EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA

EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA

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 hereContinue reading “EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA”

Human Brain Project and other Flagships: is EU outsourcing funding decisions?

Human Brain Project and other Flagships: is EU outsourcing funding decisions?

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?”

Lack of transparency in ERC funding decisions, by Shravan Vasishth

Lack of transparency in ERC funding decisions, by Shravan Vasishth

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”

Human Brain Project: bureaucratic success despite scientific failure

Human Brain Project: bureaucratic success despite scientific failure

The EU €1-Billion-Flagship Human Brain Project (HBP) has passed its midterm evaluation with flying colours. Noone knows exactly what the objectives of this bombastic project is, as members of the evaluation panel indicated to me, while others refused to answer this question. The HBP leadership sure keeps the exact definition of these objectives secret, or maybe they don’t know them themselves. Which is easy to understand, because given the leniency HBP keeps receiving from those supposed to evaluate it, its real objective becomes perfectly clear: to secure the public funding. There, HBP succeeded indeed, the €1 Billion seems rather safe. It is none of the public’s business where the money will go, but it can rest assured it will certainly go somewhere. The public should also not expect any deliverables or return on its research investment, this the HBP leadership already made perfectly clear. I am showing below what a farce the recent HBP evaluations were, while the positive outcome was much hailed as evidence for excellent scientific performance.  Continue reading “Human Brain Project: bureaucratic success despite scientific failure”

Birchall’s trachea transplant trial at UCL suspended by health authorities

Birchall’s trachea transplant trial at UCL suspended by health authorities

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”

Business interests trump patient safety, says EU about trachea transplant trial

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”

Collapse of Biotrachea, or how Macchiarini’s greed saved human lives

Collapse of Biotrachea, or how Macchiarini’s greed saved human lives

The trachea transplant experiments by Paolo Macchiarini left many of his trusting patients dead or mutilated. His €5.5 Million EU-funded research project Biotrachea started in April 2012 and was specifically designed to treat even more human beings with lethal plastic tracheas (and with the slightly less lethal cadaveric ones). The consortium was terminated in 2014 (see some background here), but not because the Biotrachea scientists or EU officials suddenly had second thoughts when the Macchiarini scandal unraveled and when his misconduct, ethics breaches as well as painful deaths and suffering of his plastic trachea recipients became known. Unlike an EU spokesperson previously insisted, there were no ethics concerns at all regarding Biotrachea. In fact, all ethics approvals were in place, human Guinea pigs were supposed to be lured en masse using a highly inappropriate patient consent form towards their likely deaths for the sake of EU-funded mega-science.

In truth, Biotrachea collapsed only because of Macchiarini’s greed for money. His financial conflict about patent revenues with the British university UCL drove the star surgeon to seek another plastic transplant manufacturer and then to destroy the entire multinational research consortium which he was presiding over, after the EU rejected his new plastic provider. Not because that one was also deemed unsafe, but as the EU negotiators mentioned, it was because that new type of plastic trachea lacked novelty. All this only became known after the original Biotrachea documents, which the EU and all consortium participants refused to grant me any insight into, were fully legally obtained by Jonas Malmstedt under Swedish transparency from Macchiarini’s ex-employer, the Karolinska Institutet (KI). Thanks to this brave and decent surgeon, I make all that secret documentation available below.

Continue reading “Collapse of Biotrachea, or how Macchiarini’s greed saved human lives”