Healthy Skepticism Library item: 16987

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Publication type: Journal Article

Barrington KJ
Drug firm conflicting interests: If only industry funded trials were as well done as the WHI
BMJ 2009 Dec 31; 339:
http://www.bmj.com/cgi/content/extract/339/dec31_1/b5655

Abstract:

Lawton shoots himself in the foot when he uses the women’s health initiative study as an example of a non-industry funded study that deviates from good standards.1 Unlike many industry funded studies this enormous and extremely complex trial had impeccable standards. The protocol was published in great detail, including details of the data safety monitoring procedures, and the trial was stopped because the design-specified weighted log rank test statistic for breast cancer (z=–3.19) crossed the designated boundary (z=–2.32). There was no post hoc change in the significance level as claimed, and breast cancer was one of the end points of the study from the start, as can be seen in the protocol published in 1998, the trial being stopped in 2002. Such transparency in study design is unfortunately rare for industry funded studies, in which changes in outcomes or analyses or simply a decision not to . . .