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June, 2018 in Melbourne, Australia, where he is even listed as Plenary Speaker, for some reason under his very much outdated affiliation of the Hannover Medical School MHH (amazing university btw, read more here).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”

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”

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”

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”

Swedish Central Ethics Review Board finds Macchiarini guilty of misconduct, requests retraction of 6 papers

Swedish Central Ethics Review Board finds Macchiarini guilty of misconduct, requests retraction of 6 papers

Breaking news, Central Ethics Review Board (CEPN) decided today on the case of trachea transplant surgeon Paolo Macchiarini. The expert review by Martin Björck, professor of surgery at University of Uppsala, and Detlev Ganten, professor emeritus of pharmacology and former CEO of the Charité, on which this decision is based, is available here on my site.

Here the press release I received:

The Expert Group on Scientific Misconduct has on request from the Karolinska Institut (KI) delivered a Statement in a case where Paolo Macchiarini is one of the researchers accused of scientific misconduct.
The case comprises six articles which mainly deals with transplantation of synthetic tracheas. These articles have previously been reviewed by Professor Bengt Gerdin, who found scientific misconduct in all six articles. Despite that, KI choose to clear Paolo Macchiarini and the co-authors. KI have thereafter opened the case again.
The Expert Group have appointed two external experts, Professor Martin Björck, Uppsala and Professor Detlev Ganten, Berlin. They have similarly to Bengt Gerdin, founded that there arescientific misconduct in the articles in question.
The Expert Group state that the transplantations are described successfully in the articles, which is not the fact. The Expert Group also establish that the information in the articles are misleading and beautifying regarding the patients conditions and furthermore that information has been withhold in this purpose and that this constitutes scientific misconduct. In addition,there is false information of ethical approval, which also constitute scientific misconduct.
The Expert Group finds that all co-authors to the six articles are guilty of scientific misconduct. The responsibility is however different amongst the authors. The main responsibility lies on Paolo Macchiarini as the main author and research-leader and others who have had a more prominent role in the research and the authorship. The more detailed responsibility and the future consequences for the respective authors is up to their employers to decide.
The Expert Group request the different publications to withdraw all six articles.

Continue reading “Swedish Central Ethics Review Board finds Macchiarini guilty of misconduct, requests retraction of 6 papers”

Swedish police investigation acquitted Macchiarini on advice of misconduct-tainted trachea transplanters

Swedish police investigation acquitted Macchiarini on advice of misconduct-tainted trachea transplanters

On October 12th 2017, the Swedish prosecutor Jennie Nordin  gave a long-awaited press conference about the case of the scandal surgeon Paolo Macchiarini. The surprise hardly anyone expected was: all manslaughter charges were dropped, the case closed. The operations on three patients, whom Macchiarini gave a plastic trachea at the hospital of the Karolinska Institutet (KI), and who died as the result, were declared  mere negligence. Andemariam Beyene, Chris Lyles and Yesim Cetir (details of their cases here) were considered as dying anyway and without any other possibility to help, in fact the prosecution decreed that there was no way to prove if they would have lived longer had Macchiarini not experimented on them without ethics permits or any previous animal testing.

While Sweden and the world listened in disbelief at the words of Nordin, everyone wondered how could the police investigators come to such radically different conclusion about the medical aspects of these trachea transplant operations than the experts in Sweden and worldwide, who clearly see Macchiarini’s trachea transplants as unethical human experimenting and misconduct (see here). The prosecution refused to divulge which experts advised them though, also their assessments remain confidential. Now, thanks to KI’s emeritus professor and whistleblower Johan Thyberg, I found out what the Chairman of the Judicial Council Camilla Olsson, and her rapporteur Robert Grundin wrote to the prosecution:

“The Board has obtained the opinion of Professor Hasse Ejnell and Professor Michael Olausson”

Update 27.10.2017: Prosecutor Nordin confirmed to Thyberg by email that the experts appointed by the National Board of Health and Welfare (Socialstyrelsen) were indeed Hasse Ejnell and Michael Olausson.

These are the two clinical professors from the University of Gothenburg who themselves transplanted a cadaveric trachea, without obtaining a proper ethics vote or an approval of authorities on the treatment and its medication. The patient died soon afterwards and the publication describing that operation  (Berg et al, Tissue Eng Part A. 2014) was retracted for data manipulations. The scientist behind this was the notorious Gothenburg regenerative medicine researcher Suchitra Sumitran-Holgersson. She and Olausson were both found guilty of misconduct and ethics breach by the University of Gothenburg, regarding that trachea transplantation as well as transplants of “regenerated” veins into three child patients.

On top of this, Olausson was involved into the case of Yesim Cetir, Macchiarini’s third patient. Unlike previous two patients Yesim had no slow-growing or any kind of cancer, all she had was a tracheostomy due to damaged trachea after a botched operation in her home country Turkey. With such a defect alone, she was in no life danger at all, as long as she did not try to swim. It was Macchiarini who declared her in his recent television interview as “bleeding a glass of blood” daily, or the Swedish prosecution claiming she was suffering of “life-threatening” chest infection, without explaining how this can be cured with a plastic trachea transplant. Olausson, who helped the prosecution form this diagnosis, has made together with Sumitran-Holgersson a cadaveric trachea which was supposed to save Yesim’s life after her first plastic trachea transplant failed. Macchiarini’s acolyte Philipp Jungebluth (the one who keeps suing me in court in Germany) travelled to Gothenburg to pick up that trachea in 2013.  Macchiarini then changed his mind, sent Olausson his necro-trachea back and implanted another plastic graft into Yesim. Which wade matters even worse, Yesim died in March of this year in the hospital of the Temple University, USA. Her father Hayrullah, who dedicated all his time and attention to trying to save her, died soon after Yesim, on untreated cancer.

Continue reading “Swedish police investigation acquitted Macchiarini on advice of misconduct-tainted trachea transplanters”

Alexander Seifalian, UCL’s Persian Scapegoat

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”