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Regulation of carcinogens in cigarettes
Tuberculosis in Russia
Authors’ reply
Sir—In his July 3 news item Nicholas Banatvala (p 56)1 draws attention to the difficulties of accurately reporting tuberculosis rates in Russia. He states that “The aim of the deal was to put a TB control programme in place that would, for the first time in Russia, include patients with multidrug resistant (MDR) TB”. In addition to Russian efforts to control MDR-TB, there is at least one other externally supported DOTS-Plus programme at an advanced stage of preparation: the Ivanovo region pilot in the civilian population, financed by the US Agency for International Development in Moscow, with technical assistance and supervision being provided by the US Centers for Disease Control and Prevention, and by WHO (available at http://www.cdc.gov/nchstp/tb/notes/ TBN_1_99/international.htm, accessed Sept 9, 1999). Banatvala’s statement with respect to the Indian-supplied drugs: “For most regions, these drugs will last only a few months . . .” is incorrect. The Russian Ministry of Health conducted a public tender for first-line TB drugs on May 7, 1999. The amount of the tender was the Indian Rupee equivalent of US$17 million. The amount of drugs acquired in the tender is sufficient to treat 100 000 new cases of uncomplicated TB in Russia per year for 3 years. The Russian health authorities have taken the first necessary step in procuring an adequate drug supply, and the challenge will be to ensure that these drugs are properly distributed and used. Finally, although the effort in Tomsk may be the longest-running foreign-assisted pilot programme in the civilian sector, there are at least 11 other pilot programmes under way or planned in Russia. With Russia’s size and the diversity of its regions, no single regional programme, whether in the civilian or prison sectors, is able to serve as a model for the entire country. Experience gained in all the regional programmes will form the input to the expected World Bank TB loan and future MDR-TB control efforts in Russia.
Sir—The USAID and Centers for Disease Control and Prevention plan to treat a small number of people with MDR-TB in Ivanovo, and the project of Médecins sans Frontières in Kemerovo, were included in the report submitted to The Lancet, but were omitted at the editor’s request for reasons of space. Perhaps we should have contested this decision. George Oswald and colleagues, however, raise important issues. With active cases of MDR-TB in Russia reaching about 50 000, and WHO’s adoption of the DOTS-Plus idea for demonstration projects, several local and foreign collaborations have arisen. Such projects, however, if improperly administered, may exacerbate rather than solve this public health problem. Poorly supervised DOTS-Plus projects could lead to MDR TB-Plus strains resistant to first-line and second-line drugs. For these reasons the notion that Russia’s size and diversity justifies regional variations in TB control merits qualifications. Too many variations might serve to confuse Russian physicians, government authories, and the public, leading to uncontrolled use of drugs, widespread non-compliance, and high default rates. The structure of health-care delivery throughout Russia is generally uniform. Regional programmes should follow well defined and controlled algorithms (allowing for variations in resistance patterns), irrespective of whether they are local or foreign-assisted pilot projects or part of larger government initiatives. Programmes should include standard guidelines ensuring cooperation of regional agencies, coordination with federally-run prisons, centralised region-wide management, strict adherence to treatment schemes, standard reporting and data management, quality control of laboratory diagnosis, and regulated distribution of drugs. Omission of any of these elements, lack of supporting infrastructure, or inadequate funding, could lead to failure. We stand by the characterisation of the European Union/Open Society Institute-Supported PHRI/MERLIN/ WHO project in Tomsk, as the first effort to address all these issues systematically. We urge investigators of pilot studies to submit their programmes for scrutiny by WHO, which has constituted a scientific panel to evaluate
*George R Oswald, Nikita Yu Afanasicv, J Peter Cegielski, Nancy J Binkin *US Agency for International Development, Novinsky Boulevard 19/23, 121099 Moscow, Russia; and Division of TB Elimination, E-10, Centers for Disease Control and Prevention, Atlanta, GA, USA 1
Banatvala N. Deal struck for Russians with tuberculosis. Lancet 1999; 353: 56.
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DOTS-Plus efforts, to safeguard against unintended consequences. We stand by our statement about inadequate drugs supply to regions. Our surveys show that because of the high costs and erratic drug supply, treatment of MDR-TB is currently with inadequate regimens of secondline drugs of uncertain quality. As for purchase of first-line drugs on the Indian debt, Indian workers report that certain commercial Indian combinations of rifampicin and isoniazid are not bioequivalent. 1 Colleagues in Latvia are concerned that their rates of MDR-TB may be due partly to large-scale use of poor quality Indian drugs in the past (Janis Leimans, Centre of TB and Lung Diseases of Latvia, personal communication). We applaud the Russian government for arranging this tender, but call for further study of the quality of drugs purchased. International bodies, such as the International Dispensary Association, can help to assess such formulations, since inadvertent underdosing is another threat to the programme’s success. The MDR-TB debate is healthy, but there is no room for complacency. *Nicholas Banatvala, Srdjan Matic, Michael Kimerling, Paul Farmer, Alex Goldfarb *Medical Emergency Relief International, 14 David Mews, London W1M 1HW, UK; Network Public Health Programmes,Open Society Institute, New York, NY, USA; University of Alabama, USA; Harvard Medical School and Partners in Health, Boston, MA; and Public Health Research Institute, Soros Russian TB Programme, New York, NY 1
Padgaonkar KA, Revankar SN, Bhatt AD, et al. Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers. Int J Tuberc Lung Dis 1999; 3: 627–31.
Regulation of carcinogens in cigarettes Sir—In a research letter to The Lancet 1 we proposed a system for regulation of carcinogens in cigarette smoke by setting upper limits on the basis of the market median. We illustrated this system with figures for Polish cigarettes. These figures were for tobacco content, not mainstream smoke, as we believed. The proposed system is valid for either. *Nigel Gray, Witold Zatonski, Peter Boyle *Division of Epidemiology and Biostatistics, European Institute of Oncology, 20141 Milano, Italy 1
Gray N, Boyle P, Zatonski W. Tar concentrations in cigarettes and carcinogen content. Lancet 1998; 352: 787–88.
THE LANCET • Vol 354 • September 18, 1999
Authors’ reply
Sir—In his July 3 news item Nicholas Banatvala (p 56)1 draws attention to the difficulties of accurately reporting tuberculosis rates in Russia. He states that “The aim of the deal was to put a TB control programme in place that would, for the first time in Russia, include patients with multidrug resistant (MDR) TB”. In addition to Russian efforts to control MDR-TB, there is at least one other externally supported DOTS-Plus programme at an advanced stage of preparation: the Ivanovo region pilot in the civilian population, financed by the US Agency for International Development in Moscow, with technical assistance and supervision being provided by the US Centers for Disease Control and Prevention, and by WHO (available at http://www.cdc.gov/nchstp/tb/notes/ TBN_1_99/international.htm, accessed Sept 9, 1999). Banatvala’s statement with respect to the Indian-supplied drugs: “For most regions, these drugs will last only a few months . . .” is incorrect. The Russian Ministry of Health conducted a public tender for first-line TB drugs on May 7, 1999. The amount of the tender was the Indian Rupee equivalent of US$17 million. The amount of drugs acquired in the tender is sufficient to treat 100 000 new cases of uncomplicated TB in Russia per year for 3 years. The Russian health authorities have taken the first necessary step in procuring an adequate drug supply, and the challenge will be to ensure that these drugs are properly distributed and used. Finally, although the effort in Tomsk may be the longest-running foreign-assisted pilot programme in the civilian sector, there are at least 11 other pilot programmes under way or planned in Russia. With Russia’s size and the diversity of its regions, no single regional programme, whether in the civilian or prison sectors, is able to serve as a model for the entire country. Experience gained in all the regional programmes will form the input to the expected World Bank TB loan and future MDR-TB control efforts in Russia.
Sir—The USAID and Centers for Disease Control and Prevention plan to treat a small number of people with MDR-TB in Ivanovo, and the project of Médecins sans Frontières in Kemerovo, were included in the report submitted to The Lancet, but were omitted at the editor’s request for reasons of space. Perhaps we should have contested this decision. George Oswald and colleagues, however, raise important issues. With active cases of MDR-TB in Russia reaching about 50 000, and WHO’s adoption of the DOTS-Plus idea for demonstration projects, several local and foreign collaborations have arisen. Such projects, however, if improperly administered, may exacerbate rather than solve this public health problem. Poorly supervised DOTS-Plus projects could lead to MDR TB-Plus strains resistant to first-line and second-line drugs. For these reasons the notion that Russia’s size and diversity justifies regional variations in TB control merits qualifications. Too many variations might serve to confuse Russian physicians, government authories, and the public, leading to uncontrolled use of drugs, widespread non-compliance, and high default rates. The structure of health-care delivery throughout Russia is generally uniform. Regional programmes should follow well defined and controlled algorithms (allowing for variations in resistance patterns), irrespective of whether they are local or foreign-assisted pilot projects or part of larger government initiatives. Programmes should include standard guidelines ensuring cooperation of regional agencies, coordination with federally-run prisons, centralised region-wide management, strict adherence to treatment schemes, standard reporting and data management, quality control of laboratory diagnosis, and regulated distribution of drugs. Omission of any of these elements, lack of supporting infrastructure, or inadequate funding, could lead to failure. We stand by the characterisation of the European Union/Open Society Institute-Supported PHRI/MERLIN/ WHO project in Tomsk, as the first effort to address all these issues systematically. We urge investigators of pilot studies to submit their programmes for scrutiny by WHO, which has constituted a scientific panel to evaluate
*George R Oswald, Nikita Yu Afanasicv, J Peter Cegielski, Nancy J Binkin *US Agency for International Development, Novinsky Boulevard 19/23, 121099 Moscow, Russia; and Division of TB Elimination, E-10, Centers for Disease Control and Prevention, Atlanta, GA, USA 1
Banatvala N. Deal struck for Russians with tuberculosis. Lancet 1999; 353: 56.
1036
DOTS-Plus efforts, to safeguard against unintended consequences. We stand by our statement about inadequate drugs supply to regions. Our surveys show that because of the high costs and erratic drug supply, treatment of MDR-TB is currently with inadequate regimens of secondline drugs of uncertain quality. As for purchase of first-line drugs on the Indian debt, Indian workers report that certain commercial Indian combinations of rifampicin and isoniazid are not bioequivalent. 1 Colleagues in Latvia are concerned that their rates of MDR-TB may be due partly to large-scale use of poor quality Indian drugs in the past (Janis Leimans, Centre of TB and Lung Diseases of Latvia, personal communication). We applaud the Russian government for arranging this tender, but call for further study of the quality of drugs purchased. International bodies, such as the International Dispensary Association, can help to assess such formulations, since inadvertent underdosing is another threat to the programme’s success. The MDR-TB debate is healthy, but there is no room for complacency. *Nicholas Banatvala, Srdjan Matic, Michael Kimerling, Paul Farmer, Alex Goldfarb *Medical Emergency Relief International, 14 David Mews, London W1M 1HW, UK; Network Public Health Programmes,Open Society Institute, New York, NY, USA; University of Alabama, USA; Harvard Medical School and Partners in Health, Boston, MA; and Public Health Research Institute, Soros Russian TB Programme, New York, NY 1
Padgaonkar KA, Revankar SN, Bhatt AD, et al. Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers. Int J Tuberc Lung Dis 1999; 3: 627–31.
Regulation of carcinogens in cigarettes Sir—In a research letter to The Lancet 1 we proposed a system for regulation of carcinogens in cigarette smoke by setting upper limits on the basis of the market median. We illustrated this system with figures for Polish cigarettes. These figures were for tobacco content, not mainstream smoke, as we believed. The proposed system is valid for either. *Nigel Gray, Witold Zatonski, Peter Boyle *Division of Epidemiology and Biostatistics, European Institute of Oncology, 20141 Milano, Italy 1
Gray N, Boyle P, Zatonski W. Tar concentrations in cigarettes and carcinogen content. Lancet 1998; 352: 787–88.
THE LANCET • Vol 354 • September 18, 1999