- Email: [email protected]
Regulating medical tourism
Correspondence
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3
4
5
Harris-Roxas B, Harris E. Differing forms, differing purposes: a typology of health impact assessment. Environ Impact Assess Rev (in press). IFC. Introduction to health impact assessment. Washington, DC: International Finance Corporation, 2009. Listorti JA, Doumani FM. Environmental health: bridging the gaps. Washington, DC: World Bank, 2001. WHO. Closing the gap in a generation: health equity through action on the social determinants of health. Geneva: Commission on the Social Determinants of Health, 2008.
Authors’ reply We appreciate the points offered by Salim Vohra and colleagues. Yet we strongly disagree with their perspective, justified on the following grounds. First, our Comment was centred on the need to clarify important distinctions between private sector projects and government-sponsored policies, programmes, and projects, which are currently being conflated. The field of health impact assessment (HIA) is being wrapped in a cloak of aspirational social determinants rhetoric, which fosters a misperception of universality of this framework and its implementation. The social determinants movement has an important objective to identify and potentially alleviate social inequalities. Although worthy, this is not the role and responsibility of a private company. Our key point is to recognise the aspects of a project that the private sector can directly affect. As part of a project, key core competencies (eg, engineering and logistics) of the private sector can be selectively focused to avoid or mitigate negative health effects and enhance positive ones. The International Finance Corporation (IFC) HIA toolkit recognises the link between broadly defined environmental health and the burden of diseases in the developing world.1 It therefore builds on pioneering work by the World Bank,2 supported by contemporary HIA in developing countries.3,4 We believe that it is a mistake to embed HIA for large industrial projects, and subsequent local community follow-up, in a discussion of social issues that no www.thelancet.com Vol 376 October 30, 2010
private-sector project can realistically and sustainably manage. Second, Vohra and colleagues reveal a misreading of the development of the Equator Principles, which are a voluntary set of standards for the identification, assessment, and management of social and environmental risk in project financing. Describing the history of the Equator Principles as a “demand” by governments for financial institutions’ “accountability” is simply not correct.5 Third, our group was indeed commissioned by the IFC to develop technical guidance for HIA. We stated in our conflict of interest statement that we had done work for “the private sector, development banks, and multinational organisations”. We apologise if this did not explicitly mention the IFC. Similar to other private sector and multinational organisations, IFC has a rigorous process for vetting and reviewing guidance materials. Our contribution went through exhaustive stakeholder consultation and extensive review by IFC’s in-house technical experts and IFC retained editorial control of the process and final product. Finally, we agree that transparency, accountability, and having a wide scope—along with operationalisation—are key issues to move the field of HIA forward. A post-Gothenburg international HIA consensus is critical, but this requires clarity about the distinctions between HIAs done as part of nationally focused government initiatives, and those accompanying private-sector projects with only local community effects. We have done work for the private sector, development banks, and multinational organisations, including the IFC, and have served as experts on WHO committees and for other international organisations.
Gary R Krieger, *Jürg Utzinger, Mirko S Winkler, Mark J Divall, Scott D Phillips, Marci Z Balge, Burton H Singer [email protected] NewFields LLC, Denver, CO, USA (GRK, SDP, MZB); Department of Epidemiology and Public Health,
Swiss Tropical and Public Health Institute, 4002 Basel, Switzerland (JU, MSW); NewFields LLC, Pretoria, South Africa (MJD); and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA (BHS) 1
2
3
4
5
Prüss-Ustün A, Bonjour S, Corvalán C. The impact of the environment on health by country: a meta-synthesis. Environ Health 2008; 7: 7. Listorti JA, Doumani FM. Environmental health: bridging the gaps. http://www. worldbank.org/afr/environmentalhealth (accessed Aug 25, 2010). Krieger GR, Balge MZ, Chanthaphone S, et al. Nam Theun 2 hydroelectric project, Lao PDR. In: Fewtrell L, Kay D, eds. Health impact assessment for sustainable water management. London: IWA Publishing, 2008: 199–232. Winkler MS, Divall MJ, Krieger GR, Balge MZ, Singer BH, Utzinger J. Assessing health impacts in complex eco-epidemiological settings in the humid tropics: advancing tools and methods. Environ Impact Assess Rev 2010; 30: 52–61. Heal GM. When principles pay: corporate social responsibility and the bottom line. New York: Columbia University Press, 2008.
Regulating medical tourism We were interested to read Priya Shetty’s World Report examining the booming medical tourism industry in India (Aug 28, p 671).1 The Lancet is to be commended for bringing attention to this issue. It is of the utmost importance that trends in medical tourism be watched closely given the implications for patients’ health and safety2,3 and for health systems more broadly.4 Shetty places significant focus on the need to regulate the medical tourism industry in India. We would like to note that additional, complementary regulatory guidelines are also needed in patients’ home countries. Several prominent source countries for medical tourists, such as Canada and Australia, currently have no national or regional guidelines for patients or clinicians on their involvement in medical tourism, which is concerning. Such guidelines are needed to ensure that patients’ health and safety is prioritised, that adequate health-system responses are in place, and that risks to patients and others are minimised. Those aimed at patients could also incorporate some ethical buying guidelines. 1465
Correspondence
Although we support the need for regulatory guidelines in India and other medical tourism destinations, we believe that such guidelines must be coupled with guidelines in source countries as part of a comprehensive and global approach. If these guidelines are developed piecemeal they risk being less effective or not implemented owing to worries that less regulated countries will develop pricing advantages. We declare that we have no conflicts of interest.
*Valorie A Crooks, Jeremy Snyder [email protected] Department of Geography, Simon Fraser University, Burnaby, BC V5A 1S6, Canada 1 2
3 4
Shetty P. Medical tourism booms in India, but at what cost? Lancet 2010; 376: 671–72. Birch DW, Vu L, Karmali S, Stoklossa CJ, Sharma AM. Medical tourism in bariatric surgery. Am J Surg 2010; 199: 604–08. Cheung IA, Wilson A. Arthroplasty tourism. Med J Aust 2007; 187: 666–67. Turner L. First world health care at third world prices: globalization, bioethics and medical tourism. Biosocieties 2007; 2: 303–25.
interpretation is that the formation of β amyloid might be the brain’s protective mechanism against the disease process. But this view is regarded as pure heresy. Is that because so much research funding and such large drug development budgets are at stake? The review by Mangialasche and colleagues3 concluded that “the one protein, one drug, one disease hypothesis used as a basis of most Alzheimer’s disease therapy studies needs to be revised.” It is time that we stopped looking for a “cure” but directed our research effort to the prevention of Alzheimer’s disease. This complex disease will yield not to a single drug but to multiple approaches to modify the disease process, starting in mid-life. Two examples of hopeful avenues are the treatment of hypertension in mid-life4 and the lowering of homocysteine early in the disease process.5 I declare that I have no conflicts of interest.
Why are drug trials in Alzheimer’s disease failing?
A David Smith [email protected] Oxford Project to Investigate Memory and Ageing (OPTIMA) and Department of Pharmacology, University of Oxford, Oxford OX1 3QT, UK 1
You suggest several reasons why trials in Alzheimer’s disease are failing (Aug 28, p 658),1 but you do not consider an obvious one: that the hypothesis on which most Alzheimer’s trials are based might not be valid. If a scientist does several experiments on the basis of a hypothesis and they all fail, he will abandon the hypothesis. Why are we so reluctant to do this in medicine? The dominant hypothesis in the field is the amyloid hypothesis and almost all trials of potential disease-modifying drugs are based on manipulation of β amyloid. In the recently abandoned semagacestat trial,2 some patients on the drug got worse—ie, the drug, which was designed to inhibit formation of β amyloid, seemed to speed up cognitive decline. One 1466
2
3
4
5
The Lancet. Why are drug trials in Alzheimer’s disease failing? Lancet 2010; 376: 658. PR Newswire. Lilly halts development of semagacestat for Alzheimer’s disease based on preliminary results of phase III clinical trials. http://newsroom.lilly.com/releasedetail. cfm?ReleaseID=499794 (accessed Oct 21, 2010). Mangialasche F, Solomon A, Winblad B, Mecocci P, Kivipelto M. Alzheimer’s disease: clinical trials and drug development. Lancet Neurol 2010; 9: 702–16. Peila R, White LR, Masaki K, Petrovitch H, Launer LJ. Reducing the risk of dementia: efficacy of long-term treatment of hypertension. Stroke 2006; 37: 1165–70. Smith AD, Smith SM, de Jager CA, et al. Homocysteine-lowering by B vitamins slows the rate of accelerated brain atrophy in mild cognitive impairment: a randomized controlled trial. PLoS One 2010; 5: e12244.
Department of Error Ismail-Beigi F, Craven T, Banerji MA, et al, for the ACCORD trial group. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet 2010; 376: 419–30—In this Article (Aug 7), there were some errors in figures 4 and 5. Additionally, on page 419 (Summary), the last line of the Findings should have read “Six secondary measures at study end favoured intensive therapy (p<0·05).” On page 423, paragraph 2 of column 1 should have read “For diabetes-related eye events, cataract extraction was significantly reduced (by 21%) in the intensive group compared with the standard group at study end (figure 5). Other diabetesrelated eye outcomes did not differ significantly between the two groups.” On page 423, paragraph 3 of the right column should have read “Analysis of secondary renal endpoints shows that the risk of development of macroalbuminuria was 31% lower with intensive therapy at transition and 28% lower at study end than with standard therapy.” These corrections have been made to the online version as of Oct 29, 2010. The webappendix has also been updated as of this date.
www.thelancet.com Vol 376 October 30, 2010
2
3
4
5
Harris-Roxas B, Harris E. Differing forms, differing purposes: a typology of health impact assessment. Environ Impact Assess Rev (in press). IFC. Introduction to health impact assessment. Washington, DC: International Finance Corporation, 2009. Listorti JA, Doumani FM. Environmental health: bridging the gaps. Washington, DC: World Bank, 2001. WHO. Closing the gap in a generation: health equity through action on the social determinants of health. Geneva: Commission on the Social Determinants of Health, 2008.
Authors’ reply We appreciate the points offered by Salim Vohra and colleagues. Yet we strongly disagree with their perspective, justified on the following grounds. First, our Comment was centred on the need to clarify important distinctions between private sector projects and government-sponsored policies, programmes, and projects, which are currently being conflated. The field of health impact assessment (HIA) is being wrapped in a cloak of aspirational social determinants rhetoric, which fosters a misperception of universality of this framework and its implementation. The social determinants movement has an important objective to identify and potentially alleviate social inequalities. Although worthy, this is not the role and responsibility of a private company. Our key point is to recognise the aspects of a project that the private sector can directly affect. As part of a project, key core competencies (eg, engineering and logistics) of the private sector can be selectively focused to avoid or mitigate negative health effects and enhance positive ones. The International Finance Corporation (IFC) HIA toolkit recognises the link between broadly defined environmental health and the burden of diseases in the developing world.1 It therefore builds on pioneering work by the World Bank,2 supported by contemporary HIA in developing countries.3,4 We believe that it is a mistake to embed HIA for large industrial projects, and subsequent local community follow-up, in a discussion of social issues that no www.thelancet.com Vol 376 October 30, 2010
private-sector project can realistically and sustainably manage. Second, Vohra and colleagues reveal a misreading of the development of the Equator Principles, which are a voluntary set of standards for the identification, assessment, and management of social and environmental risk in project financing. Describing the history of the Equator Principles as a “demand” by governments for financial institutions’ “accountability” is simply not correct.5 Third, our group was indeed commissioned by the IFC to develop technical guidance for HIA. We stated in our conflict of interest statement that we had done work for “the private sector, development banks, and multinational organisations”. We apologise if this did not explicitly mention the IFC. Similar to other private sector and multinational organisations, IFC has a rigorous process for vetting and reviewing guidance materials. Our contribution went through exhaustive stakeholder consultation and extensive review by IFC’s in-house technical experts and IFC retained editorial control of the process and final product. Finally, we agree that transparency, accountability, and having a wide scope—along with operationalisation—are key issues to move the field of HIA forward. A post-Gothenburg international HIA consensus is critical, but this requires clarity about the distinctions between HIAs done as part of nationally focused government initiatives, and those accompanying private-sector projects with only local community effects. We have done work for the private sector, development banks, and multinational organisations, including the IFC, and have served as experts on WHO committees and for other international organisations.
Gary R Krieger, *Jürg Utzinger, Mirko S Winkler, Mark J Divall, Scott D Phillips, Marci Z Balge, Burton H Singer [email protected] NewFields LLC, Denver, CO, USA (GRK, SDP, MZB); Department of Epidemiology and Public Health,
Swiss Tropical and Public Health Institute, 4002 Basel, Switzerland (JU, MSW); NewFields LLC, Pretoria, South Africa (MJD); and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA (BHS) 1
2
3
4
5
Prüss-Ustün A, Bonjour S, Corvalán C. The impact of the environment on health by country: a meta-synthesis. Environ Health 2008; 7: 7. Listorti JA, Doumani FM. Environmental health: bridging the gaps. http://www. worldbank.org/afr/environmentalhealth (accessed Aug 25, 2010). Krieger GR, Balge MZ, Chanthaphone S, et al. Nam Theun 2 hydroelectric project, Lao PDR. In: Fewtrell L, Kay D, eds. Health impact assessment for sustainable water management. London: IWA Publishing, 2008: 199–232. Winkler MS, Divall MJ, Krieger GR, Balge MZ, Singer BH, Utzinger J. Assessing health impacts in complex eco-epidemiological settings in the humid tropics: advancing tools and methods. Environ Impact Assess Rev 2010; 30: 52–61. Heal GM. When principles pay: corporate social responsibility and the bottom line. New York: Columbia University Press, 2008.
Regulating medical tourism We were interested to read Priya Shetty’s World Report examining the booming medical tourism industry in India (Aug 28, p 671).1 The Lancet is to be commended for bringing attention to this issue. It is of the utmost importance that trends in medical tourism be watched closely given the implications for patients’ health and safety2,3 and for health systems more broadly.4 Shetty places significant focus on the need to regulate the medical tourism industry in India. We would like to note that additional, complementary regulatory guidelines are also needed in patients’ home countries. Several prominent source countries for medical tourists, such as Canada and Australia, currently have no national or regional guidelines for patients or clinicians on their involvement in medical tourism, which is concerning. Such guidelines are needed to ensure that patients’ health and safety is prioritised, that adequate health-system responses are in place, and that risks to patients and others are minimised. Those aimed at patients could also incorporate some ethical buying guidelines. 1465
Correspondence
Although we support the need for regulatory guidelines in India and other medical tourism destinations, we believe that such guidelines must be coupled with guidelines in source countries as part of a comprehensive and global approach. If these guidelines are developed piecemeal they risk being less effective or not implemented owing to worries that less regulated countries will develop pricing advantages. We declare that we have no conflicts of interest.
*Valorie A Crooks, Jeremy Snyder [email protected] Department of Geography, Simon Fraser University, Burnaby, BC V5A 1S6, Canada 1 2
3 4
Shetty P. Medical tourism booms in India, but at what cost? Lancet 2010; 376: 671–72. Birch DW, Vu L, Karmali S, Stoklossa CJ, Sharma AM. Medical tourism in bariatric surgery. Am J Surg 2010; 199: 604–08. Cheung IA, Wilson A. Arthroplasty tourism. Med J Aust 2007; 187: 666–67. Turner L. First world health care at third world prices: globalization, bioethics and medical tourism. Biosocieties 2007; 2: 303–25.
interpretation is that the formation of β amyloid might be the brain’s protective mechanism against the disease process. But this view is regarded as pure heresy. Is that because so much research funding and such large drug development budgets are at stake? The review by Mangialasche and colleagues3 concluded that “the one protein, one drug, one disease hypothesis used as a basis of most Alzheimer’s disease therapy studies needs to be revised.” It is time that we stopped looking for a “cure” but directed our research effort to the prevention of Alzheimer’s disease. This complex disease will yield not to a single drug but to multiple approaches to modify the disease process, starting in mid-life. Two examples of hopeful avenues are the treatment of hypertension in mid-life4 and the lowering of homocysteine early in the disease process.5 I declare that I have no conflicts of interest.
Why are drug trials in Alzheimer’s disease failing?
A David Smith [email protected] Oxford Project to Investigate Memory and Ageing (OPTIMA) and Department of Pharmacology, University of Oxford, Oxford OX1 3QT, UK 1
You suggest several reasons why trials in Alzheimer’s disease are failing (Aug 28, p 658),1 but you do not consider an obvious one: that the hypothesis on which most Alzheimer’s trials are based might not be valid. If a scientist does several experiments on the basis of a hypothesis and they all fail, he will abandon the hypothesis. Why are we so reluctant to do this in medicine? The dominant hypothesis in the field is the amyloid hypothesis and almost all trials of potential disease-modifying drugs are based on manipulation of β amyloid. In the recently abandoned semagacestat trial,2 some patients on the drug got worse—ie, the drug, which was designed to inhibit formation of β amyloid, seemed to speed up cognitive decline. One 1466
2
3
4
5
The Lancet. Why are drug trials in Alzheimer’s disease failing? Lancet 2010; 376: 658. PR Newswire. Lilly halts development of semagacestat for Alzheimer’s disease based on preliminary results of phase III clinical trials. http://newsroom.lilly.com/releasedetail. cfm?ReleaseID=499794 (accessed Oct 21, 2010). Mangialasche F, Solomon A, Winblad B, Mecocci P, Kivipelto M. Alzheimer’s disease: clinical trials and drug development. Lancet Neurol 2010; 9: 702–16. Peila R, White LR, Masaki K, Petrovitch H, Launer LJ. Reducing the risk of dementia: efficacy of long-term treatment of hypertension. Stroke 2006; 37: 1165–70. Smith AD, Smith SM, de Jager CA, et al. Homocysteine-lowering by B vitamins slows the rate of accelerated brain atrophy in mild cognitive impairment: a randomized controlled trial. PLoS One 2010; 5: e12244.
Department of Error Ismail-Beigi F, Craven T, Banerji MA, et al, for the ACCORD trial group. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet 2010; 376: 419–30—In this Article (Aug 7), there were some errors in figures 4 and 5. Additionally, on page 419 (Summary), the last line of the Findings should have read “Six secondary measures at study end favoured intensive therapy (p<0·05).” On page 423, paragraph 2 of column 1 should have read “For diabetes-related eye events, cataract extraction was significantly reduced (by 21%) in the intensive group compared with the standard group at study end (figure 5). Other diabetesrelated eye outcomes did not differ significantly between the two groups.” On page 423, paragraph 3 of the right column should have read “Analysis of secondary renal endpoints shows that the risk of development of macroalbuminuria was 31% lower with intensive therapy at transition and 28% lower at study end than with standard therapy.” These corrections have been made to the online version as of Oct 29, 2010. The webappendix has also been updated as of this date.
www.thelancet.com Vol 376 October 30, 2010