UCL trachea transplants: Videregen sets lawyers on Liverpool academics Murray and Levy

UCL trachea transplants: Videregen sets lawyers on Liverpool academics Murray and Levy

The Science and Technology Committee of the British House of Commons opened in November 2017 an inquiry into Research Integrity. This prompted two University of Liverpool academics to submit a letter to the committee, describing the inaccuracies, misrepresentations and blatant lies which incurred in the course of the trachea transplants performed by the surgeons Paolo Macchiarini and Martin Birchall. The two academics were 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 and imaging. The two also notified the relevant UK authorities and Birchall’s employer UCL of their concerns, especially after even suspected data manipulations came to light. UCL representative gave as a reply an oral and written testimony to the parliamentary committee, other stakeholders provided their own written replies. The first Murray-Levy letter was followed by a second one, because UCL needed help recalling correctly what they did to which patient, and how many have died from the very similar trachea replacement technology which UCL still demands to be allowed to test on 60 more patients.

Now the most vile thing happened, as reported by The BMJ on July 12. Videregen, the Liverpool-based company which bought the trachea regeneration patent from UCL and engages Birchall’s services as advisor, deployed lawyers against Murray and Levy, precisely via their employer University of Liverpool. The main issue is the parliamentary submission by Levy and Murray, subject to absolute privilege. Yet Videregen also cites from the confidential notice of suspected research misconduct Murray and Levy submitted in good faith to UCL (which has not yet decided whether misrepresenting data and providing false information in applications for funding, ethics approval and regulatory permissions is serious enough to warrant an investigation). One wonders who forwarded Videregen this notice, which was confidential and absolutely none of their business? UCL, or their professor Birchall, or Birchall with permission from UCL? Another question is: is our tax money which the EU Commission gave Videregen for trachea transplanting now being used to threaten critics? Continue reading “UCL trachea transplants: Videregen sets lawyers on Liverpool academics Murray and Levy”

UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose

UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose

In 2017, the great London university UCL invited an external expert commission to investigate its role into the deadly trachea transplants performed by the former UCL honorary professor and scandal surgeon Paolo Macchiarini. An already sacked UCL nanotechnology professor, Alexander Seifalian, whose lab made the two UCL plastic POSS-PCU tracheas in 2011, was announced as the main culprit on UCL side for all the suffering of these two patients Andemariam Beyene and Keziah Shorten, as well as some recipients of vascular grafts. All this despite Seifalian’s having had no clinical role, training or ambitions, as he professed in his interview to the investigative committee, which I now obtained.

The interview also makes perfectly clear that the investigative committee’s surprise finding, namely that the nanotechnology specialist fabricated non-GMP certified plastic grafts for clinical use behind everyone’s back, was actually slanderous. Not only did UCL know very well that the product, which their own business branch UCLB approved for clinical use in Iran, Switzerland and India, was not GMP-certified, they even used it on their own patient at UCL hospital UCLH, in an attempt to grow a plastic nose. Even the UK regulatory authority MHRA was informed, and apparently did not mind or interfere. All this did not stop UCL investigators from publicly fingering cancer survivor Seifalian as the only culprit for that GMP-non-compliance.

Finally, the committee had information that Birchall allegedly proposed to make a plastic trachea for the child patient Ciaran Lynch in December 2009. Seifalian refused, for technical reasons, but this definitely and literally saved the boy’s life. Ciaran, presently one of just 3 known survivors of ~20 trachea transplants performed by Macchiarini and his former close associate, the UCL laryngologist Martin Birchall, was operated in London in March 2010 with a freshly decellurised cadaveric trachea graft supplied from Italy; Macchiarini was the surgeon. That clever Birchall-attributed idea, of being the first one to implant the utterly untested plastic trachea, and into a child no less, was somehow dropped from the final UCL report. Sod knows why. Continue reading “UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose”

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”

Birchall’s two dead pigs to prove trachea transplants are safe

Birchall’s two dead pigs to prove trachea transplants are safe

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”

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””

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”