Treatment of multidrug-resistant tuberculosis in Russian prisons
This letter first appeared in The Lancet.
Sir - Ben Aris (Lancet, Nov 8, p 1557)1 highlights important shortfalls in the Russian public-health system and its devastating effect on health. Predetention facilities and penal colonies are breeding grounds for diseases such as tuberculosis, and contribute a third of all new tuberculosis cases in Russia each year.2
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,3 which provides Russian doctors with protocols for the detection and treatment of tuberculosis and multidrug-resistant tuberculosis. These new protocols, approved by WHO, should mean that control of this disease throughout Russia now incorporates internationally recognised standards--a necessary prerequisite for a promised World Bank loan of more than US$100 million for treatment and prevention of tuberculosis. We now know that, at least for multidrug-resistant tuberculosis, these standards are not being met. We also know that second-line drugs are currently used in many Russian regions for more than one year without clear guidelines, appropriate infrastructure, trained personnel, and with non-existent follow-up for released patients under treatment. All these mean an increased risk of creating super-resistant tuberculosis. Urgent action needs to be taken by WHO and the World Bank to rectify the inconsistencies between the Ministry of Health's ordinance and the drug legislative authorities in Russia. Future control of tuberculosis in Russia is in the balance, and the donor community runs a high risk of doing more harm than good.
Médecins Sans Frontières, 3 Shmitovskyi Proezd, Building 3, Moscow 123100, Russia
- 1 - Aris B. Russia's health crisis fuels 20-year cut in lifespan estimates. Lancet 2003; 362: 1557.
- 2 - Shilova MV. TB in Russia in year 2000. Moscow: Ministry of Health, 2001.
- 3 - Ministry of Health of the Russian Federation. Ordinance (Prikaz) Number 109. On improvement of anti-tuberculosis activities in the Russian Federation. Moscow: Ministry of Health, 2003.