After five years of refusing to retract the two falsified publications by Macchiarini and colleagues,1,2 the Lancet has published an expression of concern about both papers.3 The link is https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00293-3/fulltext
Publication of an expression of concern is only appropriate when serious concerns about the accuracy or integrity of a publication are raised and are being investigated. Once it is confirmed that a publication is fatally flawed retraction is the only acceptable course, whether the faults resulted from honest error or falsification. In this case, there is no doubt that both Lancet papers were falsified.4 They should be retracted and the reason for retraction should be stated.
The original 2008 paper on “clinical transplantation of a tissue-engineered airway” reported that a trachea from a cadaveric donor had the cells removed by chemical treatment, leaving an airway-shaped skeleton of connective tissue, much of it cartilage rings. The skeleton was then said to have been “colonised by epithelial cells and mesenchymal stem-cell-derived chondrocytes that had been cultured from cells taken from the recipient…..This graft was then used to replace the recipient’s left main bronchus.”1
The paper was published on-line less than one month after it was submitted to the Lancet. It appears that editorial desire for a news scoop overwhelmed scientific assessment of the plausibility of the revolutionary claims made. The speed of publication contrasts with the delay in the Lancet addressing concerns about the paper.
The Lancet and its editor, Richard Horton, have known for at least 5 years that the publications are false.4 As described in an earlier blog by Professor Murray and me, some of the evidence of fraud is so obvious that people who are not doctors or scientists can see it.5 I will not repeat the evidence described in the blog. The link is https://drpeterwilmshurst.wordpress.com/2022/09/25/is-the-lancet-complicit-in-research-fraud/
Immediately after publication of the 2008 paper, experts in the specialty questioned whether the transplanted airway would be prone to collapse and whether an adequate vascular supply would develop.6,7 The plausibility of the claims in the paper have been consistently doubted since then.8,9 The 2009 authors’ reply in the same issue of the Lancet gave Macchiarini, Birchall and colleagues the opportunity to correct the false claims in the 2008 paper about the mechanical properties of the graft, but they did not do so.10 The 2009 authors’ reply by Macchiarini, Birchall and colleagues should also be retracted because it compounds the earlier fraud.
At the outset, Horton and the Lancet may have been deceived, but by 2018 they had indisputable evidence of falsification in the 2008 paper. After 2018 they colluded in cover up and were disingenuous when dealing with those who raised concerns. Horton tried to portray the major fraud as minor honest error by soliciting a doctor, who was unconnected with the paper, to publish a letter of correction in the Lancet describing the subsequent clinical course of the patient, Claudia Castillo.11 (Her name and the names of other patients are in the public domain because they were identified in publicity by those treating them.)
Letters from members of the UK Parliament, including a joint letter from the Chairs of the House of Commons Science and Technology Committee (Rt Hon Norman Lamb MP) and the Health and Social Care Committee (Dr Sarah Wollaston MP) failed to get the Lancet to act with integrity and retract the papers.
I believe that Horton’s responses were deliberately misleading because he failed to accurately and fully report the facts to Norman Lamb MP and Sarah Wollaston MP. For example, in his reply to them on 25 January 2019, Horton quoted only part of the advice he received from the Committee on Publication Ethics (COPE). Horton said that COPE advised “We must not assume that evidence of past misconduct always indicates misconduct in other cases”. This sentence gives the impression that COPE advised Horton that, despite numerous other proven falsified research publications by Macchiarini and colleagues, including two other retracted publications in the Lancet,12 the two Lancet papers that now have an expression of concern should not be retracted.1,2 Horton failed to mention that COPE’s advice also said “The journal could retract the articles even without a finding by the institution in Spain if they are satisfied they have done due diligence.”
Horton also told the MPs “We asked the host institution to investigate the allegations (of research fraud)”. In fact, the Lancet did not initiate the investigation. Dr Castells, a newly appointed medical director of the Hospital Clinic Barcelona, where the airway transplantation operation was performed, notified the Lancet in March 2018 when he learned that the claims in the 2008 paper were false. Castells was surprised by the 4 months delay before he got a response from the Lancet.
In March 2019, I wrote to Sabine Kleinert, senior executive editor of the Lancet, and complained that Horton’s apparent attempts to mislead Parliament should make his position as editor-in-chief of the Lancet untenable.
The Lancet’s belated expression of concern states “The Committee on Publication Ethics (COPE) has discussed these concerns at length again and their view, as an expert body in publication ethics, is that these two unretracted articles should, at a minimum, have received an Expression of Concern given the severity of the concerns raised and the length of time during which the concerns have persisted.”
The Lancet has done the “minimum” that COPE believed was required. Doing the “minimum” that you think you will get away with is not adequate. The only morally acceptable course is to retract both fraudulent papers. It appears that Horton has learnt no lessons from refusing to retract the fraudulent publication by Andrew Wakefield that was published in the Lancet exactly 25 years ago on 28th February 1998.
However, many other individuals and organisations that the public might expect to protect the integrity of research and publications have either turned a blind-eye to the fraud or colluded in cover up.
COPE
COPE should not have advised that publication of an expression of concern is an option in this case. Because both papers are fraudulent, COPE should have insisted that the Lancet retract them and that the notice of retraction should state that the reason for retraction is that claims in both papers were falsified.
COPE should have also told the Lancet to publish an apology for the attempts by Horton and colleagues to cover up the publication fraud for several years. There is an argument for the Lancet to apologise for failure to do due diligence when it rapidly accepted the original 2008 paper that made such ground-breaking claims.
Furthermore, COPE should inform all journals that have published articles by Macchiarini and his colleagues that they should arrange for the claims in the articles to be checked for accuracy in order to determine whether the articles they published require an expression of concern or retraction.
I believe that during the last five years the officers of COPE have been too concerned about upsetting Horton, the editor of one of medicine’s most influential journals, and the Lancet’s owner, Elsevier, which contributes enormously to COPE’s funds,13 that they have been unwilling to call out unethical editorial conduct.
I raised concerns about the 2008 paper with COPE more than four years ago. In 2018, I requested that I discuss my concerns at a COPE forum. Two days later, COPE’s response was to inform me that I could not raise my concerns because I was no longer a member of COPE. After email correspondence, COPE’s Facilitation and Integrity Officer wrote “I have raised this case to the attention of a member of the COPE Facilitation and Integrity subcommittee for review and I will be in touch in due course.” In a separate email, I was also told that discussion of the case would be on COPE’s website and I would be able to comment on the decision. COPE has never informed me of the outcome of the subcommittee review and I have not seen evidence of the discussion on COPE’s website. Richard Horton told me that COPE advised him that he “should not be stampeded into acting”. Who can judge whether that is true, when Horton has been prepared to mislead Members of the UK Parliament?
In addition to the Lancet and COPE, others were implicated in the failure to retract the falsified Lancet papers.
The Hospital Clinic Barcelona
Soon after publication of the 2008 paper, Macchiarini left Barcelona and moved first to Careggi University in Florence where 5 patients had cadaveric bioengineered trachea transplants. They all died.14 Macchiarini then moved to the Karolinska Institute in Sweden. At the Karolinska, he switched to implanting plastic tracheas, onto which so-called “stem cells” were squirted. The reason for the switch is discussed below, but for patients the outcome was equally disastrous.
Macchiarini did not leave Barcelona because he was head-hunted, but because his contract at the Hospital Clinic Barcelona was not renewed when the ethics committee discovered that he had failed to accurately report the outcome in the patient described in the 2008 paper.
The Hospital Clinic Barcelona should have informed the Lancet immediately that the paper was falsified. That took another decade and the appointment of a new medical director. Even so, if one believes what the Lancet says in its expression of concern, the head of the institution in Barcelona, where the patient was originally treated told the Lancet “upon reviewing all information and after verification of the original documents and records supporting the study, we concluded that there is not enough ground to ask The Lancet for retraction of the article”.
The Lancet’s expression of concern states “We did, however, publish an update of this case from the institution in Barcelona in a letter in 2019 to alert our readers to the subsequent clinical course of the patient.” The expression of concern fails to state that the Lancet solicited the letter in an apparent attempt to depict the fraud as an error.11 The task of writing the letter was delegated to Dr Molins who was not an author of the original falsified paper. The Lancet was apparently content to publish Molin’s letter even though the editors knew that it did not detail all the false statements in the paper, which Castells, the hospital’s medical director, had notified to the Lancet in 2018.
Martin Birchall and his employers
On 14 March 2019, after two programmes about this scandal on BBC television, Kleinert wrote to Norman Lamb MP “Following the Newsnight programmes, we have asked the UK-based authors of the 2008 paper for a response to the issues raised in the programme and to Dr Wilmshurst’s concerns. Once we have their responses, we will decide what the appropriate next steps are.”
The Lancet has not explained why they consulted only the six UK-based authors, when the 2008 paper had 9 additional authors listed with affiliations to institutions in Barcelona, Milan and Padua. The Lancet has not revealed what the UK-based authors replied and attempts to get the most senior UK-based authors to disclose what they told the Lancet and / or to retract the paper have been fruitless.
Macchiarini has been found to be a research fraudster and has criminal convictions in Italy and Swden,4 but it is reasonable to question whether he was solely responsible for dishonest claims about the 2008 surgery. As I discuss below, others made false claims about subsequent transplantations of bioengineered tracheas. Was there an earlier deception? Would Macchiarini have performed the original 2008 trachea transplantation if the Bristol team had not convinced him that they could take a trachea from a cadaver, remove all the donor’s cells and replace them with so called “stem cells” from the intended recipient to produce a viable airway that would be antigenically identical to the recipient? Was the ethics committee that approved the operation in Barcelona misled? What evidence did Birchall and the Bristol team provide to convince Macchiarini and the ethics committee that they could perform the transformation, which was illusory?
Martin Birchall was Macchiarini’s co-principal investigator on the 2008 Lancet paper. The so-called “tissue engineering” of the airway was performed in Birchall’s laboratory in Bristol University. It took place in a building that was not licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.15 Harvesting of recipients cells used for the seeding occurred before ethical approval for the procedure had been obtained. Seeding of the airway with the recipient’s cells four days before the surgery also happened in Birchall’s laboratory without the necessary Medicines and Healthcare products Regulatory Agency (MHRA) approval. Two days later the airway was flown to Barcelona where Macchiarini performed the surgery. Birchall would later brag “We ran roughshod over regulations—with permission”.16 Birchall has not revealed who granted permission.
In 2009, soon after the 2008 paper was published, Birchall moved from Bristol University to University College London (UCL). However he retained the post of honorary visiting professor in the School of Clinical Sciences at the University of Bristol until at least 2014.
The Special Inquiry into Regenerative Medicine Research at UCL noted that on Birchall’s recommendation, Macchiarini was awarded an honorary professorship at UCL despite concerns about his rapid succession of jobs and lack of supporting references.15 Macchiarini held the honorary contract at UCL with accompanying clinical rights at hospitals associated with UCL for 5 years. At the same time he was committing criminal offences in Italy and Sweden.
We do not know when Birchall first became aware that claims about the clinical outcomes for Claudia Castillo, the patient described in the 2008 paper, were falsified. As co-principal investigator Birchall had a responsibility to ensure that the publication was accurate, particularly so because he had most to gain or lose by the report. Macchiarini’s role involved standard surgical skills and he later switched from “bioengineered” to plastic tracheas after he realised that “bioengineered” airways consistently collapsed because they were weakened by the preparation process (see below). Birchall still cannot resile from the original claims about “bioengineered” airways which may be because he stands to gain if his claims are vindicated. Birchall still will not admit that the 2008 paper was false and retract it.
Let us assume that Birchall was not conscientious in the role of co-principal investigator, that he was originally deceived by Macchiarini and that he did not know that the clinical outcome data in the 2008 paper was false. In the time after Birchall moved to UCL, he continued to claim that the clinical outcome in the patient reported in the 2008 Lancet paper was good, for example in response to a 2010 letter by Delaere.8,17
As subsequent patients had surgery and nearly every one of them died, Birchall covered up the horrific mortality rates and misrepresented the fatal outcomes in individual patients as procedural successes.
For example, Bristol University’s Research Excellence Framework in 2014 (REF2014) in clinical medicine refers to Birchall’s continuing association with the university and uses his work as an impact case study to increase funding.18 It includes the following:
“In 2008, Professors Martin Birchall and Anthony Hollander (University of Bristol) and a team of scientists and surgeons led from Bristol successfully created and then transplanted the first tissueengineered trachea (windpipe), using the seriously ill patient’s own stem cells. The bioengineered trachea immediately provided the patient with a normally functioning airway, thereby avoiding higher risk surgery or life-long immunosuppression. This sequence of events, which raised public interest and understanding around the world as a result of huge media coverage, acted as proof of concept for this kind of medical intervention. A new clinical technology with far-reaching implications for patients had passed a major test. This development demonstrated the potential of stem cell biology and regenerative medicine to eradicate disease as well as treat symptoms and has already led to the implantation of bioengineered tracheas in at least 14 other patients.”18
I presume that Birchall had some role in drafting the impact statement. By then, Birchall knew that proof of concept had not been established as claimed in the report, because nearly every one of the 14 patients that had implantation of so-called “bioengineered” tracheas had died as a result of the surgery. The patients that died included some that had surgery at hospitals associated with UCL and Birchall was involved in their surgery.
A major innovation by Birchall’s team was to perform transplantation of so-called “bioengineered” tracheas in children at Great Ormond Street Hospital. Some might question why Birchall and colleagues were switching to children, when the outcomes on adults were so poor and when there are always greater concerns about obtaining consent for treatment of children.
Transplantation in children introduces the need for the graft to grow with the child. If it grew, it would prove Birchall’s claim that a living graft had been implanted, which would be an improvement on existing operative techniques. It would also make Birchall famous and bring in private patients from around the World, provided he and UCL could put the right spin on media releases. It is worth looking at patient outcomes and the spin that Birchall and UCL have placed on their outcomes.
In February 2012, 15 year old Shauna Davison had a bioengineered cadaveric trachea transplant at Great Ormond Street. Surgeon, Professor Martin Elliott, transplanted the trachea that had been “bioengineered” by Birchall’s team. Although the transplanted airway of Claudia Castillo, the first patient to have a so-called bioengineered airway, had collapsed after three weeks and required a stent, no stent was implanted in Shauna Davison.
Claudia Castillo’s surgery was on her left main bronchus which supplies air to only the left lung, so that when the airway collapsed she had gas exchange through her right lung and she survived. Shauna Davison’s operation was a trachea transplant. When Shauna Davison’s trachea collapsed the day after she was discharged from Great Ormond Street Hospital, 15 days after the operation, she had no air entry to either lung and she suffered a fatal cardiorespiratory arrest. Elliott would later express regret that he had not stented Shauna’s trachea. For his part, Birchall has misrepresented the timing of Shauna’s death as occurring longer after surgery and as a result of haemorrhage, for example during a lecture he gave at an industry sponsored seminar in Prague on 8th November 2013. During the lecture, Birchall also said “the family (of Shauna Davison) wished us to continue” but her mother subsequently stated on television that after Shauna’s death nobody from UCL or Great Ormond Street Hospital contacted the family.
In addition, UCL displayed on its website images of patients that had unsuccessful surgery, as judged in one case by their death as a result of the surgery, but described the outcomes as successful and “life-saving breakthroughs”. In the case of Shauna Davison, they displayed a photograph from a tribute article in a local newspaper that was taken before surgery and used it to give the impression that it was a photograph taken after surgery and that she was well after the operation. The photograph was removed from the website after UCL was sent complaints about misuse of the photograph to misrepresent the truth. It is unlikely that Macchiarini was responsible for that misrepresentation or some other dishonesty about clinical outcomes of patients that had surgery in the UK.
A 2016 paper, which included Birchall and Elliott as co-authors, reported three patients who had tissue-engineered trachea transplants.19 They reported “All three patients were treated under Compassionate Use legislation, within the UK National Health Service (NHS) hospital setting..….. All three patients were in a state of poor health at time of treatment.”
Shauna Davison was one of the three patients described in the paper. She was not in a state of poor health at the time of her surgery. We know because her assessment for surgery was filmed and broadcast on television. The assessing physician at Great Ormond Street Hospital stated that she had a good quality of life and Shauna Davison stated that her reason for wanting surgery was to enable her to swim with her friends, which she was unable to do with her tracheostomy.
A treatment can be used on compassionate grounds if the treatment is expected to help patients with life-threatening, long-lasting or seriously debilitating illnesses, which cannot be treated satisfactorily with any currently authorised treatments. It is intended for patients that cannot be entered into clinical trials.
Birchall and colleagues were doing experimental surgery using Compassionate Use justification and Birchall publicly stated that was the case. For example, in an interview for MSc students at UCL in 2015, Birchall described compassionate use as an intermediate step in gaining approval for a clinical trial as an alternative to animal experiments.20 He said “You can use these treatments on a compassionate basis in somebody who is dying and for whom there is no conventional treatment, and on several occasion we have done that. We used tissue engineered windpipes to save the lives of people. On two occasions it worked very well and on the third occasion it did not work quite so well. These were one offs in very sick patients.”20 Shauna Davison was one of the three patients that Birchall referred to. The television programme about the lead up to her surgery suggest that she was not dying and the words “it did not work quite so well” are a euphemism for it killed her.
In a letter to the Lancet, Birchall and a colleague put forward the idea of doing experimental treatment under compassionate use instead of doing animal experiments to get data to inform clinical trials.21
I find it hard to believe that Shauna Davison fitted the criteria for compassionate use. The decision to operate on Shauna Davison is even more surprising because the surgery was performed only one month after the death of Keziah Shorten at University College Hospital (UCH).
Keziah Shorten was one of the patients that had bioengineered cadaveric trachea transplantation in Careggi by Macchiarini. She was 19 at the time of her operation in July 2010. The operation was funded by the NHS.15 Paul O’Flynn, consultant ENT surgeon at UCH, who had referred her to Machiarini attended the operation.15 She returned to UCH a few weeks after her surgery in Careggi. The stent in her transplanted trachea was removed in December 2010 and the transplant collapsed. A trachea-oesophageal fistula was caused during attempts to correct the situation.15 She spent six months in intensive care.15 In an attempt to provide palliative treatment a plastic trachea was transplanted in September 2011. She died in January 2012.15
Even if Birchall and colleagues were unaware that Claudia Castillo’s “bioengineered” airway collapsed and required a stent three weeks after the transplantation in Barcelona, they knew that Keziah Shorten’s trachea collapsed when the supporting stent was removed. In addition, Birchall and his collaborators at UCL and Great Ormond Street Hospital had their own observational evidence that “bioengineered” airways were mechanically weak.
Shauna Davison was the second child to have transplantation of a bioengineered trachea at Great Ormond Street Hospital. The first was Ciaran Finn-Lynch in March 2010. Details of the operation and two year follow up were provided in the Lancet in 2012.22 Professor Martin Elliott was the principal surgeon for Ciaran as well as Shauna Davison.
The twenty authors listed do not include Macchiarini. However UCL’s website features a picture of the child and says “Ciaran’s transplant team was led by Professor Martin Elliott of Great Ormond Street Hospital, and comprised Professor Martin Birchall, Professor of Laryngology at the UCL Ear Institute, Dr Paolo De Coppi of the UCL Institute of Child Health, Professor Paolo Macchiarini, now at the Karolinska Institute in Stockholm, and Dr Mark Lowdell of the Royal Free Hospital.”23
The report describes how informed consent was obtained – “In view of our previous success with an autologous stem-cell-based tracheal replacement, the child’s parents were approached and asked to consider the use of a similar method for their child.” We now know that there was no “previous success”.22
Ciaran’s surgery differed from Claudia Castillo’s in that omentum was wrapped around the graft to encourage revascularisation.22 Ciaran’s graft did not have four days of seeding in a “bioreactor” as used for Claudia. Instead cells were squirted on immediately before the graft was stitched in, which means that the claims of growing a living organ in a laboratories are nonsense. Importantly the graft had a stent inserted at the time of surgery but that fact is not made clear in the Lancet paper.22 It was more explicit in an earlier report from the same department which had Elliott as the second author.24
Despite the tracheal stent in Ciaran, three hours after surgery, difficulty with ventilation necessitated insertion of two further stents at the origins of each main bronchi where they joined the trachea graft, because they were narrowed.22 Six weeks after surgery the absorbable graft in the trachea had dissolved and there was mild collapse of the proximal trachea graft.22 So a further stent was implanted. Another stent was implanted after five months.22 The graft needed repeated balloon dilatations. The authors reported “The graft did not have biomechanical strength focally until 18 months.”22 A report of the four-year follow up describes further stents.25 The three reports of the surgery on Ciaran are not consistent, but all show that there were major problems with the radial strength of the “bioengineered” trachea after transplantation.22,24,25
With their experiences with Keziah Shorten and Ciaran Finn-Lynch, it is difficult to understand the decision not to stent the “bioengineered” trachea transplanted into Shauna Davison irrespective of whether Birchall and colleagues knew about the airway collapse in Claudia Castillo.
For its part, UCL was willing to spin disaster as triumph. The UCL website reported the use of stents in Ciaran – “In another world-first, a biodegradable stent was inserted to maintain Ciaran’s airway while the cells regrew within the organ over the following six months.”23
Ciaran Finn-Lynch and Shauna Davison are two of the three patients described in the report by Culme-Seymour et al.19 There is little information published about the outcome of the third patient. In the case of Ciaran, Elliott has said that Ciaran has grown but the trachea has not.26
At the Karolinska Institute, Macchiarini had switched to using plastic “tracheas” onto which so-called “stem-cells” were squirted because of the problems caused when the so-called bioengineered cadaveric tracheas collapsed soon after transplantation, which resulted from the preparation process weakening them. The switch to plastic creates intellectual and practical difficulties.
The intellectual difficulty is that when a decellularised cadaveric trachea was used in Claudia Castillo, the authors postulated that “The extracellular matrix plays an active part in regulating diverse aspects of cell biology that are essential to the normal function of tissues……Scaffolds derived from decellularised tissues have been shown to promote adhesion, growth and function of several cell types……angiogenic cytokines might be present within decellularised matrices, and postulated that similar expression will contribute to timely revascularisation.”1 In other words, they claimed that the so-called stem cells could detect by some unexplained mechanism that they were in tissue that needed to develop all the cell types required to make a functional airway and those cell types would develop in the appropriate numbers, distribution and orientation to make the tissue function with a supporting blood supply. As soon as the same authors switched to using a piece of plastic moulded to look to the human eye like a piece of trachea, but obviously unrecognisable to a “stem cell”, they had confirmed that their original claims were nonsense.
The practical difficulty is that if a plastic tube is stitched into an airway, it will get infected and sooner or later the anastomoses with the patient’s tissues will breakdown and result in death.
The first plastic trachea implanted in a Karolinska patient (Andemariam Beyene) was manufactured by Professor Seifalian (Royal Free Hospital / UCL) but it was not made to GMP (Good Manufacturing Practice) standards.15,27 A member of Seifalian’s team with help from UCL’s Professor Lowdell also manufactured Keziah Shorten’s second (the plastic) trachea. Seifalian was dismissed from UCL on 15 July 2016. Two UCL research misconduct investigations of Professor Seifalian were ongoing at the time of his dismissal.28 As far as I am aware, nine patients received plastic tracheas.29 One survived because it was possible to form a tracheostomy as the graft did not extend into the chest. Eight died, of whom one survived for 5 years on intensive care having suction every 4 hours to prevent her suffocating and she died after an unsuccessful lung-trachea transplant.29 (The reference has a table that lists seven died and two survivors, but one of the survivors, Yesim Cetir, is also dead now.)
Meanwhile, Great Ormond Street Hospital advertised bioengineered cadaveric trachea transplantation to wealthy private patients in the Middle East.30
Even if Birchall was originally ignorant that the 2008 paper had falsified clinical findings, there is no doubt that he has known since 2018. By then Macchiarini was discredited. Birchall, as the other co-principal investigator, had the responsibility to correct the scientific record, particularly because this research was causing patient deaths as further operations were attempted based on the false claims.
In addition, research fraud wastes research funds when researchers attempt to replicate and extend the false claims. But in this case, most of the wasted research grants were going to Birchall and his colleagues. Birchall has been awarded at least £14 million in public funded grants to extend his research into airway transplantation. It is important that Birchall’s research on transplantation of bioengineered tracheas into pigs using similar techniques to the operations performed earlier on children at Great Ormond Street Hospital had a setback. After the first two pigs operated on died the animal research “was stopped on humane grounds” in 2016.
Even after 2018, when there is no doubt that Birchall knew that the original claims in the 2008 Lancet paper were false and he also knew that nearly every patient that subsequently had transplantation of a so-called “tissue engineered airway” has died, he has consistently refused to retract the paper.
University College London (UCL)
Requests to UCL to instruct Birchall to reveal his response to the Lancet and for UCL to press him to retract the paper have been fruitless.31
Professor Spence, the Principle of UCL, states he will do nothing because the paper was published before Birchall was employed at UCL and the Lancet must decide whether to retract it. Spence is not swayed by knowledge that:
- Birchall either colluded in the fraud or was unaware of it because he was not a conscientious co-principal investigator.
- Birchall’s role in the research involved him breaching regulations intended to protect patients.
- Birchall has failed in his role as co-principal investigator of the research to retract the paper once he became aware it was falsified, which was while working at UCL.
- Birchall has misrepresented outcomes of surgery in patients who subsequently had transplantation of bioengineered tracheas, which was while working at UCL.
- Birchall’s treatment of patients under Compassionate Use grounds was inappropriate.
Some people may think that Spence is prepared to turn a blind eye to these concerns because of the amount of grant funding Birchall and colleagues bring into UCL.
I expressed concern to Baroness Neuberger, the chair of the Board of University College London Hospitals (the UCL associated hospitals at which Birchall does his clinical work). She says that she can do nothing because the concerns that I raised with her about Birchall “were investigated formally and in great detail by UCL some years ago”. That is untrue. The UCL investigations did not consider the information that the medical director of the Hospital Clinic Barcelona sent to the Lancet in 2018.
Neuberger is also a member of the House of Lords in the UK Parliament. So I would expect her to be concerned that Birchall brags about breaching regulations that were designed to protect patients.
She is also a religious leader. So I would expect her to be concerned about treatment of patients inappropriately under Compassionate Use legislation.
The unethical research and fraudulent Lancet publication of Andrew Wakefield also occurred at one of the University College London Hospitals. The publication was exactly 25 years ago. Horton is an honorary professor at UCL.
The Medical Research Council (MRC)
The MRC website has a “Timeline of MRC research and discoveries”. It proclaimed “First stem cell-based windpipe transplant conducted” as one of its two “Successes” in 2008. In 2018, when Parliament’s Science and Technology Committee became aware that the 2008 Lancet paper was fraudulent, the Committee asked the MRC to remove the claim from its Timeline. The MRC refused saying “it is not a healthcare provider, nor a source of medical information, and therefore there is no reason to alert readers to the more recent controversies in this area”. The Chair of the Science and Technology Committee, Norman Lamb MP wrote to Declan Mulkeen, Chief of Strategy of MRC on 14th January 2019 asked the MRC to justify retaining the false information about trachea transplantation on its website. Norman Lamb MP questioned the MRC’s position that if something is thought to be true when it was published there is no reason for the MRC to amend the information when it is discovered to be false or even fraudulent. The MRC’s stance on correcting fraudulent information in the scientific record is similar to the position of the Lancet, but the MRC did back down and removed the entry from the timeline.
Nevertheless, public funding is still being invested in research predicated on the false claims in the Lancet and the lives of patients remain at risk.
Conclusion
It is clear that individuals and organisations that should be concerned about the integrity of medical research and publishing, and should place patient safety first will turn a blind eye to misconduct, which results in death and injury to young patients including children.
References
1. Macchiarini P, Jungebluth P, Go T et al. Clinical transplantation of a tissue-engineered airway. Lancet 2008;372:2023-2030.
2. Gonfiotti A, Jaus MO, Barale D et al. The first tissue-engineered airway transplantation: 5-year follow-up results. Lancet 2014;383: 238–244.
3. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00293-3/fulltext
4. Schneider L, Murray P, Lévy R, Wilmshurst P. Time to retract Lancet paper on tissue engineered trachea transplants. BMJ 2022;376:o498.
5. https://drpeterwilmshurst.wordpress.com/2022/09/25/is-the-lancet-complicit-in-research-fraud/
6. Wu W, Liu Y, Zhao Y. Clinical transplantation of a tissue-engineered airway. Lancet 2009;373:717.
7. Delaere PR, Hermans R. Clinical transplantation of a tissue-engineered airway. Lancet 2009:373:717-8.
8. Delaere P. Stem cell “hype” in tracheal transplantation? Transplantation 2010;90:927-8.
9. Delaere PR, Van Raemdonck D. The trachea: The first tissue-engineered organ? J Thorac Cardiovasc 2014;147:1128-32.
10. Macchiarini P, Birchall M, Hollander A, Mantero S, Conconi MT. Authors’ reply. Lancet 2009;373:718-9.
11. Molins L. Patient follow-up after tissue-engineered airway transplantation. Lancet 2019;393(10176):1099.
12. Editorial. The final verdict on Paolo Macchiarini: guilty of misconduct. Lancet 2018;392:2.
14. https://forbetterscience.com/2017/06/16/macchiarinis-trachea-transplant-patients-the-full-list/
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Dr Peter Wilmshurst 
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