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?”
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”
With his three trachea transplant clinical trials suspended, the British laryngologist and UCL professor Martin Birchall now tries to pull at least the clinical trial RegenVox, which is about the “regenerated” voice-box (larynx) and upper trachea, out of the bog. In order to get an approval to transplant human patients, UCL’s chief trachea transplanter tries to prove in several papers to his funder MRC that the technology is safe in pigs. For this he seems to be reusing data in his recent papers from 2017, to illustrate utterly different experiments, in fact some of this data is at least 7 years old. One wonders if Birchall fibbed the authorities and the scientific community about the novel nature of his results. Was the confused scientist simply salami-publishing and re-interpreting the preclinical data he actually obtained long before he received MRC funding for RegenVox? The evidence of the larynx transplant data reuse across two recent papers and the grant proposal document from 2010 follows below, background on Birchall’s RegenVox and his trachea transplant adventures is here and here.
The UCL laryngologist uses the technology which developed with his former partner, the scandal trachea transplant surgeon Paolo Macchiarini. The method is to strip the cadaveric donor organ of all cells (in a process called decellurisation) and then bring it back to life as recipient’s own organ using the magic of bone marrow cells. In Birchall’s own words, those magic cells recognise the decellurised organ by its shape and know what to do then: Continue reading “Image reuse, the new low of UCL trachea transplanter Martin Birchall?”
This is a new episode of the data manipulation affair around Weizmann Institute of Science in Rehovot, Israel (and another guest post by “Smut Clyde“), with the hope that Israeli researchers and their state officials finally step in and investigate what goes on in this institute, supported by external experts from the academic community. There are many good and honest researchers working at Weizmann, the dishonest deeds which used to happen (and maybe still happen at Weizmann) should never throw a shadow upon their work. This can only be achieved by an open debate in the scientific community worldwide and a large, independent investigation inside Weizmann.
My earlier article about Weizmann’s “stars” of research integrity, and the follow-up guest post by Smut Clyde, prompted a wider scrutiny by internet sleuths on PubPeer. One of them was the well-known pseudonymous Claire Francis. In this case presented below, while Ofer Lider, associate professor of Immunology at Weizmann, was dying from leukaemia, his dedicated colleagues were apparently secretly stuffing manipulated data into his publications. They continued to do so even after his death in 2004, and now Lider papers are being plucked apart on PubPeer. There are many co-authors, and the scientific narrative mostly circles around a “visionary” diabetes cure, the substance DiaPep277, a peptide fragment of the ubiquitous heatshock protein Hsp60.
What was done to the scientific and human legacy of the immunologist Ofer Lider, is the basically academic equivalent of urinating of someone’s literal grave. If this won’t make Weizmann leadership feel shame, I do not know what would. It was a travesty of two retracted papers and a meeting abstract of a DiaPep277 clinical trial by the trainwreck company Andromeda Biotech, and it made world news in 2014. What came out only now, thanks to the sleuths of PubPeer, is that this scandal of clinical trial statistics was supported by a preclinical cornucopia of rigged western blots made at Weizmann, which all served the purpose of delivering a promise of a diabetes “vaccine”.
Continue reading “How Irun Cohen and Weizmann Institute almost cured diabetes”
The British laryngologist and UCL professor Martin Birchall is one of the two founding fathers of “bioengineered” trachea, the other one being his former partner, the scandal surgeon Paolo Macchiarini. Birchall presently runs three trachea transplant trials clinical trials, two in the UK and one EU-wide. His patients must however wait to be cured, because the two UK trials, Inspire and RegenVox (with the latter primarily about larynx and upper trachea transplant) were both placed on hold, and the EU funded phase 2 trial TETRA is still far from getting an ethics approval and just now lost one potential trial site after the Medical University Vienna jumped ship. The EU Commission refuses to tell me anything about TETRA, except that it has not applied for ethics approval yet. EU’s Transparence department still evade commenting on how to put this scheduled 48 patient clinical trial in context of the 11 cadaveric trachea transplants by Macchiarini and Birchall, most or maybe even all of which left the patients either dead or mutilated.
In this article, I publish the most recent patient information sheets for the two suspended Inspire and RegenVox trachea transplant clinical trials, which I obtained under Freedom of Information request from the UK Health Research Authority (HRA). Continue reading “Martin Birchall’s shaky road to mass trachea transplanting”
John Carlisle is a British anaesthesiologist, who works in a seaside Torbay Hospital near Exeter, at the English Channel. Despite not being a professor or in academia at all, he is a legend in medical research, because his amazing statistics skills and his fearlessness to use them exposed scientific fraud of several of his esteemed anaesthesiologist colleagues and professors: the retraction record holder Yoshitaka Fujii and his partner Yuhji Saitoh, as well as Scott Reuben and Joachim Boldt. This method needs no access to the original data: the number presented in the published paper suffice to check if they are actually real. Carlisle was fortunate also to have the support of his journal, Anaesthesia, when evidence of data manipulations in their clinical trials was found using his methodology. Now, the editor Carlisle dropped a major bomb by exposing many likely rigged clinical trial publications not only in his own Anaesthesia, but in five more anaesthesiology journals and two “general” ones, the stellar medical research outlets NEJM and JAMA. The clinical trials exposed in the latter for their unrealistic statistics are therefore from various fields of medicine, not just anaesthesiology. The medical publishing scandal caused by Carlisle now is perfect, and the elite journals had no choice but to announce investigations which they even intend to coordinate. Time will show how seriously their effort is meant.
Continue reading “Carlisle’s statistics bombshell names and shames rigged clinical trials”
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”