- Email: [email protected]
Abacavir and increased risk of myocardial infarction
Correspondence
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Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31–41. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Ann Intern Med 1999; 130: 461–70. Mocroft A, Kirk O, Gatell J, et al. Chronic renal failure among HIV-1-infected patients. AIDS 2007; 21: 1119–27. SMART/INSIGHT and D:A:D Study Groups. Use of NRTIs and risk of myocardial infarction in HIV-infected patients. AIDS 2008; 22: 1–8.
forward. The implications of delay for those that could be at risk are clear. The need for strong evidence to allow for informed and correct regulatory communication or action is also obvious since incorrect actions might deprive many of useful treatment. The balance of timeliness versus certainty is a real challenge.4 We declare that we have no conflict of interest.
Ralph Edwards, Andrew Bate, *Marie Lindquist [email protected] Uppsala Monitoring Centre, 75140 Uppsala, Sweden
As mentioned in the D:A:D study report,1 the possible relation between abacavir and myocardial infarction was signalled in 2005 after data-mining the 4 million spontaneous reports in the WHO database, VigiBase.2 This signal is one of only seven referring to myocardial infarction circulated to regulators within the WHO Programme for International Drug Monitoring in the past 10 years; another involves glitazones, signalled in 2003, also under review. Other key parties receiving the abacavir signal included the D:A:D Study Group, who incorporated an investigation in their ongoing research. Early signals must be regarded very cautiously and mostly require further work before any firm regulatory action. The signal and the subsequent D:A:D report is an important pharmacovigilance success and a model for investigations of early serious signals. A signal such as this might have been found in other data—eg, patients’ records, but would still require confirmation in the absence of an a-priori hypothesis. The delay in producing more substantial evidence on this risk from abacavir was 2 years: and this was an optimum situation where the study platform was already in place. Even now there is the start of further debate on the result.3 Openness, yet caution, over first signals, allowing others to respond and investigate, seems the ethical way www.thelancet.com Vol 372 September 6, 2008
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D:A:D Study Group. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration. Lancet 2008; 371: 1417–26. Sanz E. Abacavir—myocardial infarction. WHO Signal 2005. http://www.who-umc.org/ graphics/15962.pdf (accessed March 14, 2008). Cutrell A, Brothers C, Yeo J, Hernandez J, Lapierre D. Abacavir and the potential risk of myocardial infarction. Lancet 2008; 371: 1413. Bowdler J. Effective communications in pharmacovigilance, 1st edn. Birmingham: W Lake, 1997.
Coordination and accountability in the World Health Assembly Gaudenz Silberschmidt and colleagues (May 3, p 1483)1 call for the creation of a “committee C” of the World Health Assembly, charged with coordination in global health. However, who is coordinating whom? The ambiguity of the committee structure makes it likely that donors and international agencies will be coordinating developing countries—the opposite of what is most needed. Silberschmidt and colleagues argue that there is no broad coordination in international health. However, would coordination help meet the health needs of the poor? It might, in fact, make it more difficult for developing countries to align donors towards their national health priorities. Previous attempts at coordination in international development have resulted in funding becoming
dependent on addressing donorspecificed priorities.2,3 Maintenance of national control might allow some issues that are not priorities for donors, such as non-communicable disease, maternal health, mental health, and health infrastructure,4,5 to be addressed. Most dangerous is the call for committee C to involve representatives of “international agencies, philanthropic organisations, multinational health initiatives, and… civil society groups.” Silberschmidt and colleagues propose that this amalgamation would increase transparency and accountability. It does seem designed to increase accountability—just in the wrong direction. As proposed, the committee would probably increase the accountability of developing countries to donors and institutions in developed countries. If we learned anything from the tried and failed attempts at coordination in other aspects of international aid and development policy, it is that we need to create structures that move accountability in the other direction. Governance reform in global health needs to improve accountability to— not of—developing countries. WHO Oliver O’Hanlon
London, UK (CAS, ANP); and Rigshospitalet & University of Copenhagen, 2200 Copenhagen, Denmark (SW, JDL)
I declare that I have no conflict of interest.
Rajaie Batniji [email protected] Global Economic Governance Programme, Department of Politics and International Relations, University College, Oxford OX1 4BH, UK 1
2
3
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Silberschmidt G, Matheson D, Kickbusch I. Creating a committee C of the World Health Assembly. Lancet 2008; 371: 1483–86. Murray CJL, Frenk J, Evans T. The Global Campaign for the Health MDGs: challenges, opportunities, and the imperative of shared learning. Lancet 2007; 370: 1018–20. Hecht R, Shah R. Recent trends and innovations in development assistance for health. In: Jamison DT, Breman JG, Measham AR, et al, eds. Disease control priorities in developing countries, 2nd edn. New York: Oxford University Press, 2006: 243–57. Shiffman J. Donor funding priorities for communicable disease control in the developing world. Health Policy Plann 2006; 21: 411. MacKellar L. Priorities in global assistance for health, AIDS, and population. Popul Dev Rev 2005; 31: 293–312.
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1
2
3
4
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31–41. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Ann Intern Med 1999; 130: 461–70. Mocroft A, Kirk O, Gatell J, et al. Chronic renal failure among HIV-1-infected patients. AIDS 2007; 21: 1119–27. SMART/INSIGHT and D:A:D Study Groups. Use of NRTIs and risk of myocardial infarction in HIV-infected patients. AIDS 2008; 22: 1–8.
forward. The implications of delay for those that could be at risk are clear. The need for strong evidence to allow for informed and correct regulatory communication or action is also obvious since incorrect actions might deprive many of useful treatment. The balance of timeliness versus certainty is a real challenge.4 We declare that we have no conflict of interest.
Ralph Edwards, Andrew Bate, *Marie Lindquist [email protected] Uppsala Monitoring Centre, 75140 Uppsala, Sweden
As mentioned in the D:A:D study report,1 the possible relation between abacavir and myocardial infarction was signalled in 2005 after data-mining the 4 million spontaneous reports in the WHO database, VigiBase.2 This signal is one of only seven referring to myocardial infarction circulated to regulators within the WHO Programme for International Drug Monitoring in the past 10 years; another involves glitazones, signalled in 2003, also under review. Other key parties receiving the abacavir signal included the D:A:D Study Group, who incorporated an investigation in their ongoing research. Early signals must be regarded very cautiously and mostly require further work before any firm regulatory action. The signal and the subsequent D:A:D report is an important pharmacovigilance success and a model for investigations of early serious signals. A signal such as this might have been found in other data—eg, patients’ records, but would still require confirmation in the absence of an a-priori hypothesis. The delay in producing more substantial evidence on this risk from abacavir was 2 years: and this was an optimum situation where the study platform was already in place. Even now there is the start of further debate on the result.3 Openness, yet caution, over first signals, allowing others to respond and investigate, seems the ethical way www.thelancet.com Vol 372 September 6, 2008
1
2
3
4
D:A:D Study Group. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration. Lancet 2008; 371: 1417–26. Sanz E. Abacavir—myocardial infarction. WHO Signal 2005. http://www.who-umc.org/ graphics/15962.pdf (accessed March 14, 2008). Cutrell A, Brothers C, Yeo J, Hernandez J, Lapierre D. Abacavir and the potential risk of myocardial infarction. Lancet 2008; 371: 1413. Bowdler J. Effective communications in pharmacovigilance, 1st edn. Birmingham: W Lake, 1997.
Coordination and accountability in the World Health Assembly Gaudenz Silberschmidt and colleagues (May 3, p 1483)1 call for the creation of a “committee C” of the World Health Assembly, charged with coordination in global health. However, who is coordinating whom? The ambiguity of the committee structure makes it likely that donors and international agencies will be coordinating developing countries—the opposite of what is most needed. Silberschmidt and colleagues argue that there is no broad coordination in international health. However, would coordination help meet the health needs of the poor? It might, in fact, make it more difficult for developing countries to align donors towards their national health priorities. Previous attempts at coordination in international development have resulted in funding becoming
dependent on addressing donorspecificed priorities.2,3 Maintenance of national control might allow some issues that are not priorities for donors, such as non-communicable disease, maternal health, mental health, and health infrastructure,4,5 to be addressed. Most dangerous is the call for committee C to involve representatives of “international agencies, philanthropic organisations, multinational health initiatives, and… civil society groups.” Silberschmidt and colleagues propose that this amalgamation would increase transparency and accountability. It does seem designed to increase accountability—just in the wrong direction. As proposed, the committee would probably increase the accountability of developing countries to donors and institutions in developed countries. If we learned anything from the tried and failed attempts at coordination in other aspects of international aid and development policy, it is that we need to create structures that move accountability in the other direction. Governance reform in global health needs to improve accountability to— not of—developing countries. WHO Oliver O’Hanlon
London, UK (CAS, ANP); and Rigshospitalet & University of Copenhagen, 2200 Copenhagen, Denmark (SW, JDL)
I declare that I have no conflict of interest.
Rajaie Batniji [email protected] Global Economic Governance Programme, Department of Politics and International Relations, University College, Oxford OX1 4BH, UK 1
2
3
4
5
Silberschmidt G, Matheson D, Kickbusch I. Creating a committee C of the World Health Assembly. Lancet 2008; 371: 1483–86. Murray CJL, Frenk J, Evans T. The Global Campaign for the Health MDGs: challenges, opportunities, and the imperative of shared learning. Lancet 2007; 370: 1018–20. Hecht R, Shah R. Recent trends and innovations in development assistance for health. In: Jamison DT, Breman JG, Measham AR, et al, eds. Disease control priorities in developing countries, 2nd edn. New York: Oxford University Press, 2006: 243–57. Shiffman J. Donor funding priorities for communicable disease control in the developing world. Health Policy Plann 2006; 21: 411. MacKellar L. Priorities in global assistance for health, AIDS, and population. Popul Dev Rev 2005; 31: 293–312.
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