- Email: [email protected]
HIV testing and human rights
Correspondence
EMB and HB declare that they have no conflict of interest. RC was statistical expert/consultant in the Lantus medical expert panel for Sanofi-Aventis (Denmark) in 2006. AA participates in several advisory boards for biotechnical and pharmaceutical boards, some of which develop CB-1 antagonists for treatment of obesity; was member of the Danish Rimonabant Advisory Board until August 2006; and is currently president of the International Association for the Study of Obesity that receives unrestricted grants for activities related to the prevention of obesity.
*Arne Astrup, Robin Christensen, Else Marie Bartels, Henning Bliddal [email protected] Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, DK-1958 Frederiksberg, Denmark (AA); Parker Institute, Musculoskeletal Statistics Unit, Frederiksberg Hospital, Denmark (RC, HB); and Copenhagen University Library, Copenhagen, Denmark (EMB) 1
2
3
4
5
Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA 2006; 295: 761–75. Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet 2006; 368: 1660–72. Rucker D, Padwal R, Li SK, Curioni C, Lau DCW. Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ 2007; 335: 1194–99. Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized trials. J Clin Epidemiol 1997; 50: 683–91. Astrup A. Effect of rimonabant on weight reduction and cardiovascular risk. Lancet 2005; 366: 368.
www.thelancet.com Vol 371 February 16, 2008
Obesity surgery The excellent Clinical update on obesity surgery by Michael Korenkov and Stefan Sauerland (Dec 15, p 1988)1 is very timely. I would particularly like to emphasise that this treatment is cost effective and saves lives. However, one aspect this review did not cover was how to deliver such a treatment in a socialised health-care system such as the UK’s National Health Service (NHS). Currently, obesity surgery is being offered to around 1–3% of eligible patients in the UK. The country’s National Institute for Health and Clinical Excellence (NICE) in 2002 independently assessed obesity surgery and updated its guidance in 2006.2 NICE made it clear that this was a cost-effective treatment and suggested that it should be available on the NHS. Indeed, obesity surgery is much more cost effective than many other services available today on the NHS. The UK government has looked for any excuse to delay establishing obesity surgical centres: initially there were not enough surgeons, but now there are plenty clamouring to offer this treatment but are unable to do so because of ignorance and prejudice on the commissioners’ part. UK bariatric services are patchy and very much a postcode exercise, with some areas not having any significant service and others struggling to cope. Most commissioners of obesity surgery services have arbitrarily raised the threshold beyond NICE guidelines in order to ration the service. This has had the effect of driving much of service into private practice (around 50% of all procedures done last year) and also encouraging patients to go overseas where prices are cheaper (but follow-up is often a problem). It is high time the UK government came off the fence and admitted to the voting public that the NHS cannot and will never cope with the demand for obesity surgery, and that other
ways of funding it must be found (eg, part private funding). I declare that I have no conflict of interest.
John Baxter [email protected] President, British Obesity Surgery Society, c/o Swansea University, Swansea SA2 8PP, UK 1
2
Korenkov M, Sauerland S. Clinical update: bariatric surgery. Lancet 2007; 370: 1988–90. National Institute for Health and Clinical Excellence. Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children. London: NICE, 2007. http://www.nice.org.uk/nicemedia/pdf/ CG43NICEGuideline.pdf (accessed Jan 21, 2008).
HIV testing and human rights Ruth Dixon-Mueller and Adrienne Germain (Dec 1, p 1808)1 argue that the rights of those tested for HIV or offered a test have dominated debate about the ethics of scaling up HIV testing to the exclusion of rights of individuals’ sexual partners to protect themselves from HIV. There is a reason why this has generally been the case: the rights to privacy, informed consent, and autonomy are well established by medical ethics and human rights standards. By contrast, partner disclosure is enormously complex because of the diversity of types of relationships and varying levels of intimacy, power, and trust. Transcending the debate presented by Dixon-Mueller and Germain is the importance of their call for greater emphasis on training HIV counsellors to address power dynamics within sexual partnerships and the possibility of abandonment or abuse. Our research in Lesotho suggests that, as efforts are made to scale up testing, countries face substantial challenges in preparing enough counsellors to provide basic HIV counselling. We found that many counsellors did not discuss the risks of disclosure or legitimate reasons for
The printed journal includes an image merely for illustration
Still Pictures
In conclusion, we tend to share the view that, when rimonabant is prescribed to the right high-risk patients by skilled obesity experts, the benefits outweigh the risks. However, obese patients who are prescribed rimonabant in most clinical practices are less likely to be screened for depression disorders than the participants in the trials. Consequently, the number needed to harm could be much lower than this finding in clinical practice. Patients who seek treatment in clinical practice are often obese women with less comorbidity than those in the trials, and for this group the risk of severe adverse events is less acceptable.
557
Correspondence
not disclosing with clients. Because support services and legal protections are scarce, many women who face abuse after being pressured into disclosing have nowhere to turn. Ideally, expanded HIV testing programmes and increased disclosure rates can lead to decreased HIV transmission and increased access to care. To make that ideal a reality, simultaneous attention must be paid to protecting, respecting, and enforcing the human rights of all parties involved—those tested and their sexual partners. We declare that we have no conflict of interest.
*Diederik Lohman, Joseph J Amon [email protected] HIV/AIDS Program, Human Rights Watch, New York, NY 10118, USA 1
Dixon-Mueller R, Germain A. HIV testing: the mutual rights and responsibilities of partners. Lancet 2007; 370: 1808–09.
Meta-analysis audit trail For a demonstration of the meta-analysis audit trail see http://www.wolfson.qmul.ac.uk/ maaudit/
Meta-analyses can provide precise estimates of the effect of different treatments and exposures. Such analyses have become increasingly complex and multilayered, with data derived from several trials grouped into different categories, for example by age or level of exposure. The results are presented as forest plots with point estimates of the effect for each category, based on a summary of the studies in that category. It can be difficult to see how the plot was derived. We here describe
an online facility to enable readers to track back from such a plot, with a series of clicks, to a forest plot of the individual studies, and from there to the data used to construct each estimate with its reference and from there to access the publication, if it is available online. In published metaanalyses, the link between a point estimate on the forest plot and the reference is currently not accessible on a simple click, and in multilayered meta-analyses it is not possible to link a point estimate relating to a group of studies to the individual component references. Our proposal would make this possible in a simple and transparent manner. To illustrate our online metaanalysis audit trail, we here use a meta-regression of the MTHFR polymorphism on ischaemic heart disease (IHD) in case-control studies of people with and without IHD who had their genotype determined and their serum homocysteine measured.1 People homozygous for the MTHFR C677T mutation (TT) tend to have raised homocysteine concentrations compared with people without the mutation (CC) and have an increased risk of IHD. The effect of the mutation on homocysteine and risk of IHD varies according to folate intake. The meta-analysis plot shows this (figure). A click on any point estimate in the online figure will illustrate the meta-analysis audit trail by revealing the meta-analysis plot of the component studies that
comprise each subgroup estimate. Then a click on each of those points will lead to the relevant data used to plot the point estimate together with the publication reference. A click on that will access the paper if available online. This facility, if adopted by authors and journals, would help make a complex meta-analysis transparent. It would be useful educationally as well as scientifically. We declare that we have no conflict of interest.
*Nicholas J Wald, Joan K Morris, Neville J Young, David S Wald [email protected] Wolfson Institute of Preventive Medicine, Barts and the London Queen Marys School of Medicine and Dentistry, Charterhouse Square, London EC1M 6BQ, UK 1
Wald DS, Morris JK, Law M, Wald NJ. Folic acid, homocysteine, and cardiovascular disease: judging causality in the face of inconclusive trial evidence. BMJ 2006; 333: 1114–17.
Department of Error See Correspondence page 555
Mean homocysteine difference (μmol/L)
Number of studies
Odds ratio (95% CI)
0·7
6
0·87 (0·70–1·08)
2·1
7
1·09 (0·91–1·30)
5·8
7
1·54 (1·19–1·98) 0·2
0·5
1·0
2·0
5·0
Relative risk p for trend=0·02
Figure: Odds ratio of ischaemic heart disease between TT and CC homozygotes according to differences in homocysteine concentration
558
Christensen R, Kristensen PK, Bartels EM, Bliddal H, Astrup A. Efficacy and safety of the weight-loss drug rimonabant: a meta analysis of randomised trials. Lancet 2007; 370: 1706–13— In this Article (Nov 17), the first paragraph on page 1712 should have read “The OR for the incidence of suicidality was examined by the FDA from all available studies, including smoking cessation trials, and was found to be 1·9 (1·1–3·1) for 20 mg rimonabant versus placebo. When limited to seven obesity studies, including the unpublished and continuing trials, the OR for incidence of suicidality for 20 mg rimonabant versus placebo was 1·8 (0·8–3·8).”
www.thelancet.com Vol 371 February 16, 2008
EMB and HB declare that they have no conflict of interest. RC was statistical expert/consultant in the Lantus medical expert panel for Sanofi-Aventis (Denmark) in 2006. AA participates in several advisory boards for biotechnical and pharmaceutical boards, some of which develop CB-1 antagonists for treatment of obesity; was member of the Danish Rimonabant Advisory Board until August 2006; and is currently president of the International Association for the Study of Obesity that receives unrestricted grants for activities related to the prevention of obesity.
*Arne Astrup, Robin Christensen, Else Marie Bartels, Henning Bliddal [email protected] Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, DK-1958 Frederiksberg, Denmark (AA); Parker Institute, Musculoskeletal Statistics Unit, Frederiksberg Hospital, Denmark (RC, HB); and Copenhagen University Library, Copenhagen, Denmark (EMB) 1
2
3
4
5
Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA 2006; 295: 761–75. Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet 2006; 368: 1660–72. Rucker D, Padwal R, Li SK, Curioni C, Lau DCW. Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ 2007; 335: 1194–99. Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized trials. J Clin Epidemiol 1997; 50: 683–91. Astrup A. Effect of rimonabant on weight reduction and cardiovascular risk. Lancet 2005; 366: 368.
www.thelancet.com Vol 371 February 16, 2008
Obesity surgery The excellent Clinical update on obesity surgery by Michael Korenkov and Stefan Sauerland (Dec 15, p 1988)1 is very timely. I would particularly like to emphasise that this treatment is cost effective and saves lives. However, one aspect this review did not cover was how to deliver such a treatment in a socialised health-care system such as the UK’s National Health Service (NHS). Currently, obesity surgery is being offered to around 1–3% of eligible patients in the UK. The country’s National Institute for Health and Clinical Excellence (NICE) in 2002 independently assessed obesity surgery and updated its guidance in 2006.2 NICE made it clear that this was a cost-effective treatment and suggested that it should be available on the NHS. Indeed, obesity surgery is much more cost effective than many other services available today on the NHS. The UK government has looked for any excuse to delay establishing obesity surgical centres: initially there were not enough surgeons, but now there are plenty clamouring to offer this treatment but are unable to do so because of ignorance and prejudice on the commissioners’ part. UK bariatric services are patchy and very much a postcode exercise, with some areas not having any significant service and others struggling to cope. Most commissioners of obesity surgery services have arbitrarily raised the threshold beyond NICE guidelines in order to ration the service. This has had the effect of driving much of service into private practice (around 50% of all procedures done last year) and also encouraging patients to go overseas where prices are cheaper (but follow-up is often a problem). It is high time the UK government came off the fence and admitted to the voting public that the NHS cannot and will never cope with the demand for obesity surgery, and that other
ways of funding it must be found (eg, part private funding). I declare that I have no conflict of interest.
John Baxter [email protected] President, British Obesity Surgery Society, c/o Swansea University, Swansea SA2 8PP, UK 1
2
Korenkov M, Sauerland S. Clinical update: bariatric surgery. Lancet 2007; 370: 1988–90. National Institute for Health and Clinical Excellence. Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children. London: NICE, 2007. http://www.nice.org.uk/nicemedia/pdf/ CG43NICEGuideline.pdf (accessed Jan 21, 2008).
HIV testing and human rights Ruth Dixon-Mueller and Adrienne Germain (Dec 1, p 1808)1 argue that the rights of those tested for HIV or offered a test have dominated debate about the ethics of scaling up HIV testing to the exclusion of rights of individuals’ sexual partners to protect themselves from HIV. There is a reason why this has generally been the case: the rights to privacy, informed consent, and autonomy are well established by medical ethics and human rights standards. By contrast, partner disclosure is enormously complex because of the diversity of types of relationships and varying levels of intimacy, power, and trust. Transcending the debate presented by Dixon-Mueller and Germain is the importance of their call for greater emphasis on training HIV counsellors to address power dynamics within sexual partnerships and the possibility of abandonment or abuse. Our research in Lesotho suggests that, as efforts are made to scale up testing, countries face substantial challenges in preparing enough counsellors to provide basic HIV counselling. We found that many counsellors did not discuss the risks of disclosure or legitimate reasons for
The printed journal includes an image merely for illustration
Still Pictures
In conclusion, we tend to share the view that, when rimonabant is prescribed to the right high-risk patients by skilled obesity experts, the benefits outweigh the risks. However, obese patients who are prescribed rimonabant in most clinical practices are less likely to be screened for depression disorders than the participants in the trials. Consequently, the number needed to harm could be much lower than this finding in clinical practice. Patients who seek treatment in clinical practice are often obese women with less comorbidity than those in the trials, and for this group the risk of severe adverse events is less acceptable.
557
Correspondence
not disclosing with clients. Because support services and legal protections are scarce, many women who face abuse after being pressured into disclosing have nowhere to turn. Ideally, expanded HIV testing programmes and increased disclosure rates can lead to decreased HIV transmission and increased access to care. To make that ideal a reality, simultaneous attention must be paid to protecting, respecting, and enforcing the human rights of all parties involved—those tested and their sexual partners. We declare that we have no conflict of interest.
*Diederik Lohman, Joseph J Amon [email protected] HIV/AIDS Program, Human Rights Watch, New York, NY 10118, USA 1
Dixon-Mueller R, Germain A. HIV testing: the mutual rights and responsibilities of partners. Lancet 2007; 370: 1808–09.
Meta-analysis audit trail For a demonstration of the meta-analysis audit trail see http://www.wolfson.qmul.ac.uk/ maaudit/
Meta-analyses can provide precise estimates of the effect of different treatments and exposures. Such analyses have become increasingly complex and multilayered, with data derived from several trials grouped into different categories, for example by age or level of exposure. The results are presented as forest plots with point estimates of the effect for each category, based on a summary of the studies in that category. It can be difficult to see how the plot was derived. We here describe
an online facility to enable readers to track back from such a plot, with a series of clicks, to a forest plot of the individual studies, and from there to the data used to construct each estimate with its reference and from there to access the publication, if it is available online. In published metaanalyses, the link between a point estimate on the forest plot and the reference is currently not accessible on a simple click, and in multilayered meta-analyses it is not possible to link a point estimate relating to a group of studies to the individual component references. Our proposal would make this possible in a simple and transparent manner. To illustrate our online metaanalysis audit trail, we here use a meta-regression of the MTHFR polymorphism on ischaemic heart disease (IHD) in case-control studies of people with and without IHD who had their genotype determined and their serum homocysteine measured.1 People homozygous for the MTHFR C677T mutation (TT) tend to have raised homocysteine concentrations compared with people without the mutation (CC) and have an increased risk of IHD. The effect of the mutation on homocysteine and risk of IHD varies according to folate intake. The meta-analysis plot shows this (figure). A click on any point estimate in the online figure will illustrate the meta-analysis audit trail by revealing the meta-analysis plot of the component studies that
comprise each subgroup estimate. Then a click on each of those points will lead to the relevant data used to plot the point estimate together with the publication reference. A click on that will access the paper if available online. This facility, if adopted by authors and journals, would help make a complex meta-analysis transparent. It would be useful educationally as well as scientifically. We declare that we have no conflict of interest.
*Nicholas J Wald, Joan K Morris, Neville J Young, David S Wald [email protected] Wolfson Institute of Preventive Medicine, Barts and the London Queen Marys School of Medicine and Dentistry, Charterhouse Square, London EC1M 6BQ, UK 1
Wald DS, Morris JK, Law M, Wald NJ. Folic acid, homocysteine, and cardiovascular disease: judging causality in the face of inconclusive trial evidence. BMJ 2006; 333: 1114–17.
Department of Error See Correspondence page 555
Mean homocysteine difference (μmol/L)
Number of studies
Odds ratio (95% CI)
0·7
6
0·87 (0·70–1·08)
2·1
7
1·09 (0·91–1·30)
5·8
7
1·54 (1·19–1·98) 0·2
0·5
1·0
2·0
5·0
Relative risk p for trend=0·02
Figure: Odds ratio of ischaemic heart disease between TT and CC homozygotes according to differences in homocysteine concentration
558
Christensen R, Kristensen PK, Bartels EM, Bliddal H, Astrup A. Efficacy and safety of the weight-loss drug rimonabant: a meta analysis of randomised trials. Lancet 2007; 370: 1706–13— In this Article (Nov 17), the first paragraph on page 1712 should have read “The OR for the incidence of suicidality was examined by the FDA from all available studies, including smoking cessation trials, and was found to be 1·9 (1·1–3·1) for 20 mg rimonabant versus placebo. When limited to seven obesity studies, including the unpublished and continuing trials, the OR for incidence of suicidality for 20 mg rimonabant versus placebo was 1·8 (0·8–3·8).”
www.thelancet.com Vol 371 February 16, 2008