The British laryngologist and UCL professor Martin Birchall is one of the two founding fathers of “bioengineered” trachea, the other one being his former partner, the scandal surgeon Paolo Macchiarini. Birchall presently runs three trachea transplant trials clinical trials, two in the UK and one EU-wide. His patients must however wait to be cured, because the two UK trials, Inspire and RegenVox (with the latter primarily about larynx and upper trachea transplant) were both placed on hold, and the EU funded phase 2 trial TETRA is still far from getting an ethics approval and just now lost one potential trial site after the Medical University Vienna jumped ship. The EU Commission refuses to tell me anything about TETRA, except that it has not applied for ethics approval yet. EU’s Transparence department still evade commenting on how to put this scheduled 48 patient clinical trial in context of the 11 cadaveric trachea transplants by Macchiarini and Birchall, most or maybe even all of which left the patients either dead or mutilated.
In this article, I publish the most recent patient information sheets for the two suspended Inspire and RegenVox trachea transplant clinical trials, which I obtained under Freedom of Information request from the UK Health Research Authority (HRA). Continue reading “Martin Birchall’s shaky road to mass trachea transplanting”
John Carlisle is a British anaesthesiologist, who works in a seaside Torbay Hospital near Exeter, at the English Channel. Despite not being a professor or in academia at all, he is a legend in medical research, because his amazing statistics skills and his fearlessness to use them exposed scientific fraud of several of his esteemed anaesthesiologist colleagues and professors: the retraction record holder Yoshitaka Fujii and his partner Yuhji Saitoh, as well as Scott Reuben and Joachim Boldt. This method needs no access to the original data: the number presented in the published paper suffice to check if they are actually real. Carlisle was fortunate also to have the support of his journal, Anaesthesia, when evidence of data manipulations in their clinical trials was found using his methodology. Now, the editor Carlisle dropped a major bomb by exposing many likely rigged clinical trial publications not only in his own Anaesthesia, but in five more anaesthesiology journals and two “general” ones, the stellar medical research outlets NEJM and JAMA. The clinical trials exposed in the latter for their unrealistic statistics are therefore from various fields of medicine, not just anaesthesiology. The medical publishing scandal caused by Carlisle now is perfect, and the elite journals had no choice but to announce investigations which they even intend to coordinate. Time will show how seriously their effort is meant.
Continue reading “Carlisle’s statistics bombshell names and shames rigged clinical trials”
Trachea is a very difficult organ to transplant, because its blood supply happens through many tiny blood vessels and it is practically impossible to connect them all (same is true also for the oesophagus). An organ transplanted without blood supply will die, and this is where the regenerative medicine of Paolo Macchiarini and Martin Birchall comes in: a treatment with stem cells and growth factors will somehow magically ensure quick vascularization and bring the dead tissue to life. There is no independent evidence for this, and most patients died as the consequence or became dangerously ill when their new tracheas, made from plastic or from dead, decellurised cadaveric organs predictably failed. One boy has survived: Ciaran Lynch. His current clinical state is not too rosy, even by Birchall’s own admittance, but nevertheless the sole fact that Ciaran (unlike almost all other trachea transplant patients) is alive, sufficed for Birchall to have one or two more patients operated (both dead) and to push through a clinical trial in UK with a much larger follow-up trial EU-wide. The difference though: that boy never had much choice anyway, since he had no real trachea in the first place. He received very early on a pickled trachea homograft from dead human donor tissue which functioned very well for many years, but at some point urgently needed replacement in order to save his life. Now Birchall however wishes to remove the live airways of stable patients outside any life danger, who suffer from tracheal stenosis, and replace them with his regenerated dead ones (see this report). Noone seems to wonder why these tracheas are to be prepared in a radically different way from that of the sole success, Ciaran Lynch: Birchall’s bioreactor vs so-called “bionic” method of Macchiarini.
Continue reading “Ciaran’s success story”
Christmas season is the time to eat lots of chocolate. And as science teaches us, your confectionery is actually the superfood which will make you healthy, slim and clever. Good for you, good for the chocolate industry which often generously sponsors such scientists.
In May 2016, I brought a story about chocolate health research and how it is funded by food industry giants Mars and Nestle. The main protagonist was Thomas Lüscher, cardiology professor at the University of Zürich and head of the heart centre at the University Hospital Zurich in Switzerland. Lüscher postulated that eating dark chocolate daily is beneficial for heart insufficiency patients and may prevent heart attacks, he now offers some additional advice. Now his peer, the Swedish vascular surgeon Jonas Malmstedt, provides his analysis of Lüscher’s publications below. Another study which Malmstedt unpicks, is an opus from the Luxembourg Institute of Health (Alkerwi et al, 2016), which declared that eating chocolate makes you younger and healthier, and prevents diabetes on top. Continue reading “Chocolate health: advice by Thomas Lüscher and peer review by Jonas Malmstedt”
This is a new instalment of my investigation into UK and EU funded clinical trials on trachea replacement by the throat surgeon Martin Birchall at UCL. The method of using bone marrow cells to regenerate a dead decellurised donor trachea was developed by Birchall together with Paolo Macchiarini, and tested since 2008 on several human patients, with catastrophic results. Macchiarini by now is a pariah sacked by his formerly proud employer, the Karolinska Institute in Sweden, but Birchall was given further millions in British and EU money for his human trachea transplant experiments.
I finally obtained the patient information brochure for such phase 1 clinical trial INSPIRE, which was consistently denied to me by all participants. The information therein, or rather the strategic lack of it and the consequential wilful misleading of prospective patients, is truly scandalous. There is no mention whatsoever of any of the previous trachea transplant experiments Birchall performed and the clinical outcome of which he likely misrepresented in order to obtain this very funding and even his current full professorship at UCL (with the help of Macchiarini, see page 43 of his CV). His described strategy of transplant preparation and implantation seems scientifically nonsensical, while suggestive of medical obfuscation and even deceit. Now that I finally received the INSPIRE patient information sheet, I understand why the consortium partners preferred in to be hidden from public scrutiny.
For the scientific and medical ethics background of this complicated case, please refer to my earlier reporting (in chronological order):
Researchers have removed the previously openly available anonymised patient data of the clinical trial FINE from their publication in PLOS One. The correction, issued on May 18th 2016 states:
“S1 Dataset was published in error. The error was corrected in the XML and PDF versions of this article on May 9, 2016. Please download this article again to view the correct version”.
The now removed S1 dataset was previously described by the authors around Alison Wearden, professor of Health Psychology at the University of Manchester, in their Data Availability statement:
“The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supplementary Information”.
FINE was a “randomised controlled trial of a nurse-led self-help treatment, versus supportive listening, versus treatment as usual for patients in primary care with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)”, performed at the University of Manchester. It was funded by the British Medical Research Council (MRC) and the UK Department of Health.
These new restrictive developments are very important. FINE is considered as a sister CFS/ME therapy trial of the PACE trial (on which I previously reported), where the sharing of anonymised patient data to non-collaborators was repeatedly denied by the King’s College London and Queen Mary University London, with the consequence that now the courts are expected to decide upon this issue of clinical data sharing. A judge has already decreed that certain documents associated with PACE trial are to be released (information and list with links are available from the website by the lawyer and CFS/ME activist Valerie Eliot Smith). Continue reading “PLOS Correction removes (then reinstates) previously available anonymised patient clinical trial data”
Chocolate is good for your health, scientists keep saying. This may sound counter-intuitive; given that chocolate is an extremely calorie-rich confectionery, which mostly contains industrially refined cocoa fat and huge quantities of added sugar, a substance finally about to be recognised as the prime cause for the obesity epidemics.
A recent clinical study from the Luxembourg Institute of Health, published in the British Journal of Nutrition (Alkerwi et al, 2016), discovered that “chocolate consumers (81·8 %) were more likely to be younger, physically active, affluent people with higher education levels and fewer chronic co-morbidities”. The authors used data from the nationwide Observation of Cardiovascular Risk Factors in Luxembourg (ORISCAV-LUX) survey to determine that “chocolate consumption may improve liver enzymes and protect against insulin resistance, a well-established risk factor for cardiometabolic disorders”. Basically, this paper advices hyperglycaemic and diabetic patients to eat sugar-rich confectionery, which may appear somewhat irresponsible or even dangerous. These alleged chocolate benefits on diabetes prevention present a new turn in a long history of bold claims about the medicinal magic inside the sweets wrapper. Moreover, the lead author Ala’a Alkerwi also determined that chocolate improves cognitive capacities (Crichton et al 2016).
A fresh editorial in the BMJ journal Heart simply asked: “Is life longer with a box of chocolates?”. The authors Donaldson et al present “the health benefits of eating chocolate” as a scientific fact, which only needs physiological and molecular elucidation. Clinical studies have allegedly proven that regular consumption of chocolate reduces risk of heart attack and heart failure. The authors, led by Phyo Kyaw Myint, Chair for Medicine of Old Age at University of Aberdeen, decree that “future studies will need to narrow down exactly how chocolate exerts its beneficial effects”.
There were however quite a lot of chocolate studies done for more than a decade, funded with millions from the public, but also from the chocolate industry. Reliable reports of people cured of any cardiovascular diseases by eating chocolate do not exist. Even the health benefits of the purportedly medicinal raw cocoa ingredients of the flavanol compound family are far from being conclusively proven. Continue reading “Chocolate is good for your funding”