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”
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):
- The stem cell faith healers, or magic inside your bone marrow
- EU threatens to terminate TETRA Consortium funding for phase 2 trachea transplant trial
- Brexiting out of EU research and patient rights
The science of the fallen star of regenerative medicine Paulo Macchiarini was simple: take a dead organ, strip it of its cells and seed the carcass with stem cells (usually the magic cells from bone marrow). After some days in a “bioreactor”, you take out a living trachea, esophagus, even heart, and implant it into a patient. Another human life saved, and not only media, even scientist colleagues fell for this outrageous quackery. As the result of this hubris, several patients died, others remained in permanent critical care. Macchiarini and his partners Philipp Jungebluth, Martin Birchall and others had to fake ethics approvals as well as to lie and cheat about medical records in their publications in The Lancet, all in order to present a miserably suffering recipient of a ”regenerated” trachea as fully recovered. Animal experiments were performed only after Macchiarini’s team operated their first human patient, as indirectly evidenced by Jungebluth’s own doctorate thesis at the Medical University Hannover (MHH) in Germany.
Macchiarini began to develop his “decell-recell” method of organ regeneration while working in Hannover, close to the renowned heart surgeon and MHH clinic director, Axel Haverich (see Part 1 for the background). In 2009, the Italian cheater then moved on to a professorship at the Karolinska Institute in Stockholm, where he was showered in funding money and received best institutional protection, despite his patient abuse and his lies about his qualifications. Continue reading “Regenerating in Hannover, Part 2: Axel Haverich’s “growing” heart valves”
Britain voted itself out of the European Union, and with this act UK research will soon be also out of EU funding and EU scientists (or any foreign scientists for that matter, given that the central point of the Brexit vote was immigration). Without freedom of movement, there cannot be any access to EU research funding, as Switzerland had to learn after their citizens also bravely voted in their own referendum against immigration in 2014. Thus, with the genie of racism and xenophobia out of the bottle in UK now, it is highly unlikely that the next Tory government will agree to allow foreign work-seekers onto their precious island. This Brexit out of Horizon 2020, ERC and other European research programmes will hurt, because, as the UK scientist and open science activist Stephen Curry mentioned in an interview: “The UK is a net contributor to the EU overall but ‘wins’ in terms of research funding”. While Scotland might find a way out through another vote on independence, England will be stuck where it is.
Maybe this is actually not that bad, given the interesting attitude British authorities and bureaucracy have to clinical research. Their prime concern goes out not towards the public interest or the patients’ wellbeing, but to the financial profits of biotech and pharma industry. All my inquiries about the most basic documentation or permits granted to the INSPIRE clinical trial on trachea-replacement were ignored or outright rejected, with the simple argument that sharing information with me would hurt the business interests of the commercial participants involved. The INSPIRE trial is about transplanting four patients with donor tracheas, which are prior to this to be decellurised and “regenerated” using a “stem cell” approach developed by Paolo Macchiarini (now accused of involuntary manslaughter for his trachea transplant experiments). Macchiarini’s former partner Martin Birchall, laryngology surgeon at the UCL and UCLH in London, is leading this trial (see my detailed analysis here and here), and the company whose interests need the most careful protection by British authorities is Videregen, which seems to imagine the trachea replacement in humans as similar to that of exchanging a car part. Only much more lucrative of course, Birchall himself put the revenue at up to the mouth-watering $740,000 per patient (Culme-Seymour et al, 2016). Continue reading “Brexiting out of EU research and patient rights”
Image manipulations are unfortunately a rather widespread practice in biomedical literature, where a large part of research data in figures consists of microscopy or gel images. Some of the most commonly detected issues in this regard are image duplications. These can range from possible negligence like duplicated western blot images, to deliberate data fabrication, evidenced by duplications of select image fragments such as gel bands. Sometimes, it is difficult to believe in the accidental nature of duplications: I reported of a case where one single western blot put an appearance whole twelve times in several publications by the Brazilian diabetes researcher Mario Saad and his colleagues. Some of his papers have been retracted by now.
Elisabeth Bik is not only a competent microbiologist at Stanford University and public-outreach-blogger, she is also a human image fabrication detector. Even the most cleverly spliced band duplications are unlikely to be overlooked by Bik, who by now screened over 20,000 papers from 40 different journals for duplications and other image irregularities. For her project, Dutch-born microbiologist teamed up with colleagues and known research integrity activists Arturo Casadevall and Ferric Fang (who previously established misconduct as lead cause of retractions and demanded a reform of the Nobel Prize). The trio presented the results of Bik’s analysis in a bioarxiv-preprint titled “The Prevalence of Inappropriate Image Duplication in Biomedical Research Publications”, where they calculated that
“3.8% of published papers contained problematic figures, with at least half exhibiting features suggestive of deliberate manipulation”.
The Heidelberg-based company TICEBA (abbreviated from Tissue & Cell Banking) is not your ordinary run-of-the-mill cell bank. This German company, scientifically advised by the Harvard professor Markus Frank, claims that our skin contains pluripotent stem cells, which are capable of curing all kinds of diseases. This concept is utterly unsupported by scientific literature, and is widely rejected by stem cell scientists. Nevertheless, there is internet evidence that the company’s founder, Christoph Ganss is already treating patients with these cells, in East Asia and even in EU and in Germany. According to certain (sometimes already removed) internet information, patients are being offered autologous “stem cell” injections not only for beauty treatments, but also as cures for type II diabetes, cardiovascular problems, hereditary degenerative eye diseases, and possibly even cancer.
A small price to pay for youth and health
My investigation started with an advertisement in a Lufthansa in-flight magazine, which I was browsing during my return flight from a family visit in Riga in August 2015. The Heidelberg-based company TICEBA advertised to inclined customers on page 41 under the headline “You will age. Your cells won’t” some very exciting service:
“We like a tiny sample of your skin. Separate the stem cells. Store your stem cells in liquid nitrogen. Forever. Then, one day, when old age or illness overtakes you, we re-programme them. Introduce them back into your body. Regenerate you using your younger, stronger, healthier self. It’s not science fiction. Just science”.