EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA

EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA

The European Commission now took 40 days to deny my second Freedom of Information (FOI) Inquiry about the TETRA phase 2 clinical trial with cadaveric trachea transplant they are currently financing with €7 Million. This is EU’s second attempt to become world-leading manufacturer of industrial trachea transplants, after the €5mn Biotrachea led by the scandal surgeon Paolo Macchiarini was terminated mid-term. No, not because EU had any concerns for the patients, quite the opposite: he was given a clean ethics vote to go ahead. Biotrachea was terminated by the EU because the plastic tracheas Macchiarini wanted to use lacked novelty, as the documents I obtained revealed.

The TETRA trial, led by Macchiarini’s past collaborator, the UCL laryngologist Martin Birchall, was already on the brink of being terminated in the wake of the Macchiarini scandal, as EU previously indicated to me. Now, exactly the opposite happens. The trial is being prepared at full speed despite the fact that its predecessor phase 1 trial INSPIRE was suspended (because of my reporting), never recruited any of its four patients and it most likely never will. That trial is also led by Birchall (details here), it is likely that its Innovate UK funding has ran out meanwhile. EU however seems to signal that they will go ahead with phase 2 trial even if phase 1 never happens. After all, there are those 10 patients who received a cadaveric trachea transplant  (here and below) and were operated under hospital exemptions between 2008 and 2012 by Macchiarini and Birchall. At least half of these 10 are dead, the lucky survivors either had their graft removed or live with permanently installed stents to prevent their rotting airways from collapsing (INSPIRE’s and TETRA’s clinical promise is actually that the patients will never need a stent). But this disaster seems exactly the reason for EU to try it again, and on a much, much bigger scale. Probably because it will create employment.

The EU spokesperson ceased long ago answering my emails, after I declined to be instructed over the phone (strictly off-the-record) why EU’s approach to trachea transplanting is right; this is why I had to resort to FOI. The official time limit to answer my FOI inquiry from July 1st 2017 was 15 days, but the EU first pretended not to have received my postal address, then said they need more time, then said they need extra time to assemble the documents for me, and finally, the Director-General of the European Commission, Robert-Jan Smits, wrote to me on September 11th. He basically told me again to get lost and that he will never release any information (read here his past rejection of my FOI inquiry). His reasons, as before: the trachea transplant trial is a business enterprise and revealing any of its progress might endanger the financial interests of its stakeholders, and then there are privacy concerns. Exactly, Smits decided that the public must under no circumstances find out whom exactly the EU is giving this public’s money for research on humans. I am not making it up, read Smits’ letter yourself hereContinue reading “EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA”

Hannover Medical School MHH: where doctor careers matter more than patient lives?

Hannover Medical School MHH: where doctor careers matter more than patient lives?

Philipp Jungebluth, formerly right-hand man and student of the lethal trachea transplant surgeon Paolo Macchiarini, is threatening another lawsuit against me. This time, he is unhappy about being associated with the 5 trachea transplant operations Macchiarini performed in Italy (only one of these five might still be alive, with a permanent brain damage). Jungebluth freely admits through his lawyer to have been part in the two operations in Barcelona: the very first trachea transplant on Claudia Castillo in 2008, and another one, performed in secret against an explicit ban issued by the Hospital Clinic Barcelona, in a neighbouring hospital on the Argentinian patient DD. Both patients Castillo and DD were previously unsuccessfully operated on their airways by Macchiarini, both were eventually offered a bronchus or trachea transplant, respectively.  I was informed how the 55-year old  DD fared after the operation, and it was a total disaster (it is all but clear if she is still alive, in fact even survivor Claudia Castillo can’t be found anymore).

These two operations were however according to Jungebluth part of his German medical education, the so-called “practical year”, as student of the Hannover Medical School (MHH). It seems that a past MHH professor, Heike Kielstein (nee Nave) was involved in the histological analyses of these trachea transplants. In 2010, Kielstein as part of award ceremony presented Jungebluth with a €2500 prize for his Macchiarini-supervised medical dissertation, which described only the first trachea transplant patient, but kept the second transplant operation on DD as a total secret. But MHH apparently knew about that highly unethical act, and did not mind at all.

Hence, MHH did not cease all trachea transplant research in 2006, as they once told to me untruthfully. The technology was simply outsourced in a good MHH tradition to poorer parts of Europe. To escape tough German regulations or legal responsibilities? Or maybe because the non-German patients abroad were seen as more suitable for medical experiments? MHH, whose rector just recently ordered its own university not to investigate Jungebluth’s dissertation, remains deadly silent. Herr Professor Macchiarini, whose German is near-native (the Italian grew up in Switzerland) and is much better than his English, remains adjunct professor at MHH, against state law.  Continue reading “Hannover Medical School MHH: where doctor careers matter more than patient lives?”

The one who asked questions: interview with Johannes Wahlström, by Alla Astakhova

The one who asked questions: interview with Johannes Wahlström, by Alla Astakhova

Below I am re-publishing an interview which the Russian health journalist Alla Astakhova conducted with the Swedish journalist Johannes Wahlström. Wahlström’s work for the Swedish television SVT, together with Bosse Lindquist, was decisive in uncovering the patient abuse by the fallen star surgeon Paolo Macchiarini (see here the full list of trachea transplant patients). Without the dedicated work of the Swedish journalists, Macchiarini would probably still be experimenting on humans with his cadaveric and plastic tracheas, generating even more death and suffering in the process. In the interview with Astakhova, Wahlström tells about his research for the famous SVT film Experimenten, and how the SVT team found out about the four Karolinska Institutet whistleblowers Oscar SimonsonKarl-Henrik Grinnemo, Matthias Corbascio and Thomas Fux (see my reports about them here, here and here).

For Wahlström, the scandal is not just about Macchiarini. The central figures here are the abused patients, most, if not almost all of them no longer alive. And Macchiarini is not the only one guilty. Wahlström explains how everyone else orbiting that grandiose thorax surgeon was co-responsible, by looking away, covering things up or contributing their small share to the grand horror. The multilingual Swedish journalist specifically criticises the irresponsible dishonesty of Macchiarini’s Russian surgeon partners Vladimir Parshin and Igor Polyakov in the face of the catastrophe they participated in, or the bizarre attitude of Macchiarini’s biographer and Megagrant-manager Elena Kokurina, who seems to have been deliberately avoiding learning the real fate of his patients. Wahlström also questions the ethics of German TV producers who decided to air their Macchiarini-extolling documentary Supercells! in Germany and France despite knowing that its protagonist, Yulia Tuulik, was not cured at all. She was miserably dying. Continue reading “The one who asked questions: interview with Johannes Wahlström, by Alla Astakhova”

Unpublished Macchiarini manuscript confirms 5 forgotten trachea transplant patients

Unpublished Macchiarini manuscript confirms 5 forgotten trachea transplant patients

7.09.2017 This article was slapped with an injunction by Berlin court (here), on behalf of Jungebluth. Sentences forbidden by injunction are replaced to show the legal truth. 

I have been forwarded a manuscript by the scandal surgeon Paolo Macchiarini, which was originally intended to present in detail all of his known 9 cadaveric trachea recipients (only 4 are recorded officially). The compilation follows exactly all the patients who are already listed on my site, with the small difference that the paper (allegedly rejected at Nature Communications) presents their clinical evolutions quite differently from reality. One of these now fully confirmed victims of Macchiarini’s research was his second patient from Barcelona, whom Macchiarini transplanted in secret; five were operated in Italy (including Keziah Shorten and the Czech patient MK). The manuscript also confirms that Macchiarini’s acolyte Philipp Jungebluth [is an angel of innocence and never did anything bad in his life. Every patient ever treated by him is in fact eternally grateful]. The German doctor is currently suing me in court for alleged libel, insisting that all these patient deaths and his proven research misconduct in Sweden would never ever disqualify him from developing trachea transplants and training as thorax surgeon at the University Clinic Heidelberg, where he however doesn’t work anymore.

The first author of this lost and now found unpublished paper is Johannes Haag, Macchiarini’s other acolyte and former MD student from Hannover Medical School (MHH) in Germany. Haag is apparently still employed at the Thoraxklinik at the University of Heidelberg, where Jungebluth used to be. The manuscript, which was supposed to be Haag’s big paper, was written to deal with the fact that too many of Macchiarini’s cadaveric trachea recipients died or developed very severe complications. To this end, the team hatched an idea to do “reverse translational experiments“, where rat experiments would follow those on 9 humans, prove that the cadaveric trachea technology works in principle and it was the human patients who were making problems. This notion was to be supported also by their earlier pig study Go et al, Biomaterials 2010, where Macchiarini and Jungebluth claim, without a shred of evidence, that the large animal testing was performed before the first patient, Claudia Castillo, received a cadaveric trachea in 2008 (details here, here and here). Update 7.09.2017: Go et al  2010 paper was criticised on PubPeer for its heavy scientific and technical deficits.

Continue reading “Unpublished Macchiarini manuscript confirms 5 forgotten trachea transplant patients”

Walles court trial against me ends with “amicable settlement”

Walles court trial against me ends with “amicable settlement”

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.   Continue reading “Walles court trial against me ends with “amicable settlement””

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

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.

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

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

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.

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