March 23, 2009

Analysis of “Breast Cancer Education and Awareness Requires Learning Young Act of 2009” (EARLY Act)

It is laudable that Congress continues to care deeply about breast cancer and strives to address it. However, it is vital that Congressional action is the right action that helps and does not harm the public and is a responsible use of federal funding and outreach. Unfortunately, the bill at issue is based on several false premises, contains incorrect information, and will not achieve these goals. The bill is addressed to a population of women in whom breast cancer is rare, and presumes we know what to tell these women about prevention, risk reduction and early detection. We do not. If we believe a public campaign to this population is important, we need scientific inquiry to find the answers to these questions before we launch any public campaign.

Our concerns center on the following:

1.) That breast cancer in women under 40, an admittedly rare occurrence, necessitates a broad public health campaign and education in secondary schools and universities;

2.) That we know what women should do to prevent or lower their risk of breast cancer;

3.) That breast self examination and clinical breast examination are effective in saving lives in this age group;

4.) That ethnicity is sufficient to trigger genetic counseling and testing

5.) That there are significant differences in what we know and what we should tell women under 40 years old versus over 40 years old.

What follows is background on some of the specific issues raised by the bill.

Ages covered by the bill.

Breast cancer is primarily a disease of older women; it is estimated that a woman age twenty has about a 5 in 10,000 risk of developing breast cancer in the next ten years; for a woman age 30, the estimated risk is about 4 in 1,000; and for a woman age 40, it is about 1 in 100; yet this bill includes all women in that age group (15-39). While it is important to address breast cancer at all ages, it must be done in a responsible manner. Messages to a younger population designed to raise awareness of breast cancer must be very carefully designed and targeted.

The American Cancer Society reports that during 2000-2004, only 5% of new cases and 3% of breast cancer deaths occurred in women under 40 years of age.(i) For women aged 20-24, there were 1.4 cases per 100,000 women.(ii)

Prevention and risk reduction.
The bill proposes a public health awareness campaign giving messages on risk and prevention to younger women. But there is very little known about what puts a woman at avoidable risk of breast cancer at any age. We do not know how to prevent breast cancer.(iii,1) There is no evidence that the interventions described in the bill lower risk of breast cancer in this age group and would result in saving lives. Evidence for an association between dietary factors and breast cancer has been largely inconsistent and modest at best. The largest recent prospective study to look at diet found no significant decrease in breast cancer incidence in women who modified their diets to decrease fat intake and increase fruits and vegetables.(iv)

The research on body mass index (BMI) adds yet another layer of complexity. BMI is associated with breast cancer risk in postmenopausal women; women with high BMI are at increased risk of breast cancer. But in premenopausal women, the opposite appears to be true: those with high BMI are actually at lower risk of breast cancer than premenopausal women with lower BMI.(iii)

Early detection.
The goal of screening is to find disease and save lives.(v) There is no known effective method of detecting breast cancer in a healthy population of women under 40. Breast self examinations have been shown to be ineffective and potentially harmful.(vi)  As the NCI explains on its website

"Monthly breast self-examination (BSE) is frequently advocated, but evidence for its effectiveness is weak.[55,56] [In] the only large, well-conducted, randomized clinical trial of BSE that has been completed… the number of invasive breast cancers diagnosed in the two groups was about the same, but women in the [BSE] group had more breast biopsies and more benign lesions diagnosed than did women in the control group.[57] (vii)"

Spreading the message to the public that early detection is important in this age group would result in an extraordinary waste of funds, and unnecessary exposure to the health risks associated with the additional interventions.

Genetic testing.
The bill is based on the belief that women “including, but not limited to the African-American and Ashkenazi Jewish populations under 40 years of age” should contemplate genetic counseling and testing. Again, this is a complex issue that is evolving as our knowledge base grows. There have been very recent studies indicating the serious problems that can result when we paint this issue with a broad brush.(viii)

Mutations in the BRCA1 and BRCA2 genes are very rare in the general population. For example, only about 1 in 800 individuals (0.125%) have the BRCA 1 mutation. And not all individuals with such mutations develop cancer. (Penetrance ranges from 36% to 85% lifetime risk for breast cancer.)

Despite the association between mutations in these genes and breast cancer, only 5-10% of all breast cancer patients have BRCA1 or BRCA2 mutations. (ix) Scientists believe there may be other unknown genes that are strongly associated with breast cancer risk. However, the large majority of breast cancer cases are "sporadic" cancers; in other words, the individual has no known inherited predisposition to breast cancer.

The complexities surrounding these issues are underscored by the fact that the National Comprehensive Cancer Network has genetic testing guidelines that fill up more than 30 pages.(x) They also recommend being very cautious:

"For those who meet one or more of the [genetic testing] inclusion criteria, further in-depth assessment is warranted. The first step in evaluating a woman’s risk for hereditary breast cancer is to assess her concern and reasons for seeking counseling and to guarantee that her personal needs and priorities will be met in the counseling process. Because of the anxiety felt by those with a self-perceived high risk of breast cancer, individuals who do not meet these broad criteria should still be considered for more generalized cancer risk counseling to accurately determine their risk. Several studies have documented a highly exaggerated perception of risk among women with a family history of breast cancer who seek cancer risk counseling.(xi)"

Options for reducing risk.
The health management options for those found to be at very high risk create their own problems. (xii) Prophylactic surgeries have both emotional and physical risks that must be carefully weighed against the potential benefits. In particular, pre-menopausal women who have bilateral oophorectomies will lose their ability to have children and will undergo early menopause. They also may be at increased risk for heart disease and sexual dysfunction.(xiii)

No studies have clearly demonstrated whether these invasive procedures reduce the risk of dying from breast cancer. Lostumbo and colleagues conducted a systematic review of thirteen studies on contralateral prophylactic mastectomy.(xiv) All studies that met the inclusion criteria were observational studies with some methodological limitations; no randomized trials were found. These studies consistently reported reductions in contralateral incidence of breast cancer but were unable to show improvements in disease-specific survival.

Public education campaign.
The messaging about what to do about this disease raises exceedingly complex questions, many of which we do not yet have answers to. What this bill contemplates is a nationwide public health campaign that will reach out to millions of women with a message that may be misleading in some instances and pertinent to a tiny percentage. The important nuances of the issues will not be captured in this type of campaign, and will result in more harm than good.

1. The bill contains a section entitled “Prevention Research Activities” mandating prevention research on breast cancer in younger women yet discusses areas of diagnosis and detection.

(i) Ries LAG, Melbert D, Krapcho M, Stinchcomb DG, Howlader N, Horner MJ, Mariotto A, Miller BA, Feuer EJ, Altekruse SF, Lewis DR, Clegg L, Eisner MP, Reichman M, Edwards BK (eds). SEER Cancer Statistics Review, 1975-2005, National Cancer Institute. Bethesda, MD, available at: http://seer.cancer.gov/csr/1975_2005/results_merged/sect_04_breast.pdf

(ii) Breast Cancer Facts and Figures 2007-2008, American Cancer Society, available at: http://www.cancer.org/downloads/STT/BCFF-Final.pdf

(iii) Ursin G, Longnecker MP, Haile RW, Greenland S. A meta-analysis of body mass index and risk of premenopausal breast cancer. Epidemiology 1995; 6:137-141.

(iv) Prentice RL, Caan B, Chlebowski RT et al. Low-fat dietary pattern and risk of invasive breast cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA 2006; 295:629-42.