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Withdrawal/Redaction Sheet
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001a. letter
Dr Duvall to Dr Varmis re background correspondence (2 pages)
05/01/1995
b(6)
001b. letter
Linda Ruiz to Dr Duvall re response (2 pages)
04/12/1995
b(6)
001c. letter
Dr Duvall to Linda Ruiz re thank you (1 page)
04/17/1995
b(6)
001d. letter
Maryland Medicare Part A to patient re corrected bill (1 page)
04/05/1995
b(6)
COLLECTION:
Clinton Presidential Records
First Lady's Office
Jennifer Klein
OA/Box Number: 13530
FOLDER TITLE:
Mammogram Frequency [1]
2014-0536-S
kc1561
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)]
Freedom of Information Act - 15 U.S.C. 552(b)]
P1 National Security Classified Information |(a)(1) of the PRA
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office |(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute |(a)(3) of the PRA]
an agency |(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute |(b)(3) of the FOIA]
financial information [(a)(4) of the PRA
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information l(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRAJ
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA|
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions [(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA)
RR. Document will be reviewed upon request.
SENT BY:NIH Exec Secretariat ; 6- 8-95 :10:49AM ;
3014968276-
CCITT G3:# 2
&
MAY 3 1 1995
Charles P. Duvall, M.D.
American Society of Internal Medicine
2011 Pennsylvania Avenue, N.W., Suite 800
Washington, DC 20006-1808
Dear Dr. Duvall:
Thank you for your inquiry regarding appropriate breast cancer
screening intervals. Dr. Varsus has asked me to respond since
the issue of screening effectiveness falls within the purview of
this scientific program.
A large volume of scientific information has become available
regarding the effectiveness of breast cancer screening by
mammography in the past three years. The National Cancer
Institute (NCI) reviewed its Working Guidelines on Screening for
Breast Cancer in light of this new information. Following
extensive discussion, the Division of Cancer Prevention and
Control's Board of Scientific Counselors voted to discontinue
the NCI guidelines in favor of statements of scientific knowledge
issued through the Physician's Data Query (PDQ). The National
Cancer Advisory Board subsequently endorsed this decision. Other
federal organisations, such as the Agency for Health Care Policy
Research, were felt to be better suited by mission and staffing
to deal with guidelines development; and the Health Care
Financing Agency (HCFA) determines levels of payment for medical
procedures funded by the federal government.
New results from eight randomized, controlled screening trials in
Sweden, the United Kingdom, and Canada were reported in the
scientific literature in 1993. There were reports from
individual trials and overview analyses combining the results
from all trials. The data and findings from these trials were
critically reviewed at the NCI's International Workshop on
Screening for Breast Cancer, February 24-25, 1993, and the
Workshop Report published in the Journal of the National Cancer
Institute (Fletcher, et al., JNCI, Vol. 20, NO. 20, October 20,
1993).
Screening intervals from 12 to 33 months were employed in the
trials. The benefits of screening, mortality reductions of 30-35
percent were quite consistent across trials for women aged 50 to
69 years irrespective of screening interval. To quote from the
Fletcher report, "Because the effectiveness of screening women
aged 50 or older varied little across the studies, there is
little evidence to show that shorter screening intervals were
more effective in reducing breast cancer mortality." This
conclusion remains as valid in 1995 as it was in 1993, so far as
wa can datermine from the literature.
SENT BY:NIH Exec Secretariat ; 6- 8-95 :10:49AM ;
3014968276-
CC111 G3:# 3
Page 2 -- Dr. Duvall
one of the most important screening issues we face today is
encouraging women of 50 years and older to undergo regular breast
cancer screening. It has been reported in a number of studies
that a substantial proportion of women in this age group are not
having nammograms even at biannial intervals. Yet the weight of
clinical trial results assures us that these are the women who
will benefit most from screening at intervals of one to two
years.
Thank you again for the opportunity to share with you some of
what has been learned regarding the effectiveness of breast
cancer screening, due in part to deliberations sponsored by the
NCI.
sincerely yours,
Tsigned
Peter Greanwald, M.D.
Director
Division of Cancer Prevention
and Control
MEMORANDUM
To:
Jennifer Klein
From: Karen Guss
Date: May 22, 1995
Re:
Recommended frequency of mammography screening.
Women under age 40:
There is a nearly universal belief that women in this age group should not receive regular
mammography screening. The American Cancer Society used to recommend that women get
a "baseline mammogram" at approximately age 35, but they no longer do so. Some
advocates in the African-American women's health community believe that African-
American women in this age group should be screened because they are at higher risk of
developing breast cancer than are younger white women.
Women aged 40-49:
This is a controversial topic, with recent articles having been published on both sides of the
issue. The National Cancer Institute (NCI) recommends that women in this age group make
individual determinations, in consultation with their physicians, whether to get regular
mammograms. The United States Preventive Services Task Force and the American College
of Physicians, among other groups, do not recommend screening in younger women; the
American Cancer Society and the American College of Radiology are two of the
organizations in favor of screening women in this age group.
Women aged 50+:
Here, everyone is in agreement that women should receive regular mammograms once they
reach age 50 (although it is less clear when the regular screening should stop (see below)).
The controversy is whether women should be screened every year or every other year.
NCI recommends screening "every 1 to 2 years" because clinical trials show essentially the
same mortality reduction resulting from bi-annual as from annual screening. The American
Cancer Society and several other groups recommend annual screening.
Studies of the efficacy of regular mammography have not been performed on women over the
age of 69. However, most experts, including NCI, believe that the results of studies on
women aged 50 to 69 do apply to women aged 70 and over who are in reasonably good
health and who are expected to live long enough to warrant an effort to detect breast cancer
early.
The ASIM letter:
Dr. Duvall states that "he thinks" that NIH and CDC recommend annual screening for women
aged 65 and older. However, CDC does not have a position on screening frequency, and, as
stated above, NIH (through NCI) has stated that bi-annual screening is appropriate.
Accordingly, Medicare coverage of bi-annual screening mammograms (remember that more
frequent diagnostic screening is also available under certain conditions) is consistent with the
NIH guidelines. In fact, the Health and Human Services Secretary is required to establish
Medicare's coverage rules with respect to mammography in consultation with NCI.
Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001a. letter
Dr Duvall to Dr Varmis re background correspondence (2 pages)
05/01/1995
b(6)
COLLECTION:
Clinton Presidential Records
First Lady's Office
Jennifer Klein
OA/Box Number: 13530
FOLDER TITLE:
Mammogram Frequency [1]
2014-0536-S
kc1561
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)]
Freedom of Information Act - 15 U.S.C. 552(b)|
P1 National Security Classified Information |(a)(1) of the PRA
b(1) National security classified information |(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA|
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information [(a)(4) of the PRA|
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRAJ
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRA]
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions [(b)(8) of the FOIA|
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001b. letter
Linda Ruiz to Dr Duvall re response (2 pages)
04/12/1995
b(6)
COLLECTION:
Clinton Presidential Records
First Lady's Office
Jennifer Klein
OA/Box Number: 13530
FOLDER TITLE:
Mammogram Frequency [1]
2014-0536-S
kc1561
RESTRICTION CODES
Presidential Records Act 144 U.S.C. 2204(a)]
Freedom of Information Act - - 15 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA
b(1) National security classified information [(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office |(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute |(a)(3) of the PRA|
an agency [(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute [(b)(3) of the FOIA]
financial information ((a)(4) of the PRAJ
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA]
personal privacy [(a)(6) of the PRAJ
b(7) Release would disclose information compiled for law enforcement
purposes |(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions |(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001c. letter
Dr Duvall to Linda Ruiz re thank you (1 page)
04/17/1995
b(6)
COLLECTION:
Clinton Presidential Records
First Lady's Office
Jennifer Klein
OA/Box Number: 13530
FOLDER TITLE:
Mammogram Frequency [1]
2014-0536-S
kc1561
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)|
Freedom of Information Act - 15 U.S.C. 552(b)]
P1 National Security Classified Information |(a)(1) of the PRAJ
b(1) National security classified information [(b)(1) of the FOIA)
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency [(b)(2) of the FOIA|
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute |(b)(3) of the FOIA]
financial information [(a)(4) of the PRA|
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors |a)(5) of the PRA]
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy ((b)(6) of the FOIA]
personal privacy |(a)(6) of the PRA|
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions |(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001d. letter
Maryland Medicare Part A to patient re corrected bill (I page)
04/05/1995
b(6)
COLLECTION:
Clinton Presidential Records
First Lady's Office
Jennifer Klein
OA/Box Number: 13530
FOLDER TITLE:
Mammogram Frequency [1]
2014-0536-S
kc1561
RESTRICTION CODES
Presidential Records Act - |44 U.S.C. 2204(a)]
Freedom of Information Act - [5 U.S.C. 552(b)]
P1 National Security Classified Information [(a)(1) of the PRA]
b(1) National security classified information |(b)(1) of the FOIA]
P2 Relating to the appointment to Federal office [(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute |(a)(3) of the PRA
an agency |(b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute |(b)(3) of the FOIA]
financial information [(a)(4) of the PRAJ
b(4) Release would disclose trade secrets or confidential or financial
P5 Release would disclose confidential advice between the President
information [(b)(4) of the FOIA]
and his advisors, or between such advisors [a)(5) of the PRAJ
b(6) Release would constitute a clearly unwarranted invasion of
P6 Release would constitute a clearly unwarranted invasion of
personal privacy |(b)(6) of the FOIA]
personal privacy |(a)(6) of the PRA|
b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions |(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
ORIGINAL INVESTIGATION
Improving Compliance With Breast Cancer
Screening in Older Women
Results of a Randomized Controlled Trial
Carla J. Herman, MD, MPH; Theodore Speroff, PhD; Randall D. Cebul, MD
Background: To compare three approaches for improv-
During the intervention period, women without a pre-
ing compliance with breast cancer screening in older
vious clinical breast examination were offered an
women.
examination significantly more often in the Prevention
Team group than in the control group, adjusting for
Methods: Randomized controlled trial using three
age, race, and comorbidity and for physicians' gender
parallel group practices at a public hospital. Subjects
and training level. The patients in the Prevention
included women aged 65 years and older (n=803) who
Team group were offered clinical breast examination
were seen by residents (n=66) attending the ambula-
(31.5%) more frequently than those in the patient
tory clinic from October 1, 1989, through March 31,
education or control groups, but this was not signifi-
1990. All provider groups received intensive education
cant after adjusting for the above covariates. Likewise,
in breast cancer screening. The control group received
mammography was offered more frequently to
no further intervention. Staff in the second group
patients in the Prevention Team and in the patient
offered education to patients at their visit. In addition,
education group than to patients in the control group,
flowsheets were used in the "Prevention Team" group
after adjusting for the factors above using logistic
and staff had their tasks redefined to facilitate compli-
regression.
ance.
Conclusions: The results provide support for patient
Results: Medical records were reviewed to determine
education and organizational changes that involve
documented offering/receipt of clinical breast éxami-
nonphysician personnel to enhance breast cancer
nation and mammography. A subgroup of women
screening among older women, particularly those
without previous clinical breast examination (n=540)
without previous screening.
and without previous mammography (n=471) were
analyzed to determine the effect of the intervention.
(Arch Intern Med. 1995;155:717-722)
IFTY PERCENT of breast can-
1987, the number of women obtaining
F
cers occur in women older
regular screening remains at 33%.6 Many
than 60 years. The inci-
barriers exist that have prevented opti-
dence of breast cancer has
mum screening for breast cancer: physi-
been increasing during the
cian and patient attitudes, 7-12 accessibil-
last 30 years, while the mortality has re-
ity, lack of information, and competing
From the Department of
mained unchanged.¹ A growing body of
concurrent acute medical conditions. 13-15
scientific evidence has shown that breast
Medicine, Division of Geriatric
Women with lower income, less educa-
Medicine, University Hospitals
cancer screening for asymptomatic women
tion, and minority women have tradition-
of Cleveland (Dr Herman):
aged 50 through 74 years decreases mor-
ally underused mammography. 16-19
Department of Medicine,
tality and, using decision analysis, it is es-
Attempts to increase breast cancer
Division of General Internal
timated that it may remain beneficial for
screening have included public educa
Medicine at MetroHealth
healthy women through their 80s. 2-5 The
tion programs, a variety of physician of-
Medical Center (Drs Speroff
screening modalities most frequently em-
fice prompts, and physician educa-
and Cebul) and Department of
ployed have been mammography and clini-
tion.
20-34 In general, however, successful
Epidemiology and Biostatistics
cal breast examination (CBE).
(Drs Speroff and Ccbul), Case
Western Reserve University
Compliance with recommended
School of Medicine, Cleveland.
screening is an important issue for older
Ohio. Dr Herman is non with
women. Although the percentage of older
See Materials and Methods
the University of New Mexico.
women undergoing one-time mammog-
on next page
Albuquerque.
raphy screening has increased to 67% since
ARCH INTERN MEDA'OL 155 APR 10. 1995
717
Clinical Strategies for Breast Cancer Screening:
Weighing and Using the Evidence
Russell Harris, MD, MPH, and Linda Leininger. MD, MPH
When balancing the benefits of screening women for
Screening for any disease is a seductive activity. Who
breast cancer against the harms and costs of such
could oppose finding disease in an early stage, before
screening, one needs to consider the risk for dying of
symptoms appear? This may be one reason why screening
breast cancer, the relative reduction in that risk that will
is omnipresent in medical care. It is also one of the
result from screening women in different age groups,
reasons why it is so difficult to explain to patients that
and the harms and costs associated with screening.
screening is a "two-edged sword," that it has the potential
Seven randomized controlled trials provide evidence of
to injure as well as to help (1). From this perspective, it
the relative risk reduction that results from screening
is particularly relevant to examine the issue of screening
women in different age groups; other studies estimate
for breast cancer in an "In the Balance" article. Only by
the harms and costs of screening. These studies indi-
weighing the benefits against the harms and costs of
cate that the benefit of screening, expressed as the
screening can we, patients and physicians alike, make a
absolute number of lives extended per 1000 women
rational decision about who should be screened and how
screened, increases with age and that the harm of
often.
screening, expressed as the number of follow-up pro-
The question of who should be screened for breast
cedures per cancer detected, decreases with age.
cancer is not simply an academic debate. The real prob-
Thus, the tradeoff between the benefits and the harms
lem is a practical one: What do we say to the patient we
and costs of screening is better for older than for
will see this afternoon? How do we explain her risk for
younger women. Because there is no clear cut-point for
breast cancer, the effect that screening will have on that
determining when benefits outweigh harms and costs,
risk, and the harms and costs of screening? How do we
it is important to involve women in discussions of
help her make an informed decision? We will focus on
breast cancer screening. The women who most need to
this issue by reviewing the risk for breast cancer, weighing
be involved are those for whom the benefits of screen-
the evidence of benefits and of the harms and costs of
ing clearly outweigh the harms and costs and those for
screening, and offering some preliminary ideas about what
whom the benefits and the harms and costs constitute
to say to our patients.
a "close call." For women in both groups, the physician
should routinely raise the issue of screening, first elic-
The Risk for Breast Cancer
iting the patient's perceptions and then providing infor-
mation and discussion about the risk for breast cancer
Age is the most important risk factor for breast cancer.
and about the benefits and the harms and costs of
The risk for being diagnosed with invasive breast cancer
screening. Furthermore, the physician should encour-
in the coming year increases with age up to 75 or 80 years
age the patient to use her own values to weigh the
of age, increasing more than 15-fold between 30 and 70
benefits against the harms and costs, pointing out
years of age (Figure 1) (2). For a woman aged 30 to 34
biases in reasoning and minimizing socioeconomic
years, the risk for being diagnosed with breast cancer in
barriers. Finally, when the benefits obviously outweigh
the coming year is about 2.7 per 10 000 women; for a
the harms and costs, the physician should make a clear
woman aged 70 to 74 years, it is about 43.4 per 10 000
recommendation for screening.
women.
Another common way of expressing the risk for being
diagnosed with breast cancer is lifetime risk at a given
age. As most people know, a white woman's lifetime risk
at birth for being diagnosed with invasive breast cancer
has increased from 1 in 10 to about 1 in 8 in the past 10
to 20 years (2, 3). The lifetime risk at birth for a black
woman is about 1 in 11. The lifetime risk for being
diagnosed with breast cancer remains about the same
until 40 years of age when, because fewer years of life
remain in which a woman can be diagnosed with breast
cancer, the lifetime risk actually declines. At 60 years of
age. a white woman's risk for being diagnosed with breast
Ann Intern Med. 1995:122:539-547.
cancer during the rest of her life is about 1 in 10, and at
70 years of age, her risk is about 1 in 14. For a black
woman at 70 years of age. the lifetime risk is about 1 in
From the Department of Medicine and the UNC-Lineberger
Comprehensive Cancer Center. University of North Carolina
20 (2. 3).
School of Medicine. Chapel Hill. North Carolina For current
The problem with these expressions of risk is that
author addresses. see end of text.
screening does not reduce the risk for being diagnosed
© 1995 American College of Physicians
539
1138
THE NEW ENGLAND JOURNAL OF MEDICINE
April 27, 1995
SPECIAL ARTICLE
MEDICARE COVERAGE, SUPPLEMENTAL INSURANCE, AND THE USE OF MAMMOGRAPHY
BY OLDER WOMEN
JAN BLUSTEIN, M.D., PH.D.
Abstract Background. On January 1, 1991, the Medi-
percent of those with self-purchased supplemental in-
care program began offering reimbursement for screening
surance, and 23.9 percent of those with Medicaid sup-
mammography every two years. This study examined the
plemental insurance. These differences persisted in the
use of mammography in women covered by Medicare
stratified and multivariate analyses. As compared with
during the first two years that the screening benefit was
women lacking supplemental insurance, women with em-
offered.
ployment-based supplemental insurance were more likely
Methods. Medicare bills for 1991 and 1992 from a
to undergo mammography (adjusted odds ratio, 3.03; 95
nationally representative sample of 4110 women 65
percent confidence interval, 2.17 to 4.23), as were wom-
years of age or older were examined to determine the
en with self-purchased supplemental insurance (adjusted
degree of compliance with recognized guidelines for
odds ratio, 2.97; 95 percent confidence interval, 2.13 to
screening mammography and the extent to which the
4.15) and women with Medicaid supplemental insurance
use of mammography was associated with having sup-
(adjusted odds ratio, 1.99; 95 percent confidence interval,
plemental insurance, which shields patients from the
1.30 to 3.07).
out-of-pocket costs associated with using Medicare ben-
Conclusions. The use of mammography was substan-
efits.
tially below recommended levels during the first two years
Results. A total of 36.9 percent of older U.S. women
of Medicare coverage for screening mammography. Wom-
had mammography during the first two years of the Medi-
en lacking supplemental health insurance were at partic-
care benefit for screening mammography. Only 14.4 per-
ularly high risk of failing to undergo mammography. Re-
cent of the women lacking supplemental insurance had
quiring copayments for preventive services is an obstacle
mammography, as compared with 44.7 percent of those
to the effective mass screening of older women for breast
with employer-sponsored supplemental insurance, 40.1
cancer. (N Engl J Med 1995;332:1138-43.)
B
REAST cancer is the most common cancer in wom-
on the basis of data from the Medicare Current Bene-
en, and its incidence increases with age.¹ Since the
ficiary Survey. The survey provides a detailed picture
late 1970s and early 1980s, key organizations - includ-
of the personal, social, and medical circumstances of a
ing the National Cancer Institute and the American
large, nationally representative sample of older women.
Cancer Society - have recommended regular screen-
Several investigators have demonstrated that health
ing mammography for women more than 50 years of
insurance is an important determinant of the use of
age.² However, it was not until January 1, 1991, that
mammography: For example, women with health insur-
the Medicare program instituted coverage for biennial
ance are more likely to have mammography than are
screening mammograms.²
women who are uninsured,⁷ and women enrolled in
Many Medicare beneficiaries have supplemental
prepaid health plans are more likely to have mammog-
health insurance - employer-sponsored, individually
raphy than are women receiving their care in the fee-
purchased (so-called Medigap), or Medicaid.³ To varv-
for-service sector.⁸ Preliminary data from the 1992
ing degrees, these supplemental policies shield patients
National Health Interview Survey suggest that supple-
from the copayments, deductibles, and "balance bills"
mental insurance may be an independent predictor of
associated with using Medicare-reimbursed services. 3-6
the use of various cancer-screening services by older
Out-of-pocket health care costs can be substantial for
women.⁹ However, a host of other patient characteris-
older people lacking supplemental insurance, many of
tics are associated with the use of mammography, in-
whom have low incomes, do not qualify for Medicaid
cluding having a usual source of care, higher income,
insurance, and are unable to purchase private supple-
white race, higher educational attainment, and younger
mental plans. For these patients, the extra costs asso-
age. Patients' knowledge and attitudes about preven-
ciated with the use of Medicare-reimbursed services
tive care 10-13 as well as physicians' behavior are
may keep them from taking advantage of Medicare
also important determinants of whether mammography
benefits, particularly for services that are perceived as
is used. The analysis reported here incorporates meas-
being discretionary.
ures reflecting some of these important determinants of
This report explores the extent to which supplemen-
mammography use to estimate the effect of supplemen-
tal insurance was associated with the use of mammog-
tal insurance.
raphy by older women during the years 1991 and 1992.
METHODS
From the Division of General Medicine. College of Physicians and Surgeons.
Study Population
and the Division of Health Policy and Management, School of Public Health. Co.
lumbia University. New York. Address reprint requests to Dr. Blustein at the Di-
The Medicare Current Beneficiars Survey is a probability survey
VISION of General Medicine. PH9 East. College of Physicians and Surgeons. 630
based on a multistage. stratified cluster sample of Medicare benefici-
W. 168th St.. New York. NY 1(8132
aries in the 50 states. the District of Columbia. and Puerto Rico.
Supported by a grant from the Commonwealth Fund.
Both community-dwelling people and people living in long-term-
JUN-22-1995 09:02 FROM ADMINISTRATOR'S OFFICE
TO
94562878 P.01
HEALTH CARE FINANCING ADMINISTRATION
456-2878
ADDRESSEE:
FROM: Kathy King
Jennifer Klein
OFFICE OF THE ADMINISTRATOR
200 INDEPENDENCE AVE., S.W.
ROOM 314G
WASHINGTON, DC 20201
PHONE: 202-690-6726
PHONE:
FAX : 202-690-6262
TOTAL PAGES:
ADDRESSEE'S FAX MACHINE NUMBER:
DATE:
Ct2
456-2878
REMARKS:
JUN-22-1995
09:03
FROM ADMINISTRATOR'S OFFICE
TO
94562878 P.02
MAMMOGRAPHY ESTIMATES
Current policy:
Medicare helps pay for screening mammograms
once every two years for women age 65 and
older. Coverage for beneficiaries under age
65 varies according to the age and risk
category of the patient. Mammograms
currently are subject to the Part B
deductible and coinsurance.
Proposal 1:
To eliminate cost-sharing on the screening
mammography benefit.
O
Effective 1/1/97.
O
Estimates reflect the deductible and
coinsurance for screening manmograms
only; however, mammograms used for
screening purposes are commonly miscoded
as diagnostic mammograms. Eliminating
cost-sharing for diagnostic mammograms
is shown separately.
o
The screening fee used in the estimates
includes the cost of biopsies and other
ancillary services resulting from false
positives. The costs of eliminating
cost-sharing were computed for the
mammography screening only.
0
Pay-as-you-go estimates from OACT:
5-year
FY 1997-2001
$90m
7-year
FY 1997-2003
$130m
10-year
FY 1997-2006
$205m
Proposal 2:
To cover annual mammography screenings with
current deductibles and coinsurance.
Effective 1/1/97.
Pay-as-you-go estimates from OACT:
5-year
FY 1997-2001
$245m
7-year
FY 1997-2003
$370m
10-year
FY 1997-2006
$580m
JUN-22-1995
09:03
FROM ADMINISTRATOR'S OFFICE
TO
94562878 P.03
Proposal 3:
To cover annual mammography screenings with
no cost-sharing.
0
Effective 1/1/97.
o
Pay-as-you-go estimates from OACT:
5-year
FY 1997-2001
$380m
7-year
FY 1997-2003
$585m
10-year FY 1997-2006 $930m
Addendum:
Additional cost of eliminating cost-sharing
for diagnostic mammograms.
O
Effective 1/1/97.
O
Pay-as-you-go estimates from OACT:
5-year
FY 1997-2001
$175m
7-year
FY 1997-2003
$265m
10-year
FY 1997-2006
$420m
FROM THE OFFICE OF CABINET SECRETARY
202-456-2572
Date: 10/26/94
Response Needed by: N/A
Chris Jennings
Joan Baggett
Mack McLarty
Erskine Bowles
Abner Mikva
Rahm Emanuel
Dee Dee Myers
Mark Gearan
Jack Quinn
Jennifer Klein
Pat Griffen
Leon Panetta
Marcia Hale
John Podesta
Alexis Herman
Carol Rasco
N. Hernreich
Bob Rubin
Harold Ickes
Alice Rivlin
Anthony Lake
G. Stephanopoulos
Bruce Lindsey
Billy Webster
Katie McGinty
M. Williams
Remarks: Urgent. Please see attached wine
Story regarding NIH study linking (suppuredly)
abostions + breast cancer
1
-Jen.
Response:
EXECUTIVE OFFICE OF THE PRESIDENT
26-Oct-1994 02:26pm
TO:
Carol H. Rasco
FROM:
Jennifer M. O'Connor
Office of Cabinet Affairs
CC:
Jeremy D. Benami
SUBJECT:
Abortion story out today
FYI - -
HHS just called to tell me there are a few stories in Seattle
papers today and 1 wire story today that say that an NIH study
shows that young women who have abortions are more likely to get
breast cancer. It also supposedly shows that the likelihood of
breast cancer doubles when the woman has a second abortion. HHS
is talking to NIH to see if there is truth to the report, and they
will send the clips/ talking points when they get them. (They
don't have the clips yet because they were alerted to the story by
Kate Michelman).
OCT-26-1994 14:26 FROM
TO
94566704 P.02
v50933exec
r W AP-Abortions-Cancer
10-26 0324
"Ap-Abortions-Cancer, 3005
^Study Finds Abortion Increases Rish Of Breast Cancer:
^By PAUL RECER*
^AP Science Writer=
WASHINGTON (AP) - Women aged 45 or younger who have undergone an
abortion are 50 percent sore likely to develop breast cancer than
other women that age, according to a study released today.
The study, by a team at the Fred Hutchinson Cancer Center in
Seattle, is based on interviews with 845 breast cancer patients and
961 women of the same age group who were healthy.
Using data from the interviews, researchers compared the
reproductive history of the two groups and found that induced
abortions appear to increase the risk of breast cancer by about 50
percent.
This increased risk did not vary by the number of induced
abortions or by the history of a coupleted prequancy, but it was
higher if the abortion was performed ages younger than 18 years,'
according to a susnary of the study by the Journal of the National
Cancer Institute, which will publish the research next week.
There was no breast cancer risk found for abortions that
occurred spontaneously, the study said.
An editorial in the Journel by Lynn Rosenberg said that the
study, led by Janet R. Daling, was carefully designed and
conducted, but that additional research is needed before a proven
link between abortion and breast cancer can be drawn.
The editorial also noted that some earlier studies have failed
to find B link between induced abortions and breast cancer.
Both Rosenberg and Daling pointed out that a 90 percent increase
in risk is considered small in epidemiology and that statistical
distortions are enhanced in such studies when the detected risk is
small.
Daling and her colleagues note that the study limitations
include the possibility of reporting inaccuracies, particularly
among the health group that was interviewed, and the inability to
validate whether abortions were spontaneous or induced.
APWR-10-26-94 1031EDT(
03/08/94 13:47
202 690 5432
HHS OASH
0
001/003
OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH
Room 713E, 200 Independence Avenue, SW
Washington, DC, 20201
tel (202) 401-7736
fax (202) 690-5432
fax
transmittal
to:
Jennifer Klein
fax #: 456-2878
from:
Lisa Simpson, MB, BCh, MPH
date: 3/8/94
re:
ime
pages:
, including this cover sheet
NOTES: Here it is - hope it meets your needs. We are all working on the side by side for
benefits.
Apparently AGI is releasing the results of a study on the coverage of abortion and
other services by plans tomorrow - it is embargoed til 2:00 - I am getting a copy for us
(Most plans cover...)
Manon -
As far as mammograms are concerned, other than the data you have
Any ideas on
42 states mandated coverage of mammograms in 1991;
Institute on women's policy research is looking at costs of specific preventive services
finding out.
for women;
more on this
KFF is also funding that institute to look at how women get health insurance and the
impact of various policies - should be out next month.
Even on the AGI study they only asked about whether they cover mammography -
not with how much cost sharing, or how often
Finally, we (HHS) is currently doing an employer survey on insurance coverage, but
again, the level of information on mammography just won't be there.
Early Detection of Breast Cancer and Health Care Reform
The Congressional Women's Caucus is right to call for a comprehensive benefits package
spelled out in law, and for preventive care focusing on early detection and treatment of
breast cancer.
Women are increasingly at risk for life-threatening illnesses such as breast cancer,
ovarian cancer, and heart and lung disease, yet still anchor the bottom of our medical
research agenda. Of all the health problems women face, however, breast cancer is one of
the deadliest:
One in nine women in the U.S. will develop breast cancer in her lifetime. (National
Breast Cancer Coalition)
2.6 million women in the U.S. have breast cancer today, and this year another
182,000 American women will be diagnosed with the disease, approximately one
woman every three minutes. (National Breast Cancer Coalition)
The Health Security Act addresses women's health -- and the threat of breast cancer --
aggressively and comprehensively, guaranteeing all women coverage, regardless of
whether they are healthy or sick, married or single, working or unemployed, wealthy or
low income. And the President's approach will provide unprecedented coverage of
preventive care, including mammography. It will cover a whole schedule of
preventive screenings, tests and check-ups at no cost, protection available in only a
few of today's insurance policies.
Coverage of Mammograms and other preventive services under The Health Security Act:
Coverage for all women:
Women of any age can receive clinical breast exams and mammograms at any time
when the patient and doctor feel it is medically necessary or appropriate, and will pay
a standard co-pay (for example, ten dollars) set by their plan.
Extra coverage for women at risk:
Women of any age who are defined to be at risk of breast cancer will receive
additional visits, including clinical breast exams and mammograms, with no cost
sharing.
Additional coverage of mammograms:
For certain age groups, at certain intervals, mammograms are free of any cost sharing,
so there is no charge when a woman goes to the doctor for these services.
As part of the preventive services package, all women age 50 and older would have
routine mammogram screening every other year, free of charge. Again, any woman
who needs more frequent mammograms would be covered, and would pay a co-pay.
Additional coverage of clinician visits:
Clinician visits, including clinical breast exams, are covered for all women, and
additional coverage is available for women in certain age groups. Clinician visits are
free once every three years for women age 20-39, and every other year for women
from 40-64.
New investments in combating breast cancer
This year, the National Institute of Health's breast cancer research budget increased by
44 percent, from $208 million to almost $300 million.
Under reform, new research initiatives will concentrate on the prevention of illnesses
affecting women, including breast cancer, mental health, reproductive health and
osteoporosis.
Women's groups support the President's plan:
"The Older Women's League (OWL) endorses President Clinton's health care reform
bill"
- Older Women's League, March 6, 1994
"In reviewing the current health proposals pending in Congress, only two proposals,
the Health Security Act, proposed by President Clinton and introduced by Senator
Mitchell and Representative Gephardt, and the American Health Security Act,
introduced by Senator Wellstone and Representative McDermott, demonstrate a
significant commitment to the principles developed by the Campaign for Women's
Health. These plans offer unprecedented opportunities to provide coverage of health
care services for women far beyond what is currently available."
- Campaign for Women's Health, March 1994
We believe that the proposed Health Security Act reflects
the most recent and valid scientific evidence. It is also based
on the recommendations of the U.S. Preventive Services Task Force
and the American College of Physicians. While screening
mammography for women over 50 has been shown to reduce mortality
by 30%, population-based mammography screening for women between
40 and 50 has not been shown to reduce mortality. Mammography
for women under 50 may have a false negative rate as high as 40%,
leaving significant numbers of women with a false sense of
security. In addition, any test or procedure has both emotional
and physical risks associated with it.
Under the Health Security Act, women of any age will be
covered for clinician visits, which include clinical breast
exams, and screening mammograms when these services are
appropriate, and will pay a standard copayment. All women over
50 will receive routine mammogram screening every other year at
no cost. Clinician visits will be covered without cost sharing
every three years for women ages 20 to 39 and every other year
for women ages 40 to 64. In addition, women who are defined to
be at risk for breast cancer may receive clinician visits and
mammograms beyond those included in the periodicity schedule
without cost sharing.
Author: Douglas Kamerow at ~ODPHP
Date:
10/03/1994 11:45
Priority: Normal
TO: Lisa Simpson at ~HHH7
Subject: WH Letter
Message Contents
I got the fax. Comments:
Add American Academy of Family Physicians to the ACP.
This then includes all of the primary care docs (except
ob-gyns).
At end of first paragraph, mention large number of
false-positives as well, adding to costs and worries of
a substantial number of women (you can use the JAMA
article on positive predictive value-1000 women, XX
procedures, etc).
Last paragraph, add "increased" before "risk" in last
sentence.
I'm off to my clinic. The number there is 301 699-7700.
Push 0 and ask for ext 42. fax there is 301 779 9001.
Cheers.
TO:
Hillary Rodham Clinton
FROM:
Jennifer Klein
DATE:
3/8/94
RE:
Congressional Women's Caucus
Attached please find talking points written by Christine
Heenan in response to the position paper released by the Women's
Caucus on mammograms. I will turn this into a letter from you to
the Women's Caucus tomorrow.
03/08/94
11:58
CCWI
001/002
Post-It" brand
Fax Transmittal Memo 7672
No. of Pages
Today's Date
Time
To
Jennifer Kline
From
Carcus for Women's Issue's
Company
white House
Company
Location
Location
Dept. Charge
Fax #
Telephone #
Fax #
Telephone #
225-6740
Comments
Original
Disposition:
Destroy
Return
Call for pickup
Executive Committee Officers
2471 Rayburs Building
Patricia Schroeder, Co-chair
Congressional Caucus
(202) 225-6740
Olympia Snowe, Co-chair
Cardiss Collins, Secretary
Lealey Primmer
Executive Director
Marcy Kaptur. Treasurer
For Release
Women S Issues
Contact: Susan Wood
Tuesday, March 8, 1994
(202) 225-6740
Congress of the United States
Andrea Camp (Schroeder)
Washington, S.C. 20515
(202) 225-4431
Nicholas Graham (Snowe)
(202) 225-6306
NEWS RELEASE
CONGRESSWOMEN CALL FOR BROAD COVERAGE
OF SCREENING MAMMOGRAMS IN HEALTH CARE REFORM
Today, the Congressional Caucus for Women's Issues called for broader coverage of
screening mammograms in any health care reform package that comes before the Congress.
With a number of committees about to take up various health care reform measures, the Caucus
made clear that screening mammograms must be part of any basic benefits package.
"With all the conflicting recommendations that are coming from a number of highly
respected sources, women need to know that screening mammograms will be covered," said
Caucus Co-Chair Patricia Schroeder (D-Co). "Sending women the message that some
mammograms may not be covered sends the message that mammograms are not important -- and
that's a dangerous message."
"Women under 50 have been left once again in the now familiar situation that the
research is not clear and the experts are still debating," Caucus Co-Chair Rep. Olympia Snowe
(R-ME) pointed out. "We unfortunately have only mammograms in our arsenal against breast
cancer -- which will strike one out of every eight women over a lifetime -- so until we have
something more to offer these women, we can't take this away."
The position established by the Caucus calls for complete coverage (no copayments or
deductibles) of mammograms for women over 50 every one to two years, where screening
mammography has been shown to reduce mortality by 30 percent. Coverage should be provided
with applicable cost-sharing every two years for women between the ages of 40-49, where
mammography has an uncertain impact on mortality but does help in early detection. In
addition, an annual clinical breast exam should be covered for all women over forty.
"This just makes explicit what the President and Mrs. Clinton have been saying that they
want all along." said Rep. Louise Slaughter (D-NY), Chair of the Caucus Task Force on
Women's Health and the Environment, "Women in their forties will be assured of basic
coverage of a screening mammogram without having to argue with a health plan or national
board that it is medically appropriate."
"The Caucus will be watching and working with the committees of jurisdiction as they
take up health care reform," noted Rep. Nita Lowey (D-NY), Chair of the Caucus Task Force
on Reproductive Choice. "We're not just watching the Clinton plan; we want to make sure that
all health care proposals reach this standard."
The position adopted by the Caucus is similar to one recently proposed in a Sense of
Congress Resolution introduced by Rep. Ed Towns (D-NY) and several Congresswomen.
Attached is a summary of the Caucus position.
002/002
CCWI
03/08/94 11:58
Congressional Caucus for Women's Issues
EMBARGOED UNTIL 10:00 AM, TUESDAY, MARCH 8
Caucus Position on Coverage of Screening Mammography
in any Basic Benefits Package
- For women age 50 or older, where mammography has proven to bring about a 30
percent reduction in mortality:
Plans should provide free screening mammograms, every one to two
years.
- For women age 40-49, where mammography has a less certain impact in reducing
mortality, but does help in earlier detection:
=
Plans should cover screening mammograms every two years, with
applicable co-pays and deductibles for those reform plans that
include cost-sharing.
All cost-sharing should be based on a sliding scale, so that it does not
constitute a barrier to low-income women receiving care.
- For women of any age:
*
Plans should provide free screening mammograms for any woman at
high risk for breast cancer.
Plans should cover annual clinical breast exams for women over 40.
Released March 8, 1994
2471
Ravhurn
Building
The Congressional Women's Caucus and Health Care Reform
The Congressional Women's Caucus is right to call for a comprehensive benefits package
spelled out in law, and for preventive care focusing on early detection and treatment of
breast cancer.
Women are increasingly at risk for life-threatening illnesses such as breast cancer, ovarian
cancer, and heart and lung disease, yet still anchor the bottom of our medical research
agenda. Of all the health problems women face, however, breast cancer is one of the
deadliest:
One in nine women in the U.S. will develop breast cancer in her lifetime. (National
Breast Cancer Coalition)
2.6 million women in the U.S. have breast cancer today, and this year another 182,000
American women will be diagnosed with the disease, approximately one woman
every three minutes. (National Breast Cancer Coalition)
The Health Security Act addresses women's health -- and the threat of breast cancer --
aggressively and comprehensively, guaranteeing all women coverage, regardless of
whether they are healthy or sick, married or single, working or unemployed, wealthy or
low income. And the President's approach will provide unprecedented coverage of
preventive care, including mammography. It will cover a whole schedule of
preventive screenings, tests and check-ups at no cost, protection available in only a
few of today's insurance policies.
Coverage of Mammograms and other preventive services under The Health Security Act:
Coverage for all women:
Women of any age can receive clinical breast exams and mammograms at any time
when the patient and doctor feel it is medically necessary or appropriate, and will pay
a standard co-pay (for example, ten dollars) set by their plan.
Extra coverage for women at risk:
Women of any age who are defined to be at risk of breast cancer will receive
additional visits, including clinical breast exams and mammograms, with no cost
sharing.
Additional coverage of mammograms:
For certain age groups, at certain intervals, mammograms are free of any cost sharing,
so there is no charge when a woman goes to the doctor for these services.
As part of the preventive services package, all women age 50 and older would have
routine mammogram screening every other year, free of charge. Again, any woman
who needs more frequent mammograms would be covered, and would pay a co-pay.
Additional coverage of clinician visits:
Clinician visits, including clinical breast exams, are covered for all women, and
additional coverage is available for women in certain age groups. Clinician visits are
free once every three years for women age 20-39, and every other year for women
from 40-64.
New investments in combating breast cancer
This year, the National Institute of Health's breast cancer research budget increased by
44 percent, from $208 million to almost $300 million.
Under reform, new research initiatives will concentrate on the prevention of illnesses
affecting women, including breast cancer, mental health, reproductive health and
osteoporosis.
Women's groups support the President's plan:
"The Older Women's League (OWL) endorses President Clinton's health care reform
bill"
- Older Women's League, March 6, 1994
"In reviewing the current health proposals pending in Congress, only two proposals,
the Health Security Act, proposed by President Clinton and introduced by Senator
Mitchell and Representative Gephardt, and the American Health Security Act,
introduced by Senator Wellstone and Representative McDermott, demonstrate a
significant commitment to the principles developed by the Campaign for Women's
Health. These plans offer unprecedented opportunities to provide coverage of health
care services for women far beyond what is currently available."
- Campaign for Women's Health, March 1994
The Journal of the American Medical Association (January 12,
1994) reported that a recent analysis of all relevant studies
ever conducted on screening mammography of asymptomatic women
confirmed a clear benefit for screening women over 50 years of
age every year or two. It found, however, no basis for promoting
mammographic screening in women under 50 in the general
population.
within the membership of the American Society of Addiction
11. Hartgers C, Buning EC. van Santen GW, et al. The impact of the needle and
syringe-exchange programme in Amsterdam in injecting risk behavior. AIDS. 1989;
Medicine and the American Academy of Psychiatrists in Al-
3:571-576.
coholism and the Addictions, and specialized nurses, coun-
12. Hart GJ, Carvell ALM. Woodward N, et al. Evaluation of needle exchange in
central London: behaviour change and anti-HIV status over one year. AIDS. 1989;
selors, and social workers may also have much to teach us.
3:261-265.
Generalists can spend time with such experts to learn man-
13. Ljunberg B, Christensson B. Tuning K. et al. HIV prevention among injecting
drug users: three years' experience from a syringe exchange program in Sweden.
agement principles and can then serve as resources within
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their own facilities. The Oath of Hippocrates states that
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of AIDS. Am J Public Health. 1991;81:1506-1517.
"into whatever houses I shall enter, I will go into them for the
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HIV/AIDS prevention for injection drug users. JAMA.1904:271:115-120.
benefit
of
the
sick
1930 In the case of IDUs, we rarely enter
16. New York City Dept of Health Report. The Pilot Needle Exchange Study in New
their "houses"-certainly not the shooting gallery and not
York City: A Bridge to Treatment: A Report on the First Ten Months of Operation.
New York, NY: New York City Dept of Public Health: 1989.
even the drug treatment facility-and we do not allow them
17. Purchase D, Hagan H, Des Jarlais DC, Reid T. Historical account of the Tacoma
to easily enter ours. We can learn to treat IDUs in whichever
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on AIDS; June 4-9, 1989; Montreal, Quebec. Abstract THDP74.
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18. Kaplan EN, Heimer R. HIV prevalence among intravenous drug users: model-
based estimates from New Haven's legal needle exchange. J Acquir Immune Defic
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19. Carvell AM. Hart GJ. Help-seeking and referrals in a needle exchange: a com-
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Am , Public Health. 1988;78:394-410.
20. Cooper JR. Methadone treatment and acquired immunodeficiency syndrome.
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21. Novick DM, Joseph H, Croxson TS, et al. Absence of antibody to human immu-
3. Nace E, Davis C, Gaspari J. Axis II comorbidity in substance abuse. Am J Psy-
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23. Dans PE, Matricciani RM. Otter SE, Reuland DS. Intravenous drug abuse and
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26. Wartenberg AA, Liepman MR. Medical complications of substance abuse. In:
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30. Edelstein L. The Hippocratic Oath: Text Translation and Interpretation by
10:5-10.
Ludwig Edelstein. Baltimore, Md: The Johns Hopkins Press; 1943.
Mammo
Mammographic Screening
Since 1987, the United States has stood alone among major
A recent meta-analysis of all relevant studies ever conducted
developed countries in having encouraged asymptomatic
on screening mammography of asymptomatic women confirmed
women under 50 years of age to undergo screening mam-
a clear benefit-a 30% reduction in deaths for women over 50
mography, although US mortality rates for women these
years of age who were screened every year or two. It found,
ages continue to mirror those of other Western countries.¹
however, "no basis for the promotion of mammographic screen-
Recent reports in JAMA and elsewhere compel a reexami-
ing in women under age 50 in the general population."3 Ker-
nation of this policy.
likowske et al4 provide an important new contribution to this
Diagnostic mammographic evaluation is indicated at any
subject in a recent issue of JAMA with their carefully conducted
age if a woman has a lump or other signs of disease. In
study of the positive predictive value of screening mammogra-
contrast to diagnostic assessments, screening mammography
phy in 814 women referred to the University of California San
is a routine measure seeking to detect latent disease in
Francisco Mobile Mammography Screening Program from 1985
asymptomatic women, in order to provide treatment, which
to 1992. They found that "women younger than 50 years will
may increase the likelihood of a cure.2
have approximately 2.5 times as many biopsies and three times
as many diagnostic procedures for every cancer diagnosed com-
pared with women aged 50 years or older," yet fewer than 20%
From the Office of the Assistant Secretary for Health, Department of Health and
Human Services. Washington, DC (Dr Davis) and the UCLA Breast Center. Los An-
of all cancers occur in the younger age group. An international
geles, Calif (Dr Love).
workshop on this subject in February 1993 indicated that for
Reprint requests to the Office of the Assistant Secretary for Health, Department of
every 1000 women under 50 years of age screened with mam-
Health and Human Services. 200 Independence Ave SW. Washington, DC 20201
(Dr. Davis).
mography in a decade, 700 would require some sort of diagnostic
152 JAMA, January 12. 1994- Voi 271, No. 2
Editorials
detect fewer than 15 tumors, and seven tumors
Despite efforts to improve current imaging technologies,
be missed entirely.
imaging just may not be the best screening approach in young
Screening mammography cannot prevent breast cancer, but
women because of the density of their breast tissue. A non-
can detect some small tumors early when they are more
invasive biochemical test of blood or urine that pinpoints
amenable it to treatment and cure in women over 50 years of age.
early markers or risk factors for breast cancer might prove
Despite the strong evidence that the number of deaths from
to be a better population screening tool for younger women,
breast cancer in women over 50 years of age can be reduced
with imaging technologies used only to locate occult cancers.
by 30% through regular mammography, women in this group
The public policy dilemma posed by these findings for women
have not been receiving the lifesaving test; thus, in 1990, 40%
and their health providers in the United States today is
of women over 50 years of age had never had a mammogram.67
profound. Chalmers¹² has reminded us that "if our society had
Over the past two decades at Harlem Hospital Center, New
been oriented towards finding out whether new techno-
York, NY, one study found that half of all breast cancer cases
logy is efficacious as soon as possible after its introduction
were incurable on admission, and only 5% were in stage I.*
there would not be much left to debate more than 30 years
An especially disappointing finding of the study by Ker-
(later]
But wistful wishing cannot alter the fact that
likowske et al' was the fact that the proportion of women over
mammographic screening in women under 50 years of age
50 years of age seeking mammograms fell between 1985 and
does not reduce deaths, while for those over the age of 50
1992 from about 47% to 33%, while it rose for those under 50
years it saves lives. The reasons for these results are un-
years from 53% to 67%, and for those under 40 years from 22%
known and need to be resolved through additional clinical
to 29%. The Centers for Disease Control and Prevention re-
studies that assess the importance of menopausal status and
port similar trends, with older women with lower levels of
other factors, including breast tissue change with age. In the
education having the lowest rate of mammography screening.⁷
meantime, women must be told the truth, so that they can
The two biggest risk factors for breast cancer remain sex
make informed choices about their health care. And efforts
and age, with nearly 85% of cases occurring in women over
must proceed apace to develop better techniques to detect
50 years of age. Growing concerns about the rising incidence
early breast cancer in asymptomatic younger women, to en-
of breast cancer have fueled screening programs worldwide.
sure that all woman over 50 years of age are provided access
Mammography is a major enterprise, involving widespread
to the lifesaving benefit of screening mammography, and to
public efforts including posters, brochures, print and televi-
identify avoidable causes of this major cancer.13
sion specials, and public service ads in English and Spanish
Devra Lee Davis, PhD, MPH
urging every woman to have a mammogram "once a year for
Susan M. Love, MD
the rest of your life." Despite the fact that the United States
1. Hoel DG, Davis DL, Miller AB, Sondik EJ, Swerdlow AJ. Trends in cancer mor-
has had excess capacity since 1990,9 firms continue to sell
tality in 15 industrialized countries, 1969-1986. J Nall Cancer Inst. 1992;84:313-320.
equipment for use in physicians' offices.
2. US Dept of Health and Human Services, Public Health Service. Treatment of
Early-Stage Breast Cancer. Bethesda, Md: National Cancer Institute; 1992. J Natl
As to the current state of mammography, it is important to
Cancer Inst Monograph 11, National Institutes of Health publication 90-3187.
consider the newness of the venture. The American Board of
3. Elwood JM. Cox B. Richardson AK. The effectiveness of breast cancer screening
by mammography in younger women. Online J Curr Clin Trials. February 25, 1993.
Radiology included a section on mammography only in the past
Document 32.
4. Kerlikowske K. Grady D. Barelay J, Sickles EA, Eaton A. Ernster V. Positive
three examinations. Last year, Congress passed the National
predictive value of screening mammography by age and family history of breast
Mammography Standards Quality Assurance Act in response to
cancer. JAMA. 1993;270;2444-2450.
5. Fletcher SW, Black W, Russell R. Rimer RK, Shapiro S. Report of the Interna-
reports that more than half of the current facilities and tech-
tional Workshop on Screening for Breast Cancer. J Natl Cancer Inst. 1993;85:1644-
nologists failed to meet minimal quality assurance standards. In
1656.
6. Breen N, Kessler 1,. Changes in the use of screening mummography: evidence
many southern states, fewer than 30% of all radiology centers
from the 1987 and 1990 National Health Interview Surveys. Am J Public Health. In
currently comply with the American College of Radiology guide-
press.
7. US Dept of Health and Human Services, Public Health Service. Mammography
lines for safety and effectiveness. A reevaluation of first screen-
and clinical breast examinations among women aged 50 years and older-hehavioral
risk factor surveillance system. 1992. MMWR Morb Mortal Wkly Rep. 1992;42:737-
ing films in one urban practice found that "imaginomas" or ghost
741.
images accounted for more than half of those recommended for
8. Freeman H. The impact of clinical trial protocols on patient care systems in a large
city hospital: access for the socially disadvantaged. Cancer. 1993;72:2834-2838.
biopsy (oral communication, Gillian Newstead, MD. director of
9. General Accounting Office. Breast Cancer, 1971-91: Prevention, Treatment and
Breast Imaging, New York University Medical Center, August
Research. Washington, DC: General Accounting Office; 1991. Document 145490.
10. Report of State Mammography Program Activities, 1991. Frankfort, Ky: Con-
6. 1993). In addition, mammography in women younger than 50
ference of Radiation Control Program Directors; 1991. CRCPD publication 93-5.
years is not without risk. This risk includes the economic and
11. Eddy D. The value of mammography screening in women under age 50 years.
JAMA. 1988:259:1512-1519.
social cost of the procedure, the health hazards linked with
12. Chalmers TC. Mainmography after 30 years. Online J Curr Clin Trials. May 28,
1993. Document 66.
radiation exposure begun at a younger age (one cancer induced
13. Davis DL, Bradlow HI. Wolff M. Woodruff T. Hoel DG, Anton-Culver H. Medi-
per 25 000 mammograms), and the considerable human and eco-
cal hypothesis: xenoestrogens RS preventable causes of breast cancer. Engiren
Health Perspect. 1992;101:372-377.
nomic toll of unnecessary diagnostic procedures; overall, about
one of 10 biopsies recommended on the basis of mammography
will be cancerous.¹¹
JAMA. January 12, 1994-Vol 271, No. 2
Editorials 153
JOHNS HOPKINS
UNIVERSITY
School of Hygiene and Public Health
624 N. Broadway. Room 482
Baltimore MD 21205-1996
(410) 955-3625 / FAX (410) 955-0876
Department of Health Policy and Management
Sam Shapiro, Acting Chair
January 27, 1994
Dr. Edward Sickles
Associate Professor
Department of Radiology
Box 0628
University of California Medical Center
San Francisco, CA 94143
Dear Ed:
I have just run across two news items on the controversy about
NCI's conclusions regarding the status of knowledge about the
efficacy of routine screening at ages 40-49 in which you are quoted
extensively and in ways that I just do not understand.
You mention a 26% reduction in breast cancer mortality at
these ages in a Swedish study. I assume you are referring to the
two county study and more specifically to the Kopparberg result.
But what about the 28% higher relative risk reported for
Ostergotland, the other county? Why was this not mentioned?
You are also cited as describing results of an analysis of
data on mammographic screening at the University of California and
in British Columbia. Quite aside from the problems in interpreting
the findings you report, what about the results described in the
JAMA article by Kerlikowske
Sickles
?
I
assume
that
the
mobile unit referred to is yours and that you do not have any
problems with the quality of mammography performed.
The conclusion in the abstract, supported by the analysis in
the body of the paper, is that "Efforts to promote screening
mammography should focus on women in these groups (women aged 50
and over and women 40 and older with a family history of breast
cancer), in whom the majority of breast cancers occur and for whom
mammography has the highest PPVs." I was at the meeting where
Dr. Kerlikowske presented the data and the clear conclusion was
that they did not support routine screening for women at ages 40-
49, except for those at elevated risk.
So, what's going on? I do not know whether there's an overlap
between the 63,000 mammograms noted in the news items and the cases
in Kerlikowske et al's paper, but your name appears on the latter
paper.
FEB RECD
Dr. Sickles
January 27, 1994
-2
I know that arguments can be made that evidence is not
available regarding the efficacy of routine screening at ages 40-
49. That would mean we do not have the data to advocate mass
screening at these ages and from a public health standpoint the NCI
position remains correct until new evidence becomes available.
I would appreciate hearing from you on the above.
Best regards.
Sincerely,
Sam
Sam Shapiro
Acting Chair and
Professor Emeritus
CC: Dr. Suzanne Fletcher
Dr. Ed Sondik
Dr. Barry Kramer
SERVICES
HUMAN
USA
DEPARTMENT OF HEALTH & HUMAN SERVICES
Office of the Secretary
HEALTH
of
DEPARTMENT
Washington, D.C. 20201
JAN 24 I994
TO:
Pam Barnett
Office of the First Lady
The White House
FROM:
Ray Martinez Rrv-
White House Liaison
Health and Human Services
SUBJECT:
Breast Cancer Study
Attached please find a copy of the October 20, 1993, Volume 85,
Number 20 of the Journal of the National Cancer Institute which
contains the study on Breast Cancer that you requested. I
apologize for the delay in getting this to you.
Please feel free to call me on 690-6625, for any further
information or assistance that you might need. I have also
enclosed the business card of Jana S. Johnston, Public Affairs
Specialist, NCI, in case you would like to contact them directly
for additional copies or other information.
Attachment
301-496-9569
at a 5AM 2
gam
International Cancer
Information Center
NATIONAL
Building 82, Room 123
Bethesda, Maryland 20892
CANCER
(301) 496-4907
INSTITUTE
Jana S. Johnston
Public Affairs Specialist
Marketing Office
Clinton Presidential Records
Digital Records Marker
This is not a presidential record. This is used as an administrative
marker by the William J. Clinton Presidential Library Staff.
This marker identifies the place of a publication.
Publications have not been scanned in their entirety for the purpose
of digitization. To see the full publication please search online or
visit the Clinton Presidential Library's Research Room.
October 20, 1993
Volume 85, Number 20
OF THE NATIONAL CANCER INSTITUTE
CONTENTS
In This Issue
1617
EDITORIALS
Early Cancer Clinical Trials: Safety, Numbers, and Consent, M. J. Hawkins
1618
Screening for Breast Cancer: What Should National Health Policy Be? T. C. Chalmers
1619
Deficiencies in the Analysis of Breast Cancer Screening Data, E. A. Sickles, D. B. Kopans
1621
NEWS
NCI Proposes New Breast Cancer Screening Guidelines, K. Smigel
1626
NCI's Proposed Breast Cancer Screening Guidelines, K. Smigel
1627
Stat Bite: Cancer Information Service: Telephone Inquiries
1628
Angiogenesis Research Yields New Approaches to Cancer Treatment and Prognosis,
1629
N. S. Larsen
Cancer Program Praised and Criticized As Plans Are Forged for the 21st Century, S. Jenks 1631
Peer Review Put to the Test: Credibility at Stake, C. Vanchieri
1632
Prostate Cancer Prevention Trial Launched, T. Reynolds
1633
Awards, Appointments, Announcements
1635
NIH Appropriations Due, D. A. Tisevich
1636
COMMENTARY
Statistical and Ethical Issues in the Design and Conduct of Phase I and II Clinical
1637
Trials of New Anticancer Agents, M. J. Ratain, R. Mick, R. L. Schilsky, M. Siegler
SPECIAL ARTICLE
Report of the International Workshop on Screening for Breast Cancer, S. W. Fletcher,
1644
W. Black, R. Harris, B. K. Rimer, S. Shapiro
ARTICLES
p53 Protein Accumulation and Gene Mutation in the Progression of Human Prostate
1657
Carcinoma, N. M. Navone, P. Troncoso, L. L. Pisters, T. L. Goodrow, J. L. Palmer,
W. W. Nichols, A. C. von Eschenbach, C. J. Conti
Cancer Mortality Among New Mexico's Hispanics, American Indians, and Non-Hispanic
1670
Whites, 1958-1987, C. L. Wiggins, T. M. Becker, C. R. Key, J. M. Samet
REPORTS
Radiation-Induced Breast Cancer: Long-Term Follow-up of Radiation Therapy for
1679
Benign Breast Disease, A. Mattsson, B.-1. Rudén, P. Hall, N. Wilking, L. E. Rutqvist
Measurement of Cremophor EL Following Taxol: Plasma Levels Sufficient to Reverse
1685
Drug Exclusion Mediated by the Multidrug-Resistant Phenotype, L. Webster,
M. Linsenmeyer. M. Millward, C. Morton, J. Bishop, D. Woodcock
BOOK REVIEWS
Gastrointestinal Cancer, L. M. Weiner
L. Leichman
1691
Books Received
1692
CORRESPONDENCE
Are Esterases Involved in Multidrug Resistance? O. Markovic, N. Markovic
1693
Re: Relationship Between Environmental Tobacco Smoke Exposure and Carcinogen-
1693
Hemoglobin Adduct Levels in Nonsmokers, M. J. Reasor
Response,
S. K. Hammond, J. Coghlin, P. H. Gann, P. L. Skipper, S. R. Tannenbaum
Re: Blood Levels of Organochlorine Residues and Risk of Breast Cancer,
1696
M. P. Longnecker, S. J. London
Response, N. Dubin, P. G. Toniolo, et al.
Re: Lung Cancer Incidence Among Patients With Beryllium Disease, M. Eisenbud
1697
Response, K. Steenland, E. Ward
(Contents continued on back cover)