In 2017, the great London university UCL invited an external expert commission to investigate its role into the deadly trachea transplants performed by the former UCL honorary professor and scandal surgeon Paolo Macchiarini. An already sacked UCL nanotechnology professor, Alexander Seifalian, whose lab made the two UCL plastic POSS-PCU tracheas in 2011, was announced as the main culprit on UCL side for all the suffering of these two patients Andemariam Beyene and Keziah Shorten, as well as some recipients of vascular grafts. All this despite Seifalian’s having had no clinical role, training or ambitions, as he professed in his interview to the investigative committee, which I now obtained.
The interview also makes perfectly clear that the investigative committee’s surprise finding, namely that the nanotechnology specialist fabricated non-GMP certified plastic grafts for clinical use behind everyone’s back, was actually slanderous. Not only did UCL know very well that the product, which their own business branch UCLB approved for clinical use in Iran, Switzerland and India, was not GMP-certified, they even used it on their own patient at UCL hospital UCLH, in an attempt to grow a plastic nose. Even the UK regulatory authority MHRA was informed, and apparently did not mind or interfere. All this did not stop UCL investigators from publicly fingering cancer survivor Seifalian as the only culprit for that GMP-non-compliance.
Finally, the committee had information that Birchall allegedly proposed to make a plastic trachea for the child patient Ciaran Lynch in December 2009. Seifalian refused, for technical reasons, but this definitely and literally saved the boy’s life. Ciaran, presently one of just 3 known survivors of ~20 trachea transplants performed by Macchiarini and his former close associate, the UCL laryngologist Martin Birchall, was operated in London in March 2010 with a freshly decellurised cadaveric trachea graft supplied from Italy; Macchiarini was the surgeon. That clever Birchall-attributed idea, of being the first one to implant the utterly untested plastic trachea, and into a child no less, was somehow dropped from the final UCL report. Sod knows why. Continue reading “UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose”
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”
The London university UCL has now completed the investigation into the affair around their past honorary professor and now disgraced thoracic surgeon Paolo Macchiarini and the trachea transplants. Subject of the investigation were: the two plastic tracheas UCL produced (one sent to Karolinska Institutet and implanted in patient Andemariam Beyene in Stockholm, another used by UCL laryngologist Martin Birchall to treat Keziah Shorten, who previously received a cadaveric trachea from Macchiarini as requested by UCL) as well as four more cadaveric trachea transplants, namely the very first such intervention organised by Macchiarini and Birchall in Barcelona in 2008, on patient Claudia Castillo, as well as the three trachea transplants which took place under UCL oversight in London, on paediatric patients Ciaran Lynch, Shauna Davison and a 3-year old child who was transplanted just in May 2017 at the same Great Ormond Street Hospital (GOSH). The offhand revelations about the last transplant in this UCL report came as surprise, since it was otherwise kept secret.
No information is provided by the investigative report on how that child is doing now, in fact it seems no evidence like laboratory books, research data or patients’ medical files was ever requested and the committee relied solely on the opinions provided by the very people they were supposed to investigate: Paolo Macchiarini, Martin Birchall and GOSH paediatric surgeon and past director Martin Elliott. In fact, the report seems to become very nebulous or even creative with its use of alternative facts to avoid implicating Birchall in anything unethical at all. The only guilty party in this medical scandal is incidentally also the only non-clinician and the only non-white character in the entire Macchiarini affair: the nuclear physicist Alexander Seifalian, a Persian-Armenian and dual citizen of Iran and UK, whose lab manufactured two plastic tracheas. He was already sacked by UCL in July 2016, accused of bribery. Seifalian is also bowel cancer survivor, which did not prevent UCL of accusing him of failing to oversee the abroad clinical application of his produce just when he was receiving chemotherapy.
These are the results of UCL investigation in the nutshell:
- All UCL-employed clinicians involved in trachea transplants, in particular UCL’s chief trachea transplanter Martin Birchall, are fully acquitted from any suspicion of misconduct or clinical wrongdoing. Even Macchiarini seems partially exonerated from the gist of the UCL report, because:
- The maker of the two plastic tracheas, Alexander Seifalian, is to take all the UCL-related blame for the failed transplants (as well as other plastics implants in India, Iran and Switzerland). His fault is to have manufactured these products though his UCL lab lacked GMP (Good Manufacturing Practice) certificate. Only this lack of GMP-quality seal was what apparently made plastic tracheas too dangerous to implant in humans.
- All five cadaveric trachea transplants under the scope of investigation were considered ethically, medically and scientifically justified. Deaths of the patients were explained with new discoveries of recurrent cancer, or demands of other patients for the same hospital bed.
- Birchall’s clinical trials with cadaveric tracheas (phase 1/2a INSPIRE, and by extension, also EU-wide phase 2 TETRA) are to go ahead as planned and to recruit patients. Same positive recommendation for Birchall’s related trial RegenVox on cadaveric larynx, decellurised and “regenerated” with same technology as tracheas.
Continue reading “Alexander Seifalian, UCL’s Persian Scapegoat”
This article lists all known (including those not officially declared) patients of the scandal surgeon Paolo Macchiarini, who received from him a cadaveric or plastic trachea. All these grafts were “regenerated” with bone marrow and epithelial cells, in some cases a bioreactor was used to incubate cells on the trachea carcass, in some cases a “bionic” method was applied, where cells were brought straight into the open patient, together with growth factors like EPO. Not all patients are named in my list, though names of all are available, certainly at the hospitals where they were treated. One of my sources is a patients list from the Careggi Hospital in Florence, Italy, which the Corriere Fiorentino journalist Alessio Gaggioli sent me. Some of the patients I already described in an earlier article.
This now is a full list, and it will be updated whenever I receive any new evidence. All Macchiarini trachea transplant patients are listed in the chronological order of their operation. The 2003 operated patient (story here), who received from Macchiarini (together with Heike and Thorsten Walles) a small “regenerated” tracheal patch of pig intestine, is not included here, as it was not a trachea transplant as such. There is a total of 17 patients, at least 11 are dead, the rest, if alive, were left mutilated.
Continue reading “Macchiarini’s trachea transplant patients: the full list”
Trachea is a very difficult organ to transplant, because its blood supply happens through many tiny blood vessels and it is practically impossible to connect them all (same is true also for the oesophagus). An organ transplanted without blood supply will die, and this is where the regenerative medicine of Paolo Macchiarini and Martin Birchall comes in: a treatment with stem cells and growth factors will somehow magically ensure quick vascularization and bring the dead tissue to life. There is no independent evidence for this, and most patients died as the consequence or became dangerously ill when their new tracheas, made from plastic or from dead, decellurised cadaveric organs predictably failed. One boy has survived: Ciaran Lynch. His current clinical state is not too rosy, even by Birchall’s own admittance, but nevertheless the sole fact that Ciaran (unlike almost all other trachea transplant patients) is alive, sufficed for Birchall to have one or two more patients operated (both dead) and to push through a clinical trial in UK with a much larger follow-up trial EU-wide. The difference though: that boy never had much choice anyway, since he had no real trachea in the first place. He received very early on a pickled trachea homograft from dead human donor tissue which functioned very well for many years, but at some point urgently needed replacement in order to save his life. Now Birchall however wishes to remove the live airways of stable patients outside any life danger, who suffer from tracheal stenosis, and replace them with his regenerated dead ones (see this report). Noone seems to wonder why these tracheas are to be prepared in a radically different way from that of the sole success, Ciaran Lynch: Birchall’s bioreactor vs so-called “bionic” method of Macchiarini.
Continue reading “Ciaran’s success story”