UCL trachea transplants: Videregen sets lawyers on Liverpool academics Murray and Levy

The Science and Technology Committee of the British House of Commons opened in November 2017 an inquiry into Research Integrity. This prompted two University of Liverpool academics to submit a letter to the committee, describing the inaccuracies, misrepresentations and blatant lies which incurred in the course of the trachea transplants performed by the surgeons Paolo Macchiarini and Martin Birchall. The two academics were Patricia Murray, professor in stem cell biology and regenerative medicine, previously a nurse on a Head and Neck unit, and Raphael Lévy, senior lecturer in nanotechnology and imaging. The two also notified the relevant UK authorities and Birchall’s employer UCL of their concerns, especially after even suspected data manipulations came to light. UCL representative gave as a reply an oral and written testimony to the parliamentary committee, other stakeholders provided their own written replies. The first Murray-Levy letter was followed by a second one, because UCL needed help recalling correctly what they did to which patient, and how many have died from the very similar trachea replacement technology which UCL still demands to be allowed to test on 60 more patients.

Now the most vile thing happened, as reported by The BMJ on July 12. Videregen, the Liverpool-based company which bought the trachea regeneration patent from UCL and engages Birchall’s services as advisor, deployed lawyers against Murray and Levy, precisely via their employer University of Liverpool. The main issue is the parliamentary submission by Levy and Murray, subject to absolute privilege. Yet Videregen also cites from the confidential notice of suspected research misconduct Murray and Levy submitted in good faith to UCL (which has not yet decided whether misrepresenting data and providing false information in applications for funding, ethics approval and regulatory permissions is serious enough to warrant an investigation). One wonders who forwarded Videregen this notice, which was confidential and absolutely none of their business? UCL, or their professor Birchall, or Birchall with permission from UCL? Another question is: is our tax money which the EU Commission gave Videregen for trachea transplanting now being used to threaten critics? Continue reading “UCL trachea transplants: Videregen sets lawyers on Liverpool academics Murray and Levy” →

Macchiarini victim Zhadyra Iglikova is dead

English version below

Умерла еще одна жертва Маккиарини – Жадыра Игликова

Еще одна из пациенток, которым Маккиарини в прошлом проводил трансплантацию трахеи, умерла 9 июля 2018. Об этом сообщила российский медицинский журналист Алла Астахова, упомнув в качестве источника аккаунт в Instagram одного из членов семьи пациентки. Аккаунт содержит много ценной информации. Жадыра Игликова получила от Маккиарини обесклеченную трахею посмертного донора в декабре 2010 года. Эта операция была шоу своего рода и должна была привлечь чудо-хирурга в российский проект мегагрантов. Результатом стали до 6 смертельных трансплантаций пластиковой трахеи . Трансплантат был получен в больнице Careggi во Флоренции, где Маккиарини работал в то время, и доставлен в Россию. Операция была проведена в московской Национальном научном центре хирургии имени Петровского. Ведущим хирургом наряду с Маккиарини был Владимир Паршин . Сразу же после этого последовали осложнения, трансплантат развалился и сгнил, как сообщает Дземешкевич 2015 .

К 2018 году состояние Жадыры критически ухудшилось, у нее была хроническая пневмония, трахеопищеводный свищ и весила она менее 39 кг. В феврале 2018 ее семья отправилась с ней из Казахстана в Москву искать помощи в клинике МГМУ имени Сеченова. Совпадение или нет, но руководит отделением торакальной хирургии в этой клинике Паршин, выполнивший первую операцию по пересадке трахеи Жадыре в 2010 году. Continue reading “Macchiarini victim Zhadyra Iglikova is dead” →

Gothenburg to sack Sumitran-Holgersson, requests 7 retractions

The travesty around the data faking regenerative medicine enthusiast Suchitra Sumitran-Holgersson is finally over. Her Swedish employer University of Gotheburg (GU) announced yesterday to have opened labour law proceedings against her, with the expressed goal of her dismissal as university professor. No appeal is possible anymore, and her loyal GU supporters Elias Eriksson and Kristoffer Hellstrand can now take a rest from nearly 10 years of lobbying, obstructing and bullying everyone involved in the misconduct investigations of their dear colleague. On top, retractions of 7 Sumitran-Holgersson publications were requested by the GU rector.

Sumitran-Holgersson, formerly a Karolinska Institutet researcher, survived a misconduct investigation by the Swedish Research Council from 2009-2011, because her friends achieved a dismissal of all damning evidence of data manipulation on formality grounds; the two investigators themselves ended up threatened with lawsuits. The newly appointed GU professor only had to retract one paper. In early 2016, when the regenerative medicine scandal around Paolo Macchiarini exploded in Sweden, PubPeer evidence of image manipulations was posted en masse (including by certain readers of my site) about Sumitran-Holgersson’s work in the field. That prompted a new misconduct investigation by GU and the Swedish Central Ethics Review Board (CEPN). In spring 2016, Sumitran-Holgersson saw her funding frozen and her paper retracted, which reported an unethical Macchiarini-style trachea transplant, likely responsible for the death of that patient. That work was performed together with GU surgeon Michael Olausson, with whom Sumitran-Holgersson also developed bioengineered blood vessels which they tested on children without proper ethics approvals. For that, both were found guilty of misconduct one year later, in March 2017. Which not only still didn’t cost Sumitran-Holgersson her job as GU professor: her own business Verigraft was right after awarded €2.3 mn by the EU Commission under Horizon 2020, based on her papers tainted with data manipulations and severe ethics breaches. The money was earmarked by excited EU bureaucrats to market and bring that very same blood vessel graft technology into a large clinical trial; in this regard please read the excellent investigation for my site by Sophia Tibblin. Olausson’s own misconduct activities in the area of regenerative medicine and especially trachea transplantation served as his qualification to advice the Swedish State Prosecutor to drop manslaughter charges against Macchiarini in October 2017.

In March 2018, both Sumitran-Holgersson and Olausson were found guilty of misconduct once again, this time it was about data manipulation flagged on PubPeer 2 years before. Retractions of 8 papers was recommended by the CEPN decision, which GU now largely upheld in the rector’s yesterday’s announcement, with the difference that now all co-authors were freed of suspicions of misconduct. Update 7.07.2018: That was because GU’s (now updated) good scientific practice rules of the time did not sanction negligence, of which Michael Olausson and Jan Holgersson (Suchitra’s husband, also professor at GU and Chairman of Verigraft) were found guilty of, but with no disciplinary consequences.

For the indestructible Sumitran-Holgersson though it is now the end of the road. Continue reading “Gothenburg to sack Sumitran-Holgersson, requests 7 retractions” →

“Me llamo Paloma Cabeza Jiménez”: Macchiarini victim speaks out

English version, and a secret of yet another dead trachea transplant patient below.

Me llamo Paloma Cabeza Jiménez,

tengo 43 años y vivo en Alicante aunque nací en Madrid (España)

Con tan solo 10 años, tuve un accidente doméstico con un caustico.

En aquella época (1986) no se manejaban con buen acierto ni criterio las lesiones traqueales.

Mi lesión primaria era de tan solo dos centímetros de longitud y a causa de malas decisiones médicas y pocos recursos… aquellos dos centímetros degeneraron en una lesión que abarcaba la longitud total de la tráquea, lo cual me obligó a la colocación de una prótesis de silicona tipo “T” llamada Montgomery en 1992 (el verano que cumplía 18 años)

Tras años de múltiples recambios de Mongomerys para evitar la colonización por bacterias, se dieron cuenta que esas mismas manipulaciones (cada 3-6 meses) en quirófano estaban favoreciendo y provocando la aparición de nuevas bacterias por contaminación y sumada a esta realidad la propia manipulación destrozaba la regeneración natural de la mucosa traqueal.

Asi mismo, las reiteradas manipulaciones con fibrobroncoscopio rigido y aspiraciones…dañaron parcialmente mi bronquio principal izquierdo, quedándose con una estenosis estable de diámetro entre 6-7mm. Calibre compatible con una calidad de vida normal si no pretendes ser deportista profesional. Continue reading ““Me llamo Paloma Cabeza Jiménez”: Macchiarini victim speaks out” →

Karolinska requests retraction of Macchiarini and Jungebluth papers

Today the Swedish Karolinska Institutet (KI) will announce its decision about 6 papers of their former professor and surgeon, Paolo Macchiarini. This article will be updated accordingly. Update 14:00: a decision was published, all 6 papers are to be retracted, 7 scientists found guilty of misconduct.

The background: On 30 October 2017, Swedish Central Ethics Review Board (CEPN) requested that 6 publications by Macchiarini and co-authors, all authored while at KI, are to be retracted, in a press release and a statement I received, in English original. The decision was based on the expert review by Martin Björck, professor of surgery at University of Uppsala, and Detlev Ganten, professor emeritus of pharmacology and former CEO of the Charité university hospital in Berlin, Germany, their report is available here on my site. The two experts found Macchiarini and his former acolyte and right-hand man Philipp Jungebluth guilty of breaching the Nuremberg Code of 1947 and Helsinki declaration, which forbid unethical and dangerous medical research on humans. One of those papers set for retraction is Jungebluth et al Lancet 2011, where a patient from Iceland was tricked to subject himself to a deadly experiment with a never before tested plastic trachea (that issue lead to a major investigation in Iceland and now is even about to be addressed by the Icelandic parliament).

Judging from last week’s email by Jungebluth to KI which I quote below, a call for retraction is expected.

Continue reading “Karolinska requests retraction of Macchiarini and Jungebluth papers” →

Karolinska gets taught German medical ethics

A most bizarre thing happened. In the aftermath of the scandal around the thoracic surgeon and regenerative medicine enthusiast Paolo Macchiarini, which left many patients dead, his former employer Karolinska Institutet (KI) in Stockholm, Sweden, requested a retraction of one of his papers. It was not about a trachea transplant, but about unethical and painful medical experiments on a dying patient (actually, two of them). KI’s decision to request a retraction of the paper Jungebluth et al, “Autologous peripheral blood mononuclear cells as treatment in refractory acute respiratory distress syndrome”, Respiration, 2015 was based on the investigation commissioned by Swedish Central Ethics Review Board (CEPN). The Swiss-German and family-owned medical publisher Karger and its journal Respiration however categorically refused to retract the paper and ordered KI not “to patronize the readers of the journal ‘Respiration’.”

It gets much worse. The German Editor-in-Chief of this journal has a huge conflict of interest. It is better you just read on, because if I try to summarize it here, I might get sued by Macchiarini’s German friends and associates once again, and next time it might even be prison for me. In Germany, doctors have a very special status. Journalists or even patients do not, as I learned in court.

Continue reading “Karolinska gets taught German medical ethics” →

UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose

In 2017, the great London university UCL invited an external expert commission to investigate its role into the deadly trachea transplants performed by the former UCL honorary professor and scandal surgeon Paolo Macchiarini. An already sacked UCL nanotechnology professor, Alexander Seifalian, whose lab made the two UCL plastic POSS-PCU tracheas in 2011, was announced as the main culprit on UCL side for all the suffering of these two patients Andemariam Beyene and Keziah Shorten, as well as some recipients of vascular grafts. All this despite Seifalian’s having had no clinical role, training or ambitions, as he professed in his interview to the investigative committee, which I now obtained.

The interview also makes perfectly clear that the investigative committee’s surprise finding, namely that the nanotechnology specialist fabricated non-GMP certified plastic grafts for clinical use behind everyone’s back, was actually slanderous. Not only did UCL know very well that the product, which their own business branch UCLB approved for clinical use in Iran, Switzerland and India, was not GMP-certified, they even used it on their own patient at UCL hospital UCLH, in an attempt to grow a plastic nose. Even the UK regulatory authority MHRA was informed, and apparently did not mind or interfere. All this did not stop UCL investigators from publicly fingering cancer survivor Seifalian as the only culprit for that GMP-non-compliance.

Finally, the committee had information that Birchall allegedly proposed to make a plastic trachea for the child patient Ciaran Lynch in December 2009. Seifalian refused, for technical reasons, but this definitely and literally saved the boy’s life. Ciaran, presently one of just 3 known survivors of ~20 trachea transplants performed by Macchiarini and his former close associate, the UCL laryngologist Martin Birchall, was operated in London in March 2010 with a freshly decellurised cadaveric trachea graft supplied from Italy; Macchiarini was the surgeon. That clever Birchall-attributed idea, of being the first one to implant the utterly untested plastic trachea, and into a child no less, was somehow dropped from the final UCL report. Sod knows why. Continue reading “UCL trachea transplant inquiry: scapegoating, obfuscation and a lost nose” →

For Better Science

Science journalism by Leonid Schneider, on research integrity and academic publishing in life sciences and biomedicine

Tag: regenerative medicine