Macchiarini gave five patients in Russiaartificial windpipes; three of them have died.
Lars Granstrand, SVT
By Alla Astakhova May. 16, 2017 , 5:30 PM
After Paolo Macchiarinis star fell in Sweden, the Italian surgeon still had a place to shine: Russia. The Karolinska Institute (KI) in Stockholm fired him in March 2016 for multiple ethical violations, including "breach of KIs fundamental values" and "scientific negligence." But Russia had long showered Macchiarini with funding and opportunities to perform his experimental surgeries to implant artificial tracheas, and it allowed him to stay. Now, a year later, his Russian refuge has ended as well.
On 30 March, it became clear that the Russian Science Foundation (RSF) would not renew its funding for Macchiarinis work, which now focuses on the esophagus rather than the trachea. The decision came 9 days after Nature Communications retracted a paper by Macchiarini that documented successful esophagus transplantations in rats. Minutes of a meeting made public last week show that Kazan Federal University (KFU), Macchiarinis current employer, decided to end his research project there on 20 April, effectively firing him.
They have probably realized that its all based on nothing but hot air, says Pierre Delaere of the University of Leuven in Belgium, one of the first to criticize Macchiarinis work. Yet despite a passionate plea by four Swedish doctors who blew the whistle on Macchiarinis work at Karolinska in 2014, Russian authorities appear to have no plans to launch a misconduct investigation of his work in Russia.
Macchiarini has not said publicly what he plans to do next, and did not respond to an interview request from Science.
Once considered a pioneer of regenerative surgery, Macchiarini aimed to give patients whose tracheas had been damaged a new windpipe. Seeded with stem cells, it was supposed to grow into a new, fully functional organ. (He initially used donor tracheas as a basis, but later switched to an artificial scaffold.) But he has been accused of painting a false picture of his patients in scientific papers, several of which have been retracted; operating without ethical approval; and lying on his CV. At least six of the eight artificial trachea recipients have died. In Sweden, where the case has plunged science into a crisis, investigations continue into allegations including involuntary manslaughter.
They have probably realized that its all based on nothing but hot air.
Macchiarinis parallel life in Russia began in February 2010, when he conducted a master class in regenerative surgery at the invitation of Mikhail Batin, president of theScience for Life Extension Foundation(SLEF), which aims to make radical extension of life a Russian national goal, according to its website. Eight months later, Macchiarini agreed to do a trachea transplantation, in tandem with surgeon Vladimir Parshin at the Boris Petrovsky Research National Center for Surgery in Moscow. Glowing television coverage quickly made Macchiarini a scientific star.
SLEF then helped secure a $2.6 million megagrant from the Russian government, aimed at luring foreign talent, and additional funding from Kuban State Medical University (KSMU), a well-known medical school in Krasnodar, some 1400 kilometers south of Moscow. Macchiarini carried out four artificial trachea transplantations at Krasnodar Regional Hospital No. 1. In 2014, his work was featured in a permanent exhibition about Russias scientific and technological prowess at the Polytechnic Museum in Moscow.
But dramatic footage of one Russian patient eventually triggered Macchiarinis downfall in Sweden.Experimenten,a three-part documentary broadcast in January 2016, claimed that the patient, Yulia Tuulik, didnt have a life-threatening condition; her trachea had been damaged in a car accident, but she was able to breathe through a stoma. Macchiarini and his colleagues presented Tuuliks operation as a medical triumph at a press conference. But her trachea later collapsed, and she received a replacement, which didnt work well either; she died in 2014. Two other Krasnodar patients have died as well; the only survivor had his transplant removed.
AfterExperimentenaired in Sweden and a few publications about Macchiarini appeared in the Russian press, an audit by the Federal Service for Supervision of Healthcare of the Krasnodar hospital revealed that he had operated without a Russian medical license and had filed no documentation about the materials in the artificial windpipe with the state register. The hospital was ordered to correct those violations, but no sanctions were imposed.
Macchiarinis defenders have interpreted the criticism as an attack on Russia; a January article on a portal for Russian doctors, for instance, suggested that Macchiarini had come under fire in Sweden because of the success of the laboratory he founded in Krasnodar. Im outraged not so much by criticism of myself, as by criticism of the conditions and standards of research in Russia, Macchiarini himself told the website Lenta.ru.
Even before Macchiarinis megagrant ended, RSF provided him with a new grant for some $1 million annually to develop a tissue-engineered esophagus and test it in nonhuman primates. In 2016, Macchiarini asked RSF to transfer the grant from KSMU to KFU, 800 kilometers east of Moscow in Tatarstan. Since then he has worked out of the limelight.
But KFU soon grew uneasy. In a December 2016 newspaper interview, KFU Rector Ilshat Gafurov said that Macchiarini would not carry out operations at KFU as long as he did not have the required papers, and would not even see patients. According to RSFs website, Macchiarini has given 10 baboons small pieces of artificial esophagusat the Research Institute of Medical Primatology in Sochi, a city on the Black Sea; all supposedly recovered. Data from the experiment have not been published, but KFU can guarantee that the results, whatever they may be, will reflect the real state of affairs, will be truthful, a spokesperson for the university says.
We hope that a police investigation is initiated in Russia and that Macchiarini will face criminal charges.
Last December, the four original whistle-blowers in Sweden sent several Russian government agencies a 57-page petition asking for a criminal investigation of Macchiarini because he systematically falsified, omitted or glorified data from his operations in Sweden to obtain an ethical approval for his work in Krasnodar. None of the agencies has responded, says one of the authors, Matthias Corbascio of Karolinska University Hospital. Corbascio welcomes Macchiarinis dismissal but says it should only be the beginning: We hope that a police investigation is initiated in Russia and that Macchiarini will face criminal charges. (A spokesperson for the Russian health ministry says it has never received the document.)
Macchiarinis Russian patients or their relatives could sue the Krasnodar hospital, says Alexander Saversky, president of the Russian League for the Protection of Patients, if there is strong suspicion that the operations did more harm than good. So far, nobody has done that. Theres no point, Natalia Tuulik, Yulias mother, told a newspaper: The court will not return my daughter to me.
With reporting by Martin Enserink.
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