any suspicions of misconduct and told to be more careful with his research in the future. Science seemingly has corrected itself: everybody move on, nothing to see here.

But then, the media journalists stepped in. Swedish television channel SVT aired in January 2016 a long three-part documentary on Paolo Macchiarini’s work, named “Experimenten” and authored by the journalist Bo Lindqvist. The series reported about the deadly outcomes of experimental transplants of artificial tracheas seeded with patients’ own mesenchymal stem cells. More and more Swedish and international media took attention to the scandal and picked up the story. Even the glamour magazine Vanity Fair wrote a revealing article about Macchiarini, the celebrity-obsessed seducer and a charming liar.

In the midst of the media storm, senior leadership of KI went jumping for cover and distancing themselves from Macchiarini, claiming to have been unaware of the true extent of his misconduct or even that his clinical stem cell research was unrelated to KI.

However, soon heads started to roll at Sweden’s most venerated research institution. The first one to resign was Urban Lendahl, professor of genetics at the Department of Cell and Molecular Biology. Lendahl resigned from his highly prestigious position as Secretary General of the Nobel Assembly and the Nobel Committee in Physiology or Medicine at Karolinska Institutet. He did so because he is apparently about to be investigated himself for his role in the recruitment of Macchiarini and his handling of KI misconduct investigation. As the Chairman of the Nobel Assembly announced on February 7th:

“The Board of Karolinska Institutet has initiated an external investigation concerning the Macchiarini case. As Professor Lendahl anticipates that he may be involved in this investigation, he resigns from his position as Secretary General out of respect for the integrity of the Nobel Prize work”.

The next resignation was by Vice-Chancellor and Rector of KI, Anders Hamsten, who admitted to have “completely misjudged” Macchiarini. There is however enough evidence that this misjudgement by the KI directorate might have been quite deliberate and purposeful, with more energy dedicated to covering up Macchiarini’s misconduct than to protecting his patients from it.

More senior positions at KI might become vacant very soon, given that a new external investigation has been initiated. It is totally outside of KI control (and very understandably so), “furnished with whatever administrative resources are required” and headed by the former president of the Supreme Administrative Court of Sweden Sten Heckscher, who is assisted by the journalist Ingrid Carlberg and the Finnish biochemistry professor Carl Gahmberg. Macchiarini himself already has lost his grant funding, his job contract and his laboratory at KI and is now under police investigation, as I was told by an informed Stockholm scientist.

Bo Risberg, emeritus professor of surgery at the University of Gothenburg, described in the medical newspaper Läkartidningen the handling of the Macchiarini case as “Karolinska’s Ethics Chernobyl“. He kindly provided me with a statement in the form of an open letter, detailing scientific, medical and ethical shortcomings of Macchiarini’s method. The Risberg letter can be read in whole here. Quote:

“The surgeries were all a total disaster with almost all complications imaginable, infection, fistulation, series of reoperations. […] It was stated that the patients were compassionate cases. A closer look reveals that this was not the case.

Remarkable is that PM [Paolo Macchiarini, -LS] bypassed all ethical check-points when he performed these totally unethical operations. PM is apparently lacking an ethics compass. To me as an experienced academic surgeon this  a totally unbelievable story.

The material they used (POSS-polyurethan) has never been tested in humans. Vascular grafts made from this material have been tested in sheep by another research group (the inventors), but never trachea”.

While the future might spell doom for the remaining KI directorship and maybe even the institution’s international reputation, it is worth to study how it got there.

CazmZD6W0AA_2Af(Guest cartoon by: Jill Howlin)

Macchiarini was recruited in 2010 as guest professor to KI and senior physician at Karolinska University hospital. As the Swedish medical newspaper Dagens Medicin reports, this recruitment was promoted by 14 Karolinska researchers, primarily by Lendahl and Li Felländer-Tsai, head of the Department of Clinical Science, Intervention and Technology (CLINTEC).

Back then, these 14 scientists wrote to KI’s recruitment committee that they expect to have a functional regenerative airway transplant operations up and running in just three months after Macchiarini’s assignment to CLINTEC, at the Ear, Nose and Throat (ENT) clinic of the Karolinska University Hospital, Huddinge. By the turn of the year 2010/2011, the promise went, first Swedish patients should be recruited, followed up by those from wider Europe. According to Dagens Medicin, KI scientists wrote in their recommendation letter:

“To achieve success, decision-making within the Karolinska Institutet and Stockholm County Council must be shortened”.

Indeed, there was a small snag that the surgeon Macchiarini did not have the necessary license to treat patients in Sweden. This formal document (Läkarlegitimation) is issued by the Swedish National Board of Health and Welfare (Socialstyrelsen). To speed things up, the directors of KI requested and promptly obtained a special permit for their newly recruited star. From Dagens Medicin we learn that in 2010 Richard Kuylenstierna, former KI operations manager, and Mats Holmström, professor at the Ear, Nose and Throat clinic, wrote to Socialstyrelsen:

“It is thus important for the Karolinska Institutet and Karolinska University Hospital that he [Macchiarini] is formally given the opportunity to practice medicine in Sweden and that this application is approved.”

This article in Dagens Medicin indicates that follow-up requests for further and extended licence exceptions for Macchiarini’s surgical operations were also swiftly approved. Even in 2012 and 2013, when allegations of misconduct were long known, the clinic kept applying to Socialstyrelsen to grant Macchiarini new exceptions.

In fact, these exceptions requests to allow Macchiarini to operate patients in Sweden were made just as he was persecuted by Italian justice system for corruption and extortion of his patients in Florence.

In September 2012, Macchiarini was arrested by the Italian Guardia di Finanza, waiting for him in front of the operating theatre of the Careggi Hospital. The pioneer of tracheal transplant was recruited to this Florentine hospital in 2008 by the governor of Tuscany, Enrico Rossi, to lead a newly founded research centre. As the local newspaper Corriere Fiorentino reported, Macchiarini was accused at his arrest of attempted fraud, extortion and manipulating patient waiting lists. He was also said to have been abusing the desperate state of cancer patients in order to talk them into expensive private practice treatments, which included substantial fees for himself. In one case he specifically asked for €44,663 of which €25,000 were his personal honorary fee.  Macchiarini also was accused of having (unsuccessfully) attempted to sell two cancer patients special treatment in clinics in Hannover, Germany, and London, for a fee of €150,000 and €130,000, respectively. The Florentine hospital directorate defended Macchiarini in a statement:

“As an international prominent scientist Macchiarini has had the honour to publish his results in the prestigious journal The Lancet, and a few weeks ago he was presented in the New York Times as one of the leaders of regenerative medicine”.

There have been also enough warnings from Macchiarini’s peers to stop his dangerous experimenting on living patients.

Pierre Delaere is professor at KU Leuven, Belgium, and specialist in respiratory surgery. In May 2015 he told the Swedish TV channel SVT:

“If you are operating a synthetic trachea you know in advance that the patient will die. After a month, two months, three months, until up to two years, maybe three years at best. But the patient will die”.

Delaere described Macchiarini’s method as

“one of the biggest lies in medical history, because you are doing something that is impossible from a theoretical point of view and not grounded in medical trials. You do new things to people which are destined to fail, so for me this is a criminal act. This is medical torture”.

Yet all scientific and clinical criticisms of Delaere’s were dismissed in 2015 by KI Ethics Council, chaired by the KI professor of Healthcare Ethics, Niels Lynöe. Karolinksa’s medical ethicists apparently found Macchiarini more credible and qualified:

“We find that the issues raised by Professor Delaere are of a philosophy-of-science kind rather than of a research-ethical kind. Accordingly, the Ethics Council concludes that, on the backdrop of the examined issues, Professor Delaere’ s allegations of scientific misconduct are unfounded”.

KI Ethics Council was not only scoffing at such “philosophy-of-science” disagreements, but at the same time apparently dismissing or ignoring the concerns previously raised by some KI scientists about Macchiarini’s data integrity.

In 2014, three KI researchers, namely Matthias Corbascio, Oscar Simonson and Karl-Henrik Grinnemo, have submitted to the KI directorate an Appeal for Investigation. They now describe in an open letter to KI directorate how the evidence for Macchiarini’s misconduct and his endangerment of patient lives was known to the KI leadership since their Appeal in 2014. The three original KI researchers as well as graduate student Thomas Fux write:

“The handling of the investigation of Prof Macchiarini by KI has been a biased farce where because of moral paralysis yet another young patient with a benign diagnosis was operated in the summer of 2014 in Krasnodar, and subsequently also developed severe complications. This is several months after we had informed KI and years after others had submitted repeated warnings dating back to 2011. Up until our warning in February of 2014, several patients had died after horrific complications and mutilating procedures”. 

The whistle-blowers insist that Hamsten was already in 2014 well informed about Macchiarini’s misrepresentation of patient true conditions, namely them being “in stable clinical status”, and not at all as “threatened with eminent death or suffocation”, which might have justified untested experimental interventions.

“Prof Hamsten was informed personally in detail on Feb 21, 2014 by Dr Grinnemo of the state of the patients operated on at Karolinska and the gross and serial misrepresentation of their clinical outcome in the articles published by Prof Macchiarini. Prof Hamsten stated that Prof Macchiarini could continue to perform the procedures outside of Sweden, and that only his lab work would continue at Karolinska. At this time it was well known that the surgeries were taking place in Krasnodar, as it was clearly stated in the application for extension of Prof Macchiarini’s guest professorship written by Prof Felländer-Tsai (Head of CLINTEC) in October 2013 and signed by Prof Hamsten in January of 2014. Prof Hamsten was also informed that the rat trachea implantations that were performed by Dr Simonson after the patients had been operated in Stockholm demonstrated catastrophic results. Prof Hamsten then informed Dr Grinnemo that he would discuss these issues with Prof Lendahl (Head of StratRegen and WIRM, Secretary Noble Assembly) and Prof Cardell (Head of ENT), both Prof Macchiarini’s superiors at KI”.

The precise nature of Macchiarini’s data manipulations has not been made public yet, but there is already some PubPeer evidence of suspicious image duplications regarding his 2014 paper in Biomaterials on biocompatibility of his synthetic tracheas.

An internal investigation was set up at KI, led by Bengt Gerdin, professor at the Department of Surgical Sciences, Uppsala University.

Specifically, the suspicion of falsified data in a paper in Nature Communications was raised, where Macchiarini and his devoted acolyte Philipp Jungebluth claimed to have successfully transplanted a tissue-engineered oesophagus in animal experiments. This study would theoretically allow Macchiarini to extend his range of transplants from trachea to oesophagus in human patients, possibly using compassionate case exceptions.

The KI leadership, namely Vice-Chancellor and Rector Anders Hamsten, his Advisor and Chair of Steering Committee for the medical programme  Jan Carlstedt-Duke, and Dean of Research at KI, Hans-Gustaf Ljunggren, decreed in August 2015 that Macchiarini did not commit any misconduct, but was solely negligent. Worldwide media (here, New York Times and Science) then went on to report how Macchiarini was exonerated by the KI investigative commission. RetractionWatch invited Macchiarini to contribute a guest post.  There, Macchiarini decried being falsely accused, mentioned an “official request from Karolinska Institutet, informing them [RetractionWatch, -LS] of the police investigation now in progress into the leaking of the records” and proclaimed himself an “honest researcher, who wants to see all scientific misconduct eradicated” [abbreviated quote, please also note this text section was corrected -LS).

However, the investigator Gerdin did not at all see Macchiarini as innocent. Gerdin kindly provided me with a rough English translation of his recent article In the Swedish newspaper Dagens Nyheter:

“In May 2015 my statement of opinion was finalized. It showed that Paolo Macchiarini had committed scientific misconduct. Three months later, in August, KI […] chose to free him from all accusations, contrary to my judgment. This was done without showing that I was wrong on any single point”.

Gerdin continues in his newspaper article:

“the truth is that everything that was shown in the three SVT documentaries [summary and video excepts here, -LS] concerning the fraud itself, was found in the investigational material I got from KI more than a year ago. There can only be the interpretation that KI either still does not see that the errors I pointed out reflect research fraud, or that they are now trying to cover up that they have made a wrong decision in August 2015”.

Just as the original whistleblowers, Gerdin lists examples where Macchiarini falsified or misrepresented data on the transplant progress in patients, which the KI leaders chose to believe anyway. In regard to institutional responsibilities for tolerating or even covering up Macchiarini’s misconduct, Gerdin writes:

“Hamsten has already proven to have courage and bravery to admit that he had made an almost total miscalculation and had taken his personal decision based on that. Do the other two who gave him advice and thus are at least as responsible for the decision as him [Carlstedt-Duke and Ljunggren, -LS], have the same courage? As long as these two remain in senior positions, the “good KI” has to accept that it is difficult for anyone outside KI to regain trust and confidence in KI”.

Also Arvid Carlsson, Swedish winner of the 2009 Nobel Prize in Medicine, protested that results of Gerdin’s investigations were “completely swept under the carpet” and voiced his demands for resignations of the KI directorate. Just before Hamsten took his hat, Carlsson told Dagens Nyheter  that Lendahl’s resignation was not enough and that the entire direction of the Karolinska Institute should resign, as a kind of “housecleaning”:

“It should be radical and start from the top. We must ensure that these people no longer have any responsible position”.

Also the emeritus surgery professor Risberg demands in his open letter the mass resignation of the KI leaders responsible for the Macchiarini disaster:

“There must be a new crew in the top of both the Karolinska Institute and hospital. The old management and board of directors at the Institute and the management of the hospital have to leave. The sooner the better.

It is not enough that only the vice-chancellor (Anders Hamsten) left. He was not acting alone. 

These new leaderships have to start the crisis handling immediately”.

Meanwhile, the Swedish government announced that Karin Dahlman-Wright has been appointed as new acting rector to KI, while Hamsten was said to be assigned a new job at “government offices”.

The Royal Swedish Academy of Sciences expressed its desire to see Macchiarini’s and Jungebluth’s 2011 publication in The Lancet (where the clinical functionality of artificial trachea was allegedly demonstrated) retracted or at least corrected:

“The Academy finds it deeply unfortunate that the well-publicised report about the first operation with an artificial trachea, published in The Lancet in 2011, remains unchanged on the journal’s website. The Academy demands that a supplement is added to the journal, accounting for the further events, the complications and the patient’s death”.

To this, the journal’s editor-in-Chief Richard Horton replied in The Lancet editorial that Macchiarini is to be presumed “innocent until proven guilty”. He recalls that the Italian surgeon was already found not guilty once (by Hamsten & Co), and insists that the results of the new independent investigation must be awaited first. Horton (who is also one of the original founders of COPE) seems to take pity for Hamsten’s media-forced resignation and writes:

“Pre-emptive judgments about Macchiarini’s work would only worsen the reputation of science in the public sphere”.

Why did KI so obviously chose to cover up the misconduct of their star stem cell scientist and surgeon?

First of all, there were solid financial reasons to recruit Macchiarini. As Swedish government decided to concentrate research funding on selected elite universities, Karolinska and its Nobel connection was the prime choice. As the Nobelist Carlsson and his University of Gothenburg colleagues Elias Eriksson and Kristoffer Hellstrand write in the newspaper Dagens Nyheter, one of the prestige areas selected by Swedish Research Council was stem cell research, and for that KI received SEK 30 million (approx €3.2 Million) per year: “which among other things allowed the purchase of Macchiarini”. The grant was for five years initially, but could become permanent if with a favourable subsequent evaluation. Therefore, the Gothenburg scientists write:

“Given the amounts at stake, it is perhaps understandable that KI, when delivering in May 2014 their report on its stem cell research, could not resist the temptation to highlight Macchiarini’s supposedly successful transplants as number two in the list of important breakthroughs. This, despite that they knew that the operations had been stopped because the technology did not work, and despite having been warned that Macchiarini could have been guilty of research fraud”.

Delaere, the Belgian respiratory surgeon, has provided May 2015 in his SVT interview some clues why politicians, media, bureaucrats and even academics and scientists fell for Macchiarini’s grand promises (Delaere confirmed that he stands by this quote in his email to me):

“Because of the hype surrounding stem cells, many people believe in anything when the words “stem cells” turn up, that is what is misleading. It is also misleading that people who do this type of therapies know how to write a paper. They know how to mislead, and how to turn a non-issue to something that can even be published in The Lancet. It is so misleading. You can turn shit into promising research”.

The Author wishes to thank a Stockholm scientist who preferred not to be named, and Jill Howlin, as well as others, for their help in collecting this material. -LS

Update 22.02.2015, 20:40 Macchiarini is about to be sacked by Karolinska, according to Läkartidningen:

KI’s press secretary Claes Keisu confirms that Macchiarini is threatened with dismissal :

»Paolo Macchiarini has today been informed that KI is considering to fire him. The reason is that KI no longer have confidence in him as employee.

Also, the Dean of Research Hans-Gustaf Ljunggren has resigned. He was one of the key KI officials involved in Macchiarini’s acquittal after the misconduct investigation.

Update 26.02.2016, 13:30 The third KI leader, Jan Carlstedt-Duke, chief advisor to the Rector, and responsible for Macchiarini aquittal, has resigned as well (or has been sacked, by the new rector Karin Dahlman-Wright), according to Swedish media.

Update 03.03.2016. According to Dagens Medicin, Swedish minister for research and higher education, Helene Hellmark Knutsson, announced that “a number of members” of the Karolinska Institute’s Board of Directors (the Senate) will be replaced. Exactly who will be dismissed and who will be nominated as new Senate members, is to be decided by the special commission by April 1st. More in English on Radio Sweden:

Update 05.03.2016. The KI new Vice-Chancellor, Dahlman-Wright, issued a statement after her meeting with the Ethics Council. Her quote can be interpreted that the entire Council will be dismissed, and a new Ethics Council established (though members are allowed to re-apply):

“In association with appointing a new council, the present council members will be asked whether they are potentially available to serve in a future organization for ethical questions at KI”.

Update 11.05.2016. SVT reports suggest that  Li Felländer-Tsai, prefect and head of the Department of Clinical Science, Intervention and Technology (CLINTEC) is about to lose her position. Reason: she misled funders like the Swedish Research Council and the Heart-Lung-Foundation about the ethics status of Macchiarini’s research. His funding was extended despite that he received in October 2013  an operating ban at Karolinska Hospital, issued by the hospital director Birgir Jakobsson. 

94 thoughts on “Macchiarini and Karolinska: the biomedical ethics meltdown

  1. Macchiarini already had to retract a paper in 2012 for plagiarism:

    http://www.sciencedirect.com/science/article/pii/S000349751201315X
    Development and Validation of a New Outcome Score in Subglottic Stenosis
    Presented at the Forty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–Feb 1, 2012.
    Alessandro Gonfiotti, MD, Massimo Osvaldo Jaus, MD, Daniel Barale, MD, Silvia Baiguera, PhD, Leonardo Polizzi, MD, Philipp Jungebluth, MD, Matteo Paoletti, PhD, Massimo Pistolesi, MD, PhD, Paolo Macchiarini, MD, PhD, ⁎, paolo.macchiarini@ki.se

    “This article has been retracted at the request of the Editor-in-Chief.
    This article has been retracted for scientific misconduct for reproducing a table but failing to acknowledge and cite the previous, original work from which it was taken: Nouraei, S.A.R., Nouraei, S.M., Upile, T., Howard, D.J. and Sandhu, G.S. A proposed system for documenting the functional outcome of adult laryngotracheal stenosis. Clin. Otolaryngol., 32 (2007) 407–409, http://dx.doi.org/10.1111/j.1749-4486.2007.01474.x.”

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  2. Macchiarini still insists on his innocence. The scary part of this story is that he still has chances to continue his work in Russia. One of major Russian web news portals published interview with Macchiarini where he accuses everybody around of misconduct and unfair treatment, gives compliments to Russian medical system and describes his plans for research. He even mentioned some grant which allows him to continue research. At the same time, Kuban University issued press release in support of Macchiarini.

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  3. Correction: in the earlier version of my text I suspected that RetractionWatch was possibly pressured by Karolinska, which resulted in their publishing of Macchiarini’s guest post. This misunderstanding was created by Macchiarini’s own quote from the same guest post:
    http://retractionwatch.com/2015/10/09/where-i-think-retraction-watch-went-wrong-a-guest-post-from-paolo-macchiarini/

    “I wrote personally to Retraction Watch asking them to remove the medical records they published from their site. (They also received an official request from Karolinska Institutet, informing them of the police investigation now in progress into the leaking of the records.) In response they asked if I would write an article outlining my concerns. This article is the result of that request and now I ask once again”.

    This supposition is, according to Ivan Oransky, founder of RetractionWatch, not correct. He explained to me in an email:

    “Readers may wonder what else we did for KI, in the course of our covering the story. (Answer: Nothing.) To clear that up once and for all, I’m forwarding you email proof that we made the judgment ourselves. The idea for a guest post came from Alison McCook, in response to an email Macchiarini independently sent us presenting his objections to our coverage. That email, which I’ll forward under separate cover, is from September 2015. The letters we received from KI objecting to our publication of patient data, which I will also forward you under separate cover, came in December 2014, before Alison even came on board as an employee in early 2015.
    The two email exchanges are separated by nine months, and were entirely unrelated”.

    The emails were forwarded to me and I have corrected the main text accordingly.

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  4. I invite everyone to read this editorial at The Lancet from September 5th, 2015, and make their own conclusions.
    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00118-X/fulltext
    This is what Lancet’s Editor-in-Chief, Richard Horton, co-founder of COPE, has to say about the Gerdin investigation:

    “Although Karolinska has exonerated Macchiarini, the means by which it did so—a flawed initial inquiry completed by a single individual with widely disseminated, damaging, and mistaken findings—suggests that the university needs to review its procedures for investigating allegations of misconduct. Dragging the professional reputation of a scientist through the gutter of bad publicity before a final outcome of any investigation had been reached was indefensible”.

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    1. I wonder how R.Horton come to these conclusions. As a “single individual”, without any initial inquiry he judged 4 months work by independent expert. I doubt R.Horton had access to 4000 pages of investigation or even tried to read it.
      Unfortunately, the Macchiatini case is only very top of iceberg. There is well developed culture of publishing high level claims by top journals and hiding all negative evidence, refusing to publish comments and corrections. Once the fakes are published, only negligible percent of them is actually retracted even if proven to be fake or to be incorrect.
      The worst side of Macchiarini’s affair is that it demonstrated to all young scientists that fraud itself is not punishable. Assume that the case would be limited only to fraud in publications, no death of people involved = no interest from TV? Macchiarini would be safe to continue to fabricate more papers. He would become top official in some larger academic institutions.
      There always be some people who are ready to “improve” reality for the sake of career growth. They risk very little as it looks and have a lot to win. Once they win, they will be not interested in anyone who could expose their problems. So, it goes into a bad cycle.
      How many of known and famous professors become ones by the same methods as Macchiarini? Scary question….

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      1. Regarding misconduct cases where nobody died: you might be interested in my journalistic investigation of the Olivier Voinnet misconduct case, which I have been doing for over a year: https://forbetterscience.wordpress.com/2016/01/21/olivier-voinnet-case-correcting-the-uncorrectable/
        There, things also only moved once main media like Le Monde and Neue Züricher Zeitung (NZZ) picked up on this story, thanks to excellent science journalist-editors Herve Morin and Patrick Imhasly, respectively.

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    1. This pub peer comment line has now links to documents which prove that Lancet paper was used as an instrument to obtain permission for operations in Russia.

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    1. It is not that simple. The Macchiarini case is surprisingly little described in Russian media.
      Macchiarini was given a possibility to present his version of events (very peculiar) on major news portal without any presenetation of scadal:
      https://lenta.ru/articles/2016/02/11/macchiarini/

      At that moment this was basically the only information about scandal: version of Macchiarini and very little about accusations. Most of readers of his interview may actually belive that Macchiarini is kind of hero atatcked by concurrents (he presented it this way). Week ago REN TV channel aired 5 minutes news about Macchiarini, indeed calling him charalatain, and that is all. Few minor web sites replicated this news but once again all major mass media keep silence. None of major Russian mass media, TV and newspapers, showed anything on the case. There is no investigation of fraud, nothing at all. None of famous professors or any officials called for investigation either.
      There is only a local check of hospital where operations took place by regional controll organization which is far from real investigation. The check was already called “regular”. It looks like Macchiarini has very strong lobby in Russia which is not interested in making this story publi and there is no pressure from mass media.

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  5. Macchiarini’s research at Karolinska was funded by EU, until the funding was terminated:
    BIOTRACHEA
    Project reference: 280584
    Funded under: FP7-NMP
    Biomaterials for Tracheal Replacement in Age-related Cancer via a Humanly Engineered Airway
    From 2012-04-01 to 2017-03-31, Grant Agreement terminated
    Total cost: EUR 5 464 792
    EU contribution: EUR 3 999 300
    Coordinated in: Sweden
    Topic(s): NMP.2011.2.2-2 – Biomaterials for tissue engineering for age-related cancer and sensory organ diseases
    Call for proposal: FP7-NMP-2011-SMALL-5
    Funding scheme: CP-FP – Small or medium-scale focused research project
    http://cordis.europa.eu/project/rcn/103069_en.html

    Among other grant recipients were:
    HARVARD APPARATUS GMBH with EU contribution: EUR 289 200
    University Leipzig (likely Macchiarini’s partner and inventor of a now forgotten stem cell wound healing cream, Prof. Augustinus Bader), with EU contribution: EUR 181 680
    UNIVERSITY COLLEGE LONDON,(likely Alexander Seifalian, UCL Division of Surgery & Interventional Science – See more at: https://www.ucl.ac.uk/news/news-articles/1107/11070701#sthash.V5HmU1BF.dpuf), with EU contribution: EUR 695 800
    etc.

    And there was apparently also this funding, to develop a stem cell-seeded artificial lung, coordinated by Novalung GmbH
    http://www.ambulung.com/fileadmin/downloads/ambulung/2012-10-05_Press-release_AmbuLung_09-10-2012.pdf
    http://cordis.europa.eu/project/rcn/104053_en.html
    Ambulatory Bio-Artificial Lung
    From 2012-07-01 to 2015-06-30, closed project
    Total cost: EUR 7 416 968,34
    EU contribution: EUR 5 650 000
    Coordinated in: Germany
    Topic(s): HEALTH.2012.1.4-2 – Medical technology for transplantation and bioartificial organs
    Call for proposal: FP7-HEALTH-2012-INNOVATION-2
    Funding scheme: CP-FP – Small or medium-scale focused research project

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    1. I received this statement in reply to my questions on Macchiarini’s EU funding BIOTRACHEA, from an EU official, my questions precede quoted answers:

      Who were the natural persons applying and receiving the funds, as well as their relevant publications, submitted as justification for this funding proposal?>

      “The natural persons applying for and receiving funds from the EU at the time of original grant application are the named representatives of each member of the proposed consortium. During the FP7 Grant Award review process, all proposals are treated confidentially, therefore named representatives, as well as the list of relevant publications, and related information, data and documents submitted by applicants, cannot be disclosed. This is based on the Grant Manual and fully in line with the Financial Regulation/Rules of Application, which talks about submission systems securing security and confidentiality”.

      As for 280584 Biotrachea, please kindly inform me why and when the funding was terminated. Finally, is there any intention to demand back the dishonestly obtained funding, especially if the new investigation should make the misconduct by Macchiarini, his team and possibly also the company Harvard Apparatus GmbH official?

      “The project was suspended in 2014 due to difficulties related to important deliverables, and a formal request was made to rectify these circumstances within a period of sixty days. The Biotrachea consortium failed to honour this request to the satisfaction of the European Commission within the specified time period. Therefore the Commission decided to terminate the Grant Agreement from 4 May 2015, after the consortium had exercised its right of appeal.

      At no time did any EU funding for this project involve activities, tests or investigations with human subjects. The Commission services scrutinised every aspect of its work until termination – there has been no suggestion that EU funding was used for any purpose that has been harmful towards citizens.

      The procedure in the case of project termination is that the Commission requires reimbursement of all or part of the financial contribution made by its services, taking into account the nature and results of the work carried out and its usefulness in the context of the specific programme concerned. The legal basis for requiring reimbursement of all or part of the financial contribution made by its services in the event of termination is underlined in the FP7 Grant Agreement for the project (Article II.39 : “Financial contribution after termination and other termination consequences”, Annex II General Conditions). As part of the procedure, the consortium must prove that any non-recoverable funds constitute “eligible costs incurred and accepted up to the effective date of such termination and of any legitimate commitments taken prior to that date, which cannot be cancelled”.

      The Commission is proceeding with this procedure of requiring reimbursement of all or part of the financial contribution made by its services”.

      Like

      1. Thanks for posting the questions and for posting the formal responses.

        “The project was suspended in 2014 due to difficulties related to important deliverables, and a formal request was made to rectify these circumstances within a period of sixty days. The Biotrachea consortium failed to honour this request to the satisfaction of the European Commission within the specified time period.”
        .
        So the core problem was “difficulties related to important deliverables” and this was already apparent in 2014. Anyone with ideas abouts details of these ‘difficulties’ and with ideas about details of these ‘important deliverables’?

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      2. “At no time did any EU funding for this project involve activities, tests or investigations with human subjects. The Commission services scrutinised every aspect of its work until termination – there has been no suggestion that EU funding was used for any purpose that has been harmful towards citizens.”

        Lancet 2011 proof of concept study (patient 1) acknowledges funding from EU Commission; paper is Appendix 4
        http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-1-10.pdf

        What is EU Commission policy on misconduct, i.e. falsification in publication?

        KI physicians claim serial falsification in research: http://retractionwatch.com/wp-content/uploads/2014/12/Analysis-of-Clinical-Outcome-of-Synthetic-Tracheal-Transplantation.pdf

        papers 11, 12, and 13 all cite terminated grant; perhaps there are additional papers?
        http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-11-20-review-article.pdf

        External investigator finds misconduct: http://retractionwatch.com/wp-content/uploads/2015/05/Translation-investigation.doc

        What is EU Commission policy if falsified CV submitted in grant application?
        CV of Macchiarini ca. 2012: http://www.regmedgrant.com/files/CV_eng.pdf
        KI preliminary investigation of CV: https://internwebben.ki.se/en/ki-confirms-inaccuracies-cv

        Final post on this thread at PubPeer shows Lancet 2011 used to support Russian Megagrant
        https://pubpeer.com/publications/55F676FA8BAD7D7B631AB941F96B63

        What is EU Commission policy if awardee comes under judicial investigation for fraud?

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      3. Commission needs to better scrutinize information lest it create the appearance of a cover up – see how well that worked for KI:
        “The main objectives of the BIOtrachea programme are:

        Iterative improvement of the procedure and widening of our clinical experience with tracheal implantation.
        Tissue engineering and clinical methods development for airway regeneration using synthetic scaffolds.
        To scale-up airway engineering methods and develop Good Manufacturing Practice (GMP) procedures for commercial production.
        To develop airway tissue engineering as a model.”
        http://cordis.europa.eu/result/rcn/141304_en.html

        “widening of our clinical experience with tracheal implantation” harm citizens numbering 8.

        “Objective

        Age-related cancers, especially of the trachea, are neoplastic lesions that significantly impact upon the lives of thousands of European patients each year. Unfortunately, most present with inoperable lesions for which median survival is less than 12 months. Based on our previous clinically successful experiences with in vivo completely tissue engineered tracheal replacement in benign tracheal diseases, we recently applied this technology in 2 patients with otherwise inoperable primary tracheal cancers. The successful observed outcome confirms the unique opportunity to scale-up an effective therapeutic approach into a widely accessible clinical technology, which could enhance not only the quality of life but even cure otherwise untreatable patients. However, a limitation of our current technology is the time it takes to re-populate the decellularized trachea. This may prove critical in the case of cancer patients. Further, the size of the transplant is currently limited due to the fact that the transplanted tissue needs to be efficiently and rapidly vascularised to prevent necrosis in vivo. To surmount these limitations, we aim to: i) improve our current technique of in vivo tissue engineering human tracheae in a small number of patients and subsequently begin a formal clinical trial, ii) develop pharmacological approaches to activate endogenous stem cells, stimulate tissue regeneration and vascularisation in situ, iii) develop a synthetic tracheal scaffold using a novel nanocomposite polymer as alternatives to natural human scaffolds and iv) develop good medical practice manufacturing process for safe, efficient and cost effective commercial production. This research project is aimed to define a robust airway implantation technique assuring a better outcome for thousands of patients each year. Moreover, we aim to use these results as a starting point to develop clinical approaches that could improve the treatment of age-related cancers of other hollow organs.”

        http://cordis.europa.eu/project/rcn/103069_en.html

        “To surmount these limitations, we aim to: i) improve our current technique of in vivo tissue engineering human tracheae in a small number of patients and subsequently begin a formal clinical trial” – done: 6 dead, 1 maimed, 1 explanted so also maimed. Maybe unfair to Commission to count dead Russian and Canadian-Korean citizens?

        “iii) develop a synthetic tracheal scaffold using a novel nanocomposite polymer as alternatives to natural human scaffolds” – also achieved: novel nano-rubbish trachea lethal.

        Like

  6. The Macchiarini scandal grows even more bizarre, and unfortunately, it involves more unnecessary patient deaths.
    Scientists at the Sahlgrenska University Hospital of Gothenburg applied Macchiarini’s method of bioreactor-engineered trachea to operate on a 76-year old patient, without any medical necessity (he had asthma since childhood) The patient died 23 days later “due to cardiac arrest but with a patent, open, and stable tracheal transplant and intact anastomoses”.
    http://www.ncbi.nlm.nih.gov/pubmed/24004248
    It is far from certain that the death however was unrelated to the tracheal transplant, as authors claim. In fact, he died from an infection. The case is now being investigated, with the involvement of the original Macchiarini-investigator Bengt Gerdin (whom The Lancet has attempted to discredit in 2015):
    http://www.svd.se/efter-kiskandalen-operation-av-luftstrupe-utreds-i-goteborg
    http://www.dn.se/debatt/vetenskapsradets-friande-av-forskningsfusk-obegripligt/

    Now another, even more sinister twist:
    The paper’s last author, Suchitra Sumitran-Holgersson, used to work at Karolinksa Institutet had a paper retracted in May 2011 for data manipulation and was found guilty of misconduct in a large investigation by KI and University of Gothenburg: http://retractionwatch.com/2011/05/06/blood-retracts-two-including-a-disputed-paper-from-the-karolinska-institute/
    However, similar to Macchiarini later on, Sumitran-Holgersson was fully exonerated. The decision of the investigative commission was overruled without any further evidence or explanation by the Swedish Research Council (VR) and its Director-General Mille Millnert, who later on declared that the investigators “overstepped their mandate”: http://www.dn.se/debatt/vetenskapsradets-friande-av-forskningsfusk-obegripligt/
    Therefore, despite clear evidence of fraud obtained after a 1.5 year investigation, Sumitran-Holgersson was allowed to test Macchiarini’s experimental method on a patient who at no point was anywhere near a life-threatening condition.

    And it gets even more twisted:
    The investigators of Sumitran-Holgersson’s misconduct, Olle Kämpe and Lena Welsh, were threatened by a CEO of a company which heavily invested into her technology, approved by the FDA. The CEO threatened them both directly with legal consequences of “significant sums” in compensation, should his business suffer, if Sumitran-Holgersson were to be found guilty of misconduct. Yet this is not all. The said letter was forwarded to the investigators by the Swedish Research Council (VR), who made clear that they alone will be legally responsible for any compensation claims and that VR will offer them no legal protection whatsoever.
    http://www.sjukhuslakaren.se/svenska-staten-skyddar-inte-de-sakkunniga/

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    1. It is indeed bizarre. I remember this story with Sumitran-Holgersson, thanks for pointing out that she was the same person who made this operation. Already at that time it made me wondering why was she excused and the way how it happened was far from trivial. According to my memories , there was very strong pressure from mass media provided by some feministic activists. The case was turned up side down and depicted as a “men violence against women” and VR gave up to this pressure. It worth to look again into this story, it was very much publicised at the time in Swedish press.
      There were several cases in Sweden over last 10 years when whistleblowers accused professors of misiconduct. Few of them made it into news. None of senior staff was ever admitted to be guilty to my knowledge. Some stories were quite bizarre as well, e.g. when professors got away by blaming their postdocs or PhD students for all problems. The professors were by definition right and postdocs wrong, even if Professor took all credits for “discovery” when it was published. In one case, postdoc was not even asked for his version of events, it was enough for professor to tell that he is falsificator. Then the postdoc actually published letter in Swedish newspapers (expressen or aftonbladet?) pointing out that professor knew well about excluding some data and insisted on rapid publication. Several other facts provided by this guy also were pointing out serious misconduct by professor. No additional investigation followed. Like I wrote above- Macchiarini’s case is top of iceberg. The science is sinking in lies and nobody is charged to fight fraud. Nobody is even interested except few whistleblowers. It is not only Sweden, whole system is rotten.
      http://www.the-scientist.com/?articles.view/articleNo/24974/title/Science-retracts-major-Arabidopsis-paper/

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      1. Angry, is any assistance needed with the Ove Nilsson literature? Do you believe that the Nilsson literature may have issues with it? Seems like a case got forgotten over time. To understand the rot of the whole system, we have to break it down.

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      2. What? You recall that “there was very strong pressure from mass media provided by some feministic activists. The case was turned up side down and depicted as a ‘men violence against women’”.

        The fraud investigation on Suchitra Sumitran-Holgersson was punctured by the all-male, distinctly non-feministic team Elias Eriksson, professor of pharmacology, and Kristoffer Hellstrand, professor of virology, both from University of Gothenburg. The investigation was dismissed based on procedural flaws (e.g. failure to properly register e-mails regarding the case).

        The female Vice Chancellor of Gothenburg University, Pam Fredman, who had instituted a procedure to sack SSH was strongly criticized by two other non-feminist male professors Ola Stenqvist, professor of anaesthesilogy and Michael Olausson, professor of transplantation surgery, both at University of Gothenburg, who asked her to resign in a paper in the evening paper Expressen/GT. A third male professor, Börje Haraldsson, joined them in demanding the resign of our female Vice Chancellor.

        Where do you find the feminist plot?

        Agnes Wold
        Professor, University of Gothenburg

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      3. To Agnes Wold. Thanks for providing direct input from Gothenburg. I did not pictured whole story as feministic plot, but there was some journalist who wrote many aritcles on that subject, this was in my memory some kind of feministic activist. It was pointed out that first investigation which admitted Suchitra guilty was performed by male professors only (you also noted it here). Like it had some effect on investigation of female scientist. I can search for old articles if you doubt it.
        If you are aware of details of story: why did VR director canceled results of first investigation? What was the trigger? I think it was because of some publications in mass media to defend her but it could be something else before these publications, information from inside of Insitute would be very interesting to hear. The letter of these guys published in DN is cited above. They clearly can not understand why their investigation was completely dismissed. They cite some arhiving issues which VR controlled but not them. It looks like the issue of accusations was replaced there with technical details of protocols. Looking at these 9 papers now exposed on PubPeer, it seem to me that first investigation was much closer to reality than second which excused Suchitra Hilgersson completely. Was her research of so high quality to add her a lot of funding from VR immediately after excusing her? She is rather rapid to react to new accusations also, she actually responds to PubPeer posts and sends new data to journals. The same pattren as in the first investigation when experts were “bombarded” with lots of documents only to find that they were manipulated. The second investigation simply ignored these files and these manipulations, right? I do not pretend to know all details fo story, just trying to find it out and it looks like very complicated case with years of events and twists.

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      4. I’m happily surprised to find none other than the venerable A. Wold taking such an active stance against claims of “feministic activists”-nonsense!
        Sadly the prevailing sentiment among young men on the internet is that “feminazis”, as they are called, are nothing but power hungry men-haters who tries to push their agenda on the (I’m not joking here, sadly) discriminated men. Their proof of this is constructed by setting up straw-man arguments of misrepresented feminist values, and by pointing to a few crack-pot, self proclaimed “feminists” who actually hate men, but is as representative of the wider movement as an astrologist is to astronomy.

        You will find this all over the net, regrettably.

        /A Swedish guy ashamed of his generation

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    2. Here I post a link to documents which provide conclusion by ethics expert groupd from 2012. This was final document which describes history of the case and concludes re-evaluation which removed all accusations from Suchitra Sumitran-Holgersson against opinion of first investigation lasted for 1.5 years.

      http://farad.se/dokument/CEPNExpertgruppensYttrandeO1-2012.pdf

      There are some interesting points in this document.
      For example, Suchitra provided first expert group with lots of documents aimed to explain her problems and to show data which were under question. However, experts found some clear evidence of falsifications in these documents which was considered as an especially heavy evidence of fraud.
      How was it re-evaluated? Citing the document: ” …The same goes for accusations that Suchitra Holgersson attempted to mislead VR- group and their experts with help of false documents, the suspicion which can not be seen as related to research and, therefore, not investigated in this case”.

      Once again: cheating to VR experts is considered as not related to research and not worth to investigate in principle. Suchitra could send whatever data and documents and get away with it.

      One more interesting point is that new study have not considered “meaningful” to interview colleagues of Suchitra, partly because a lot of time has passed after the events. However, the group provided Suchitra with possibility to describe in details her excuses, to present them in written form and in interview.

      Experts also wrote that some of the manuscripts in question were not published and not going to be published. Well, students obviously succeded to stop false publications but that made their case weaker. Were they supposed to wait until false data are published? If the studies were all correct, why Suchitra have not published them?

      The story looks for me like that: students performed experiments and found that manuscripts include experiments which they did not make. Suchitra claims that she did these experiments additionally and secretly from her own students. Then it is very hard for students to prove that she didn’t. They know she did not as they spend their time in the lab while professor is writing manuscripts, but it is now their problem to provide evidence that professor did not make experiments. One obvious way to verify it is to ask for raw data. Professor provided these additional data but experts found some clear signs of fabrication, files were manipulated. Suchitra claims that someone else manipulated these files. New group of experts have not studied these additional data but admitted them as sufficient to remove all suspicions. Moreover, these data are “not related to research” in their opinion. Circle is closed. The data files are excluded from investigation. What remains?

      In absence of data files, the experts conclusion is that word stands against word. But word of Professor is heavier than words of three students obviously. For example, point 2 tells that student made one experiment but Suchitra provided table with three experiments and average value exactly the same as students single experiment.
      How is that explained? Suchitra tells that she had no reason to make up the table and it had to be the student himself who made it. Evil student makes up table and acuse professor of doing it.
      Point one- students tells that he made one experiment but when reviewers of paper asked for additional data, Suchitra submitted results of five experiments. How Suchitra explained it? She responds that students showed her…7 experiments and she considered two of them incorrect and kept only 5. This paper by Suchitra was actually retracted by 3 co-authors due to the absence of data which could confirm her version.

      One of the experts of first investigation, Olle Kämpe said in his interview: ” I was first time appointed as an expert and that will be the last one” …”never again and I advise others also to stay away “. They spent several years of time on this investigation and lost their fight. In a way they were exposed to the same problems as whistleblowers who started the case.

      Like

      1. You may be thinking of the journalist Sus Andersson, who aided Elias Eriksson and Kristoffer Hellstrand in dismissing the VR investigation.

        http://www.justitiemord.se/bristande_likabehandling_vid_vetenskapsradet_-_fallet_suchitra_holgersson.htm

        Does being a female journalist make her a feministic activists? Has she ever written anything like the Suchitra case representing “male violence against women”? I do not think so.

        The one who accused Suchitra Holgersson of fraud was a female researcher in her group, if I recall it correctly. There was also a married couple in the group who reported that she had committed scientific fraud. The ones who conducted the investigation were Lena Welsh (female) and Olle Kämpe.

        Yes, please find the papers from that period that show how the Suchitra Holgersson fraud case was a feminist consipiracy. I am eagerly waiting.

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      2. Agnes, I already made a search, found all articles of Sus Andersson and admitted that my memory was wrong, see my previous comment with links to Sus articles. It could be that I mixed up the case with something else.
        However, I found interesting this link which you provided, about two professors who eagerly supported Suchitra Holgersson and demanded rektors resignation. As someone who work in the same University, can you give us more information about what is happeneing there now?
        Now already ten papers with duplicate and even triplicate figures are questioned at PubPeer, some very obvious fraud is uncovered. How these two professors, Michael Olausson och Ola Stenqvist feel about their old role and react to new information? Are they demanding new investigation of fraud? Are they demanding rektor resigning? Is there any intention to start investigation in principle in Gotheborg? Do you, personally, think that that new inverstigation is needed? Don’t you think that pardoning of Holgersson was actually big failure of the system and resulted in more fraud? The evidence of misconduct was rather obvious already in 2012, at least one paper was retracted. Why VR awarded new 1.7 mls SEK to researcher with just retracted paper, big problems in own group and mess in datafiles (even if they considered her not guilty of fraud at the moment)?
        Let’s shift discussion to these real questions.
        For me it looks like as soon Holgersson got new money, she continued to produce fraudulent papers and was producing them even in process of investigation: some o fthe questioned papers are dated by 2012-2013.

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    3. https://pubpeer.com/publications/23486834
      This lady has now problems with duplicated figures in two papers, published on PubPeer. Even in this case she is rather rapidly responding and claim to correct “mistake” with editors. It is rather disturbing that this type of person has right to perform operations. All together 9 papers of this author have now comments in PubPeer, duplicated images are reported. No news about fraud investigation at her home institution? Good idea to make separate aritcle about her papers, may be this would trigger something.

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      1. This is clear fraud and she should be forced to leave the university. However, she has never done surgery. She is, to the best of my knowledge, not a MD. The surgeon is Michael Olausson. He is also on the paper.

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      2. Ok, thanks for correcting that point. I assumed that she made operations looking at the text by Leonid. Bu tit is not stated there that she did operations, only that she was working with bioreactor. Sorry for misunderstanding.

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      3. Apologies for the misunderstanding. Sumitran-Holgersson was certainly not operating herself, but as the last author of several clinical publications a key team member who was most probably directly involved into the preparations and the decision making of the surgery.

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      4. Again, you have a very naive input on the matter. If the investigation from VR was declared unprofessional this is the verdict. KI went on to CEPN who came to the same conclusions. After that KI used their own ethical board and declared that she was still guilty because no new info was at hand. Extremely difficult to accept

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      5. Welcome to Michael Olausson to the discussion. Hopefully we can clarify for us some questions from first hands. So far we only read newspapers.

        Question number one. Citing your comment “If the investigation from VR was declared unprofessional this is the verdict.”

        If the KI dumed first Macchiarini investigation by Bengt Gerdin to be wrong, is that final verdict? I think we have all reasons to doubt verdicts in Holgersson case in the light of new accusations published during several recent days at PubPeer.

        Question number 2. You read all old investigation and have not found there evidence of fraud. Otherwise, I guess you would not collaborate with Holgersson. Please make search at Pubpeer by the name of Suchitra Holgersson , find 10 papers with duplicated and triplicated figures revealed by anonymous peers. Does it change your view on Holgersson and old investigation results? Are we naive to consider these images as an evidence of fraud?

        I can note that only two types of fraud out of possible hundreds were ever used as hard evidence of cheating: duplicating the same figures and direct plagiat. Both are extremely stupid and expose simple laziness of cheater. Doing fraud in just little smarter ways is impossible to dicover and to prove. So, if the clear evidence is present , one can suspect a lot more cheating.

        Question 3. We only know what newspapers wrote and that what is written: that operation was performed using procedure similar to the one used by Macchiarini in 2008 and that permisison to perform operation can not be found in documents. It is written also that patient was not deadly sick. Heavy sick but not deadly.
        I assume that newspapers not always write truth and sometimes make mistakes but is my translation incorrect?
        http://www.dagensmedicin.se/artiklar/2016/02/29/darfor-vill-sahlgrenska-granska-transplantationen/
        http://www.dagensmedicin.se/artiklar/2016/02/29/sahlgrenska-granskar-transplantation/

        So, the question is : were there any other methods which could extend life of died patient, something more traditional and not experimental? Is it ethical to perform experimental operations on people even if they agree? When they agree, was their agreement based on publications of Macchiarini where he falsified all results and silenced negative effects? The newspapers claim that you actually cited Macchiarini’s papers in your own publication. Are you disturbed by the fact that these Macchiarini’s papers provided false evidence which likely affected decision to perform operation?

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    4. http://farad.se/article.php?rowId=208

      I made a search for old articles and found possible origin of VR retraction of Suchitra’s investigation.
      I shall admit that my memory was wrong- there is indeed nothing here on feministic issues, at least from this author.
      But this journalist, Sus Andersson had played major role. She wrote like 10 articles and scared VR director, basically forced not only cancel of this investigation but also forced VR to cancel punishment for fraud. Suchitra was not allowed to search funding from VR for next 10 years. Sus claimed it is not legal and this form of punishment was completely removed by decision of VR director. The link above gives her major argument: some documents were stored in VR archives under wrong dates. As experts pointed out- this was not their mistake but VR’s. The second point of Sus was that group of experts had no protocols of their meetings. That is all. Technical details which have nothing to do with arguments on Suchitra’s research and data manipulations. The VR director cancealed 1.5 years work of own experts based on publication of one journalist in relatively obscure media. That is the power of mass media.
      Though it feels like on that occasion it played on the side of fraudsters. Result was dramatic- Suchitra got away , freed from all accusations, given new 1.7 mln sek as a “cure” for her suffering and future fraudsters got much brigheter perspective- no bans from VR funding, experts scared to death to take on new missions and so on. The system of fraud investigations basically stopped to function. The way for Macchiarini was cleared.

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      1. I looked little close to this”Farad” web page http://farad.se/omfarad.php
        Now I realized that this was not mass media at all, it is project of one single person. It was started in december 2011 by Sus Andersson and immediately started writing about Suchitra Holgersson case, first article is from january 2012.. The journalist requested all posisble documents from VR and made extreme efforts to find anything wrong with this investigation. Sus Andersson was actually writing about few other things, but the case of Suchitra is main message of whole her project for two years. As soon as the case is finished, the whole Farad is frozen in 15/5/2013. Without Suchitra Holgersson Farad have not survived for more than half year. The reason for stop of project is said to be economical. The web site was finansed “only by announses income”. So, to generate scandalous articles was the only way to survive for the project. Holgersson case is named at the moment of project stop as top 3 stories of its existance. http://farad.se/article.php?rowId=299
        It is actually suprizing how quickly the director of VR give up in this case own experts and own investigation.
        Single journalist had basically ruined work of several experts, helped fraudster to get away and to continue with new fraud. The case resulted in dismissal of punishments for fraud for next several years. The system (possibly not perfect anyway) of fraud investigation was basically paralized. One can not excase of this thought: was the Suchitra Holgersson case the main reason why the Farad project was started in principle?

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      2. I am amazed by your efforts to find women to blame in this bizarre case (besides Suchitra Holgersson, of course). Now you imply that a female blog journalist is the sole cause of overturning VRs fraud investigation.

        Let us think really hard. Is it most likely that the VR changed their mind due to pressure from a) a female blog journalist or b) a couple of male influential medical university professors?

        For pieces of their correspondence with VR, see pp 128-132 in the link below.The link mainly deals with another fraud investigation at the KI, but contains copies of some documents regarding the Suchitra Holgersson fraud investigation:

        http://www.uppdatering-av-en-rattsskandal.se/uploaded/uppdatering_av__en_rattsskandal.pdf

        Regarding the overruling of the decision to withhold Holgerssons VR grants, the appeal to the administrative court was written by two of these male professors.

        http://medarbetarportalen.gu.se/News/gu-journal/arkiv/2011/nummer-5-11/-vr-har-svartat-ner-sveriges-rykte-som-forskarnation-

        Second very difficult question: Do you think that a journalist with (according to my knowledge) no prior interest in medical science or science politics, did this investigation all on her own? Or do you think that she was fed information from people with insight in the medical science world? Would it be possible that it was convenient to let a journalist be the front runner?

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      3. “Or do you think that she was fed information from people with insight in the medical science world? Would it be possible that it was convenient to let a journalist be the front runner?”

        Do you suggest that Suchitra had used help of Farad and Sus Andersson ? The “Farad” does look like project opened specially for this case…

        Once again I repeat my question to Agnes: how these two professors feel now and are they going to request new investigation? While we are discussing this case, the number of publications by Suchitra questioned on PubPeer increased from 9 to 12. All comments are about recycling the same images in different papers.
        Do you, personally, think that investigation must be started into this case?

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    5. I’m sorry to correct you. I read the whole documentation in the Holgersson case and obviously you did not. KI used the same techniques as in the Macchiarini case and Carlsted-Duke was the conductor

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      1. Hi Michael, I cannot read Swedish beyond Google translate and rely for my upcoming report on help from readers like “Angry”, Agnes and you. Please share what you know here, or contact me via the Impressum & Contact page

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      2. The Dean Dean of the Medical Faculty of has asked the Vice Chancellor of the University of Gothenburg to investigate the suspected fraudulent manipulation of images by the Suchitra Sumitran-Holgersson group.

        If you wonder how those who defended Suchitra Holgersson feel now, why don’t you ask them? It is just to send an e-mail.

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      3. To Agnes. Thank you for providing links to some documents from investigation. Like it was written before- it is 1000-th of pages, lots about conflicts between two groups of professors at KI and Gotheborg, references to hundreds of attachments and so on. Obviously, the cost of fraud in this case is mutliplied. Hundreds of hours spent only on reading documents by at least 10 professors an dmay be even more. Only director of VR spent 1000 hours on reading as he writes there. All on state salaries. All about few expriments which students claim they did not do but Holgersson claims they did. It had to be an easy issue to resolve.
        Somehow I feel mostly sorry for students. They come to University to do science. Instead they first observed data manipulations and then years of this paper exchanges, fights, bureaucratic mess and stresses. I know more than one talanted young researchers who dropped their careers in academia after going trough great disillusioning. Some of them actually cited data manupulations by their seniours , in other case continuous raws between co-authors over who made largest contributions, almost all cite people who become co-authors of their papers with zero or almost zero contributions.
        It is also now more clear to me that the re-ivestigation of VR investigation was initiated by new employers
        of Suchitra from Gotheborg. First of them was Michael Olausson. Now he is co-author of 7 papers with Suchitra out of 12 questioned on PubPeer. Type of ironical….

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    6. Hi Mr Schneider
      You spread false information which makes this site questionable. The patient transplanted acquired his problems 34 years previously after a trauma. The patient and the daughter wanted the procedure and the patient consented the procedure – he did not want live in the present conditions. He

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    7. I think you should read the paper from this case. It was published despite that The patient died. The new information was The resultat from The autopsy which shown a very good recellulirized trachea (Berg et al). The paper was difficult to publish due to the Macchiarini group was reviewing the paper. It was considered unethical to publish this case since it might destroy the whole field of tissue engineering. The paper is published now

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  7. There is no way this story will be re-investigated again, it was too long ago . “Small” ethical issues are not that important if researcher gives big money to University. In 2007 there was web page made by chinese guys describing this story in all details, it had no effect at all. Too long to describe it here.
    Why KI did not alarmed about Macchiarini and defended him for so long?
    Grants from EU which you listed above may be the answer. Now Universities care too much about who brings them money.
    I can give example of yet another old story from KI. The guy was sent off from his dean position but is still Professor at KI:
    http://sverigesradio.se/sida/artikel.aspx?programid=103&artikel=3480570
    The story gives rare window into the system: how the money are awarded. The only mistake this guy did was to write letters (which actually had effect of decisions) instead of more common way to wisper into right year. Everybody knows it.
    These guys supervise students and students learn a lot. Did you hear much about what happened to Jungebluth, the “like a son” of Macchiarini? He had all information, he is co-author of Lancet paper and so on. No news that he is under investigation?
    How would you break that system down by the way? Any ideas?

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  8. Hi MR/MRs Tired
    Why not read the documentation before you have opinions? The letter to the vice chancellor of GU mention no names. The anonymous letter to dean has resulted in a letter to the vice chancellor for investigation. Meanwhile the group look into the allegations and have sent errata to two journals. The raw data has been delivered to the dean and any investigation is welcomed. In two papers wrong pictures have been delivered but the same market is the target. No impact of the conclusions can be seen.

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    1. It’s ten, not two papers. The same figure show two (bone marrow cells and fetal hepatocytes), or even three (EPCAM-positive cells in nasal biopsy, fetal hepatocytes and SV40LT-HFT) different cell types. We are fortune to live in a civilized society so everyone is innocent until proven otherwise, so let’s wait for the external evaluation. However, stop pretending that these serious inaccuracies are trivial mistakes.

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  9. The letter does not any specific names since at least the two senior authors, Michael Olausson and Suchitra Sumitran-Holgersson, will be subjected to an investigation of scientific misconduct for obvious reasons.

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  10. It is worrisome to see the announcement on March 10 (http://www.wbjournal.com/article/20160310/NEWS01/160319991/hart-adds-to-board-as-it-moves-toward-new-human-trials) by HART that they are moving toward new human trials.
    This may be a reason why the company is removing older web pages that mention the implants by Macchiarini that failed. There was a video “Krasnodar Surgery” that featured him prominently. First one link disappeared, then the page “General videos” was removed, and now the whole page with media links is gone. There is no cache on Google because of their robots.txt.
    HART has a history of glossing over problems. In this article from January 2014, CEO David Green described the first patient Beyene as “alive and well”: http://www.rdmag.com/articles/2014/01/synthetic-solution-saves-lives
    Yes, Beyene was alive, but he died that same month. And he had not been well at all during the last year of his life.

    Now HART is collaborating with the Mayo clinic. I find it strange that there is so little interest for this case in the United States. An American died (Chris Lyles), a baby died in Peoria. Rachel Phillips and the rapper D.O.C. survived because they were not operated on by Macchiarini.

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  11. http://www.dn.se/nyheter/sverige/stjarnkirurgen-fran-fakta-till-fusk/
    P.Macchiarini become unemployed today, at least in Sweden. Newspapers describe whole story using this occasion. DN asked several involved persons for intereview. Some interesting details are described. For example, that KI was preparing to appoint Macchiarini as full professor in 2012 but stopped the procedure because of his arrest in Italy.
    Macchiarini “was searched for interview” .

    “Hade inte media visat upp detta så hade mörkläggningen kunnat fortsätta i det slutna systemet.” Translating this:
    “If it was not for media who showed it, the hiding (“shadowing”?) could continue in this closed system”.

    Power of free media proved to be decisive in this case. How many similar cases are still there and waiting for attention of media?

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  12. Macchiarini is back to Sweden and very active once again with several public statements and interviews. Basically it looks like a planned tactics: to wait until pressure fades and to fight back through mass media. He was on national TV in Sweden yesterday http://www.svtplay.se/klipp/8316487/macchiarini-karolinska-kande-till-allt (english)
    He also provided interview for Expressen, one of the major newspapers in Sweden.
    http://www.expressen.se/nyheter/paolo-macchiarini-karolinska-visste-allt/
    According this article, Macchiarini provided them with 7 pages long document where he presents his own version of events. He looks healthy, confident and , yes, I am afraid convincing for people not familiar with the whole story (if any left by now). He mentioned several times results of investigation in Russia about his operations, but results of this “investigation” are not available in any Rusian meadia. In fact, in contrast to what he claims, this was not “investigation” of his work but only a “regular check” of hospital where operations were performed. Results of thsi check can’t be found anywhere, not even clear if it was completed.

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    1. Planned yes but recall he has a court date in Florence on 10 May: http://corrierefiorentino.corriere.it/firenze/notizie/cronaca/16_aprile_05/macchiarini-chiede-l-abbreviato-raccontero-mia-verita-78cd9f2c-fb2e-11e5-b3ca-c061e4fe836a.shtml

      I can’t be certain but the proceeding may be a plea bargain. At any rate the TV interview suggests he’s been extensively prepared for legal questioning (deposition training), which isn’t crazy under the circumstances. His healthy tan, whether solar or chemical, effectively conceals facial flushing from emotional response – recall one of the interviews with Anders Hamsten in Experimenten where he turned beet red asserting KI had confidence in PM – definitely problematic.

      Like all persons he has the right to defense before the law but legal assistance will not change who he is or what he did.

      As for Vanity Fair, the accuracy of his CV is not a private matter nor is the wedding to which public persons were invited. You wonder who else was invited: perhaps Christopher Lyles’ mom and sister? Darryl and Mi-Young, Hannah Warren’s parents?

      The trial in Krasnodar needs to be audited for compliance with Good Clinical Practices. Among other things it should be determined why the Kuban State Medical University ethics committee did not require revision of the consent form when it approved changes to the protocol (composition of trachea scaffold to make it “better”): http://www.regmedgrant.com/files/protocol11.pdf

      Likewise subject selection, hospital database per protocol vs. international video conference: http://www.regmedgrant.com/files/report_videoconf_eng.pdf

      Then of course there is the egregious action of allowing the manufacturer’s representative (David Green) to meet with a subject and provide false misleading information about the safety of the investigational synthetic trachea, which hopelessly tainted the process of informed consent.

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  13. I would be interested to know what the American FDA has to say about an American company whose CEO was directly involved in personally convincing at least one of Macchiarini’s victims to participate in his experiments, as it was recorded on camera with audio in the above mentioned broadcast on Swedish television. I also wonder what they would say about this company being involved right now with clinical trials with the Mayo Clinic in the US. HART / Harvard Apparatus Regenerative Tech has been recently renamed Biostage.

    There are right now people posting on American investment message boards with excitement about this Biostage company. For example Spencer Osborne wrote “Is Biostage Setting The Stage For Regenerative Technology?”, dated May 9 2016 – http://seekingalpha.com/article/3973205-biostage-setting-stage-regenerative-technology

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  14. At first I felt a bit sorry for him, but after watching a documentary by the BBC, it came across like he was more bothered about the money and fame than the victims. I could have forgiven him if he had stopped the moment problems arouse, but to know it’s not working and just carryon, avoiding to be There for the first ones when it’s going wrong makes it far from involuntary manslaughter and more murder. Shocking

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