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”
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”
Following is my email interview with Thomas Lippert, professor and director of the Institute for Advanced Simulation and the Jülich Supercomputing Centre at the Forschungszentrum Jülich in the west of Germany, located somewhere between the cities of Cologne and Aachen. Lippert’s FZ Jülich is a central partner at the Human Brain Project (HBP), the Future and Emerging Technologies (FET) Flagship mega-consortium which is funded with €1 Billion, half of which coming from the European Union. Lippert heads the Subproject (SP) 7 at the HBP, named High-Performance Analytics and Computing Platform, tasked with providing the high-performance computational power in order to help the HBP megaproject simulate the human brain and its diseases.
I previously wrote some critical articles about HBP, about the hubris of its founding father Henry Markram, the bizarre way EU positively evaluated the performance of HBP without actually evaluating it, and also about the purpose of HBP and Flagship projects in general. Incidentally, the last article’s cover photo showed Lippert at a HBP conference. We got into a discussion over Twitter during HBP’s recent Open Day show in Glasgow, where Lippert kindly agreed to answer my questions about the purpose and orientation of HBP.
Continue reading “Human Brain Project interview with Thomas Lippert: Simulating brain in computer is like simulating weather”
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: 48 patients are scheduled to receive cadaveric tracheas. 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”
The EU €1-Billion-Flagship Human Brain Project (HBP) started in 2013 as an closed enterprise run by three men. The triumvirate is no more: the visionary founder Henry Markram sidelined into almost insignificance after a coup, his Lausanne colleague Richard Frackowiak almost retired, only the German Karlheinz Meier, physics professor at University of Heidelberg, still seems to hold quite a lot of sway. The control of HBP is now basically in German hands: the “independent” mediator of the anti-Markram coup and director of Forschungzentrum Jülich (FZJ), Wolfgang Marquardt, is key member of the all-decisive HBP Stakeholder Board representing Germany, his FZJ colleague Katrin Amunts is the new scientific director of HBP. The bombastic goal of HBP used to be simulating the human brain in a supercomputer, including various brain diseases and even consciousness (read here and here for HBP background). That Markram’s “brain child” was silently mothballed, the big plan is now only revealed to select insider audiences (who occasionally blab on Twitter). The once high and mighty Markram, whose not-so-groundbreaking Cell paper (Markram et al, 2015) was once touted as HBP’s mega-success, was apparently forced to publish his recent brain simulation research in his own publishing outlet Frontiers (Reimann et al 2017), where he proclaimed a discovery of nothing less but a “Multi-Dimensional Universe in Brain Networks”. Regardless of what Markram thinks he is doing or what fairy tales HBP graduate students are told: dissolving the monster HBP and redistributing its EU funding onto smaller projects was obviously not an opinion. The new purpose of HBP seems to be:
- distributing the EU Flagship money, in the way HBP see it best fit, thus
- sparing the EU Commission the tedious work of research grant reviewing and management
Continue reading “Human Brain Project and other Flagships: is EU outsourcing funding decisions?”
Academic research is dependent on funding, and funding agencies, both public and charity ones, play a crucial gatekeeper function in deciding who will go on to continue researching or even working in science, and who will not. With great power comes great responsibility. Unfortunately, funders traditionally end up serving the interests of select elite scientists by confusing the needs of those with the greater good of science as such. Money is dumped on the biggest pile, either to established star researchers or to their privileged academic scions. In this zero-sum game of science funding, many early career researchers see their grant applications rejected and are forced out of academia. The logic seems to be that this research proletariat would have spent it on booze and candy anyway, while the high elite will be investing it wisely to produce great science. Or whatever the funders, advised by that very elite, perceive to be great science. The guest post below by Shravan Vasishth, professor for psycholinguistics and neurolinguistics at the University of Potsdam, Germany, tells of a peer reviewer experience of his when it hit against such attitude from the most prestigious EU research funder, the European Research Council (ERC).
Continue reading “Lack of transparency in ERC funding decisions, by Shravan Vasishth”