EU trachea transplant clinical trial TETRA “uncertain to take place”

EU trachea transplant clinical trial TETRA “uncertain to take place”

The European Commission now admits to me, through European Ombudsman, that their €6.8 mn phase 2 clinical trial TETRA with cadaveric tracheas, led by the UCL laryngologist Martin Birchall is unlikely to ever recruit any patients, because “the current delay to the INSPIRE project therefore makes the prospects for the commencement and completion of the TETRA project uncertain“.

INSPIRE is a phase 1 clinical trial in UK, suspended since December 2016, which was about to recruit 4 patients for trachea transplants using the technology of cadaveric tracheas Birchall developed together with his former partner, the scandal surgeon Paolo Macchiarini. The UK trial was suspended by UK authorities because of my reporting, its funding ran out and it is unlikely to be ever resumed. Even the official sponsor of both INSPIRE and TETRA, Cell & Gene Therapy Catapult, sulkily announced to change the status of the former trial from “active, not recruiting” to “suspended” at the Clinicaltrials.gov website. And without INSPIRE (which EU Commission prefers to see as “delayed“, not as suspended) the phase 2 clinical trial TETRA becomes just a grave for tax money, but luckily not for patients. This is something however EU Commission sees no problem with, and these are their views declared to me in the nutshell, via a letter from European Ombudsman to whom I complained after my Freedom of Information request was rejected by EU Commission twice (here and here):

  • EU Commission refuses access to TETRA documentation because this could be “potentially causing reputational damage to the consortium and individuals linked to it“.
  • EU Commission sees no imminent “public health concerns or public benefits” because “the TETRA clinical trial is dependent on the successful completion of the INSPIRE project
  • The trial will not be terminated, and will simply trudge on until the end of its funding period on 31 December 2019.
  • EU Commission maintains that Macchiarini only transplanted plastic tracheas and had no contribution to the cadaveric trachea technology of INSPIRE and TETRA: “the scientific research involved in TETRA is pursuing a different method than the one developed by the doctor who has been subject to misconduct investigations
  • EU commission maintains that cadaveric trachea transplants, including those principal investigator Birchall was involved in, were either full successes (where patients survived) or they never happened (where patients died). The list of dead and mutilated patients who received cadaveric tracheas, which I specifically sent to EU Commission, was dismissed as not relevant for the current clinical trial

Continue reading “EU trachea transplant clinical trial TETRA “uncertain to take place””

Los secretos de Macchiarini en Barcelona

Los secretos de Macchiarini en Barcelona

English version below.

El 12 de junio de 2008, el cirujano torácico y entusiasta de la medicina regenerativa Paolo Macchiarini operó a su paciente Claudia Castillo en el Hospital Clínic de Barcelona. La paciente recibió parte de una tráquea de un cadáver. El injerto fue despojado de todas sus células mediante un proceso llamado descelurización, y luego fue incubado dentro del llamado biorreactor junto con muestras de células de médula ósea y epitelio de las vías respiratorias de Claudia recogidas previamente, las cuales se esperaba que regeneraran el injerto muerto y lo hicieran cobrar vida, para convertirse en parte de su organismo. Esto desencadenó lo que hasta hace poco era una historia de éxito de hasta 19 trasplantes de tráquea artificial realizados por Macchiarini, ahora considerado por algunos como uno de los mayores crímenes en la historia reciente de la medicina.

A pesar del bombo de publicitario, Claudia no recibió un trasplante de tráquea. Tan sólo una parte de su bronquio izquierdo fue reemplazada, se la retiró un segmento delimitado de 2,75 centímetros de longitud debido a una infección tuberculosa y se le reemplazó con un injerto descelurizado. El trasplante tampoco resulto un éxito. La razón por la que Macchiarini reemplazo el bronquio de Claudia con un fragmento de la tráquea de cadáver fue que Claudia no tomó correctamente los dilatadores metálicos que dilataban las vías respiratorias. Justo medio año después, su injerto reblandeció y necesitó mantenerse constantemente abierto con una cánula. Después de que Macchiarini terminara de publicitar ese supuesto éxito en dos artículos The Lancet (Macchiarini et al 2008 y Gonfiotti et al 2014), en julio de 2016 el pulmón izquierdo de Claudia fue amputado junto con el injerto podrido, con el fin de salvar su vida. Actualmente está viva pero no gracias al trasplante de tráquea de Macchiarini sino más bien a pesar de él. Si el milagroso cirujano hubiera reemplazado su tráquea en vez de uno de sus bronquios, la paciente muy probablemente habría muerto, ahogada por el colapsado del injerto, tal y como ocurrió en la mayoría de los receptores de tráqueas de cadáver que Macchiarini trató después de Claudia. De hecho, esto es exactamente lo que sucedió en 2009, cuando Macchiarini operó a otro paciente barcelonés suyo, en otro hospital de Barcelona, ​​el Institut Dexeus, y sin ni siquiera intentar obtener ningún permiso ético. En Barcelona, al menos dos pacientes más estaban esperando para recibir un trasplantae, pero Hospital Clinic denegó el permiso y se deshizo de Macchiarini. El cual, en enero de 2010, fue a Florencia, Italia, y trasplantó allí a otros 5 pacientes con injertos de tráquea de cadáver durante ese mismo año. Todos murieron. Continue reading “Los secretos de Macchiarini en Barcelona”

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”

Jessus investigator identity leaked, CNRS President to expose whistleblowers

Jessus investigator identity leaked, CNRS President to expose whistleblowers

An update to the ongoing cartoon Stalinism propaganda and purge activities at the EU largest research institution, the French CNRS, in the wake of the affair around manipulated data of CNRS chief biologist Catherine Jessus, according to their press release an innocent “victim” of my “slanderous” and “unscientific” blogging.  First of all, a reliable source forwarded to me information from inside CNRS who one of the anonymous investigators was: Francis-André Wollman, CNRS researcher and professor at Jessus’s university UPMC (now Sorbonne University) in Paris. Wollmann is plant cell biologist, specialising in chloroplasts, the technology of western blot is standard in his lab. He did not reply to my emails, also the CNRS and Sorbonne University press speakers chose not to deny his role as anonymous Jessus investigator. The experts namely declared western blot manipulation to be good scientific practice, and lashed out at those who have a problem with copy-pasted gel bands (read here).

Then, the new CNRS President Antoine Petit, who replaced interim president Anne Peyroche (deposed after my reporting about data manipulations in her papers) proved to be not really a reformer, quite the opposite. Petit approved the new definition of what research misconduct in biology is, following cues from Sorbonne University and its president Jean Chambaz (who is cell biologist, specialising on intestinal metabolism and thus also a western blot expert), as well as Wollman and other Jessus investigators. New Sorbonne and CNRS Party doctrine is that data manipulation is definitely not research misconduct, but criticising that data manipulation is.

This is how Petit responded to the Jessus affair in public so far:

  • Called myself and other PubPeer commenters “arseholes” (in French connards) at his first meeting with the section heads of CNRS (one of whom is Jessus)
  • Claimed that PubPeer evidence and my reporting was an accusation of misconduct directed personally at Jessus and Peyroche (a lie, check my articles here and here), in this radio interview.
  • Described documented and now validated data integrity concerns raised against publications by Jessus and Peyroche as equivalent to false accusations of pederasty (then corrected to paedophilia), in same radio interview.
  • Announced to use IT surveillance technology to identify anonymous PubPeer commenters after their evidence was exposed as “wrong” (as it was in case of Jessus), in same radio interview.

Continue reading “Jessus investigator identity leaked, CNRS President to expose whistleblowers”

Expert witness Macchiarini to help Berlin court sentence criminal journalist

Expert witness Macchiarini to help Berlin court sentence criminal journalist

The stem cell pioneering surgeon Paolo Macchiarini is back in court now. No, he is not the accused this time. He is an unbiased, independent expert witness invited by his student and acolyte Philipp Jungebluth to help him sue me in Berlin. There are two court injunctions against me, one was already partially lifted, while another was upheld in full, and the main issue are Macchiarini’s trachea transplants in Italy described in an unpublished manuscript. I cannot say much more without facing a €250,000 fine or a 6 months prison term.

Macchiarini recently saw the Swedish state prosecutor drop charges against him because another misconduct-tainted Swedish trachea transplanter, Michael Olausson, served as secret expert for prosecution. At least, no journalists faced court sentencing in Sweden for exposing trachea transplant scandals. It is different in Germany, where constitutional press freedom counts little if someone doesn’t like your reporting, which is why medical scandals in Germany are so rare. The ruinous court trials Macchiarini-associates Jungebluth and Heike & Thorsten Walles imposed on me seem to have scared German media into near-complete silence on the trachea transplant affair. What about the central role of Germany, especially Macchiarini’s and Jungebluth’s university Hannover Medical School (MHH) and their recent cover up of the trachea transplants? Definitely no public interest there, even if Macchiarini’s only remaining (adjunct) professor title was bestowed by MHH. My appeal hearing for both Jungebluth injunctions is at the Berlin Kammergericht court on May 24th. It is public, feel free to come. Maybe even Prof Macchiarini pops in?

Continue reading “Expert witness Macchiarini to help Berlin court sentence criminal journalist”

Editor sacked over rejection rate: “not inline with Frontiers core principles”

Editor sacked over rejection rate: “not inline with Frontiers core principles”

Frontiers, the Switzerland-based publishing company run by EPFL professor and brain simulant Henry Markram and his wife Kamila and owned by the German giant Holtzbrinck and some investors, describes itself as “a community-rooted, open-access academic publisher”, and as such it boasts a ~71,000 head strong “virtual editorial office” which is bigger than the number of all Frontiers articles published since its inception in 2007 (~65,000). This communal character however doesn’t mean that the editorial board the size of a large town is invited to have any actual influence over editorial policies at Frontiers (which fits into one open-space office in Lausanne). In fact, the following guest post by Regina-Michaela Wittich, a former senior editor of a Frontiers journal narrates how she was sacked by Frontiers because she rejected too many papers for being of insufficient scientific quality, instead of sending them into the “rigorous” Frontiers peer review process (allegedly “enhanced with artificial intelligence”) where rejection becomes quite unlikely, and reviewers are sometimes reminded of their duty to be constructive. Continue reading “Editor sacked over rejection rate: “not inline with Frontiers core principles””

Linköping researcher protests bad science of corneal implants

Linköping researcher protests bad science of corneal implants

Imagine: Your collaborative research work is about to submitted for publication, but you are not convinced of its scientific validity. The lead author tells you: either you accept her interpretation of results and become co-author, or she kicks you off the paper. Her shady claims will pass peer review and be published, the scientific community as well as clinicians and patients will be misled.  You can be part of it, with another paper decorating your CV, or you surrender your data and leave, but this paper is happening.

This is what happened to Jaywant Phopase, principal research engineer at the Linköping University (LiU) in Sweden, who now asks for your advice below. The university is known to readers of my site for the scandal around the fake professor and predatory conference organiser Ashutosh Tiwari. Incidentally, Phopase’s research was originally performed at the same Faculty of Science and Engineering (IFM), where Tiwari found support and protection by the former prefect Ulf Karlsson. Same Karlsson who allegedly used to bully Phopase, exactly because the latter raised a fuss about bad science being published and patients abroad being mistreated.

That science in question was led by former LiU professor May Griffith, then at LiU Faculty of Medicine and Health Sciences (FSM). Griffith’ research project was about artificial corneal implants, made as a composite of a chemical polymer and human collagen, manufactured at LiU and tested for biocompatibility on human subjects in Ukraine and India. For that she was found guilty of research misconduct by “repeated negligence”, in a LiU investigation from 2015 (see LiU press release and the Swedish-language report summary). Continue reading “Linköping researcher protests bad science of corneal implants”