Walles court trial against me ends with “amicable settlement”

The court trial against me by German trachea transplanters Heike and Thorsten Walles ended with the settlement in the appeal court in Bamberg. A costly one, which I had to accept, giving the danger of seeing me and my family driven to bankruptcy before the next very costly court instance can even be invoked for my defence, what with the two impending court fines for the alleged breach of the injunction Walles passed against me with the help of a certain evidence-allergic judge in Würzburg. My legal costs tally up to at least €12,000 and I am now stuck with those. On the plus side, none of my own and my generous donors’ money goes to Walles, they have to pay their own lawyers and half of the court fees, which made them very fuming and livid indeed, as their behaviour in the court room showcased. There the married trachea transplanters also made clear that they saw the operation on their 3 patients (described here and here) as successful research. This Walles stance is unblemished by the undisputed fact that their patients received no actual health benefits from those pig-intestine-based tracheal grafts whatsoever, in fact it looks quite the opposite. Thing is, those 3 operations were all performed in 2003, 2007 and 2009 as compassionate use, without any previous animal experiments, appropriate safety tests or in fact any ethics approvals. A question rises if, or rather how far Walles breached the Nuremberg Code of 1947 and the German medicinal product law, which forbid exactly that kind of research on patients. Continue reading “Walles court trial against me ends with “amicable settlement”” →

Paul-Ehrlich Institute admits to have approved Walles tracheal transplant over phone, without questions

The German trachea transplanters Heike and Thorsten Walles treated the 3 patients with their pig-intestine-based tracheal transplants (one of them performed with Paolo Macchiarini). They are currently suing me in court for reporting about those, while their employer, the University of Würzburg, investigates these tracheal transplants together with the evidence for blatant data manipulations in several Walles publications on suspicion of misconduct. None of those 3 patients is alive today, yet Walles insist that neither of their transplant operations was in any way related to the patients deaths or that it might have reduced their quality of life. They keep declaring those operations as resounding successes, free from any evidence, though the last transplant was performed in 2009 and never again. A corresponding clinical trial, financed by the German Ministry of Education and Research with €1.5 Million between 2009 and 2015 (and briefly mentioned at the beginning of the PEI letter), did not achieve even a single milestone. Not even animal experiments were permitted by the responsible watchdog institution, the Paul Ehrlich Institute (PEI). For almost 7 months, PEI refused to answer my Freedom of Information inquiry. It seems however, my complaints to authorities and the Federal Ministry of Health, finally had an effect.

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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” →

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 him a cadaveric or plastic trachea. All these grafts were “regenerated” with bone marrow and epithelial cells, in some cases a bioreactor was used to incubate cells on the trachea carcass, in some cases a “bionic” method was applied, where cells were brought straight into the 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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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

Category: medicine