18 January 2017

Petition of the doctors of the Karolinska Clinic

"It is necessary to investigate the activities of Macchiarini in Russia"

On January 5, a message appeared on the pages of the Swedish media about a petition written on December 15, 2016 and published on January 4 on the website of the human rights organization "Citizens for Responsible Care and Clinical Research" (Citizens for Responsible Care and Research, abbreviated CIRCARE) [1].

The petition was addressed to Karin Dahlman-Wright, Rector of the Karolinska Institute, Viktor Tatarintsev, Russian Ambassador to Sweden, the Commission of the Russian Academy of Sciences on Combating Pseudoscience and Falsification of Scientific Research, the Ministers of Education and Science and Health of the Russian Federation, Roszdravnadzor and other organizations.

Its authors were the same doctors of the Karolinska Clinic (Oscar Simonson, Karl-Henrik Grinnemo, Thomas Fux and Matthias Corbascio. – Ed.), who at one time decided to take out the trash from the hut and make public some unpleasant secrets of the Karolinska medical "kitchen". "At one time, they tried to warn the Karolinska Institute that patient records are kept irregularly, and published data on Paolo Macchiarini, but for this they were persecuted by the previous rector," German scientific journalist Leonid Schneider writes on his website For Better Science [2]. He noted that in April 2016, these four doctors were awarded the Transparency International Sweden's Whistleblower of the Year Award for civic courage [3].

In the current petition, the doctors decided to draw attention to the results of their analysis of the protocol of the clinical trial "Tracheal Transplantation" dated February 5, 2012, according to which several patients were operated on in Krasnodar [4]. (This document became one of the reporting documents for the 2011 megagrant of 150 million rubles, under which Paolo Macchiarini supervised scientific research [5]. In November 2013, this mega-grant from the "second wave" of mega-grants was extended for another two years, in 2014, Macchiarini and his colleagues received 22.5 million rubles. from the Ministry of Education and Science with the condition that the Kuban State Medical University will pay the same amount from its extra–budgetary funds in 2015 [6] - Ed.)

The authors of the petition came to the following conclusion: when signing the study protocol in February 2012, Macchiarini knew about the disastrous results of plastic trachea transplantation performed earlier to two patients at the Karolinska Clinic. However, he concealed these facts and misled both the organizations responsible for issuing mega-grants and the ethics committees that issued permits for operations.

Citing the data of numerous analyses from the archives of the Karolinska Clinic and comparing their dates with the date of signing the protocol, the authors of the petition insist: Macchiarini was well aware that in previous experiments there were no traces of epithelium on the surface of the transplanted plastic trachea, and that patients of the Karolinska Clinic who underwent plastic trachea transplantation had serious life-threatening complications.

Instead , in the protocol of the experiments at the Karolinska Clinic it was written: "In both cases, luminal ingrowth of healthy epithelial cells of the respiratory tract was observed"; "In the course of previous studies, no negative consequences were recorded that would lead to the rejection of the proposed research plan (protocol)."

"The results of these risky procedures were well known by the time Paolo Macchiarini signed the protocol. This should seriously concern the regulatory authorities," the authors of the petition conclude. "If the accusations turn out to be true, then it can be concluded that several Russian patients were subjected to deadly experiments on the basis of deliberate manipulation by the aforementioned regulatory authorities and that criminal procedural actions should be taken against the responsible parties so that they are punished in accordance with Russian law."

As addressees of the petition, the text of the document also lists the Kuban State Medical University, the ethics committees of this university and the Regional Clinical Hospital No. 1 named after S. V. Ochapovsky. So far, none of the Russian organizations has received this petition.

Representatives of the Karolinska Institute told Swedish journalists that she was "being processed according to the accepted procedures, which means that she was expelled by Paolo Macchiarini, who until January 13, 2017 had the opportunity to express his opinion on the new charges." However, the Russian Ministry of Health is already waiting for the petition. "If the relevant documents are received by the Ministry, they will be reviewed in the prescribed manner," Oleg Salagai, director of the Department of Public Health and Communications, told me.

We can expect that the proceedings in Russia will begin when the petition arrives at the relevant departments. Perhaps, in this case, questions will arise not only to Paolo Macchiarini. "It seems that those who approved the protocol of tracheal transplantation approached this very formally, if not casually. There are many points there that require separate serious consideration. It is unclear why this was not done," the head of the department believes. laboratory of Biomedical technologies of the FNCC of Physico-Chemical Medicine Sergey Kiselyov.

Alla Astakhova, medical journalist
See also details on the case of P. Macchiarini on the website alla-astakhova.ru

Links:

The authors of the petition called on the Karolinska Institute to immediately inform the relevant organizations that conducted the examination and made decisions on the issuance and prolongation of the multimillion-dollar megagrant, and the ethics committees in Russia about the accusations contained in it.

We will definitely continue this topic in the next issues of the newspaper. Currently, Paolo Macchiarini is working at Kazan Federal University, implementing a grant he received from the Russian Science Foundation (RNF) for 2014-2016 on the topic "Creating a tissue-engineered esophagus structure to replace a damaged organ with a model of lower primates." The development is being carried out by the Macchiarini Group in cooperation with the Kurchatov Institute Research Center: http://kpfu.ru/news/paolo-makkiarini-ndash-domysly-i-fakty-261752.html.

Project card: http://grant.rscf.ru/prjcard_int?14-45-00018. The grant was received within the framework of the 2014 competition "Conducting fundamental scientific research and exploratory scientific research by international scientific groups". The reports for 2014-2015 so far list 5 publications, three of them in the scientific and practical journal "Genes and Cells" (its editor–in-chief is Roman Deev), one in the journal Regenerative Medicine and one in the journal "Modern Problems of Science and Education".

The publication in the journal Regenerative Medicine is a summary of the poster presentation, which was published in the issue with the materials of the International Conference on Regenerative Medicine in Leipzig in 2015, 7 posters with the participation of P. Macchiarini were published there: www.futuremedicine.com/doi/abs/10.2217/rme.15.73

Portal "Eternal youth" http://vechnayamolodost.ru 18.01.2017

Petition of the doctors of the Karolinska Clinic

"It is necessary to investigate the activities of Macchiarini in Russia"

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