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Conflicts of interest

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).

2 Comments

  1. Keith O'Rourke says:

    I believe this provides a fuller context to understand the issues in these cases – Dr. John Ioannidis Keynote: Evidence-Based Medicine Has Been Hijacked https://www.youtube.com/watch?v=N63skNtYaJw

    Especially like the graph at ~ 10 minutes.

    • Martha (Smith) says:

      Thanks for the link. Yes, the graph you mention is very informative; the idea of looking at it is a good one (giving an overview of clinical trials comparing two drugs — there are very few that compare drugs from different manufacturers).

      I also noted that he mentioned the Garden of Forking Paths (although not by name) at a couple of places: around minute 12 (concerning meta-analyses of effectiveness of anti-depressants) and around minute 25 (concerning effectiveness of alpha tocopherol).

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