- Email: [email protected]
Influenza vaccination for elderly people and their care workers
Correspondence
indeed rationality of a system that ranks tobacco ninth in terms of potential for harm. The likely reason for their conclusion is that their scoring system aggregates data into a simple arithmetic mean of the nine points rated. For tobacco, the score for chronic harm resulting from killing more than 100 000 people each year in the UK2 is more than offset by low scores for acute harm and intravenous use. Nutt and colleagues acknowledge that their score might not be ideal. We agree. They mention the need for further assessment to validate the entire system independently. It might have been wise to pursue this before publication. Nutt and colleagues also suggest that harm caused by tobacco is offset by the tax revenue it generates. This is a misrepresentation of taxes as a “benefit” to the economy, when they are in fact a transfer from one part of the economy to another. It is in any case wholly inappropriate to offset health costs against the tax take. National and international regulatory bodies seeking to reduce the toll of death and disability caused by drugs in society would be ill-advised to base tobacco policy on this study. RW does research and consultancy for, and has received hospitality and travel funds from, manufacturers of smoking cessation medications, and has a share of a patent for a novel nicotine delivery device. All other authors declare that they have no conflict of interest.
*John Britton, Ann McNeill, Deborah Arnott, Robert West, Christine Godfrey [email protected] University of Nottingham, Division of Epidemiology and Public Health, Clinical Sciences Building, City Hospital, Nottingham NG5 1PB, UK (JB, AM); Action on Smoking and Health, London, UK (DA); Cancer Research UK Health Behaviour Unit, Department of Epidemiology and Public Health, University College London, London, UK (RW); and Department of Health Sciences, University of York, York, UK (CG) 1
2
Nutt D, King L, Saulsbury W, Blakemore C. Development of a rational scale to assess the harm of drugs of potential misuse. Lancet 2007; 369: 1047–53. Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years’ observations on male British doctors. BMJ 2004; 328: 1519–28.
www.thelancet.com Vol 369 June 2, 2007
Authors’ reply Philip Murphy and John Britton and colleagues raise important issues, which we acknowledged in our paper. The harms of ecstasy do indeed need reviewing in light of the growing research base. We argued for a rolling review of the evidence for all drugs, and for a system of classification that is easily modified. Opinion about the acute dangers of ecstasy has not really changed since the early years, and the risks are partly mitigated by harm-reduction interventions, such as chill-out rooms and free water in dance clubs. However, the question of longterm harm is yet to be resolved, and the papers cited by Murphy make a contribution here. He will be pleased to know that the Advisory Council on the Misuse of Drugs, in association with the Health Technology Assessment programme, is currently undertaking a systematic review of the evidence, which could inform a further harm assessment for ecstasy and related drugs. We were disappointed by Britton and colleagues’ accusation that we under-rated the harm of tobacco. We pointed out that “tobacco is estimated to cause up to 40% of all hospital illness and 60% of drugrelated fatalities” and that “tobacco is the most addictive commonly used drug”. Consequently, our estimate of chronic harm was “unsurprisingly, very high”. The fact that taxation on legal drugs partly offsets health-care costs cannot be ignored in any economic analysis, and heavy taxes on tobacco have influenced prevalence. But we most definitely did not “suggest that harm caused by tobacco is offset by the tax revenue”. This had no part at all in our analysis of harm. Our method focused on the intrinsic harm of substances, independent of prevalence, because, to guide investment in policing and education, we need to be able to assess substances when their use is low, but
which have the potential to become widespread. Even the simple consolidated harm score for tobacco was higher than that of several class A drugs. However, we fully acknowledged the main issue raised by Britton and colleagues, namely the disparity in scores across different categories of harm for certain drugs, especially tobacco. Multicriteria decision analysis might be useful but is unlikely to generate single harm scores appropriate for every aspect of policy. One advantage of having explicit scores for different aspects of harm is that they could be differently weighted to guide approaches to policing, strategies to reduce acute harm, sentencing, education, health-care provision, and public health interventions. Of course further consideration and refinement are needed, but we hope that our paper is a useful step towards evidence-based classification of drugs. We declare that we have no conflict of interest.
*David Nutt, Les King, William Saulsbury, Colin Blakemore [email protected] Psychopharmacology Unit, University of Bristol, Bristol BS1 3NY, UK (DN); Forensic Science Service, London, UK (LK); Police Foundation, London, UK (WS); Medical Research Council, London, UK (CB); and Department of Physiology, Anatomy and Genetics, Oxford, UK (CB)
Influenza vaccination for elderly people and their care workers We are not familiar with the supposedly Cochrane origin of the outcome definitions described by Nicole Smith and David Shay in their Comment (Nov 18, p 1752).1 Perusal of the Cochrane Reviewers’ Handbook2 does not support the interpretation of efficacy and effectiveness as being tied to any particular study design. We can also reassure Smith and Shay that the diversity of outcomes encountered in the preparation of our 1857
Correspondence
Cochrane reviews reflect the variety of outcomes presented in primary literature, not our personal choice. The role of systematic reviews is that of summarising what is available, weighted by its quality, not to invent what is not there. It is precisely because Cochrane reviews present all relevant data in an explicit fashion that readers such as Smith and Shay are able to analyse the findings. Additionally, the Cochrane Collaboration has created a Criticism Management System through which successive versions of each review can be updated to reflect not only the emergence of new data, but also valid criticisms. Successive versions of a particular review, together with any intervening criticisms, are archived electronically.2 This form of post-publication peer review is accountable, explicit, and will always be available. Our choice of equating efficacy with the capacity of the vaccines to prevent influenza and effectiveness with that of preventing influenza-like illness reflects what is available in the literature. Often, though, the two are confused and used as synonymous with the result of confusing the threat of influenza with that posed by other pathogens and making the assessment of benefits accrued from vaccination unreliable. As of today there is no global, real-time, reliable surveillance system providing information on circulating respiratory viruses. Smith and Shay might not agree with our choice of definitions, but they were at least used in a clear and consistent fashion, a rarity in literature. Prioritisation of outcomes is not a function of any systematic review that we have ever read and cannot be justified a posteriori, especially if not included in the original protocol. Irrespective of whether influenza researchers should prioritise outcomes or not, the evidence of effects of influenza vaccines from randomised controlled 1858
trials in elderly people is very thin: five trials, with only one done in the past decade. Whether we like it or not, the bulk of the evidence comes from retrospective cohort studies with the attendant problems of interpretation of such designs. In the Conclusion or Discussion sections of any systematic review (as in any study following Introduction, Methods, Results, and Discussion [IMRAD] structure) readers can agree or disagree with the authors’ conclusions once they have been through the totality of evidence explicitly gathered and synthesised in the Results section of the review. Lastly we are surprised that Smith and Shay declare no conflicts, as they work for an organisation that recommends and assesses influenza vaccination policies. Theirs is perhaps the biggest of all conflicts. TJ owned shares in GlaxoSmithKline and received consultancy fees from Sanofi-Synthelabo (2002) and Roche (1997–99). VD is responsible for vaccination policies for the Regional government of Piemonte Region (Italy). TJ and VD are co-authors of the Cochrane reviews quoted by Smith and Shay.
*Tom Jefferson, Vittorio Demicheli jeff[email protected] Cochrane Vaccines Field, ASL 20, Via Venezia 6, 15100 Alessandria, Italy 1
2
Smith MN, Shay DK. Influenza vaccination for elderly people and their care workers. Lancet 2006; 368: 1752–53. Alderson P, Green S, Higgins JPT, eds. Cochrane Reviewers’ Handbook 4.2.2. In: The Cochrane Library, Issue 1. Chichester: John Wiley & Sons, 2004.
first Millennium Development Goal (MDG-1) of poverty reduction and MDG-3 of women’s empowerment, it is not enough. Governments and civil society have to translate these financial resources into tangible improvements in women’s freedom in managing their properties, increased representation in parliament, and equity in the labour market. Simply putting a law in place will not change culturally entrenched values. An Egyptian study revealed that 52% of a sample of 5th year medical students at Alexandria University supported the continuation of FGM and 73·2% were in favour of its medicalisation as a strategy for reducing the risk associated with it.3 However, the prevalence of FGM in Frontier’s Governorates including Alexandria city was significantly lower (71·5%) than the national figure (95·5%), according to Egypt’s Demographic and Health Survey 2005.4 Community discussions and talks in mosques or churches are much more likely than conventional methods such as the mass media to be associated with Egyptian women’s positive attitude towards discontinuation of the practice.5 Therefore the battle cry should start from the community. I declare that I have no conflict of interest.
Mustafa Afifi afifi[email protected]
Female genital mutilation in Egypt I would like to add a few comments to the World Report by Wairagala Wakabi (March 31, p 1069).1 Research from Egypt has shown that highly empowered women were eight times less likely to intend female genital mutilation (FGM) for their daughters than those less empowered.2 And although the Naserian Women Group’s experience in incomegenerating projects is strong evidence of the link between the
Department of Non Communicable Diseases Control, MOH (HQ), PO Box 393, PC 113, Muscat, Oman 1 2
3
4
5
Wakabi W. Africa battles to make female genital mutilation history. Lancet 2007; 369: 1069–70. Afifi M. Women empowerment and the intention to continue the practice of female genital cutting in Egypt. East Mediterr Health J (in press). Mostafa SR, El Zeiny NA, Tayel SE, Moubarak EI. What do medical students in Alexandria know about female genital mutilation? East Mediterr Health J 2006; 2 (12 suppl): S78–92. El-Zanaty F, Way A. Egypt Demographic and Health Survey 2005. Cairo: Ministry of Health and Population, National Population Council, El-Zanaty and Associates, ORC Macro, 2006. Afifi M. Predictors of ever-married women attitudes toward the discontinuation of female genital cutting practice in Egypt. East Mediterr Health J (in press).
www.thelancet.com Vol 369 June 2, 2007
indeed rationality of a system that ranks tobacco ninth in terms of potential for harm. The likely reason for their conclusion is that their scoring system aggregates data into a simple arithmetic mean of the nine points rated. For tobacco, the score for chronic harm resulting from killing more than 100 000 people each year in the UK2 is more than offset by low scores for acute harm and intravenous use. Nutt and colleagues acknowledge that their score might not be ideal. We agree. They mention the need for further assessment to validate the entire system independently. It might have been wise to pursue this before publication. Nutt and colleagues also suggest that harm caused by tobacco is offset by the tax revenue it generates. This is a misrepresentation of taxes as a “benefit” to the economy, when they are in fact a transfer from one part of the economy to another. It is in any case wholly inappropriate to offset health costs against the tax take. National and international regulatory bodies seeking to reduce the toll of death and disability caused by drugs in society would be ill-advised to base tobacco policy on this study. RW does research and consultancy for, and has received hospitality and travel funds from, manufacturers of smoking cessation medications, and has a share of a patent for a novel nicotine delivery device. All other authors declare that they have no conflict of interest.
*John Britton, Ann McNeill, Deborah Arnott, Robert West, Christine Godfrey [email protected] University of Nottingham, Division of Epidemiology and Public Health, Clinical Sciences Building, City Hospital, Nottingham NG5 1PB, UK (JB, AM); Action on Smoking and Health, London, UK (DA); Cancer Research UK Health Behaviour Unit, Department of Epidemiology and Public Health, University College London, London, UK (RW); and Department of Health Sciences, University of York, York, UK (CG) 1
2
Nutt D, King L, Saulsbury W, Blakemore C. Development of a rational scale to assess the harm of drugs of potential misuse. Lancet 2007; 369: 1047–53. Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years’ observations on male British doctors. BMJ 2004; 328: 1519–28.
www.thelancet.com Vol 369 June 2, 2007
Authors’ reply Philip Murphy and John Britton and colleagues raise important issues, which we acknowledged in our paper. The harms of ecstasy do indeed need reviewing in light of the growing research base. We argued for a rolling review of the evidence for all drugs, and for a system of classification that is easily modified. Opinion about the acute dangers of ecstasy has not really changed since the early years, and the risks are partly mitigated by harm-reduction interventions, such as chill-out rooms and free water in dance clubs. However, the question of longterm harm is yet to be resolved, and the papers cited by Murphy make a contribution here. He will be pleased to know that the Advisory Council on the Misuse of Drugs, in association with the Health Technology Assessment programme, is currently undertaking a systematic review of the evidence, which could inform a further harm assessment for ecstasy and related drugs. We were disappointed by Britton and colleagues’ accusation that we under-rated the harm of tobacco. We pointed out that “tobacco is estimated to cause up to 40% of all hospital illness and 60% of drugrelated fatalities” and that “tobacco is the most addictive commonly used drug”. Consequently, our estimate of chronic harm was “unsurprisingly, very high”. The fact that taxation on legal drugs partly offsets health-care costs cannot be ignored in any economic analysis, and heavy taxes on tobacco have influenced prevalence. But we most definitely did not “suggest that harm caused by tobacco is offset by the tax revenue”. This had no part at all in our analysis of harm. Our method focused on the intrinsic harm of substances, independent of prevalence, because, to guide investment in policing and education, we need to be able to assess substances when their use is low, but
which have the potential to become widespread. Even the simple consolidated harm score for tobacco was higher than that of several class A drugs. However, we fully acknowledged the main issue raised by Britton and colleagues, namely the disparity in scores across different categories of harm for certain drugs, especially tobacco. Multicriteria decision analysis might be useful but is unlikely to generate single harm scores appropriate for every aspect of policy. One advantage of having explicit scores for different aspects of harm is that they could be differently weighted to guide approaches to policing, strategies to reduce acute harm, sentencing, education, health-care provision, and public health interventions. Of course further consideration and refinement are needed, but we hope that our paper is a useful step towards evidence-based classification of drugs. We declare that we have no conflict of interest.
*David Nutt, Les King, William Saulsbury, Colin Blakemore [email protected] Psychopharmacology Unit, University of Bristol, Bristol BS1 3NY, UK (DN); Forensic Science Service, London, UK (LK); Police Foundation, London, UK (WS); Medical Research Council, London, UK (CB); and Department of Physiology, Anatomy and Genetics, Oxford, UK (CB)
Influenza vaccination for elderly people and their care workers We are not familiar with the supposedly Cochrane origin of the outcome definitions described by Nicole Smith and David Shay in their Comment (Nov 18, p 1752).1 Perusal of the Cochrane Reviewers’ Handbook2 does not support the interpretation of efficacy and effectiveness as being tied to any particular study design. We can also reassure Smith and Shay that the diversity of outcomes encountered in the preparation of our 1857
Correspondence
Cochrane reviews reflect the variety of outcomes presented in primary literature, not our personal choice. The role of systematic reviews is that of summarising what is available, weighted by its quality, not to invent what is not there. It is precisely because Cochrane reviews present all relevant data in an explicit fashion that readers such as Smith and Shay are able to analyse the findings. Additionally, the Cochrane Collaboration has created a Criticism Management System through which successive versions of each review can be updated to reflect not only the emergence of new data, but also valid criticisms. Successive versions of a particular review, together with any intervening criticisms, are archived electronically.2 This form of post-publication peer review is accountable, explicit, and will always be available. Our choice of equating efficacy with the capacity of the vaccines to prevent influenza and effectiveness with that of preventing influenza-like illness reflects what is available in the literature. Often, though, the two are confused and used as synonymous with the result of confusing the threat of influenza with that posed by other pathogens and making the assessment of benefits accrued from vaccination unreliable. As of today there is no global, real-time, reliable surveillance system providing information on circulating respiratory viruses. Smith and Shay might not agree with our choice of definitions, but they were at least used in a clear and consistent fashion, a rarity in literature. Prioritisation of outcomes is not a function of any systematic review that we have ever read and cannot be justified a posteriori, especially if not included in the original protocol. Irrespective of whether influenza researchers should prioritise outcomes or not, the evidence of effects of influenza vaccines from randomised controlled 1858
trials in elderly people is very thin: five trials, with only one done in the past decade. Whether we like it or not, the bulk of the evidence comes from retrospective cohort studies with the attendant problems of interpretation of such designs. In the Conclusion or Discussion sections of any systematic review (as in any study following Introduction, Methods, Results, and Discussion [IMRAD] structure) readers can agree or disagree with the authors’ conclusions once they have been through the totality of evidence explicitly gathered and synthesised in the Results section of the review. Lastly we are surprised that Smith and Shay declare no conflicts, as they work for an organisation that recommends and assesses influenza vaccination policies. Theirs is perhaps the biggest of all conflicts. TJ owned shares in GlaxoSmithKline and received consultancy fees from Sanofi-Synthelabo (2002) and Roche (1997–99). VD is responsible for vaccination policies for the Regional government of Piemonte Region (Italy). TJ and VD are co-authors of the Cochrane reviews quoted by Smith and Shay.
*Tom Jefferson, Vittorio Demicheli jeff[email protected] Cochrane Vaccines Field, ASL 20, Via Venezia 6, 15100 Alessandria, Italy 1
2
Smith MN, Shay DK. Influenza vaccination for elderly people and their care workers. Lancet 2006; 368: 1752–53. Alderson P, Green S, Higgins JPT, eds. Cochrane Reviewers’ Handbook 4.2.2. In: The Cochrane Library, Issue 1. Chichester: John Wiley & Sons, 2004.
first Millennium Development Goal (MDG-1) of poverty reduction and MDG-3 of women’s empowerment, it is not enough. Governments and civil society have to translate these financial resources into tangible improvements in women’s freedom in managing their properties, increased representation in parliament, and equity in the labour market. Simply putting a law in place will not change culturally entrenched values. An Egyptian study revealed that 52% of a sample of 5th year medical students at Alexandria University supported the continuation of FGM and 73·2% were in favour of its medicalisation as a strategy for reducing the risk associated with it.3 However, the prevalence of FGM in Frontier’s Governorates including Alexandria city was significantly lower (71·5%) than the national figure (95·5%), according to Egypt’s Demographic and Health Survey 2005.4 Community discussions and talks in mosques or churches are much more likely than conventional methods such as the mass media to be associated with Egyptian women’s positive attitude towards discontinuation of the practice.5 Therefore the battle cry should start from the community. I declare that I have no conflict of interest.
Mustafa Afifi afifi[email protected]
Female genital mutilation in Egypt I would like to add a few comments to the World Report by Wairagala Wakabi (March 31, p 1069).1 Research from Egypt has shown that highly empowered women were eight times less likely to intend female genital mutilation (FGM) for their daughters than those less empowered.2 And although the Naserian Women Group’s experience in incomegenerating projects is strong evidence of the link between the
Department of Non Communicable Diseases Control, MOH (HQ), PO Box 393, PC 113, Muscat, Oman 1 2
3
4
5
Wakabi W. Africa battles to make female genital mutilation history. Lancet 2007; 369: 1069–70. Afifi M. Women empowerment and the intention to continue the practice of female genital cutting in Egypt. East Mediterr Health J (in press). Mostafa SR, El Zeiny NA, Tayel SE, Moubarak EI. What do medical students in Alexandria know about female genital mutilation? East Mediterr Health J 2006; 2 (12 suppl): S78–92. El-Zanaty F, Way A. Egypt Demographic and Health Survey 2005. Cairo: Ministry of Health and Population, National Population Council, El-Zanaty and Associates, ORC Macro, 2006. Afifi M. Predictors of ever-married women attitudes toward the discontinuation of female genital cutting practice in Egypt. East Mediterr Health J (in press).
www.thelancet.com Vol 369 June 2, 2007