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.
Heike Walles wrote an email to a number of European stem cell researchers, where she declared:
You all received the attached e-mail of the German internet-blogger Leonid Schneider (LS). My husband and I are exposed to his defaming smear campaign since we made our stand against inaccurate and false statements about us and our work. Beforehand, LS never contacted us directly to obtain information about our work or to discuss his hypotheses. For the moment we try enforce our legal rights by a court order. Since LS confronted you with his allegations with the intention to involve you in his campaign, we want to state the following:
(1) We have cooperated with Paolo Macchiarini until 2005. We never were involved in the development or clinical application of his synthetical trachea implants. This is a lie put in the world by LS that he continues to repeat.
(2) The statement “the (tracheal) transplants were never tested in animals, in fact they proved too toxic for even simple subcutaneous tests in rodents.” is wrong and represents a lie.
(3) The account of our clinical results as “One patient died right away, the other suffered from heavy inflammation for months, his tracheotomy had to be re-opened, he eventually committed suicide.” is not accurate.
Please find attached the German court document which shows that LS continues to misinform the public despite better knowledge and information from our side. We also have assigned an official English translation of the injunction which we will sent to all of you asap. This document will expose the incorrect translation provided by LS to set up his defaming smear campaign against us.
In our eyes, the true motivation of LS is to destroy reputation, but not to improve science. His hatred can hit any scientist. Including you. Therefore, please scrutinize the information provided by LS and do not become engaged in his unworthy campaign. If you feel that we have made scientific mistakes we of course are happy to clarify them in a fair process. Please contact us if you have questions.
Heike and Thorsten Walles
Prof. Dr. Heike Walles
Department Tissue Engineering and Regenerative Medicine (TERM), University Hospital Wuerzburg and
Translational Center Wuerzburg ´Regenerative therapies in oncology and musculoskelettal diseases`
Wuerzburg branch of the Fraunhofer-Institute Interfacial Engineering and Biotechnology, IGB”
The point 1 is a twisted misrepresentation. In fact, what Walleses categorically denied to the German court was that Macchiarini ever had anything at all to do with their method of pig-intestine tracheas and its transplantation into patients. The Würzburg court conveniently agreed and basically sentenced me never to suggest that the paper where the first patient transplant (for which Walles claimed to court exclusive responsibility) was reported, had Macchiarini as co-author. Well, see for yourself if this court injunction makes any sense: Macchiarini et al, 2004, “First human transplantation of a bioengineered airway tissue”. Check who the sole corresponding author is.
Point 2 I will address below, but Point 3 is simply bizarre, because Walleses even admit all of its content in their own court testimonies. They seem to think however that the expertise of Thorsten Walles as surgeon was somehow that tremendously grand that he is able to assess the patient’s state and the performance of the graft remotely and retrospectively. The fact is (as evidenced by the Bernhard Albrecht book from 2013, which described that operation, and which I am now legally barred from quoting under the threat of a 6 months prison term) that Thorsten Walles never saw his patient Singh for over two years after he transplanted him with the pig-intestine made trachea implant. Even though Walles missed out on this patient’s subsequent heavy “many months”-long inflammation and re-opened tracheostomy, his authority as Würzburg professor of thoracic surgery suffices entirely to dismiss those incidents as utterly irrelevant and in fact libellous to consider the allegedly excellent performance of his transplant.
This tidbit of information from Walles’ own report to the German Ministry of Education and Research (BMBF) is worth following up upon:
“The applicants developed using the methods of bioengineering the BioVaSc, a biological replacement tissue with its own blood vessel supply, and applied it between 2004 and 2007 as one of the first groups worldwide for the reconstruction of extensive airway defects on 3 patients within the framework of compassionate use. This therapy option was first legally regulated into the German federal law the form of the Tissue Law, through the implementation of the EU- guidelines 2004/23/EG, 2006/17/EG and 2006/86/EG, for the first time from 1. August 2007 on. A subsequent clinical use of BioVaSc for the reconstruction of an airway defects in the framework of compassionate use would represent a punishable offense against the German Medicinal Product law (AMG)”.
Here is the Tissue Law in question. Did Walles break it by operating the patient Singh on April 27th 2009, which he apparently declared as compassionate use case?
Update 23.03.2017. As it turned out, also the previous patient was operated AFTER the Tissue Law became officially binding, in August 2007 (see this report).
The subsequent publication (Steinke et al, 2015) makes no mention of any ethical votes or official permits aside of patient’s informed consent (the Stuttgart hospital, Clinic Schillerhöhe, refused to explain or give me the patient information sheet or the empty form which Singh signed). The University of Würzburg head of the Ethics Commission, Eva-Bettina Bröcker, indicated to me that in her view this operation was a compassionate use case, and as such needed no ethics vote. Same was generally confirmed by the head of Press and Information Office at the federal watchdog Susanne Stöcker Paul-Ehrlich-Institut (PEI), without however addressing the 3 specific cases of Walles transplants. This institution however is currently breaking a federal law itself, namely that of federal Freedom of Information (FOI), by refusing to give me a simple reply if the 3 Walles transplants were performed in accordance to valid laws (I now complained about this to the respective federal authority).
In the same BMBF report Walles admitted that lab tests revealed too high endotoxin content in his BioVaSc tracheal transplants, and that experiments on large animals were not approved by PEI. This happened years after Walles transplanted 3 human patients.
Dr.-Ing Hansmann, with expertise in “Tracheal tissue engineering” who knows all about animal experiments which did or did not happen far away while he studied engineering (source: Siemens magazine, under fair use).
Maybe the public has the right to know this? Walles’ employee Hansmann however sees things very differently. He now contacted every single signatory of the Open Letter to the University Clinic Würburg by Rafael Cantera, informing them that:
“I am a colleague of Prof. Heike Walles.
Since a few weeks, I am following the blog of Leoind Schneider on his webpage “forbetterscience.com”, and the disturbing trend makes me concerned.
I would like to comment on a few of the presented statements. For example, in the blog “Untangling forgotten tracheal transplants of Heike and Thorsten Walles, who set a lawyer upon me” in section “Silent night”, Leonid Schneider states that “… Siemens magazine refused to explain and Hansmann never replied to my email”. There is only one e-mail addressed to the Siemens magazine I was cc. From this correspondence, I know that Siemens replied, but the response did not support Leonid Schneider hypothesis, and I cannot find it on his website.
Another example is the statement that no animal tests were performed. Leonid Schneider draws this conclusion from a response from Fraunhofer. Fraunhofer never stated that no animal test were performed. Fraunhofer rather replied that due to the existing work, no animal tests were done in the requested timeframe.
As far as I am informed, also the regulatory body the Paul Ehrlich Institute provided information to Leonid Schneider.
Interestingly, Schneider also states that there was a trial, in which he was found guilty without having the chance the present his situation. The letter he received is only an injunction that is part of an interim legal protection, and for sure, Leonid Schneider had/has the right to lodge an objection (please see http://www.gesetze-im-internet.de/zpo/__924.html). Schneider prefers to present himself as a victim of the German justice and makes suggestive movements by mentioning “Mein Kampf”. Do you really think that somebody will be sent to prison without a fair trial in Germany?
Thus, I think that some of the statements are strongly biased and I am sad that scientists take site without contacting the accused persons to get a second opinion.
Dr.-Ing. Jan Hansmann
Universitätsklinikum Würzburg – Lehrstuhl Tissue Engineering und Regenerative Medizin (TERM) und
Fraunhofer-Institut für Grenzflächen- und Bioverfahrenstechnik IGB
Translationszentrum »Regenerative Therapien für Krebs-
und Muskuloskelettale Erkrankungen« – Institutsteil Würzburg
Röntgenring 11, 97070 Würzburg, Germany
Well, here is that informative Siemens response, and also my entire communication with them:
“With respect to your answer Siemens cannot make any statement to the details of the story. Please contact the Uniklinikum Würzburg for this”.
As I already mentioned above, the medicinal product watchdog PEI chose to break the federal FOI law and not to tell me anything at all about Walles transplants. Hansmann thinks this is exactly the kind of reply I should have satisfied myself with. I agree with Hansmann here that this kind of response “did not support Leonid Schneider hypothesis” of some obscure public right to know what is being done to patients in German hospitals. I am however not sure why none of this is anyone’s business, especially given that there is nothing at all to indicate that the Walles method was ever tested on animals like the engineer Hansmann insists. This is the response of the Fraunhofer Institute in Stuttgart again (full quote here), to which Hansmann refers in his mass email:
“In the case of the project for the production of an autologous trachea graft, no animal experiments were necessary until 2009 due to the preliminary work of Prof. Walles in Hanover. The publications can be found via PubMed”.
There is NOTHING at all on PubMed even suggesting that any tracheal grafts were ever tested in animals prior to 2004 when Heike and Thorsten Walles left MHH and moved to Stuttgart. Not even long-term subcutaneous biocompatibility or toxicity tests were performed, judging from that same PubMed. According to his CV on LinkedIn, Hansmann never set foot at MHH professionally (he was a young student of engineering elsewhere back then), his entire career happened under the guidance of Heike Walles, first in Stuttgart, now in Würzburg. Is he really expecting scientists to trust his authority as a German engineer with a doctorate that there were indeed animal experiments performed at MHH prior to 2003 (when the first patient was transplanted by Walleses and Macchiarini), which these scientists somehow forgot to publish so far? And even if there was some secret animal testing at MHH, what was its outcome? Why was the next patient nevertheless operated in Stuttgart in 2007, whose Fraunhofer-made pig-intestine transplant according to the Albrecht book “rotted” inside his body without a blood supply? A patient who died just some weeks after the operation (according to Walles himself), but who now re-appeared suddenly, seemingly very much alive and cured with a perfectly integrated graft, as mentioned in Steinke et al, 2015, where the alleged success of the 3rd late patient, Singh, was discussed in this way:
“These results confirm our previous report in another patient 6 months after airway reconstruction that the tissue-engineered transplant facilitates the complete regeneration of the airway defect.10”
It’s probably all none of our business really. When two German Professors and a Dr-Ing tell you something out of their sheer authority, you are not supposed to ask for evidence. Or even worse, dare to present your own. So far, the German court in Würzburg has followed this argument. Let’s see for how long.