Lilly buoyed by findings on Evista
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Rating
Lilly buoyed by findings on Evista
Our Review Summary
This story reports the initial results of the Study of Tamoxifen and Raloxifene Trial (STAR) for estrogen-receptor positive women at high risk of developing breast cancer. This study was partially funded by Eli Lilly, though this is not mentioned, and the results here are presented as a financial boon for the company. There is less emphasis on the accuracy and interpretation of the trial from a women’s health perspective. There is also no attempt at corroboration with breast cancer researchers not affiliated with the trial: A lead investigator of the study (partially supported by Eli Lilly) and the president of science and technology at Eli Lilly are not unbiased sources.
Costs were not mentioned. The story mentioned that 19,747 women were randomized to either raloxifene or tamoxifen and provides quantitative evidence of improved risk of blood clots or uterine cancers, however, both of those results were just shy of statistical significance, which is not mentioned in the article or in NCI press materials. (Source ACS: http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Raloxifene_as_Good_as_Tamoxifen_to_Prevent_Breast_Cancer.asp) In addition, raloxifene did not appear to raise the risk of cataracts, which tamoxifen does appear to do. That difference was statistically significant. The story didn’t mention this.
The story mentions equivalent comparison with tamoxifen in preventing invasive breast cancer, however, tamoxifen protected women better from non-invasive breast cancer such as DCIS (ductal carcinoma in situ) and LCIS (lobular carcinoma in situ). And these conditions are being diagnosed much more frequently these days.
Criteria
Not Satisfactory
No mention of the cost of treatment for women outside clinical trials.
Satisfactory
Some quantitative benefit mentioned of taking hormone therapy for chemoprevention. Incomplete discussion of reduced rate of side effects in raloxifene group.
Satisfactory
Mentions harms of hormone therapy, such as an increased risk of blood clots and uterine cancers. Does not mention that raloxifene, like tamoxifen, has bothersome side effects such as hot flashes and vaginal discharge, which are reported as comparable and mild to moderate in the NCI press release of the initial results of this trial.
Not Satisfactory
Mentions that the STAR trial was a 5-year trial, but not that is was unblinded early (around year 4) due to positive side effect profile of raloxifene. Mentions that 19,747 women were randomized to either raloxifene or tamoxifen and provides quantitative evidence of improved risk of blood clots or uterine cancers, however, both of those results were just shy of statistical significance, which is not mentioned in the article or in NCI press materials. (Source ACS: http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Raloxifene_as_Good_as_Tamoxifen_to_Prevent_Breast_Cancer.asp) In addition, raloxifene did not appear to raise the risk of cataracts, which tamoxifen does appear to do. That difference was statistically significant.
The story mentions equivalent comparison with tamoxifen in preventing invasive breast cancer, however, tamoxifen protected women better from non-invasive breast cancer such as DCIS (ductal carcinoma in situ) and LCIS (lobular carcinoma in situ).
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Satisfactory
No evidence of disease mongering. Mentions that this drug is for post-menopausal women at higher than average lifetime risk of developing breast cancer.
Not Satisfactory
This study was partially funded by Eli Lilly. There is a a lot of Eli Lilly promotional information in this story. Of course, Indianapolis is the home of Eli Lilly. No attempt and independent corroboration with other breast cancer researchers. There was not much effort to get opinions on the study from outside sources. A lead investigator of the Eli Lilly-funded study and the president of science and technology at Eli Lilly are not unbiased sources.
Satisfactory
The story discusses the STAR trial, which compared current hormone treatment, tamoxifen, with raloxifene. It should be noted that the results here are initial findings after 4 years of raloxifene. The story could have done a better job in explaining that tamoxifen is usually taken for 5 years and there is much more long-term clinical data on safety and efficacy for this drug.
Satisfactory
It’s clear form the story that raloxifene is currently available for use in post-menopausal women to prevent osteoporosis. What isn’t clear is that use in chemoprevention would be an off-label use. This type of hormone therapy should be used in estrogen-receptor positive, post-menopausal women.
Satisfactory
Notes that use of Raloxifene (Evista) as chemoprevention is still in the clinical trial phase and that there are plans to file for FDA approval for use in preventing and treating breast cancer. Evista is already approved to prevent osteoporosis.
Not Applicable
We can’t judge if the story relied solely or largely on a news release. However, there is certainly a lot of Eli Lilly promotional information in this story. And Indianapolis is the home of Eli Lilly.
Total Score: 6 of 9 Satisfactory
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