Imagine you are Martin Birchall, laryngologist and ENT surgeon, star of regenerative medicine at UCL and trachea transplant enthusiast. You and your business partner Videregen need to explain to EU bureaucrats why your technology of decellurised cadaveric trachea is perfectly safe, what with all the dead patients of yours and your former best friend Paolo Macchiarini. Preclinical animal tests? Good idea indeed, though you have already published some very shady pig studies with Macchiarini in 2010, after you operated your first human patient in 2008 (whom you keep parading as success story of your stem cell magic superpowers, despite heavy complications which almost killed your research subject).
To distance yourself from that horrid Macchiarini, you do new preclinical tests. Enter three more pigs, which you decide transplant with a cadaveric decellurised human trachea. One trachea turns out to have been dirty not just with human “stem” cells, but also with pathogenic bacteria. So that one piggy got lucky and was set free. The unlucky other two: dead “of respiratory compromise”, one already after 12 days, the other suffered for a whole month after trachea transplant. You now have 100% preclinical mortality rate, and you still manage to convince the bureaucrats that the method works and 48 human patients must experience same, in the EU-funded phase 2 clinical trial TETRA. Thing is, that trachea transplant trial was supposed to help tracheal stenosis patients, by ridding them of burdensome stents and bronchoscopies, and not to euthanise them. Continue reading “Birchall’s two dead pigs to prove trachea transplants are safe”
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 Lancet, Jungebluth 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”
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””
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”
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”
This is a follow-up to the previous article, about a misconduct investigation at the Cardiff University in UK into the published works of cancer researcher Wen Jiang, professor of Surgery and Tumour Biology, Fellow of Royal Society of Medicine and chair of Cardiff China Medical Research Collaborative. The following guest post by my regular contributor Smut Clyde now delves deep into the peculiar approach with which Professor Jiang intends to cure cancer: namely by peddling herbal (and not so herbal) medicinal powders, manufactured by a Chinese company Yiling Pharmaceuticals. Jiang sees there no conflict of interest, even in presenting the patented concoctions of Yiling as his own research in Cardiff. It is not exactly the case that Jiang was hiding his connections to Yiling, outside of his conflict of interest declarations, that is. His own Cardiff University initiated the collaboration with the Chinese company in 2013 and proudly announced the engagement to the British Parliament in 2014. In 2015, Yiling helped Jiang and Cardiff University to organise The China–United Kingdom International Cancer Conference, attended by the First Minister of Wales and the Vice-Chancellor of the Cardiff University.
Jiang’s cancer-fighting magic ingredients are ginseng and other herbs, plus a cockroach, a parasitic fungus and bits of chicken gizzard, all sold by Yiling. Sometimes it includes Divine Comedy (don’t ask). Yiling’s potion named “Yangzheng Xiaoji” was certified by Cardiff University in an Impact statement as a metastasis inhibitor, which “has been shown to be beneficial to patients with certain solid tumours when used alone…“. The sole basis for this bold claim from respected British university was a 2009 paper by Yiling in an obscure Chinese journal, which incidentally is edited and published by Yiling.
Continue reading “Fried Divine Comedy, featuring anti-cancer cockroach and phallic fungus”
The Cardiff University in UK is now investigating two cancer researchers, both senior professors, for suspected scientific misconduct. The evidence was submitted by pseudonymous Clare Francis, I publish below the results of preliminary investigations. One of these two professors is Robert Nicholson, specialist in breast cancer, former director of Tenovus Centre for Cancer Research, now professor of Cardiff School of Pharmacy & Pharmaceutical Sciences, celebrated on BBC in 2008 for discovering a therapy target for tamoxifen-resistant tumours. The other is Wen Jiang, professor of Surgery and Tumour Biology at Cardiff University School of Medicine specialising in metastatic solid tumours, Fellow of Royal Society of Medicine and chair of Cardiff China Medical Research Collaborative. Jiang also made it into BBC news in 2013, when he announced to have discovered a “formula”, “consisting of 14 herbs” from traditional Chinese medicine, to stop cancer metastasis.
The two great doctors Jiang and Nicholson made great promises to cancer patients. A preliminary investigation by Cardiff University now determined that those promises were based on duplicated images and cloned gel bands. Importantly, the committee also saw irregular splicing of gels as a problem, an issue many tend to dismiss. The traditional excuse goes that gel splicing was allegedly permitted until 2008 or so. In fact, irregular splicing of gels, where bits of different gels are assembled to look as it were one intact physical gel, was never permitted and always considered to be data manipulation. Especially where due to splicing the gel loading controls are proven not to match the analytic gels, the entire figure becomes meaningless. Or worse, it indicates research misconduct. Continue reading “Cardiff investigates two cancer research professors for data manipulation”