Karolinska gets taught German medical ethics

A most bizarre thing happened. In the aftermath of the scandal around the thoracic surgeon and regenerative medicine enthusiast Paolo Macchiarini, which left many patients dead, his former employer Karolinska Institutet (KI) in Stockholm, Sweden, requested a retraction of one of his papers. It was not about a trachea transplant, but about unethical and painful medical experiments on a dying patient (actually, two of them). KI’s decision to request a retraction of the paper Jungebluth et al, “Autologous peripheral blood mononuclear cells as treatment in refractory acute respiratory distress syndrome”, Respiration, 2015 was based on the investigation commissioned by Swedish Central Ethics Review Board (CEPN). The Swiss-German and family-owned medical publisher Karger and its journal Respiration however categorically refused to retract the paper and ordered KI not “to patronize the readers of the journal ‘Respiration’.”

It gets much worse. The German Editor-in-Chief of this journal has a huge conflict of interest. It is better you just read on, because if I try to summarize it here, I might get sued by Macchiarini’s German friends and associates once again, and next time it might even be prison for me. In Germany, doctors have a very special status. Journalists or even patients do not, as I learned in court.

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UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose

In 2017, the great London university UCL invited an external expert commission to investigate its role into the deadly trachea transplants performed by the former UCL honorary professor and scandal surgeon Paolo Macchiarini. An already sacked UCL nanotechnology professor, Alexander Seifalian, whose lab made the two UCL plastic POSS-PCU tracheas in 2011, was announced as the main culprit on UCL side for all the suffering of these two patients Andemariam Beyene and Keziah Shorten, as well as some recipients of vascular grafts. All this despite Seifalian’s having had no clinical role, training or ambitions, as he professed in his interview to the investigative committee, which I now obtained.

The interview also makes perfectly clear that the investigative committee’s surprise finding, namely that the nanotechnology specialist fabricated non-GMP certified plastic grafts for clinical use behind everyone’s back, was actually slanderous. Not only did UCL know very well that the product, which their own business branch UCLB approved for clinical use in Iran, Switzerland and India, was not GMP-certified, they even used it on their own patient at UCL hospital UCLH, in an attempt to grow a plastic nose. Even the UK regulatory authority MHRA was informed, and apparently did not mind or interfere. All this did not stop UCL investigators from publicly fingering cancer survivor Seifalian as the only culprit for that GMP-non-compliance.

Finally, the committee had information that Birchall allegedly proposed to make a plastic trachea for the child patient Ciaran Lynch in December 2009. Seifalian refused, for technical reasons, but this definitely and literally saved the boy’s life. Ciaran, presently one of just 3 known survivors of ~20 trachea transplants performed by Macchiarini and his former close associate, the UCL laryngologist Martin Birchall, was operated in London in March 2010 with a freshly decellurised cadaveric trachea graft supplied from Italy; Macchiarini was the surgeon. That clever Birchall-attributed idea, of being the first one to implant the utterly untested plastic trachea, and into a child no less, was somehow dropped from the final UCL report. Sod knows why. Continue reading “UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose” →

Macchiarini victim’s family sues trachea makers for wrongful death

Yesim Cetir was a young woman from Turkey, whose vulnerability the scandal surgeon used to test his plastic trachea (twice), a third such operation he performed at the hospital of the Karolinska Institutet in Sweden, and his fifth plastic trachea recipient. Like almost all the at least 17 patients whom Paolo Macchiarini experimented upon with either cadaveric or plastic trachea, Yesim died. Her suffering was long and horrible, her father Hayrullah Cetir dedicated all his waking hours to caring for his daughter. He died himself soon after her, from a neglected cancer.

Since April 2017, Yesim’s family (or in US legalese, the Estate of Yasim Cetir) is suing the company Harvard Bioscience, which spin-off Biostage (in turn formerly known as Harvard Apparatus) produced the bioreactors and the second plastic trachea graft used by Macchiarini on Yesim. Also the manufacturer of her first plastic trachea, Nanofiber Solutions, is being sued at the Suffolk County Superior Court in Massachusetts, USA, case number 1784CV01174. An article in Boston Business Journal indicated that even Macchiarini himself might be subject to the wrongful death lawsuit:

“Now, the estate of one of the deceased patients is pursuing wrongful death claims against both Biostage and Macchiarini”

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Trachea transplanters without borders

News from the trachea transplant entrepreneurs. What with the UK authorities having officially suspended both phase 1 clinical trials Inspire and RegenVox, and the EU phase 2 clinical trial TETRA going nowhere, the technology’s owner, Liverpool-based company Videregen decided to seek new clinical partners. Surgeons and universities from outside the EU, especially from US, China and Japan are invited to test Videregen’s trachea transplant technology, which was originally developed together with Paolo Macchiarini by the UCL laryngologist and paid Videregen advisor Martin Birchall.

While tracheal stenosis was the indication sought to treat with trachea transplants in UK and EU (as the authorities drew curtains before the show even started), Videregen now goes for bronchopleural fistula, while pretending (quite dishonestly) that “all required regulatory and ethical approvals necessary to commence clinical trials in the UK” would exist.

The other bit of news is that UCL finally published the 2015 PhD thesis of Birchall’s student Claire Crowley (now postdoctoral scientist in charge of clinical research on oesophagus replacement with UCL professor and another trachea transplanter Paolo De Coppi). It reads as if certain parts of the thesis were edited or even written by UCL’s legal department. Not what thesis says, but what is omitted is worrisome. Crowley was namely responsible for the production of 3 trachea replacements requested by Birchall, which all proved deadly to their human recipients. One was a decellurised cadaveric graft, and two were POSS-PCU plastic tracheas, which Crowley made herself, in the lab of her other advisor, the (now sacked) UCL nanotechnologist Alexander Seifalian. Yet the thesis only mentions one graft, in a brief one-page statement, simply because Crowley could not deny her role there. She is co-author on the Macchiarini paper Jungebluth et al Lancet 2011 telling the alleged success story of the very first plastic trachea transplant performed in Sweden on the patient Andemariam Beyene. Otherwise, Crowley never mentions in her thesis the cases of Keziah Shorten or Shauna Davison, whose lethal trachea grafts she also made herself, as part of her PhD studies. Continue reading “Trachea transplanters without borders” →

The Kathrin Maedler Dynasty

German academic jargon has a peculiar expression: Doktorvater. It means “doctoral father”, a fatherly figure who takes his helpless PhD student progeny by the hand and guides and teaches the offspring of his academic loins the wisdom of science, up to the graduation. Nowadays with the system being less patriarchal, one can instead have the figure of a Doktormutter, doctoral mother. Which obviously doesn’t bring same gravitas or inspires same respect and awe, and is therefore hardly ever used.

The German diabetologist and Professor and University of Bremen Kathrin Maedler is a central figure of an academic dynasty. Using Photoshop simulations (read here), she discovered a cure for diabetes via inhibition of the inflammatory cytokine interleukin-1-beta (IL-1β), which was then confirmed as a definite cure for diabetes in clinical trials led by her own Swiss Doktorvater Marc Donath, then professor at University of Zürich, now in Basel. Over 15 years later, the Maedler-Donath cure was proven as utterly ineffective against hypoglycaemia and diabetes by same Donath, in another clinical trial. Because of her Photoshop creativity with discovering diabetes cures and ensuing retractions, Donath’s past PhD student Maedler was asked by the German Research Council DFG to surrender her prestigious Heisenberg professorship, while the German Diabetes Society (DDG) revoked her Ferdinand Bertram Prize from 2011 (read here). Since 2017, her PhD thesis is again under investigation of University of Zürich.

That diabetes research was also what made the career of Maedler’s own PhD student, Amin Ardestani, presently junior research group leader at the University of Bremen. His thesis received an award from the local Rotary Club, of course also Ardestani got a prize from DDG, which he also saw revoked for engaging into same activities as his Doktormutter. Still, he is still receiving awards, including from Elsevier. I will present below some data irregularities and unacknowledged textual reuse from Ardestani’s 2013 PhD thesis, which was supervised by Maedler.

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Birchall’s two dead pigs to prove trachea transplants are safe

Imagine you are Martin Birchall, laryngologist and ENT surgeon, star of regenerative medicine at UCL and trachea transplant enthusiast. You and your business partner Videregen need to explain to EU bureaucrats why your technology of decellurised cadaveric trachea is perfectly safe, what with all the dead patients of yours and your former best friend Paolo Macchiarini. Preclinical animal tests? Good idea indeed, though you have already published some very shady pig studies with Macchiarini in 2010, after you operated your first human patient in 2008 (whom you keep parading as success story of your stem cell magic superpowers, despite heavy complications which almost killed your research subject).

To distance yourself from that horrid Macchiarini, you do new preclinical tests. Enter three more pigs, which you decide transplant with a cadaveric decellurised human trachea. One trachea turns out to have been dirty not just with human “stem” cells, but also with pathogenic bacteria. So that one piggy got lucky and was set free. The unlucky other two: dead “of respiratory compromise”, one already after 12 days, the other suffered for a whole month after trachea transplant. You now have 100% preclinical mortality rate, and you still manage to convince the bureaucrats that the method works and 48 human patients must experience same, in the EU-funded phase 2 clinical trial TETRA. Thing is, that trachea transplant trial was supposed to help tracheal stenosis patients, by ridding them of burdensome stents and bronchoscopies, and not to euthanise them. Continue reading “Birchall’s two dead pigs to prove trachea transplants are safe” →

University of Iceland: no formal legal sanctions against Macchiarini partner Gudbjartsson

The University of Iceland in Reykjavik previously published an external investigation report into the first ever plastic trachea transplant, performed by Paolo Macchiarini at the hospital of Karolinska Institutet (KI) in Stockholm, Sweden. The patient was Andemariam Teklesenbet Beyene, PhD student at University of Iceland, and the Icelandic surgeon who treated Beyene and then delegated him to Macchiarini for that deadly treatment was Tomas Gudbjartsson, professor of surgery at same university (see my report here). One year after the operation, when Beyene already started to suffer from the plastic trachea which eventually killed him, Gudbjartsson organised a conference on regenerative medicine in Reykjavik, featuring Macchiarini as guest of honour and Beyene as a kind of trophy.

The University now announces to investigate the circumstances of that conference, for which it apologises, and to host on June 1st 2018 a new one, on research ethics. Gudbjartsson will not suffer any disciplinary consequences, because he was said to have expressed sufficient level of protest against the attempts by Macchiarini and his acolyte Philipp Jungebluth to twist the patient abuse into a success story which they published in The Lancet, Jungebluth et al, 2011. A paper which University of Iceland now describes as “objectionable”. Continue reading “University of Iceland: no formal legal sanctions against Macchiarini partner Gudbjartsson” →

For Better Science

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

Category: medicine