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.
Keziah Shorten was a 19-year old teenager from England and officially Paolo Macchiarini 3rd patient receiving a cadaveric trachea transplant. She suffered from a slow growing form of cancer and received a cadaveric trachea transplant from Macchiarini at the Careggi hospital in Florence. After life-threatening complications ensued, her second transplant, a plastic trachea made and implanted at UCL and its UCL hospital (UCLH) in London, failed also. Keziah died one and a half years after her first operation. With new evidence provided to me by a source close to the patient, I present here a version of Keziah’s story which is very much different from the official one. This makes UCL and UCLH at least in part responsible for her death, from the very beginning. It was their decision to treat Keziah with the first cadaveric transplant, which sealed her fate. Next to the UCL honorary professor Macchiarini himself, the British doctors, who according to my source promised Keziah a complete cure and initiated this transplant, were UCL professors and surgeons Martin Birchall and Paul O’Flynn. Keziah was even supposed to be operated at UCLH, but once Macchiarini got an ethics permit in Italy, she was moved there. O’Flynn followed her and joined Macchiarini in the transplant operation. Afterwards, it was an ongoing catastrophe which was exacerbated by an apparent botched intervention at UCL Hospital. Death seemed a relief after terrible suffering imposed on Keziah by fame-seeking doctors worshipping their own magic of regenerative medicine. Continue reading “Keziah’s deadly trachea transplant: UCL hospital’s secret”→
As we learned it from the Swedish documentary „Experimenten“, the scandal trachea surgeon Paolo Macchiarini didn’t much like to operate on sick cancer patients: they died too quickly after receiving a trachea transplant. This is why Macchiarini was said to have moved on to patients outside of any life-threatening conditions, like the Russian car accident victim Yulia Tuulik. She died because of the plastic trachea which Macchiarini implanted into her. Yesim Cetir, young victim of a botched operation, was slightly luckier to survive the plastic trachea, but only because it was removed and because of constant emergency care and multiple organ transplants (she is presently in very grave state). However, it seems that even Macchiarini’s cancer patients could have led a relatively long life, had they not agreed to receive his trachea transplants. And I am not speaking about the lethal plastic ones. In fact, the “biological” grafts made of decellurised dead donor tracheas were not such a great success either, and seem to have brought suffering and have shortened lives instead of prolonging them. The British UCL and its hospital UCLH are preparing their own clinical trial with cadaveric tracheas, while busily covering up their role in the Macchiarini scandal.
The trachea transplant experiments by Paolo Macchiarini left many of his trusting patients dead or mutilated. His €5.5 Million EU-funded research project Biotrachea started in April 2012 and was specifically designed to treat even more human beings with lethal plastic tracheas (and with the slightly less lethal cadaveric ones). The consortium was terminated in 2014 (see some background here), but not because the Biotrachea scientists or EU officials suddenly had second thoughts when the Macchiarini scandal unraveled and when his misconduct, ethics breaches as well as painful deaths and suffering of his plastic trachea recipients became known. Unlike an EU spokesperson previously insisted, there were no ethics concerns at all regarding Biotrachea. In fact, all ethics approvals were in place, human Guinea pigs were supposed to be lured en masse using a highly inappropriate patient consent form towards their likely deaths for the sake of EU-funded mega-science.
In truth, Biotrachea collapsed only because of Macchiarini’s greed for money. His financial conflict about patent revenues with the British university UCL drove the star surgeon to seek another plastic transplant manufacturer and then to destroy the entire multinational research consortium which he was presiding over, after the EU rejected his new plastic provider. Not because that one was also deemed unsafe, but as the EU negotiators mentioned, it was because that new type of plastic trachea lacked novelty. All this only became known after the original Biotrachea documents, which the EU and all consortium participants refused to grant me any insight into, were fully legally obtained by Jonas Malmstedt under Swedish transparency from Macchiarini’s ex-employer, the Karolinska Institutet (KI). Thanks to this brave and decent surgeon, I make all that secret documentation available below.