- Email: [email protected]
Prevention of cardiovascular disease in developing countries
Comment
in the same ear. The benefits of preserved residual low-frequency acoustic hearing include improved word understanding in the presence of background noise and the preservation of musical perception.7,10 These benefits are largely due to the ability of patients to distinguish fine differences in pitch as a result of preserved residual low-frequency acoustic hearing.7,10 As selection criteria for cochlear implantation continue to expand, it will become increasingly important to preserve residual low-frequency hearing to improve the perception of speech in noisy environments and to provide patients with a better musical appreciation. *Benjamin Wei, Stephen O’Leary, Richard Dowell The Bionic Ear Institute, Melbourne East, Victoria 3002, Australia; and Department of Otolaryngology, University of Melbourne, Melbourne, Victoria, Australia [email protected] We declare that we have no conflict of interest.
Science Photo Library
1
2 3 Cochlear implant surgery 4
patients has been reported in a multicentre FDA clinical trial of the new hybrid 10 mm implant.7 Furthermore, some residual hearing can also be preserved in up to 70% of patients implanted with the standard full-length cochlear implant using an atraumatic “soft” surgical technique.8,9 However, continued progression of hearing loss after surgery remains a major unresolved issue. Irrespective of the implant design, recipients with preserved low-frequency residual acoustic hearing may benefit from combined electric and acoustic stimulation
5 6 7
8
9
10
NIDCD, National Institute of Deafness and other communication disorders. Cochlear implant. Oct 5, 2006. http://www.nidcd.nih.gov/health/hearing/ coch.htm (accessed April 19, 2007). van Hoesel RJ, Tyler RS. Speech perception, localization, and lateralization with bilateral cochlear implants. J Acoust Soc Am 2003; 113: 1617–30. Ricketts TA, Grantham DW, Ashmead DH, Haynes DS, Labadie RF. Speech recognition for unilateral and bilateral cochlear implant modes in the presence of uncorrelated noise sources. Ear Hear 2006; 27: 763–73. Litovsky RY, Johnstone PM, Godar SP. Benefits of bilateral cochlear implants and/or hearing aids in children. Int J Audiol 2006; 45 (suppl 1): S78–91. Long CJ, Carlyon RP, Litovsky RY, Downs DH. Binaural unmasking with bilateral cochlear implants. J Assoc Res Otolaryngol 2006; 7: 352–60. Neuman AC, Haravon A, Sislian N, Waltzman SB. Sound-direction identification with bilateral cochlear implants. Ear Hear 2007; 28: 73–82. Gantz BJ, Turner C, Gfeller KE. Acoustic plus electric speech processing: preliminary results of a multicenter clinical trial of the Iowa/Nucleus Hybrid implant. Audiol Neurootol 2006; 11 (suppl 1): 63–68. James CJ, Fraysse B, Deguine O, et al. Combined electroacoustic stimulation in conventional candidates for cochlear implantation. Audiol Neurootol 2006; 11 (suppl 1): 57–62. Gstoettner WK, Helbig S, Maier N, Kiefer J, Radeloff A, Adunka OF. Ipsilateral electric acoustic stimulation of the auditory system: results of long-term hearing preservation. Audiol Neurootol 2006; 11 (suppl 1): 49–56. Gfeller KE, Olszewski C, Turner C, Gantz B, Oleson J. Music perception with cochlear implants and residual hearing. Audiol Neurootol 2006; 11 (suppl 1): 12–15.
Prevention of cardiovascular disease in developing countries Cardiovascular disease is the main cause of disability and premature death worldwide,1 and is projected to remain the leading cause of death. An estimated 17·5 million people died from this disease in 2005, representing 30% of all global deaths. Of these deaths, 7·6 million were because of coronary heart disease and 5·7 million because of stroke. If appropriate action is not taken, by 2015 an estimated 20 million people will die from cardiovascular disease, 720
mainly from heart disease and stroke.2 Hence, this disease greatly contributes to the rising costs of health care in the world. It is a major public-health challenge, especially for low-income and middle-income countries, where 80% of these deaths occur and where there are competing health priorities and few resources for health care. WHO has released cardiovascular risk prediction charts for all WHO regions that will help low-income and middle-income www.thelancet.com Vol 370 September 1, 2007
Comment
www.thelancet.com Vol 370 September 1, 2007
Men Risk level <10% 10–<20% 20–<30% 30–<40% ≥40%
Women Smoker
Non-smoker
Non-smoker
SBP (mm Hg)
Smoker
70
180 160 140 120
60
180 160 140 120
50
180 160 140 120
40
180 160 140 120
Age (years)
countries to manage the burden of cardiovascular disease effectively by targeting limited health-care resources at people who are at high risk of cardiovascular disease. High blood pressure, glucose, and cholesterol, as well as high body-mass index, can be manifestations of unhealthy behaviours and major risk factors that determine cardiovascular risk. For successful prevention and control of cardiovascular disease the present distribution of risk factors within the population should be reduced. A combination of population-based strategies and strategies that focus on individuals are essential to achieve this objective.1,3 The underlying abnormality in coronary heart disease and cerebrovascular disease is atherosclerosis, which develops over many years, and it is usually advanced by the time symptoms become manifest. Acute life-threatening events such as heart attacks and strokes occur in middle age as well as in later stages of life. These events frequently happen suddenly and are often fatal. Modification of risk factors reduces mortality and morbidity in people with diagnosed or undiagnosed cardiovascular disease. Health systems in low-income and middle-income countries are unable to use resource-intensive risk-prediction interventions, especially in primary health care. In 2001, WHO released a cardiovascular risk management package containing simple algorithms for management of cardiovascular risk with hypertension as entry point, which has been subsequently validated in primary health care in low-income and middle-income countries.4,5 Apart from this strategy, to the best of our knowledge, there have been no cardiovascular risk prediction systems until now that are not only applicable worldwide but are also specifically applicable for different populations in low-income countries. The cardiovascular risk prediction charts,6 developed in collaboration with the International Society of Hypertension (ISH),6,7 enable the risk of heart attacks and strokes to be predicted, even in settings that do not have sophisticated technology (figure). Collaborations between WHO and ISH are in progress to validate this approach against other methods, such as those that rely on the Framingham Heart Study risk prediction equations.8 The new WHO guidelines provide recommendations for reducing disability and premature deaths from coronary heart disease, cerebrovascular disease, and peripheral vascular disease in high-risk people who have not yet
4
5
6
7
8
4
5
6 7 8 4 5 6 7 Total cholesterol (mmol/L)
8
4
5
6
7
8
Figure: A sample of a WHO/ISH risk prediction chart (South East Asia subregion D) for use in settings in which blood cholesterol can be measured 10-year risk of a fatal or non-fatal cardiovascular event by sex, age, systolic blood pressure, total blood cholesterol, and smoking status for people without diabetes mellitus. SBP=systolic blood pressure.6
had a cardiovascular event.4 People with established cardiovascular disease are at very high risk of recurrent events and are not the subject of these guidelines, but they have been addressed in previous WHO guidelines.9 Several forms of treatment can prevent coronary, cerebral, and peripheral vascular events. Decisions about whether to start specific preventive action, and with what degree of intensity, should be guided by estimation of the risk of any such vascular event. The risk prediction charts6 allow treatment to be targeted according to simple predictions of absolute cardiovascular risk for the populations of different WHO-defined regions. Recommendations are made for the management of major cardiovascular risk factors through changes in behaviour related to diet, physical activity, tobacco use, and drug treatments. The guidelines provide a framework for the development of national guidance on prevention of cardiovascular disease that consider political, economic, social, and medical circumstances.5,6 Population-wide strategies, such as tobacco control and promotion of a healthy diet and physical activity, need to be implemented by reduction of dietary salt through voluntary agreements with food industry, mass education, and other appropiate measures. These strategies are cost effective in all countries.1,7 A shift from management of single risk factors to total cardiovascular risk prediction and management will 721
Comment
enable restricted health-care resources to be targeted to individuals who are most in need and most likely to benefit. Hence, taking the absolute-risk approach for prevention of cardiovascular disease through the new WHO/ISH cardiovascular risk-prediction charts and the WHO guidelines for primary prevention of cardiovascular disease is an important step forward for cost-effective management of the burden of cardiovascular disease in low-income and middle-income countries.
1 2 3 4 5
6
7
*Lars H Lindholm, Shanthi Mendis Department of Public Health and Clinical Medicine, Umeå University, SE 901 85 Umeå, Sweden (LHL); and World Health Organization, Geneva, Switzerland (SM) [email protected] LHL and SM have contributed to the writing of the WHO guidelines.3 LHL is the President of the International Society of Hypertension for 2006–08 and has received speakers’ honoraria from the drug industry. SM declares no conflict of interest.
8
9
WHO. World Health Report 2002: reducing risks, promoting healthy life. Geneva: World Health Organization, 2002. WHO. Preventing chronic diseases a vital investment. Geneva : World Health Organization, 2005. WHO. Cardiovascular disease prevention and control: translating evidence into action. Geneva: World Health Organization, 2005. WHO. Integrated management of cardiovascular risk. Geneva: World Health Organization, 2001. Abegunde D, Shengalia B, Luyten A, et al. Can non physician health-care workers assess and manage cardiovascular risk in primary care? Bull World Health Organ 2007; 85: 432–40. WHO. Prevention of Cardiovascular Disease. Guidelines for assessment and management of total cardiovascular risk. Geneva: World Health Organization, 2007. Mendis S, Lindholm LH, Mancia G, et al. World Health Organization (WHO) and International Society of Hypertension (ISH) risk prediction charts: assessment of cardiovascular risk for prevention and control of cardiovascular disease in low and middle-income countries. J Hypertens 2007; 25: 1578–82. D’Agostino RB, Grundy S, Sullivan LM, Wilson P. CHD Risk Prediction Group. Validation of the Framingham coronary heart disease prediction scores: results of a multiple ethnic groups investigation. JAMA 2001; 286: 180–87. WHO. Prevention of recurrent heart attacks and strokes in low and middle income populations. Evidence-based recommendations for policy makers and health professionals. Geneva: World Health Organization, 2003.
The African private sector steps in to fill the drug gap Published Online July 20, 2007 DOI:10.1016/S01406736(07)61094-0
In April, 2007, Canada’s Access to Medicines Regime (CAMR) was reviewed.1 The goal was to assess the contribution the system has made to the AIDS crisis. In 2005, the legislation designed to improve access through the export of generic drugs from Canada came into force. Despite lofty aspirations, CAMR has yet to see a single pill exported to countries in need. Citing cumbersome hurdles, Canadian manufacturers have been slow to get behind the effort.1 Only one company,
Corbis
The printed journal includes an image merely for illustration
722
Apotex Inc, has made any serious attempt to engage with CAMR, by producing a triple-fixed-dose pill.2 However, as of May, 2007, efforts to get the drug to those who need it seem to have been fruitless, with neither a voluntary nor a compulsory licence for export on the horizon.2 Meanwhile, over the past year in Ghana, DanAdams, a Ghanaian generic manufacturer, has been quietly producing antiretroviral drugs for distribution throughout the country. The Government of Ghana has placed several orders for first-line antiretrovirals from the manufacturer. DanAdams has developed the same generic triple-fixed dose as Apotex and is awaiting approval from Ghana’s regulatory authority. If DanAdams could afford the bioequivalence tests to obtain WHO approval, it could be supplying even more of the country’s drug needs at prices on a par with or lower than those from India. Monies from the Global Fund to Fight AIDS, Tuberculosis and Malaria can only be used to purchase from companies with WHO prequalification3 or approval from one of the qualifying national regulators (almost exclusively from developed nations).4 Although quality assurances are important for antiretrovirals, obtaining WHO approval is expensive and daunting for burgeoning manufacturers. By linking Fund money to WHO approval, a monopoly has been created, ensuring that only well established manufacturers, such www.thelancet.com Vol 370 September 1, 2007
in the same ear. The benefits of preserved residual low-frequency acoustic hearing include improved word understanding in the presence of background noise and the preservation of musical perception.7,10 These benefits are largely due to the ability of patients to distinguish fine differences in pitch as a result of preserved residual low-frequency acoustic hearing.7,10 As selection criteria for cochlear implantation continue to expand, it will become increasingly important to preserve residual low-frequency hearing to improve the perception of speech in noisy environments and to provide patients with a better musical appreciation. *Benjamin Wei, Stephen O’Leary, Richard Dowell The Bionic Ear Institute, Melbourne East, Victoria 3002, Australia; and Department of Otolaryngology, University of Melbourne, Melbourne, Victoria, Australia [email protected] We declare that we have no conflict of interest.
Science Photo Library
1
2 3 Cochlear implant surgery 4
patients has been reported in a multicentre FDA clinical trial of the new hybrid 10 mm implant.7 Furthermore, some residual hearing can also be preserved in up to 70% of patients implanted with the standard full-length cochlear implant using an atraumatic “soft” surgical technique.8,9 However, continued progression of hearing loss after surgery remains a major unresolved issue. Irrespective of the implant design, recipients with preserved low-frequency residual acoustic hearing may benefit from combined electric and acoustic stimulation
5 6 7
8
9
10
NIDCD, National Institute of Deafness and other communication disorders. Cochlear implant. Oct 5, 2006. http://www.nidcd.nih.gov/health/hearing/ coch.htm (accessed April 19, 2007). van Hoesel RJ, Tyler RS. Speech perception, localization, and lateralization with bilateral cochlear implants. J Acoust Soc Am 2003; 113: 1617–30. Ricketts TA, Grantham DW, Ashmead DH, Haynes DS, Labadie RF. Speech recognition for unilateral and bilateral cochlear implant modes in the presence of uncorrelated noise sources. Ear Hear 2006; 27: 763–73. Litovsky RY, Johnstone PM, Godar SP. Benefits of bilateral cochlear implants and/or hearing aids in children. Int J Audiol 2006; 45 (suppl 1): S78–91. Long CJ, Carlyon RP, Litovsky RY, Downs DH. Binaural unmasking with bilateral cochlear implants. J Assoc Res Otolaryngol 2006; 7: 352–60. Neuman AC, Haravon A, Sislian N, Waltzman SB. Sound-direction identification with bilateral cochlear implants. Ear Hear 2007; 28: 73–82. Gantz BJ, Turner C, Gfeller KE. Acoustic plus electric speech processing: preliminary results of a multicenter clinical trial of the Iowa/Nucleus Hybrid implant. Audiol Neurootol 2006; 11 (suppl 1): 63–68. James CJ, Fraysse B, Deguine O, et al. Combined electroacoustic stimulation in conventional candidates for cochlear implantation. Audiol Neurootol 2006; 11 (suppl 1): 57–62. Gstoettner WK, Helbig S, Maier N, Kiefer J, Radeloff A, Adunka OF. Ipsilateral electric acoustic stimulation of the auditory system: results of long-term hearing preservation. Audiol Neurootol 2006; 11 (suppl 1): 49–56. Gfeller KE, Olszewski C, Turner C, Gantz B, Oleson J. Music perception with cochlear implants and residual hearing. Audiol Neurootol 2006; 11 (suppl 1): 12–15.
Prevention of cardiovascular disease in developing countries Cardiovascular disease is the main cause of disability and premature death worldwide,1 and is projected to remain the leading cause of death. An estimated 17·5 million people died from this disease in 2005, representing 30% of all global deaths. Of these deaths, 7·6 million were because of coronary heart disease and 5·7 million because of stroke. If appropriate action is not taken, by 2015 an estimated 20 million people will die from cardiovascular disease, 720
mainly from heart disease and stroke.2 Hence, this disease greatly contributes to the rising costs of health care in the world. It is a major public-health challenge, especially for low-income and middle-income countries, where 80% of these deaths occur and where there are competing health priorities and few resources for health care. WHO has released cardiovascular risk prediction charts for all WHO regions that will help low-income and middle-income www.thelancet.com Vol 370 September 1, 2007
Comment
www.thelancet.com Vol 370 September 1, 2007
Men Risk level <10% 10–<20% 20–<30% 30–<40% ≥40%
Women Smoker
Non-smoker
Non-smoker
SBP (mm Hg)
Smoker
70
180 160 140 120
60
180 160 140 120
50
180 160 140 120
40
180 160 140 120
Age (years)
countries to manage the burden of cardiovascular disease effectively by targeting limited health-care resources at people who are at high risk of cardiovascular disease. High blood pressure, glucose, and cholesterol, as well as high body-mass index, can be manifestations of unhealthy behaviours and major risk factors that determine cardiovascular risk. For successful prevention and control of cardiovascular disease the present distribution of risk factors within the population should be reduced. A combination of population-based strategies and strategies that focus on individuals are essential to achieve this objective.1,3 The underlying abnormality in coronary heart disease and cerebrovascular disease is atherosclerosis, which develops over many years, and it is usually advanced by the time symptoms become manifest. Acute life-threatening events such as heart attacks and strokes occur in middle age as well as in later stages of life. These events frequently happen suddenly and are often fatal. Modification of risk factors reduces mortality and morbidity in people with diagnosed or undiagnosed cardiovascular disease. Health systems in low-income and middle-income countries are unable to use resource-intensive risk-prediction interventions, especially in primary health care. In 2001, WHO released a cardiovascular risk management package containing simple algorithms for management of cardiovascular risk with hypertension as entry point, which has been subsequently validated in primary health care in low-income and middle-income countries.4,5 Apart from this strategy, to the best of our knowledge, there have been no cardiovascular risk prediction systems until now that are not only applicable worldwide but are also specifically applicable for different populations in low-income countries. The cardiovascular risk prediction charts,6 developed in collaboration with the International Society of Hypertension (ISH),6,7 enable the risk of heart attacks and strokes to be predicted, even in settings that do not have sophisticated technology (figure). Collaborations between WHO and ISH are in progress to validate this approach against other methods, such as those that rely on the Framingham Heart Study risk prediction equations.8 The new WHO guidelines provide recommendations for reducing disability and premature deaths from coronary heart disease, cerebrovascular disease, and peripheral vascular disease in high-risk people who have not yet
4
5
6
7
8
4
5
6 7 8 4 5 6 7 Total cholesterol (mmol/L)
8
4
5
6
7
8
Figure: A sample of a WHO/ISH risk prediction chart (South East Asia subregion D) for use in settings in which blood cholesterol can be measured 10-year risk of a fatal or non-fatal cardiovascular event by sex, age, systolic blood pressure, total blood cholesterol, and smoking status for people without diabetes mellitus. SBP=systolic blood pressure.6
had a cardiovascular event.4 People with established cardiovascular disease are at very high risk of recurrent events and are not the subject of these guidelines, but they have been addressed in previous WHO guidelines.9 Several forms of treatment can prevent coronary, cerebral, and peripheral vascular events. Decisions about whether to start specific preventive action, and with what degree of intensity, should be guided by estimation of the risk of any such vascular event. The risk prediction charts6 allow treatment to be targeted according to simple predictions of absolute cardiovascular risk for the populations of different WHO-defined regions. Recommendations are made for the management of major cardiovascular risk factors through changes in behaviour related to diet, physical activity, tobacco use, and drug treatments. The guidelines provide a framework for the development of national guidance on prevention of cardiovascular disease that consider political, economic, social, and medical circumstances.5,6 Population-wide strategies, such as tobacco control and promotion of a healthy diet and physical activity, need to be implemented by reduction of dietary salt through voluntary agreements with food industry, mass education, and other appropiate measures. These strategies are cost effective in all countries.1,7 A shift from management of single risk factors to total cardiovascular risk prediction and management will 721
Comment
enable restricted health-care resources to be targeted to individuals who are most in need and most likely to benefit. Hence, taking the absolute-risk approach for prevention of cardiovascular disease through the new WHO/ISH cardiovascular risk-prediction charts and the WHO guidelines for primary prevention of cardiovascular disease is an important step forward for cost-effective management of the burden of cardiovascular disease in low-income and middle-income countries.
1 2 3 4 5
6
7
*Lars H Lindholm, Shanthi Mendis Department of Public Health and Clinical Medicine, Umeå University, SE 901 85 Umeå, Sweden (LHL); and World Health Organization, Geneva, Switzerland (SM) [email protected] LHL and SM have contributed to the writing of the WHO guidelines.3 LHL is the President of the International Society of Hypertension for 2006–08 and has received speakers’ honoraria from the drug industry. SM declares no conflict of interest.
8
9
WHO. World Health Report 2002: reducing risks, promoting healthy life. Geneva: World Health Organization, 2002. WHO. Preventing chronic diseases a vital investment. Geneva : World Health Organization, 2005. WHO. Cardiovascular disease prevention and control: translating evidence into action. Geneva: World Health Organization, 2005. WHO. Integrated management of cardiovascular risk. Geneva: World Health Organization, 2001. Abegunde D, Shengalia B, Luyten A, et al. Can non physician health-care workers assess and manage cardiovascular risk in primary care? Bull World Health Organ 2007; 85: 432–40. WHO. Prevention of Cardiovascular Disease. Guidelines for assessment and management of total cardiovascular risk. Geneva: World Health Organization, 2007. Mendis S, Lindholm LH, Mancia G, et al. World Health Organization (WHO) and International Society of Hypertension (ISH) risk prediction charts: assessment of cardiovascular risk for prevention and control of cardiovascular disease in low and middle-income countries. J Hypertens 2007; 25: 1578–82. D’Agostino RB, Grundy S, Sullivan LM, Wilson P. CHD Risk Prediction Group. Validation of the Framingham coronary heart disease prediction scores: results of a multiple ethnic groups investigation. JAMA 2001; 286: 180–87. WHO. Prevention of recurrent heart attacks and strokes in low and middle income populations. Evidence-based recommendations for policy makers and health professionals. Geneva: World Health Organization, 2003.
The African private sector steps in to fill the drug gap Published Online July 20, 2007 DOI:10.1016/S01406736(07)61094-0
In April, 2007, Canada’s Access to Medicines Regime (CAMR) was reviewed.1 The goal was to assess the contribution the system has made to the AIDS crisis. In 2005, the legislation designed to improve access through the export of generic drugs from Canada came into force. Despite lofty aspirations, CAMR has yet to see a single pill exported to countries in need. Citing cumbersome hurdles, Canadian manufacturers have been slow to get behind the effort.1 Only one company,
Corbis
The printed journal includes an image merely for illustration
722
Apotex Inc, has made any serious attempt to engage with CAMR, by producing a triple-fixed-dose pill.2 However, as of May, 2007, efforts to get the drug to those who need it seem to have been fruitless, with neither a voluntary nor a compulsory licence for export on the horizon.2 Meanwhile, over the past year in Ghana, DanAdams, a Ghanaian generic manufacturer, has been quietly producing antiretroviral drugs for distribution throughout the country. The Government of Ghana has placed several orders for first-line antiretrovirals from the manufacturer. DanAdams has developed the same generic triple-fixed dose as Apotex and is awaiting approval from Ghana’s regulatory authority. If DanAdams could afford the bioequivalence tests to obtain WHO approval, it could be supplying even more of the country’s drug needs at prices on a par with or lower than those from India. Monies from the Global Fund to Fight AIDS, Tuberculosis and Malaria can only be used to purchase from companies with WHO prequalification3 or approval from one of the qualifying national regulators (almost exclusively from developed nations).4 Although quality assurances are important for antiretrovirals, obtaining WHO approval is expensive and daunting for burgeoning manufacturers. By linking Fund money to WHO approval, a monopoly has been created, ensuring that only well established manufacturers, such www.thelancet.com Vol 370 September 1, 2007