The court trial against me by German trachea transplanters Heike and Thorsten Walles ended with the settlement in the appeal court in Bamberg. A costly one, which I had to accept, giving the danger of seeing me and my family driven to bankruptcy before the next very costly court instance can even be invoked for my defence, what with the two impending court fines for the alleged breach of the injunction Walles passed against me with the help of a certain evidence-allergic judge in Würzburg. My legal costs tally up to at least €12,000 and I am now stuck with those. On the plus side, none of my own and my generous donors’ money goes to Walles, they have to pay their own lawyers and half of the court fees, which made them very fuming and livid indeed, as their behaviour in the court room showcased. There the married trachea transplanters also made clear that they saw the operation on their 3 patients (described here and here) as successful research. This Walles stance is unblemished by the undisputed fact that their patients received no actual health benefits from those pig-intestine-based tracheal grafts whatsoever, in fact it looks quite the opposite. Thing is, those 3 operations were all performed in 2003, 2007 and 2009 as compassionate use, without any previous animal experiments, appropriate safety tests or in fact any ethics approvals. A question rises if, or rather how far Walles breached the Nuremberg Code of 1947 and the German medicinal product law, which forbid exactly that kind of research on patients.
After the Bamberg court settlement, Thorsten Walles went on to describe me in an email to a Swedish academic as a “convicted liar”. Which is most obviously libel from his side, because – neither was I convicted of anything by any court, nor was anything of my writings or sayings proven as a lie there. The past injunction against me and the threat of fines for breaking is lifted, no guilt was admitted or established. The “amicable settlement” I conceded to specifically states that I do so “without recognition of any legal liability “. This is what I agreed to accept:
a) Paolo Macchiarini did not contribute to the scientific development of the pig-intestine trachea implants. However, his central role as lead clinician in the transplant operation, the follow-up graft performance evaluation and the interpretation and publication of the results remain all undisputed.
b) no patient received a plastic trachea transplant. I had based my earlier reporting on the Albrecht book who talked about “künstliche” (in English (alternatively): artificial, synthetic, plastic) transplants. This reporting in the Albrecht book was obviously erroneous or at least misleading, and the University of Würzburg back then refused to answer to my requests for clarification. No plastic trachea transplants were in fact used, a technical error I corrected long before the injunction was passed.
c) that the graft of the 3rd patient did not fail, and that it did not cause him to suffer “very much”. Indeed, from the research perspective it even looks as a success, by virtue of being published in a scientific journal (Steinke et al, 2015), even though Walles presented that long deceased patient as being alive and well. I also may, of course, still claim that the implanted graft effected no real health improvement whatsoever with the 3rd patient. It remains undisputed that after the transplantation, there was a 6 months long heavy inflammation and a re-opened tracheostomy. Also, Thorsten Walles cannot know the actual extent of the patient’s suffering, he did not see the patient for over 2 years after the operation (Heike Walles is a biologist, with great interest in diagnosing patients and recommending therapies, read here). The Albrecht book also mentions the patient’s mental suffering in regard to re-opened tracheostomy.
d) the death of neither of the 3 patients was caused by the pig-intestine grafts. I am still free to say that patient 2 had his graft removed 14 days after the implant, because it necrotised and rotted inside. The patient suffered multi-organ failure and bled to death 4 weeks later.
This second patient, operated in 2007, was put under a harsh anti-coagulation drug regime by Thorsten Walles, in the course of the graft implantation (read here). Of course it may be indeed an utter coincidence that the patient then died from excessive internal bleeding. Interestingly, Walles’ applied this specific drug therapy despite his previous negative experience, with haemorrhage directly connected to his anti-blood-clotting treatment when another pig-intestine graft was first tested in the upper arm of the same patient (Mertsching et al 2009). Noteworthy in his regard is that the University of Würzburg decreed that Walles have been misrepresenting that patient’s clinical state in their publications. It appears, the 63 year old man was invited to participate as a research subject in a clinical experiment, due to his very short remaining life expectation.
The third patient, a psychiatrically treated suicide attempt victim, was never informed in 2009 of any of that when signing his “informed consent”. The biologist Heike Walles discussed his medical case over the phone with regenerative medicine watchdog Paul-Ehrlich-Institute, who supported her desire to transplant that allegedly dying patient with a pig-intestine tracheal graft, yet referred her to the proper German authority. Which Walles however never contacted for a permit and her husband went ahead with transplanting.
The tracheal grafts were apparently never subjected to appropriate safety tests before human transplantation (read here). Thus, it remains to be objectively elucidated what the patients were told about the tracheal implants safety when they signed their “informed consents” and how those likely heavily endotoxin-contaminated pig-intestine grafts fared inside them afterwards. It also seems all patients were misinformed about non-existent animal tests. In fact, Walles even now still maintain that the animal experiments were performed, though the organiser of the 2007 and 2009 transplants, the Fraunhofer Institute, proudly admitted to have skipped all animal experiments for ethical reasons. Also Walles employer, the University of Würzburg determined the absence of any animal tests (Walles are currently under extended investigation for suspected misconduct there).
In fact, Thorsten Walles recently left Würzburg University to a place some may consider to be somewhat less prestigious: the University of Magdeburg in eastern Germany, 400 km away from Würzburg where his wife Heike still holds her professorship. In Würzburg Walles used to be a full (W2) professor, but in Magdeburg he is listed as Oberarzt (consultant), instead of professor he now goes as “Privatdozent”. Is he still involved in any research, one wonders? Walles however declared in court (where he still presented himself as Prof. Dr. Walles, not as a mere PD Dr.) to have two more standing applications. One is with the University of Rostock, and the other with the University of Heidelberg and its Thorax Clinic, where Macchiarini’s acolyte Philipp Jungebluth tried to become a thorax surgeon until last year, and who is suing me about the nature of his departure from that clinic and thorax surgery altogether (read here).
With the court settlement I happily acknowledge that Heike Walles and her husband can claim their exclusive intellectual rights for developing that pig-intestine trachea transplant technology. Because, even though they said something else in their own interviews, they will not be able now to shift even a shred of responsibility for that “masterpiece” to Macchiarini. After wasting of up to €1.5 Million of public money for a clinical trial which has not really achieved even the first milestone, never mind operating the announced 15 patients (read here), Heike Walles declared in court that her technology will not be used ever again for trachea transplants, but for an obscure “something else”. Whatever this something else may be, it is unlikely to happen anywhere near a living human patient, or possibly even an animal, given earlier evaluations by Paul Ehrlich Institute. And of course, there is still the evidence of gross data manipulation in Walles publications, where part of this “something else” was described.
Dear readers, many thanks for your support with the Walles case. I hope I will find a way to refund you eventually, if my seminar speaker gig invitations become regular. Maybe your university or grad school is interested? Drop me an email at leonidDOTschneiderATgmailDOTcom.
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