Alexander Seifalian, UCL’s Persian Scapegoat

The London university UCL has now completed the investigation into the affair around their past honorary professor and now disgraced thoracic surgeon Paolo Macchiarini and the trachea transplants. Subject of the investigation were: the two plastic tracheas UCL produced (one sent to Karolinska Institutet and implanted in patient Andemariam Beyene in Stockholm, another used by UCL laryngologist Martin Birchall to treat Keziah Shorten, who previously received a cadaveric trachea from Macchiarini as requested by UCL) as well as four more cadaveric trachea transplants, namely the very first such intervention organised by Macchiarini and Birchall in Barcelona in 2008, on patient Claudia Castillo, as well as the three trachea transplants which took place under UCL oversight in London, on paediatric patients Ciaran Lynch, Shauna Davison and a 3-year old child who was transplanted just in May 2017 at the same Great Ormond Street Hospital (GOSH). The offhand revelations about the last transplant in this UCL report came as surprise, since it was otherwise kept secret.

No information is provided by the investigative report on how that child is doing now, in fact it seems no evidence like laboratory books, research data or patients’ medical files was ever requested and the committee relied solely on the opinions provided by the very people they were supposed to investigate: Paolo Macchiarini, Martin Birchall and GOSH paediatric surgeon and past director Martin Elliott. In fact, the report seems to become very nebulous or even creative with its use of alternative facts to avoid implicating Birchall in anything unethical at all. The only guilty party in this medical scandal is incidentally also the only non-clinician and the only non-white character in the entire Macchiarini affair: the nuclear physicist Alexander Seifalian, a Persian-Armenian and dual citizen of Iran and UK, whose lab manufactured two plastic tracheas. He was already sacked by UCL in July 2016, accused of bribery. Seifalian is also bowel cancer survivor, which did not prevent UCL of accusing him of failing to oversee the abroad clinical application of his produce just when he was receiving chemotherapy.

These are the results of UCL investigation in the nutshell:

All UCL-employed clinicians involved in trachea transplants, in particular UCL’s chief trachea transplanter Martin Birchall, are fully acquitted from any suspicion of misconduct or clinical wrongdoing. Even Macchiarini seems partially exonerated from the gist of the UCL report, because:
The maker of the two plastic tracheas, Alexander Seifalian, is to take all the UCL-related blame for the failed transplants (as well as other plastics implants in India, Iran and Switzerland). His fault is to have manufactured these products though his UCL lab lacked GMP (Good Manufacturing Practice) certificate. Only this lack of GMP-quality seal was what apparently made plastic tracheas too dangerous to implant in humans.
All five cadaveric trachea transplants under the scope of investigation were considered ethically, medically and scientifically justified. Deaths of the patients were explained with new discoveries of recurrent cancer, or demands of other patients for the same hospital bed.
Birchall’s clinical trials with cadaveric tracheas (phase 1/2a INSPIRE, and by extension, also EU-wide phase 2 TETRA) are to go ahead as planned and to recruit patients. Same positive recommendation for Birchall’s related trial RegenVox on cadaveric larynx, decellurised and “regenerated” with same technology as tracheas.

Continue reading “Alexander Seifalian, UCL’s Persian Scapegoat” →

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 here. Continue reading “EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA” →

Berlin court grants Jungebluth new injunction against my reporting

The Kafkaesque farce of court injunction trials from German trachea transplanters against me continues. The Landesgericht court in Berlin issued a second injunction against me, as requested by the angel of innocence Philipp Jungebluth, the former right hand man and acolyte of Paolo Macchiarini. The target of the injunction is this article, concerning an unpublished Macchiarini paper Haag et al. As it practice in German law, this legally binding verdict, the breach of which is punishable by a fine of up to €250,000, was passed without allowing me to present my evidence. In fact, Jungebluth also was not asked to present any evidence, his word that I wronged him sufficed. The legal idea behind such injunctions “the element of surprise”, that is, to present the other party with a binding court verdict, a huge bill for it, followed by a huge fine for any alleged breach of the injunction, the pretext for which is always easy to conjure, all of which should discourage any attempts to fight back. You are expected to lose your court case without even knowing there was one going on. Germans think this is a great and just way to keep internet and other media at bay.

So this is obviously a financially heavily mismatched war of Macchiarini and his partners against me, with all the media who used to celebrate their (now known as lethal) human experiments suddenly very silent. I am however grateful for the past and current support of my readers, and ask you to keep donating. Because nobody in Germany cares about these dead and mutilated patients, who were all foreigners experimented upon abroad anyway. Continue reading “Berlin court grants Jungebluth new injunction against my reporting” →

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

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 Simonson, Karl-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

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.

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Human Brain Project and other Flagships: is EU outsourcing funding decisions?

The EU €1-Billion-Flagship Human Brain Project (HBP) started in 2013 as an closed enterprise run by three men. The triumvirate is no more: the visionary founder Henry Markram sidelined into almost insignificance after a coup, his Lausanne colleague Richard Frackowiak almost retired, only the German Karlheinz Meier, physics professor at University of Heidelberg, still seems to hold quite a lot of sway. The control of HBP is now basically in German hands: the “independent” mediator of the anti-Markram coup and director of Forschungzentrum Jülich (FZJ), Wolfgang Marquardt, is key member of the all-decisive HBP Stakeholder Board representing Germany, his FZJ colleague Katrin Amunts is the new scientific director of HBP. The bombastic goal of HBP used to be simulating the human brain in a supercomputer, including various brain diseases and even consciousness (read here and here for HBP background). That Markram’s “brain child” was silently mothballed, the big plan is now only revealed to select insider audiences (who occasionally blab on Twitter). The once high and mighty Markram, whose not-so-groundbreaking Cell paper (Markram et al, 2015) was once touted as HBP’s mega-success, was apparently forced to publish his recent brain simulation research in his own publishing outlet Frontiers (Reimann et al 2017), where he proclaimed a discovery of nothing less but a “Multi-Dimensional Universe in Brain Networks”. Regardless of what Markram thinks he is doing or what fairy tales HBP graduate students are told: dissolving the monster HBP and redistributing its EU funding onto smaller projects was obviously not an opinion. The new purpose of HBP seems to be:

distributing the EU Flagship money, in the way HBP see it best fit, thus
sparing the EU Commission the tedious work of research grant reviewing and management

Continue reading “Human Brain Project and other Flagships: is EU outsourcing funding decisions?” →

For Better Science

Science journalism by Leonid Schneider, on research integrity and academic publishing in life sciences and biomedicine

Tag: regenerative medicine