Bioethicist Arthur Caplan calls for retraction of all Macchiarini papers

Bioethicist Arthur Caplan calls for retraction of all Macchiarini papers

Arthur Caplan, internationally respected professor of bioethics and director of the Division of Medical Ethics at the New York University, requested publicly retractions of the bioethics reviews on regenerative medicine he co-authored with the scandal surgeon Paolo Macchiarini. Caplan notified the journals with his retraction requests, but said to have received no response from them yet. Not only this: Caplan calls for all works of Macchiarini to be retracted.

Macchiarini is now an international pariah, he recently again lost his job, this time with the Kazan Federal University in Russia (see my report). His publications are under investigation at his former workplace the Karolinska Institutet in Stockholm (where he was previously sacked), the Swedish state announced to soon charge him with manslaughter, due to 3 lethal plastic trachea transplants he performed at Karolinska. Continue reading “Bioethicist Arthur Caplan calls for retraction of all Macchiarini papers”

Macchiarini leaves Russia: federal grant denied and Kazan lab shut down

Macchiarini leaves Russia: federal grant denied and Kazan lab shut down

Paolo Macchiarini is leaving Russia, his research and surgery stint there is over. The fallen star surgeon was able to find a professorship with the Federal University of Kazan (KFU), after his plastic trachea transplants at the Kuban State Medical University in Krasnodar left 3 patients dead, and one with a lucky escape (see details here).  His new research focus was on artificial oesophagus, which he apparently already started to test on hapless baboons. In March 2017, the Russian state decided that Macchiarini’s federal grant on oesophagus research will not be renewed, the Kazan University announced in regard to their professor’s further employment to follow the instructions from the Russian Science Foundation. The professorship contract expires by December 2017. On April 20th, Kazan University made the official decision to shut down Macchiarini’s research programme. A Russian opposition party, Yabloko, demanded of the Ministry for Research and Education to investigate Macchiarini’s Megagrant funding and the use of that money, especially in view of the fact that no final report was published. All this information was revealed by the Russian health and medicine journalist Alla Astakhova on her website. Continue reading “Macchiarini leaves Russia: federal grant denied and Kazan lab shut down”

Ciaran’s success story

Ciaran’s success story

Trachea is a very difficult organ to transplant, because its blood supply happens through many tiny blood vessels and it is practically impossible to connect them all (same is true also for the oesophagus). An organ transplanted without blood supply will die, and this is where the regenerative medicine of Paolo Macchiarini and Martin Birchall comes in: a treatment with stem cells and growth factors will somehow magically ensure quick vascularization and bring the dead tissue to life. There is no independent evidence for this, and most patients died as the consequence or became dangerously ill when their new tracheas, made from plastic or from dead, decellurised cadaveric organs predictably failed.  One boy has survived: Ciaran Lynch. His current clinical state is not too rosy, even by Birchall’s own admittance, but nevertheless the sole fact that Ciaran (unlike almost all other trachea transplant patients) is alive, sufficed for Birchall to have one or two more patients operated (both dead) and to push through a clinical trial in UK with a much larger follow-up trial EU-wide. The difference though: that boy never had much choice anyway, since he had no real trachea in the first place. He received very early on a pickled trachea homograft from dead human donor tissue which functioned very well for many years, but at some point urgently needed replacement in order to save his life. Now Birchall however wishes to remove the live airways of stable patients outside any life danger, who suffer from tracheal stenosis, and replace them with his regenerated dead ones (see this report). Noone seems to wonder why these tracheas are to be prepared in a radically different way from that of the sole success, Ciaran Lynch: Birchall’s bioreactor vs so-called “bionic” method of Macchiarini.

Continue reading “Ciaran’s success story”

Sumitran-Holgersson and Olausson guilty of misconduct and unethical experiments on children

Sumitran-Holgersson and Olausson  guilty of misconduct and unethical experiments on children

Game over apparently near for the indestructible Swedish regenerative medicine researcher Suchitra Sumitran-Holgersson, after investigations at her University of Gothenburg  draw to an end. It is about experimental transplants of decellurised veins “regenerated” with the patient’s own bone marrow cells into three child patients, all of whom ended up in life-long medical care, one patient received  a liver transplant after her graft failed, another child suffered severe complications (see this earlier report about an external investigation by Bengt Gerdin into that matter). The University of Gothenburg then established an investigative committee, which followed up on the Gerdin report and specific concerns voiced by a journal editor and a colleague. I publish below the two decisions which revealed that Sumitran-Holgersson and her surgeon partner Michael Olausson never performed any animal testing before recruiting their human patients, they also failed to obtain ethics permits for these operations. Instead the two lied in their publications (Olausson et al, Lancet, 2012; Olausson et al EBioMedicine, 2014) about having obtained ethics votes (something I already uncovered before). During the investigation, Olausson and Sumitran-Holgersson were caught submitting false information to the committee. They were now found guilty of misconduct and ethics breach in both these publications. Continue reading “Sumitran-Holgersson and Olausson guilty of misconduct and unethical experiments on children”

Will words or actual evidence count in the Walles case?

Will words or actual evidence count in the Walles case?

On March 16th I stood a court trial by the trachea transplanters and University of Würzburg professors  Heike and Thorsten Walles against myself. The judge (it was the same who passed the injunction against me) will announce his decision on April 6th, just as I will stand trial in Berlin against their trachea transplant colleague Philipp Jungebluth (see this report). I publish here an extended memory-based protocol which I first published on Facebook. Meanwhile, several large institutions built a protective wall of silence around Walles and their tracheal transplants. The German Medical Association refused investigation in a bizarre letter which I also publish below.

The court hearing

It was the so-called speed trial, so instead of examining evidence, everyone was free to tell the judge their views. Mostly, Walles and their lawyer spoke, occasionally, my lawyer and I were able to squeeze a word in to reject the outlandish or false claims. For example, while her lawyer insisted the tracheal transplants were full success despite dead patients, Heike Walles challenged me to compare her transplants with the first heart transplant which failed. I pointed out that this is exactly the same argument Paolo Macchiarini uses to defend his own failed trachea transplants (for example, here). Continue reading “Will words or actual evidence count in the Walles case?”

Retraction, and another looming misconduct finding for Macchiarini and Jungebluth

Retraction, and another looming misconduct finding for Macchiarini and Jungebluth

The misconduct-tainted paper on oesophagus transplants in rats (Sjöqvist et al 2014) by the fallen star of regenerative medicine Paolo Macchiarini is finally retracted by the journal Nature Communications. This happens after Swedish investigations found the authors (primarily the scandal thorax surgeon and his right-hand man Philipp Jungebluth) guilty of data manipulation and research misconduct in September 2016 and after the Karolinska Institutet (KI) shortly before Christmas publicly demanded a retraction (see my report here). Today’s retraction is a major setback for Macchiarini, since his current employment and funding at the Federal University of Kazan (KFU) in Russia depend on his experiments with oesophageal transplants in primates (see my reports here and here). That Russian project was in turn only possible because of Macchiarini’s allegedly successful experiments in rats, published in a prestige journal with “Nature” in its title. This paper’s retraction is therefore probably only the beginning of a whole looming avalanche of bad news for Macchiarini and his acolyte Jungebluth (who currently sues me in court). An expert review of their publication Jungebluth et al 2015 declares the findings of misconduct, ethics breach and patient abuse. The report however has yet to be confirmed by a commission at the Swedish Central Ethics Review Board (CEPN) and then formulated as an official decree by the KI. I publish the expert reviewer report below. Continue reading “Retraction, and another looming misconduct finding for Macchiarini and Jungebluth”

Walles tracheal transplant patients: secrets and lies

Walles tracheal transplant patients: secrets and lies

The German trachea transplanters Heike and Thorsten Walles fitted three patients with pig-intestine-based airway grafts. They responded to my inquisitive reporting about these with a court injunction, the trial takes place this week, on March 16th. A commission of their Unversity of Würzburg initially absolved Walles of all suspicions of research misconduct, only to start the investigation anew as evidence of heavy data manipulation in their papers emerged (see my previous report). Roland Jahns, specially recruited as medical expert from the same University Clinic Würzburg where both Walleses work, was dismissed after he insulted me as “pseudoscientist” to defend his colleagues’ questionable attitude to data integrity, medical ethics and patient welfare. A new expert will be recruited, but Jahns did reveal some clues to what happened to the two last Walles patients operated in Stuttgart in 2007 and 2009, just before they received their professorships in Würzburg.

It appears Thorsten Walles issued two radically opposing versions of the 2007 patient’s state. In his publications, he presented the intervention as “compassionate use” case and the patient as stable, but in need of innovative strategies to cure his condition. In the medical file however, Walles described the patient as terminally ill and dying from cancer. The intervention to replace his airways with a never-before-tested pig-intestine large patch was presented as a palliative approach, which however turns the entire concept of either palliative care or compassionate use care on its head. In any case, the graft had to be removed after only 2 weeks, the patient died four weeks later due to massive bleeding and multi-organ failure. Walles decided that this disastrous incident had nothing to do with the transplant, so when they recruited their next patient to sign an informed consent in 2009, they simply didn’t tell him what happened to his predecessor. That last patient was also post-suicidal and in psychiatric treatment (though not yet officially of unsound mind, his mental state further deteriorated later on). Continue reading “Walles tracheal transplant patients: secrets and lies”