Ciaran’s success story

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.

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Sumitran-Holgersson and Olausson guilty of misconduct and unethical experiments on children

Game over apparently near for the indestructible Swedish regenerative medicine researcher Suchitra Sumitran-Holgersson, after investigations at her University of Gothenburg draw to an end. It is about experimental transplants of decellurised veins “regenerated” with the patient’s own bone marrow cells into three child patients, all of whom ended up in life-long medical care, one patient received a liver transplant after her graft failed, another child suffered severe complications (see this earlier report about an external investigation by Bengt Gerdin into that matter). The University of Gothenburg then established an investigative committee, which followed up on the Gerdin report and specific concerns voiced by a journal editor and a colleague. I publish below the two decisions which revealed that Sumitran-Holgersson and her surgeon partner Michael Olausson never performed any animal testing before recruiting their human patients, they also failed to obtain ethics permits for these operations. Instead the two lied in their publications (Olausson et al, Lancet, 2012; Olausson et al EBioMedicine, 2014) about having obtained ethics votes (something I already uncovered before). During the investigation, Olausson and Sumitran-Holgersson were caught submitting false information to the committee. They were now found guilty of misconduct and ethics breach in both these publications. Continue reading “Sumitran-Holgersson and Olausson guilty of misconduct and unethical experiments on children” →

Retraction, and another looming misconduct finding for Macchiarini and Jungebluth

The misconduct-tainted paper on oesophagus transplants in rats (Sjöqvist et al 2014) by the fallen star of regenerative medicine Paolo Macchiarini is finally retracted by the journal Nature Communications. This happens after Swedish investigations found the authors (primarily the scandal thorax surgeon and his right-hand man Philipp Jungebluth) guilty of data manipulation and research misconduct in September 2016 and after the Karolinska Institutet (KI) shortly before Christmas publicly demanded a retraction (see my report here). Today’s retraction is a major setback for Macchiarini, since his current employment and funding at the Federal University of Kazan (KFU) in Russia depend on his experiments with oesophageal transplants in primates (see my reports here and here). That Russian project was in turn only possible because of Macchiarini’s allegedly successful experiments in rats, published in a prestige journal with “Nature” in its title. This paper’s retraction is therefore probably only the beginning of a whole looming avalanche of bad news for Macchiarini and his acolyte Jungebluth (who currently sues me in court). An expert review of their publication Jungebluth et al 2015 declares the findings of misconduct, ethics breach and patient abuse. The report however has yet to be confirmed by a commission at the Swedish Central Ethics Review Board (CEPN) and then formulated as an official decree by the KI. I publish the expert reviewer report below. Continue reading “Retraction, and another looming misconduct finding for Macchiarini and Jungebluth” →

My Walles trachea transplant reporting fails peer review

My attempt recently to inform the readers of the journal Tissue Engineering Part A about grave omissions and factual inconsistencies in the Steinke et al 2015 publication by Heike and Thorsten Walles failed spectacularly. Not because the concerns I raised about their tracheal transplants where deemed is irrelevant, far from it. It was the messenger who was seen as disreputable. The editor chose to send my letter out for peer review, despite the fact that I was never addressing the science of the paper, but the omitted, yet verified medical complications and deaths of the patients, as well as non-existent animal tests. Two of three peer reviewers simply chose not to believe me and my evidence, one of the reasons was: my blog site where I published it is not peer reviewed. I was also decreed to be scientifically incompetent, driven by personal vendetta against poor Walles (who are presently suing me at court for reporting about these transplants) and simply as a liar, who made all these things up. At the same time, the notorious third reviewer warns the editor that the journal’s readers must never see or hear of my accusations. Continue reading “My Walles trachea transplant reporting fails peer review” →

The vexatious life-saving question of cadaveric tracheas

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.

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Image duplication and other irregularities of Heike and Thorsten Walles

More inconsistencies arise in publications and statements of the litigation-happy professors of the University of Würzburg, Heike and Thorsten Walles. These regenerative medicine scientists turned the entire might of German justice system against my reporting, while their academic employer remains shamefully silent. Their elusive animal experiments with the pig intestine-based tracheal transplants seem to be very real when Heike Walles speaks about them and become non-existent when her husband and research partner Thorsten does. While the University of Würzburg and the federal watchdog Paul-Ehrlich-Institute (PEI) protect the surgeon by asserting that no ethics vote was needed to perform his tracheal transplants on 3 patients, his wife claimed that he actually needed and obtained an ethics approval to do this. Thorsten Walles himself in fact indicated that his last transplant in 2009 might have broken the German Tissue Law from 2007, i.e., if he indeed failed to obtain an ethics vote, while operating under compassionate use. In any case, no German institution was willing to discuss with me the existence or non-existence of these ethics approvals. Despite the simple fact that none of these 3 patients is alive today (one died in fact very soon after operation), it is none of public’s business.

Now, a seemingly duplicated image was spotted in two Walles publications (Linke et al 2007 and Schanz et al 2010). They describe the creation of an “artificial liver”, made from decellurised pig intestine (just like the tracheal transplants), seeded with endothelial and liver cells. These two publications are 3 years apart, the methodology description is also slightly different (e.g., decellurisation process and the speed and kind of perfusion). A minor aspect may be that the Linke et al 2007 paper described the use of pig cellular material, and Schanz et al 2010 employed primary human cells from patient biopsies. Finally, the image seems not just duplicated, but one looks actually brighter and like a zoom-in of the other.

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Evidence is a lie, listen to our authority, say Walles to scientists

The Würzburg regenerative medicine researchers Heike and Thorsten Walles, joined by their colleague Jan Hansmann, are now hitting back at the evidence I presented, which all clearly suggests that no animal testing was performed on their tracheal transplants made of pig intestine before those were tested on 3 patients, coincidently none of whom is alive today. The first test was performed in 2003 at the Hannover Medical School (MHH) in Germany, and led by none other than the scandal surgeon Paolo Macchiarini, Walleses’ former superior. Two more tests were performed on two patients in Stuttgart, where Walleses moved to in 2004 (see details here). About the last tracheal transplant in 2009, an analysis of Thorsten Walles’ own words raise new questions about its legality in regard to German Tissue Law from 2007. The University Clinic Würzburg shamefully continues to refuse to share any information with me, despite the protests of many international scientists. In fact, it even refuses to say if Walleses were given persmission to use their institutional affiliation to achieve that court injunction against me. Continue reading “Evidence is a lie, listen to our authority, say Walles to scientists” →

For Better Science

Science journalism by Leonid Schneider, on research integrity and academic publishing in life sciences and biomedicine

Tag: stem cells