Appeal to Italian Parliament for an investigation into trachea transplants in Florence by Paolo Macchiarini

Appeal to Italian Parliament for an investigation into trachea transplants in Florence by Paolo Macchiarini

This is an Open Letter I sent today by email to the Italian Senate and its Health Committee, appealing for an investigation into the trachea transplants of the scandal surgeon Paolo Macchiarini.

It is published below bilingually, in Italian and in English. After the earlier Open Letter by Prof Rafael Cantera was signed by over 220 academics and thus led the University of Würzburg in Germany to investigate the trachea transplants of Macchiarini’s former colleagues, Heike and Thorsten Walles, I invite now

  • all Italian clinicians and researchers, in Italy and abroad, as well as their international colleagues working in Italy, to sign this letter in the comment section below. Please use your full affiliation.

The signed Open Letter will be then forwarded to both chambers of Italian parliament and other state authorities.

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Paolo Macchiarini, with his supporter, Governor of Tuscany Enrico Rossi. Photo credit: Corriere Fiorentino

Versione italiana

Appello per un’inchiesta sui trapianti di trachea eseguiti a Firenze da Paolo Macchiarini

Gentili Senatrici, Egregi Senatori membri della 12ª Commissione permanente Igiene e sanità,

questo appello è indirizzato a Voi affinché vogliate considerare l’opportunità di investigare uno dei più gravi casi internazionali di abuso ai danni di pazienti, che è avvenuto e si sta ancora oggi verificando, in grandissima parte anche in Italia.

Chi vi scrive è un giornalista scientifico indipendente, il cui sito web (in lingua inglese) è diventato la più completa fonte di informazioni oggi disponibile a livello globale sul caso di Paolo Macchiarini e della sua “medicina rigenerativa”.

In breve, queste sono state fino a oggi le sue vittime: https://forbetterscience.com/2017/06/16/macchiarinis-trachea-transplant-patients-the-full-list/

Forse avete già avuto modo di apprendere di questa scandalosa vicenda, nella quale persone malate sono state utilizzate quali cavie per esperimenti con trachee artificiali. La maggior parte di essi ora è deceduta, mentre i pochi sopravvissuti soffrono di gravi mutilazioni. Continue reading “Appeal to Italian Parliament for an investigation into trachea transplants in Florence by Paolo Macchiarini”

Tissue-engineered tracheas: an assessment of the scientific, clinical and ethical implications

Tissue-engineered tracheas: an assessment of the scientific, clinical and ethical implications

Here I republish the written evidence submitted to by two UK scientists to the Science and Technology Committee of the British House of Commons and its inquiry into Research Integrity, as originally published on November 21st 2017. It deals with the trachea transplants performed by the surgeons Paolo Macchiarini and his former parter at UCL, Martin Birchall. The report’s lead author is Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit. She generously invited me in May 2017 to give a seminar at her department at the University of Liverpool on this topic. Her coauthor is Raphael Lévy, senior lecturer in nanotechnology and imaging at the same university. I wrote about his reproducibility studies on the topic of nanoparticles in this article.

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Prof. Patricia Murray

UCL recently investigated Birchall’s past trachea transplants, and recommended to continue with his two current clinical trials to transplant cadaveric decellurised trachea and larynx, regenerated with bone marrow cells, as I reported here. For some reason, UCL Registrar Wendy Appleby, when speaking as witness on November 21st in front of the Parliament Inqury, found herself unable to answer the rather straightforward question whether the UCL investigative commission advised to continue transplanting trachea or not (watch here, from 11:50 on). Appleby and her UCL were instructed by the Inquiry to address the concerns by Murray and Levy in writing.

Both clinical trials  Inspire and RegenVox were already placed by the supervising authorities on hold, Murray and Levy now call to stop the dangerous and science-unsupported experimenting on misinformed human patients and to return back to the lab.

Following is a copy of the (originally published on the UK Parliament website), Continue reading “Tissue-engineered tracheas: an assessment of the scientific, clinical and ethical implications”

Martin Birchall’s shaky road to mass trachea transplanting

Martin Birchall’s shaky road to mass trachea transplanting

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”

Swedish police investigation acquitted Macchiarini on advice of misconduct-tainted trachea transplanters

Swedish police investigation acquitted Macchiarini on advice of misconduct-tainted trachea transplanters

On October 12th 2017, the Swedish prosecutor Jennie Nordin  gave a long-awaited press conference about the case of the scandal surgeon Paolo Macchiarini. The surprise hardly anyone expected was: all manslaughter charges were dropped, the case closed. The operations on three patients, whom Macchiarini gave a plastic trachea at the hospital of the Karolinska Institutet (KI), and who died as the result, were declared  mere negligence. Andemariam Beyene, Chris Lyles and Yesim Cetir (details of their cases here) were considered as dying anyway and without any other possibility to help, in fact the prosecution decreed that there was no way to prove if they would have lived longer had Macchiarini not experimented on them without ethics permits or any previous animal testing.

While Sweden and the world listened in disbelief at the words of Nordin, everyone wondered how could the police investigators come to such radically different conclusion about the medical aspects of these trachea transplant operations than the experts in Sweden and worldwide, who clearly see Macchiarini’s trachea transplants as unethical human experimenting and misconduct (see here). The prosecution refused to divulge which experts advised them though, also their assessments remain confidential. Now, thanks to KI’s emeritus professor and whistleblower Johan Thyberg, I found out what the Chairman of the Judicial Council Camilla Olsson, and her rapporteur Robert Grundin wrote to the prosecution:

“The Board has obtained the opinion of Professor Hasse Ejnell and Professor Michael Olausson”

Update 27.10.2017: Prosecutor Nordin confirmed to Thyberg by email that the experts appointed by the National Board of Health and Welfare (Socialstyrelsen) were indeed Hasse Ejnell and Michael Olausson.

These are the two clinical professors from the University of Gothenburg who themselves transplanted a cadaveric trachea, without obtaining a proper ethics vote or an approval of authorities on the treatment and its medication. The patient died soon afterwards and the publication describing that operation  (Berg et al, Tissue Eng Part A. 2014) was retracted for data manipulations. The scientist behind this was the notorious Gothenburg regenerative medicine researcher Suchitra Sumitran-Holgersson. She and Olausson were both found guilty of misconduct and ethics breach by the University of Gothenburg, regarding that trachea transplantation as well as transplants of “regenerated” veins into three child patients.

On top of this, Olausson was involved into the case of Yesim Cetir, Macchiarini’s third patient. Unlike previous two patients Yesim had no slow-growing or any kind of cancer, all she had was a tracheostomy due to damaged trachea after a botched operation in her home country Turkey. With such a defect alone, she was in no life danger at all, as long as she did not try to swim. It was Macchiarini who declared her in his recent television interview as “bleeding a glass of blood” daily, or the Swedish prosecution claiming she was suffering of “life-threatening” chest infection, without explaining how this can be cured with a plastic trachea transplant. Olausson, who helped the prosecution form this diagnosis, has made together with Sumitran-Holgersson a cadaveric trachea which was supposed to save Yesim’s life after her first plastic trachea transplant failed. Macchiarini’s acolyte Philipp Jungebluth (the one who keeps suing me in court in Germany) travelled to Gothenburg to pick up that trachea in 2013.  Macchiarini then changed his mind, sent Olausson his necro-trachea back and implanted another plastic graft into Yesim. Which wade matters even worse, Yesim died in March of this year in the hospital of the Temple University, USA. Her father Hayrullah, who dedicated all his time and attention to trying to save her, died soon after Yesim, on untreated cancer.

Continue reading “Swedish police investigation acquitted Macchiarini on advice of misconduct-tainted trachea transplanters”

After misconduct investigation, Irina Stancheva left Edinburgh, in secret

After misconduct investigation, Irina Stancheva left Edinburgh, in secret

A scientist was “dismissed” by the Department of Biological Sciences at the University of Edinburgh, UK. All evidence points towards that it was the cell biologist Irina Stancheva who specialises on the epigenetics and regulatory methylation of DNA, and who departed from the university recently, after a forced leave. She also has an impressive record on PubPeer, where her publications were flagged for suspected data manipulations around 2 years ago. The suspicions were mostly of western blot band re-use and duplication. Around same time, an investigation started about these PubPeer issues, and by now Stancheva’s name does not feature of the Department’s list of academic staff. A archived version from December 2016 does feature Stancheva, but not that of August 2017. Her institutional website was deleted just hours after I sent my email inquiries to her former faculty colleagues. Continue reading “After misconduct investigation, Irina Stancheva left Edinburgh, in secret”

EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA

EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA

The European Commission now took 40 days to deny my second Freedom of Information (FOI) Inquiry about the TETRA phase 2 clinical trial with cadaveric trachea transplant they are currently financing with €7 Million. This is EU’s second attempt to become world-leading manufacturer of industrial trachea transplants, after the €5mn Biotrachea led by the scandal surgeon Paolo Macchiarini was terminated mid-term. No, not because EU had any concerns for the patients, quite the opposite: he was given a clean ethics vote to go ahead. Biotrachea was terminated by the EU because the plastic tracheas Macchiarini wanted to use lacked novelty, as the documents I obtained revealed.

The TETRA trial, led by Macchiarini’s past collaborator, the UCL laryngologist Martin Birchall, was already on the brink of being terminated in the wake of the Macchiarini scandal, as EU previously indicated to me. Now, exactly the opposite happens. The trial is being prepared at full speed despite the fact that its predecessor phase 1 trial INSPIRE was suspended (because of my reporting), never recruited any of its four patients and it most likely never will. That trial is also led by Birchall (details here), it is likely that its Innovate UK funding has ran out meanwhile. EU however seems to signal that they will go ahead with phase 2 trial even if phase 1 never happens. After all, there are those 10 patients who received a cadaveric trachea transplant  (here and below) and were operated under hospital exemptions between 2008 and 2012 by Macchiarini and Birchall. At least half of these 10 are dead, the lucky survivors either had their graft removed or live with permanently installed stents to prevent their rotting airways from collapsing (INSPIRE’s and TETRA’s clinical promise is actually that the patients will never need a stent). But this disaster seems exactly the reason for EU to try it again, and on a much, much bigger scale: 48 patients are scheduled to receive cadaveric tracheas. Probably because it will create employment.

The EU spokesperson ceased long ago answering my emails, after I declined to be instructed over the phone (strictly off-the-record) why EU’s approach to trachea transplanting is right; this is why I had to resort to FOI. The official time limit to answer my FOI inquiry from July 1st 2017 was 15 days, but the EU first pretended not to have received my postal address, then said they need more time, then said they need extra time to assemble the documents for me, and finally, the Director-General of the European Commission, Robert-Jan Smits, wrote to me on September 11th. He basically told me again to get lost and that he will never release any information (read here his past rejection of my FOI inquiry). His reasons, as before: the trachea transplant trial is a business enterprise and revealing any of its progress might endanger the financial interests of its stakeholders, and then there are privacy concerns. Exactly, Smits decided that the public must under no circumstances find out whom exactly the EU is giving this public’s money for research on humans. I am not making it up, read Smits’ letter yourself hereContinue reading “EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA”

Karolinska embarrasses itself to save two professors

Karolinska embarrasses itself to save two professors

The Swedish Karolinska Institutet (KI) is going through turbulent times. The Paolo Macchiarini scandal sensitised the European elite biomedical research centre and home of the Nobel Prize not just to patient abuse, but also to research misconduct and data manipulations, which its past professor Macchiarini was found guilty of. The misconduct and patient abuse investigations are ongoing. In parallel, several non-clinical KI professors were or still are under KI investigation, because of PubPeer evidence against their publications, as I reported before on my site. Two of them, as I wrote in a separate article, were the autophagy researcher Helin Vakifahmetoglu-Norberg and her former PhD supervisor, the apoptosis specialist  Boris Zhivotovsky. Both are now finally and irrevocably acquitted by KI of all suspicions of data manipulations in their common publications. The case is closed, there will be no external investigation.

In a previous decision regarding 9 of her papers, KI performed an amazing show of contortionism to absolve Vakifahmetoglu-Norberg from all suspicions of data manipulation (see this report). In one case, manipulated data was declared as non-existent because the paper containing it (Shen et al, Oncogene 2008) was retracted, and hence non-existent itself. No papers from Vakifahmetoglu-Norberg’s postdoctoral period in the US in the lab of Junying Yuan in Harvard were scrutinised by KI, despite the fact that KI originally based their decision to recruit Vakifahmetoglu-Norberg as assistant professor in no small part on these very publications. For example, western blot images from Vakifahmetoglu-Norberg et al, Genes & Dev 2013 were apparently re-used in her new lab’s paper in KI, Xia et al JCB 2015, see this PubPeer evidence: Continue reading “Karolinska embarrasses itself to save two professors”