- Email: [email protected]
Saints and sinners: the devil is in the historical details
Correspondence
Despite 2008 being a year of record grain production internationally, the dramatic rise in food prices resulted from deregulation of financial and commodities derivatives markets in the USA in 2000. This sparked a sharp increase in traded volumes on agricultural commodity futures, with index fund speculation increasing by 1900% between 2003 and March, 2008.9 Such speculation increased price volatility, affecting the poorest most. Global food prices reached record levels in 2011, with many families coping by eating less and reducing the number and quality of meals per day.10 Growing national food insecurity is further witnessed by the rise in the number of developing countries that are now food importers (from 74 in 1995–99 to 89 in 2005–09),11 putting them at risk due to price volatility.12 More recently, food insecurity is threatened by the rise in land grabs—long-term lease or sales agreements for agricultural land to foreign investors intent on biofuel or food crop production for export markets.13,14 The liberalisation of food trade, the escalation of foreign direct investment by (especially) transnational food corporations, and the rapid spread of supermarkets, in turn, have resulted in an exponential increase in the availability of cheap, energy-dense, nutrient-poor processed foods, even in rural areas.15 Studies have shown a dramatic change in the food environment, with cheap ultraprocessed foods becoming increasingly dominant.16 In this global context, a focus on behaviour change without enacting policies to address these structural drivers of the food-related NCD epidemic not only obfuscates the true causes of undernutrition and obesity problems, it also shifts the responsibility to individuals, especially the most vulnerable. Quoting Lenin, Richard Horton17 identifies the context in which this manifestation of economic globalisation is happening 904
and which those concerned with NCD control need to understand and challenge: “Capitalism has grown into a world system of colonial oppression and of the financial strangulation of the overwhelming majority of the people of the world by a handful of ‘advanced’ countries.” We would add to this: “and by transnational corporations”.
10
11
12
We declare that we have no conflicts of interest.
Sharon Friel, Ronald Labonte, *David Sanders [email protected] National Centre for Epidemiology and Population Health, Australian National University, Acton, ACT, Australia (SF); University of Ottawa, Ottawa, ON, Canada (RL); and School of Public Health, University of the Western Cape, Cape Town 7535, South Africa (DS) 1
2
3
4
5
6
7
8
9
UN General Assembly. Political declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases. New York: United Nations, 2011. WHO. Report of the Formal Meeting of Member States to conclude the work on the comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of noncommunicable diseases, Nov 5–7, 2012. Geneva: World Health Organization, 2012. http://apps.who.int/gb/NCDs/pdf/A_ NCD_2-en.pdf (accessed Dec 18, 2012). Beaglehole R, Bonita R, Horton R, et al. Measuring progress on NCDs: one goal and five targets. Lancet 2012; 380: 1283–85. Commission on the Social Determinants of Health. Closing the gap in a generation: health equity through action on the social determinants of health. Final report of the Commission on Social Determinants of Health. Geneva: World Health Organisation, 2008. http://www.who.int/ social_determinants/thecommission/finalreport/ en/index.html (accessed Dec 18, 2012). De Schutter O. Five ways to tackle disastrous diets—UN food expert. http://www.srfood. org/index.php/en/component/content/ article/1-latest-news/2054-five-ways-totackle-disastrous-diets-un-food-expert (accesed Dec 18, 2012). Lock K, Stuckler D, Charlesworth K, McKee M. Potential causes and health effects of rising global food prices. BMJ 2009; 339: b2403. Standing Committee on Nutrition. The impact of high food prices on maternal and child nutrition. http://reliefweb.int/report/world/ impact-high-food-prices-maternal-and-childnutrition (accessed Dec 18, 2012). Stuckler D, Nestle M. Big food, food systems, and global health. PLos Med 2012; 9: e1001242. De Schutter O. Food commodities speculation and food price crisis. http://www.srfood.org/ index.php/en/component/content/ article/894-food-commodities-speculationand-food-price-crises (accessed Dec 18, 2012).
13
14
15
16
17
Save the Children. Costing lives: the devastating impact of rising and volatile food prices. http://www.savethechildren.org.uk/ resources/online-library/costing-livesdevastating-impact-rising-and-volatile-foodprices (accessed Dec 18, 2012). Valdés A, Foster W. Net food-importing developing countries: who they are, and policy options for global price volatility. http://ictsd. org/downloads/2012/08/net-food-importingdeveloping-countries-who-they-are-andpolicy-options-for-global-price-volatility.pdf (accessed Dec 18, 2012). Ng F, Aksoy MA. Who are the net food importing countries? http://www-wds. worldbank.org/external/default/ WDSContentServer/IW3P/IB/2008/01/02/000 158349_20080102095804/Rendered/PDF/ wps4457.pdf (accessed Dec 18, 2012). GRAIN. The great food robbery: how corporations control food, grab land and destroy the climate. Kenya: Pambazuka Press, 2012. Zerfu Gurara D, Birhanu D. Large-scale land acquisitions in Africa. Africa Econ Brief 2012; 3: 1–8. D’Haese M, Huylenbroeck GV. The rise of supermarkets and changing expenditure patterns of poor rural households case study in the Transkei area, South Africa. Food Policy 2005; 30: 97–113. Monteiro CA, Levy RB, Claro RM, de Castro IR, Cannon G. Increasing consumption of ultra-processed foods and likely impact on human health: evidence from Brazil. Public Health Nutr 2011; 14: 5–13. Horton R. Offline: The advantages of universal health. Lancet 2012; 380: 1632.
Saints and sinners: the devil is in the historical details Michael Rawlins (Oct 27, p 1462)1 reviews Ben Goldacre’s Bad Pharma as a long and often angry book that can repeat criticisms that are not new. For Rawlins, the book lacks equipoise— it fails to balance criticisms of big pharma with industry’s benefits. Rawlins echoes the remark by Stephen Whitehead2 (Chief Executive Officer of the British Pharmaceutical Association) that it has become fashionable to criticise the pharmaceutical industry and overlook its contributions to medicine. The book is indeed long, but rich in details of a regulatory system in peril. Bad Pharma incites laughter as well as justifiable anger. And its length is warranted by the complexity of the regulatory problems it delineates. www.thelancet.com Vol 381 March 16, 2013
Correspondence
I declare that I have no conflicts of interest.
Mark Wilson [email protected] Health Research Associates, Guelph, ON N1G 3S4, Canada 1 2 3
4 5
Rawlins M. Saints or sinners. Lancet 2012; 380: 1462–63. Whitehead S. Fashionable to criticise the drug industry? BMJ 2012; 345: e70893. Goldacre B, Godlee F, Horton R, et al. Drug companies must come clean. Times Oct 29, 2012. http://www.thetimes.co.uk/tto/ opinion/letters/article3582286.ece (accessed Feb 26, 2013). Godlee F. Clinical trial data for all drugs in current use. BMJ 2012; 345: e7304. PharmAware National Committee. Book review: What can we do about ‘Bad Pharma’? http://blogs.plos.org/speakingofmedicine/ 2012/11/19/book-review-what-can-we-doabout-bad-pharma/ (accessed Feb 26, 2013).
www.thelancet.com Vol 381 March 16, 2013
Breastfeeding and psychotropic medications We write in response to the tragic case of Felicia Boots, who killed both her children after stopping her treatment for postnatal depression because she feared it would harm her baby (Nov 10, p 1621).1 We agree that perinatal mental health is very much stigmatised. There is a dearth of information to guide the use of psychotropic medication in pregnant and breastfeeding women, with even less information available about antipsychotic medication than antidepressants. Because of tragic cases like that of Felicia Boots, the National Register of Antipsychotic Medication in Pregnancy (NRAMP) was established in Australia in 2005. To date, more than 200 women have been enrolled, with their progress monitored every 6 weeks during pregnancy and the health of mother and baby monitored for 1 year post partum. Most women enrolled in NRAMP have delivered healthy babies. However, the safety of antipsychotic medication while breastfeeding remains unknown. In an analysis of 114 babies in the NRAMP database, those who were exclusively breastfed from delivery were less likely to have withdrawal symptoms than were babies who were exclusively bottlefed (nine of 74 [12·2%] vs 11 of 40 [27·5%]; odds ratio 2·74, 95% CI 1·02–7·32; p=0·04). Since 10% of women have a mental illness in pregnancy,2 further research is urgently needed to provide women and clinicians with sound information on which to base their decisions. Funding has been obtained from various sources including charities (Australian Rotary Health Research Fund), and drug companies (AstraZeneca, Janssen-Cilag, Hospira, and Eli Lilly). Ethics approval has thus far been obtained from 17 ethics committees, mostly hospital-based, Australia-wide.
*Roisin Worsley, Heather Gilbert, Emorfia Gavrilidis, Brooke Naughton, Jayashri Kulkarni [email protected]
Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, VIC 3004, Australia 1
The Lancet. Bringing postnatal depression out of the shadows. Lancet 2012; 380: 1621. Yonkers KA, Vigod S, Ross LE. Diagnosis, pathophysiology, and management of mood disorders in pregnant and postpartum women. Obstet Gynecol 2011; 117: 961–77.
2
Moving the goalposts for tuberculosis targets in Africa In an Editorial (Oct 20, p 1359),1 you recommend the initiation of a Global Commission on Tuberculosis Elimination. We advocate for the inclusion of more clear and consistent methods for generating and communicating estimates of country progress on its list of priorities. WHO incidence and mortality figures for several African countries in its Global Tuberculosis Reports of 20112 and 20123 differ by more than an order of magnitude. Some countries’ status for the tuberculosis indicators of Millennium Development Goal 6 (MDG-6) seem to oscillate from report to report (figure)—owing not necessarily to changes in programme effectiveness, but to poorly communicated changes in the reports’ methods. Although both reports cite the same epidemiological assessment guidelines,4 precisely why certain 400 New cases or deaths per 100 000 population
It offers what is probably the best overview to date of the institutional culture of medicine, its regulatory challenges, and the forces that have shaped it. Rawlins also rightly notes that some salient points in the book have been made by others. However, they bear repeating because they reflect unresolved issues that negatively affect the public. There is a good reason why physicians—including Goldacre and the Editor of this journal—recently lobbied the health minister for greater transparency in clinical trials.3 Their call is not new—just more urgent given the legitimation crisis accurately portrayed in Bad Pharma. Rawlins underplays the crisis or fails to appreciate its breadth and depth. He also overlooks a key message in Bad Pharma that others take seriously. The message is that although the pharmaceutical industry has contributed much to public health—a point Goldacre makes in the book—it is important not to lose sight of its history of suppressing adverse events, intimidation of physicians, and biased publications that favour market products that can be at the expense of public health and safety.4 One reason others recommend Bad Pharma as essential reading5 is that the public can ill afford a historical amnesia that sustains the status quo.
WHO 2011 Niger incidence off track Namibia mortality on track
350
WHO 2012 Niger incidence on track Namibia mortality off track
300 250 200 150 100 50 0 1990
1995
2000 Year
2005
2010
Figure: Examples of discrepant WHO estimates of country tuberculosis burdens
905
Despite 2008 being a year of record grain production internationally, the dramatic rise in food prices resulted from deregulation of financial and commodities derivatives markets in the USA in 2000. This sparked a sharp increase in traded volumes on agricultural commodity futures, with index fund speculation increasing by 1900% between 2003 and March, 2008.9 Such speculation increased price volatility, affecting the poorest most. Global food prices reached record levels in 2011, with many families coping by eating less and reducing the number and quality of meals per day.10 Growing national food insecurity is further witnessed by the rise in the number of developing countries that are now food importers (from 74 in 1995–99 to 89 in 2005–09),11 putting them at risk due to price volatility.12 More recently, food insecurity is threatened by the rise in land grabs—long-term lease or sales agreements for agricultural land to foreign investors intent on biofuel or food crop production for export markets.13,14 The liberalisation of food trade, the escalation of foreign direct investment by (especially) transnational food corporations, and the rapid spread of supermarkets, in turn, have resulted in an exponential increase in the availability of cheap, energy-dense, nutrient-poor processed foods, even in rural areas.15 Studies have shown a dramatic change in the food environment, with cheap ultraprocessed foods becoming increasingly dominant.16 In this global context, a focus on behaviour change without enacting policies to address these structural drivers of the food-related NCD epidemic not only obfuscates the true causes of undernutrition and obesity problems, it also shifts the responsibility to individuals, especially the most vulnerable. Quoting Lenin, Richard Horton17 identifies the context in which this manifestation of economic globalisation is happening 904
and which those concerned with NCD control need to understand and challenge: “Capitalism has grown into a world system of colonial oppression and of the financial strangulation of the overwhelming majority of the people of the world by a handful of ‘advanced’ countries.” We would add to this: “and by transnational corporations”.
10
11
12
We declare that we have no conflicts of interest.
Sharon Friel, Ronald Labonte, *David Sanders [email protected] National Centre for Epidemiology and Population Health, Australian National University, Acton, ACT, Australia (SF); University of Ottawa, Ottawa, ON, Canada (RL); and School of Public Health, University of the Western Cape, Cape Town 7535, South Africa (DS) 1
2
3
4
5
6
7
8
9
UN General Assembly. Political declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases. New York: United Nations, 2011. WHO. Report of the Formal Meeting of Member States to conclude the work on the comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of noncommunicable diseases, Nov 5–7, 2012. Geneva: World Health Organization, 2012. http://apps.who.int/gb/NCDs/pdf/A_ NCD_2-en.pdf (accessed Dec 18, 2012). Beaglehole R, Bonita R, Horton R, et al. Measuring progress on NCDs: one goal and five targets. Lancet 2012; 380: 1283–85. Commission on the Social Determinants of Health. Closing the gap in a generation: health equity through action on the social determinants of health. Final report of the Commission on Social Determinants of Health. Geneva: World Health Organisation, 2008. http://www.who.int/ social_determinants/thecommission/finalreport/ en/index.html (accessed Dec 18, 2012). De Schutter O. Five ways to tackle disastrous diets—UN food expert. http://www.srfood. org/index.php/en/component/content/ article/1-latest-news/2054-five-ways-totackle-disastrous-diets-un-food-expert (accesed Dec 18, 2012). Lock K, Stuckler D, Charlesworth K, McKee M. Potential causes and health effects of rising global food prices. BMJ 2009; 339: b2403. Standing Committee on Nutrition. The impact of high food prices on maternal and child nutrition. http://reliefweb.int/report/world/ impact-high-food-prices-maternal-and-childnutrition (accessed Dec 18, 2012). Stuckler D, Nestle M. Big food, food systems, and global health. PLos Med 2012; 9: e1001242. De Schutter O. Food commodities speculation and food price crisis. http://www.srfood.org/ index.php/en/component/content/ article/894-food-commodities-speculationand-food-price-crises (accessed Dec 18, 2012).
13
14
15
16
17
Save the Children. Costing lives: the devastating impact of rising and volatile food prices. http://www.savethechildren.org.uk/ resources/online-library/costing-livesdevastating-impact-rising-and-volatile-foodprices (accessed Dec 18, 2012). Valdés A, Foster W. Net food-importing developing countries: who they are, and policy options for global price volatility. http://ictsd. org/downloads/2012/08/net-food-importingdeveloping-countries-who-they-are-andpolicy-options-for-global-price-volatility.pdf (accessed Dec 18, 2012). Ng F, Aksoy MA. Who are the net food importing countries? http://www-wds. worldbank.org/external/default/ WDSContentServer/IW3P/IB/2008/01/02/000 158349_20080102095804/Rendered/PDF/ wps4457.pdf (accessed Dec 18, 2012). GRAIN. The great food robbery: how corporations control food, grab land and destroy the climate. Kenya: Pambazuka Press, 2012. Zerfu Gurara D, Birhanu D. Large-scale land acquisitions in Africa. Africa Econ Brief 2012; 3: 1–8. D’Haese M, Huylenbroeck GV. The rise of supermarkets and changing expenditure patterns of poor rural households case study in the Transkei area, South Africa. Food Policy 2005; 30: 97–113. Monteiro CA, Levy RB, Claro RM, de Castro IR, Cannon G. Increasing consumption of ultra-processed foods and likely impact on human health: evidence from Brazil. Public Health Nutr 2011; 14: 5–13. Horton R. Offline: The advantages of universal health. Lancet 2012; 380: 1632.
Saints and sinners: the devil is in the historical details Michael Rawlins (Oct 27, p 1462)1 reviews Ben Goldacre’s Bad Pharma as a long and often angry book that can repeat criticisms that are not new. For Rawlins, the book lacks equipoise— it fails to balance criticisms of big pharma with industry’s benefits. Rawlins echoes the remark by Stephen Whitehead2 (Chief Executive Officer of the British Pharmaceutical Association) that it has become fashionable to criticise the pharmaceutical industry and overlook its contributions to medicine. The book is indeed long, but rich in details of a regulatory system in peril. Bad Pharma incites laughter as well as justifiable anger. And its length is warranted by the complexity of the regulatory problems it delineates. www.thelancet.com Vol 381 March 16, 2013
Correspondence
I declare that I have no conflicts of interest.
Mark Wilson [email protected] Health Research Associates, Guelph, ON N1G 3S4, Canada 1 2 3
4 5
Rawlins M. Saints or sinners. Lancet 2012; 380: 1462–63. Whitehead S. Fashionable to criticise the drug industry? BMJ 2012; 345: e70893. Goldacre B, Godlee F, Horton R, et al. Drug companies must come clean. Times Oct 29, 2012. http://www.thetimes.co.uk/tto/ opinion/letters/article3582286.ece (accessed Feb 26, 2013). Godlee F. Clinical trial data for all drugs in current use. BMJ 2012; 345: e7304. PharmAware National Committee. Book review: What can we do about ‘Bad Pharma’? http://blogs.plos.org/speakingofmedicine/ 2012/11/19/book-review-what-can-we-doabout-bad-pharma/ (accessed Feb 26, 2013).
www.thelancet.com Vol 381 March 16, 2013
Breastfeeding and psychotropic medications We write in response to the tragic case of Felicia Boots, who killed both her children after stopping her treatment for postnatal depression because she feared it would harm her baby (Nov 10, p 1621).1 We agree that perinatal mental health is very much stigmatised. There is a dearth of information to guide the use of psychotropic medication in pregnant and breastfeeding women, with even less information available about antipsychotic medication than antidepressants. Because of tragic cases like that of Felicia Boots, the National Register of Antipsychotic Medication in Pregnancy (NRAMP) was established in Australia in 2005. To date, more than 200 women have been enrolled, with their progress monitored every 6 weeks during pregnancy and the health of mother and baby monitored for 1 year post partum. Most women enrolled in NRAMP have delivered healthy babies. However, the safety of antipsychotic medication while breastfeeding remains unknown. In an analysis of 114 babies in the NRAMP database, those who were exclusively breastfed from delivery were less likely to have withdrawal symptoms than were babies who were exclusively bottlefed (nine of 74 [12·2%] vs 11 of 40 [27·5%]; odds ratio 2·74, 95% CI 1·02–7·32; p=0·04). Since 10% of women have a mental illness in pregnancy,2 further research is urgently needed to provide women and clinicians with sound information on which to base their decisions. Funding has been obtained from various sources including charities (Australian Rotary Health Research Fund), and drug companies (AstraZeneca, Janssen-Cilag, Hospira, and Eli Lilly). Ethics approval has thus far been obtained from 17 ethics committees, mostly hospital-based, Australia-wide.
*Roisin Worsley, Heather Gilbert, Emorfia Gavrilidis, Brooke Naughton, Jayashri Kulkarni [email protected]
Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, VIC 3004, Australia 1
The Lancet. Bringing postnatal depression out of the shadows. Lancet 2012; 380: 1621. Yonkers KA, Vigod S, Ross LE. Diagnosis, pathophysiology, and management of mood disorders in pregnant and postpartum women. Obstet Gynecol 2011; 117: 961–77.
2
Moving the goalposts for tuberculosis targets in Africa In an Editorial (Oct 20, p 1359),1 you recommend the initiation of a Global Commission on Tuberculosis Elimination. We advocate for the inclusion of more clear and consistent methods for generating and communicating estimates of country progress on its list of priorities. WHO incidence and mortality figures for several African countries in its Global Tuberculosis Reports of 20112 and 20123 differ by more than an order of magnitude. Some countries’ status for the tuberculosis indicators of Millennium Development Goal 6 (MDG-6) seem to oscillate from report to report (figure)—owing not necessarily to changes in programme effectiveness, but to poorly communicated changes in the reports’ methods. Although both reports cite the same epidemiological assessment guidelines,4 precisely why certain 400 New cases or deaths per 100 000 population
It offers what is probably the best overview to date of the institutional culture of medicine, its regulatory challenges, and the forces that have shaped it. Rawlins also rightly notes that some salient points in the book have been made by others. However, they bear repeating because they reflect unresolved issues that negatively affect the public. There is a good reason why physicians—including Goldacre and the Editor of this journal—recently lobbied the health minister for greater transparency in clinical trials.3 Their call is not new—just more urgent given the legitimation crisis accurately portrayed in Bad Pharma. Rawlins underplays the crisis or fails to appreciate its breadth and depth. He also overlooks a key message in Bad Pharma that others take seriously. The message is that although the pharmaceutical industry has contributed much to public health—a point Goldacre makes in the book—it is important not to lose sight of its history of suppressing adverse events, intimidation of physicians, and biased publications that favour market products that can be at the expense of public health and safety.4 One reason others recommend Bad Pharma as essential reading5 is that the public can ill afford a historical amnesia that sustains the status quo.
WHO 2011 Niger incidence off track Namibia mortality on track
350
WHO 2012 Niger incidence on track Namibia mortality off track
300 250 200 150 100 50 0 1990
1995
2000 Year
2005
2010
Figure: Examples of discrepant WHO estimates of country tuberculosis burdens
905