Human Brain Project: bureaucratic success despite scientific failure

Human Brain Project: bureaucratic success despite scientific failure

The EU €1-Billion-Flagship Human Brain Project (HBP) has passed its midterm evaluation with flying colours. Noone knows exactly what the objectives of this bombastic project is, as members of the evaluation panel indicated to me, while others refused to answer this question. The HBP leadership sure keeps the exact definition of these objectives secret, or maybe they don’t know them themselves. Which is easy to understand, because given the leniency HBP keeps receiving from those supposed to evaluate it, its real objective becomes perfectly clear: to secure the public funding. There, HBP succeeded indeed, the €1 Billion seems rather safe. It is none of the public’s business where the money will go, but it can rest assured it will certainly go somewhere. The public should also not expect any deliverables or return on its research investment, this the HBP leadership already made perfectly clear. I am showing below what a farce the recent HBP evaluations were, while the positive outcome was much hailed as evidence for excellent scientific performance.  Continue reading “Human Brain Project: bureaucratic success despite scientific failure”

The vexatious life-saving question of cadaveric tracheas

The vexatious life-saving question of cadaveric tracheas

s we learned it from the Swedish documentary „Experimenten“, the scandal trachea surgeon Paolo Macchiarini didn’t much like to operate on sick cancer patients: they died too quickly after receiving a trachea transplant. This is why Macchiarini was said to have moved on to patients outside of any life-threatening conditions, like the Russian car accident victim Yulia Tuulik. She died because of the plastic trachea which Macchiarini implanted into her. Yesim Cetir, young victim of a botched operation, was slightly luckier to survive the plastic trachea, but only because it was removed and because of constant emergency care and multiple organ transplants (she is presently in very grave state). However, it seems that even Macchiarini’s cancer patients could have led a relatively long life, had they not agreed to receive his trachea transplants. And I am not speaking about the lethal plastic ones. In fact, the “biological” grafts made of decellurised dead donor tracheas were not such a great success either, and seem to have brought suffering and have shortened lives instead of prolonging them. The British UCL and its hospital UCLH are preparing their own clinical trial with cadaveric tracheas, while busily covering up their role in the Macchiarini scandal.

Continue reading “The vexatious life-saving question of cadaveric tracheas”

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., 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. 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.

Heike Walles wrote an email to a number of European stem cell researchers, where she declared:

“Dear colleagues,

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

Head of

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.

screenshot-www-tib-eu-2017-02-02-14-53-23
“Keywords: Trachea, Plastic Replacement”. Who’s speaking of plastic tracheas here? Sue yourself, Prof. Dr. Walles! Screenshot Thorsten Walles’ BMBF report from 2016.

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? 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.

Best regards,

Jan Hansmann

Dr.-Ing. Jan Hansmann

Gruppenleiter

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

Telefon +49 931 31-81209 | Fax +49 931 31-81068

www.ukw.de www.igb.fraunhofer.de/translationszentrum-wuerzburg

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.

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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”

Open Letter in support of my investigation of trachea transplants in Germany, by Rafael Cantera

Below a support letter by Rafael Cantera, professor of zoology at the University of Stockholm in Sweden, addressed to the leadership of the University Clinic Würzburg. This is because two professors of this German university, Thorsten Walles and Heike Mertsching (now Walles) chose to respond to my inquiries about their earlier trachea transplants made from pig intestine (see my detailed report here) with lawyers’ financial blackmail and right after, with court actions, which had me sentenced guilty with a  threat of a prison term of 6 months, without my prior knowledge (see case description here). Such are the peculiarities of German law: internet bloggers are basically  legally defined here by default as criminals, and professors as infallible and divine beings (in fact, even Walleses’ former boss and collaborator Paolo Macchiarini is still a protected adjunct professor at their former common place of work, the Medical University Hannover). I received lots of support from my readers, and was also invited to give an interview with the French magazine Mediapart (German version here). Now, I am deeply grateful to Prof. Cantera for his support, and hope other international and maybe even German academics join in and sign below.  Continue reading “Open Letter in support of my investigation of trachea transplants in Germany, by Rafael Cantera”

Macchiarini and his Russian megagrant

Macchiarini and his Russian megagrant

Below I am publishing the most recent dossier authored by the four whistle-blowers from the Karolinska Institutet (KI) in Sweden: Oscar SimonsonKarl-Henrik Grinnemo, Matthias Corbascio and Thomas Fux. Two of their earlier notifications of research misconduct to KI by their former colleague Paolo Macchiarini are available in full on my site, here and here.

This time it is about Macchiarini’s trachea transplants in Russia, and the so-called Megagrant funding he received from the Russian government for his work at the Kuban State Medical University in Krasnodar. The accusation goes that the KI star surgeon misrepresented the true outcomes of his two first disastrous human experiments with a plastic trachea, performed at KI on the patients Andemariam Beyene and Chris Lyles, both of who died. Also, the whistle-blowers criticise that KI failed to investigate these failed transplants and patient deaths and did not report those to the Russian authorities, which might have helped avoid the unnecessary deaths of at least two Russian patients, Yulia Tuulik and Alexander Zozulya. Continue reading “Macchiarini and his Russian megagrant”