BreastCancerChoices.org  
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Scrutinizing the evidence for breast
cancer procedures and treatments
Imaging FAQ Article - Samuel Epstein, MD

Take home questions to
ask yourself:

1.  If other reliable imaging
procedures are available,
should do you want to
risk having a mammogram
if the compression during
the mammogram is
more than minimal?

2.  If you've already had a
mammogram, can you
shorten the time
between the mammogram
and surgery date to
minimize the chance of
traumets before they can
become real "mets"
(metastases)?
    Mammography Article by Samuel Epstein, MD

    Danger and Unreliability of Mammography
    Breast Examination is a Safe, Effective, and Practical Alternative

    by Samuel S. Epstein , Rosalie Bertell, Ph.D., GNSH and Barbara Seaman
    Published in International Journal of Health Services, Volume 31, Number 3, Pages
    605-615, 2001  Baywood Publishing Co., Inc.

    Mammography screening is a profit-driven technology posing risks compounded by
    unreliability. In striking contrast, annual clinical breast examination (CBE) by a trained
    health professional, together with monthly breast self-examination (BSE), is safe, at
    least as effective, and low in cost. International programs for training nurses how to
    perform CBE and teach BSE are critical and overdue.
    Contrary to popular belief and assurances by the U.S. media and the cancer
    establishment--the National Cancer Institute (NCI) and American Cancer Society
    (ACS)--mammography is not a technique for early diagnosis. In fact, a breast cancer
    has usually been present for about eight years before it can finally be detected.
    Furthermore, screening should be recognized as damage control, rather than
    misleadingly as ««secondary prevention.

    DANGERS OF SCREENING MAMMOGRAPHY
    Mammography poses a wide range of risks of which women worldwide still remain
    uninformed.
    Radiation Risks
    Radiation from routine mammography poses significant cumulative risks of initiating
    and promoting breast cancer (1-3). Contrary to conventional assurances that radiation
    exposure from mammography is trivial--and similar to that from a chest X-ray or
    spending one week in Denver, about 1/1,000 of a rad (radiation-absorbed dose)--the
    routine practice of taking four films for each breast results in some 1,000-fold greater
    exposure, 1 rad, focused on each breast rather than the entire chest (2). Thus,
    premenopausal women undergoing annual screening over a ten-year period are
    exposed to a total of about 10 rads for each breast. As emphasized some three
    decades ago, the premenopausal breast is highly sensitive to radiation, each rad of
    exposure increasing breast cancer risk by 1 percent, resulting in a cumulative 10
    percent increased risk over ten years of premenopausal screening, usually from ages
    40 to 50 (4); risks are even greater for ««baseline»» screening at younger ages, for
    which there is no evidence of any future relevance. Furthermore, breast cancer risks
    from mammography are up to fourfold higher for the 1 to 2 percent of women who are
    silent carriers of the A-T (ataxia-telangiectasia) gene and thus highly sensitive to the
    carcinogenic effects of radiation (5); by some estimates this accounts for up to 20
    percent of all breast cancers annually in the United States (6).

    Cancer Risks from Breast Compression
    As early as 1928, physicians were warned to handle ««cancerous breasts with care--
    for fear of accidentally disseminating cells»» and spreading cancer (7). Nevertheless,
    mammography entails tight and often painful compression of the breast, particularly
    in premenopausal women. This may lead to distant and lethal spread of malignant
    cells by rupturing small blood vessels in or around small, as yet undetected breast
    cancers (8).

    Delays in Diagnostic Mammography
    As increasing numbers of premenopausal women are responding to the ACS's
    aggressively promoted screening, imaging centers are becoming flooded and
    overwhelmed. Resultingly, patients referred for diagnostic mammography are now
    experiencing potentially dangerous delays, up to several months, before they can be
    examined (9).

    UNRELIABILITY OF MAMMOGRAPHY
    Falsely Negative Mammograms
    Missed cancers are particularly common in premenopausal women owing to the
    dense
    and highly glandular structure of their breasts and increased proliferation late in their
    menstrual cycle (10, 11). Missed cancers are also common in post-menopausal
    women on estrogen replacement therapy, as about 20 percent develop breast
    densities that make their mammograms as difficult to read as those of premenopausal
    women (12).
    Interval Cancers
    About one-third of all cancers--and more still of premenopausal cancers, which are
    aggressive, even to the extent of doubling in size in one month, and more likely to
    metastasize--are diagnosed in the interval between successive annual mammograms
    (2, 13). Premenopausal women, particularly, can thus be lulled into a false sense of
    security by a supposedly negative result on an annual mammogram and fail to seek
    medical advice.

    Falsely Positive Mammogram
    Mistakenly diagnosed cancers are particularly common in premenopausal women, and
    also in postmenopausal women on estrogen replacement therapy, resulting in
    needless anxiety, more mammograms, and unnecessary biopsies (14, 15). For women
    with multiple high-risk factors, including a strong family history, prolonged use of the
    contraceptive pill, early menarche, and nulliparity--just those groups that are most
    strongly urged to have annual mammograms--the cumulative risk of false positives
    increases to ««as high as 100 percent»» over a decade's screening (16).

    Overdiagnosis
    Overdiagnosis and subsequent overtreatment are among the major risks of
    mammography. The widespread and virtually unchallenged acceptance of screening
    has resulted in a dramatic increase in the diagnosis of ductal carcinoma-in-situ (DCIS),
    a pre-invasive cancer, with a current estimated incidence of about 40,000 annually.
    DCIS is usually recognized as micro-calcifications and generally treated by
    lumpectomy plus radiation or even mastectomy and chemotherapy (17). However,
    some 80 percent of all DCIS never become invasive even if left untreated (18).
    Furthermore, the breast cancer mortality from DCIS is the same-- about 1 percent--
    both for women diagnosed and treated early and for those diagnosed later following
    the development of invasive cancer (17). That early detection of DCIS does not
    reduce
    mortality is further confirmed by the 13-year follow-up results of the Canadian National
    Breast Cancer Screening Study (19). Nevertheless, as recently stressed, ««the public
    is much less informed about overdiagnosis than false positive results. In a recent
    nationwide survey of women, 99 percent of respondents were aware of the possibility
    of false positive results from mammography, but only 6 percent were aware of either
    DCIS by name or the fact that mammography could detect a form of `cancer' that often
    doesn't progress»» (20).

    Quality Control
    In 1992 Congress passed the National Mammography Standards Quality Assurance
    Act requiring the Food and Drug Administration (FDA) to ensure that screening
    centers
    review their results and performance: collect data on biopsy outcomes and match
    them
    with the original radiologist's interpretation of the films (21). However, the centers do
    not release these data because the Act does not require them to do so. It is essential
    that this information now be made fully public so that concerns about the reliability of
    mammography can be further evaluated. Activist breast cancer groups would most
    likely strongly support, if not help to initiate, such overdue action by the FDA.

    FAILURE TO REDUCE BREAST CANCER MORTALITY
    Despite the long-standing claims, the evidence that routine mammography screening
    allows early detection and treatment of breast cancer, thereby reducing mortality, is at
    best highly questionable. In fact, ««the overwhelming majority of breast cancers are
    unaffected by early detection, either because they are aggressive or slow growing»»
    (21). There is supportive evidence that the major variable predicting survival is
    ««biological determinism--a combination of the virulence of the individual tumor plus
    the host's immune response,»» rather than just early detection (22).
    Claims for the benefit of screening mammography in reducing breast cancer mortality
    are based on eight international controlled trials involving about 500,000 women (23).
    However, recent meta-analysis of these trials revealed that only two, based on 66,000
    postmenopausal women, were adequately randomized to allow statistically valid
    conclusions (23). Based on these two trials, the authors concluded that ««there is no
    reliable evidence that screening decreases breast cancer mortality--not even a
    tendency towards an effect.»» Accordingly, the authors concluded that there is no
    longer any justification for screening mammography; further evidence for this
    conclusion will be detailed at the May 6, 2001, annual meeting of the National Breast
    Cancer Coalition in Washington, D.C., and published in the July report of the Nordic
    Cochrane Centre.
    Even assuming that high quality screening of a population of women between the
    ages
    of 50 and 69 would reduce breast cancer mortality by up to 25 percent, yielding a
    reduced relative risk of 0.75, the chances of any individual woman benefiting are
    remote (18). For women in this age group, about 4 percent are likely to develop breast
    cancer annually, about one in four of whom, or 1 percent overall, will die from this
    disease. Thus, the 0.75 relative risk applies to this 1 percent, so 99.75 percent of the
    women screened are unlikely to benefit.

    THE UNITED STATES VERSUS OTHER NATIONS
    No nation other than the United States routinely screens premenopausal women by
    mammography. In this context, it may be noted that the January 1997 National
    Institutes of Health Consensus Conference recommended against premenopausal
    screening (24), a decision that the NCI, but not the ACS, accepted (4). However, under
    pressure from Congress and the ACS, the NCI reversed its decision some three
    months later in favor of premenopausal screening. The U.S. overkill extends to the
    standard practice of taking two or more mammograms per breast annually in
    postmenopausal women. This contrasts with the more restrained European practice
    of a single view every two to three years (4).

    BREAST EXAMINATION IS A SAFE AND EFFECTIVE ALTERNATIVE TO
    MAMMOGRAPHY

    That most breast cancers are first recognized by women themselves was admitted in
    1985 by the ACS, an aggressive advocate of routine mammography for all women
    over the age of 40: ««We must keep in mind the fact that at least 90 percent of the
    women who develop breast carcinoma discover the tumors themselves»» (25).
    Furthermore, as previously shown, ««training increases reported breast self-
    examination frequency, confidence, and the number of small tumors found»» (26).
    A pooled analysis of several 1993 studies showed that women who regularly
    performed BSE detected their cancers much earlier and with fewer positives nodes
    and smaller tumors than women failing to examine themselves (27); BSE would also
    enhance earlier detection of missed or interval cancers, especially in pre-menopausal
    women (28). There is a strong consensus that the effectiveness of BSE critically
    depends on careful training by skilled professionals, and that confidence in BSE is
    enhanced with annual CBEs by an experienced professional using structured
    individual training (29). The tactile sensitivity of BSE can be increased by the use of
    Mammacare techniques to enhance lump detection skills (30, 31), and by the use of
    FDA-approved and nonprescription thin and pliable lubricant-filled sensor pads (32,
    33).
    In a joint U.S. and Chinese large-scale trial based on 520 Chinese factories, women
    in half the factories were trained in and practiced BSE, while the other group of
    women
    served as controls (34). The five-year follow up results reported no reduction in
    breast
    cancer mortality in women in the BSE group. However, these findings are of little, if
    any, significance in view of the minimum of a 10- to 13-year period required before the
    efficacy of mammography is claimed to occur in premenopausal women (24),
    especially as some of the trial's participants were in their thirties (28).
    The critical importance and reliability of CBE has been strikingly confirmed by the
    recent Canadian National Breast Cancer Screening Study (19). This reported the
    results of a unique individually randomized controlled trial on some 40,000 women,
    aged 50 to 59 on entry, followed by record linkage for nine to 13 years, with active
    follow-up of cancer patients for an additional three years. Half the women performed
    monthly BSE, following instruction by trained nurses, had annual CBEs (taking
    approximately ten minutes) by trained nurses, and had annual mammograms, while
    the other half practiced BSE and had annual CBEs but no mammograms. It should be
    noted that the CBE performance by trained nurses had been shown to be as good as,
    if not better than, that of the study surgeons (35), a finding of particular interest in
    view
    of the growing perception among women that professional women are more sensitive
    than men to women's health issues (36). The results of this study provide clear
    evidence on the reliability of CBE, in association with BSE (19): ««In women age 50-59
    years, the addition of annual mammography screening to physical examination has no
    impact on breast cancer mortality.»» In other words, the mammographic detection of
    nonpalpable cancers failed to improve survival rates, as ««the majority of the small
    cancers detected by mammography represent pseudo-disease or overdiagnosis»»
    (37); confirmation of this explanation awaits a trial, a protocol of which is available,
    comparing mammography alone with physical examination alone. It should further be
    noted that the mammogram group had a three-fold increase in the number of false
    positives compared with the CBE and BSE group, resulting in unnecessary biopsies.
    The effectiveness of CBE is further supported by the results of a new Japanese mass
    screening study (38). Breast cancer mortality was compared in municipalities with or
    without ««high coverage»» by CBE. The age-adjusted breast cancer mortality between
    1986-1990 and 1991-1995 was reduced by over 40 percent in ««high coverage»»
    municipalities, in contrast to only 3 percent in controls.

    In spite of such evidence, the ACS and radiologists persist in their dismissiveness of
    CBE and BSE, particularly as ««a substitute for screening practices that have a
    `proven' benefit such as mammograms»» (33). The NCI no longer prints a BSE guide
    in its breast cancer booklet, claiming that ««no studies have clearly shown a benefit
    of using BSE»»; similarly, the ACS no longer distributes information on BSE, such as
    shower-hanger cards.

    There are immediate needs for a large-scale crash program for training nurses in how
    to perform annual CBE and how to teach BSE. This need is critical for underinsured
    and uninsured low-socioeconomic and ethnic women in the United States, and even
    more so for developing countries. Once well trained, women of all social and cultural
    classes could perform monthly BSE, at no cost or risk apart from false positives, which
    decrease with increasing practice, along with annual CBE screening. Clinics offering
    CBE and training in BSE could be established nationwide, and eventually worldwide,
    in a network of clinics, community hospitals, churches, synagogues, and mosques.
    These clinics could also act as a comprehensive source of reliable information on
    how
    to reduce the risks of breast cancer, about which women still remain largely
    uninformed by the cancer establishment (2). Besides lifestyle and reproductive risk
    factors, emphasis should be directed to the massive overprescription of carcinogenic
    hormonal drugs and the avoidable and involuntary exposures to petrochemical and
    radionuclear carcinogens in the totality of the environment (39-41).

    COSTS OF SCREENING
    The dangers and unreliability of mammography screening are compounded by its
    growing and inflationary costs; Medicare and insurance average costs are $70 and
    $125, respectively. Inadequate Medicare reimbursement rates are now prompting
    fewer hospitals and clinics to offer mammograms, and deterring young doctors from
    becoming radiologists. Accordingly, Senators Charles Schumer (D-NY) and Tom
    Harkin (D-IA) are introducing legislation to raise Medicare reimbursement to $100 (42).
    If all U.S. premenopausal women, about 20 million according to the Census Bureau,
    submitted to annual mammograms, minimal annual costs would be $2.5 billion (4).
    These costs would be increased to $10 billion, about 5 percent of the $200 billion 2001
    Medicare budget, if all postmenopausal women were also screened annually, or about
    14 percent of the estimated Medicare spending on prescription drugs. Such costs will
    further increase some fourfold if the industry, enthusiastically supported by
    radiologists, succeeds in its efforts to replace film machines, costing about $100,000,
    with the latest high-tech digital machines, approved by the FDA in November 2000,
    costing about $400,000. Screening mammography thus poses major threats to the
    financially strained Medicare system. Inflationary costs apart, there is no evidence of
    the greater effectiveness of digital than film mammography (43), as confirmed by a
    study reported at the November 2000 annual meeting of the Radiological Society of
    North America (44). In fact, digital mammography is likely to result in the increased
    diagnosis of DCIS.
    The comparative cost of CBE and mammography in the 1992 Canadian Breast Cancer
    Screening Study was reported to be 1 to 3 (45). However, this ratio ignores thehigh
    costs of capital items including buildings, equipment, and mobile vans, let alone the
    much greater hidden costs of unnecessary biopsies, specialized staff training, and
    programs for quality control and professional accreditation (46). This ratio could be
    even more favorable for CBE and BSE instruction if both were conducted by trained
    nurses. The excessive costs of mammography screening should be diverted away
    from industry to breast cancer prevention and other women's health programs.

    CONFLICTS OF INTEREST
    The ACS has close connections to the mammography industry (39). Five radiologists
    have served as ACS presidents, and in its every move, the ACS promotes the
    interests
    of the major manufacturers of mammogram machines and films, including Siemens,
    DuPont, General Electric, Eastman Kodak, and Piker. The mammography industry
    also conducts research for the ACS and its grantees, serves on advisory boards, and
    donates considerable funds. DuPont also: is a substantial backer of the ACS Breast
    Health Awareness Program; sponsors television shows and other media productions
    touting mammography; produces advertising, promotional, and information literature
    for hospitals, clinics, medical organizations, and doctors; produces educational films;
    and, of course, lobbies Congress for legislation promoting availability of
    mammography services. In virtually all its important actions, the ACS has been and
    remains strongly linked with the mammography industry, while ignoring or attacking
    the development of viable alternatives (39).
    ACS promotion continues to lure women of all ages into mammography centers,
    leading them to believe that mammography is their best hope against breast cancer.
    A leading Massachusetts newspaper featured a photograph of two women in their
    twenties in an ACS advertisement that promised early detection results in a cure
    ««nearly 100 percent of the time.»» An ACS communications director, questioned by
    journalist Kate Dempsey, admitted in an article published by the Massachusetts
    Women's Community's journal Cancer, ««The ad isn't based on a study. When you
    make an advertisement, you just say what you can to get women in the door. You
    exaggerate a point. . . . Mammography today is a lucrative [and] highly competitive
    business»» (39).

    NEEDED REFORMS
    Mammography is a striking paradigm of the capture of unsuspecting women by
    runaway powerful technological and pharmaceutical global industries, with the
    complicity of the cancer establishment, particularly the ACS, and the rollover
    mainstream media. Promotion of the multibillion dollar mammography screening
    industry has also become a diversionary flag around which legislators and women's
    product corporations can rally, protesting how much they care about women, while
    studiously avoiding any reference to avoidable risk factors of breast cancer, let alone
    other cancers.
    Screening mammography should be phased out in favor of annual CBE and monthly
    BSE, as an effective, safe, and low-cost alternative, with diagnostic mammography
    available when so indicated. Such action is all the more critical and overdue in view
    of the still poorly recognized evidence that screening mammography does not lead to
    decreased breast cancer mortality (18, 21, 23).
    Networks of CBE and BSE clinics, staffed by trained nurses, should be established
    internationally, including in developing nations. These low-cost clinics would further
    empower women by providing them with scientific evidence on breast cancer risk
    factors and prevention, information of particular importance in view of the continued
    high incidence of breast cancers, with an estimated 192,200 new U.S. cases predicted
    for 2001 (47), exceeding the number for any previous years. The multibillion dollar
    U.S. insurance and Medicare costs of mammography, besides those in other nations,
    should be diverted to outreach and research on prevention of breast and other
    cancers
    and on other women's health programs.
    Acknowledgments -- The comments and advice of Dr. Cornelia Baines and Maryann
    Napoli are gratefully acknowledged.

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