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Response to “Rosiglitazone no longer recommended”
Correspondence
Response to “Rosiglitazone no longer recommended”
Getty
GlaxoSmithKline (GSK) disagrees with The Lancet’s endorsement (Nov 1, p 1520)1 of the recommendations on rosiglitazone from the panel of experts convened by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).2 Simply stated, the panel’s consensus statement was not based on any new information about the safety or efficacy of thiazolidinediones or rosiglitazone. All of the clinical trial data that have emerged since the ADA/EASD guidance of January, 2008, have failed to support the hypothesis generated from the meta-analysis by Nissen and colleagues,3 purporting that rosiglitazone is associated with an increase in myocardial ischaemia or death. Importantly, your Editorial asserts that the results of the ACCORD study suggest that rosiglitazone was associated with increased cardiovascular risk. This is not true. Published reports and presentations of the ACCORD study, and the conclusions of its investigators, do not suggest that rosiglitazone was associated with an increased cardiovascular risk in this study.4,5 The evidence on the association of rosiglitazone with increased risk of cardiovascular mortality and morbidity remains inconclusive, with no long-term trial finding definitive evidence of an increased risk. GSK strongly believes that rosiglitazone has a place in the therapeutic armamentarium for type 2 diabetes when used appropriately.
Ellen Strahlman [email protected] Senior Vice President & Chief Medical Officer, GlaxoSmithKline, King of Prussia, PA 19406, USA 1
544
The Lancet. Rosiglitazone no longer recommended. Lancet 2008; 372: 1520.
2
3
4
5
Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2009; 52: 17–30. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457–71. Gerstein HC, Miller ME, Byington RP, et al, for the Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008; 358: 2545–59. Miller ME. Relationship between glycemia medications and mortality in ACCORD. Presentation at the 68th Scientific Sessions of the American Diabetes Association, June 10, 2008, San Francisco, CA, USA. http:// diabetesconnect.org/storetemplate/Webcast_ list.aspx?ses=952 (accessed Jan 20, 2009).
Women and the global AIDS epidemic We are concerned that the single reference to women’s vulnerability to HIV/AIDS in your Special Report “What next for UNAIDS?” (Dec 20, p 2099)1 is not only also misleading and inaccurate, but anonymous. Why would a “researcher” require his or her statement to be off the record? Perhaps the answer is the statement’s obvious bias. The researcher states “There is only one region in the world where the majority of infections are in women and that is Africa”, ignoring two crucial facts. First, most people living with HIV/AIDS— more than 22 of 33·2 million—live in sub-Saharan Africa and, among adults (those older than 15 years), 59% of these are women.2 Second, women are increasingly at risk in many of the world’s most affected regions, and are often at higher risk than men.2 The statement “…we see this [majority of new infections in women] only in certain age ranges” downplays what most would agree is one of the most egregious aspects of the pandemic: in sub-Saharan Africa, 76% of young people aged 15–24 years living with HIV/AIDS are female.3 The researcher quoted by Pam Das and Udani Samarasekera concludes
by blaming attention to the feminisation of HIV/AIDS for failure to address the epidemic in men who have sex with men. We are not aware of any evidence for this assertion. Why would The Lancet print such a statement and allow it to be anonymous? I declare that I have no conflict of interest.
Adrienne Germain [email protected] International Women’s Health Coalition, New York, NY 10001, USA 1 2
3
Das P, Samarasekera U. What next for UNAIDS? Lancet 2008; 372: 2099–102. UNAIDS. 2008 report on the global AIDS epidemic: executive summary. Geneva: UNAIDS, 2008. http://www.unaids.org/en/Knowledge Centre/HIVData/GlobalReport/2008/2008_ Global_report.asp (accessed Jan 26, 2009). UNAIDS. 2004 report on the global AIDS epidemic. Geneva: UNAIDS, 2004. http://www. unaids.org/bangkok2004/GAR2004_html/ ExecSummary_en/ExecSumm_00_en.htm (accessed Jan 26, 2009).
Combination HIV prevention must be based on evidence In their Correspondence (Nov 22, p 1805)1 on our Comment,2 Michael Merson and colleagues agree that “partner reduction is crucially important in generalised epidemics”. However, many of their other assertions are incorrect. Contrary to the claim that we advocate a “narrowing of HIV prevention to just one or two stand-alone interventions”, we discussed more than a dozen strategies, including harm reduction for injecting drug users, consistent condom use, empowerment of sex workers, and the need to address sexual coercion, gender-based violence, and homophobia.2 Although there is strong evidence for partner reduction and male circumcision,2,3 we did not claim they are “magic bullet solutions”, and they were mentioned in only four of our Comment’s 19 paragraphs. Merson and colleagues’ assertion that partner reduction is “not a clearly defined intervention that can www.thelancet.com Vol 373 February 14, 2009
Response to “Rosiglitazone no longer recommended”
Getty
GlaxoSmithKline (GSK) disagrees with The Lancet’s endorsement (Nov 1, p 1520)1 of the recommendations on rosiglitazone from the panel of experts convened by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).2 Simply stated, the panel’s consensus statement was not based on any new information about the safety or efficacy of thiazolidinediones or rosiglitazone. All of the clinical trial data that have emerged since the ADA/EASD guidance of January, 2008, have failed to support the hypothesis generated from the meta-analysis by Nissen and colleagues,3 purporting that rosiglitazone is associated with an increase in myocardial ischaemia or death. Importantly, your Editorial asserts that the results of the ACCORD study suggest that rosiglitazone was associated with increased cardiovascular risk. This is not true. Published reports and presentations of the ACCORD study, and the conclusions of its investigators, do not suggest that rosiglitazone was associated with an increased cardiovascular risk in this study.4,5 The evidence on the association of rosiglitazone with increased risk of cardiovascular mortality and morbidity remains inconclusive, with no long-term trial finding definitive evidence of an increased risk. GSK strongly believes that rosiglitazone has a place in the therapeutic armamentarium for type 2 diabetes when used appropriately.
Ellen Strahlman [email protected] Senior Vice President & Chief Medical Officer, GlaxoSmithKline, King of Prussia, PA 19406, USA 1
544
The Lancet. Rosiglitazone no longer recommended. Lancet 2008; 372: 1520.
2
3
4
5
Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2009; 52: 17–30. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457–71. Gerstein HC, Miller ME, Byington RP, et al, for the Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008; 358: 2545–59. Miller ME. Relationship between glycemia medications and mortality in ACCORD. Presentation at the 68th Scientific Sessions of the American Diabetes Association, June 10, 2008, San Francisco, CA, USA. http:// diabetesconnect.org/storetemplate/Webcast_ list.aspx?ses=952 (accessed Jan 20, 2009).
Women and the global AIDS epidemic We are concerned that the single reference to women’s vulnerability to HIV/AIDS in your Special Report “What next for UNAIDS?” (Dec 20, p 2099)1 is not only also misleading and inaccurate, but anonymous. Why would a “researcher” require his or her statement to be off the record? Perhaps the answer is the statement’s obvious bias. The researcher states “There is only one region in the world where the majority of infections are in women and that is Africa”, ignoring two crucial facts. First, most people living with HIV/AIDS— more than 22 of 33·2 million—live in sub-Saharan Africa and, among adults (those older than 15 years), 59% of these are women.2 Second, women are increasingly at risk in many of the world’s most affected regions, and are often at higher risk than men.2 The statement “…we see this [majority of new infections in women] only in certain age ranges” downplays what most would agree is one of the most egregious aspects of the pandemic: in sub-Saharan Africa, 76% of young people aged 15–24 years living with HIV/AIDS are female.3 The researcher quoted by Pam Das and Udani Samarasekera concludes
by blaming attention to the feminisation of HIV/AIDS for failure to address the epidemic in men who have sex with men. We are not aware of any evidence for this assertion. Why would The Lancet print such a statement and allow it to be anonymous? I declare that I have no conflict of interest.
Adrienne Germain [email protected] International Women’s Health Coalition, New York, NY 10001, USA 1 2
3
Das P, Samarasekera U. What next for UNAIDS? Lancet 2008; 372: 2099–102. UNAIDS. 2008 report on the global AIDS epidemic: executive summary. Geneva: UNAIDS, 2008. http://www.unaids.org/en/Knowledge Centre/HIVData/GlobalReport/2008/2008_ Global_report.asp (accessed Jan 26, 2009). UNAIDS. 2004 report on the global AIDS epidemic. Geneva: UNAIDS, 2004. http://www. unaids.org/bangkok2004/GAR2004_html/ ExecSummary_en/ExecSumm_00_en.htm (accessed Jan 26, 2009).
Combination HIV prevention must be based on evidence In their Correspondence (Nov 22, p 1805)1 on our Comment,2 Michael Merson and colleagues agree that “partner reduction is crucially important in generalised epidemics”. However, many of their other assertions are incorrect. Contrary to the claim that we advocate a “narrowing of HIV prevention to just one or two stand-alone interventions”, we discussed more than a dozen strategies, including harm reduction for injecting drug users, consistent condom use, empowerment of sex workers, and the need to address sexual coercion, gender-based violence, and homophobia.2 Although there is strong evidence for partner reduction and male circumcision,2,3 we did not claim they are “magic bullet solutions”, and they were mentioned in only four of our Comment’s 19 paragraphs. Merson and colleagues’ assertion that partner reduction is “not a clearly defined intervention that can www.thelancet.com Vol 373 February 14, 2009