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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 J Acquir Immune Defic Syndr. 1991;4:890-895. their own facilities. The Oath of Hippocrates states that 14. Anderson W. The New York needle trial: the politics of public health in the age of AIDS. Am J Public Health. 1991;81:1506-1517. "into whatever houses I shall enter, I will go into them for the 15. Watters JK. Estilo MJ, Clark GL, Lorvick J. Syringe and needle-exchange as 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 syringe exchange. In: Program and abstracts of the Fifth International Conference on AIDS; June 4-9, 1989; Montreal, Quebec. Abstract THDP74. houses they, or we, may enter. 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 Alan A. Wartenberg, MD Syndr. 1992;5:163-169. 19. Carvell AM. Hart GJ. Help-seeking and referrals in a needle exchange: a com- 1. Becker MN, Joseph JG. AIDS and behavioral changes to reduce risk: a review. prehensive service to injecting drug users. Br J Addict. 1990;85:235-240. Am , Public Health. 1988;78:394-410. 20. Cooper JR. Methadone treatment and acquired immunodeficiency syndrome. 2. Des Jarlais DC, Friedman SR. The psychology of preventing AIDS among intra- JAMA. 1989:262:1664-1668. venous drug users: a social learning conceptualization. Am Psychol. 1988;43;865-870. 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- nodeficiency virus in long-term, socially rehabilitated methadone maintenance chiatry. 1991;148:118-120. patients. Arch Intern Med. 1990;150:98-99. 4. Selwyn PA, Feingold AR. lezza A, et al. Primary care for patients with human 22. Newman RG. Advocacy for methadone treatment. Ann Intern Med. 1990;113: immunodeficiency virus (HIV) infection in a methadone maintenance treatment 819-820. program. Ann Intern Med. 1989;111:761-763. 23. Dans PE, Matricciani RM. Otter SE, Reuland DS. Intravenous drug abuse and 5. Samet JH, Libman H. Steger KA, et al. Compliance with zidovudine therapy in one academic health center. JAMA. 263;3173-3176. patients infected with HIV type 1: a cross-sectional study in a municipal hospital 24. Stein MD, O'Sullivan PS, Ellis P. Perrin H, Wartenberg A. Utilization of medi- clinic. Am J Med. 1992;92:495-502. cal services by drug abusers in detoxification. J Subst Abuse. 1993;5:187-193. 6. O'Connor PG, Molde S. Henry S, Shockeor WT, Schottenfeld RL. Human immu- 25. Northfelt DW. Hayward RA, Shapiro MF. The acquired immunodeficiency syn- nodeficiency virus infection in intravenous drug users: a model for primary care. Am drome is a primary care disease. Aun Intern Med. 1989;109:773-774. J Med. 1993:93:382-385. 26. Wartenberg AA, Liepman MR. Medical complications of substance abuse. In: 7. Stein MD. Sumet JJ, O'Connor PG. The linkage of primary care services with Lerner WD. Barr MA. eds. Handbook of Hospital Based Substance Abuse substance abuse treatment: new opportunities for academic generalists. J Gen In. Treatment. New York, NY: Pergamon Press; 1990:45-65. tern Med. 1993:8:106-107. 27. Stein MD. Medical complications of intravenous drug use. J Gen Intern Med. 8. Des Jarlais DC, Friedman SR. Sotheran JL, et al. Continuity and change within 1990;5:249-257. an HIV epidemic: injecting drug users in New York City, 1984 through 1992. JAMA. 28. Wartenberg AA. HIV disease in the intravenous drug user: role of the primary 1994;271:121-127. care physician. J Gen Intern Med. 1991:6(suppl):35-40. 9. Vlahov D, Anthony JC, Celentano D. Trends of HIV-1 risk reduction among initiates 29. Wartenberg AA. The drug using patient. In: Libman J. Witzburg RA. eds. HIV into intravenous drug use, 1982-1987. Am ./ Drug Alcohol Abuse. 1991:17:39-48. Infection: A Clinical Manual. 2nd ed. Boston. Mass: Little Brown & Co Inc; 1992: 10. Schottenfeld RS, O'Malley S, Abdul-Salaam K, O'Connor PG. Decline in intra- 455-466. venous drug use among treatment-secking opiate users. J Subst Abuse Treat. 1993; 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)