(This article was originally published at Statistical Modeling, Causal Inference, and Social Science, and syndicated at StatsBlogs.)
Paul Alper writes:
The following involves Novartis so it may be of interest to you. This Washington Post article headline says:
Extending anti-estrogen therapy to 10 years reduces breast-cancer recurrence, new cancers
Nevertheless,
However, women who were treated with the drug for a total 10 years didn’t live longer than those who were given a placebo in the study. Goss said at a news briefing on Sunday that he’s confident a survival benefit will emerge in the data in coming years.
Consequently, is this an instance of a surrogate criterion? That is, recurrence was reduced via the treatment but the end point of death is the same. Further, despite detailed numbers for disease-free survival,
Looked at another way, 95 percent of the women in the letrozole group experienced disease-free survival for five years, compared with 91 percent in the placebo group.
The possible harms of treatment have no numbers, only vague comparisons:
Letrozole has side effects, and the women who took it for a prolonged period as part of the study suffered more bone pain, fractures and the onset of osteoporosis compared with the women who didn’t get the drug.
This from Sharon Begley:
Older women who took drugs called aromatase inhibitors for 10 years rather than the usual five had a lower risk of their breast cancer returning.
The study, which was also published Sunday in the New England Journal of Medicine, was partially funded by Novartis, which sells letrozole — the aromatase inhibitor used in the trial — as the branded drug Femara. Several of the authors have received speaking fees or consulting payments from Novartis, AstraZeneca (which makes letrozole), and Pfizer (maker of the aromatase inhibitor exemestane).
I know nothing at all about any of this but I decided to post because I receive consulting payments from Novartis (and have also been paid by Pfizer).
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