Macchiarini victim’s family sues trachea makers for wrongful death

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”

Continue reading “Macchiarini victim’s family sues trachea makers for wrongful death”

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

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 LancetJungebluth 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”

Sumitran-Holgersson and Olausson to retract 8 papers for research misconduct

Sumitran-Holgersson and Olausson to retract 8 papers for research misconduct

Bad news for regenerative medicine enthusiasts, the data manipulating biologist Suchitra Sumitran-Holgersson and her surgeon partner Michael Olausson, both professors at the University of Gothenburg (GU) in Sweden. They were previously found guilty of breach of medical ethics and patient abuse for their experiments with “regenerated” decellurised veins, which incidentally serve as basis for an EU-funded clinical trial currently prepared by the Gothenburg-based company VeriGraft (founded by Sumitran-Holgersson and her husband Jan Holgersson, also a GU professor, read here). There was even a trachea transplant: that patient died very soon after, the paper later retracted for data manipulation and absent ethics vote. It was a decellurised cadaveric graft by method very similar to that of Paolo Macchiarini. Another tracheal graft was prepared for one of Macchiarini’s patients at Karolinska Institutet (KI) after her plastic trachea failed, but it was sent back unused. Because of such expertise in misconduct and medical ethics breach, Olausson and his GU colleague Hasse Ejnell served as experts who helped Swedish prosecutor drop manslaughter charges against Macchiarini (read all that here).

Now that Sumitran-Holgersson’s research funding was withdrawn, with the new decision by the Expert Group at the Swedish Central Ethical Review Board (CEPN) she becomes even more of a liability for GU: eight out of her ten analysed papers with Olausson are set for retraction, due to data manipulation by the corresponding author Sumitran-Holgersson (while all her co-authors were made co-responsible to various degrees). I reported the evidence before, on my site, after my readers notified me and posted it on PubPeer. The 2012 paper in The Lancet describing a regenerated vein transplant was however not earmarked for retraction, despite that among other things it contained a fake ethics vote (see my earlier reporting), which the journal The Lancet couldn’t care less about.

The original misconduct report was written for GU in September 2017 by the external investigator Ole Didrik Laerum, medicine professor at University of Bergen in Norway, who was appointed exactly one year before that. Sumitran-Holgersson didn’t like his results and demanded from CEPN a revision by the Expert Group on Research Misconduct, in which she was supported by her GU colleague Kristoffer Hellstrand. This now proved to be her big mistake, because what Sumitran-Holgersson et al got now, was findings of research misconduct and instructions for retractions. The Swedish original of CEPN Expert Group report is available here, (Update 21.03.2018: English version here), these are its findings: Continue reading “Sumitran-Holgersson and Olausson to retract 8 papers for research misconduct”

Pravda of Jessus report, CNRS Politburo scared of own people

Pravda of Jessus report, CNRS Politburo scared of own people

Following my recent article about attempts to fix data irregularities in the papers by CNRS’ chief biologist and director of l’Institut des sciences biologiques (INSB) Catherine Jessus, this state-owned French research institution, the biggest in Europe, now went full Pravda. Just as the notorious propaganda newspaper of the Communist Party of the Soviet Union (Pravda means Truth in Russian), CNRS press release of February 21st about the Jessus misconduct investigation combines lies, disinformation, and thinly veiled threats and calls for mass denunciation of traitors. The foreign enemy of French science is clearly identified: myself, the slanderous blogger.

All that would be mildly entertaining, were it not for the main victim of that investigative report: research integrity. We learn from that Soviet-style propaganda piece that Jessus took responsibility for almost all of the data manipulations in her papers, in fact even more data integrity problems emerged during the investigation, in figures previously not flagged either on my site or on PubPeer. Jessus was tasked by the commission to analyse her own incriminated figures herself, and to report her findings to her investigators. These professors of the l’Université Pierre et Marie Curie (UPMC, now Sorbonne University) who wisely chose to hide their identities (while decrying same with PubPeer commenters, sic!) had then the cheek to actually endorse the practice of data manipulations, in a public document, most astonishingly that of gel band duplications across different gel images, “for reasons of visual symmetry”. In other instances of cloned gel bands, the investigators spoke of scientifically-irrelevant “assembly errors” of western blots. No, not of separate antibody panels. Of individual gel images. They do not believe in monolithic photographs of an experimental gel, but prefer those as a digital puzzle or a collage, to be assembled from various bits and pieces in Photoshop, where a scientist sometimes inadvertently slips and uses the same gel band or bit of background twice.

Masquerading  research misconduct as good scientific practice is a form of scientific misconduct in itself. It doesn’t matter if these so-called experts really believed into the greater good of data manipulations, or strategically trolled the scientific community under cover of anonymity to save Jessus from herself, or were professionally unqualified to judge on the matters of biological science. Their decision not to see any misconduct despite ascertained evidence, while appropriating the entire blame onto those who blew the whistle, was borderline criminal, considering the circumstances. These dishonest UPMC investigators should be dragged out of their anonymity and publicly shamed and disciplined for the damage they just did to the reputation of French science. Continue reading “Pravda of Jessus report, CNRS Politburo scared of own people”

Karl Lenhard Rudolph barred from DFG funding for 2 years, as supportive peers flock to his conference

Karl Lenhard Rudolph barred from DFG funding for 2 years, as supportive peers flock to his conference

More trouble for the German stem cell and DNA damage researcher Karl Lenhard Rudolph (not to be confused this Christmas season with Rudolph The Red-Nosed Reindeer), after his own Leibniz Society found him guilty of misconduct in 8 papers and forced his resignation as director of the the Fritz-Lippmann-Institute (FLI) in Jena (read here). Before that, FLI he used to head was raided by the police for suspected animal abuse, and forbidden to perform any mouse experiments. Today the central German funding agency DFG issued a press release declaring that Rudolph received a written reprimand for data manipulation in 3 of his recent papers, and was barred from DFG funding for 2 years. As usual in Germany, no investigative reports were released, we know no details or which papers or which data is affected. The DFG assures that Rudolph was only responsible by failing to provide oversight, and that no data was faked anyway, though the previous Leibniz Society investigation determined the loss of original data and lab books.

This is also probably why Rudolph is still welcome at the ISSCR Annual Meeting 2018, to take place on 20-23 June, 2018 in Melbourne, Australia, where he is even listed as Plenary Speaker, for some reason under his very much outdated affiliation of the Hannover Medical School MHH (amazing university btw, read more here). Rudolph also used to be listed as invited speaker at the prestigious Keystone Symposium “Pushing the Limits of Healthspan and Longevity“, to take place also in Hannover, on April 15th -19th, 2018, but then something strange happened and Rudolph’s name was removed from the programme. Never mind, for Rudolph set up his own meeting, at FLI in Jena, and almost everyone who counts is coming to show support. Continue reading “Karl Lenhard Rudolph barred from DFG funding for 2 years, as supportive peers flock to his conference”

Sharma’s bad karma, or is anyone peer reviewing nanotechnology?

Sharma’s bad karma, or is anyone peer reviewing nanotechnology?

Nanotechnology is the way to cure cancer and to save humanity of all its problems in general, often using all possible plants and their parts to create nanoparticles. This is what one learns from certain publications which often appear in chemistry journals, where one can be quite sure no biologist was ever invited to peer review those. In fact, one wonders if anyone at all ever peer reviewed them. That is certainly the impression one gets from the evidence gathered by my now regular pseudonymous guest contributor, “Smut Clyde. Below, he will tell us a tale of the photoshopping team around the physicist Prashant Sharma at the Indian School of Mines in Dhanbad, India. There are currently two dozens of Sharma papers flagged on PubPeer, several feature a regular coauthor Rashmi Madhuri, who was apparently threatening hers and Sharma’s critics with “an International cyber complaint and formal police complaint” and “a case of defamation of worth 50,000 $ (per author)”.

Besides already available PubPeer evidence of what looks like the most lazy approach to data photoshopping, Smut Clyde lists a case of a single cell culture microscopy image which found its way in no less but (currently) 8 papers by Sharma et al, in different context. There are also examples of some apparently very insolent cloning of nanoparticles and other stuff inside same image, that bad that one feels ashamed for everyone involved. Certainly for the respected journals.

In those cases, the expert nanotechnology editors and reviewers do not have an excuse to have missed the evidence of gross data manipulation due to being dazzled by heavy biology they are not really experts in. Here, it was obviously duplicated electron microscopy, spectra analyses and chemical reaction kinetics which did not at all look like they represented original experimental data. Maybe they are supposed to stand in as illustration, and the authors promised to send their real research data afterwards, and then forgot.

Except that in one case, Sharma et al did have to fix a publication with a Corrigendum, which apparently shows the same photoshopped collage, but slightly zoomed out. For the esteemed editor-in-chief of ACS Biomaterials and professor at Tufts University School of Engineering, David Kaplan, this was apparently good enough. The irony: this was only caught because the original manuscript version is available on the “pirate” site Sci-Hub, which hosts almost all paywalled scholarly publications. The same site, which ACS (American Chemical Society) just now successfully sued in US court and had several of its internet domains removed, to prevent nosy people from accessing ACS property without paying. All, as ACS declares: “for the benefit of Earth and its people”.

After the evidence against Sharma et al papers began to pop up on PubPeer, a strange thing happened. Massive wave of comments targeting many papers from Sharma’s institutional colleague at Indian School of Mines, Sagar Pal, appeared on PubPeer, which were basically randomly picked figures from Pal’s papers combined with a comment declaring those to be fake. The tone occasionally tried to emulate the jovial descriptions of irregularities found in Sharma et al papers. Yet those accusations were all without exception ridiculously empty and utterly unfounded, and indeed PubPeer removed them soon (possibly after my tweets).  Continue reading “Sharma’s bad karma, or is anyone peer reviewing nanotechnology?”

Tissue-engineered tracheas: an assessment of the scientific, clinical and ethical implications

Tissue-engineered tracheas: an assessment of the scientific, clinical and ethical implications

Here I republish the written evidence submitted to by two UK scientists to the Science and Technology Committee of the British House of Commons and its inquiry into Research Integrity, as originally published on November 21st 2017. It deals with the trachea transplants performed by the surgeons Paolo Macchiarini and his former parter at UCL, Martin Birchall. The report’s lead author is Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit. She generously invited me in May 2017 to give a seminar at her department at the University of Liverpool on this topic. Her coauthor is Raphael Lévy, senior lecturer in nanotechnology and imaging at the same university. I wrote about his reproducibility studies on the topic of nanoparticles in this article.

800ABE38-9C0C-4E6A-A0A6-014E8827B9E3 Trish
Prof. Patricia Murray

UCL recently investigated Birchall’s past trachea transplants, and recommended to continue with his two current clinical trials to transplant cadaveric decellurised trachea and larynx, regenerated with bone marrow cells, as I reported here. For some reason, UCL Registrar Wendy Appleby, when speaking as witness on November 21st in front of the Parliament Inqury, found herself unable to answer the rather straightforward question whether the UCL investigative commission advised to continue transplanting trachea or not (watch here, from 11:50 on). Appleby and her UCL were instructed by the Inquiry to address the concerns by Murray and Levy in writing.

Both clinical trials  Inspire and RegenVox were already placed by the supervising authorities on hold, Murray and Levy now call to stop the dangerous and science-unsupported experimenting on misinformed human patients and to return back to the lab.

Following is a copy of the (originally published on the UK Parliament website), Continue reading “Tissue-engineered tracheas: an assessment of the scientific, clinical and ethical implications”