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

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Fried Divine Comedy, featuring anti-cancer cockroach and phallic fungus

Fried Divine Comedy, featuring anti-cancer cockroach and phallic fungus

This is a follow-up to the previous article, about a misconduct investigation at the Cardiff University in UK into the published works of cancer researcher Wen Jiang, professor of Surgery and Tumour Biology, Fellow of Royal Society of Medicine and chair of Cardiff China Medical Research Collaborative. The following guest post by my regular contributor Smut Clyde now delves deep into the peculiar approach with which Professor Jiang intends to cure cancer: namely by peddling herbal (and not so herbal) medicinal powders, manufactured by a Chinese company Yiling Pharmaceuticals. Jiang sees there no conflict of interest, even in presenting the patented concoctions of Yiling as his own research in Cardiff. It is not exactly the case that Jiang was hiding his connections to Yiling, outside of his conflict of interest declarations, that is. His own Cardiff University initiated the collaboration with the Chinese company in 2013 and proudly announced the engagement to the British Parliament in 2014. In 2015, Yiling helped Jiang and Cardiff University to organise The China–United Kingdom International Cancer Conference, attended by the First Minister of Wales and the Vice-Chancellor of the Cardiff University.

Jiang’s cancer-fighting magic ingredients are ginseng and other herbs, plus a cockroach, a parasitic fungus and bits of chicken gizzard, all sold by Yiling. Sometimes it includes Divine Comedy (don’t ask). Yiling’s potion named “Yangzheng Xiaoji” was certified by Cardiff University in an Impact statement as a metastasis inhibitor, which “has been shown to be beneficial to patients with certain solid tumours when used alone…“. The sole basis for this bold claim from respected British university was a 2009 paper by Yiling in an obscure Chinese journal, which incidentally is edited and published by Yiling.

Continue reading “Fried Divine Comedy, featuring anti-cancer cockroach and phallic fungus”

Indestructible Sumitran-Holgersson: Commit misconduct on patients, get EU funding to continue

Indestructible Sumitran-Holgersson: Commit misconduct on patients, get EU funding to continue

This is a story uncovered and researched with the tremendous help of Swedish investigative journalist, Sophia Tibblin. A Swedish start-up company, fed with generous funding from Swedish state, now received €2.2 Million from the European Union, to further develop the same regenerative medicine technology which was determined in two investigations to be tainted by research misconduct and patient abuse by the founder of this very company: Suchitra Sumitran-Holgersson. A clinical trial is scheduled based on debunked science of recellurising dead blood vessel grafts, to continue where 3 previous child patients were used as human Guinea pigs .

This might remind you of another ongoing Horizon 2020 clinical trial, where a similar decell-recell technology of the trachea transplanter Paolo Macchiarini is being prepared for mass-use in patients. There, EU refused to share any information. Also in the case of Sumitran-Holgersson and her company, all EU commission members and even press speakers I approached refused any communication.

Much credit for research behind this post goes to Sophia Tibblin.

Continue reading “Indestructible Sumitran-Holgersson: Commit misconduct on patients, get EU funding to continue”

Pfizer announces more retractions for sacked lab head Min-Jean Yin, whistleblower revealed

The pharma giant Pfizer announced to continue investigating the data manipulations committed by their former cancer researcher Min-Jean Yin, retractions of two more publications were requested and yet another paper’s fate is being currently decided. Again it is about studies of pharmacological inhibitors of cancer molecular pathways which Yin’s former lab at the Pfizer California research site has faked. These two retraction requests come is addition to 5 Yin retractions which Pfizer already announced on my site in October 2016 and which meanwhile happened. The PubPeer-listed evidence was first presented on my site in May 2016. Back then, the reader of my site, who posted that evidence of duplicated western blots on PubPeer and alerted me to it, preferred to remain unnamed. Now however, she agreed to be named: it was the microbiologist, image integrity specialist and host of the successful public outreach blog Microbiome Digest, Elisabeth Bik. She now forwarded to me this message: Continue reading “Pfizer announces more retractions for sacked lab head Min-Jean Yin, whistleblower revealed”

The Kenneth Chien Case at Karolinska, by Johan Thyberg

The Kenneth Chien Case at Karolinska, by Johan Thyberg

This is a new guest post from Johan Thyberg, a retired professor for cell and molecular biology from Sweden, a known activist against science fraud and author of the 2009 book “Scientific Fraud or Legal Scandal?”. Thyberg played a key role in uncovering the research misconduct and horrendous patient abuse around the trachea transplant surgeon Paolo Macchiarini, which took place at Alma Mater, the Karolinska Institutet (KI) in Stockholm, and left at KI alone 3 patients dead (his last plastic trachea recipient there, Yesim Cetir, died yesterday after years of suffering).

After a previous guest post by Thyberg, which criticised KI’s handling of the Macchiarini scandal, it is an honour for me to present his new article on my site. It deals with another international star of regenerative medicine whom KI recruited soon after Macchiarini: Kenneth Chien. The people who recruited Chien were also the same who made Macchiarini’s professorship at KI possible: the then-chancellor Harriet Wallberg and the cell biology professor Urban Lendahl. Both had to resign from their positions with the KI’s Nobel Committee in the wake of Macchiarini scandal (see my report here).

This is what Chien’s 20-head strong lab is working on at KI, according to its website:

“The central scientific interest of the Chien lab is to understand heart development at the molecular and cellular level, with the ultimate goal of applying the developmental principles, logic, pathways, technology, and model systems to unravel human heart disease”.

According to Thyberg, Chien’s engagement at KI is less about his actual scientific achievements, which seem objectively rather modest relative to his elite status there, but more about personal networks and money, which include pharma industry and a certain Chinese investor. One of these Chien-related businesses is Moderna Therapeutics, a biotech start-up which STAT News brought a critical special report on.

Below I am publishing Thyberg’s own English version article, a Swedish version appeared on March 17th on NewsVoice.

Continue reading “The Kenneth Chien Case at Karolinska, by Johan Thyberg”

5 retractions and a sack for Pfizer lead cancer researcher Min-Jean Yin

Five months ago, I reported about data integrity concerns in 6 publications authored by Min-Jean Yin, who had been working at the pharma giant Pfizer in La Jolla, California, as Senior Principal Scientist since 2003. One paper, where she contributed as a collaborator (Lamoureux et al, European Urology, 2014), has been corrected already in March 2016. Five other cancer research papers, on the efficiency of Pfizer’s own pharmacological enzyme inhibitors, will now be retracted, after an investigation performed by Pfizer confirmed the suspicions of data manipulation, originally raised on PubPeer. These five papers stemmed directly from the Pfizer lab which Yin used to be in charge of. Used to be – because according to her recently updated LinkedIn profile, Yin doesn’t work there anymore. Since September 2016, she joined a rather unremarkable Californian biotech start-up Diagnologix LLC in San Diego, as “General Manager”. With such a career (and surely also salary) setback, it is safe to assume Yin did not leave Pfizer after 13 years of service entirely voluntarily. Continue reading “5 retractions and a sack for Pfizer lead cancer researcher Min-Jean Yin”

How UCL throat surgeon Martin Birchall misleads patients and tricks public funders

How UCL throat surgeon Martin Birchall misleads patients and tricks public funders

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):

Continue reading “How UCL throat surgeon Martin Birchall misleads patients and tricks public funders”