On March 16^th 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).

In fact, we wasted the entire trial of around one hour of debating whether the first, last and corresponding authorship of their former superior Paolo Macchiarini ever qualified him as a scientific collaborator on the first tracheal transplant with the pig-intestine-based patch which they performed in Hannover. Walles categorically deny Macchiarini’s role and wish all the fame and admiration for themselves, hence their claim of libel against me. They insist they recruited Macchiarini in 2003 as a service surgeon to transplant the organ they created all by themselves (even though Thorsten Walles himself said something rather different in an earlier interview):

“I could convince my then-boss Paolo Macchiarini of the concept of treating such injuries with bioartificial tissues. Together, we modified the methods developed by Prof. Mertsching [Heike Walles’ name back then, -LS] and myself for the production of human bioartificial tissues for tracheal transplants. As early as 2004, we were able to successfully treat the first patient”.

The operation actually took place in summer 2003. The patient died 17 months later, the actual success of that operation, just as that of the following two, is highly debatable (see my report here). As a reward for having done as ordered, Macchiarini was generously allowed by Walles to be first author on their paper describing the operation (Macchiarini et al 2004) and the last author on their paper describing the technology (Walles et al 2004), and corresponding author on both. This, the judge was educated by Heike Walles, is the custom in biomedicine. I had no opportunity though to ask if this silly claim applies everywhere except to her own papers, where she rightfully got first and last authorships for being the scientist in charge. Those papers by the way are full of clear evidence of data manipulation (see my report here), for which Walles are now under investigation in Würzburg and Hannover.

Otherwise, Thorsten Walles presented himself as an unbiased expert of his own surgeries and decreed to the judge that all transplants worked out excellently and I had no right to ever mention the patients’ deaths. In fact, he and his wife declared their patients’ deaths scientifically irrelevant, this is also why they openly admitted to have deliberately omitted them from their publications. Walles then explained that he did mention those patients’ deaths in some (rather obscure) German-language interviews and that should fully suffice to inform the public.  In addition, his lawyer made clear to the court that scientific publications are utterly irrelevant as evidence and mean absolutely nothing. What alone counts, is the word of his clients, except of certain contradicting things Walles said in his own interviews, those are also to be disregarded as unreliable evidence. Basically, the court was instructed to follow the twisting story Walles keep narrating free from any evidence, even if their story constantly contradicts itself and keeps changing abruptly every time they get caught saying untruth. It didn’t matter a bit that Thorsten Walles previously under oath declared himself to be the only surgeon who operated that Hannover patient. Now he admits that it was Macchiarini who transplanted the graft, yet did Walles’ crime of perjury count so far in court? So far, it did not, just like in the following instance.

Thorsten Walles namely previously declared to court under oath that the next patient he operated (in 2007) died from “his airway illness”. At the March 16th court hearing, he elaborated that he implanted that pig-intestine-made tracheal graft in order to reduce a chronic inflammation in his patient’s throat. This is from the medical point of view more than counter-intuitive. That pig-intestine-based graft was never before tested for its immunogenic response in animal models (or in fact even afterwards, see report here). It was most likely highly contaminated by inflammation-causing endotoxins, as later measurements by Walles themselves clearly suggested. At the hearing, Walles again insisted that this patient died from pneumonia. Do read his true cause of death here, I am not sure that emergency-removed graft, followed by internal haemorrhage inside the airways and into the lungs and multi-organ failure are classical highlights of pneumonia. All this seems to indicate a rather different cause of death. Yet again, the court offered us no possibility to challenge this outrageous claim or to point out the repeated perjury Walles was obviously committing.

Noone cares

I was denied information almost everywhere. The Fraunhofer Society is a federally funded network of research institutes, but they simply denied to me being subject to the federal law of Freedom of Information (FOI). Instead, Heike Walles’ Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer IGB) refused to process my evidence of data manipulations in her papers and instead have been apparently forwarding my emails to Walles, in order to assist her with her court case against me.  Why is Fraunhofer behaving so weirdly? Well, their goal was to establish a new Fraunhofer Institute for Regenerative Medicine in Würzburg, at which university Heike Walles now holds a professorship. The grand project was funded with €10 Million by the state of Bavaria, in 2014. The Fraunhofer Society pumps additional money into this; they only recently proudly announced that Heike Walles became member in the German Academy of Technical Sciences. Obviously, the engineers of the Fraunhofer are looking forward to churn out lab-made human tissues and organs on a conveyor belt from their brand-new Würzburg facility. And given their demonstrated attitude with Walles patients in 2007 and 2009, Fraunhofer doesn’t give much of a toss about how these masterpieces of tissue engineering fare inside their patients. Or if indeed, these pieces of pig intestine get implanted into the grossly misinformed human beings legally.

Exactly this is a big question. Walles themselves insinuated in several own quotes that their transplants might have broken the German laws (see this report, and also here). This is exactly why everyone refuses to share any facts or assessments. Breaking laws which serve patient protection is a criminal offence, and Thorsten Walles was in trouble with authorities before, in 2009, after he operated his last patient (see here). So now all institutions close ranks to protect him from my nosy inquiries.

The Stuttgart-area-based hospital where Walles transplanted their last two patients, Clinic Schillerhöhe, refuses to tell anything while hiding behind doctor-patient confidentiality. The federal watchdog Paul-Ehrlich-Institute, which official task is to promote ”quality, efficacy and safety of biomedical drugs through research and testing”, keeps weaselling out from answering my FOI inquiry about the ethics and legal status of the three Walles tracheal transplants. Since early December 2016, my emails are either ignored or (after I complained to the overarching authority, the Federal FOI office) are repeatedly postponed because the PEI people are always, always, very, very busy. The official deadline for a FOI reply is one month, by the way.

The University of Würzburg refuses to tell me if they bothered to obtain all medical files of the Walles patients, or only the one Walles wrote himself. The point is, his last patient, operated in April 2009, was right after cared for by other doctors only. Walles had no access to this patient for at least 2 years, that is if he ever since did. The Würzburg investigative commission refuses to name the date when Walles allegedly performed the biopsy on that patient (published as  Steinke et al, 2015). Even the Walleses are unable to assign this biopsy to any part of 2011 (see this report). The patient committed suicide at the end of the year, 2.5 years after the transplant. Was that indeed a biopsy of a living patient or an autopsy of a dead one? No authority wishes to answer this question. Würzburg University does react to my emails though. They quickly removed two webpages where Walles lied about “successful”, but utterly fictional, animal experiments with tracheal transplants (backup copies here and here).

The Ethics Commission of the medical faculty of the University of Tübingen had a meeting on March 13^th to debate the Walles operations. Update 25.03.2017: the Ethics Commission decided that the Würzburg investigative Commission possibly mislead the public when it claimed that ethics votes were obtained. It also cautiously supported my concern about the legal correctness of Walles patients’ “informed consents” (see letter and  details here).

Another authority, which according to Walles approved their operation, is the Ärztekammer, the Medical Association. I tried twice to get them to investigate the Walles operations, and was twice told to go away, by their central “Department 6 – Science, Research and Ethics”. I succeeded the 3^rd time, and once again sent all my articles as evidence. This is the reply I eventually received (full letter here), signed by Ass. jur. Annett Montes de Oca, of the legal department of the Medical Association:

“As a result of our audits, we have to inform you that there is currently no ground for a concrete suspicion of a breach of duty, whereupon a further investigation could be supported.

According to legal regulations, the Medical Association of the state Saxony-Anhalt is responsible for the regulation of the professional duties of the doctors and the monitoring of their compliance, as well as the perception of the professional interests of its members. […]

In so far as concrete facts are put forward, which supports the suspicion of a unprofessional behaviour, we are required to carry out an investigation according to professional law. To this end, we have interviewed the affected chamber member [Thorsten Walles, -LS] and could question witnesses. On the other hand, an inspection of premises or the confiscation of documents are not legally permitted to us, unlike to the Prosecutor’s Office.

You have raised the general accusation that the doctor performed experiments with people, also with a fatal outcome. Ethics approvals were not obtained. Publications were made with false representations. Deaths were hushed up. There were abuse of official position and justice, threats and coercion.

These general claims are lacking the concrete case design. Any information about the time frame are missing. Also, it is not known which persons concretely were affected, which experiments were specifically carried out where and when or which studies could not obtain an ethics vote as well as in which concrete cases the doctor has threatened or coerced someone. No concrete persons or backgrounds are named in the publications. […]

We regret to have to inform you that in view of your previous statements we are not in a position to start an investigation in accordance with professional law, so that we consider the process with this letter as finished”.

I replied and reminded Montes de Oca of all the articles on my site which I submitted together with my request for investigation. Maybe the problem was that they were in English, an obscure foreign language unfamiliar to the German doctors of the Medical Association, which they then dismissed as some raving gibberish by a paranoid village idiot who is afraid of people in white coats. Montes de Oca eventually wrote to me again, explaining that the Medical association indeed never considers foreign-language evidence and the cases from 2007 and 2009 were beyond the 5-year deadline anyway.

The Walles story gets more and more Kafkaesque, and it would be funny were it not for my already now bombastic legal costs.

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Update 13.04.2017. Yesterday I finally received the decision from the Würzburg court. The judge followed the arguments of Walles and upheld 4/5 of the injunction. In summary, the judge asserted the factual correctness of my statements, but decreed that they cannot be made anyway as they hurt the careers of Walles. The court decided:

• Macchiarini had by court decision no role whatsoever in the development of the pig-intestine-based tracheal transplant, which he implanted in the first patient in Hannover and published as corresponding author in (Macchiarini et al 2004 and Walles et al 2004). By court decision, Macchiarini only ever performed research with plastic tracheas, and not with implants based on decellurised tissue, e.g. pig intestine. Any assumption to otherwise constitutes libel towards the exclusive scientific discoverers of this successful method, Walles.
• The death of the second patient in Stuttgart was utterly unrelated to the transplant, despite the uncontested fact that the transplant had to be removed and that patient died from airway haemorrhage and multi-organ-failure less than 7 weeks after the operation. This cause of death was by court decision clearly a symptom of the patient’s airway defect. To name this death in the context of the tracheal transplant constitutes libel of Walles.
• The compassionate use operation on the third patient, Singh, was a full success. This is based on the assertion of Walles that the transplant healed well, and has apparently nothing to do with the success definition of whether this healing attempt brought any curative or life-quality-improving effect to the patient (as mandated by the law on compassionate use). The graft was also found by court as “not attacked by the patient’s immune defence“, though the court did quote elsewhere the Albrecht book describing a many-month-long heavy inflammation which followed the operation. To assume that this tracheal transplant has failed in any way constitutes libel of Walles.
• The re-opened tracheostoma of the patient Singh was unrelated to the performance of the transplant, even if Walles has initially closed it after the operation, and other doctors had to open it again. To assume a correlation between the reopened tracheostoma and the performance of the tracheal transplant constitutes libel of Walles.
• The suicide of Singh cannot be mentioned in the context of the tracheal transplant, because it is proven as medically unrelated, also from the psychiatric perspective, since it happened whole 2,5 years later. To mention this patient’s suicide while describing the tracheal transplant constitutes libel of Walles.

Update 19.04.2017. The same judge now sentenced me to a fine of €1000 plus court costs for publishing the original injunction. The verdict is: if I ever report, or even privately tell any potential supporter or a media journalist what I was exactly sentenced for, I will be facing further, much higher fines, up to imprisonment, should I not be able to pay those. This is not a Kafkaesque exaggeration, this is a real and actual decision in the name of the people by a German court against a journalist in 2017.

I will of course file an appeal with the higher court (Oberlandesgericht) against this decision.

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