In the United States, about 12% of women develop invasive breast cancer. In 2019 alone, there were approximately 268,600 new invasive cases, 62,930 new non-invasive cases, and 41,760 deaths.[i] Because breast cancer is so inconsistently cured, the principal effort at preventing breast-cancer-related deaths is early detection.
Initial efforts at early detection were centered on self-examination. Women were instructed to perform breast self- examinations once a month (using the arrival of the electric bill as a reminder, for example) with the aim of detecting new or unusual lumps in their breasts. Unfortunately, not only did such efforts suffer from inconsistency in compliance, but also the wide variety of breast densities and even density variations within a woman's gestational cycle made the exercise quite ineffective. Predictably, women were presenting to their doctors with reports of what turned out to be benign lesions while others were missing the diagnosis of malignancy entirely.
Technological advances allowed for the use of mammography to become the principal method for the early detection of suspicious breast lesions. These low-intensity x-rays allowed pictures to be taken through a woman's breasts facilitating the identification of suspicious lesions. The lesions could then be biopsied for definitive diagnoses as benign or malignant growths.
Although much more effective at identifying early cancerous lesions than the breast self-examination, mammography still suffered from inaccuracies and complications. First, the interpretations of the pictures were often subjective and dependent on a trained human eye to determine whether a lesion was worthy of being biopsied or not. This uncertainty was exacerbated by the denseness of the underlying breast tissue, and since younger women have denser breasts, they were particularly prone to experiencing erroneous mammograms with falsely positive results.
The radiation associated with mammograms was also a concern. This, combined with the lower incidence of breast cancer in younger women, made recommending mammography in young women unfavorable. The competing priorities between the desire to save women's lives through the early detection and avoidance of unnecessary procedures and their complications led to a balancing act in determining the best approach for mammography. If the recommendation was too aggressive, women were going to be unnecessarily exposed to pain, suffering, expense, worry, and confusion. Too lax, and women would die.
Various medical groups studied the issue and published their opinions regarding the best ways of detecting the appearance of breast cancer. Initial recommendations were that women undergo baseline mammography at some point between the ages of 35 and 40 years of age followed by yearly mammograms beginning at age 40. Some recommended biennial mammograms in women between 40 and 50 years of age followed by yearly mammograms for those 51 and older. And presently, the National Comprehensive Cancer Network, the American Congress of Obstetricians and Gynecologist, and the American College of Radiology each recommend yearly mammographic screening for breast cancer starting at 40 years of age.[ii]
Enter the federal government and the United States Preventive Services Task Force (USPSTF). The USPSTF is a "volunteer panel of national experts in prevention and evidence-based medicine"[iii]created in 1984 by the United States Public Health Service.[iv] Originally, its purpose was to provide " evidence-based recommendations about clinical preventive services and health promotion."[v] Generally, the USPSTF provides approval or disapproval of certain preventive services and procedures by assigning each a grade. An "A" or "B" grade meant that the practice had sufficient scientific support in the panel's opinion to recommend that the service be offered to the public.[vi] Grade "C," "D," or "I" recommendations carried varied implications, but shared a commonality in the lack of enthusiasm for it by the USPSTF.[vii]
In 2002, in keeping with the prevailing positions of the nation's leading physician organizations, the USPSTF awarded a B grade to the recommendation that women 40 years old and older should undergo mammography every one to two years.[viii]
That changed in 2009.
Although biennial mammography was awarded a B grade in women 50 to 74 years of age, a C grade was given to the practice of routinely performing screening mammograms in women aged 40-49 years.[ix] In contraposition to the opinions of most national physician and patient organizations, the USPSTF did not support mammography in 40 to 50-year-old women and abandoned the practice of screening women older than 74 years of age. In defending its position to abandon screening of women in their fifth decade of life, the USPSTF simply and offensively averred, "While screening mammography in women aged 40 to 49 years may reduce the risk of breast cancer death, the number of deaths averted is smaller than that in older women and the number of false-positive results and unnecessary biopsies is larger."[x] But in 2017 alone, 49,360 thousand women between the ages of 40-and 49 years were diagnosed with breast cancer (36,920 of those invasive) and 3,480 women in that age group died from it.[xi] These are women at the height of their productivity who were raising families and making invaluable contributions to society.
The USPSTF's change in recommendations regarding women aged 75 and older is just as perplexing since the risk of developing breast cancer is known to increase exponentially with age. The chances of developing breast cancer in women between 7- and 80 years of age are one in 26.[xii] Moreover, in 2017, there were 92,070 new cases of breast cancer (77,940 of them invasive) and 19,130 deaths in women who were 75 years of age or older.
If it weren't for the ACA, however, this would only be a story about internal disagreements among physician groups. But in a move screaming of unconstitutionality, Congress included a provision within the ACA requiring insurers to cover any preventive services awarded a grade of A or B by the USPSTF without copays or deductibles.[xx] It also gave the SecHHS, the authority to allow Medicare to cover preventive measures only if they carried an A or B rating from the USPSTF.[xxi] In light of the USTPSF's decisions, many insurers opted to no longer cover mammography in 40 to 50 year-olds, and Medicare discontinued its coverage for mammograms in women 75 years of age and older.
Why did Congress pick the USPSTF's position as the "official" harbinger of recommendations regarding preventive health over the other professional groups? Because the USPSTF is part of the machinery of government. It is an official government agency, and therefore the legislature could reasonably conclude that it ought to serve as the official voice of the federal government on issues of disease prevention.
Suddenly, the panel of "volunteers" serving on the USPSTF went from being a relatively obscure group delivering just another set of opinions on how the nation should approach its preventive medicine efforts to being the object of intense lobbying efforts by a variety of interests with millions of dollars at stake.[xxii],[xxiii]
And just who are these volunteers? They are a group of sixteen "members who are nationally recognized experts in prevention, evidence-based medicine, and primary care. . . with expertise in behavioral health, family medicine, geriatrics, internal medicine, pediatrics, obstetrics and gynecology, and nursing."[xxiv] For the record, thirteen of the sixteen members are physicians.[xxv] These members are assigned by the Director of the Agency for Healthcare Research and Quality,[xxvi]who, in turn, is appointed by the SecHHS.[xxvii] So, although the USPSTF likes to think of itself as a scientific, apolitical group, the fact that it is composed of members whose assignments can be traced back to a hierarchy ending at the President of the United States negates that view.
Predictably, the USPSTF's decision to not affirmatively recommend screening mammograms for women in their fifth decades of life and for those older than 74 was fraught with controversy, particularly in light of the newly created funding and access implications the decision carried. The fallout from the recommendations was so bad that Congress overruled it, first temporarily and then, in 2015, permanently.[xxviii] And although Congress can nullify the effects of the USPSTF decision as it relates to Medicare, its authority does not extend to private insurers such that nonfederal programs are still free to honor USPSTF's 2009 recommendations. Incidentally, in its obstinacy, the USPSTF reaffirmed its 2009 recommendations in 2016.
The story of the USPSTF and mammography brings up a number of issues regarding the interplay between government and medicine. First is the overarching question we have previously visited regarding the pinnacle of a democratic state's authority. Is it we the people who stand at that pinnacle with government at our service, or is it government that crowns it? If government is allowed to take its place at the apex, then it is totally appropriate for it to determine what interventions are appropriate for the sake of prolonging our lives and which are not. Can one have a mammogram, and if so at what age? When is someone no longer allowed to have a mammogram? Should they even be tested? These questions may validly fall upon government only if it were the ultimate purveyor of power, and we, its servants.
If, however, each human being has an inestimable value and government exists to facilitate the peaceful coexistence of men, then the concept of government deciding whose life to prolong and whose not is nonsensical and unacceptable.
We may question how it is that things progressed to such an extent that Congress felt compelled to intercede. But it was Congress that created this mess in the first place. Until the Obama administration, with the Democrats' zeal to centralize healthcare, the USPSTF was a mere think tank, albeit one under the umbrella of the fourth branch of government, but still, a mere think tank. Whether the federal government should even be running such a think tank is subject to debate, but regardless, before 2010 and certainly in 2009 when the USPSTF's position on mammography became more restrictive, its opinion on mammography was simply that, an opinion. It was not until Congress decided to dictate healthcare prevention policy through one of its agencies that things went awry.
Also, consider how deeply enmeshed within the recesses of bureaucratic layers the USPSTF is. This is an agency whose members are appointed by a Director, who is himself appointed by a Secretary who is appointed by the President of the United States. At least three levels of unaccountability exist between the American people and the persons making decisions on preventive medicine resources, with each level cloaked in increasing anonymity.
Who are the actual members of the USPSTF? From what parts of the country do they proceed? What are their political views and inclinations? What are their philosophies on government and its role in healthcare? The public does not know the answers to these questions, yet those individuals are the ones making life and death decisions for our nation.
Their apologists claim this is not a political body, as it is made up of scientists. But here, the observations made by Thomas Jefferson regarding judges are equally as applicable to the members of the USPSTF: "[They] are as honest as other men, and not more so. They have, with others, the same passions for party, for power, and the privilege of their corps. . . and their power the more dangerous as they are. . . not responsible, as the other functionaries are, to the elective control."[xxix]
Finally, there is the inherent contradiction of having Congress intervene in a decision made by one of its agencies. By its very assignment of a matter to an agency, Congress has acknowledged that it does not possess the expertise or the political will to handle the matter directly. If it did, Congress itself would have passed the necessary law.
So what does it say about Congress that after it handed the ball on a matter to an unelected band of experts it should have to overrule it? Do we believe it appropriate for Congress to be deciding whether any one of us ought to be ineligible for mammography as an insurance benefit? Yet this situation, and hundreds of thousands like it, would flourish if we adopt a government-run system of healthcare.
The issue with all of this is that it is apt to happen again. The same people that ran these agencies are the ones who are preparing to take control again. We must fight back against their misguided views of public policy and of their role in administering their healthcare system.
Please help us by contributing $20, $50, $100, or more to the Center for Healthcare Policy Solutions to fight this battle.
Any amount is greatly appreciated. And all assistance is welcomed. We cannot allow these missteps to take place again.
[i]"U.S. Breast Cancer Statistics," Breastcancer.org, accessed Sept. 18, 2019, https://journalofethics.ama-assn.org/article/medical-ethics-and-media-value-story/2014-05.
[ii]Gradishar, William J., "USPSTF Breast Cancer Screening Recommendations Remain Unchanged Despite Controversy," Healio(blog), Jan. 11, 2016, accessed Sept. 21, 2019, https://www.healio.com/hematology-oncology/breast-cancer/news/online/%7B4e79de36-911d-41ef-bed3-3ad171be2f26%7D/uspstf-breast-cancer-screening-recommendations-remain-unchanged-despite-controversy.
[iii]"About the USPSTF," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Name/about-the-uspstf.
[iv]"Section 1. Overview of the U.S. Preventive Services Task Force Structure and Processes," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Name/section-1-overview-of-us-preventive-services-task-force-structure-and-processes.
[v]"Section 1. Overview of the U.S. Preventive Services Task Force Structure and Processes," U.S. Preventive Services Task Force, accessed Sept. 21, 2019,https://www.uspreventiveservicestaskforce.org/Page/Name/section-1-overview-of-us-preventive-services-task-force-structure-and-processes.
[vi] "Grade Definitions," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions.
[vii]"Grade Definitions," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions.
[viii]"Archived: Breast Cancer: Screening, 2002," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-screening-2002.
[ix]"Archived: Breast Cancer: Screening Original Release Date: November 2009," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-screening.
[x]"Final Recommendation Statement Breast Cancer: Screening," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/breast-cancer-screening1#table-of-contents.
[xi]"Breast Cancer Facts and Figures 2017-2018," American Cancer Society, Table 1, accessed Sept. 21, 2019, https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2017-2018.pdf.
[xii]"Risk of Developing Breast Cancer," Breastcancer.org, accessed Jan. 18, 2020, https://www.breastcancer.org/symptoms/understand_bc/risk/understanding
[xiii]A.L Siu, Screening for Breast Cancer; U.S. Preventive Services Task Force Recommendation Statement," Annals of Internal Medicine, 2016; (164):279-296.
[xiv]K. C. Oeffinger, E. T. Fontham, et al., "Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update from the American Cancer Society," JAMA,2015;314(15):1599-1614.
[xv]American College of Obstetricians-Gynecology, "Practice Bulletin No. 122: Breast Cancer Screening, Obstetrics and Gynecology 2011;118(2 Pt 1):372-382
[xvi]B. Lauby-Secretan, D. loomis, and K. Straif, "Breast Cancer Screening-Viewpoint of the IARC Working Group," New England Journal of Medicine, 2015;373(15):1478-1479.
[xvii]C. H. Lee, D. D. Dershaw, et al., "Breast Cancer Screening with Imaging: Recommendations from the Society of Breast Imaging and the ACR on the USe of Mammography, Breast MRI, Breast Ultrasound, and Other Techniques for the Detection of Clinically Occult Breast Cancer," Journal of the American College of Radiology, 2010;7(1):18-27.
[xviii]T. J. Wilt, R. P. Harris, et al., "Screening for Cancer: Advice for High-Value Care from the American College of Physicians," Annals of Internal Medicine, 2015;162(10):718-725.
[xix]American Academy of Family Physician, "Summary of Recommendations for Clinical Preventive Services. July 2017," accessed on Feb. 1, 2020, https://www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/cps-recommendations.pdf.
[xx]Roubein, Rachel, "Preventive Task Force Facing Influx of Lobbying," The Hill(blog), Oct. 13, 2016, accessed Sept. 21, 2019, https://thehill.com/policy/healthcare/300922-preventive-task-force-facing-influx-of-lobbying.
[xxi]Wehrwein, Peter, "Has the ACA Put the USPSTF in Over Its Head?" Managed Care (blog), Nov. 3, 2016, accessed Sept. 21, 2019, https://www.managedcaremag.com/editorsdesk/has-aca-put-uspstf-over-its-head.
[xxii]Rachel Roubein, "Preventive Task Force Facing Influx of Lobbying," The Hill(blog), Oct. 13, 2016, accessed Sept. 21, 2019, https://thehill.com/policy/healthcare/300922-preventive-task-force-facing-influx-of-lobbying.
[xxiii]Villani J, Ngo-Metzger Q, Vincent IS, Klabunde CN. Sources of Funding for Research in Evidence Reviews That Inform Recommendations of the US Preventive Services Task Force. JAMA. 2018;319(20):2132–2133. doi:10.1001/jama.2018.5404.
[xxiv]"Our Members," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Name/our-members.
[xxv]"Our Members," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Name/our-members.
[xxvi]"Our Members," U.S. Preventive Services Task Force, accessed Sept. 21, 2019, https://www.uspreventiveservicestaskforce.org/Page/Name/our-members;
[xxvii]Bindman, Andrew B., "JAMA Forum: The Politics of AHRQ," news@JAMA (blog), Aug. 3, 2017, accessed Sept. 21, 2019, https://newsatjama.jama.com/2017/08/03/jama-forum-the-politics-of-ahrq/.
[xxviii]Pub. L. No. 114-113 § 228 (2015).
[xxix]Thomas Jefferson to William Charles Jarvis, Sept. 28, 1820.