Paul-Ehrlich Institute admits to have approved Walles tracheal transplant over phone, without questions

The German trachea transplanters Heike and Thorsten Walles treated the 3 patients with their pig-intestine-based tracheal transplants (one of them performed with Paolo Macchiarini). They are currently suing me in court for reporting about those, while their employer, the University of Würzburg, investigates these tracheal transplants together with the evidence for blatant data manipulations in several Walles publications on suspicion of misconduct. None of those 3 patients is alive today, yet Walles insist that neither of their transplant operations was in any way related to the patients deaths or that it might have reduced their quality of life. They keep declaring those operations as resounding successes, free from any evidence, though the last transplant was performed in 2009 and never again. A corresponding clinical trial, financed by the German Ministry of Education and Research with €1.5 Million between 2009 and 2015 (and briefly mentioned at the beginning of the PEI letter), did not achieve even a single milestone. Not even animal experiments were permitted by the responsible watchdog institution, the Paul Ehrlich Institute (PEI). For almost 7 months, PEI refused to answer my Freedom of Information inquiry. It seems however, my complaints to authorities and the Federal Ministry of Health, finally had an effect.

This is the German original of the letter I received today, below my translation. The key points are:

• Heike Walles, on behalf of her Fraunhofer Institute obtained an unofficial permission from PEI over the phone to operate her 3rd tracheal transplant patient in 2009.
• Neither Heike Walles (who is a biologist) nor her engineering-focused Fraunhofer institute have any medical qualifications to discuss patient treatment options, yet they did so anyway.  Her surgeon husband Thorsten, who treated that patient,  had no academic affiliation at that time, neither was his employing Clinic Schillerhöhe a research hospital, it also lacked its own ethics board.
• Heike Walles did not inform PEI about the existence of her past two tracheal transplant patients from 2003 and 2007 at all. The patient from 2007 died only some weeks after the failed transplant on internal bleeding and massive organ failure (details here). The next patients was never informed about that.
• PEI never inquired about any previous tests, on animals or otherwise, before issuing their unofficial approval. There were no animal tests done at all, nor were any toxicity assays done at that time (later tests revealed dangerous endotoxin levels).
• PEI regarded the pig-intestine based transplant as containing solely patient’s own unmodified tissues, thus exempt from medicinal product regulations.
• The 2009 patient was presented to PEI by the biologist Walles as in acutely life-threatening condition, his only way to survive being an airway transplant. Given the clinical background of this patient (see here), this assessment is not really credible. His breathing was  in a very stable condition thanks to a tracheostomy, while his main damage was in fact the tracheo-oesophagal fistula and damaged oesophagus. Both defects were treated by standard therapies, latter by other doctors, after Walles were done with that patient.
• Unlike advised by PEI, Walles never sought approval from the German medicinal product supervision authorities (which would be Regierungspräsidium Tübingen). They instead approached an Ethics Commission of the medical faculty of University of Tübingen, which refusal to deal with hospital exemptions was presented by Walles as an ethics vote by that commission (details see here).
• PEI president Klaus Cichutek gave a misleading information to public in 2011 when he pretended in a magazine article not to have dealt with those pig-intestine based tracheal grafts before

Now follows the letter from PEI, in full.

Dear Mr Schneider,
For your request dated 06.12.2016, supplemented with an e-mail dated 14.12.2016, I can inform you that the information provided by you is not attributable to any clinical trial known to the Paul-Ehrlich-Institute.
On this occasion, I would like to point out that the fact that the funding of a clinical trial has also been approved within the framework of a research project does not necessarily mean that the clinical trial has also been carried out.
To the treatment of the three patients you mention, the PEl can only give precise information in one case.
In 2009, Mrs Walles (at that time Mertsching) contacted the PEI by phone on behalf of the Fraunhofer Institute for Interfacial Engineering and Biotechnology (IGB Stuttgart) about a medical emergency. At that time, contacts to the PEI existed at the time of development processes as well as procedures for the production authorization of various clinical test samples at the IGB Stuttgart under the leadership of the authority responsible for this institution (Regierungspräsidium Tübingen).
Mrs. Walles described the situation by phone, that she was requested by a clinical institution regarding the care of an emergency patient. The condition was said to be acutely life threatening because of an airway defect. The only available treatment option was presented to be the transplantation of a biotechnologically produced tracheal patch developed by the IGB Stuttgart. The production of this transplant should take place in the presence and under the direct professional responsibility of the treating physician. The PEI held these descriptions as credible. The PEl also does not have any indications so far that Mrs Walles could have presented the facts incorrectly, incompletely or distorted.

Mrs Walles has been informed by telephone that the PEl is in principle not authorized to issue any form of exemption. However, it was pointed out that the provisions of section 4a paragraph 3 AMG [medicinal product law, -LS] (1) were still in force at that time, according to which the AMG did not apply to medicinal products which are both produced and used under the direct professional responsibility of a physician (so-called doctor’s privelege). Furthermore, it was pointed out to Mrs Walles that her activities could be covered by Section 34 of the Criminal Code (StGB) (justified emergency). Finally, Mrs Walles was informed that, according to PEI in the situation presented by Mrs Walles, the production and application in the so-called “unlicensed use” seem plausible. This assessment of the PEl is not, however, legally binding for her and is not based on a thorough examination of PEI. Such examination by PEI is not provided for by law, in principle. Mrs Walles was also advised to contact the German medicinal law supervisory authority responsible for GB Stuttgart.
It is known to PEI that in the immediate period following the telephone call described here, the treatment in question was carried out by Mr. Walles as treating physician. Furthermore, PEl is aware of the fact that other treatments with corresponding trachea patches have been carried out in comparable situations. However, the PEl can not dtermine whether also before these treatemnts contact has been made with the PEl, or whether the PEl has been informed about the further treatments by the spouses Walles or learned of those by other means.
Best regards
In representation
Dörte Ruhaltinger

1. www.gesetz-im-internet.de/amg 1976/4a.html

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