Karolinska requests retraction of Macchiarini and Jungebluth papers

Karolinska requests retraction of Macchiarini and Jungebluth papers

Today the Swedish Karolinska Institutet (KI) will announce its decision about 6 papers of their former professor and surgeon, Paolo Macchiarini. This article will be updated accordingly. Update 14:00: a decision was published, all 6 papers are to be retracted, 7 scientists found guilty of misconduct.

The background: On 30 October 2017, Swedish Central Ethics Review Board (CEPN) requested that 6 publications by Macchiarini and co-authors, all authored while at KI, are to be retracted, in a press release and a statement I received, in English original. The decision was based on the expert review by Martin Björck, professor of surgery at University of Uppsala, and Detlev Ganten, professor emeritus of pharmacology and former CEO of the Charité university hospital in Berlin, Germany, their report is available here on my site. The two experts found Macchiarini and his former acolyte and right-hand man Philipp Jungebluth guilty of breaching the Nuremberg Code of 1947 and Helsinki declaration, which forbid unethical and dangerous medical research on humans. One of those papers set for retraction is Jungebluth et al Lancet 2011, where a patient from Iceland was tricked to subject himself to a deadly experiment with a never before tested plastic trachea (that issue lead to a major investigation in Iceland and now is even about to be addressed by the Icelandic parliament).

Judging from last week’s email by Jungebluth to KI which I quote below, a call for retraction is expected.

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Karolinska gets taught German medical ethics

Karolinska gets taught German medical ethics

A most bizarre thing happened. In the aftermath of the scandal around the thoracic surgeon and regenerative medicine enthusiast Paolo Macchiarini, which left many patients dead, his former employer Karolinska Institutet (KI) in Stockholm, Sweden, requested a retraction of one of his papers. It was not about a trachea transplant, but about unethical and painful medical experiments on a dying patient (actually, two of them). KI’s decision to request a retraction of the paper Jungebluth et al, “Autologous peripheral blood mononuclear cells as treatment in refractory acute respiratory distress syndrome”, Respiration, 2015 was based on the investigation commissioned by Swedish Central Ethics Review Board (CEPN). The Swiss-German and family-owned medical publisher Karger and its journal Respiration however categorically refused to retract the paper and ordered KI not “to patronize the readers of the journal ‘Respiration’.

It gets much worse. The German Editor-in-Chief of this journal has a huge conflict of interest. It is better you just read on, because if I try to summarize it here, I might get sued by Macchiarini’s German friends and associates once again, and next time it might even be prison for me. In Germany, doctors have a very special status. Journalists or even patients do not, as I learned in court.

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No good news, instead a major disaster in appeal court re: Macchiarini affair

The German justice has spoken on trachea transplants again, in the appeal hearing at Kammergericht Berlin, and found the problem to lie with the journalists and press freedom. Good news first: I might have won the first injunction case against Philipp Jungebluth, or at least in large part, so I will probably get most of my money refunded there (Update 30.05.2018: the court tricked me and rejected my appeal on that injunction too. It remains valid to 1/3 just as before, see below). This only happened because the judges regarded how exactly Jungebluth left his job in Heidelberg being a minor enough issue (they did advice him to sue a Swedish newspaper for interviewing him about his sacking in Sweden (sic!)). This money I then will pay back to Paolo Macchiarini‘s acolyte and the court, and much, much more on top, because the three appeal court judges announced to uphold the second injunction in full. These are their oral arguments from yesterday summarised: Continue reading “No good news, instead a major disaster in appeal court re: Macchiarini affair”

Macchiarini victim’s family sues trachea makers for wrongful death

Macchiarini victim’s family sues trachea makers for wrongful death

Yesim Cetir was a young woman from Turkey, whose vulnerability the scandal surgeon used to test his plastic trachea (twice), a third such operation he performed at the hospital of the Karolinska Institutet in Sweden, and his fifth plastic trachea recipient. Like almost all the at least 17 patients whom Paolo Macchiarini experimented upon with either cadaveric or plastic trachea, Yesim died. Her suffering was long and horrible, her father Hayrullah Cetir dedicated all his waking hours to caring for his daughter. He died himself soon after her, from a neglected cancer.

Since April 2017, Yesim’s family (or in US legalese, the Estate of Yasim Cetir) is suing the company Harvard Bioscience, which spin-off Biostage (in turn formerly known as Harvard Apparatus) produced the bioreactors and the second plastic trachea graft used by Macchiarini on Yesim. Also the manufacturer of her first plastic trachea, Nanofiber Solutions, is being sued at the Suffolk County Superior Court in Massachusetts, USA, case number 1784CV01174. An article in Boston Business Journal indicated that even Macchiarini himself might be subject to the wrongful death lawsuit:

“Now, the estate of one of the deceased patients is pursuing wrongful death claims against both Biostage and Macchiarini”

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Los secretos de Macchiarini en Barcelona

Los secretos de Macchiarini en Barcelona

English version below.

El 12 de junio de 2008, el cirujano torácico y entusiasta de la medicina regenerativa Paolo Macchiarini operó a su paciente Claudia Castillo en el Hospital Clínic de Barcelona. La paciente recibió parte de una tráquea de un cadáver. El injerto fue despojado de todas sus células mediante un proceso llamado descelurización, y luego fue incubado dentro del llamado biorreactor junto con muestras de células de médula ósea y epitelio de las vías respiratorias de Claudia recogidas previamente, las cuales se esperaba que regeneraran el injerto muerto y lo hicieran cobrar vida, para convertirse en parte de su organismo. Esto desencadenó lo que hasta hace poco era una historia de éxito de hasta 19 trasplantes de tráquea artificial realizados por Macchiarini, ahora considerado por algunos como uno de los mayores crímenes en la historia reciente de la medicina.

A pesar del bombo de publicitario, Claudia no recibió un trasplante de tráquea. Tan sólo una parte de su bronquio izquierdo fue reemplazada, se la retiró un segmento delimitado de 2,75 centímetros de longitud debido a una infección tuberculosa y se le reemplazó con un injerto descelurizado. El trasplante tampoco resulto un éxito. La razón por la que Macchiarini reemplazo el bronquio de Claudia con un fragmento de la tráquea de cadáver fue que Claudia no tomó correctamente los dilatadores metálicos que dilataban las vías respiratorias. Justo medio año después, su injerto reblandeció y necesitó mantenerse constantemente abierto con una cánula. Después de que Macchiarini terminara de publicitar ese supuesto éxito en dos artículos The Lancet (Macchiarini et al 2008 y Gonfiotti et al 2014), en julio de 2016 el pulmón izquierdo de Claudia fue amputado junto con el injerto podrido, con el fin de salvar su vida. Actualmente está viva pero no gracias al trasplante de tráquea de Macchiarini sino más bien a pesar de él. Si el milagroso cirujano hubiera reemplazado su tráquea en vez de uno de sus bronquios, la paciente muy probablemente habría muerto, ahogada por el colapsado del injerto, tal y como ocurrió en la mayoría de los receptores de tráqueas de cadáver que Macchiarini trató después de Claudia. De hecho, esto es exactamente lo que sucedió en 2009, cuando Macchiarini operó a otro paciente barcelonés suyo, en otro hospital de Barcelona, ​​el Institut Dexeus, y sin ni siquiera intentar obtener ningún permiso ético. En Barcelona, al menos dos pacientes más estaban esperando para recibir un trasplantae, pero Hospital Clinic denegó el permiso y se deshizo de Macchiarini. El cual, en enero de 2010, fue a Florencia, Italia, y trasplantó allí a otros 5 pacientes con injertos de tráquea de cadáver durante ese mismo año. Todos murieron. Continue reading “Los secretos de Macchiarini en Barcelona”

Expert witness Macchiarini to help Berlin court sentence criminal journalist

Expert witness Macchiarini to help Berlin court sentence criminal journalist

The stem cell pioneering surgeon Paolo Macchiarini is back in court now. No, he is not the accused this time. He is an unbiased, independent expert witness invited by his student and acolyte Philipp Jungebluth to help him sue me in Berlin. There are two court injunctions against me, one was already partially lifted, while another was upheld in full, and the main issue are Macchiarini’s trachea transplants in Italy described in an unpublished manuscript. I cannot say much more without facing a €250,000 fine or a 6 months prison term.

Macchiarini recently saw the Swedish state prosecutor drop charges against him because another misconduct-tainted Swedish trachea transplanter, Michael Olausson, served as secret expert for prosecution. At least, no journalists faced court sentencing in Sweden for exposing trachea transplant scandals. It is different in Germany, where constitutional press freedom counts little if someone doesn’t like your reporting, which is why medical scandals in Germany are so rare. The ruinous court trials Macchiarini-associates Jungebluth and Heike & Thorsten Walles imposed on me seem to have scared German media into near-complete silence on the trachea transplant affair. What about the central role of Germany, especially Macchiarini’s and Jungebluth’s university Hannover Medical School (MHH) and their recent cover up of the trachea transplants? Definitely no public interest there, even if Macchiarini’s only remaining (adjunct) professor title was bestowed by MHH. My appeal hearing for both Jungebluth injunctions is at the Berlin Kammergericht court on May 24th. It is public, feel free to come. Maybe even Prof Macchiarini pops in?

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Jungebluth injunction hearing, another court travesty

Yesterday, November 23rd 2017, I travelled 600 km to Berlin to stand my second injunction trial, instigated by Philipp Jungebluth, former student and acolyte of the scandal surgeon. The first injunction was achieved by Jungebluth based on his claim to be world-famous, renowned researcher and clinician, who helped save the lives of patients like Andemariam Beyene and Hannah Warren with plastic tracheas and published about this in The Lancet (a paper which is now up for retraction due to his and Macchiarini’s proven misconduct). The second injunction was pushed against my article about an unpublished manuscript of Macchiarini’s and Jungebluth’s, from which I have quoted and interpreted with reference to the quotes. That injunction was founded now on the opposite: Jungebluth denies to have had anything at all to do with any of Macchiarini’s trachea transplants, aside of a very general academic, but never ever any clinical, contribution.

The hearing yesterday was a proper farce. It began with the judge asking Jungebluth’s lawyer why he didn’t forbid me to say his client had anything at all to do with Claudia Castillo’s transplant as well (read more here, also about Jungebluth’s role). The court and indicated it would be more than happy to oblige Jungebluth and his lawyer if they were interested. Soon it became rather obvious that the main judge and his two colleagues have never read my English-language article before passing the injunction against it, that they are more confident in their knowledge of English language than they should be, and that they have no understanding whatsoever on the practices of how a biomedical research paper is written. Yet they believe that their power position allows them to make such decisions and disperse punishments nevertheless.

The main issue was the authors’ contributions statement “P.J. assisted in clinical transplantations and preclinical experiments and helped to write the report” which went with the unpublished manuscript describing 9 cadaveric trachea transplants in human patients and some rat experiments. Jungebluth and his lawyer never denied the existence of that manuscript or my quotes from it. But now guess how the judges understood the statement “P.J. assisted in clinical transplantations“?

Continue reading “Jungebluth injunction hearing, another court travesty”