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

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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Data manipulation evidence in Helin Vakifahmetoglu papers “warrants no further consideration”

Data manipulation evidence in Helin Vakifahmetoglu papers “warrants no further consideration”

The Swedish Karolinska Institutet (KI) has investigated its own cell biologist and well-funded autophagy researcher Helin Vakifahmetoglu-Norberg, following my publishing of a dossier with evidence for data manipulations in her papers. Also PubPeer evidence was considered. This was a second investigation of Vakifahmetoglu-Norberg, who was fully acquitted by KI already in 2016. While the new KI investigation progressed, one of Vakifahmetoglu-Norberg’s publications was retracted (Shen et al, Oncogene 2008), due to image duplications and unavailability of original data. With their second decision, KI again exonerated  Vakifahmetoglu-Norberg from all suspicions. One of the reasons was: since the Shen et al 2008 is retracted, it ceases to exist. Hence, all image duplications it shares with other Vakifahmetoglu-Norberg papers cease existing also. Other arguments were the author’s assertions to have reproduced more than 10 year old results faithfully (since the original data was unavailable), or her presenting evidence that similar looking images were in fact dissimilar. Unfortunately, where such original data could be recovered, it was shown only to internal investigators at KI, noone else. The case is closed, no appeal is possible. There will be no corrections even, unless journals do the unlikely thing and decide not to accept the KI decision.

Another Vakifahmetoglu paper (Imreh et al, J Cell Biol. 2011) is still under KI investigation but she has officially nothing to do with it. KI announced to follow this through with her former boss and the paper’s last author, Boris Zhivotovsky. He is under another KI investigation already, together with several of his colleagues including the  department’s prefect Ulla Stenius (see my report here), who received the KI letter about  Vakifahmetoglu whitewashing in cc.  Continue reading “Data manipulation evidence in Helin Vakifahmetoglu papers “warrants no further consideration””

German Leibniz institute director Karl Lenhard Rudolph guilty of misconduct

German Leibniz institute director Karl Lenhard Rudolph guilty of misconduct

A major misconduct finding hits German life sciences. Karl Lenhard Rudolph, stem cell and ageing researcher, director of the Fritz-Lippmann-Institute (FLI) of the Leibniz Society, was found guilty of research misconduct by an investigation of the Leibniz Society, in a decision published on June 15th. 11 papers in total were investigated, going back as far as 2001. One paper is to be retracted, seven Errata were requested. The investigation confirmed duplications of image parts, inappropriate splicing, rigged loading controls etc. No original data or lab books were available.

Just in Mai 2016, Rudolph’s FLI was raided by the police “on  suspected breaches of the animal welfare and drug law, as well as embezzlement” . All animal experimenting was stopped till present day, according to Radio Jena, other sources quoted Rudolph in May 2017 that mouse experiments were approved again, though the police investigation continued. Rudolph also admitted that his own lab was also part of the problem and that 13,000 mice were killed unnecessarily. Was Leibniz Society’s recent tough and public disciplinary action upon FLI director Rudolph the consequence?

The translated report on Rudolph’s research misconduct (my own version) is published below, the German original is here. I have not yet determined which publications from Rudolph lab were investigated, but 5 Rudolph papers were previously flagged on PubPeer. His institute, located in the Eastern German town of Jena, is now banned from Leibniz funding for 3 years, FLI now must report back to the Leibniz Executive Board until November 1st 2017 on the improvements regarding data documentation, quality control as well as tutoring and supervision of employees. Continue reading “German Leibniz institute director Karl Lenhard Rudolph guilty of misconduct”

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

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”

Journal announces to clean up past literature, gets “smeared” by Retraction Watch

Journal announces to clean up past literature, gets “smeared” by Retraction Watch

On June 9th 2017, the research integrity news website Retraction Watch brought an article titled: „Journal won’t look at allegations about papers more than six years old, nor from “public websites””. A public outcry followed, protesting about what was perceived an outrageous case of editorial cover-up of research fraud. The journal in question was Molecular & Cellular Biology (MCB), published by the American Society for Microbiology (ASM); the vituperative Retraction Watch article was prompted by an editorial in the June issue of this journal. The problem with that name-and-shame Retraction Watch article however was: the accusatory title did not fit their own main text at all, which did actually clarify that evidence on public websites like PubPeer is in fact very much looked at by the MCB journal editors, just not publicly commented upon. And that:

“The ASM spokesperson explained that, like the ORI, ASM journals will make exceptions to the six-year statute of limitations, for instance if older papers “provide evidence of an extensive pattern of misconduct.””

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Expert review: Macchiarini papers on plastic trachea transplants are misconduct

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

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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