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”
Continue reading “Macchiarini victim’s family sues trachea makers for wrongful death”
News from the trachea transplant entrepreneurs. What with the UK authorities having officially suspended both phase 1 clinical trials Inspire and RegenVox, and the EU phase 2 clinical trial TETRA going nowhere, the technology’s owner, Liverpool-based company Videregen decided to seek new clinical partners. Surgeons and universities from outside the EU, especially from US, China and Japan are invited to test Videregen’s trachea transplant technology, which was originally developed together with Paolo Macchiarini by the UCL laryngologist and paid Videregen advisor Martin Birchall.
While tracheal stenosis was the indication sought to treat with trachea transplants in UK and EU (as the authorities drew curtains before the show even started), Videregen now goes for bronchopleural fistula, while pretending (quite dishonestly) that “all required regulatory and ethical approvals necessary to commence clinical trials in the UK” would exist.
The other bit of news is that UCL finally published the 2015 PhD thesis of Birchall’s student Claire Crowley (now postdoctoral scientist in charge of clinical research on oesophagus replacement with UCL professor and another trachea transplanter Paolo De Coppi). It reads as if certain parts of the thesis were edited or even written by UCL’s legal department. Not what thesis says, but what is omitted is worrisome. Crowley was namely responsible for the production of 3 trachea replacements requested by Birchall, which all proved deadly to their human recipients. One was a decellurised cadaveric graft, and two were POSS-PCU plastic tracheas, which Crowley made herself, in the lab of her other advisor, the (now sacked) UCL nanotechnologist Alexander Seifalian. Yet the thesis only mentions one graft, in a brief one-page statement, simply because Crowley could not deny her role there. She is co-author on the Macchiarini paper Jungebluth et al Lancet 2011 telling the alleged success story of the very first plastic trachea transplant performed in Sweden on the patient Andemariam Beyene. Otherwise, Crowley never mentions in her thesis the cases of Keziah Shorten or Shauna Davison, whose lethal trachea grafts she also made herself, as part of her PhD studies. Continue reading “Trachea transplanters without borders”
Imagine you are Martin Birchall, laryngologist and ENT surgeon, star of regenerative medicine at UCL and trachea transplant enthusiast. You and your business partner Videregen need to explain to EU bureaucrats why your technology of decellurised cadaveric trachea is perfectly safe, what with all the dead patients of yours and your former best friend Paolo Macchiarini. Preclinical animal tests? Good idea indeed, though you have already published some very shady pig studies with Macchiarini in 2010, after you operated your first human patient in 2008 (whom you keep parading as success story of your stem cell magic superpowers, despite heavy complications which almost killed your research subject).
To distance yourself from that horrid Macchiarini, you do new preclinical tests. Enter three more pigs, which you decide transplant with a cadaveric decellurised human trachea. One trachea turns out to have been dirty not just with human “stem” cells, but also with pathogenic bacteria. So that one piggy got lucky and was set free. The unlucky other two: dead “of respiratory compromise”, one already after 12 days, the other suffered for a whole month after trachea transplant. You now have 100% preclinical mortality rate, and you still manage to convince the bureaucrats that the method works and 48 human patients must experience same, in the EU-funded phase 2 clinical trial TETRA. Thing is, that trachea transplant trial was supposed to help tracheal stenosis patients, by ridding them of burdensome stents and bronchoscopies, and not to euthanise them. Continue reading “Birchall’s two dead pigs to prove trachea transplants are safe”
The University of Iceland in Reykjavik previously published an external investigation report into the first ever plastic trachea transplant, performed by Paolo Macchiarini at the hospital of Karolinska Institutet (KI) in Stockholm, Sweden. The patient was Andemariam Teklesenbet Beyene, PhD student at University of Iceland, and the Icelandic surgeon who treated Beyene and then delegated him to Macchiarini for that deadly treatment was Tomas Gudbjartsson, professor of surgery at same university (see my report here). One year after the operation, when Beyene already started to suffer from the plastic trachea which eventually killed him, Gudbjartsson organised a conference on regenerative medicine in Reykjavik, featuring Macchiarini as guest of honour and Beyene as a kind of trophy.
The University now announces to investigate the circumstances of that conference, for which it apologises, and to host on June 1st 2018 a new one, on research ethics. Gudbjartsson will not suffer any disciplinary consequences, because he was said to have expressed sufficient level of protest against the attempts by Macchiarini and his acolyte Philipp Jungebluth to twist the patient abuse into a success story which they published in The Lancet, Jungebluth et al, 2011. A paper which University of Iceland now describes as “objectionable”. Continue reading “University of Iceland: no formal legal sanctions against Macchiarini partner Gudbjartsson”
The European Commission now admits to me, through European Ombudsman, that their €6.8 mn phase 2 clinical trial TETRA with cadaveric tracheas, led by the UCL laryngologist Martin Birchall is unlikely to ever recruit any patients, because “the current delay to the INSPIRE project therefore makes the prospects for the commencement and completion of the TETRA project uncertain“.
INSPIRE is a phase 1 clinical trial in UK, suspended since December 2016, which was about to recruit 4 patients for trachea transplants using the technology of cadaveric tracheas Birchall developed together with his former partner, the scandal surgeon Paolo Macchiarini. The UK trial was suspended by UK authorities because of my reporting, its funding ran out and it is unlikely to be ever resumed. Even the official sponsor of both INSPIRE and TETRA, Cell & Gene Therapy Catapult, sulkily announced to change the status of the former trial from “active, not recruiting” to “suspended” at the Clinicaltrials.gov website. And without INSPIRE (which EU Commission prefers to see as “delayed“, not as suspended) the phase 2 clinical trial TETRA becomes just a grave for tax money, but luckily not for patients. This is something however EU Commission sees no problem with, and these are their views declared to me in the nutshell, via a letter from European Ombudsman to whom I complained after my Freedom of Information request was rejected by EU Commission twice (here and here):
- EU Commission refuses access to TETRA documentation because this could be “potentially causing reputational damage to the consortium and individuals linked to it“.
- EU Commission sees no imminent “public health concerns or public benefits” because “the TETRA clinical trial is dependent on the successful completion of the INSPIRE project“
- The trial will not be terminated, and will simply trudge on until the end of its funding period on 31 December 2019.
- EU Commission maintains that Macchiarini only transplanted plastic tracheas and had no contribution to the cadaveric trachea technology of INSPIRE and TETRA: “the scientific research involved in TETRA is pursuing a different method than the one developed by the doctor who has been subject to misconduct investigations“
- EU commission maintains that cadaveric trachea transplants, including those principal investigator Birchall was involved in, were either full successes (where patients survived) or they never happened (where patients died). The list of dead and mutilated patients who received cadaveric tracheas, which I specifically sent to EU Commission, was dismissed as not relevant for the current clinical trial
Continue reading “EU trachea transplant clinical trial TETRA “uncertain to take place””
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”