Saturday, July 11, 2009

The EARLY act - issues and controversies

On March 26, 2009, Representative Debbie Wasserman-Schultz (D-FL) introduced a bill with a stated objective to increase awareness of the risks of breast cancer in young women and provide support for young women diagnosed with breast cancer. The bill (H.R. 1740) was referred to as the Breast Cancer Education and Awareness Requires Learning Young Act of 2009 or EARLY act.

According to a press release from Congressman Schultz, The EARLY act "directs the Centers for Disease Control to develop and implement a national education campaign to increase awareness of the threats posed by breast cancer in young women of all ethnic and cultural backgrounds, and the particular heightened risks faced by certain groups. The campaign will help young women and providers identify the specific threats and warning signs of breast cancer that lead to early diagnoses, and prevention efforts women can undertake to reduce their risks."

One would think that this legislative effort would have been applauded by most groups who are concerned with the care of women with breast cancer. In fact, there are many within the medical community who have voiced concerns about the legislation. The National Breast Cancer Coalition (NCCN) suggests that the bill is based on several false premises, contains incorrect information, and will not achieve these goals. The full text of their analysis is available here - The NCCN memo questions several premises in the bill (the comments that follow each point are outlined from the NCCN analysis):

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

The EARLY act is directed at women under 40. The NCCN suggests that this may be an inappropriate population to target with a large public health campaign. According to the American Cancer Society, during 2000-2004, only 5% of new cases and 3% of breast cancer deaths occurred in women under 40 years of age. For women aged 20-24, there were 1.4 cases per 100,00 women

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

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. Evidence for an association between dietary factors and breast cancer has been largely inconsistent and modest at best

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

According to information on the National Cancer Institute website, breast self-exams cannot replace regular screening mammograms and clinical breast exams. Studies have not shown that breast self-exams alone reduce the number of deaths from breast cancer (

4. That ethnicity is sufficient to trigger genetic counseling and 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. Despite the association between mutations in these genes and breast cancer, only 5-10% of all breast cancer patients have BRCA1 or BRCA2 mutations. 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

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

The messaging about what to do about breast cancer 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.

In my assessment, there is value in this public spending proposal, notwithstanding the valid points discussed above. While young patients make up the minority of breast cancer patients, the economic and social impact of an illness in a young person has clear reverberating effects. The economic impact of days lost from work and the impact of illness on a spouse and children is devastating. Moreover, educating younger women may lead to discussion regarding breast cancer screening in their parents or extended family, leading to earlier diagnosis and lower treatment costs overall. I imagine that a 40 year old woman conversing with her mother or aunt regarding the importance of screening for breast cancer has real impact. These are the analyses that I'd like to see studied under the Obama administration's emphasis on comparative effectiveness.


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