Sun, Nov 08 2009

Stem cells row

Fri, Aug 15 2008 11:00 CET 506 Views
Stem cells row

What began as a scientific debate about Bulgaria's conduct of stem cells transplants has cost the jobs of an entire hospital management and a deputy health minister.

The story started on July 28, when Bulgarian-language daily Trud published a piece claiming that methods used by Sofia's Sveti Ivan Rilski Hospital in stem cell transplants lacked a scientific basis and contravened national legislation. According to the story, based on Trud's source at one of the hospitals, transplants have been taking place for more than two years. Trud's insider claimed that the hospital had been collecting stem cells from an individual and transplanting them back to the same person's body.

The hospital's methods prompted a number of specialists to say that its efficacy had no scientific proof and hence should not have been used on patients suffering from genetic diseases, as well as spinal cord injuries, strokes, neural degenerations and paralysis. Underlying the attack was that stem cells collected from patients should not have been transplanted back into their bodies because the cells had already been damaged by the patients' diseases. There was also no convincing evidence that the procedure alleviated the respective ailments.

If it was just a debate on method and conclusive results the issue would have stayed in the domain of expert argument. Unfortunately, it transpired that Sveti Ivan Rilski had been charging patients between 2000 and 3900 leva for the transplants. Professor Ventseslav Brousarski, head of Sveti Ivan Rilski's neurology department, himself announced the tariffs at a news conference defending the method used by the hospital. He claimed that about 300 transplants had been carried out at the hospital since 2005. He maintained that the hospital started offering the treatment on the back of specific requests from patients who would otherwise have had to pay up to $40 000 to travel to Russia.

Brousarski, one of the leading Bulgarian specialists and experts in his field, used the term "treatment" to describe the stem cell methods. This, he said, was one of the major differences in the work of the hospital as compared to other similar institutions. He said that the autologous stem cell method was not a transplant but a treatment. As such, it did not flout the law that stipulates that transplants can only be performed in compliance with the law on medical establishments. Since Rilski's method was a form of medical treatment, not a transplant, the hospital was not technically breaching the law, Brousarski claimed. He said that all patients were well informed that their treatment could not guarantee full recovery.

The medics' interest in the issue, however, made Health Minister Evgenii Zhelev order an inspection of Sveti Ivan Rilski Hospital's work. When Zhelev took the post this spring, one of his promises had been to bring more transparency to the ministry's work.

On August 8, the results of the probe were announced at a news conference. It confirmed some of the media reports about alleged conflict of interest in the hospital's work. The investigation revealed - firstly - that the actions performed by the hospital with regard to autologous stem cells were - without doubt - a form of transplantation. Secondly, after attacking Brousarski's claims, the commission appointed by Zhelev to monitor his actions said that the hospital was not entitled to perform the transplants. Thirdly, it said that there was no conclusive proof that the method used by the hospital could lead to positive results. It also added that the transplants contradicted medical ethics. The head of the hospital, Roumen Stoilov, has been issued with an order forbidding the hospital's neurology department from performing transplants "but it seems it has been ignored", the commission concluded.

Based on the findings, Zhelev decided to change the entire management of the hospital and send the report to the State Agency for National Security, the General-Prosecutor's Office and to the police for further investigations.

These investigations related to other commission findings. According to documents provided by the hospital to the commission, the former has not received money for its work. Ninety per cent of the money paid by patients has gone to the private health consultancy centre Fokus 5, which, in turn, has been transferring the money to ProCell-Stem medical centre.

What the hospital did was to rent out to Fokus 5 equipment and premises - such as an operating theatre - as well as staff to perform operations. The commission asked but did not receive statements from the specialist involved in the transplants about their exact role, "just statements that they were not transplants but a form of treatment".

This was when the matter became political. Minutes after it was announced that the management of the hospital would be replaced, deputy heath minister Matei Mateev filed his resignation. He said that it was a manifestation "of my disapproval of the campaign against leading Bulgarian expert neurosurgeons regarding the methods they are implementing in medical treatment with relation to stem cells". At first sight, it looked as if Mateev was defending a new and controversial medical treatment that was not shared by the country's broader medical community. However, Zhelev's response showed that the reason was different.

"I have had two conversations with Mateev insisting that he file his resignation because of violations of the code of ethics adopted by the Cabinet for top officials in the executive. Unfortunately, at the moment he is presenting the reasons for his resignation in a different light by citing the conclusions of the commission in the work of Sveti Ivan Rilski Hospital as the justification. These conclusions have nothing in common with the real reasons for his resignation," Zhelev's said on the ministry's website.

What he meant was the fact that Mateev had his mother and son as minority shareholders in both Fokus 5 and ProCell medical centres, as media reports had previously suggested.

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