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Breast Cancer

Boo: Scary New Guidelines for Breast Cancer

October 30, 2015 • By

This year, it’s fitting that Breast Cancer Awareness Month is in October, because just in time for Halloween, diagnosis and treatment of early breast cancer just got scary.

New breast screening guidelines are recommending fewer screenings beginning at age 45 instead of 40, as well as eliminating clinical breast exams (See: http://jama.jamanetwork.com/article.aspx?articleid=2463262 and http://www.huffingtonpost.com/2015/10/19/breast-cancer-screening-guidelines-american-cancer-society_n_8337850.html ).

Meanwhile, there is a growing trend to recommend “doing nothing” for a diagnosis of DCIS when there is no way to predict which early breast cancers will remain indolent, and which will become invasive. (See http://time.com/4057310/breast-cancer-overtreatment/ and http://www.wsj.com/articles/debate-over-early-stage-cancer-to-treat-or-not-to-treat-1445276596 )

These are dramatic shifts that fly in the face of the breast health mantra: “prevention and early detection” as explained to women here: http://preventcancer.org/prevention/preventable-cancers/breast-cancer/breast-cancer-prevention-early-detection/.

Right now, the experts in the breast cancer community sharply disagree about screening guidelines and early breast cancer treatment (See: http://www.nytimes.com/2015/10/29/opinion/why-the-annual-mammogram-matters.html?_r=1).

The Principle of Beneficence in clinical ethics obligates healthcare providers to maximize benefits, while minimizing harms. Early detection and prevention fit these criteria, as there is still a greater balance of benefits than harms in stopping invasive breast cancer before it starts. Meanwhile, leaving biopsy-confirmed breast tumors inside of women, when early treatment is available, could violate the Principle of Non-Maleficence, which, at minimum, obligates healthcare providers not to deny patients a standard treatment when one exists. Those who defend “doing nothing” make the “over treatment” argument, and are concerned about false positives and iatrogenic harms. However, millions of women in countries where early detection and prevention are accessible are alive because of early detection, diagnosis and treatment (See: http://www.nbcnews.com/health/cancer/catching-breast-cancer-early-saves-lives-study-confirms-n439591)

Much Ado About Nothing

Merely watching, or observing the natural history of an untreated disease resembles another study that the public eventually found unethical: The Tuskegee Syphilis Study, in which observation (what is generally meant by “active surveillance” or “watch and wait”) of a known disease was presented as a standard of care to poor African-American patients who were not informed that treatment (when it became available) was an option. (See: http://www.cdc.gov/tuskegee/timeline.htm).

The study led to the formation of codified research ethics guidelines in The Belmont Report, which specifically outlined special protections for vulnerable populations in the Principle of Respect for Persons. (See: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html )

Yep, I went there.

Proponents of observational (“active surveillance”) protocols really hate it when bioethicists yell “Tuskegee” in a crowded clinic. But unfortunately, I need to go there because that’s where this is going when you factor in the widening gap in healthcare disparities, poor access to genetic screening for BRCA1 and 2 mutations (costs range from $500-4000), and the dozens of barriers to informed consent that include low literacy, low numeracy, and non-English speaking patients. Few know about “Tuskegee India” – a U.S. funded cervical cancer study in the late 1990s that repeated Tuskegee’s design flaws. Here, over 250 vulnerable women in unscreened control groups — without proper consent — died from cervical cancer in a study designed to look at whether screening made a difference — when we already knew that it did. See: http://www.al.com/opinion/index.ssf/2015/06/india_cervical_cancer_testing.html

If you’re going to change breast cancer screening guidelines, it must be balanced with improved access. Since so many vulnerable populations do not have access to women’s healthcare, it’s ethically problematic to change guidelines to avoid over-diagnosis and over-treatment when so much under-treatment exists. At least 15 million U.S. women have no healthcare access at all (not including undocumented women), while breast cancer continues to affect African American women disproportionately due to both initial access and follow up. See:

The ACS Guidelines even admit: In the United States, barriers to access continue to exist among low-income or uninsured women, those without a usual source of care, or those residing in rural counties.

Telling women to skip their screenings (which include some 5-10% of women in the general population who do not know they are BRCA1 or 2 carriers) is ethically problematic. Telling women with biopsy-confirmed breast tumors that observation is a “reasonable treatment alternative”, when there is not enough evidence to conclude that, is also ethically problematic unless women are told what the risk of doing nothing entails. In our unequal healthcare system, where coverage is not uniform, informed consent my be insufficient, and many are lost to follow-up, these new guidelines are…well… just scary.