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UCL fibs Parliament about trachea transplants

The esteemed London university UCL seems to live in its own world. There, the regenerative medicine magic thrives, living organs miraculously grow in labs, while stem cell-made trachea transplants proved a blessing for humanity, despite the negative vibes from UCL’s former honorary professor Paolo Macchiarini. UCL’s own laryngology professor and regenerative medicine enthusiast Martin Birchall cured several patients already, and it is imperative that he is allowed to save more lives with his tracheas and voiceboxes, regenerated from dead decellurised carcasses using patient’s own bone marrow cells. Scientific evidence and research integrity are nothing but cumbersome bureaucracy, which restrain the genius of Birchall, whose educated guess alone should suffice as solid proof.

This is basically how UCL replied to the to request from the Science and Technology Committee of the British House of Commons, following a critique of Birchall’s trachea transplants submitted as RES0022 on November 21st 2017 by the Liverpool scientists  Patricia Murray and Raphael LévyThe undated UCL reply appeared online around the New Year and is a staunch defence of  Birchall’s endeavours, while calling the two Liverpool researchers “emotive” and dismissing the evidence on my site as inaccurate.  It is authored by UCL Registrar Wendy Appleby, who incidentally was now appointed by UCL to investigate Birchall’s data re-use, where he apparently resurrected long-dead pigs twice, by turning some ancient animal experiment data with regenerated larynx into two fresh and very distinct studies.

The biggest inaccuracy, or barefaced lie (as you prefer), is UCL’s pretence that they had nothing at all to do with a certain lethal transplant of a cadeveric trachea, performed by Macchiarini on July 13th 2010 in Italy on the young British patient Keziah Shorten. I have been protesting to UCL Hospital (UCLH) and the British information authorities for a whole year against the refusal of UCLH to release the information about their involvement into that trachea transplant, and eventually UCLH was forced to reply to me. Even then they only admitted what I already knew, and now they hide this information from the UK Parliament inquiry. I will share it here then.Keziah Shorten was a 19-year old teenager, who suffered from a slow-growing form of cancer of the trachea, not curable with current technology, but very well manageable, e.g. by laser debulking and other life-extending therapies. Macchiarini and his UCL colleagues promised Keziah’s family to cure her completely and make her cancer disappear, by removing a deceased organ and replacing it with a cadeveric trachea. It ended with most gruesome suffering for Keziah, which took place during postoperative care at UCL Hospital and included a ripped-open oesophagus, chest infection, a second transplant with a plastic trachea made by Birchall, then slow suffocation followed by death; I narrate Keziah’s story here. UCL wants all this forgotten, or at least blamed on Macchiarini alone. Their philosophy is: Macchiarini was the problem, never his technology, which is actually their Birchall’s excellent and highly successful technology. As UCL explains now to the Parliament Committee (“Swedish case” being an euphemism for Macchiarini):

“The thrust of the case put forward in the written evidence RES0022 to the Select Committee appears to be that because there were serious problems in the applications of ethics and untried technology (very different from that of UCL and its partners) by un-monitored individuals in Sweden, then all work on tissue engineered airways should cease.  The assumption appears to be that all the unfortunate characteristics of the Swedish case must apply to all those in the wider airway regenerative medicine field.  We do not share this assumption.  Whilst we have some concern that this particular written evidence submission RES0022 is emotive and may not be entirely factually accurate, the authors do raise some issues worthy of further exploration which we wish to address as follows”.

The situation with Keziah was very similar to that another deceased patient of Macchiarini’s, namely Andemariam Beyene (read here), who suffered from a similar form of cancer and received a UCL-made plastic trachea in June 2011 at the hospital of Karolinska Institutet in Sweden, which then slowly and painfully killed him. The lead scientist in charge of research on Beyene, Philipp Jungebluth, keeps suing me in Berlin Landgericht court, where his elite lawyer happened to have a very forthcoming judge who dismissed or even disallowed all my evidence for no other reason but that it contradicted Jungebluth’s claims. Jungebluth does not deny he was with Macchiarini at Careggi from beginning of 2010 on till they both left for KI in 2011/2012, what he was doing there exactly, is however a contested subject the Berlin court trials which in turn are about this unpublished manuscript. The Italian authorities seemed so far not really interested in investigating the deaths and suffering of the five patients transplanted by Macchiarini in Careggi, I hope this appeal to Italian Senate will eventually change that.

dt-organregeneration-7
Keziah never existed, and Shauna was saved, the world according to UCL.

I found out that the decision to operate Keziah with a cadaveric trachea was made in London, by an interdisciplinary committee of clinical specialists at UCLH. The UCL doctors also made sure that the trachea transplant in Italy, which was not cheap at all, had been paid by the British NHS. A UCL surgeon, Paul O’Flynn, travelled to Florence and assisted Macchiarini with the operation. At that time, all Keziah had as symptoms was a difficulty of breathing, due to a growth in her airways. A number of conventional therapeutic options were available to her, to treat her cancer and improve the duration and quality of her life as much a possible, given the potentially uncurable slow-growing cancer she suffered from.  Keziah was certainly not dying when she became a UCL patient, but the trachea transplant therapy which Macchiarini and UCL got her into, soon changed that. Yet this is the version of UCL’s involvement from the current letter to the Science and Technology Committee (Keziah is Patient C):

“These were seriously ill patients. One was about to lose a lung (Patient A in the UCL Special Inquiry report who had a Bronchial, not Tracheal, replacement) and four (three children (Patients D, E & F in the Special Inquiry report) and one young woman (Patient C)) were about to lose their lives. Conventional therapeutic options were exhausted. There was a priori evidence that the therapeutic approach adopted in each case might work at that time and full local ethics and national guidance were applied. Two (both children) of the four tracheal implants survived, and the second young woman was implanted for purely palliative reasons (to improve her quality of life and permit discharge to home) rather than curative. One child died of complications a month later, very sadly.  The patient who received the bronchial replacement experienced good early airway function for a number of years but then developed a recurrence of her bronchial stenosis which required multiple stents.  She underwent a left pneumonectomy in 2016, but remains alive and is reportedly in reasonable health”.

You can read about the above mentioned Patient A, Claudia Castillo, here. Why UCL is so evangelical that the bronchus graft (which Birchall’s team “regenerated” in 2008 in his veterinary lab in Bristol, behind the back of authorities) saved her life, is a mystery. The bronchus graft was eventually removed together with the lung, which in turn started to rot and had to be removed not despite that cadaveric graft was working, but exactly because it wasn’t. Castillo was never treated in UK, and UCL and its Special Inquiry never bothered gathering objective evidence or patient medical records, as UCL’s chief investigator admitted to me here. They simply relied on Birchall’s word, and this is why they dismissed my evidence, like that of illegal graft preparation in Bristol pig lab, as wrong:

“The UCL Special Inquiry team was concerned about the accuracy of some of the evidence held by Dr Schneider and also the way that evidence was presented in the blog”

You can read about other above mentioned  patients on my site (Patient D and E, namely Ciaran Lynch and the late Shauna Davison, here, and patient F here, all known trachea transplant patients are listed here. Birchall’s trickery while describing his past patients, especially Shauna, was last referenced here). Patient C, Keziah, however suffered so horribly UCL will probably never openly admit to have had any role in her first trachea transplant, as not to scare off prospective patients for current clinical trials they intend to perform. The UCL Hospital rejected my request for information, twice, as vexatious (see this report).  This was how UCLH justified towards The Information Commissioner’s Office its refusal to share with me and my readers the information about the circumstances of Keziah’s operation:

“UCLH believes that the complainant is deliberately attacking individuals who are connected with the research and clinical trials he blogs about, including members of UCLH’s staff, UCLH considers that the complainant is deliberately harming the professional reputation of the clinicians he discusses in the blog, for which the complainant has recently been taken to court and found guilty of libel. […]

UCLH has stated that such treatment of individuals is distressing for the people involved and it does not think that its members of staff should be exposed to it. In addition, UCLH believes that there is deliberate intent to frustrate the work being carried out as the requester’s blog is now having a detrimental effect on the Professor’s clinical trial, in so much that other healthcare facilities are not recommending patients to be included in his trial and patients themselves have opted out as a result of the claims made by the requester in his blog.”

screenshot-drive.google.com-2018-01-07-23-06-32

The above UCLH’s own quotes stem from this document, where it was ordered on October 26th 2017 to answer my three questions in the course of 35 calender days. Naturally, UCLH ignored the deadline, and only deigned to send me on December 14th 2017 a terse email which went like this (my original questions in bold):

Dear Dr Schneider,

Please see below for the information that you requested.

Yours sincerely,

Annie Lindsay
Trust Archivist and Records Manager
020 3447 7717

Mobile: 07415 500 109

ICT Directorate, 2nd Floor A, Maple House, 149 Tottenham Court Road, London W1T 7NF

annielindsay@nhs.net

arts.heritage@uclh.nhs.uk

http://www.uclh.nhs.uk/aboutus/whoweare/archives

 

  1. Why and in which capacity did Dr. O’Flynn travel to Careggi in regard to this operation?

Mr O’Flynn attended the operation as an observer but also removed some respiratory mucosa from the nose.

  1. Who recommended this Careggi operation to NHS so it was paid by it [the NHS]?

The decision was made by a multi-disciplinary team.

  1. When did Paolo Macchiarini discuss this patient’s case with the multidisciplinary team at UCLH prior to the operation’s approval, and who was present from the UCLH side?

June 2010.

Mr O’Flynn is recorded as the consultant; no other UCLH staff names are recorded.

We still do not know who the multidisciplinary team at UCLH consisted of (aside of Macchiarini and O’Flynn), maybe UCL will tell it to the Parliament commission. Maybe they will also amend their current declaration that UCL had nothing at all to do with Keziah’s first trachea transplant, and the disaster it caused. Maybe UCL will even reconsider this cynical statement about their rationale for more trachea transplants on human subjects:

“In accordance with the opinions of MHRA and EMA, the case for additional pig experiments is fallacious. […] There is already a body of evidence sufficient for large numbers of peer reviewers around the world, and the MHRA, our highly respected regulatory body in the UK, therefore, to kill more animals would not be ethical”.

Update 10.01.2018. Maybe because I lodged a complaint with ICO about the incomplete FOIA reply by UCLH, I received today this email from Annie Lindsay:

“Dear Dr Schneider,

I would like to apologise for the ommission of the exact date of the meeting referred to in question 3.  The date was 11 June 2010”.

To put this in perspective: the Ethics Committee of Careggi Hospital in  Florence convened 3 days later, on June 14th, and approved Keziah’s transplant. This ultimately confirms where the decision was made to treat Keziah with that lethal cadaveric trachea: at UCL and its hospital UCLH. Which still refuses to divulge the information who these responsible London clinicians were.

Update 26.01.2018. Lindsay now declared to me that all records of the composition of the multidisciplinary team (MDT) which decided to treat Keziah with a trachea transplant in Italy, disappeared:

“The names of those attending the MDT meeting are not recorded, other than Mr O’Flynn as the consultant.  The information is not held”.

Apparently, this documentation suffered same mysterious fate of disappearance as Birchall’s records of making a trachea transplant in 2008 at the veterinary department of University of Bristol (see here).


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14 comments on “UCL fibs Parliament about trachea transplants

  1. Ana Pedro

    Forget: we will never get neither an apology nor a formal admission of guilty from this or other misleading scientists…perhaps we can get them to correct their publications and their further research proposals after a good amount of time spent in diplomacy

    Like

  2. RE: boldfaced lies … or inaccuracies that UCL may wish to correct quam primum

    nothing in the written response (December 2017) indicates the MHRA clinical trial authorizations are suspended for both RegenVOX and INSPIRE, as you quoted here: https://forbetterscience.com/2017/12/27/image-reuse-the-new-low-of-ucl-trachea-transplanter-martin-birchall/

    To the extent MHRA-speak is like US FDA-speak, I suspect it will be a cold day in hell before the suspensions are lifted. If this issue was addressed in UCL’s oral testimony to Parliament, please correct me.

    Ciaran, whom UCL perversely insists to be the first child recipient of a “tissue engineered” trachea, in fact received a decellularized cadaveric trachea – with no stem cell “seeding”, no magic bioreactors. You can listen to the lecture on the operation from Martin Elliot and Macchiarini: https://videos.rsm.ac.uk/video/medical-innovations-the-worlds-first-trachea-transplant-on-a-child

    A cynic might wonder if Elliot and Macchiarini were afraid to do stem cell seeding, aka tissue engineering, for fear the HTA might become involved. In any case, according to the lecture, after Elliot implanted the decellularized trachea, Macchiarini poured stem cells from Ciaran’s bone marrow on it. That’s it. Remarkable technological innovation, eh?

    The larger question is if Ciaran is THE purported success, and his implant had NO tissue engineering whatsoever, why the devil are Birchall and UCL testing tissue engineered decellularized implants?

    Like

  3. The larger question is if Ciaran is THE purported success, and his implant had NO tissue engineering whatsoever, why the devil are Birchall and UCL testing tissue engineered decellularized implants?
    Re: the art of getting funded

    Like

  4. Pingback: Macchiarini’s trachea transplant patients: the full list – For Better Science

  5. Pingback: Trachea transplanters: Round 2 at UK Parliament – For Better Science

  6. Here’s another UCL disgrace. House of Commons S&T Committee 2017 report on Regenerative Medicine: https://publications.parliament.uk/pa/cm201617/cmselect/cmsctech/275/275.pdf

    P. 25 and ff of the report is an “Annex: Visit to UCL and Centre for Cell Gene and Tissue Therapeutics, Royal Free Hospital”, when members visited UCL on 29 Nov. 2016.

    In addition to Martin Birchall and RegenVOX, UCL trotted out Professor Peter Coffey, to discuss his “pioneering trial of a new treatment derived from stem cells for people with ‘wet’ age-related macular degeneration (AMD)”. UCL appeared not to have mentioned that the trial had been closed early and the two subjects enrolled (not 10 projected) had been invited to participate in a multi-year safety follow-up. The safety follow up study was approved by the REC in 2 June 2016, 5 months before the members visit.
    https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/b4711005-stem-cell-transplantation-in-wet-amd-safety-follow-up-study/

    It appears the end of the visit was devoted to the “give us more money” theme.

    Like

    • The safety follow-up sounds like the method brought no improvement, so Coffey et al decided to assess if the iPS-derived RPE cells are at least safe, and do not cause a teratoma formation in the eye.

      Like

  7. Pingback: UCL’s decellurised tracheas: strong and stable? – For Better Science

  8. Pingback: EU trachea transplant clinical trial TETRA “uncertain to take place” – For Better Science

  9. Pingback: Birchall’s two dead pigs to prove trachea transplants are safe – For Better Science

  10. Pingback: Trachea transplanters without borders – For Better Science

  11. Pingback: UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose – For Better Science

  12. Pingback: Latchman and Wohl Foundation: gifts that keep on giving – For Better Science

  13. Pingback: UCL trachea transplants: Videregen sets lawyers on Liverpool academics Murray and Levy – For Better Science

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