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BMJ 2003;327:808-809 (4 October), doi:10.1136/bmj.327.7418.808-c
EDITORThe presence of a statin in the "Polypill" implies a favourable cost effectiveness of the anticholesterol agent for primary prevention.1 2 Medline reports 18 original studies (from 1995 to June 2003) evaluating the cost effectiveness of statins for this indication (8 independent, 10 sponsored3).
In the eight independent reports, the interstudy variations in the cost per life year gained are extremely wide ($C7700 to $US420 000 in men), which shows a profound uncertainty in the convenience of this indication of statins.
On the other hand, the 10 sponsored reports raise the question of whether the sponsor has any influence on the study. The results of these 10 papers are always in favour of the statin produced by the sponsor (10/10; 100%; P = 0.00098 by Signs test).
The figure summarises five studies; the other five (not presented in the figure because their results are not costs per life year gained) indicate an identical pattern, favouring the sponsor's statin. This impressive 100% rate implies that all of these 10 studies are biased by the presence of the sponsor.
One explanation is that the high level of uncertainty in the pharmacoeconomic indices (as shown by the "independent" costs per life year gained) generates a context where the sponsored studies can be guided towards the desired result. Another drawback is that the research question of eight out of 10 studies did not address the point of contrasting statins compared with no statins (the most relevant one from a scientific viewpoint) but considered only comparisons of one statin with another (which is a much less interesting question).3
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Regardless of clinical effectiveness, our data provide a negative picture on the scientific value of the pharmacoeconomic research on primary prevention with statins. Rigorous data on cost effectiveness are still needed before one can propose an indiscriminate use of statins in people aged 55 years or older.1 2
Andrea Messori, coordinator
andreamessori{at}interfree.it
Benedetta Santarlasci, researcher, Sabrina Trippoli, researcher, Monica Vaiani, researcher
Laboratorio di Farmacoeconomia, c/o Pharmaceutical Service, Careggi Hospital, Viale Morgagni 85, I-50134 Florence, Italy