Though tamoxifen and raloxifene were found to have similar efficacy in terms of reducing the incidence of invasive breast cancer in postmenopausal women at increased risk of breast cancer, the article failed to distinguish between differences in side effects that were and were not statistically significant (i.e. that there were 36% fewer uterine cancers and 29% fewer blood clots among women who took raloxifene were not statistically significant while the 21% fewer cataracts were statistically significant). The supposed benefit of raloxifene over tamoxifen is about the prevalence of side effects and so this distinction is important. This is issue is then compounded by the quote from the surgical oncologist “Obviously, if a woman says she’s had a deep vein thrombosis before, I wouldn’t hesitate to recommend the other” because it is clear that this is not an evidenced-based statement. It’s fine to include that comment, but important to put it in context of the evidence. In addition, the two drugs were reported by the NCI as producing the same level of impact on quality of life, so the distinction between these two drugs is even less clear.Though this article portrayed raloxifene as the option with enhanced benefit, the results of the study were much less clear cut.
Cost of raloxifene as well as tamoxifen were provided.
This article portrayed raloxifene as being as effective as tamoxifen in reducing the incidence of invasive breast cancer in postmenopausal women and as having decreased risk of uterine cancer and blood clots. The results of the study found that the difference in these side effects was not statistically significant. This article failed to accurately convey these results.
The increased incidence of other, less-invasive forms of breast cancer (ductal carcinoma in situ and lobular carcinoma in situ) for women taking raloxifene as compared to those taking tamoxifen was not mentioned. While mentioning that uterine cancer is a known risk of tamoxifen, and that women taking raloxifene developed 36% fewer uterine cancers (which calculates out to a difference of 3 cases per thousand), the story failed to mention that this difference was not stastically significant.
The article presented good information about the nature of the clinical trial. Though the study found that the reduction in invasive breast cancer was the same for the two drugs, the article failed to distinguish between differences in side effects that were and were not statistically significant (i.e. that there were 36% fewer uterine cancers and 29% fewer blood clots among women who took raloxifene were not statistically significant while the 21% fewer cataracts were statistically significant). The supposed benefit of raloxifene over tamoxifen is about the prevalence of side effects and so this distinction is important. This is issue is then compounded by the quote from the surgical oncologist “Obviously, if a woman says she’s had a deep vein thrombosis before, I wouldn’t hesitate to recommend the other” because it is clear that this is not an evidenced-based statement. It’s fine to include that comment, but important to put it in context of the evidence. In addition, the two drugs were reported by the NCI as producing the same level of impact on quality of life, so the distinction between these two drugs is even less clear.
While making the claim that breast cancer was a disease that ‘claims 40,000 lives a year’, there was no mention that the results of the study provide no evidence that raloxifene had any impact on death from breast cancer, only that it reduced the chance it would develop in women at increased risk. Many of the ‘40,000 lives’ lost to breast cancer each year would not be candidates for this treatment as they would not have been perceived as being at increased risk prior to diagnosis. In addition, the two drugs were reported by the NCI as producing the same level of impact on quality of life.
The sources of information for this article consisted of clinicians involved in the trial and several oncologists who did not appear to have direct connection with the study.
The article mentioned tamoxifen, the only medication to date that has been approved by the FDA for reducing breast cancer risk in healthy women.
Although the article mentions that doctors could prescribe raloxifene for the purpose of reducing breast cancer risk, it is not yet approved by the FDA for this purpose and would therefore represent an off-label use of this medication.
It’s clear from the story that the use of raloxifene as a medication to reduce breast cancer risk is new.
There is no evidence that the story relied solely or largely on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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