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.

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Expert review: Macchiarini papers on plastic trachea transplants are misconduct

Bad times for the scandal surgeon Paolo Macchiarini and his acolyte Philipp Jungebluth. Misconduct findings led previously to retraction of an oesophagus transplant paper, with more soon to be expected, their employments in academia seem to be definitely a thing of a past. Macchiarini’s big plans of world-shattering trachea and oesophagus transplants in Russia went bust, when his grant funding was not extended and the Federal University of Kazan waved him goodbye. The master’s acolyte Jungebluth is currently suing me in court about my reporting on his own past employment, because he managed to convince the Berlin judge when passing the injunction that all his now proven research misconduct and patient abuse, which led to deaths of several patients, plus several other dishonest deeds of his, had in fact perfectly qualified him for an academic research career at the University of Heidelberg in Germany. A career he claims to have aborted entirely on his own accord, hence his (now only 1/3 successful) court injunction against me. Jungebluth, after having said farewell to his 8 years of thorax surgery training in vain, even claimed in court to be desperately wanted as thoracic surgeon by all Berlin hospitals, including the huge university hospital Charité.

Which brings us to the recent setback for the two trachea transplanters. Their publications regarding the plastic trachea operations at the Karolinska Institutet (KI) in Stockholm, which left three patients dead, were investigated by two external experts. One of the experts was Martin Björck, professor of surgery at University of Uppsala, the other was Detlev Ganten, professor emeritus of pharmacology and former CEO of the Charité. And their fresh report, submitted to the Swedish Central Ethics Review Board (CEPN), does not read like the Berlin Charité or any other medical research institution in Germany, or anywhere else for that matter, might ever consider employing Jungebluth. The central Lancet publication, describing the first plastic trachea transplant performed on Andemariam Beyene (Jungebluth et al, 2011), was slammed as based on misconduct, both ethical as well as research misconduct. It is the same Lancet paper Jungebluth presented to Berlin court as evidence of his scientific fame and excellence.

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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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Melo and Kalluri defend discredited Nature paper with preprint, where they admit data “adjustments”

Sonia Melo, the Portuguese cheater scientist and her former US-boss Raghu Kalluri issued some days ago a biorxive preprint, which sole purpose is to defend their discredited Nature paper from 2015. There, they originally claimed to have found a unique biomarker for early pancreatic cancer, a much hailed promise to save lives of many cancer patients. However, soon it was found out that the results were not reproducible, the Nature paper Melo et al, 2015 contained evidence of data manipulation (just like other Melo publications with Kalluri and her PhD boss Manel Esteller). The antibody, on which the central evidence for the allegedly unique pancreatic cancer biomarker glypican 1 (GPC1) was based, proved to be delivering staining artefacts; the vendor Thermo Scientific soon discontinued it. Even Kalluri seemingly distanced himself from his results.

Now in their new preprint, Melo and Kalluri claimed to have perfectly reproduced their original 2015 GPC1 results with a new antibody, which however proved to be likely exactly the same as the old one, but sold by a different vendor. As soon as this became known, the authors issued a new preprint version just two days later, featuring yet another entirely new GPC1 antibody, with an utterly new set of results to complement the 6 day older ones. However, also these results are most likely useless. The authors namely freely admit in their preprint method description to have intentionally manipulated their flow cytometry (FACS) data to obtain a positive signal specifically where needed. It seems that one full professor and three research group leaders have absolutely no understanding about data integrity in flow cytometry (or maybe even in research in general). Obviously, they simply adjust the FACS settings for each sample in an analytic row any way it pleases them until they see a result they like. As they don’t even hide it, they seem to think this is the proper way to do science. Continue reading “Melo and Kalluri defend discredited Nature paper with preprint, where they admit data “adjustments”” →

Carlisle’s statistics bombshell names and shames rigged clinical trials

John Carlisle is a British anaesthesiologist, who works in a seaside Torbay Hospital near Exeter, at the English Channel. Despite not being a professor or in academia at all, he is a legend in medical research, because his amazing statistics skills and his fearlessness to use them exposed scientific fraud of several of his esteemed anaesthesiologist colleagues and professors: the retraction record holder Yoshitaka Fujii and his partner Yuhji Saitoh, as well as Scott Reuben and Joachim Boldt. This method needs no access to the original data: the number presented in the published paper suffice to check if they are actually real. Carlisle was fortunate also to have the support of his journal, Anaesthesia, when evidence of data manipulations in their clinical trials was found using his methodology. Now, the editor Carlisle dropped a major bomb by exposing many likely rigged clinical trial publications not only in his own Anaesthesia, but in five more anaesthesiology journals and two “general” ones, the stellar medical research outlets NEJM and JAMA. The clinical trials exposed in the latter for their unrealistic statistics are therefore from various fields of medicine, not just anaesthesiology. The medical publishing scandal caused by Carlisle now is perfect, and the elite journals had no choice but to announce investigations which they even intend to coordinate. Time will show how seriously their effort is meant.

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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” →

For Better Science

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