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., the speed and kind of perfusion). Another worrying aspect is that the image seems not just duplicated, but one looks actually brighter and like a zoom-in of the other.
The first author on the younger paper (and 2nd author on the older one) is Johanna Schanz, who did her PhD under Heike Walles and then became a group leader under her at the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer IGB) in Stuttgart, with which the Würzburg professor Heike Walles is still associated. This is the same research institution which refused any responsibility for their own tracheal transplants and passed it entirely to the “treating doctors”. Fraunhofer IGB also refused to answer my questions, and refused to process my inquiry to investigate inconsistencies in the Walles publications featuring the two Fraunhofer transplants (Mertsching et al 2009 and Steinke et al 2015). Will Fraunhofer IGB bother to investigate this newly emerged suspected image duplication? Anyone’s guess.
For these same papers featuring the seemingly duplicated image, Schanz and Walles received two awards, the Fraunhofer Society “Technik für den Menschen” (Technology for People) Prize of €10,000 in 2009, and the German government’s “Research Prize for Alternatives to Animal Experiments” of €15,000 for Schanz herself. This even made into German main evening news on television, the Tagesschau. It is not clear however how this ground-breaking Schanz-Walles technology has developed since and how many labs in Germany and worldwide have adopted it. The discoverers have not published much in that regard since either, according to PubMed.
The Fraunhofer IGB is indeed very proud of avoiding animal experiments, in fact they happily subjected two human patients to tracheal transplants which were by this institution’s own admission never tested on animals as such. Both patients suffered complications (as evidenced by the 2013 book by Bernhard Albrecht), while a 2013 dissertation by Heike Walles’ PhD student Iris Dally revealed that the pig-intestine transplants generated with that technology were likely containing dangerously high levels of endotoxins (see details here), which are bacterial debris prone to cause heavy inflammation in patients. Neither of the three Walles patients is alive today, except, well, they do seem to be still alive on paper. To a naïve reader, these late patients seem to be doing very well, as evidenced by Walles’ papers Mertsching et al 2009 and Steinke et al 2015.
As I mentioned elsewhere, the University of Würzburg and the watchdog PEI refused to comment on these Walles transplants, but indicated that those never required an ethics approval since for such compassionate use cases, the sole decision of the doctor and patient’s consent are supposed to suffice. I tried to find out where the line is drawn, e.g., could a surgeon legally talk an uncurable migraine patient into an innovative brain transplant as a compassionate use therapy. This incompetent question was only met with silence from Würzburg ethics commission. So maybe this would indeed be legal in Germany?
It is not clear if Thorsten Walles, who was a mere junior doctor back then, had the authority to decide anyway. The first transplant in a patient was done in 2003 at the Hannover Medical School (MHH), and led by Walles’s then-boss, Paolo Macchiarini. In Stuttgart, where the other two next transplants were performed, Thorsten Walles’ ex-boss, co-author and head of thoracic surgery, Godehard Friedel, refused to clarify the question of responsibility. But even if Friedel helped Walles decide, the question of ethics vote remains. Was it needed or not? This information is so bizarrely sensitive that the watchdog PEI chose to break a federal Freedom of Information law by refusing to tell it to me. In fact it seemed PEI was completely at a loss how to classify Walles’ tracheal transplants, as the institute’s head Klaus Cichutek was quoted in this Spiegel article from 2014 (all patients were long since dead):
“The question was, what is it exactly: are those body parts, medicines or medicinal products?”
Maybe PEI was so confused back in 2007 and 2009 that they decided to stay out of this completely and to trust the Walleses to do this right? In a 2011 flyer for the German Ministry of Education and Research (BMBF), Heike Walles is quoted:
“Before the implementation of the Medicinal Product Law in September 2009, compassionate use was possible with the involvement of an ethics commission”.
It is not clear if her husband ever involved any ethics commissions to approve his tracheal transplants; given the graveyard silence, there is no reason to believe that he did. The decision was left entirely to him and his patient, apparently. In the same flyer, Heike Walles also spoke about a patient of theirs who received a pig-intestine-based tracheal transplant:
“We could show in the first compassionate use case before September 2009 that the tissue heals into the airways without any problems and the blood vessels grow in from the surrounding tissue”.
Which patient did she mean there? Because there were two of them. One was operated in 2007 and died just some weeks after, his transplant was said to have “rotted” inside due to “lack of a blood supply”. The other patient was the Indian immigrant Singh, who was transplanted on April 27th, 2009 and committed suicide in December 2011. This patient was not seen by his doctor Walles for “over two years” after that operation, which made Walles miss out the “many months”-long inflammation, the re-opened tracheostomy and the persistent coughing and wheezing of his patient, as described by the Albrecht book (also see details on both patients here). So how did the biologist Heike Walles know how her husband’s patient was doing and how excellently his transplant had worked out in early 2011? The BMBF-flyer was finalised on April 14th 2011, as evidenced by the pdf-metadata. In the good German tradition, the research institute Forschungszentrum Jülich, where this flyer was made, simply refused to tell me the publication date or when they received the Walles quotes. Given the pdf metadata, it seems that the biologist Heike Walles was publicly issuing a remote diagnosis on the patient whom her surgeon husband has not managed to see or examine yet. The Walleses did later on publish a 2.5 year follow-up biopsy of Singh (Steinke et al 2015), but again, the BMBF-flyer was finalised less than two years after the operation.
More than 2 years after Singh’s death by suicide, at a conference for “Technologies for cell-based translational therapies” in March 2014, Heike Walles described his tracheal transplant as a “successful compassionate use case”, and mentioned that such grafts were successfully tested in animal models. Which is weird, since her employer Fraunhofer obviously denied just that. Even Walles’ junior colleague, Jan Hansmann, failed to convince anyone about the existence of those animal tests, despite his best attempts to do so. Well, you can’t always trust Hansmann to get the facts right. He claimed in December 2014 on the University Würzburg website, that Walles’ 3 “successful” tracheal transplants happened after 2010, coincidentally just when the BMBF-funding for the clinical trial was running out and final evaluation approached. According to Heike Walles, 15 patients were envisioned to participate in that trial, which after around 5.5 years and up to €1.5 Million invested never really succeeded to achieve a single milestone.
Walles also was indirectly quoted in that conference report from 2014, in reference to that same BMBF-funded clinical trial:
“According to Medicinal Product Law, animal experiments as required for approval were performed and implanted into pigs to prove a functioning blood vessel system. The examination of transplants showed, that those were in time re-cultivated with the cells from the patient organism and were not distinguishable from the patient’s own tissue”.
Which pigs was Heike Walles talking about in 2014? Thorsten Walles declared in his own BMBF report from two years later, describing in 2016 the pathetic outcome of the same €1.5 Million clinical trial, that all large animal experiments were postponed and obviously never performed (see details here). There are also no publications by Heike Walles to support her conference claim of animal experiments, on either pigs or rats, successful or otherwise. I even checked if Heike Walles really did say all this about successful pig experiments. Petra Blumenroth, press speaker of the Bavarian government-associated conference organiser, told me that:
“these text passages were not spoken as such, but assigned to the presentation of Prof. Walles“.
The corresponding Walles presentation from the conference was not available. According to Blumenroth, Walles either did not submit it or did not allow its publication.
What kind of animals are those which Heike Walles keeps talking about, without ever presenting any evidence? Are they virtual-reality Fraunhofer-made cyber-organisms? Or were the mice about which the Albrecht book spoke (“In mice such a graft integrated perfectly”) actually computer mice?
If you want to nudge the reluctant University of Würzburg to finally investigate and come clear about all these inconsistencies, and to cease their silent support for Walles’ legal actions against myself, sign this Open Letter by Rafael Cantera.
Update 8.02.2017. The Editor-in-Chief of Journal of Biotechnology, Christoph Sensen, informed me that the issue of suspected image duplication is now being investigated by the publisher Elsevier according to COPE guidelines.