November 16, 2009

Detailed ACR Statement on Ill-Advised and Dangerous USPSTF Mammography Recommendations

Mammography screening for women ages 40 and above is one of the major health care advances of the past 40 years. With the onset of mammography screening, the death rate from advanced breast cancer, that had been unchanged for the preceding 50 years, has decreased by 30 percent since 1990. Moreover, early mammography screening means cancers can be caught sooner, often allowing women to choose less invasive treatments that help to preserve the quality of women’s lives as well.

Newly revised U.S. Preventive Services Task Force (USPSTF) recommendations could reverse this decline in breast cancer morbidity and mortality, causing undue suffering to women facing breast cancer and their families. In a decision that dismisses thousands of scientific studies and data analysis, ignores the physical and psychological harms of the more aggressive treatment required for advance cancers, and prioritizes dollars saved over lives saved the AHRQ-supported taskforce rescinds recommendations for regular mammography screening for women 40-49 years of age and those over 74, and reduces the frequency of screening from annually to every other year for women between 50 and 74.

The Federally Supported U.S. Preventative Services now recommends:

AGAINST routine screening mammography in women age 40-49

AGAINST teaching breast self examinations

AGAINST clinical breast examinations

AGAINST previously recommended routine screening for women 75 years or older

AGAINST annual screening mammograms for women age 50-74 (Recommending screening every OTHER year versus the currently recommended annual screening)

In other words, USPSTF is recommending against ALL commonly accepted routine breast cancer screening methods for women in their forties despite their statement that the ten year risk for breast cancer in a 40 year old woman is 1 in 69. They also rescind their previous recommendation providing for screening beyond 74 because “the shortened life among woman 75 and older” makes it more likely that she could die from another cause before the cancer kills her. Finally, even for those for whom they do recommend screening, delays in treatment resulting from less frequent screening will cost lives and result in more aggressive and debilitating treatment.

The recommendations make unconscionable decisions about the value of human life

The purported basis of the recommendation not to screen women in their 40s is one of risk-benefit analysis.

As acknowledged in the research of the taskforce, if regular mammography screening does not begin until age 50, more women will die of breast cancer.

Likewise, the research cited by the taskforce acknowledges that lives will be lost if screening becomes biennial versus annual.

The taskforce recommendations are based on the implausible presumption that the “harms” of screening (the discomfort of squeezing the breast, the anxiety associated with an abnormal result, the chance of a false positive result requiring additional exams [e.g., additional mammography views, ultrasound, etc.], or biopsy, and the chance for over-diagnosis – detecting a cancer that would never have become life threatening) outweigh the benefit of lives saved.

The taskforce did not examine the benefit of less invasive and less disfiguring therapy that can be achieved with early diagnosis through screening mammography. The morbidity, personal grief AND financial costs of breast cancers diagnosed in late stages is tremendous. For example, treatment that might have consisted of a lumpectomy if caught early might instead require a mastectomy and chemotherapy. The USPSTF did not acknowledge, evaluate or account for this.

Although USPSTF states that their recommendations were not motivated by cost savings, based on the above, we cannot help but draw the conclusion that the taskforce recommendations amount to rationing on the basis of financial costs. The USPSTF’s analysis evaluates the number of lives lost under a variety of screening scenarios and then blatantly recommend the most “efficient” (i.e. less expensive) screening interval, not the one that saves more lives. Not only are these numbers based on the lowest estimate of benefit, but they have no meaning for the women being screened. Each woman has a single screening study each year regardless of the yield of cancers. Numbers only suggest the relative “cost” of curing a cancer by early detection and the USPSTF has, arbitrarily, decided that the cost of saving women ages 40-49 is too high.

USPSTF Selectively Reviewed the Literature, Ignoring Hundreds of Well-Regarded Studies on the Subject

The taskforce commissioned its own computer models that had never been subject to critical peer review, ignoring previously published computer modeling studies and direct scientific evidence from large clinical trials that contradict their conclusion. The recommendations also ignored peer reviewed journal articles that critiqued studies on which their recommendations rely. They did not consider literature that didn’t evaluate mortality as an endpoint.

Notably, the USPSTF does not even mention the actual published data from Sweden and the Netherlands that directly show what happens when new therapies and mammography are introduced into the population. These studies demonstrate that it is mammography screening and not new therapies or practices that are responsible for most of the decrease in deaths over the past 20 years.

The fact that hundreds of respected journal articles were ignored while another trial was translated from Russian to English for consideration by the taskforce makes the entire literature review suspect.

The elaborate academic exercise that the taskforce conducted is obviated by one important truth – almost universally, clinicians will agree that breast cancer therapy is far more successful when the cancer is found at a smaller size and earlier stage by mammography. In Sweden mammography screening has decreased breast cancer deaths among women in their 40’s by over 40 percent.

The taskforce makes assumptions that are contrary to the evidence. For example, the presumption that loss of life can be minimized if “high risk” women opt to be screened earlier or more frequently than recommended, overlooks the fact that about 75 percent of all breast cancers occur in women who are not at high risk.

The taskforce ignored literature describing survey results that women prefer to experience false-positives if the overall result is finding additional cancers in the screened population.

The development of the recommendations violated the Administration’s Commitment to Transparency

The taskforce made their recommendations without allowing for public input or involving anyone with expertise in breast cancer detection and diagnosis. Rejecting both randomized, controlled trials and already-existing modeling studies, they instead commissioned their own modeling study, and made recommendations in reliance on this study before the study had ever been published, made public or held to critical peer review.

The USPSTF is a Government-Sponsored Body Making Recommendations that will be Published and Recognized by the Federal Government

Notwithstanding disclaimers disassociating AHRQ with the recommendations of the taskforce, the Agency for Healthcare Research and Quality (AHRQ) funded the project, selected the USPSTF members, provided staff support to the taskforce, provided project oversight, developed key questions in conjunction with the taskforce, assisted with internal and external review of the draft manuscript, and will be posting the recommendations on their website. The bibliography even cites journal articles written by AHRQ staff.