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.
Susana Rivas, a CNRS research group leader from the French National Institute for Agricultural Research (INRA) in Toulouse is now at the epicenter of a new research integrity scandal in plant sciences. In the last two years, France was shaken by the Olivier Voinnet scandal, when their former star researcher was found guilty of data manipulation throughout his entire career, from his PhD at The Sainsbury Laboratory in Norwich, UK, over his position of many years as research director at CNRS plant science institute in Strasbourg up to his current professorship at the ETH Zürich in Switzerland. Before she became CNRS group leader in 2003, the Spanish plant scientist Rivas worked as postdoc at The Sainsbury Laboratory, in the lab of Jonathan Jones, at around the same time when Voinnet was finishing his PhD there under David Baulcombe. Now, Jones retracted a paper authored by Rivas from the journal The Plant Cell, he also requested the retraction of another paper from his lab with Rivas as first author, in The Plant Journal. Meanwhile, I share here new evidence of suspected data manipulations from Rivas’ own lab in Toulouse, in her 5 publications which include PNAS, PLOS One, The Plant Cell and Nature Communications. Continue reading “Susana Rivas: a new research integrity scandal in French plant sciences”
s 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.
The academic career of the Irish microbiologist Robert Ryan is apparently over. Following an internal misconduct investigation at the University of Dundee, Ryan had to resign from his position as group leader and lost the prestigious funding from the Wellcome Trust. Prior to this, he was suspended by his employer, while the European molecular biology society EMBO terminated his participation in the EMBO Young Investigator programme. Peculiarly, there never were any press releases or official communications. The University of Dundee apparently chose instead to leak internal emails to media (for details see my reporting here and here), the most recent announcement about Ryan’s “resignation” was no exception.
Ryan’s however is not the only name crowning all those papers now under suspicion of misconduct. Another recurrent name belongs to his former mentor of many years, the leading plant pathogen researcher Maxwell Dow, from the University College Cork (UCC) in Ireland. The PubPeer evidence is quite heavy against Ryan and Dow papers, and in fact UCC once suggested to me that they would initiate an investigation. Other media never even mentioned Dow’s name. Only on my site was his most obvious responsibility for Ryan’s research discussed, nowhere else. Now Dow decided to act against this unwelcome reporting. He submitted a DMCA takedown request to my website host WordPress and LinkedIn’s Slideshare, targeting my article and my teaching presentation from a research integrity workshop in Catania, Italy. Dow’s copyright claim concerned a photograph of his together with Ryan which was made publicly available by their university in this UCC press release. Continue reading “Ryan’s mentor Dow pretends copyright to combat my reporting”
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”
Great scientists never have any conflicts of interests, and in the case of the investigation of the research misconduct by the plant scientist Olivier Voinnet, led by his Swiss employer ETH Zürich, this was also apparently the case. Voinnet was found guilty of misconduct and admitted image manipulations in many papers. Yet his science remained largely unquestioned, and even original data behind the most outrageously manipulated figures was said to have been available in many cases. The ETH investigation recommended 6 retractions, one of which was even avoided thanks to the concerns the journal Science had towards that paper’s junior authors (Voinnet’s current retraction count stands at 8 papers and almost 20 corrections, where manipulated data was simply exchanged with new one). Professor emeritus Witold Filipowicz, of the Friedrich-Mieschner-Institute in Basel, is like Voinnet a specialist in the field of regulatory small RNAs, and he was therefore one of two external Voinnet investigators whom ETH invited in early 2015. It did not matter to ETH that it was actually Filipowicz who nominated Voinnet for the EMBO Gold Medal, which the disgraced plant scientist then lost after EMBO’s own investigation into his many years of data manipulation. Continue reading “The Voinnet investigator and the tricky issue of conflict of interests”
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”