- Email: [email protected]
Recommendations based on value, not cost
Correspondence
Published Online March 1, 2017 http://dx.doi.org/10.1016/ S0140-6736(17)30646-3
described in the CTT’s 1995 protocol.4 The first main question specified in that protocol was total mortality. As our article2 showed, statin therapy did not statistically significantly reduce total mortality in the lowrisk population. This finding has not been challenged by Rory Collins, and was upheld by two independent statistical analyses performed as part of an assessment of his (unanimously rejected) request for retraction of the article.5 Horton blurs the facts when he states that that after publication of our article in The BMJ, “patients already taking statins were more likely to stop”.1 Rather, the weak evidence links statin cessation to media coverage that started 6 months after publication of the BMJ article, which correlates temporally with Collins’ critique of our article in the media, and not publication of the article itself.6 The only fault with our BMJ article was the interpretation of a retrospective cohort study:7 our article stated that 18% of people stopped statins because of statin-related events, whereas the correct number was 9%. This error has been corrected. Horton’s point that “some observers have likened this statin scare to that of MMR” implies that our research was fraudulent and the error we made was intentional. No evidence to support these accusations exists, and they should be withdrawn. JA and NJ serve as experts in pharmaceutical and medical device litigation. HGR and JMW declare no competing interests.
*John Abramson, Harriet G Rosenberg, Nicholas Jewell, James M Wright [email protected] Harvard Medical School, Ipswich, MA 1938, USA (JA); Department of Social Science, Faculty of Liberal Arts and Professional Studies, York University, Toronto, ON, Canada (HGR); Division of Biostatistics, School of Public Health Department of Statistics, University of California, Berkeley, CA, USA (NJ); and Departments of Anesthesiology, Pharmacology and Therapeutics and Medicine, University of BC, Vancouver, BC, Canada (JMW) 1
1102
Horton R. Offline: Lessons from the controversy over statins. Lancet 2016; 388: 1040.
2
3
4
5
6
7
Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ 2013; 347: f6123. Cholesterol Treatment Trialists’ Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012; 380: 581–90. Cholesterol Treatment Trialists’ Collaboration. Protocol for a prospective collaborative overview of all current and planned randomized trials of cholesterol treatment regimens. Am J Cardiol 1995; 75: 1130–34. Heath I, Evans S, Furberg C, et al. Report of the independent panel considering the retraction of two articles in the BMJ. BMJ 2014; 349: g5176. Abramson JD, Rosenberg H, Jewell N, Halilovic L, Wright JM. RE: impact of statin related media coverage on use of statins: interrupted time series analysis with UK primary care data. http://www.bmj.com/ content/353/bmj.i3283/rr-0 (accessed Jan 19, 2017). Zhang H, Plutzky J, Skentzos S, et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med 2013; 158: 526–34.
would make that clear. If that was the case, why would a series of expensive medicines for treating hepatitis C have been approved? By carefully examining the incremental therapeutic benefit of new treatments, NICE ensures that the first—and most important— aspect of value is established before cost is considered. But to suggest that the cost to the NHS should not be a factor in the decision about whether to offer a treatment, because it is for a condition with powerful advocacy, risks compromising access to other NHS services with equally compelling arguments for funding. We need consistency, objectivity, and balance in the decisions that we make about access to new treatments. I am employed by the National Institute for Health and Care Excellence.
Andrew Dillon [email protected]
Recommendations based on value, not cost Basing decisions to recommend new treatments, appraised by the National Institute for Health and Care Excellence (NICE), on value is undoubtedly correct. But what does value mean in this context? Clearly, to patients, value means the prospect of an improvement in their condition and, for terminally ill people with cancer, the potential for life to be extended. But for the UK’s National Health Service (NHS), value also means investment of scarce resources that can be justified in light of the health benefit they will confer. To ignore cost and its association with clinical benefit requires compelling justification. Of course, these decisions become much more difficult when the treatments involved are intended to extend life, especially at the end of our lives. This occurrence is the case with trastuzumab emtansine for advanced or metastatic breast cancer. NICE does not base its recommendations purely on cost, as claimed in a Lancet Editorial (Jan 7, p 2).1 Even a cursory reading of the guidance that NICE produces
National Institute for Health and Care Excellence, London SW1A 2BU, UK 1
The Lancet. Trastuzumab emtansine and cost-based decision making. Lancet 2017; 389: 2.
Department of Error Németh G, Laszlovszky I, Czobar P, et al. Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial. Lancet 2017; 389: 1103–13—In table 1 of this Article, in the “Number of acute exacerbations, <5” subgroup in the Risperidone group column, 26 (55%) should be 126 (55%). This correction has been made to the online version as of March 1, 2017, and the printed Article is correct. Mäkikallio T, Holm NR, Lindsay M, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet 2016; 388: 2743–52—Due to administrative and coding errors, the Kaplan-Meier estimates, graph figures, and table 2 data are incorrect in this Article and have been updated. The affiliation for M Corbascio and the appendix has also been updated. These corrections have been made to the online version as of March 16, 2017.
www.thelancet.com Vol 389 March 18, 2017
Published Online March 1, 2017 http://dx.doi.org/10.1016/ S0140-6736(17)30646-3
described in the CTT’s 1995 protocol.4 The first main question specified in that protocol was total mortality. As our article2 showed, statin therapy did not statistically significantly reduce total mortality in the lowrisk population. This finding has not been challenged by Rory Collins, and was upheld by two independent statistical analyses performed as part of an assessment of his (unanimously rejected) request for retraction of the article.5 Horton blurs the facts when he states that that after publication of our article in The BMJ, “patients already taking statins were more likely to stop”.1 Rather, the weak evidence links statin cessation to media coverage that started 6 months after publication of the BMJ article, which correlates temporally with Collins’ critique of our article in the media, and not publication of the article itself.6 The only fault with our BMJ article was the interpretation of a retrospective cohort study:7 our article stated that 18% of people stopped statins because of statin-related events, whereas the correct number was 9%. This error has been corrected. Horton’s point that “some observers have likened this statin scare to that of MMR” implies that our research was fraudulent and the error we made was intentional. No evidence to support these accusations exists, and they should be withdrawn. JA and NJ serve as experts in pharmaceutical and medical device litigation. HGR and JMW declare no competing interests.
*John Abramson, Harriet G Rosenberg, Nicholas Jewell, James M Wright [email protected] Harvard Medical School, Ipswich, MA 1938, USA (JA); Department of Social Science, Faculty of Liberal Arts and Professional Studies, York University, Toronto, ON, Canada (HGR); Division of Biostatistics, School of Public Health Department of Statistics, University of California, Berkeley, CA, USA (NJ); and Departments of Anesthesiology, Pharmacology and Therapeutics and Medicine, University of BC, Vancouver, BC, Canada (JMW) 1
1102
Horton R. Offline: Lessons from the controversy over statins. Lancet 2016; 388: 1040.
2
3
4
5
6
7
Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ 2013; 347: f6123. Cholesterol Treatment Trialists’ Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012; 380: 581–90. Cholesterol Treatment Trialists’ Collaboration. Protocol for a prospective collaborative overview of all current and planned randomized trials of cholesterol treatment regimens. Am J Cardiol 1995; 75: 1130–34. Heath I, Evans S, Furberg C, et al. Report of the independent panel considering the retraction of two articles in the BMJ. BMJ 2014; 349: g5176. Abramson JD, Rosenberg H, Jewell N, Halilovic L, Wright JM. RE: impact of statin related media coverage on use of statins: interrupted time series analysis with UK primary care data. http://www.bmj.com/ content/353/bmj.i3283/rr-0 (accessed Jan 19, 2017). Zhang H, Plutzky J, Skentzos S, et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med 2013; 158: 526–34.
would make that clear. If that was the case, why would a series of expensive medicines for treating hepatitis C have been approved? By carefully examining the incremental therapeutic benefit of new treatments, NICE ensures that the first—and most important— aspect of value is established before cost is considered. But to suggest that the cost to the NHS should not be a factor in the decision about whether to offer a treatment, because it is for a condition with powerful advocacy, risks compromising access to other NHS services with equally compelling arguments for funding. We need consistency, objectivity, and balance in the decisions that we make about access to new treatments. I am employed by the National Institute for Health and Care Excellence.
Andrew Dillon [email protected]
Recommendations based on value, not cost Basing decisions to recommend new treatments, appraised by the National Institute for Health and Care Excellence (NICE), on value is undoubtedly correct. But what does value mean in this context? Clearly, to patients, value means the prospect of an improvement in their condition and, for terminally ill people with cancer, the potential for life to be extended. But for the UK’s National Health Service (NHS), value also means investment of scarce resources that can be justified in light of the health benefit they will confer. To ignore cost and its association with clinical benefit requires compelling justification. Of course, these decisions become much more difficult when the treatments involved are intended to extend life, especially at the end of our lives. This occurrence is the case with trastuzumab emtansine for advanced or metastatic breast cancer. NICE does not base its recommendations purely on cost, as claimed in a Lancet Editorial (Jan 7, p 2).1 Even a cursory reading of the guidance that NICE produces
National Institute for Health and Care Excellence, London SW1A 2BU, UK 1
The Lancet. Trastuzumab emtansine and cost-based decision making. Lancet 2017; 389: 2.
Department of Error Németh G, Laszlovszky I, Czobar P, et al. Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial. Lancet 2017; 389: 1103–13—In table 1 of this Article, in the “Number of acute exacerbations, <5” subgroup in the Risperidone group column, 26 (55%) should be 126 (55%). This correction has been made to the online version as of March 1, 2017, and the printed Article is correct. Mäkikallio T, Holm NR, Lindsay M, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet 2016; 388: 2743–52—Due to administrative and coding errors, the Kaplan-Meier estimates, graph figures, and table 2 data are incorrect in this Article and have been updated. The affiliation for M Corbascio and the appendix has also been updated. These corrections have been made to the online version as of March 16, 2017.
www.thelancet.com Vol 389 March 18, 2017