This letter first appeared in The Lancet
Sir - Ben Aris (Lancet, Nov 8, p 1557)
Médecins Sans Frontières (MSF) started work in Siberian prisons in 1996, and has treated 10,500 patients in collaboration with regional penal authorities using the WHO-led DOTS strategy up until our withdrawal from the region in September last year. During that period, our doctors were faced with a substantial number of patients with multidrug-resistant tuberculosis who cannot be cured with the first-line tuberculosis drugs we provide.
In these prisons, around 22% of new cases and 40% of retreatment cases are multidrug-resistant, which are some of the highest rates recorded worldwide. Expensive treatment options, involving the use of quality second-line drugs for anything up to two years, were not available to us then.
In an attempt to bring the hope of a cure to these prisoners, we, together with the regional authorities in Kemerovo, submitted an application to treat multidrug-resistant tuberculosis patients to the international body the Green Light Committee. We received approval to start using second-line drugs to treat initially 150 patients in the Siberian prison colonies. On application to the Russian Ministry of Health, however, we were surprised to find that the application to start treating these patients was rejected. Despite the fact that the treatment schemes proposed were based on internationally agreed guidelines, the Russian Ministry of Health rejected it on the grounds that the treatment schemes proposed contradicted the regulations of the Russian Pharmaceutical Committee. It therefore classified the DOTS-Plus pilot project as "experimental", which is forbidden within the penal system under national law.
The primary reasons given referred to Russian drug legislation that prohibits extended use of certain second-line drugs. Such legislation bears no relation to internationally recognised treatment principles on duration with potent drugs such as capreomycin, cycloserine, and fluoroquinolones. Further, the DOTS-Plus pilot project was blocked from using non-registered drugs such as amikacin and clofazimine.
To comply with the existing drug legislation, we were effectively being asked to implement a treatment strategy for multidrug-resistant tuberculosis that contradicts the basic treatment principles outlined by WHO, which must be followed if the programme is to provide a cure to these patients. As a result, MSF medical staff in Siberia felt that it was unethical to implement a treatment strategy that does not offer a cure. In September, 2003, MSF therefore made the difficult decision to pull field teams out of Siberia and to close down our programmes.
These issues have wider implications for control of multidrug-resistant tuberculosis in the Russian Federation. On Mar 21, 2003, the Russian Ministry of Health released its long-awaited legislative ordinance,