- Email: [email protected]
NICE's citizen's council: what do we ask them, and how?
CORRESPONDENCE
SARS, AIDS, and the threat of bioterrorism dominate headlines. In Canada, our new Coalition for Global Health Research and the four federal funding agencies are working to capitalise on this political awakening. VN is coordinator for the Coalition of Global Health Research (Canada).
*Jerry Spiegel, Ronald Labonte, Janet Hatcher-Roberts, Jacques Girard, Vic Neufeld, on behalf of the Coalition for Global Health Research (Canada) *Liu Institute for Global Issues, University of British Columbia, Vancouver, British Columbia V6T 1Z2, Canada (JS); Saskatchewan Public Health Evaluation and Research Unit, University of Saskatchewan, Saskatoon, Canada (RL); Canadian Society for International Health, Ottawa, Canada (JH-R); Department of Social and Preventive Medicine, Laval University, Quebec, Canada (JG); Coalition for Global Health Research (Canada), Hamilton, Canada (VN) (e-mail: [email protected]) 1
2
3
4
Evans JR. Essential national health research: a key to equity in development. N Engl J Med 1990; 323: 913–15. Global Forum for Health Research. The 10/90 report on health research 2001–2002. http://www.globalforumhealth.org/pages/ind ex.asp (accessed Aug 22, 2003). Neufeld V, MacLeod S, Tugwell P, Zakus D, Zarowsky C. The rich–poor gap in global health research: challenges for Canada. CMAJ 2001; 164: 1158–59. Labonte R, Spiegel J. Setting global health research priorities. BMJ 2003; 326: 722–23.
WHO’s 3-by-5 target Sir—We have heard much about WHO’s 3-by-5 target—to get 3 million people in developing countries on antiretrovirals by 2005. This target presents a huge challenge, as your July 19 Editorial (p 179)1 rightly points out. The attendant requirements are no less daunting. At the end of 2002, UNAIDS estimated there were 42 million people infected with HIV worldwide. Of the 5–6 million people living with AIDS who need antiretrovirals, fewer than 300 000 in the developing world—and only about 40 000 in Africa—receive
them. There are supply-side efforts underway to tackle the financing, laboratory capacity, and training of staff that are needed to close this gap. We are concerned, however, about the demand for antiretrovirals that must be created to succeed. To identify HIV-positive people in need of antiretrovirals, increased efforts are needed to promote HIV education and awareness, so that more people come forward for voluntary counselling and testing. Underpinning all of these efforts will be a reduction in stigma and discrimination so that people are prepared to access HIV services. The table2–4 shows our rough calculations for the inputs that will be needed to reach the 3 million target. We have used statistics relevant to the most heavily affected region, subSaharan Africa, although other lowerprevalence regions may have better health infrastructure to implement interventions more rapidly. Our estimates only refer to interventions that lead to start of therapy, not to those needed for maintenance. We have done this rough calculation because there is a dearth of published experience about the large-scale effectiveness of interventions that move people through a process from awareness to action—ie, for services to be in demand (WHO aims to ensure rates of 60% and 90% for accessibility of voluntary counselling and HIV testing and for AIDS education and services for youths by 2005).4 Our analysis underlines three important points. First, that treatment must be seen as a pull-through mechanism for prevention, and cannot be considered in isolation. Second, that to increase their efficiency, efforts should be targeted in terms of geographical profiles of HIV prevalence, clinical-risk groups (eg, patients with tuberculosis or sexually transmitted infection), and high-risk or priority populations. Last, that such a large-scale operation depends on full engagement of all members of society
Assumptions Proportion of population reached by awareness campaigns (A)* Proportion of population reached by awareness campaigns who seek counselling and testing (B)† Proportion of population tested who are HIV positive (C)‡ Proportion of population with HIV who need antiretrovirals (D)§ Implications Number who must be reached, counselled, tested, and able to access antiretrovirals (2·96 million [3 million–40 000]/BxCxD) Target population for awareness campaigns (2·96 million [3 million–40 000]/AxBxCxD) Number in target population who must be reached, counselled, tested, and able to access antiretrovirals per person put on antiretrovirals
from government to civil society and the private sector. Business and faithbased organisations are important in this respect, since they have experience in mass mobilisation and in developing messages that evoke action. But to get businesses involved, better numbers leading to clearer targets will be needed. We thank Catherine Hankins and Neff Walker from UNAIDS for their input during the preparation of this letter.
*Kate Taylor, Peter DeYoung Global Health Initiative, World Economic Forum, CH-1223 Cologny, Geneva, Switzerland (e-mail: [email protected]) 1
2
3
4
Editorial. WHO 2003–08: a programme of quiet thunder takes shape. Lancet 2003; 362: 179. WHO Global HIV Prevention Working Group. Global and African averages, quoting UNAIDS figures. In: Access to HIV prevention: closing the gap. Geneva: World Health Organization, May, 2003. UNAIDS Report on the Global HIV/AIDS Epidemic 2002. Geneva: Joint United Nations Programme on HIV/AIDS, December, 2002. WHO. Leading the health sector response to HIV/AIDS. Geneva: World Health Organization, May, 2003.
NICE’s citizen’s council: what do we ask them, and how? Sir—The UK’s National Institute of Clinical Excellence (NICE) recognises that its decisions have two components —technical facts and values. Technical experts are used to address the former (such issues as the cost-effectiveness of a given technology), whereas citizens are called upon to advise about the latter (the set of social value judgments that are used to show how the costeffectiveness threshold might vary according to certain patients’ characteristics, such as age). We have been engaged in seeking the public’s preferences on issues of distributional and procedural justice in Low effectiveness
High effectiveness
24% 8% 9% 14%
42% 36% 18% 20%
2·9 billion
228 million
12·2 billion 4134
544 million 184
*Global and African averages, quoting UNAIDS figures.2 †Based on average proportion of women aged 15–49 years who know where to get an HIV test and have been tested. Data from the Multi-Indicator Cluster Survey.3 ‡Average and twice-average African prevalence, assuming all who are tested return for results, which is rarely the case. §Assuming an average duration of disease of 8 or 5 years.
Interventions needed to reach WHO’s 3-by-5 target
918
THE LANCET • Vol 362 • September 13, 2003 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet publishing Group.
CORRESPONDENCE
the allocation of health-care resources, and believe that input from lay people is an important part of such decisionmaking. We, therefore, support the use of NICE’s citizen’s council, which gives the public the opportunity to consider their responses to unfamiliar and complex decisions, and thereby increases the legitimacy of those responses.1 However, we have doubts about the types of questions that have been put to NICE’s citizen’s council so far. The questions put to the council should be clear and focused if we are to keep ambiguities to a minimum. Consider the two questions that the council have addressed so far. The first question, discussed in the meeting in January, 2003, reads: “What should NICE take into account when making decisions about clinical need?” This is an odd question, since what constitutes “clinical need” should be a technical matter to be settled elsewhere. For example, we do not need advice from a citizen’s council to tell us that influenza is often more severe in those with preexisting disease than in otherwise healthy adults. A more appropriate question for the council would be what other considerations beyond clinical matters should be taken into account when assessing the outcomes of interventions. The failure to distinguish between the technical issues and values means little useful information emerged from the council’s discussions on this issue. The second question, addressed in May, 2003, which will be discussed further at the November, 2003, meeting, reads: “Are there circumstances in which the age of a person should be taken into account when NICE is making a decision about how treatments should be used in the National Health Service?” Again, this is an odd question because there are many clinical arguments for treating patients differently by age, so it seems that an answer of “‘no” would be quite absurd. In our view, one of the council’s supplementary questions gets much closer to the kind of question that it should deliberate: “Should NICE value a year of an individual’s life differently depending on their age?” But to get useful data from the deliberations about this question, it is vital that the council are forced to discuss the question that is put to them. In the context of this question, it means that bringing in considerations about life expectancy (which it seems some council members did when answering this question) is inappropriate—and the members should be told as much.
So, if the citizen’s council is to provide social value judgments, it must: first, consider focused issues of social value, and, second, be given guidance about what things are, and are not, relevant to answering those questions. Much time and money has gone into setting up and running the council. If its members are asked to consider ambiguous questions and allowed to shy away from actually answering the questions posed, then this resource will be wasted. Paul Dolan, *Aki Tsuchiya, Allan Wailoo School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK (e-mail: [email protected]) 1
Dolan P, Cookson R, Ferguson B. Effect of discussion and deliberation on the public’s views of priority setting in health care: focus group study. BMJ 1999; 318: 916–19.
Heart failure: treatment and ethnic origin Sir—We enjoyed Henry Krum and Richard Gilbert’s Review (July 12, p 147),1 but question whether metformin should be contraindicated in patients with chronic heart failure, as stated. Metformin is a commonly used antihyperglycaemic agent, which improves insulin sensitivity, decreases hepatic glucose production, and slightly reduces intestinal absorption of glucose. It is used with increasing frequency, especially in obese patients with type 2 diabetes, in whom it reduces cardiovascular mortality and morbidity compared with insulin, sulphonylureas, or diet alone.2 Type 2 diabetes, obesity, and insulin resistance are often seen in patients with chronic heart failure. Metformin promotes weight loss and has beneficial effects on several other cardiovascular risk factors, including dyslipidaemia, hypertension, raised plasminogen activator inhibitor 1 concentrations, and hyperinsulinaemia. Additionally, insulin sensitising agents such as metformin may improve peripheral blood flow,3 which could potentially lead to symptomatic benefit in patients with heart failure. Lactic acidosis is a rare, but serious complication that has been associated with metformin treatment in several case reports. The condition is characterised by raised blood lactate concentrations (>5 mmol/L), acidosis (pH <7·35), an increased anion gap, and electrolyte disturbances. Biguanides are thought to decrease gluconeogenesis from alanine, pyruvate, and lactate, so that concentrations of lactic acid might
THE LANCET • Vol 362 • September 13, 2003 • www.thelancet.com
increase under certain circumstances. The incidence of lactic acidosis in patients on metformin has been estimated from population studies to be two to nine cases per 100 000 patient-years.4 However, reported cases have arisen primarily in patients with serious renal dysfunction or circulatory shock that could have caused lactic acidosis themselves. Phenformin, another biguanide, was withdrawn from the US market in 1977, since it was associated with a much higher rate of lactic acidosis (40–64 cases per 100 000 patient-years). Phenformin has a different chemical structure to metformin and can impair oxidative phosphorylation in the liver, thereby increasing lactate production by anaerobic pathways. By contrast, metformin inhibits hepatic gluconeogenesis without altering lactate turnover or lactate oxidation. A Cochrane review4 did not show any raised risk of lactic acidosis in patients treated with metformin compared with other antihyperglycaemic treatments. The report also stated that in clinical practice, standard contraindications to metformin are largely disregarded, with 54–73% of patients having at least one contraindication to treatment. We agree that metformin should be avoided or discontinued in patients with decompensated or unstable heart failure, who are at risk of hypoxia and hypoperfusion. Continuation of treatment in patients with diabetes with stable chronic heart failure and normal renal function, in whom the drug could have potential benefits, would seem reasonable however. *Daniel B McKenzie, Robert G Wilcox Department of Cardiovascular Medicine, Queen’s Medical Centre, Nottingham NG7 2UH, UK (e-mail: [email protected]) 1
2
3
4
Krum H, Gilbert RE. Demographics and concomitant disorders in heart failure. Lancet 2003; 362: 147–58. UKPDS Group. Effect of intensive bloodglucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854–65. Jansson P-AE, Andersson OK, Gudbjornsdottir HS, et al. The effect of metformin on adipose tissue metabolism and peripheral blood flow in subjects with NIDDM. Diabetes Care 1996; 19: 160–64. Salpeter S, Greyber E, Pasternak G, et al. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software.
Sir—Henry Krum and Richard Gilbert1 summarise succinctly the effect of African-American ethnicity in heart failure. However, data from other ethnic groups should not be ignored.
919
For personal use. Only reproduce with permission from The Lancet publishing Group.
SARS, AIDS, and the threat of bioterrorism dominate headlines. In Canada, our new Coalition for Global Health Research and the four federal funding agencies are working to capitalise on this political awakening. VN is coordinator for the Coalition of Global Health Research (Canada).
*Jerry Spiegel, Ronald Labonte, Janet Hatcher-Roberts, Jacques Girard, Vic Neufeld, on behalf of the Coalition for Global Health Research (Canada) *Liu Institute for Global Issues, University of British Columbia, Vancouver, British Columbia V6T 1Z2, Canada (JS); Saskatchewan Public Health Evaluation and Research Unit, University of Saskatchewan, Saskatoon, Canada (RL); Canadian Society for International Health, Ottawa, Canada (JH-R); Department of Social and Preventive Medicine, Laval University, Quebec, Canada (JG); Coalition for Global Health Research (Canada), Hamilton, Canada (VN) (e-mail: [email protected]) 1
2
3
4
Evans JR. Essential national health research: a key to equity in development. N Engl J Med 1990; 323: 913–15. Global Forum for Health Research. The 10/90 report on health research 2001–2002. http://www.globalforumhealth.org/pages/ind ex.asp (accessed Aug 22, 2003). Neufeld V, MacLeod S, Tugwell P, Zakus D, Zarowsky C. The rich–poor gap in global health research: challenges for Canada. CMAJ 2001; 164: 1158–59. Labonte R, Spiegel J. Setting global health research priorities. BMJ 2003; 326: 722–23.
WHO’s 3-by-5 target Sir—We have heard much about WHO’s 3-by-5 target—to get 3 million people in developing countries on antiretrovirals by 2005. This target presents a huge challenge, as your July 19 Editorial (p 179)1 rightly points out. The attendant requirements are no less daunting. At the end of 2002, UNAIDS estimated there were 42 million people infected with HIV worldwide. Of the 5–6 million people living with AIDS who need antiretrovirals, fewer than 300 000 in the developing world—and only about 40 000 in Africa—receive
them. There are supply-side efforts underway to tackle the financing, laboratory capacity, and training of staff that are needed to close this gap. We are concerned, however, about the demand for antiretrovirals that must be created to succeed. To identify HIV-positive people in need of antiretrovirals, increased efforts are needed to promote HIV education and awareness, so that more people come forward for voluntary counselling and testing. Underpinning all of these efforts will be a reduction in stigma and discrimination so that people are prepared to access HIV services. The table2–4 shows our rough calculations for the inputs that will be needed to reach the 3 million target. We have used statistics relevant to the most heavily affected region, subSaharan Africa, although other lowerprevalence regions may have better health infrastructure to implement interventions more rapidly. Our estimates only refer to interventions that lead to start of therapy, not to those needed for maintenance. We have done this rough calculation because there is a dearth of published experience about the large-scale effectiveness of interventions that move people through a process from awareness to action—ie, for services to be in demand (WHO aims to ensure rates of 60% and 90% for accessibility of voluntary counselling and HIV testing and for AIDS education and services for youths by 2005).4 Our analysis underlines three important points. First, that treatment must be seen as a pull-through mechanism for prevention, and cannot be considered in isolation. Second, that to increase their efficiency, efforts should be targeted in terms of geographical profiles of HIV prevalence, clinical-risk groups (eg, patients with tuberculosis or sexually transmitted infection), and high-risk or priority populations. Last, that such a large-scale operation depends on full engagement of all members of society
Assumptions Proportion of population reached by awareness campaigns (A)* Proportion of population reached by awareness campaigns who seek counselling and testing (B)† Proportion of population tested who are HIV positive (C)‡ Proportion of population with HIV who need antiretrovirals (D)§ Implications Number who must be reached, counselled, tested, and able to access antiretrovirals (2·96 million [3 million–40 000]/BxCxD) Target population for awareness campaigns (2·96 million [3 million–40 000]/AxBxCxD) Number in target population who must be reached, counselled, tested, and able to access antiretrovirals per person put on antiretrovirals
from government to civil society and the private sector. Business and faithbased organisations are important in this respect, since they have experience in mass mobilisation and in developing messages that evoke action. But to get businesses involved, better numbers leading to clearer targets will be needed. We thank Catherine Hankins and Neff Walker from UNAIDS for their input during the preparation of this letter.
*Kate Taylor, Peter DeYoung Global Health Initiative, World Economic Forum, CH-1223 Cologny, Geneva, Switzerland (e-mail: [email protected]) 1
2
3
4
Editorial. WHO 2003–08: a programme of quiet thunder takes shape. Lancet 2003; 362: 179. WHO Global HIV Prevention Working Group. Global and African averages, quoting UNAIDS figures. In: Access to HIV prevention: closing the gap. Geneva: World Health Organization, May, 2003. UNAIDS Report on the Global HIV/AIDS Epidemic 2002. Geneva: Joint United Nations Programme on HIV/AIDS, December, 2002. WHO. Leading the health sector response to HIV/AIDS. Geneva: World Health Organization, May, 2003.
NICE’s citizen’s council: what do we ask them, and how? Sir—The UK’s National Institute of Clinical Excellence (NICE) recognises that its decisions have two components —technical facts and values. Technical experts are used to address the former (such issues as the cost-effectiveness of a given technology), whereas citizens are called upon to advise about the latter (the set of social value judgments that are used to show how the costeffectiveness threshold might vary according to certain patients’ characteristics, such as age). We have been engaged in seeking the public’s preferences on issues of distributional and procedural justice in Low effectiveness
High effectiveness
24% 8% 9% 14%
42% 36% 18% 20%
2·9 billion
228 million
12·2 billion 4134
544 million 184
*Global and African averages, quoting UNAIDS figures.2 †Based on average proportion of women aged 15–49 years who know where to get an HIV test and have been tested. Data from the Multi-Indicator Cluster Survey.3 ‡Average and twice-average African prevalence, assuming all who are tested return for results, which is rarely the case. §Assuming an average duration of disease of 8 or 5 years.
Interventions needed to reach WHO’s 3-by-5 target
918
THE LANCET • Vol 362 • September 13, 2003 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet publishing Group.
CORRESPONDENCE
the allocation of health-care resources, and believe that input from lay people is an important part of such decisionmaking. We, therefore, support the use of NICE’s citizen’s council, which gives the public the opportunity to consider their responses to unfamiliar and complex decisions, and thereby increases the legitimacy of those responses.1 However, we have doubts about the types of questions that have been put to NICE’s citizen’s council so far. The questions put to the council should be clear and focused if we are to keep ambiguities to a minimum. Consider the two questions that the council have addressed so far. The first question, discussed in the meeting in January, 2003, reads: “What should NICE take into account when making decisions about clinical need?” This is an odd question, since what constitutes “clinical need” should be a technical matter to be settled elsewhere. For example, we do not need advice from a citizen’s council to tell us that influenza is often more severe in those with preexisting disease than in otherwise healthy adults. A more appropriate question for the council would be what other considerations beyond clinical matters should be taken into account when assessing the outcomes of interventions. The failure to distinguish between the technical issues and values means little useful information emerged from the council’s discussions on this issue. The second question, addressed in May, 2003, which will be discussed further at the November, 2003, meeting, reads: “Are there circumstances in which the age of a person should be taken into account when NICE is making a decision about how treatments should be used in the National Health Service?” Again, this is an odd question because there are many clinical arguments for treating patients differently by age, so it seems that an answer of “‘no” would be quite absurd. In our view, one of the council’s supplementary questions gets much closer to the kind of question that it should deliberate: “Should NICE value a year of an individual’s life differently depending on their age?” But to get useful data from the deliberations about this question, it is vital that the council are forced to discuss the question that is put to them. In the context of this question, it means that bringing in considerations about life expectancy (which it seems some council members did when answering this question) is inappropriate—and the members should be told as much.
So, if the citizen’s council is to provide social value judgments, it must: first, consider focused issues of social value, and, second, be given guidance about what things are, and are not, relevant to answering those questions. Much time and money has gone into setting up and running the council. If its members are asked to consider ambiguous questions and allowed to shy away from actually answering the questions posed, then this resource will be wasted. Paul Dolan, *Aki Tsuchiya, Allan Wailoo School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK (e-mail: [email protected]) 1
Dolan P, Cookson R, Ferguson B. Effect of discussion and deliberation on the public’s views of priority setting in health care: focus group study. BMJ 1999; 318: 916–19.
Heart failure: treatment and ethnic origin Sir—We enjoyed Henry Krum and Richard Gilbert’s Review (July 12, p 147),1 but question whether metformin should be contraindicated in patients with chronic heart failure, as stated. Metformin is a commonly used antihyperglycaemic agent, which improves insulin sensitivity, decreases hepatic glucose production, and slightly reduces intestinal absorption of glucose. It is used with increasing frequency, especially in obese patients with type 2 diabetes, in whom it reduces cardiovascular mortality and morbidity compared with insulin, sulphonylureas, or diet alone.2 Type 2 diabetes, obesity, and insulin resistance are often seen in patients with chronic heart failure. Metformin promotes weight loss and has beneficial effects on several other cardiovascular risk factors, including dyslipidaemia, hypertension, raised plasminogen activator inhibitor 1 concentrations, and hyperinsulinaemia. Additionally, insulin sensitising agents such as metformin may improve peripheral blood flow,3 which could potentially lead to symptomatic benefit in patients with heart failure. Lactic acidosis is a rare, but serious complication that has been associated with metformin treatment in several case reports. The condition is characterised by raised blood lactate concentrations (>5 mmol/L), acidosis (pH <7·35), an increased anion gap, and electrolyte disturbances. Biguanides are thought to decrease gluconeogenesis from alanine, pyruvate, and lactate, so that concentrations of lactic acid might
THE LANCET • Vol 362 • September 13, 2003 • www.thelancet.com
increase under certain circumstances. The incidence of lactic acidosis in patients on metformin has been estimated from population studies to be two to nine cases per 100 000 patient-years.4 However, reported cases have arisen primarily in patients with serious renal dysfunction or circulatory shock that could have caused lactic acidosis themselves. Phenformin, another biguanide, was withdrawn from the US market in 1977, since it was associated with a much higher rate of lactic acidosis (40–64 cases per 100 000 patient-years). Phenformin has a different chemical structure to metformin and can impair oxidative phosphorylation in the liver, thereby increasing lactate production by anaerobic pathways. By contrast, metformin inhibits hepatic gluconeogenesis without altering lactate turnover or lactate oxidation. A Cochrane review4 did not show any raised risk of lactic acidosis in patients treated with metformin compared with other antihyperglycaemic treatments. The report also stated that in clinical practice, standard contraindications to metformin are largely disregarded, with 54–73% of patients having at least one contraindication to treatment. We agree that metformin should be avoided or discontinued in patients with decompensated or unstable heart failure, who are at risk of hypoxia and hypoperfusion. Continuation of treatment in patients with diabetes with stable chronic heart failure and normal renal function, in whom the drug could have potential benefits, would seem reasonable however. *Daniel B McKenzie, Robert G Wilcox Department of Cardiovascular Medicine, Queen’s Medical Centre, Nottingham NG7 2UH, UK (e-mail: [email protected]) 1
2
3
4
Krum H, Gilbert RE. Demographics and concomitant disorders in heart failure. Lancet 2003; 362: 147–58. UKPDS Group. Effect of intensive bloodglucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854–65. Jansson P-AE, Andersson OK, Gudbjornsdottir HS, et al. The effect of metformin on adipose tissue metabolism and peripheral blood flow in subjects with NIDDM. Diabetes Care 1996; 19: 160–64. Salpeter S, Greyber E, Pasternak G, et al. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software.
Sir—Henry Krum and Richard Gilbert1 summarise succinctly the effect of African-American ethnicity in heart failure. However, data from other ethnic groups should not be ignored.
919
For personal use. Only reproduce with permission from The Lancet publishing Group.