Will words or actual evidence count in the Walles case?

Will words or actual evidence count in the Walles case?

On March 16th I stood a court trial by the trachea transplanters and University of Würzburg professors  Heike and Thorsten Walles against myself. The judge (it was the same who passed the injunction against me) will announce his decision on April 6th, just as I will stand trial in Berlin against their trachea transplant colleague Philipp Jungebluth (see this report). I publish here an extended memory-based protocol which I first published on Facebook. Meanwhile, several large institutions built a protective wall of silence around Walles and their tracheal transplants. The German Medical Association refused investigation in a bizarre letter which I also publish below.

The court hearing

It was the so-called speed trial, so instead of examining evidence, everyone was free to tell the judge their views. Mostly, Walles and their lawyer spoke, occasionally, my lawyer and I were able to squeeze a word in to reject the outlandish or false claims. For example, while her lawyer insisted the tracheal transplants were full success despite dead patients, Heike Walles challenged me to compare her transplants with the first heart transplant which failed. I pointed out that this is exactly the same argument Paolo Macchiarini uses to defend his own failed trachea transplants (for example, here). Continue reading “Will words or actual evidence count in the Walles case?”

Walles tracheal transplant patients: secrets and lies

Walles tracheal transplant patients: secrets and lies

The German trachea transplanters Heike and Thorsten Walles fitted three patients with pig-intestine-based airway grafts. They responded to my inquisitive reporting about these with a court injunction, the trial takes place this week, on March 16th. A commission of their Unversity of Würzburg initially absolved Walles of all suspicions of research misconduct, only to start the investigation anew as evidence of heavy data manipulation in their papers emerged (see my previous report). Roland Jahns, specially recruited as medical expert from the same University Clinic Würzburg where both Walleses work, was dismissed after he insulted me as “pseudoscientist” to defend his colleagues’ questionable attitude to data integrity, medical ethics and patient welfare. A new expert will be recruited, but Jahns did reveal some clues to what happened to the two last Walles patients operated in Stuttgart in 2007 and 2009, just before they received their professorships in Würzburg.

It appears Thorsten Walles issued two radically opposing versions of the 2007 patient’s state. In his publications, he presented the intervention as “compassionate use” case and the patient as stable, but in need of innovative strategies to cure his condition. In the medical file however, Walles described the patient as terminally ill and dying from cancer. The intervention to replace his airways with a never-before-tested pig-intestine large patch was presented as a palliative approach, which however turns the entire concept of either palliative care or compassionate use care on its head. In any case, the graft had to be removed after only 2 weeks, the patient died four weeks later due to massive bleeding and multi-organ failure. Walles decided that this disastrous incident had nothing to do with the transplant, so when they recruited their next patient to sign an informed consent in 2009, they simply didn’t tell him what happened to his predecessor. That last patient was also post-suicidal and in psychiatric treatment (though not yet officially of unsound mind, his mental state further deteriorated later on). Continue reading “Walles tracheal transplant patients: secrets and lies”

Würzburg misconduct Commission acquits Walles, dismisses biased medical expert, restarts anew as data manipulations flood in

Würzburg misconduct Commission acquits Walles, dismisses biased medical expert, restarts anew as data manipulations flood in

The University of Würzburg did not ignore the Open Letter in support of my journalism, and has concluded its internal investigation into medical and scientific activities of their trachea transplanters Heike and Thorsten Walles, without finding any misconduct. This was however not the end of it. I was invited to appeal this decision in front of the commission, which I did on March 6th 2017. In the end, the medical “external consultant”, Roland Jahns (specialist in inner medicine from the University Clinic of Würzburg) was catapulted out of the commission after insulting me as “pseudoscientist” and the entire investigation will be re-opened, with a new consultant to be recruited. The main reason: a newly emerged wealth of evidence of gross data manipulations in the papers by Walles, which readers of my site posted on PubPeer just when I arrived in Würzburg to give evidence.

During my discussion with the Standing Commission for the Investigation of Scientific Misconduct of the University of Würzburg on March 6th, I was also told that the commission does not see my original text, for which I am facing a court trial on March 16th, as factually wrong. All information provided there was deemed correct except of one aspect: my readers were said to be led to misunderstand that the trachea transplant operations took place in Würzburg (while they happened in Stuttgart). The commission made clear that their university does not want to be associated with these transplants. They did however admit that the misunderstanding arose because Walles themselves have been placing such false information in media (including this recent article in the Siemens magazine), and even on the University of Würzburg website. The commission however assigned to me the responsibility of checking in advance the truthfulness of such obscure sources.  Continue reading “Würzburg misconduct Commission acquits Walles, dismisses biased medical expert, restarts anew as data manipulations flood in”

My Walles trachea transplant reporting fails peer review

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”

Image duplication and other irregularities of Heike and Thorsten Walles

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.

Continue reading “Image duplication and other irregularities of Heike and Thorsten Walles”

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

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”

No animal testing before Walles tracheal transplants, admits Fraunhofer Society

No animal testing before Walles tracheal transplants, admits Fraunhofer Society

The tracheal transplant experiments on three human patients were performed by the German scientists Heike and Throsten Walles without any previous animal testing, as now admitted to me by the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer IGB) in Stuttgart.  It also came to light that the pig intestine-based tracheal transplant was eventually deemed as too toxic, and a follow-up animal testing was apparently cancelled. Heike Walles is still associated with Fraunhofer IGB while being together with her husband employed as professors at the University Clinic of Würzburg. A patient of theirs received in 2007 a tracheal transplant of unknown size and shape, prepared from decellurised and in vitro re-populated pig intestine; this unnamed person died only some weeks after, of causes unknown to us. We know however, that two weeks before that operation, a tubular tracheal graft made from pig intestine was test-implanted into the patient’s arm for a week. After a quick analysis, a second in parallel prepared graft was implanted into the patient’s airways. Remarkably, only preliminary first in-arm test, but not the main operation, was ever published (Mertsching et al 2009), around two years after the patient’s death. The next patient, an Indian immigrant Pavninder Singh, received a large tracheal patch, which apparently did not perform as expected: the patient’s tracheostomy had to be re-opened, there was also apparently heavy inflammation. That patient committed suicide 2.5 years after the operation, and became in 2013 a central character of a book chapter which described his and the scientists Walles’ story (Bernhard Albrecht, “Patient of My Life”). Only in 2015 was the case of that patient published as a research paper (Steinke et al, 2015), his tracheostomy went for some reason unmentioned, just like the fact that Singh was no longer alive since 2011. All these tracheal transplants were prepared in the lab of Heike Walles (back then under her former husband’s name Mertsching) at Fraunhofer IGB, the transplantations took place at the neighbouring  Robert Bosch Hospital, Clinic Schillerhöhe,  where Thorsten Walles used to work as surgeon, before becoming professor in Würzburg. The details can be read in this article. Continue reading “No animal testing before Walles tracheal transplants, admits Fraunhofer Society”