Below are the comments we submitted to the U.S. Preventive Services Task Force in response to their recently released draft Recommendations on Medications for Risk Reduction of Primary Breast Cancer in Women
Dear Dr. Cosby,
Breast Cancer Action (BCAction) is a national education and advocacy organization which carries the voices of people affected by breast cancer to address and end the breast cancer epidemic. We currently represent approximately 50,000 members. Our work includes monitoring and advocating for patient interests regarding treatment approvals.
For more than twenty years, Breast Cancer Action has advocated for more effective, less toxic treatments that benefit more women. We take a science based approach and believe that in preventive medicine, there needs to be clear evidence of absolute gains and only very minimal risks before medicating otherwise healthy women.
We wish to go on public record with our concerns about the U.S. Preventive Services Task Force recently released draft Recommendations on Medications for Risk Reduction of Primary Breast Cancer in Women.
Our concerns with the draft report include these points:
1. The recommendations promote disease substitution
2. The report puts too much reliance on flawed risk assessment models
3. There is a lack of data for women of color
4. The recommendations are not reflective of actual consumer behavior
1. The Recommendations Promote Disease Substitution
The absolute number of breast cancer reduction from medications was small – 7 to 9 cases of invasive breast cancer per 1,000 women. This is far from disease prevention and constitutes a small reduction in risk. In fact, breast cancer specific and all-cause mortality rates were the same as placebo. So the ultimate measure (mortality from breast cancer) showed absolutely no change from medications compared to placebo groups.
In addition, the data show that these medications are actually causing other diseases. Disease substitution is occurring – tamoxifen caused 4-5 cases in 1000 women of uterine cancer, 2 cases in 1000 of pulmonary embolism, both medications caused thromboembolic events (4-7 cases per 1000), and a range of other health and quality of life issues including gynecologic problems, bladder control symptoms, hot flashes, and dyspareunia. Without reducing mortality and only with slight incidence reduction, women on these medications are putting themselves at increased risk for stroke, blood clots and endometrial cancers. For most healthy women, this is not a good trade-off.
Until there is better long term data for both for mortality and the long term harms, substituting one disease for another is not a good recommendation.
2. The Recommendations Lacks Good Risk Assessment Models
The presented evidence shows these drugs do not provide a good risk/benefit ratio for healthy, low or average risk women. It’s a documented fact that women already over estimate their own risk of breast cancer even though the risk for getting breast cancer is low for the majority of the population. The USPSTF recommends using the Gail model of risk assessment in making decisions regarding use of medications for risk reduction, yet we know the Gail model, and all other current risk assessment models are flawed and have low to modest discriminatory accuracy in predicting breast cancer probability in individuals. We all agree that tamoxifen and raloxifene are powerful medications that should not be given over long periods of time to healthy women without disease, yet there is high risk that health care providers and women themselves will over estimate an individual’s risk of getting the disease.
3. The Recommendations Lack Data for Women of Color
The USPSTF draft report acknowledges that we lack data for nonwhite women, as well as elderly (who would be more likely to be at higher risk of breast cancer), and women with other health conditions or taking any other medications. Millions of women fall into one of these categories – there should not be population based recommendations when there is no data one the effects of a significant proportion of the population that these medications would be targeted to.
4. The Recommendations are not Reflective of Actual Behavior and Consumer Realities
The USPSTF needs the voice of consumers as part of the process in developing these recommendations – and not just at the end point. The report is completely remiss in not understanding why women who have already had breast cancer are still reluctant to take the medications. If women whose lives have already been affected by breast cancer often are not compliant or resistant to taking these medications because of the effect on quality of life issues, why would healthy women take them (see risk of disease substitution above)?
It is our opinion that consumers would rather have more research and recommendations for actions on ‘true’ breast cancer prevention by examining environmental and other factors on what causes the disease, rather than medicating themselves and substituting side effects or getting other diseases instead. Healthy women shouldn’t be asked to gamble their health for a small reduction in getting breast cancer that includes no reduction in mortality rate, and have to hope they don’t suffer any of the harms. The only guaranteed winners in for these recommendations are the pharmaceutical companies that will see a guaranteed increase in their bottom lines.