Cardiff: no misconduct by TCM professor Wen Jiang, report secret

Cardiff: no misconduct by TCM professor Wen Jiang, report secret

Cardiff University is very proud of its collaboration with manufacturer of Traditional Chinese Medicine Yiling Pharmaceuticals, while the money it brings in is largely a private issue between the two business partners. Unfortunately Cardiff’s surgery and tumour biology professor Wen Jiang, Fellow of Royal Society of Medicine, is at the centre of an affair about data manipulation in his papers, and about criticisms of peddling Yiling’s TCM concoction of ginseng, dried fungus, chicken gizzard and crushed cockroach as a Cardiff University-certified cancer cure, all involuntarily sponsored by the Welsh public and charity Cancer Research Wales. This is why the university threw their own damning internal investigative report out of the window, and had three poorly qualified experts declare Jiang innocent of any data manipulation in his cell biology papers. Cardiff University issued then a press release accusing me personally of having slandered Jiang with false allegations of misconduct.

After having mulled another one of my Freedom of Information (FOI) inquiries for a month, this time a request for the investigative report, Cardiff University declared that their whitewashing opus is secret, because:

“the formal investigation has not upheld the allegations of misconduct and to further distribute this report would be an unnecessary invasion of the privacy of the individual involved”.

Continue reading “Cardiff: no misconduct by TCM professor Wen Jiang, report secret”

Trachea transplanters without borders

Trachea transplanters without borders

News from the trachea transplant entrepreneurs. What with the UK authorities having officially suspended both phase 1 clinical trials Inspire and RegenVox, and the EU phase 2 clinical trial TETRA going nowhere, the technology’s owner, Liverpool-based company Videregen decided to seek new clinical partners. Surgeons and universities from outside the EU, especially from US, China and Japan are invited to test Videregen’s trachea transplant technology, which was originally developed together with Paolo Macchiarini by the UCL laryngologist and paid Videregen advisor Martin Birchall.

While tracheal stenosis was the indication sought to treat with trachea transplants in UK and EU (as the authorities drew curtains before the show even started), Videregen now goes for bronchopleural fistula, while pretending (quite dishonestly) that “all required regulatory and ethical approvals necessary to commence clinical trials in the UK” would exist.

The other bit of news is that UCL finally published the 2015 PhD thesis of Birchall’s student Claire Crowley (now postdoctoral scientist in charge of clinical research on oesophagus replacement with UCL professor and another trachea transplanter Paolo De Coppi). It reads as if certain parts of the thesis were edited or even written by UCL’s legal department. Not what thesis says, but what is omitted is worrisome. Crowley was namely responsible for the production of 3 trachea replacements requested by Birchall, which all proved deadly to their human recipients. One was a decellurised cadaveric graft, and two were POSS-PCU plastic tracheas, which Crowley made herself, in the lab of her other advisor, the (now sacked) UCL nanotechnologist Alexander Seifalian. Yet the thesis only mentions one graft, in a brief one-page statement, simply because Crowley could not deny her role there. She is co-author on the Macchiarini paper Jungebluth et al Lancet 2011 telling the alleged success story of the very first plastic trachea transplant performed in Sweden on the patient Andemariam Beyene. Otherwise, Crowley never mentions in her thesis the cases of Keziah Shorten or Shauna Davison, whose lethal trachea grafts she also made herself, as part of her PhD studies. Continue reading “Trachea transplanters without borders”

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””

Fried Divine Comedy, featuring anti-cancer cockroach and phallic fungus

Fried Divine Comedy, featuring anti-cancer cockroach and phallic fungus

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.

Update: scroll down for relevant Cardiff University press release.

Continue reading “Fried Divine Comedy, featuring anti-cancer cockroach and phallic fungus”

Cardiff investigates two cancer research professors for data manipulation

Cardiff investigates two cancer research professors for data manipulation

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”

UCL’s decellurised tracheas: strong and stable?

UCL’s decellurised tracheas: strong and stable?

The European Union Commission staunchly refuses to tell me what exactly their funded scientists intend to do to the scheduled 48 trachea transplant patients under the Horizon 2020-financed phase 2 clinical trial TETRA. By now the highest authority, the European Ombudsman, is engaged, and still EU Commission does not bulge. The general technology of TETRA and its indefinitely suspended phase 1 UK predecessor Inspire is however known: cadaveric tracheas from dead donors will be collected, decellurised to remove all the host cellular tissue, and then subjected to the magic of recellurisation in bioreactors, where bone marrow and epithelial cells will turn a dead carcass into a living organ, ready for transplant.

The cadaveric grafts must either to be obtained very fresh (a nightmare of impracticability), or kept frozen before they are needed, otherwise they will rot. Leanne Partington, a PhD student of the UCL trachea makers Mark Lowdell and Martin Birchall, investigated in her 2014 PhD thesis the effect of this freeze-thaw step on the decellurisation process (it proved to increase efficiency) but also on the graft stability, as measured by compression tests. This is where it turned out that the defrosted grafts lost roughly half of their mechanical stability. Which means they would collapse immediately when implanted into patient, which was indeed exactly what happened. Yet UCL and EU Commission want to keep trying, and according to the patented technology by the trial sponsor Videregen, defrosted tracheas are to be used. Which by EU business-oriented logic suggests, the patented technology from the freezer is to be used in TETRA.

The two experiments UCL performed on the patients Ciaran Lynch and Shauna Davison in 2010 and 2012, respectively (read here), used defrosted tracheas. Both trachea grafts collapsed right away, only that Birchall and his partners decided to omit this critical information about Ciaran’s trachea in their Elliott et al Lancet 2012 paper, while telling untruths about Shauna’s fate. The UCL trachea transplanters until very recently either forgot about Shauna’s existence, or pretended her new trachea functioned great up to her allegedly unrelated death just two weeks after the transplant.  Continue reading “UCL’s decellurised tracheas: strong and stable?”

Trachea transplanters: Round 2 at UK Parliament

Trachea transplanters: Round 2 at UK Parliament

The Science and Technology Committee of the British House of Commons is now dealing with the trachea transplants performed by the scandal surgeon Paolo Macchiarini and his former parter at UCL, Martin Birchall as part of its inquiry into Research Integrity. Two UK scientists from Liverpool initiated this with their written submission from November 21st 2017 which I previously re-published: Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit, and Raphael Lévy, senior lecturer in nanotechnology. Their concerns were not just the past trachea transplants, but also the present clinical trials with bioengineered trachea and larynx which UCL is most keen to start with, following the recommendation of an investigative commission from last year. UCL’s problem is however, that the two phase 1 UK trials are suspended by the UK authorities, and the big phase 2 EU-sponsored trial cannot begin recruiting patients without the results from phase 1.

By now it looks like UCL and their laryngology professor Birchall are in a pickle. Their own reply to the letter by Murray and Levy was not really honest when describing past UCL trachea transplant patients to the Parliament committee. On top of it, it turned out Birchall was reusing data from same old experiments on 16 pigs across different publications which were meant to show separate studies. This, and many more inconsistencies of UCL’s reply to the House of Commons are addressed in the re-published new letter by Murray and Levy from January 30th 2018 below. Continue reading “Trachea transplanters: Round 2 at UK Parliament”