The European Commission now took 40 days to deny my second Freedom of Information (FOI) Inquiry about the TETRA phase 2 clinical trial with cadaveric trachea transplant they are currently financing with €7 Million. This is EU’s second attempt to become world-leading manufacturer of industrial trachea transplants, after the €5mn Biotrachea led by the scandal surgeon Paolo Macchiarini was terminated mid-term. No, not because EU had any concerns for the patients, quite the opposite: he was given a clean ethics vote to go ahead. Biotrachea was terminated by the EU because the plastic tracheas Macchiarini wanted to use lacked novelty, as the documents I obtained revealed.
The TETRA trial, led by Macchiarini’s past collaborator, the UCL laryngologist Martin Birchall, was already on the brink of being terminated in the wake of the Macchiarini scandal, as EU previously indicated to me. Now, exactly the opposite happens. The trial is being prepared at full speed despite the fact that its predecessor phase 1 trial INSPIRE was suspended (because of my reporting), never recruited any of its four patients and it most likely never will. That trial is also led by Birchall (details here), it is likely that its Innovate UK funding has ran out meanwhile. EU however seems to signal that they will go ahead with phase 2 trial even if phase 1 never happens. After all, there are those 10 patients who received a cadaveric trachea transplant (here and below) and were operated under hospital exemptions between 2008 and 2012 by Macchiarini and Birchall. At least half of these 10 are dead, the lucky survivors either had their graft removed or live with permanently installed stents to prevent their rotting airways from collapsing (INSPIRE’s and TETRA’s clinical promise is actually that the patients will never need a stent). But this disaster seems exactly the reason for EU to try it again, and on a much, much bigger scale. Probably because it will create employment.
The EU spokesperson ceased long ago answering my emails, after I declined to be instructed over the phone (strictly off-the-record) why EU’s approach to trachea transplanting is right; this is why I had to resort to FOI. The official time limit to answer my FOI inquiry from July 1st 2017 was 15 days, but the EU first pretended not to have received my postal address, then said they need more time, then said they need extra time to assemble the documents for me, and finally, the Director-General of the European Commission, Robert-Jan Smits, wrote to me on September 11th. He basically told me again to get lost and that he will never release any information (read here his past rejection of my FOI inquiry). His reasons, as before: the trachea transplant trial is a business enterprise and revealing any of its progress might endanger the financial interests of its stakeholders, and then there are privacy concerns. Exactly, Smits decided that the public must under no circumstances find out whom exactly the EU is giving this public’s money for research on humans. I am not making it up, read Smits’ letter yourself here. Continue reading “EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA”
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”
Keziah Shorten was a 19-year old teenager from England and officially Paolo Macchiarini 3rd patient receiving a cadaveric trachea transplant. She suffered from a slow growing form of cancer and received a cadaveric trachea transplant from Macchiarini at the Careggi hospital in Florence. After life-threatening complications ensued, her second transplant, a plastic trachea made and implanted at UCL and its UCL hospital (UCLH) in London, failed also. Keziah died one and a half years after her first operation. With new evidence provided to me by a source close to the patient, I present here a version of Keziah’s story which is very much different from the official one. This makes UCL and UCLH at least in part responsible for her death, from the very beginning. It was their decision to treat Keziah with the first cadaveric transplant, which sealed her fate. Next to the UCL honorary professor Macchiarini himself, the British doctors, who according to my source promised Keziah a complete cure and initiated this transplant, were UCL professors and surgeons Martin Birchall and Paul O’Flynn. Keziah was even supposed to be operated at UCLH, but once Macchiarini got an ethics permit in Italy, she was moved there. O’Flynn followed her and joined Macchiarini in the transplant operation. Afterwards, it was an ongoing catastrophe which was exacerbated by an apparent botched intervention at UCL Hospital. Death seemed a relief after terrible suffering imposed on Keziah by fame-seeking doctors worshipping their own magic of regenerative medicine. Continue reading “Keziah’s deadly trachea transplant: UCL hospital’s secret”
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”
As we learned it from the Swedish documentary „Experimenten“, the scandal trachea surgeon Paolo Macchiarini didn’t much like to operate on sick cancer patients: they died too quickly after receiving a trachea transplant. This is why Macchiarini was said to have moved on to patients outside of any life-threatening conditions, like the Russian car accident victim Yulia Tuulik. She died because of the plastic trachea which Macchiarini implanted into her. Yesim Cetir, young victim of a botched operation, was slightly luckier to survive the plastic trachea, but only because it was removed and because of constant emergency care and multiple organ transplants (she is presently in very grave state). However, it seems that even Macchiarini’s cancer patients could have led a relatively long life, had they not agreed to receive his trachea transplants. And I am not speaking about the lethal plastic ones. In fact, the “biological” grafts made of decellurised dead donor tracheas were not such a great success either, and seem to have brought suffering and have shortened lives instead of prolonging them. The British UCL and its hospital UCLH are preparing their own clinical trial with cadaveric tracheas, while busily covering up their role in the Macchiarini scandal.
Continue reading “The vexatious life-saving question of cadaveric tracheas”
The British laryngologist and UCL professor Martin Birchall is in trouble now, despite all his constant attempts to turn claims into facts and declare the “stem cell”-based cadaveric trachea transplant technology (which he initially developed together with Paolo Macchiarini) a full success. Birchall’s own little trachea transplant trial INSPIRE (see background here), where the method was about to be applied once again, and on four patients outside of any life-threatening conditions, has been now suspended indefinitely by the NHS Health Research Authority and its South Central – Oxford A Research Ethics Committee (REC), as I report exclusively below. Meanwhile, the Information Commissioner’s Office (ICO) is investigating Birchall’s employer UCL Hospital for providing me with inappropriate and misleading information about that trial under Freedom of Information Act (see email here). Also, the Human Tissue Authority (HTA) is investigating a suspected loss of laboratory documentation at the veterinary department of Bristol University, where their former professor, his Bristol colleagues and Macchiarini’s student Philipp Jungebluth generated in 2008 a trachea transplant for Macchiarini’s patient Claudia Castillo in Barcelona (for background, see my report here). Continue reading “Birchall’s trachea transplant trial at UCL suspended by health authorities”
The European Union (EU) is firmly determined to see dozens of patients transplanted with “regenerated” tracheas made by the method of Paolo Macchiarini. Just as soon as one €5.5 Million-funded trial, Biotrachea, was terminated (because the replacement plastic material Macchiarini intended to use was not novel enough), EU gave fresh €7 Million to his former partner and now competitor, the UK throat surgeon Martin Birchall (see my report here). Birchall’s TETRA will be using decellurised cadaveric tracheas, “regenerated” with bone marrow and epithelial cells after the method he developed together with his thorax surgery colleague, Macchiarini. It is a phase II clinical trial, which is rapidly progressing while the Birchall’s corresponding phase I trial, INSPIRE (funded by the public funder Innovate UK), isn’t moving anywhere. In fact, it is about to receive a re-evaluation of its ethics approval on December 2nd 2016, possibly together with Birchall’s other regenerative trial, RegenVox. There, patients are being recruited to have their voice-box replaced with a lab-made one (using same methodology as with trachea); there is also some evidence that the UCL professor already transplanted 3 patients with plastic and cadaveric larynxes even before he applied to the British MRC for the funding of RegenVox in 2012.
I submitted a Freedom of Information (FOI) inquiry to the EU, asking for the original research proposal of TETRA. My rationale was to compare its science and methodology to that of INSPIRE, which was decried as unscientific and dangerous by the throat surgery specialists I spoke with. The Director-General of the European Commission, Robert-Jan Smits denied my request on the grounds that it lacks an “overriding public interest”, despite the well-known fact that numerous patients have suffered tremendous damage to their health and even died previously when the very same technology was applied by Birchall and Macchiarini. Instead, the EU Commission declared that financial and business interests of the TETRA consortium participants trump all safety concerns about their human research subjects (the full letter can be read here). This is double as scary, also because I am well aware that among my readers are actual prospective patients of Birchall’s. At the same time, the patient information sheet Birchall is using to recruit patients to INSPIRE is highly misinformative (see my report here). Previously, EU ethics commission even approved a much more outrageous patient consent form for Macchiarini’s trachea transplant trial Biotrachea (see my report here). Bottom line: the patients are being duped by the trials’ own consent forms, while the EU has now officially denied these patients and their kin any right to learn from an independent source like my site about what their doctors intend to do to them. Continue reading “Business interests trump patient safety, says EU about trachea transplant trial”