My report from just a week ago, about the data irregularities in papers from Italian haematologist and cancer researcher Giorgio Zauliprovoked a response of a legal threat, of both criminal and civil prosecution. Zauli is namely rector of the University of Ferrara, and he issued this threat in this official capacity, acting for his Italian university. I was already made aware of Zauli’s threats of suing me from a first-hand source, and my site was indeed accessed by Italian State prosecutor’s office the day after I published my article about Zauli’s flawed cytometry and other problematic data in research papers he mostly co-authored with Ferrara’s Head of Department, Paola Secchiero. This letter from Zauli below, which reached me today per certified mail, is the more bizarre due to the fact the university denied any knowledge of Zauli’s legal threats (see the update here).
In any case, here is the letter, on the headed paper of the University of Ferrara, which even paid the postage. Zauli and his university apparently assume that their research publications and public institutional profiles are personal data, protected by EU privacy regulations. Maybe rector Zauli is confused at to where the Latin-derived word “publications” comes from. It’s from “public” and certainly not from “pubic”, hence definitely not his sphere of personal privacy. Though his publications could profit from some data integrity hygiene. In any case, the Ethics Commission of University of Ferrara will convene on June 1st to decide what to do about the publicly available PubPeer evidence I reported about. The scanned original is here. Please disseminate widely. Continue reading “Zauli and University of Ferrara announce libel suit, criminal prosecution against me”→
Giorgio Zauliis Italian clinical haematologist and cancer researcher, who used to be director of Burlo Garofolo Pediatric Institute in Trieste, till in 2015 he was appointed Rector of the respected University of Ferrara. In this position he might soon be investigating his own papers, because given the massive evidence uncovered by the pseudonymous data integrity sleuth Clare Francis and others, Zauli seems to become a second Alfredo Fusco, and given his Rector status, probably just as unshakable. In Italy, science and politics are unhealthily interconnected, as demonstrated by the deadly scandal of Paolo Macchiarini in Florence. In any case, the list of gross irregularities in Zauli’s papers on PubPeer grows daily.
Zauli’s impressive publishing record consists of almost 200 first- and last-author papers in prestigious journals and his h-index bears the impressive size of 57. Some of this academic output, largely co-authored by his close associate and head of his department in Ferrara, Paola Secchiero (h-index 41), was achieved by their rather questionable attitude to data integrity. Of course we have the usual: western blots with duplicated gel lanes and bands re-appearing in several figures and papers, standing in for different experiments and even different patients. This article however will focus on Zauli’s flow cytometry studies, and how such data in his publications apparently got manipulated in a way which is supposed to provide deniability should the authors ever be caught.
The stem cell pioneering surgeon Paolo Macchiarini is back in court now. No, he is not the accused this time. He is an unbiased, independent expert witness invited by his student and acolyte Philipp Jungebluth to help him sue me in Berlin. There are two court injunctions against me, one was already partially lifted, while another was upheld in full, and the main issue are Macchiarini’s trachea transplants in Italy described in an unpublished manuscript. I cannot say much more without facing a €250,000 fine or a 6 months prison term.
Macchiarini recently saw the Swedish state prosecutor drop charges against him because another misconduct-tainted Swedish trachea transplanter, Michael Olausson, served as secret expert for prosecution. At least, no journalists faced court sentencing in Sweden for exposing trachea transplant scandals. It is different in Germany, where constitutional press freedom counts little if someone doesn’t like your reporting, which is why medical scandals in Germany are so rare. The ruinous court trials Macchiarini-associates Jungebluth and Heike & Thorsten Walles imposed on me seem to have scared German media into near-complete silence on the trachea transplant affair. What about the central role of Germany, especially Macchiarini’s and Jungebluth’s university Hannover Medical School (MHH) and their recent cover up of the trachea transplants? Definitely no public interest there, even if Macchiarini’s only remaining (adjunct) professor title was bestowed by MHH. My appeal hearing for both Jungebluth injunctions is at the Berlin Kammergericht court on May 24th. It is public, feel free to come. Maybe even Prof Macchiarini pops in?
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.
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”.
The European Commission now took 40 days to deny my second Freedom of Information (FOI) Inquiry about theTETRA 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 here. Continue reading “EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA”→
7.09.2017 This article was slapped with an injunction by Berlin court (here), on behalf of Jungebluth. Sentences forbidden by injunction are replaced to show the legal truth.
I have been forwarded a manuscript by the scandal surgeon Paolo Macchiarini, which was originally intended to present in detail all of his known 9 cadaveric trachea recipients (only 4 are recorded officially). The compilation follows exactly all the patients who are already listed on my site, with the small difference that the paper (allegedly rejected at Nature Communications) presents their clinical evolutions quite differently from reality. One of these now fully confirmed victims of Macchiarini’s research was his second patient from Barcelona, whom Macchiarini transplanted in secret; five were operated in Italy (including Keziah Shorten and the Czech patient MK). The manuscript also confirms that Macchiarini’s acolyte Philipp Jungebluth[is an angel of innocence and never did anything bad in his life. Every patient ever treated by him is in fact eternally grateful]. The German doctor is currently suing me in court for alleged libel, insisting that all these patient deaths and his proven research misconduct in Sweden would never ever disqualify him from developing trachea transplants and training as thorax surgeon at the University Clinic Heidelberg, where he however doesn’t work anymore.
The first author of this lost and now found unpublished paper is Johannes Haag, Macchiarini’s other acolyte and former MD student from Hannover Medical School (MHH) in Germany. Haag is apparently still employed at the Thoraxklinik at the University of Heidelberg, where Jungebluth used to be. The manuscript, which was supposed to be Haag’s big paper, was written to deal with the fact that too many of Macchiarini’s cadaveric trachea recipients died or developed very severe complications. To this end, the team hatched an idea to do “reverse translational experiments“, where rat experiments would follow those on 9 humans, prove that the cadaveric trachea technology works in principle and it was the human patients who were making problems. This notion was to be supported also by their earlier pig study Go et al, Biomaterials 2010, where Macchiarini and Jungebluth claim, without a shred of evidence, that the large animal testing was performed before the first patient, Claudia Castillo, received a cadaveric trachea in 2008 (details here, here and here). Update 7.09.2017: Go et al 2010 paper was criticised on PubPeer for its heavy scientific and technical deficits.
This article lists all known (including those not officially declared) patients of the scandal surgeon Paolo Macchiarini, who received from him a cadaveric or plastic trachea. All these grafts were “regenerated” with bone marrow and epithelial cells, in some cases a bioreactor was used to incubate cells on the trachea carcass, in some cases a “bionic” method was applied, where cells were brought straight into the open patient, together with growth factors like EPO. Not all patients are named in my list, though names of all are available, certainly at the hospitals where they were treated. One of my sources is a patients list from the Careggi Hospital in Florence, Italy, which the Corriere Fiorentino journalist Alessio Gaggioli sent me. Some of the patients I already described in an earlier article.
This now is a full list, and it will be updated whenever I receive any new evidence. All Macchiarini trachea transplant patients are listed in the chronological order of their operation. The 2003 operated patient (story here), who received from Macchiarini (together with Heike and Thorsten Walles) a small “regenerated” tracheal patch of pig intestine, is not included here, as it was not a trachea transplant as such. There is a total of 17 patients, at least 11 are dead, the rest, if alive, were left mutilated.