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.

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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”

Anil Sood and how much MD Anderson doesn’t care: whistleblowers speak out

Anil Sood and how much MD Anderson doesn’t care: whistleblowers speak out

My earlier article presented the worrisome research integrity record at the gigantic US cancer research hospital MD Anderson Cancer Center, part of the University of Texas in Houston. Its particular focus was the ovarian cancer researcher Anil Sood, professor of Gynecologic Oncology and Reproductive Medicine and co-director of Center for RNA Interference and Non-Coding RNAs at MD Anderson. Meanwhile I have been contacted by no less than 4 former Sood associates with their concerns, because they say MD Anderson does not take them seriously. A pseudonymous guest post by one of these whistleblowers, together with some evidence, is published below.

Sood’s record of appalling duplications of microscopy image and western blot bands in his papers is evident on PubPeer, no less than 40 papers are flagged, spanning so far a period from 2004 until now. The whistleblowers who contacted me now also accuse Sood of inappropriate data handling, since he was apparently removing or adjusting data points on a whim, and taught his lab members to do the same. The results based on this creatively acquired mouse experiment data as well as duplicated images served to initiate at MD Anderson a clinical trial with up to 90 “patients with histologic proof of advanced solid tumors ” to test a siRNA based therapy, this trial is lead by Sood’s associate Robert Coleman, who is professor at the same department.

Worst of all: MD Anderson doesn’t care about what happens in Sood’s lab. They do have guidelines for research integrity, printable as pdf, but those seem to serve as a kind of toilet paper to wipe professorial bums with. As a whistleblower informed me, nine researchers working on different projects in Sood’s lab complained to Office of Research Integrity (ORI) or MD Anderson’s own Research Integrity Officer (RIO) William Plunkett or Department Chairs or Ombuds Office or Dean of Graduate School, Michelle Barton, since August 2016. In fact, those who complained where told to find another job, or were dealt otherwise with. There never was any investigation, only “leak of confidentiality”, while the University of Texas graduate school keeps sending fresh students to learn at Sood’s lab. Meanwhile, as a whistleblower wrote: “Most Sood core members already escaped, and got a job thanks to their publication with suspected allegations“.

Continue reading “Anil Sood and how much MD Anderson doesn’t care: whistleblowers speak out”

Martin Birchall’s shaky road to mass trachea transplanting

Martin Birchall’s shaky road to mass trachea transplanting

The British laryngologist and UCL professor Martin Birchall is one of the two founding fathers of “bioengineered” trachea, the other one being his former partner, the scandal surgeon Paolo Macchiarini. Birchall presently runs three trachea transplant trials clinical trials, two in the UK and one EU-wide. His patients must however wait to be cured, because the two UK trials, Inspire and RegenVox (with the latter primarily about larynx and upper trachea transplant) were both placed on hold, and the EU funded phase 2 trial TETRA is still far from getting an ethics approval and just now lost one potential trial site after the Medical University Vienna jumped ship. The EU Commission refuses to tell me anything about TETRA, except that it has not applied for ethics approval yet. EU’s Transparence department still evade commenting on how to put this scheduled 48 patient clinical trial in context of the 11 cadaveric trachea transplants by Macchiarini and Birchall, most or maybe even all of which left the patients either dead or mutilated.

In this article, I publish the most recent patient information sheets for the two suspended Inspire and RegenVox trachea transplant clinical trials, which I obtained under Freedom of Information request from the UK Health Research Authority (HRA).  Continue reading “Martin Birchall’s shaky road to mass trachea transplanting”

Call to research integrity, or at least a minor revolution at CNRS

Call to research integrity, or at least a minor revolution at CNRS

When I first started digging into the affair of data manipulations around the former star of plant sciences Olivier Voinnet in early 2015, I was sure to be dealing with a singular case of fraud in French science, which went totally unnoticed for decades. When 2 years later I wrote “a fish stinks from the head down” in my article about Voinnet’s former Strasbourg plant sciences institute and its problematic director, I did not know how far up to the very top this data manipulation scandal will go. Now, it looks like the entire leadership of  the Centre National de la Recherche Scientifique (CNRS), French state’s own network of research institutes, might be corrupted and rotten. Research and its integrity at this “largest fundamental research organization in Europe” are overseen by the very people whose own publications should be under investigation for suspected misconduct. A minor revolution is in order in French science, for which I would like to make a case here.

The new interim president of the entire CNRS of 32,000 research employees with the annual budget of €3.2 Billion, Anne Peyroche, has seen now her own publications flagged on PubPeer for data irregularities. In fact, PubPeer itself, which is run by two CNRS employees, seems to be in a pickle. They now vigorously police and delete attempts of criticisms of Peyroche papers. Is the whistleblowing site fighting for its survival, afraid that CNRS might impose its demise any time? How far is the CNRS’ leadership prepared to go, now that their power is threatened by the evidence of misconduct in their own papers?

Catherine Jessus, being the director of its l’Institut des sciences biologiques (INSB) basically the head biologist at CNRS, already reacted to a stream of evidence against her publications on my site and on PubPeer. No, she is apparently not going to check lab books or provide for original data. Instead she declared to her colleagues that CNRS will soon start a massive legal action against yours truly. If true, the State of France announced to soon set its power and resources upon a German blogger, yet the French media refuses to report anything until CNRS issues an official statement in this regard. This information I have from direct sources.

Continue reading “Call to research integrity, or at least a minor revolution at CNRS”

Human Brain Project interview with Thomas Lippert: Simulating brain in computer is like simulating weather

Human Brain Project interview with Thomas Lippert: Simulating brain in computer is like simulating weather

Following is my email interview with Thomas Lippert, professor and director of the Institute for Advanced Simulation and the Jülich Supercomputing Centre at the Forschungszentrum Jülich in the west of Germany, located somewhere between the cities of Cologne and Aachen. Lippert’s FZ Jülich is a central partner at the Human Brain Project (HBP), the Future and Emerging Technologies (FET) Flagship mega-consortium which is funded with €1 Billion, half of which coming from the European Union.  Lippert heads the Subproject (SP) 7 at the HBP, named High-Performance Analytics and Computing Platform, tasked with providing the high-performance computational power in order to help the HBP megaproject simulate the human brain and its diseases.

I previously wrote some critical articles about HBP, about the hubris of its founding father Henry Markram, the bizarre way EU positively evaluated the performance of HBP without actually evaluating it, and also about the purpose of HBP and Flagship projects in general. Incidentally, the last article’s cover photo showed Lippert at a HBP conference. We got into a discussion over Twitter during HBP’s recent Open Day show in Glasgow, where Lippert kindly agreed to answer my questions about the purpose and orientation of HBP.

Continue reading “Human Brain Project interview with Thomas Lippert: Simulating brain in computer is like simulating weather”

Yehiel Zick, Weizmann’s resident Western blot artist; by Smut Clyde

Yehiel Zick, Weizmann’s resident Western blot artist; by Smut Clyde

The  Weizmann Institute of Science in Rehovot, Israel, is not just a renowned biomedical research centre of world calibre. It is also home to many Israeli artists, who take mundane scientific tools like western blot and microscopy images and transform those into modern, or in fact postmodern art. I listed some of these artists in my previous article, after which one of these researchers wrote to me comparing me to “a “judge” in some totalitarian countries”, waving “a ready death sentence”. Now, I am presenting a guest post from the pseudonymous “Smut Clyde” (who honoured my site before), which extolls the artistic achievements of yet another Weizmann artist, an actual Wunderkind of postmodern Western blot collage, Yehiel Zick.

In his day job, the near-pensioner Zick is a humble diabetes researcher, still studying insulin resistance, but also mechanisms of cancer and bone remodelling. He also heads the Department of Molecular Cell Biology at Weizmann. Less known is Zick for his published Western blot collages, which are being honoured in the guest post below. No less than seven Zick publications are currently being admired on PubPeer, all appeared in the Journal Of Biological Chemistry (JBC). Which is likely soon to become a major problem, because this journal destroyed the career of Zick’s colleague and another famous Western blot artist at Weizmann, Rony Seger, after the editors retracted 9 of his papers in one go. Both Seger and Zick earned their PhD degrees in the same lab of the late biochemist Shmuel Shaltiel at Weizmann, both worked on a related project, the former in 1975-1980, the latter in 1983-1988. The two published also some papers together. Did their mentor Shaltiel fail to spot his two students’ artistic inclinations? And if he did, how did he react? We will never know.

I did learn however from one Weizmann professor that this institute has a strange approach to investigating suspected research misconduct. Seger was apparently under investigation for some time, yet not much happened until JBC pulled the plug on his nine papers. Then things happened pretty quickly, though Seger still keeps his tenured job. Is Zick facing some retractions, followed by an involuntary retirement? And are all others safe, because they mostly had the wise foresight to avoid publishing in JBC?

Continue reading “Yehiel Zick, Weizmann’s resident Western blot artist; by Smut Clyde”

How trachea transplanters tricked Andemariam Beyene to sacrifice himself for a Lancet paper

How trachea transplanters tricked Andemariam Beyene to sacrifice himself for a Lancet paper

This article reports the results of an investigation performed in Iceland by the Landspítali University Hospital, concerning the scandal surgeon Paolo Macchiarini and his past host, the Karolinska Institutet (KI) and their University Hospital. The Iceland resident Andemariam Teklesenbet Beyene was the first ever person, or in fact a living being, to receive a plastic trachea. He was 39 at that time and died two and a half years later, slowly suffocating on the collapsing and rotting plastic graft, with Macchiarini still claiming that the patient had originally no more than 6 months left to live and that his plastic trachea transplant had his life significantly extended. The investigation shows that this was not truth. A palliative laser debulking surgery was denied to Beyene, while Macchiarini and his KI decided in advance to use the unsuspecting patient for their plastic trachea experiment, and even skipped the necessary medical examinations to achieve their goal. No ethics approvals were sought, Macchiarini simply lied about those. Beyene went to KI to be examined,  clueless of what awaited him, and just 2 days later, instead of returning home to discuss the therapy options, he signed his own death sentence.

The Erithrean patient was working on his PhD in Iceland, where he was diagnosed with a slow growing form of tracheal cancer, which obstructed his airways. The surgeon Tomas Gudbjartsson operated Beyene in 2009, when he removed part of the tumour. After Beyene developed breathing difficulties again, Gudbjartsson referred him to Macchiarini and KI, to discuss treatment options. Yet the Icelandic surgeon was informed in advance that Macchiarini decided to transplant Beyene with a plastic trachea. He even helped Macchiarini remove the therapeutic option of laser debulking from the patient’s assessment. Afterwards, Gudbjartsson travelled to Stockholm to join the trachea transplant operation on Beyene. Even when during the operation the tumour proved to be much smaller than diagnosed by Macchiarini, the native trachea was removed and replaced with the deadly plastic contraption.

After the operation, Macchiarini and KI stopped caring for the patient Beyene, except of using him as material source for their publication in the elite journal The Lancet (Jungebluth et al, 2011). The first author of this lies- and misconduct-tainted masterpiece, which retraction was now requested by a Swedish Ethics Board investigation, is the German doctor Philipp Jungebluth, a student and acolyte of Macchiarini. Jungebluth is suing me in court, and there he used that same Lancet publication to convince the judge that his medical research saved patient lives. Jungebluth also convinced the same Berlin judge that he had nothing at all to do with Beyene or any other trachea transplant patient of Macchiarini’s. It does not matter that in this (and another manuscript) Jungebluth wrote that he “assisted the surgery and with collection of secondary data”. The latter means,  as the Iceland investigation uncovered, that he helped Macchiarini chase after Gudbjartsson to call in Beyene for bronchoscopies and other examinations, which sole purpose was to provide data which the Lancet peer reviewers have requested. Gudbjartsson complied unquestioningly, for which he now received a reprimand. Continue reading “How trachea transplanters tricked Andemariam Beyene to sacrifice himself for a Lancet paper”