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  1. 1. Otis W. Brawley, M.D. Chief Medical Officer Executive Vice President American Cancer Society Professor of Hematology, Oncology, Medicine and Epidemiology Emory University
  2. 2. A Skeptic’s View of Healthcare Disparities and Healthcare Reform
  3. 3. Potential Conflicts of Interest • Employed by: – American Cancer Society – Emory University • Consultant for: – Sanofi Aventis – Glaxo Smith Kline – U.S. Department of Defense – U.S. Department of Health and Human Services
  4. 4. Trends in Actual Number of Cancer Deaths and Age-adjusted Cancer Death Rates, 1970-2005 0 100,000 200,000 300,000 400,000 500,000 600,000 1970 1975 1980 1985 1990 1995 2000 2005 Numberofcancerdeaths 165 170 175 180 185 190 195 200 205 210 215 220 Rateper100,000 Death rate Number of deaths Year of death
  5. 5. Total Number of Cancer Deaths Avoided from 1991 to 2004 in men and 1992 to 2004 in Women 1975 1980 1985 1990 1995 2000 2004 0 160000 180000 200000 220000 240000 260000 280000 300000 320000 340000 360000 Numberofdeaths Year of death 1975 1980 1985 1990 1995 2000 2004 0 160000 180000 200000 220000 240000 260000 280000 300000 320000 340000 360000 Year of death 408,400 Cancer deaths 136,100 Cancer deaths Men Women The blue line represents the actual cancer deaths recorded in each year and the red line represents the expected number of cancer deaths if cancer mortality rates had remained the same since 1991/1992.
  6. 6. Clinical TrialsClinical Trials • For the patient, a clinical trial is an opportunity to get “state of the art therapy” agreed upon by a group of experts. It is a 2nd , 3rd , …20th opinion. • NCI and many corporate run trials are audited for accuracy and quality of care • Doctors who offer clinical trials have been shown to be better than doctors who do not. Clinical trials are a form of CME, but better doctors are attracted to clinical trials. • NIH has increasingly tried to get certain clinical trials into community hospitals and doctors offices.
  7. 7. Clinical TrialsClinical Trials • There are numerous examples in medicineThere are numerous examples in medicine where we have harmed our patients by notwhere we have harmed our patients by not embracing and supporting clinical trials.embracing and supporting clinical trials. • The strength of scientific evidenceThe strength of scientific evidence – Prospective Randomized Clinical TrialProspective Randomized Clinical Trial – Case Control StudyCase Control Study – Cohort StudyCohort Study – Opinion of ExpertsOpinion of Experts
  8. 8. Clinical Trials Lessons Learned • Halsted mastectomy = modified mastectomy • Lumpectomy = modified mastectomy • Hormone replacement therapy • Lidocaine after MI • Anti-oxidant Vitamin E • Anti-oxidant Beta-carotene • Anti-oxidant Selenium • Erythropoetin • Bone Marrow Transplant in breast cancer
  9. 9. Disparities in Health • The concept that some populations (however defined) do worse than others • Populations can be defined or categorized by: – Race – Culture – Area of geographic origin – Socioeconomic Status
  10. 10. Disparities in Health • The concept that some populations (however defined) do worse than others • The measure can be: – Incidence – Mortality – Survival – Quality of life
  11. 11. All Sites – Cancer Mortality Rates 1973-2004 By Race, Males and Females 100 150 200 250 300 '75 '78 '81 '84 '87 '90 '93 '96 '99 '02 Year Rate Incidence and mortality rates per 100,000 and age-adjusted to 2000 US standard population SEER Cancer Statistics Review 1975-2004. African American Caucasian AI/AN Hispanic API
  12. 12. Disparities in Health • We need to approach this issue logically and rationally • We must focus on what we can change and not on what we cannot change • We must define social and logistical issues versus scientific issues.
  13. 13. My Concern • “Equal treatment yields equal outcome among equal patients” • There is not equal treatment • There is not enough concern about nor emphasis on the fact that there is not equal treatment
  14. 14. Studies of differences among populations • Should focus on individuals and families and genetic markers (personalized medicine) • Should not focus on race • A sociopolitical categorization • Not based on biology • A categorization Americans are fixated on
  15. 15. Studies of differences among populations • Advocacy for such studies should not drown out concerns about lack of adequate treatment • Concerns about genetic differences should not become excuses allowing us to accept disparities in health
  16. 16. Some Speak as if Blacks are Doomed for Life Wise Men see that Blacks are Doomed by Life paraphrase of Dr. Fadlo R. Khuri, Physician, Scientist , and Sometimes Philosopher
  17. 17. Disparities in Health • The NIH Revitalization Act of 1993 • Minorities must be included in clinical trials such that subset analysis
  18. 18. The NIH Revitalization Act of 1993 • “Minorities must be included in Federally sponsored clinical trials” • “In phase III trials, there must be valid subset analysis of the differences among the races”
  19. 19. The NIH Revitalization Act of 1993 • Subset analysis by race, ethnicity and gender are required of all phase III clinical studies with initial funding after 1995. • Peer review must assess each funded project for inclusion and subset analysis • This creates some serious ethical issues
  20. 20. Scientific issues • Subset analysis should be avoided as they can be very wrong! • Subset analysis often require over- sampling. An ethical issue, putting the minorities at greater risk and violating equipoise. • The law implies that disparities are due to genetic differences among the races!!!
  21. 21. Scientific issues • Subset analysis should be avoided as they can be very wrong! • The case against tamoxifen in the treatment of black women with breast cancer. • The original randomized trial was before ER Receptor assays were widely available – In a world without a defined estrogen receptor and valid subset analysis. • Tamoxifen is of little use in Black Women – In a world with an estrogen receptor • Tamoxifen is a good drug for Black women with ER Positive breast cancer
  22. 22. How can we provide adequate high quality care (to include preventive care) to a population that has so often not received it?
  23. 23. Colorectal Cancer Mortality(Male) Annualized 2001-2005 Race/Ethnicity Rate per 100,000 Age-adjusted to 2000 standard White 23.3 Black 32.7 Asian/Pacific Isl. 15.0 Native American 15.9 Hispanic 17.0
  24. 24. Colorectal Cancer Mortality(Female) Annualized 2001-2005 Race/Ethnicity Rate per 100,000 Age-adjusted to 2000 standard White 16.2 Black 22.9 Asian/Pacific Isl. 10.3 Native American 10.8 Hispanic 11.1
  25. 25. U.S. Colorectal Cancer Mortality 1975-2005 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005 Rateper100,000 Blalck Male WhiteMale Black Female White Female
  26. 26. Adjusted Colorectal Cancer Survival by Stages and Insurance Status, among Patients Diagnosed in 1999-2000 and Reported to the NCDB
  27. 27. All Races combined 0 10 20 30 40 50 60 70 0-11 12 13-15 16+ % Insured Uninsured Colorectal Cancer Screening*, in Adults, ages 50- 64, by Years of Education and Insurance Status, NHIS 2005 *Either a fecal occult blood test within the past year or an endoscopy within the past ten years. Source: National Health Interview Survey 2005, National Center for Health Statistics, Centers for Disease Control and Prevention, 2006.
  28. 28. Total Number of Cancer Deaths Avoided from 1991 to 2004 in men and 1992 to 2004 in Women 1975 1980 1985 1990 1995 2000 2004 0 160000 180000 200000 220000 240000 260000 280000 300000 320000 340000 360000 Numberofdeaths Year of death 1975 1980 1985 1990 1995 2000 2004 0 160000 180000 200000 220000 240000 260000 280000 300000 320000 340000 360000 Year of death 408,400 Cancer deaths 136,100 Cancer deaths Men Women The blue line represents the actual cancer deaths recorded in each year and the red line represents the expected number of cancer deaths if cancer mortality rates had remained the same since 1991/1992.
  29. 29. Colorectal Cancer • It is estimated that 77,000 colorectal cancer deaths were averted between 1990 and 2005 due to screening, early detection, and aggressive treatment. • Colorectal cancer screening rates have actually gone down during the period 2000 to 2005
  30. 30. Colorectal Cancer • Imagine a world in which – Colorectal cancer screening rates were greater than 80% – All men and women with an abnormal screen got it evaluated – All with colorectal cancer got optimal therapy
  31. 31. We know what to do, We just need to do it!!!
  32. 32. How can we provide adequate high quality care (to include preventive care) to a population that has so often not received it?
  33. 33. A Note about Smoking and Tobacco There has been a tremendous positive culture change in the U.S. This is our greatest cancer control legacy
  34. 34. Lung Cancer Mortality Annualized 2001-2005 Race/Ethnicity Rate per 100,000 Age-adjusted to 2000 standard White 25.5 Black 33.8 Asian/Pacific Isl. 12.6 Native American 13.9 Hispanic 16.1
  35. 35. Female Breast Cancer Death Rates by Race and Ethnicity, US, 1975-2004 0 5 10 15 20 25 30 35 40 45 1975 1978 1981 1984 1987 1990 1993 1996 1999 2002 Year Rateper100,000 African Americans Whites Hispanic/Latina American Indian/Alaska Native Asian American/Pacific Islander American Cancer Society, Surveillance Research, 2007 2004
  36. 36. Adjusted Breast Cancer Survival by Stages and Insurance Status, among Patients Diagnosed in 1999-2000 and Reported to the NCDB
  37. 37. All Races combined 0 10 20 30 40 50 60 70 0-11 12 13-15 16+ % Mammogram Within the Last Year in Adult Women, ages 40-64, by Years of Education and Insurance Status, NHIS 2005 Source: National Health Interview Survey 2005, National Center for Health Statistics, Centers for Disease Control and Prevention, 2006. Insured Uninsured
  38. 38. Breast Cancer • It is estimated that 57,000 breast cancer deaths were averted between 1990 and 2005 due to screening, early detection, and aggressive treatment. • Breast cancer screening rates have actually gone down during the period 2000 to 2005
  39. 39. Breast Cancer • Imagine a world in which – Mammography rates were greater than 80% – All women with an abnormal screen got it evaluated – All women with breast cancer got optimal therapy
  40. 40. We know what to do, We just need to do it!!!
  41. 41. How can we provide adequate high quality care (to include preventive care) to a population that has so often not received it?
  42. 42. Breast Cancer Pathology Racial Issues • At diagnosis the Black population with breast cancer has disproportionately more: – Advanced disease – Higher grade tumors within stage – Less ER + tumors – Younger women (age 35 to 44) SEER data 1973 to 1997
  43. 43. Breast Cancer Pathology Socioeconomic Issues • Lower SES white women present with disproportionately more: – Advanced disease – Higher grade tumors within stage – Less ER+ tumors – Younger women (age 35 to 44) Gordon Am.J.Epidemiol., 1995
  44. 44. Breast Cancer Gene-Environment Interaction • Social deprivation studies in Europe and U.S. suggest more virulent ER negative tumors in the poor. • Several studies suggest a correlation between higher body mass index and higher stage at presentation (higher BMI can be a cultural phenomenon).
  45. 45. Anderson et al, Breast Ca Res and Tx 76: 27-36, 2002
  46. 46. Risk Factors for Cancer Death • Among women diagnosed with a premenopausal breast cancer, a body mass index of >30 at diagnosis of cancer is a risk factor for breast cancer death HR 2.22 95% CI(1.45-3.40) – Abrahamson et al, Ca Epi Biomarkers Prev 2006
  47. 47. Female Obesity Trends 1986 to 2003
  48. 48. Equal Treatment Yields Equal Outcome among equal patients? • No racial differences in survival HR 1.08 95% CI (0.97-1.2) after adjusting for – Mammography screening – Tumor characteristics – Biologic markers – Treatment – Comorbidity – Demographics • Curtis et al, Cancer 2008
  49. 49. Equal Treatment Yields Equal Outcome among equal patients? • In NSABP studies of 543 Blacks and 7582 Whites with node negative breast cancer – Black/White DFS 1.06 95% CI (0.92-1.23) – Black/White Mortality 1.21 95% CI (1.01 to 1.46) • Modestly greater and attributed to non cancer causes of death (co-morbidities?) • Excluding non-cancer deaths 1.08 95% CI (.88 to 1.33) – Dignam et al, JNCI Monographs 2001
  50. 50. Equal Treatment Yields Equal Outcome among equal patients? • In NSABP studies of 548 Blacks and 4986 Whites with node positive breast cancer – Black/White DFS 1.04 95% CI (0.95-1.17) – Black/White Mortality 1.18 95% CI (1.03 to 1.34) • Modestly greater and attributed to non cancer causes of death (co-morbidities?) • Excluding non-cancer deaths 1.09 95% CI (.96 to 1.25) – Dignam et al, JNCI Monographs 2001
  51. 51. Breast Cancer Quality of Care • There are more than two dozen patterns of care studies to show racial disparities in care received. – Delayed treatment – No adjuvant chemotherapy – Dose reductions of chemotherapy – No hormonal therapy – No surgery – No radiation when it was appropriate • The poor of all races also have similar patterns of care.
  52. 52. Breast Cancer Quality of Care • In a SEER Study of more than 870 Blacks and 2430 Whites treated in 2000 to 2001 – Blacks were 4 to 5 fold more likely to get definitive treatment more than 60 days after initial consultation – Of patient treated with lumpectomy 61% of Blacks and 72% of whites received radiation – 7.5% of Blacks with clinically localized disease got no surgical therapy vs 1.5% of whites • Lund et al Breast Ca Res Treat, 2007
  53. 53. Breast Cancer Quality of Care • In a study of women breast cancer patients aged 20 to 54, a higher proportion of Blacks had a greater than three month delay to treatment from initial consultation. – 22.4% of Blacks – 14.3% of Whites • Gwyn et al, Cancer 2004
  54. 54. Breast Cancer Quality of Care • Receipt of “minimum expect care” in SEER-Medicare data 1992-1999 • Blacks less likely 0.67 95% CI (.59-.76) • Hispanics less likely 0.77 95% CI (.66-.90) • Haggstrom, Cancer 2005
  55. 55. Multivariate Analysis of Initial Breast Cancer Chemotherapy Dose < 85% of Standard N = 737 Odds Ratio 95% CI Normal BMI 1.00 Overweight 1.18 0.74 to 1.87 P=.65 Obese 2.47 1.36 to 4.51 P=.003 Severely obese 4.04 1.46 to 11.19 P=.007 Griggs et al, JCO v25, 2007
  56. 56. Multivariate Analysis of Initial Breast Cancer Chemotherapy Dose < 85% of Standard N = 737 Odds Ratio 95% CI Education Less than High School 3.07 1.57 to 5.99 P=.001 Griggs et al, JCO v25, 2007
  57. 57. Multivariate Logistic Regression for BCa Treatment with Nonstandard Breast Cancer Regimen N=957 Odds Ratio 95% CI College Graduate 1.00 _ High School Graduate 1.80 1.08 to 3.00 Trend P=.024 Less than High School 3.24 1.17 to 9.00 Black Race 1.93 1.11 to 3.36 P=.02 Controlling for geographic region, job category, employment status, insurance status Griggs et al, JCO v 18, 2007
  58. 58. Breast Cancer The Reality • From 1993 to 1997, 561 Black women died of breast cancer in Atlanta. • If Atlanta’s Black population had the Department of Defense Health System Black rate, 330 would have died (231 less)
  59. 59. Breast Cancer The Reality • In 2000, 7.5% of Black Women in Atlanta diagnosed with localized highly curable breast cancer did not receive a surgical removal of the tumor. • Do we in science worry too much about differences in biology and not worry enough about realities of disparities in healthcare.
  60. 60. The Meaning of Race in Science and Medicine • Differences in patterns of care by race documented in: – Prostate Cancer – Colon Cancer – Breast Cancer – Lung Cancer • The full reasons for the differences have yet to be explained
  61. 61. Equal Treatment Yields Equal Outcome There is not Equal Treatment • Studies suggest that disparities in treatment may be due to: – Cultural differences in acceptance of therapy. – Disparities in comorbid diseases making aggressive therapy inappropriate. – Lack of convenient access to therapy. – Racism and SES discrimination.
  62. 62. How can we provide adequate high quality care (to include preventive care) to a population that has so often not received it?
  63. 63. Cancer Survival and Deprivation in Scotland 5yr survival Affluent Deprived Breast 58% 48% Colon 40% 34% Lymphoma 58% 42% Prostate 45% 36% Bladder 70% 58% Melanoma 84% 69%
  64. 64. Survival Rates RMS Titanic Concept of Dr. Lisa Newman First Class 60% Second Class 43% Third Class 20%
  65. 65. U.S. deaths avoided (age 25-64) if everyone had the same death rate as the most educated? • African American (Non-Hispanic) – Men 52% (28,216) – Women 33% (12,624) • White (Non-Hispanic) – Men 48% (106,146) – Women 40% (55,134) • Hispanic – Men 39% (9,337) – Women 30% (3,825) A. Jemal ACS Epi Program
  66. 66. Cancer Disparities • Are we asking the right scientific questions? • Are we allowing certain questions (race and racial genetics) to allow us to ignore other legitimate questions?
  67. 67. Trends in Obesity* Prevalence (%), Children and Adolescents, by Age Group, US, 1971-2006 *Body mass index (BMI) at or above the sex-and age-specific 95th percentile BMI cutoff points from the 2000 sex- specific BMI-for-age CDC Growth Charts. Note: Previous editions of Cancer Statistics used the term “overweight” to describe youth in this BMI category. Source: National Health and Nutrition Examination Survey, 1971-1974, 1976-1980, 1988-1994, 1999-2002, National Center for Health Statistics, Centers for Disease Control and Prevention, 2002, 2004. 2003-2006: Ogden CL, et al. High Body Mass Index for Age among US Children and Adolescents, 2003-2006. JAMA 2008; 299 (20): 2401-05. 5 4 6 5 7 5 7 11 11 10 16 16 12 17 18 0 5 10 15 20 2 to 5 years 6 to 11 years 12 to 19 years Prevalence(%) NHANES I (1971-74) NHANES II (1976-80) NHANES III (1988-94) NHANES 1999-2002 NHANES 2003-2006
  68. 68. Trends in Obesity* Prevalence (%), By Gender, Adults Aged 20 to 74, US, 1960-2006† *Obesity is defined as a body mass index of 30 kg/m2 or greater. † Age adjusted to the 2000 US standard population. Source: National Health Examination Survey 1960-1962, National Health and Nutrition Examination Survey, 1971-1974, 1976-1980, 1988-1994, 1999-2002, National Center for Health Statistics, Centers for Disease Control and Prevention, 2002, 2004. 2003- 2004, 2005-2006: National Health and Nutrition Examination Survey Public Use Data Files, 2003-2004, 2005-2006, National Center for Health Statistics, Centers for Disease Control and Prevention, 2006, 2007. 13 11 16 15 12 17 15 13 17 23 21 26 31 28 3433 32 3535 34 36 0 5 10 15 20 25 30 35 40 45 Both sexes Men Women Prevalence(%) NHES I (1960-62) NHANES I (1971-74) NHANES II (1976-80) NHANES III (1988-94) NHANES 1999-2002 NHANES 2003-2004 NHANES 2005-2006
  69. 69. Higher Per Capita Spending in the U.S. does not Translate into Longer Life Expectancy The Cost of a Long Life Life Expectancy – Per Capita Spending 2006 CIA FACTBOOK AverageLifeE PerCapitaS 74 75 76 77 78 79 80 81 82 Japan S an M arinoM onaco S w itzerland A ustraliaS w edenIcelandA ndorraC anadaFrance ItalyA ustriaS painN orw ay S ingapore Israel Luxem bourg N ew Zealand N etherlands G erm anyG reece M altaB elgiumFinland U nited Kingdom D enm ark U nited StatesC ubaC yprusIreland P ortugal 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 United States
  70. 70. Disparities in Health • Some consume too much – (Unnecessary care given) • Some consume too little – (Necessary care not given) • We could decrease the waste and improve overall health!!!!
  71. 71. Disparities in Health • There are dramatic geographical differences in use of a number of expensive screening technologies and therapies without evidence of difference in outcomes. – Prostate cancer screening and overtreatment – Lung cancer screening – Third and fourth line chemotherapy of metastatic disease – Intensity Modulated Radiation Therapy in some cancers – Overuse of radiologic imaging – Possibly colonoscopy versus stool blood testing
  72. 72. Faith Based versus Evidence Based Medicine • We in medicine have a tendency to adopt things before fully accessing their benefit or harm. • We also criticize those who question the benefit and some even praise/worship advocates with a monetary interest. – Bone marrow transplant for breast cancer – Lung cancer screening with Chest Xray – Neuroblastoma Screening with urine VMA – The Halsted Mastectomy – Postmenopausal hormone replacement – Prostate cancer screening
  73. 73. • Are American’s willing to be scientific, accept scientific reality and Give up “faith based medicine” and Adopt “evidence based medicine?” “Americans cannot handle the truth!!!”
  74. 74. Faith Based versus Evidence Based Medicine • Medicine has lost the meaning of the word “Profession” • The desire to make money has blinded many to common sense leading to: – A lack of objectivity and – A lack of belief in basic scientific principles
  75. 75. Disparities in Health • A call for the use of “Evidence Based Care” • That is: – the rational use of medicine – not the rationing of medicine
  76. 76. My Concern • “Equal treatment yields equal outcome among equal patients” • There is not equal treatment • There is not enough concern about nor emphasis on the fact that there is not equal treatment
  77. 77. How can we provide adequate high quality care (to include preventive care) to a population that has so often not received it?
  78. 78. Otis W. Brawley, M.D. Chief Medical Officer Executive Vice President American Cancer Society Professor of Hematology, Oncology, Medicine and Epidemiology Emory University

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