Walles misconduct investigation in Würzburg widens inside a federal cover-up; Jungebluth’s dissertation whitewashed in Hannover

The court litigation of the German trachea transplanters Heike and Thorsten Walles against me and my reporting has moved into the appeal stage. The appeal hearing will be on July 3rd 2017 in the Bavarian Higher State Court (Oberlandesgericht) in Bamberg. At the same time, the Walles case turns into an institutional conspiracy farce straight of a bad spy novel, which seems to go up to the very top, including the German government.

The central German watchdog on regenerative medicine, the Paul Ehrlich Institute (PEI), keeps breaking German federal law on Freedom of Information (FOI, Informationsfreiheitsgesetz) by refusing to comment on the legality of the 3 tracheal transplants Walles performed (one of them with Paolo Macchiarini). The FOI oversight authority (Bundesbeauftragter für Informationsfreiheit) failed despite several attempts to get PEI to adhere to this federal law and gave up, after admitting to me to lack any means to enforce it. My repeated complaints to the German Federal Ministry of Health, under whose roof PEI operates, did not even achieve an acknowledgement of receipt.

Meanwhile, their current employer, the University of Würzburg, has widened its misconduct investigations against Walles, to collaborate with their past employer, the Hannover Medical School (MHH) and the hospital where two tracheal transplants were performed by Thorsten Walles, the Clinic Schillerhöhe in Stuttgart. It is another question how collaborative or in fact keen on investigating anything at all these two institutions will be. The Stuttgart hospital decided to transplant two patients in 2007 and 2009 with Walles-made pig-intestine-based tracheal grafts in absence of own internal ethics review board and without procuring an ethics vote from an appropriate external institution (instead, they approached an inappropriate one, were sent away, and published this refusal of ethics opinion as an ethics approval).

The medical university MHH on the other hand seems to have no clue what medical ethics are. Just recently, they declared the MD dissertation of Macchiarini’s student Philipp Jungebluth to be utterly unproblematic and refused to investigate it. In light of this and a previous incident (see below), it appears MHH sees foreign patients abroad to be equivalent to research animals.

Even more significant about the widening of the Würzburg investigation is namely who apparently decided not to participate in it.

Continue reading “Walles misconduct investigation in Würzburg widens inside a federal cover-up; Jungebluth’s dissertation whitewashed in Hannover” →

Macchiarini’s trachea transplant patients: the full list

This article lists all known (including those not officially declared) patients of the scandal surgeon Paolo Macchiarini, who received from his a cadaveric or plastic trachea. All received grafts “regenerated” with bone marrow and epithelial cells, in some cases bioreactor was used to incubate cells on the trachea carcass, in some cases a “bionic” method was applied, where cells were brought straight into open patient, together with growth factors like EPO. Not all patients are named in my list, though names of all are available, certainly at the hospitals where they were treated. One of my sources is a patients list from the Careggi Hospital in Florence, Italy, which the Corriere Fiorentino journalist Alessio Gaggioli sent me. Some of the patients I already described in an earlier article.

This now is a full list, and it will be updated whenever I receive any new evidence. All Macchiarini trachea transplant patients are listed in the chronological order of their operation. The 2003 operated patient (story here), who received from Macchiarini (together with Heike and Thorsten Walles) a small “regenerated” tracheal patch of pig intestine, is not included here, as it was not a trachea transplant as such. There is a total of 17 patients, at least 11 are dead, the rest, if alive, were left mutilated.

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Keziah’s deadly trachea transplant: UCL hospital’s secret

Keziah Shorten was a 19-year old teenager from England and officially Paolo Macchiarini 3rd patient receiving a cadaveric trachea transplant. She suffered from a slow growing form of cancer and received a cadaveric trachea transplant from Macchiarini at the Careggi hospital in Florence. After life-threatening complications ensued, her second transplant, a plastic trachea made and implanted at UCL and its UCL hospital (UCLH) in London, failed also. Keziah died one and a half years after her first operation. With new evidence provided to me by a source close to the patient, I present here a version of Keziah’s story which is very much different from the official one. This makes UCL and UCLH at least in part responsible for her death, from the very beginning. It was their decision to treat Keziah with the first cadaveric transplant, which sealed her fate. Next to the UCL honorary professor Macchiarini himself, the British doctors, who according to my source promised Keziah a complete cure and initiated this transplant, were UCL professors and surgeons Martin Birchall and Paul O’Flynn. Keziah was even supposed to be operated at UCLH, but once Macchiarini got an ethics permit in Italy, she was moved there. O’Flynn followed her and joined Macchiarini in the transplant operation. Afterwards, it was an ongoing catastrophe which was exacerbated by an apparent botched intervention at UCL Hospital. Death seemed a relief after terrible suffering imposed on Keziah by fame-seeking doctors worshipping their own magic of regenerative medicine. Continue reading “Keziah’s deadly trachea transplant: UCL hospital’s secret” →

Macchiarini leaves Russia: federal grant denied and Kazan lab shut down

Paolo Macchiarini is leaving Russia, his research and surgery stint there is over. The fallen star surgeon was able to find a professorship with the Federal University of Kazan (KFU), after his plastic trachea transplants at the Kuban State Medical University in Krasnodar left 3 patients dead, and one with a lucky escape (see details here). His new research focus was on artificial oesophagus, which he apparently already started to test on hapless baboons. In March 2017, the Russian state decided that Macchiarini’s federal grant on oesophagus research will not be renewed, the Kazan University announced in regard to their professor’s further employment to follow the instructions from the Russian Science Foundation. The professorship contract expires by December 2017. On April 20^th, Kazan University made the official decision to shut down Macchiarini’s research programme. A Russian opposition party, Yabloko, demanded of the Ministry for Research and Education to investigate Macchiarini’s Megagrant funding and the use of that money, especially in view of the fact that no final report was published. All this information was revealed by the Russian health and medicine journalist Alla Astakhova on her website. Continue reading “Macchiarini leaves Russia: federal grant denied and Kazan lab shut down” →

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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Judge in Jungebluth trial announces to uphold his injunction, dismisses all evidence

Today I stood my second injunction trial (previous here), and once again, the evidence was irrelevant. Today’s trial of Philipp Jungebluth against myself in the Berlin regional court was set for 30 minutes and this is also how long it took. The reason: the judge (and two co-judges) already made up their decision to uphold Jungebluth’s injunction against me (see story here and here), regardless of all evidence from my side about this doctor’s past. They were perfectly free to do so, because it was a speed trial, where (in theory) I was supposed to get my chance to finally defend myself after the very same judge passed that injunction without my prior knowledge or involvement, based on the claims submitted by Jungebluth. Such is the German law on press freedom, take it or leave the country. Also now, I didn’t get to say much, while Jungebluth and his lawyer were welcomed to explain their case to the court once again. My lawyer and I hardly got a chance to squeeze a word in. Continue reading “Judge in Jungebluth trial announces to uphold his injunction, dismisses all evidence” →

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” →

For Better Science

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

Tag: regenerative medicine