- Email: [email protected]
67th WHA Resolution on violence prevention misses the mark
Correspondence
Erol Project Development House for the disorders of energy metabolism, Internal medicine, Muammer Aksoy Caddesi, Elmas sokak 4, Silivri, Istanbul, Turkey
Oxidative stress
Exercise
1 Systemic DNA damage response
Genomic instability
2
3 Type 2 diabetes mellitus
4 Figure: Oxidative stress-mediated crosstalk between type 2 diabetes and exercise 5
of patients with Werner syndrome are increased reactive oxygen species (ROS) levels and genomic instability.2 Free radicals causing oxidative stress are inevitable byproducts of mitochondrial metabolism and have been proposed to exert repetitive damage to individual cells. However, exercise-induced repeated exposure to sublethal stress (ROS) has been proposed to enhance stress resistance and ultimately increased survival rates due to hormesis.3 The molecular mechanism behind the favourable effect of exercise could be linked to redox homoeostasis. The exercise-induced oxidative challenge-associated systemic adaptation mechanism is initiated by transcription factors, resulting in increased antioxidant enzymes, more effective repair and housekeeping by the DNA repair enzymes and proteasome complex. 4 Exercise-induced IGF-1 and PGC-1 production are other beneficial aspects of exercise, leading to increased production of mitochondria. They are also crucial in the maintenance of glucose, lipid, and energy homoeostasis.5 Finally, exercise-mediated stress activates the AMPK-p53 signalling pathway, which, in turn, decreases the systemic metabolic stress, inhibits mTORC1, and induces autophagy, which are considered beneficial for preventing age-associated pathologies (figure).4 I declare no competing interests.
Adnan Erol [email protected]
854
Watson JD. Type 2 diabetes as a redox disease. Lancet 2014; 383: 841–43. Massip L, Garand C, Paquet ER, et al. Vitamin C restores healthy aging in a mouse model for Werner syndrome. FASEB J 2010; 24: 158–72. Ristow M, Zarse K, Oberbach A, et al. Antioxidant prevents health-promoting effects of physical exercise in humans. Proc Natl Acad Sci USA 2009; 106: 8665–70. Erol A. Systemic DNA damage response and metabolic syndrome as a premalignant state. Curr Mol Med 2010; 10: 321–34. Sandri M, Lin J, Handschin C, et al. PGC1a protects skeletal muscle from atrophy by suppressing FoxO3 action and atrophy-specific gene transcription. Proc Natl Acad Sci USA 2006; 103: 16260–65.
67th WHA Resolution on violence prevention misses the mark Men and boys bear most of the mortality and morbidity burden from intentional injuries. 1 Yet the recent World Health Assembly (WHA)’s resolution to strengthen the role of the health system in addressing violence specifically requests a focus on women and children. 2 The new Resolution sets a remarkable precedent: no other WHA response to a priority health condition purposively directs prevention efforts away from the most vulnerable group. The Resolution recognises that men are among those most affected, but nearly every clause directs focus to women, girls, and children without clear justification. The distinction between girls and children further entrenches a preventive effort directed at female children. Why should boys be accorded less protection? Adverse childhood experiences including harsh physical punishment predict later violent behaviour. Preventing violence against boys should be a priority not an afterthought. Women are more vulnerable than men to certain forms of violence
such as sexual assault, intimate partner violence, and rape. The role of gender features prominently in all of these forms, but if this is what the Resolution seeks to address it should do so explicitly, and not exclude men victims by also focusing on homophobic violence. For other forms of violence men and boys feature prominently among the vulnerable: youth violence, random acts of violence, abuse of the elderly, and child abuse. It is hardly coincidental that men are more frequently both the victims and perpetrators of most violence and should be primary targets for intervention. But the Resolution stops short of condemning the acceptability and tolerance of violence against boys and men in its requests to Member States, and relegates their involvement to promoting gender equality and empowerment of women and girls. The Resolution might raise the profile of violence among the world’s pressing health and development problems, but it is not clear how this omission of men is expected to strengthen the health system’s response.3 The UN system is replete with reports, resolutions, and declarations denouncing various forms of violence against women and children. The sentiment is laudable in attempting to offer redress to groups that are traditionally equated with vulnerability. For UNICEF, children are the raison d’être and the wellbeing of mothers a natural extension. For UNDP maternal and under-five mortality are key evaluative metrics for its MDG.4 But the World Health Assembly as the highest decision making authority for global health needs to be guided by epidemiology and evidence rather than sentiment. We declare no competing interests.
*Richard Matzopoulos, Morna Cornell, Brett Bowman, Jonny Myers [email protected]
www.thelancet.com Vol 384 September 6, 2014
Correspondence
School of Public Health and Family Medicine, University of Cape Town, Observatory 7925, South Africa (RM, MC, JM); Burden of Disease Research Unit, Medical Research Council, Johannesburg, South Africa (RM); and Department of Psychology, School of Human and Community Development, University of the Witwatersrand, Johannesburg, South Africa (BB) 1
2
3
4
Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–128. 67th World Health Assembly. Strengthening the role of the health system in addressing violence, in particular against women and girls, and against children. http://apps.who. int/gb/ebwha/pdf_files/WHA67/A67_ ACONF1Rev1-en.pdf (accessed July 14, 2014). Hawkes S, Buse K. Gender and global health: evidence, policy, and inconvenient truths. Lancet 2013; 381: 1783–87. Bowman B, Matzopoulos R, Butchart A, Mercy JA. The impact of violence on development in low- to middle-income countries. Int J Inj Control Saf Promot 2008; 15: 209–19.
Data protection and consent to biomedical research: a step forward? Many in the biomedical research community have expressed concern with the draft General Data Protection Regulation, as amended by a European Parliament Committee in 2013 and endorsed by the Parliament in March, 2014.1 Criticism has especially targeted Article 81, which would enable member states to legislate for an exemption from the need for specific, explicit consent to research use of health data only where research serves “a high public interest” and the data are anonymised or pseudonymised “under the highest technical standards”. Commentators 2–7 have noted that this overlooks robust broad consent models and research oversight mechanisms. Commentators 2–7 also noted that Article 81 introduces a disproportionate threshold for the consent exemption and would cause a major burden for and threat to biomedical research, large-scale www.thelancet.com Vol 384 September 6, 2014
studies, and research infrastructures such as biobanks. We are cautiously optimistic that this stringent provision might be revised. On June 30, 2014, a draft text based on discussions held during European Council’s Greek Presidency (first half of 2014) and amending the original 2012 European Commission text, was released.8 Reference to so-called specific consent and “research that serves a high public interest” has been removed in the new draft text, reflecting the original 2012 Commission text.9 Caution is warranted, however. The new draft ( June 30) text contains other provisions that create a challenging environment for researchers. It also remains to be seen whether the three European bodies (Commission, Parliament, and Council) can forge a common position on the Regulation, and how that negotiation will balance the current competing positions about health-related data and processing of personal data for scientific purposes. Indeed, the Council has not agreed to this text and it will change again as negotiations continue between member states. For these reasons, we encourage the biomedical research community to lobby the Council to aim for a more ambitious text, closer to the 2012 Commission version, 9 while there is still the opportunity to do so. If the potential benefits of public health and social needs are to be realised and not thwarted by the new Regulation, European political bodies should agree that the use of personal and pseudonymised data in biomedical research must be regulated proportionately to the real risks, and should acknowledge that techno logies increasingly allow research participants to make enlightened and autonomous decisions about the scope of consent to research. Now is the time for medical researchers and practitioners to explain these potential benefits,
harms, and safeguards to their recently elected Members of the European Parliament. We declare no competing interests.
Edward S Dove, David Townend, *Bartha M Knoppers [email protected] Centre of Genomics and Policy, McGill University, Montreal, QC H3A 0G1, Canada (ESD, BMK); and Department of Health, Ethics & Society, Maastricht University, Netherlands (DT) 1
2
3
4
5 6
7
8
9
European Parliament. Legislative resolution of 12 March 2014 on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). March 12, 2014. http://www.europarl.europa.eu/ sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7TA-2014-0212+0+DOC+XML+V0//EN (accessed Aug 21, 2014). Casali PG. Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458–61. Di Iorio CT, Carinci F, Oderkirk J. Health research and systems’ governance are at risk: should the right to data protection override health? J Med Ethics 2014; 40: 488–92. Ploem MC, Essink-Bot ML, Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: f3534. McCall B. European Parliament supports data protection reforms. Lancet 2014; 383: 1115. Mascalzoni D, Knoppers BM, Aymé S, et al. Rare diseases and now rare data? Nat Rev Genet 2013; 14: 372. Protecting health and scientific research in the Data Protection Regulation (2012/0011(COD)): Position of non-commercial research organisations and academics– July 2014. http://www.wellcome. ac.uk/stellent/groups/corporatesite/@ policy_communications/documents/web_ document/WTP055584.pdf (accessed Aug 7, 2014). Council of the European Union. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). June 30, 2014. http://register.consilium. europa.eu/doc/srv?l=EN&f=ST%2011028%20 2014%20INIT (accessed Aug 7, 2014). European Commission. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). Jan 25, 2012. http://ec.europa.eu/justice/ data-protection/document/review2012/ com_2012_11_en.pdf (accessed Aug 21, 2014).
855
Erol Project Development House for the disorders of energy metabolism, Internal medicine, Muammer Aksoy Caddesi, Elmas sokak 4, Silivri, Istanbul, Turkey
Oxidative stress
Exercise
1 Systemic DNA damage response
Genomic instability
2
3 Type 2 diabetes mellitus
4 Figure: Oxidative stress-mediated crosstalk between type 2 diabetes and exercise 5
of patients with Werner syndrome are increased reactive oxygen species (ROS) levels and genomic instability.2 Free radicals causing oxidative stress are inevitable byproducts of mitochondrial metabolism and have been proposed to exert repetitive damage to individual cells. However, exercise-induced repeated exposure to sublethal stress (ROS) has been proposed to enhance stress resistance and ultimately increased survival rates due to hormesis.3 The molecular mechanism behind the favourable effect of exercise could be linked to redox homoeostasis. The exercise-induced oxidative challenge-associated systemic adaptation mechanism is initiated by transcription factors, resulting in increased antioxidant enzymes, more effective repair and housekeeping by the DNA repair enzymes and proteasome complex. 4 Exercise-induced IGF-1 and PGC-1 production are other beneficial aspects of exercise, leading to increased production of mitochondria. They are also crucial in the maintenance of glucose, lipid, and energy homoeostasis.5 Finally, exercise-mediated stress activates the AMPK-p53 signalling pathway, which, in turn, decreases the systemic metabolic stress, inhibits mTORC1, and induces autophagy, which are considered beneficial for preventing age-associated pathologies (figure).4 I declare no competing interests.
Adnan Erol [email protected]
854
Watson JD. Type 2 diabetes as a redox disease. Lancet 2014; 383: 841–43. Massip L, Garand C, Paquet ER, et al. Vitamin C restores healthy aging in a mouse model for Werner syndrome. FASEB J 2010; 24: 158–72. Ristow M, Zarse K, Oberbach A, et al. Antioxidant prevents health-promoting effects of physical exercise in humans. Proc Natl Acad Sci USA 2009; 106: 8665–70. Erol A. Systemic DNA damage response and metabolic syndrome as a premalignant state. Curr Mol Med 2010; 10: 321–34. Sandri M, Lin J, Handschin C, et al. PGC1a protects skeletal muscle from atrophy by suppressing FoxO3 action and atrophy-specific gene transcription. Proc Natl Acad Sci USA 2006; 103: 16260–65.
67th WHA Resolution on violence prevention misses the mark Men and boys bear most of the mortality and morbidity burden from intentional injuries. 1 Yet the recent World Health Assembly (WHA)’s resolution to strengthen the role of the health system in addressing violence specifically requests a focus on women and children. 2 The new Resolution sets a remarkable precedent: no other WHA response to a priority health condition purposively directs prevention efforts away from the most vulnerable group. The Resolution recognises that men are among those most affected, but nearly every clause directs focus to women, girls, and children without clear justification. The distinction between girls and children further entrenches a preventive effort directed at female children. Why should boys be accorded less protection? Adverse childhood experiences including harsh physical punishment predict later violent behaviour. Preventing violence against boys should be a priority not an afterthought. Women are more vulnerable than men to certain forms of violence
such as sexual assault, intimate partner violence, and rape. The role of gender features prominently in all of these forms, but if this is what the Resolution seeks to address it should do so explicitly, and not exclude men victims by also focusing on homophobic violence. For other forms of violence men and boys feature prominently among the vulnerable: youth violence, random acts of violence, abuse of the elderly, and child abuse. It is hardly coincidental that men are more frequently both the victims and perpetrators of most violence and should be primary targets for intervention. But the Resolution stops short of condemning the acceptability and tolerance of violence against boys and men in its requests to Member States, and relegates their involvement to promoting gender equality and empowerment of women and girls. The Resolution might raise the profile of violence among the world’s pressing health and development problems, but it is not clear how this omission of men is expected to strengthen the health system’s response.3 The UN system is replete with reports, resolutions, and declarations denouncing various forms of violence against women and children. The sentiment is laudable in attempting to offer redress to groups that are traditionally equated with vulnerability. For UNICEF, children are the raison d’être and the wellbeing of mothers a natural extension. For UNDP maternal and under-five mortality are key evaluative metrics for its MDG.4 But the World Health Assembly as the highest decision making authority for global health needs to be guided by epidemiology and evidence rather than sentiment. We declare no competing interests.
*Richard Matzopoulos, Morna Cornell, Brett Bowman, Jonny Myers [email protected]
www.thelancet.com Vol 384 September 6, 2014
Correspondence
School of Public Health and Family Medicine, University of Cape Town, Observatory 7925, South Africa (RM, MC, JM); Burden of Disease Research Unit, Medical Research Council, Johannesburg, South Africa (RM); and Department of Psychology, School of Human and Community Development, University of the Witwatersrand, Johannesburg, South Africa (BB) 1
2
3
4
Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–128. 67th World Health Assembly. Strengthening the role of the health system in addressing violence, in particular against women and girls, and against children. http://apps.who. int/gb/ebwha/pdf_files/WHA67/A67_ ACONF1Rev1-en.pdf (accessed July 14, 2014). Hawkes S, Buse K. Gender and global health: evidence, policy, and inconvenient truths. Lancet 2013; 381: 1783–87. Bowman B, Matzopoulos R, Butchart A, Mercy JA. The impact of violence on development in low- to middle-income countries. Int J Inj Control Saf Promot 2008; 15: 209–19.
Data protection and consent to biomedical research: a step forward? Many in the biomedical research community have expressed concern with the draft General Data Protection Regulation, as amended by a European Parliament Committee in 2013 and endorsed by the Parliament in March, 2014.1 Criticism has especially targeted Article 81, which would enable member states to legislate for an exemption from the need for specific, explicit consent to research use of health data only where research serves “a high public interest” and the data are anonymised or pseudonymised “under the highest technical standards”. Commentators 2–7 have noted that this overlooks robust broad consent models and research oversight mechanisms. Commentators 2–7 also noted that Article 81 introduces a disproportionate threshold for the consent exemption and would cause a major burden for and threat to biomedical research, large-scale www.thelancet.com Vol 384 September 6, 2014
studies, and research infrastructures such as biobanks. We are cautiously optimistic that this stringent provision might be revised. On June 30, 2014, a draft text based on discussions held during European Council’s Greek Presidency (first half of 2014) and amending the original 2012 European Commission text, was released.8 Reference to so-called specific consent and “research that serves a high public interest” has been removed in the new draft text, reflecting the original 2012 Commission text.9 Caution is warranted, however. The new draft ( June 30) text contains other provisions that create a challenging environment for researchers. It also remains to be seen whether the three European bodies (Commission, Parliament, and Council) can forge a common position on the Regulation, and how that negotiation will balance the current competing positions about health-related data and processing of personal data for scientific purposes. Indeed, the Council has not agreed to this text and it will change again as negotiations continue between member states. For these reasons, we encourage the biomedical research community to lobby the Council to aim for a more ambitious text, closer to the 2012 Commission version, 9 while there is still the opportunity to do so. If the potential benefits of public health and social needs are to be realised and not thwarted by the new Regulation, European political bodies should agree that the use of personal and pseudonymised data in biomedical research must be regulated proportionately to the real risks, and should acknowledge that techno logies increasingly allow research participants to make enlightened and autonomous decisions about the scope of consent to research. Now is the time for medical researchers and practitioners to explain these potential benefits,
harms, and safeguards to their recently elected Members of the European Parliament. We declare no competing interests.
Edward S Dove, David Townend, *Bartha M Knoppers [email protected] Centre of Genomics and Policy, McGill University, Montreal, QC H3A 0G1, Canada (ESD, BMK); and Department of Health, Ethics & Society, Maastricht University, Netherlands (DT) 1
2
3
4
5 6
7
8
9
European Parliament. Legislative resolution of 12 March 2014 on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). March 12, 2014. http://www.europarl.europa.eu/ sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7TA-2014-0212+0+DOC+XML+V0//EN (accessed Aug 21, 2014). Casali PG. Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458–61. Di Iorio CT, Carinci F, Oderkirk J. Health research and systems’ governance are at risk: should the right to data protection override health? J Med Ethics 2014; 40: 488–92. Ploem MC, Essink-Bot ML, Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: f3534. McCall B. European Parliament supports data protection reforms. Lancet 2014; 383: 1115. Mascalzoni D, Knoppers BM, Aymé S, et al. Rare diseases and now rare data? Nat Rev Genet 2013; 14: 372. Protecting health and scientific research in the Data Protection Regulation (2012/0011(COD)): Position of non-commercial research organisations and academics– July 2014. http://www.wellcome. ac.uk/stellent/groups/corporatesite/@ policy_communications/documents/web_ document/WTP055584.pdf (accessed Aug 7, 2014). Council of the European Union. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). June 30, 2014. http://register.consilium. europa.eu/doc/srv?l=EN&f=ST%2011028%20 2014%20INIT (accessed Aug 7, 2014). European Commission. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). Jan 25, 2012. http://ec.europa.eu/justice/ data-protection/document/review2012/ com_2012_11_en.pdf (accessed Aug 21, 2014).
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