Walles misconduct investigation in Würzburg widens inside a federal cover-up; Jungebluth’s dissertation whitewashed in Hannover

The court litigation of the German trachea transplanters Heike and Thorsten Walles against me and my reporting has moved into the appeal stage. The appeal hearing will be on July 3rd 2017 in the Bavarian Higher State Court (Oberlandesgericht) in Bamberg. At the same time, the Walles case turns into an institutional conspiracy farce straight of a bad spy novel, which seems to go up to the very top, including the German government.

The central German watchdog on regenerative medicine, the Paul Ehrlich Institute (PEI), keeps breaking German federal law on Freedom of Information (FOI, Informationsfreiheitsgesetz) by refusing to comment on the legality of the 3 tracheal transplants Walles performed (one of them with Paolo Macchiarini). The FOI oversight authority (Bundesbeauftragter für Informationsfreiheit) failed despite several attempts to get PEI to adhere to this federal law and gave up, after admitting to me to lack any means to enforce it.  My repeated complaints to the German Federal Ministry of Health, under whose roof PEI operates, did not even achieve an acknowledgement of receipt.

Meanwhile, their current employer, the University of Würzburg, has widened its misconduct investigations against Walles, to collaborate with their past employer, the Hannover Medical School (MHH) and the hospital where two tracheal transplants were performed by Thorsten Walles, the Clinic Schillerhöhe in Stuttgart.  It is another question how collaborative or in fact keen on investigating anything at all these two institutions will be. The Stuttgart hospital decided to transplant two patients in 2007 and 2009 with Walles-made pig-intestine-based tracheal grafts in absence of own internal ethics review board and without procuring an ethics vote from an appropriate external institution (instead, they approached an inappropriate one, were sent away, and published this refusal of ethics opinion as an ethics approval).

The medical university MHH on the other hand seems to have no clue what medical ethics are. Just recently, they declared the MD dissertation of Macchiarini’s student Philipp Jungebluth to be utterly unproblematic and refused to investigate it. In light of this and a previous incident (see below), it appears MHH sees foreign patients abroad to be equivalent to research animals.

Even more significant about the widening of the Würzburg investigation is namely who apparently decided not to participate in it.

Heike Walles’ currently active academic affiliation, the Fraunhofer IGB institute in Stuttgart, is not part of that misconduct investigation into data manipulations in the Walles papers and the highly controversial transplants of pig-intestine tracheal grafts made by Heike Walles lab at that Fraunhofer IGB. The transplants were approved by this institute without any prior animal testing or toxicity analyses (see my report here). In their past emails to me, Fraunhofer press office refused to see any reasons to initiate any investigation. When I tried to contact the Fraunhofer IGB institute’s ombudsman Uwe Vohrer, I could only move him to acknowledge the receipt of my previous emails, nothing else. All considered, it appears Vohrer and his Fraunhofer colleagues are absolutely not inclined to follow up on the clear evidence of data manipulations or possible patient abuse which were published from their own institute.

The German doctors’ association, the Medical Council (Ärztekammer), first absolved their member Thorsten Walles of all suspicions based on obscure “witness” testimonies, then repeatedly refused all investigation for reasons like my texts being in a foreign language (English) and primarily because the tracheal transplants were more than 5 years old (see my report here).

Serious cases of research misconduct, especially those spanning several research institutions, are usually investigated centrally by the German Research Council (DFG). But not in this case, here DFG’s own Ombudsman for Science repeatedly announced to me NOT to feel responsible for investigating data manipulations in Walles publications. Even better: DFG proudly declared to me in a letter from April 19th that Thorsten Walles remains an active member of their Review Board for Medicine, where he is making decisions and evaluating scientists and grants for the Heart,- Thorax- and Vascular Surgery section.

Hence, the University of Würzburg are basically on their own and against the highest powers in German science and medicine, and even the law, represented by the local Würzburg state court.  Let’s see how their Walles investigation works out under such circumstances. The head of the investigative commission, Ralf Schenke, wrote to me on June 12th:

“The Permanent Commission for the Investigation of Scientific Misconduct at the University of Würzburg has re-examined the medical interventions that you have presented with the help of an external expert and other experts from the medical faculty. A final assessment is not possible on the basis of the documents available in Würzburg. In order to clarify the outstanding questions, the Würzburg Misconduct Commission contacted the MHH as well as the Schillerhöhe. Both have assured to investigate the case and to cooperatively elucidate it. The final assessment in Würzburg will then be carried out by taking into account the findings and results of the investigation in Hannover and Stuttgart. The Commission withdraws the letter of 20 February 2017.
I must continue to ask for patience before the completion of the procedure”.

That letter from February 20th originally acquitted Walles of all suspicions of misconduct, upon which I was invited to Würzburg on March 6th to give evidence of appeal, which in turn led to the entire investigation being restarted and their biased internal expert for medicine removed (see report here). However, just now Walles presented this same officially invalidated letter from February 20th to the higher court in Bamberg as evidence of the trust and support the University of Würzburg allegedly has for them.

Jungebluth, the angel of innocence

Jungebluth also issued an injunction against me, which was overturned by 2/3 in the Berlin court (see this report). The appeal hearing at the higher court (Oberlandesgericht) is being prepared, a date not set yet. Jungebluth, who was recently found guilty of patient abuse and breaching the Nuremberg Code of 1947 by two experts, however proudly presented to the Berlin higher court a letter from MHH which absolved his MD dissertation from all suspicions. The MHH president Christopher Baum decreed namely that in his supreme view there was no breach of good scientific practice and that an investigation against Jungebluth must not be initiated (see MHH letter here).

MHH looks like an absolute monarchy, and one which apparently regards human patients (of foreign origin at least) as equivalent to research animals. Macchiarini is still their adjunct professor, though illegally, while MHH fiercely guards his professorship and all information related to it (see my report). After all, only one of Macchiarini’s tracheal transplant patients was a German, and he was operated in 2003 at MHH, together with Walles. The 17 lethal and maiming trachea transplants which their adjunct professor performed, happened abroad, on foreigners.

As reminder, the central topic of this Macchiarini-supervised MHH thesis was the technology of the trachea transplant Jungebluth performed together with his master in Barcelona in 2008, on the Colombian patient Claudia Castillo. MHH received from me all evidence of the blatant ethical irregularities there (see details here), but their current decision indicates that:

• experimenting on patients without any documented or otherwise in any way corroborated previous animal experiments, is what a good German doctor is perfectly right to do
• misinforming the patient about the alleged success of likely non-existent animal tests to gain her “informed” consent, is what a good German doctor is perfectly right to do
• preparation of her trachea graft by Jungebluth in a veterinary laboratory in Bristol behind the back of British authorities, is what a good German doctor is perfectly right to do
• Wilfully misrepresenting the patient’s decline and her heavy complications in two Lancet publications as an alleged miracle cure and success of the trachea transplant, is what a good German doctor is perfectly right to do
• Ascribing to himself an MD degree (conferred by that 2010 thesis) two years in advance in 2008 and illegally passing it off in later official documents as a absolutely not at all equivalent PhD degree, is what a good German doctor is perfectly right to do

In fact, there was an earlier case when MHH outsourced research on regenerated heart valves to Moldova, a poor Eastern European country where MHH star clinician and Macchiarini’s former host, Axel Haverich, operated two or three child patients. Instead of previously testing it on any lab animals, as all evidence suggests (see my report here), and MHH had no ethics concerns with this at all.

Is the Nuremberg Code of 1947, written in the aftermath of the most horrendous torture which Nazi doctors imposed on their victims in the name of research, just a silly old rag of paper for MHH, blocking the way of medical progress? These are its 10 points off Wikipedia, I highlighted most relevant ones, for MHH, Fraunhofer and Clinic Schillerhöhe, even though I am not sure either of these German institutions cares:

1. “Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity.

2. The experiment should aim at positive results for society that cannot be procured in some other way.

3. It should be based on previous knowledge (e.g., an expectation derived from animal experiments) that justifies the experiment.

4. The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries.

5. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.

6. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.

7. Preparations and facilities must be provided that adequately protect the subjects against the experiment’s risks.

8. The staff who conduct or take part in the experiment must be fully trained and scientifically qualified.

9. The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on.

10. Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous”.

But because Germany has no freedom of information worth that name and because here institutions are safe in refusing to investigate even the worst excesses of their researchers, while those reporting scandals get immediately slapped with crippling court injunctions and damage claims, we have no scandals here.

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