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”
Bad news for regenerative medicine enthusiasts, the data manipulating biologist Suchitra Sumitran-Holgersson and her surgeon partner Michael Olausson, both professors at the University of Gothenburg (GU) in Sweden. They were previously found guilty of breach of medical ethics and patient abuse for their experiments with “regenerated” decellurised veins, which incidentally serve as basis for an EU-funded clinical trial currently prepared by the Gothenburg-based company VeriGraft (founded by Sumitran-Holgersson and her husband Jan Holgersson, also a GU professor, read here). There was even a trachea transplant: that patient died very soon after, the paper later retracted for data manipulation and absent ethics vote. It was a decellurised cadaveric graft by method very similar to that of Paolo Macchiarini. Another tracheal graft was prepared for one of Macchiarini’s patients at Karolinska Institutet (KI) after her plastic trachea failed, but it was sent back unused. Because of such expertise in misconduct and medical ethics breach, Olausson and his GU colleague Hasse Ejnell served as experts who helped Swedish prosecutor drop manslaughter charges against Macchiarini (read all that here).
Now that Sumitran-Holgersson’s research funding was withdrawn, with the new decision by the Expert Group at the Swedish Central Ethical Review Board (CEPN) she becomes even more of a liability for GU: eight out of her ten analysed papers with Olausson are set for retraction, due to data manipulation by the corresponding author Sumitran-Holgersson (while all her co-authors were made co-responsible to various degrees). I reported the evidence before, on my site, after my readers notified me and posted it on PubPeer. The 2012 paper in The Lancet describing a regenerated vein transplant was however not earmarked for retraction, despite that among other things it contained a fake ethics vote (see my earlier reporting), which the journal The Lancet couldn’t care less about.
The original misconduct report was written for GU in September 2017 by the external investigator Ole Didrik Laerum, medicine professor at University of Bergen in Norway, who was appointed exactly one year before that. Sumitran-Holgersson didn’t like his results and demanded from CEPN a revision by the Expert Group on Research Misconduct, in which she was supported by her GU colleague Kristoffer Hellstrand. This now proved to be her big mistake, because what Sumitran-Holgersson et al got now, was findings of research misconduct and instructions for retractions. The Swedish original of CEPN Expert Group report is available here, (Update 21.03.2018: English version here), these are its findings: Continue reading “Sumitran-Holgersson and Olausson to retract 8 papers for research misconduct”
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?
Continue reading “Expert witness Macchiarini to help Berlin court sentence criminal journalist”
The European Union Commission staunchly refuses to tell me what exactly their funded scientists intend to do to the scheduled 48 trachea transplant patients under the Horizon 2020-financed phase 2 clinical trial TETRA. By now the highest authority, the European Ombudsman, is engaged, and still EU Commission does not bulge. The general technology of TETRA and its indefinitely suspended phase 1 UK predecessor Inspire is however known: cadaveric tracheas from dead donors will be collected, decellurised to remove all the host cellular tissue, and then subjected to the magic of recellurisation in bioreactors, where bone marrow and epithelial cells will turn a dead carcass into a living organ, ready for transplant.
The cadaveric grafts must either to be obtained very fresh (a nightmare of impracticability), or kept frozen before they are needed, otherwise they will rot. Leanne Partington, a PhD student of the UCL trachea makers Mark Lowdell and Martin Birchall, investigated in her 2014 PhD thesis the effect of this freeze-thaw step on the decellurisation process (it proved to increase efficiency) but also on the graft stability, as measured by compression tests. This is where it turned out that the defrosted grafts lost roughly half of their mechanical stability. Which means they would collapse immediately when implanted into patient, which was indeed exactly what happened. Yet UCL and EU Commission want to keep trying, and according to the patented technology by the trial sponsor Videregen, defrosted tracheas are to be used. Which by EU business-oriented logic suggests, the patented technology from the freezer is to be used in TETRA.
The two experiments UCL performed on the patients Ciaran Lynch and Shauna Davison in 2010 and 2012, respectively (read here), used defrosted tracheas. Both trachea grafts collapsed right away, only that Birchall and his partners decided to omit this critical information about Ciaran’s trachea in their Elliott et al Lancet 2012 paper, while telling untruths about Shauna’s fate. The UCL trachea transplanters until very recently either forgot about Shauna’s existence, or pretended her new trachea functioned great up to her allegedly unrelated death just two weeks after the transplant. Continue reading “UCL’s decellurised tracheas: strong and stable?”
The Science and Technology Committee of the British House of Commons is now dealing with the trachea transplants performed by the scandal surgeon Paolo Macchiarini and his former parter at UCL, Martin Birchall as part of its inquiry into Research Integrity. Two UK scientists from Liverpool initiated this with their written submission from November 21st 2017 which I previously re-published: Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit, and Raphael Lévy, senior lecturer in nanotechnology. Their concerns were not just the past trachea transplants, but also the present clinical trials with bioengineered trachea and larynx which UCL is most keen to start with, following the recommendation of an investigative commission from last year. UCL’s problem is however, that the two phase 1 UK trials are suspended by the UK authorities, and the big phase 2 EU-sponsored trial cannot begin recruiting patients without the results from phase 1.
By now it looks like UCL and their laryngology professor Birchall are in a pickle. Their own reply to the letter by Murray and Levy was not really honest when describing past UCL trachea transplant patients to the Parliament committee. On top of it, it turned out Birchall was reusing data from same old experiments on 16 pigs across different publications which were meant to show separate studies. This, and many more inconsistencies of UCL’s reply to the House of Commons are addressed in the re-published new letter by Murray and Levy from January 30th 2018 below. Continue reading “Trachea transplanters: Round 2 at UK Parliament”
This is a story uncovered and researched with the tremendous help of Swedish investigative journalist, Sophia Tibblin. A Swedish start-up company, fed with generous funding from Swedish state, now received €2.2 Million from the European Union, to further develop the same regenerative medicine technology which was determined in two investigations to be tainted by research misconduct and patient abuse by the founder of this very company: Suchitra Sumitran-Holgersson. A clinical trial is scheduled based on debunked science of recellurising dead blood vessel grafts, to continue where 3 previous child patients were used as human Guinea pigs .
This might remind you of another ongoing Horizon 2020 clinical trial, where a similar decell-recell technology of the trachea transplanter Paolo Macchiarini is being prepared for mass-use in patients. There, EU refused to share any information. Also in the case of Sumitran-Holgersson and her company, all EU commission members and even press speakers I approached refused any communication.
Much credit for research behind this post goes to Sophia Tibblin.
Continue reading “Indestructible Sumitran-Holgersson: Commit misconduct on patients, get EU funding to continue”
The esteemed London university UCL seems to live in its own world. There, the regenerative medicine magic thrives, living organs miraculously grow in labs, while stem cell-made trachea transplants proved a blessing for humanity, despite the negative vibes from UCL’s former honorary professor Paolo Macchiarini. UCL’s own laryngology professor and regenerative medicine enthusiast Martin Birchall cured several patients already, and it is imperative that he is allowed to save more lives with his tracheas and voiceboxes, regenerated from dead decellurised carcasses using patient’s own bone marrow cells. Scientific evidence and research integrity are nothing but cumbersome bureaucracy, which restrain the genius of Birchall, whose educated guess alone should suffice as solid proof.
This is basically how UCL replied to the to request from the Science and Technology Committee of the British House of Commons, following a critique of Birchall’s trachea transplants submitted as RES0022 on November 21st 2017 by the Liverpool scientists Patricia Murray and Raphael Lévy. The undated UCL reply appeared online around the New Year and is a staunch defence of Birchall’s endeavours, while calling the two Liverpool researchers “emotive” and dismissing the evidence on my site as inaccurate. It is authored by UCL Registrar Wendy Appleby, who incidentally was now appointed by UCL to investigate Birchall’s data re-use, where he apparently resurrected long-dead pigs twice, by turning some ancient animal experiment data with regenerated larynx into two fresh and very distinct studies.
The biggest inaccuracy, or barefaced lie (as you prefer), is UCL’s pretence that they had nothing at all to do with a certain lethal transplant of a cadeveric trachea, performed by Macchiarini on July 13th 2010 in Italy on the young British patient Keziah Shorten. I have been protesting to UCL Hospital (UCLH) and the British information authorities for a whole year against the refusal of UCLH to release the information about their involvement into that trachea transplant, and eventually UCLH was forced to reply to me. Even then they only admitted what I already knew, and now they hide this information from the UK Parliament inquiry. I will share it here then. Continue reading “UCL fibs Parliament about trachea transplants”