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?
The legal letter by the London-based Keystone Law threatens the University of Liverpool with massive lawsuits and demands compensation for the derailed multi-million pound-heavy clinical trials. It is already the second letter, where a Murray and Levy are given the choice to be sued, or sign a cease-and-desist “undertakings” where they would pay Videregen all the incurred legal costs, renounce their submissions to Parliament and retract their evidence to UK regulatory authorities and UCL before the investigations can even take place. The best bit: Murray and Levy are to make sure I never speak in Liverpool again and they have to somehow delete all my articles, talks and social media posts which make reference to the trachea transplant technology Videregen patented. In particular my presentation from June 1st in Liverpool was seen as provocative in this regard. Below is a video of it I posted on YouTube, and here the corresponding SlideShare presentation, which all have to go, or else University of Liverpool and its academics will be sued. Legally, such demands make no sense whatsoever, simply because they cannot be enforced. But this is not the point. As long as their bluff works, Videregen wins.
The University of Liverpool was also expected to sign a declaration that the submissions by Murray and Levy to the UK Parliament and authorities are false, misleading, inaccurate and incomplete. Basically, the university has to declare that the technology works, is successfully proven and that nobody ever died from a trachea transplant performed by Birchall and Macchiarini.
Videregen is a small-to-medium sized company renting office space in the Liverpool Science Park. The regmed business was founded by its CEO Steve Bloor in 2011 with just one pound start capital and one single share. In 2014, the licence for the regenerated trachea and voicebox grafts was sold to Videregen by UCL and their partners Northwick Park Institute for Medical Research (NPIMR), where Birchall was apparently running animal tests (not clear how many, due to image duplications).
Since that deal, the Videregen business flourished, ie., till Macchiarini affair exploded, and certain people started to ask questions. Thanks to a clever partnering with the industry sponsor Cell and Gene Therapy Catapult of Catapult UK, Videregen runs the (now derailed) EU-funded phase 2 trachea transplant clinical trial TETRA, which was scheduled to operate 48 patients with the Videregen-patented trachea transplants from 2018 on. To get a licence from the European medicines Agency (EMA), Videregen hid the true causes of death or even the existence of Birchall’s and Macchiarini’s trachea transplant patients, and convinced EMA that the two pigs which died right after receiving a trachea transplant at NPIMR, were actually proof that the method works.
Videregen also led, again thanks to Catapult UK, the Innovate UK-funded phase 1 clinical trial Inspire, which was expected to inform the phase 2 TETRA with its predictable success stories of 4 patients. Nobody was recruited though, because the trial was suspended in 2016 after my reporting, together with another phase 1 clinical trial about to be run over 10 patients in which Videregen was also involved: RegenVox. There, the decellurised donor larynx (voicebox) was about to be regenerated with the patients’ bone marrow cells seeded in a bioreactor, just like with the trachea. RegenVox is now officially terminated. All those 3 clinical trials, where Videregen was poised to shovel millions of public funding and investor money, have the company’s paid advisor Birchall as lead investigator.
You can see now why Bloor and his Videregen are so upset, especially after their desperate recent attempt to find new partners for trachea transplanting in US, China or Japan apparently bore no fruit except embarrassment. Birchall and UCL are also unlikely to be content with how things played out, but under current circumstances they can hardly sue Murray and Levy themselves. But Videregen can try.
The BMJ bombshell
This is what BMJ wrote about the response Murray and Levy got for their engagement:
“UCL has a fixed timetable for such investigations, and the Liverpool academics pressed for answers when they believed that the time limit had been exceeded. What they got was a nine page letter from Keystone Law on behalf of Videregen, a company planning two clinical trials in collaboration with UCL.
The letter, sent to the vice chancellor of Liverpool University, says that the complaints have damaged the company by making statements that are “false, misleading, inaccurate and/or incomplete” and may have grave consequences for Videregen’s ambition, reputation, and ability to conduct research.
In a second letter Keystone Law says that Videregen believes that Murray and Lévy “have unilaterally decided to conduct an ongoing campaign against our client” and that they have made comments not based on objective data. It offers not to proceed
with litigation against the university if it dissociates itself from Murray and Lévy’s comments and those made in a similar vein by others, including the blogger Leonid Schneider, a campaigner active in the field who spoke at a meeting at the university. It provides a draft statement for the university to sign”.
This is what Murray herself has to say:
Patricia Murray on UCL trachea transplants and Videregen’s legal threats
In November 2017, my colleague and I submitted a report to the current Research Integrity Inquiry entitled ‘Tissue-engineered’ tracheas: an assessment of the scientific, clinical and ethical implications1. Our report recommended that clinical trials involving the transplantation of ‘tissue-engineered’ tracheas (the ‘Inspire’ trial, funded by Innovate UK) and larynxes (the ‘RegenVox’ trial, funded by the Medical Research Council) should not take place, and that no further transplants of ‘tissue engineered’ airways should be performed in the UK on the grounds of ‘compassionate use’ until firm evidence of safety and efficacy has been obtained from appropriate animal models. We provided supplementary evidence to the Inquiry in January2 and May3 2018, and some of the key issues were recently reported in the journal ‘Science’4.
As indicated in our January 2018 contribution to this inquiry2, we submitted (also in January) an allegation of research misconduct to UCL due to concerns relating to preclinical data from UCL’s trachea transplant team. We were motivated to do this because we felt the issues were rather serious, given that one of the research publications in question contained data to support the RegenVox clinical trial.
After submitting our allegation, we were informed by UCL that they would deal with the allegation in accordance with their published Procedure for dealing with allegations of academic research misconduct, and that they had assembled a Screening Panel. Over subsequent months, we provided additional evidence to UCL to help them with their investigation.
In April 2018, we were informed that a letter had been received from solicitors acting on behalf of UCL’s collaborator, the SME Videregen, indicating that their client was contemplating legal action in response to (i) allegations of research misconduct concerning trachea transplants we had submitted in good faith to UCL; (ii) submissions we have made to the Science and Technology Select Committee; (iii) an article in Science raising concerns about trachea and larynx transplantation trials4. Importantly, the solicitor’s letter quoted directly from a document we submitted that was not in the public domain.
In June 2018, a further letter was received from Videregen’s solicitors, threatening legal action if we do not sign a statement indicating that we will cease and desist and that we will remunerate Videregen for their current legal costs. It is interesting to see what strategies can be used to try and silence individuals who are raising concerns about suspected research misconduct in good faith.
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