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Read Original Story

Quality of Life Found Equal With 2 Breast Cancer Drugs

Rating

3 Star

Quality of Life Found Equal With 2 Breast Cancer Drugs

Our Review Summary

This story follows up on earlier reports released by the National Cancer Institute announcing results of the STAR breast cancer prevention trial, which compared tamoxifen with raloxifene in women at higher-than-average risk. Initial reports from NCI suggested that while the two drugs were equally good at lowering breast cancer risk, raloxifene offered an advantage because it caused fewer blood clots and uterine cancers.

With the release of the peer-reviewed results in the Journal of the American Medical Association, raloxifene still appears to be clearly better. It was just as good at preventing invasive breast cancer, and had a lower risk of blood clots and perhaps also of uterine cancer. The article incorrectly states that the difference in the number of blood clots was “not statistically significant.” In fact, that difference was significant. On the other hand, the difference in the number of uterine cancers was not. For readers who may not know what it means when a difference is or is not “statistically significant,” the story could have noted that although there were fewer uterine cancers among women who took raloxifene than among those who took tamoxifen, the difference was small enough that it could have happened just by chance. That means that the risk of uterine cancer might be about the same with the 2 drugs.

The article seems to approach disease mongering (in the sense of exaggerating the risk of disease) by implying that any woman with an increased breast cancer risk would be foolish not to choose one or the other of these treatments. Some balance is provided by the comment that some patient advocates question whether women should take a drug to lower their risk. By focusing primarily on the debate about which drug has the more favorable side effect and quality of life profile, the story may have missed an opportunity to draw attention to another issue–what women themselves think about taking a drug that has a relatively small chance of offering any individual woman a real benefit.

NOTE: this review does not address the portions of this article that related to the cervical cancer vaccine.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There is no mention of the costs of either drug, nor of the overall cost-effectiveness of this approach to preventing breast cancer, including savings on cancers prevented compared with no treatment. This would also have included an estimate of the costs of monitoring and treatment for the possible side effects, particularly uterine problems–which led to hysterectomy in more than 350 women during the trial.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The article states that both tamoxifen and raloxifene cut the risk of breast cancer in half, but does not indicate how many fewer cases that reduction represents. For balance, it would have been useful to have stated more explicitly how many women would have to take the drug to prevent one case of cancer, and how many women will experience a serious side effect.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

While the story lists the possible side effects and harms of the study medications, it does not mention how often these problems happened, nor how much they bothered women who had them. The article distorts the findings of the study by focusing on the quality of life data while downplaying or misrepresenting the data on outcomes for serious or life-threatening problems such as uterine cancer and blood clots.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

There is an error in the article’s statement about blood clot risk. The difference favoring raloxifene WAS statistically significant; that is, women taking it had fewer blood clots than women taking tamoxifen. Also the story implied that tamoxifen’s benefit for noninvasive breast cancer was statistically significant, but it was not, though there was a strong trend. Finally, the statement about lack of significance of reduced uterine cancer risk with raloxifene, while technically true, is not a good summary statement. The JAMA article’s authors pointed out that the estimate of uterine cancer risk for various reasons was likely an underestimate of the difference between the two drugs; that is, it likely underestimates the advantage of raloxifene over tamoxifen.

Does the story commit disease-mongering?

Satisfactory

There are no elements of disease mongering noted. However, the article missed an opportunity to provide some context by failing to mention that out of nearly 20,000 women in the trial, about 4 per 1000 women each year (a total of 331 over 4 years) developed breast cancer. If compared with the number of women who experienced side effects, this information would have helped readers understand better how many women would need to take preventive medication in order for some to get the benefits. The comment on patient advocates’ questioning does provide balance in the article.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story cites information from both the editorial that accompanied these studies as well as the researcher who presented the results at a professional meeting. It might have been helpful to note that neither the authors of the editorial nor the presenter appear to have any financial relationship with either drug manufacturer; this information was available in the published articles.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

It’s not clear from the article whether women have other options for lowering breast cancer risk. Explaining how few options there are would have helped readers to understand why these findings are important.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The article notes that both tamoxifen and raloxifene are currently available, and notes the conditions for which they are approved.

Does the story establish the true novelty of the approach?

Satisfactory

It is clear from the story that neither drug is new.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story cites information from both the editorial that accompanied these studies as well as the researcher who presented the results at a professional meeting. It might have been helpful to note that neither the authors of the editorial nor the presenter appear to have any financial relationship with either drug manufacturer; this information was available in the published articles.

Total Score: 5 of 10 Satisfactory

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