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”→
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?
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 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”→
This is an Open Letter I sent today by email to the Italian Senate and its Health Committee, appealing for an investigation into the trachea transplants of the scandal surgeon Paolo Macchiarini.
It is published below bilingually, in Italian and in English. After the earlier Open Letter by Prof Rafael Cantera was signed by over 220 academics and thus led the University of Würzburg in Germany to investigate the trachea transplants of Macchiarini’s former colleagues, Heike and Thorsten Walles, I invite now
all Italian clinicians and researchers, in Italy and abroad, as well as their international colleagues working in Italy, to sign this letter in the comment section below. Please use your full affiliation.
The signed Open Letter will be then forwarded to both chambers of Italian parliament and other state authorities.
Appello per un’inchiesta sui trapianti di trachea eseguiti a Firenze da Paolo Macchiarini
Gentili Senatrici, Egregi Senatori membri della 12ª Commissione permanente Igiene e sanità,
questo appello è indirizzato a Voi affinché vogliate considerare l’opportunità di investigare uno dei più gravi casi internazionali di abuso ai danni di pazienti, che è avvenuto e si sta ancora oggi verificando, in grandissima parte anche in Italia.
Chi vi scrive è un giornalista scientifico indipendente, il cui sito web (in lingua inglese) è diventato la più completa fonte di informazioni oggi disponibile a livello globale sul caso di Paolo Macchiarini e della sua “medicina rigenerativa”.
Here I republish the written evidence submitted to by two UK scientists to the Science and Technology Committee of the British House of Commons and its inquiry into Research Integrity, as originally published on November 21st 2017. It deals with the trachea transplants performed by the surgeons Paolo Macchiarini and his former parter at UCL, Martin Birchall. The report’s lead author is Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit. She generously invited me in May 2017 to give a seminar at her department at the University of Liverpool on this topic. Her coauthor is Raphael Lévy, senior lecturer in nanotechnology and imaging at the same university. I wrote about his reproducibility studies on the topic of nanoparticles in this article.
UCL recently investigated Birchall’s past trachea transplants, and recommended to continue with his two current clinical trials to transplant cadaveric decellurised trachea and larynx, regenerated with bone marrow cells, as I reported here. For some reason, UCL Registrar Wendy Appleby, when speaking as witness on November 21st in front of the Parliament Inqury, found herself unable to answer the rather straightforward question whether the UCL investigative commission advised to continue transplanting trachea or not (watch here, from 11:50 on). Appleby and her UCL were instructed by the Inquiry to address the concerns by Murray and Levy in writing.
Both clinical trials Inspire and RegenVox were already placed by the supervising authorities on hold, Murray and Levy now call to stop the dangerous and science-unsupported experimenting on misinformed human patients and to return back to the lab.
This article reports the results of an investigation performed in Iceland by the Landspítali University Hospital, concerning the scandal surgeon Paolo Macchiarini and his past host, the Karolinska Institutet (KI) and their University Hospital. The Iceland resident Andemariam Teklesenbet Beyene was the first ever person, or in fact a living being, to receive a plastic trachea. He was 39 at that time and died two and a half years later, slowly suffocating on the collapsing and rotting plastic graft, with Macchiarini still claiming that the patient had originally no more than 6 months left to live and that his plastic trachea transplant had his life significantly extended. The investigation shows that this was not truth. A palliative laser debulking surgery was denied to Beyene, while Macchiarini and his KI decided in advance to use the unsuspecting patient for their plastic trachea experiment, and even skipped the necessary medical examinations to achieve their goal. No ethics approvals were sought, Macchiarini simply lied about those. Beyene went to KI to be examined, clueless of what awaited him, and just 2 days later, instead of returning home to discuss the therapy options, he signed his own death sentence.
The Erithrean patient was working on his PhD in Iceland, where he was diagnosed with a slow growing form of tracheal cancer, which obstructed his airways. The surgeon Tomas Gudbjartsson operated Beyene in 2009, when he removed part of the tumour. After Beyene developed breathing difficulties again, Gudbjartsson referred him to Macchiarini and KI, to discuss treatment options. Yet the Icelandic surgeon was informed in advance that Macchiarini decided to transplant Beyene with a plastic trachea. He even helped Macchiarini remove the therapeutic option of laser debulking from the patient’s assessment. Afterwards, Gudbjartsson travelled to Stockholm to join the trachea transplant operation on Beyene. Even when during the operation the tumour proved to be much smaller than diagnosed by Macchiarini, the native trachea was removed and replaced with the deadly plastic contraption.
After the operation, Macchiarini and KI stopped caring for the patient Beyene, except of using him as material source for their publication in the elite journal The Lancet (Jungebluth et al, 2011). The first author of this lies- and misconduct-tainted masterpiece, which retraction was now requested by a Swedish Ethics Board investigation, is the German doctor Philipp Jungebluth, a student and acolyte of Macchiarini. Jungebluth is suing me in court, and there he used that same Lancet publication to convince the judge that his medical research saved patient lives. Jungebluth also convinced the same Berlin judge that he had nothing at all to do with Beyene or any other trachea transplant patient of Macchiarini’s. It does not matter that in this (and another manuscript) Jungebluth wrote that he “assisted the surgery and with collection of secondary data”. The latter means, as the Iceland investigation uncovered, that he helped Macchiarini chase after Gudbjartsson to call in Beyene for bronchoscopies and other examinations, which sole purpose was to provide data which the Lancet peer reviewers have requested. Gudbjartsson complied unquestioningly, for which he now received a reprimand. Continue reading “How trachea transplanters tricked Andemariam Beyene to sacrifice himself for a Lancet paper”→