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”
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.
This is a new instalment of my investigation into UK and EU funded clinical trials on trachea replacement by the throat surgeon Martin Birchall at UCL. The method of using bone marrow cells to regenerate a dead decellurised donor trachea was developed by Birchall together with Paolo Macchiarini, and tested since 2008 on several human patients, with catastrophic results. Macchiarini by now is a pariah sacked by his formerly proud employer, the Karolinska Institute in Sweden, but Birchall was given further millions in British and EU money for his human trachea transplant experiments.
I finally obtained the patient information brochure for such phase 1 clinical trial INSPIRE, which was consistently denied to me by all participants. The information therein, or rather the strategic lack of it and the consequential wilful misleading of prospective patients, is truly scandalous. There is no mention whatsoever of any of the previous trachea transplant experiments Birchall performed and the clinical outcome of which he likely misrepresented in order to obtain this very funding and even his current full professorship at UCL (with the help of Macchiarini, see page 43 of his CV). His described strategy of transplant preparation and implantation seems scientifically nonsensical, while suggestive of medical obfuscation and even deceit. Now that I finally received the INSPIRE patient information sheet, I understand why the consortium partners preferred in to be hidden from public scrutiny.
For the scientific and medical ethics background of this complicated case, please refer to my earlier reporting (in chronological order):
- The stem cell faith healers, or magic inside your bone marrow
- EU threatens to terminate TETRA Consortium funding for phase 2 trachea transplant trial
- Brexiting out of EU research and patient rights
Did you ever wonder why certain zombie scientists were still in academic jobs? Despite having been caught on data manipulation or biomedical ethics breach?
It seems the answer is simpler than you thought. They are paying for their protection, by giving pizzo to their crooked research institutions, just as in some unoriginal mafia film. Well, actually YOU are paying their pizzo, through your taxes, which in turn are awarded to these zombie scientists as public research funding, from the national, international and European funding agencies. In fact, the most prestigious and self-important European funding agency ERC is completely unprepared or maybe just unwilling to respond to evidence of research misconduct by their elite grant recipients.
My understanding is provocative, and I may be utterly wrong. But absent of any reasonable alternative explanations, let us for a moment go with this one. I will provide you with examples where questionable European scientists surprisingly retained their European funding unquestioned (or even received fresh millions of Euros), and coincidently or not, many institutions did not at all mind to keep them in their jobs. Continue reading “Does ERC help cheaters pay protection money?”
The science of the fallen star of regenerative medicine Paulo Macchiarini was simple: take a dead organ, strip it of its cells and seed the carcass with stem cells (usually the magic cells from bone marrow). After some days in a “bioreactor”, you take out a living trachea, esophagus, even heart, and implant it into a patient. Another human life saved, and not only media, even scientist colleagues fell for this outrageous quackery. As the result of this hubris, several patients died, others remained in permanent critical care. Macchiarini and his partners Philipp Jungebluth, Martin Birchall and others had to fake ethics approvals as well as to lie and cheat about medical records in their publications in The Lancet, all in order to present a miserably suffering recipient of a ”regenerated” trachea as fully recovered. Animal experiments were performed only after Macchiarini’s team operated their first human patient, as indirectly evidenced by Jungebluth’s own doctorate thesis at the Medical University Hannover (MHH) in Germany.
Macchiarini began to develop his “decell-recell” method of organ regeneration while working in Hannover, close to the renowned heart surgeon and MHH clinic director, Axel Haverich (see Part 1 for the background). In 2009, the Italian cheater then moved on to a professorship at the Karolinska Institute in Stockholm, where he was showered in funding money and received best institutional protection, despite his patient abuse and his lies about his qualifications. Continue reading “Regenerating in Hannover, Part 2: Axel Haverich’s “growing” heart valves”
The European multimillion research project Human Brain Project is under fresh leadership, its visionary founder Henry Markram ousted from power. Worse, both life-and-blood projects of the neuroscience professor at the Swiss elite university EPFL are not performing as he envisioned them to. His open access publishing house Frontiers was dumped by the Nature Publishing Group and ended up with the German publisher Holtzbrinck, with neither them nor Frontiers particularly keen on boasting this property relationship. Editors and reviewers ran away or refused duty in droves, Frontiers was even fingered as a possible predatory publisher. On top of everything, Markram’s outlet stands accused of being an employee-abusing spam factory.
So much for Markram the Entrepreneur and Inventor. But he is first and foremost a scientist, whose research proposal received the biggest research funding grant in history: one billion Euros from the European Union, for his “brainchild” (as journalists dubbed it), the Human Brain Project. The modest promise Markram originally made to secure this mind-boggling mountain of cash: he intended to simulate the entire human brain in his supercomputer by 2023, the possibility of artificial consciousness specifically not excluded. Now however, his consortium partners took over, Markram was dethroned in a scientists’ coup and pushed aside to tinker on his seemingly less ambitious, but just as science-fictionary mouse Blue Brain simulation. Once in control of almost everything and everyone, with all the big money going through his hands, Markram is now only one of 12 project leaders and far from being the boss. The Human Brain Project (HBP) became instead a kind of funding network without any properly defined orientation, not even the new leaders could convincingly describe any defined goals. Instead, its main purpose seems to be now set on keeping the EU funding of almost €50 Million per year flowing. Remarkably, all this was achieved after an allegedly independent mediation by the director of an HBP-consortium partner institute; coincidentally a member scientist from this Jülich Research Centre (Forschungszentrum Jülich, located in a rural triangle between German cities Düsseldorf, Cologne and Aachen) is now the new scientific director of HBP.
This is how the dream of the brain-in-the-box grew, prospered and imploded. Continue reading “The laborious delivery of Markram’s brainchild”