The right to make a mistake
A lump in the plastic throat
Nadezhda Markina, "Newspaper.Ru»
The famous surgeon Paolo Macchiarini, who works in Russia, was accused by his colleagues from Sweden of violating ethical norms and misinformation. A leading specialist in regenerative medicine denies these accusations, and explains complications after operations by saying that this is inevitable with the introduction of a new technology.
Paolo Macchiarini. Photo: esmateria.com
On Tuesday, the New York Times reported on the scandal at the Karolinska Institute (Sweden). Several doctors of this institution addressed to the management of the institute with a letter. In it, they accuse Paolo Macchiarini that he did not receive ethical permission to conduct experimental operations and gave incorrect information in a publication in a medical journal regarding the success of the operation.
Paolo Macchiarini, professor of regenerative medicine at the Karolinska Institute, created the technology of bioengineered trachea transplantation and has already performed about twenty operations to replace the damaged organ to patients. Now he is also working in Russia – in Krasnodar, where a Center for Regenerative Medicine was created with the funds of a megagrant.
The bioengineered trachea, created using Macchiarini technology, includes a framework that is seeded with the patient's stem cells from his bone marrow. Moreover, if in the first operations the surgeon used a decellurized (cell-free) frame of the donor trachea from a corpse, then later he switched to a polymer frame made using a special technology.
"Newspaper.Ru" has repeatedly written about the achievements of Paolo Macchiarini: about the first tracheal transplant operation performed in Krasnodar on a megagrant; about the first bioengineered trachea transplant to a child, which was "tailored to grow"; about the creation under his leadership of the first bioengineered esophagus (the corresponding article was published in Nature Communications) with the participation of a young scientist from Russia.
Paolo Macchiarini received a mega-grant to create a center in Krasnodar in 2011, but a year before that, with the support of the Science for Life Extension Foundation, he brought his technology to Russia, where he trained Russian surgeons. Subsequently, the correspondent of "Gazeta.En" I saw with my own eyes a girl from Kazakhstan who was operated on in Moscow under the guidance of Macchiarini, restoring her ability to breathe. And I have repeatedly heard Macchiarini speak at international conferences, where he argued that it is necessary to move from research to practice, that regenerative medicine can save lives.
The doctors' letter refers to three patients who had a trachea transplanted from a polymer frame seeded with stem cells. One patient, an Eritrean who suffered from tracheal cancer and underwent surgery in 2012, died in January 2014 after spending the last eight months of his life in the Karolinska Institute Hospital. Another patient, an American, died a few months after the operation. The letter against Macchiarini was signed by four doctors who participated in the treatment of these two patients, and also continue to work with the third patient: she has been in the hospital for two years after the operation, where she needs to have a tracheal cleansing procedure every four hours.
Doctors believe that performing operations was not what is called compassionate use, that is, the use of an unregistered method of treatment for humane reasons, when this is the only way to save a life. Doctors claim that patients had alternative methods of treatment and that this problem was not considered by the ethics committee. It is also claimed that of the three mentioned patients, only one signed informed consent, and retroactively – after the operation.
The story of an Eritrean patient with tracheal cancer is reflected in a publication in the Lancet medical journal in November 2011, the article was published five and a half months after the operation.
The article claims that the patient had no major complications. At the same time, a few days before the publication of the article, surgeons were forced to put a stent inside the bioengineered trachea so that its lumen remained open.
However, this information was not included in the publication. The specialists working with Macchiarini emphasize that, since we are talking about a completely new technology, complications are inevitable and there should be a completely different attitude to these complications. "If everything is fine with the patient, then it's luck, not a pattern. For now," Macchiarini's colleagues believe.
In the process of preparing this material, Macchiarini himself was traveling between different continents and could not give the correspondent of the newspaper.En" extensive comment. He wrote only that the allegations contained in the complaint against him are absolutely groundless. He is pleased with the official investigation that is being conducted at the Karolinska Institute and, in his opinion, will put an end to speculation and innuendo.
"When donor heart transplants began, patients, as a rule, lived no more than two weeks after surgery – they died due to various kinds of complications, predictable and unpredictable," Paolo Macchiarini recalled. – But this did not stop the development of transplantology, and now the results are much better, although even now they are not always unambiguous. It is very difficult to introduce new things in medicine, and, as a rule, a doctor takes risks and is criticized. I am open to any discussion, discussion and I am not hiding anything."
As he told the newspaper.En" a source close to Macchiarini, the deceased referred to in the letter were cancer patients. One patient, an Eritrean (he lived in Iceland), lived for two and a half years after the operation – and this, the source notes, is a great achievement. During this time, he even managed to defend his PhD. After the second patient, Christopher Lyles, died of cancer, his family wrote a letter in defense of the stem cell program. The third patient, according to the source, is really in a serious condition in the hospital: she underwent a second transplant, and doctors disagree on how she should be treated. Perhaps this discrepancy on medical issues was the reason for the doctors' letter to the leadership of the Karolinska Institute.
Commenting on the issue of experimental operations, the source notes that all patients were included in an international clinical trial, and the protocol of inclusion in the research necessarily includes the permission of the ethics committee of the Karolinska Institute or any other.
As for the informed consent story, according to information from Macchiarini, "he does not know how and why the document arose retroactively, but he knows for sure that he and his patient and the attending physician signed this informed consent with many witnesses."
There simply cannot be any other way at the Karolinska Institute, the source notes.
In addition, the source noted that unsuccessful cases of transplants do not have time to be reflected in articles, but these cases are reflected in reports and presentations, in particular under the heading "Lessons we learned from the failures of previous transplants". "The patient referred to in the article in the Lancet journal had a tracheal stenting. This happens: some patients are given a stent to support the trachea while it is being formed. Moreover, some patients had to undergo repeated transplantation, and no one hid it. They just didn't have time to add this information to the article," the source said.
Portal "Eternal youth" http://vechnayamolodost.ru26.11.2014