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Plagues of Poverty: TB and the Neglect of the Poor Social Medicine, Human Rights, and the Physician Emory MEDI 645

Tuberculosis: A Global Emergency. 1993: WHO declares TB a global public health emergency8 million new cases per year (and increasing)2 million deaths per year = 5,500 per day = 1 every 15 seconds1/3 of the world's population is infected with Mycobacterium tuberculosis. Global Emergency II. More than 100,000 children will die this yearHIV and TB co-infection are producing explosive epidemicsHundreds of thousands of children will become TB orphans this yearMDR is seriously threatening global TB control.

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Plagues of Poverty: TB and the Neglect of the Poor Social Medicine, Human Rights, and the Physician Emory MEDI 645

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    1. Plagues of Poverty: TB and the Neglect of the Poor Social Medicine, Human Rights, and the Physician Emory MEDI 645 Timothy Holtz, MD, MPH February 14, 2005 With assistance from Peter Cegielski, MD, MPH and Kayla Laserson, ScD

    2. Tuberculosis: A Global Emergency 1993: WHO declares TB a global public health emergency 8 million new cases per year (and increasing) 2 million deaths per year = 5,500 per day = 1 every 15 seconds 1/3 of the world’s population is infected with Mycobacterium tuberculosis Multi drug Resistance = MDR Multi drug Resistance = MDR

    3. Global Emergency II More than 100,000 children will die this year HIV and TB co-infection are producing explosive epidemics Hundreds of thousands of children will become TB orphans this year MDR is seriously threatening global TB control Multi drug Resistance = MDR Multi drug Resistance = MDR

    4. History TB emerged as a major cause of morbidity and mortality during 17th century feudal Europe with growth of crowded cities and widespread poverty Peaked in late 18th century causing 25% of all deaths, the “White Plague” Robert Koch discovered Mycobacterium tuberculosis and proved it was the cause of TB in 1882, later developing diagnostic tests “If the number of victims which a disease claims is the measure of its significance, then all diseases, particularly the most dreaded infectious diseases, such as Bubonic Plague, Asiatic Cholera, et cetera, must rank far behind Tuberculosis.” –Robert Koch, 1882 Multi drug Resistance = MDR Multi drug Resistance = MDR

    5. Who has succumbed? Brönte sisters Percy Bushe Shelley Lord Byron John Keats Robert Louis Stevenson George Orwell Eleanor Roosevelt

    6. Dubos “Tuberculosis is a social disease, and presents problems that transcend the conventional medical approach…its understanding demands that the impact of social and economic factors on the individual be considered as much as the mechanisms by which tubercle bacilli cause damage to the human body.”

    7. The Evolution of Epidemics

    8. The White Plague The industrial revolution brought with the exploitation of labor Crowding Poor working and living conditions 1796 report of a commission appointed by the Manchester Board of Health: “Children and others who work in the large cotton factories are peculiarly disposed to be affected by the contagion of fever, and when such infection is received, it is rapidly propagated, not only amongst those who are crowded together in the same departments, but in the families and neighborhoods to which they belong.”

    9. “The social disease of the 19th Century” 1830-Mortality in Boston, NYC, Philadelphia was approximately 400/100,000 1880-Outbreak among 2800 Sioux prisoners Mortality 10X higher than the worst European epidemics Qu’Appelle Valley Reservation in W. Canada: TB mortality 9,000/100,000 Wars: 1871 TB mortality surge in Paris during the siege by the Prussian Army WW I, WW II TB became known as the social disease of the 19th century – the estimated mortality of TB in Boston, NYC and Philadelphia in 1830 was 400/100,000. Reliable national mortality rates are not available until around 1900 at 200/100,000. By 1950 that had decreased to 26/100,000. TB became known as the social disease of the 19th century – the estimated mortality of TB in Boston, NYC and Philadelphia in 1830 was 400/100,000. Reliable national mortality rates are not available until around 1900 at 200/100,000. By 1950 that had decreased to 26/100,000.

    10. “The social disease of the 19th Century” Reform demanded Late 19th century anti-TB campaigns led to the institution of control measures: Austria’s Society of the Establishment of Sanatoria for the Consumptive Poor Denmark’s National League for the Campaign against Tuberculosis France’s French League against Tuberculosis By 1850 reformers had begun attacking social problems by political action to improve the working and living conditions. Access to clean water, food and living conditions, fresh air sunshine, became a right. The campaign for social reform gained momentum Reliable national mortality rates are not available until around 1900 at 200/100,000. By 1950 that had decreased to 26/100,000. It had become obvious that “tuberculosis was most prevalent and most destructive in the poorest elements of the population and that healthy living could mitigate its harmful effects” Anti-TB campaigns gained momentum and carried social prestige – these were presided over by royalty, chiefs of state and leaders of the political and social world Supported by the press Involvement by sociologists, businessmen, philanthropists as well as physicians By 1850 reformers had begun attacking social problems by political action to improve the working and living conditions. Access to clean water, food and living conditions, fresh air sunshine, became a right. The campaign for social reform gained momentum Reliable national mortality rates are not available until around 1900 at 200/100,000. By 1950 that had decreased to 26/100,000. It had become obvious that “tuberculosis was most prevalent and most destructive in the poorest elements of the population and that healthy living could mitigate its harmful effects” Anti-TB campaigns gained momentum and carried social prestige – these were presided over by royalty, chiefs of state and leaders of the political and social world Supported by the press Involvement by sociologists, businessmen, philanthropists as well as physicians

    11. “A communicable disease of social importance” America: the 1899 Medico-Legal Society of the City of New York and the American Congress on Tuberculosis Legislative measures Education A new approach to controlling a social disease: Political commitment Emphasis on prevention and control measures Financial support Health education of the general public: Tuberculosis as a Disease of the Masses and How to Combat it. Knopf, 1901. In America, the first organized national scale movement was led by a group of lawyers, scientists and physicians interested in social problems known as the Medico-Legal Society of the City of New York. This group organized an American Congress on tuberculosis to address laws regarding TB and its treatment. Emphasis shifted from treatment of the individual patient to control of disease in society – (new relationship between the medical profession and the public) Role of physicians Role of public health officials and social workers - - legislative and educational approach, community action Education: Knopf’s pamphlet: “ Tuberculosis as a Disease of the Masses and How to Combat It” in 1901 was translated into 27 languages and distributed world wide In America, the first organized national scale movement was led by a group of lawyers, scientists and physicians interested in social problems known as the Medico-Legal Society of the City of New York. This group organized an American Congress on tuberculosis to address laws regarding TB and its treatment. Emphasis shifted from treatment of the individual patient to control of disease in society – (new relationship between the medical profession and the public) Role of physicians Role of public health officials and social workers - - legislative and educational approach, community action Education: Knopf’s pamphlet: “ Tuberculosis as a Disease of the Masses and How to Combat It” in 1901 was translated into 27 languages and distributed world wide

    12. The White Plague Dramatic decrease in TB mortality in the 20th century: A consequence of control measures or improved standard of living? A “luxury of prosperous communities”?

    13. The White Plague “Public health is purchasable. Within natural limitations, any community can determine its own death rate.” Hermann Biggs

    14. How did we get here? TB incidence was decreasing in U.S. and W. Europe after early 1900s improved nutrition & living conditions Discovery of effective treatment 1943-1972 led to widespread optimism Trends improving in many low income countries by 1970s Scientific and public health interest waned, funding decreased in the 1970s Multi drug Resistance = MDR Multi drug Resistance = MDR

    15. How did we get here? Infrastructure for TB control deteriorated through the 1980s HIV epidemic started late 1970s, HIV/TB co-infection produced (-ing) explosive epidemics Multidrug-resistant TB (MDR TB) started threatening global TB control in many countries, circa 1990 Multi drug Resistance = MDR Multi drug Resistance = MDR

    16. How did we really get here? Increasing poverty in low and middle income countries Worsening economic inequality No international commitment to TB control Collapse of public health infrastructure Political violence Racism

    17. The Global TB Situation Outline: TB in the USA Global burden and distribution of TB Co-epidemics of TB and HIV/AIDS Drug-resistant TB Global efforts to control TB

    18. TB in the United States

    20. Reported TB Cases US, 1983-2002

    21. Excess TB cases 1985-92 After more than three decades of a steady decline in TB morbidity, averaging 5-6% annual decrease, our nation experienced a resurgence of tuberculosis from 1985 through 1992, with an estimated excess of 52,100 persons who should have never developed this disease had previous morbidity trends continued. To add insult to injury, there was a concurrent widespread occurrence of multidrug-resistant TB Several factors were associated with this resurgence, and have been documented in previous publications. Perhaps the single most important factor that set the stage for this mess consisted of the dismantling of TB clinical services during the disappearance of categorical funds in the late 1970s and early 1980s. After more than three decades of a steady decline in TB morbidity, averaging 5-6% annual decrease, our nation experienced a resurgence of tuberculosis from 1985 through 1992, with an estimated excess of 52,100 persons who should have never developed this disease had previous morbidity trends continued. To add insult to injury, there was a concurrent widespread occurrence of multidrug-resistant TB Several factors were associated with this resurgence, and have been documented in previous publications. Perhaps the single most important factor that set the stage for this mess consisted of the dismantling of TB clinical services during the disappearance of categorical funds in the late 1970s and early 1980s.

    22. TB in NYC in 1980s TB public health program underfunded due to fiscal crisis in late 1970s-1980s Cure rate 50%, <2% on DOT Over-reliance on inpatient treatment No special program for homeless, alcoholics In Harlem – 90% of cases never completed therapy, 27% readmitted Treatment default a major cause of problem 70% increase in cases during 1980s

    23. Arresting the NYC epidemic Find active cases Incentive program-free meals, rides, coupons, vouchers Directly Observed Therapy Short Course Shelter for homeless with TB Mandatory detention for refractory, chronic defaulters

    25. TB Morbidity US, 1997-2002

    26. TB Case Rates, US, 2002

    27. Reported TB Cases by Race/Ethnicity, US, 2001

    28. Number of TB Cases in US-born vs. Foreign-born Persons, US, 1992-2002*

    29. Countries of Birth for Foreign-born Persons Reported with TB US, 2002*

    30. Socioeconomic Characteristics of TB in the US More than ˝ of TB cases occur in immigrants Among non-immigrants, TB significantly associated with Poverty and unemployment Homelessness Congregate settings Incarceration Alcoholism and drug abuse HIV infection rates also high in some of these populations

    31. Global distribution and burden of disease

    32. Leading Infectious Disease Causes of Death, 1998

    33. Estimated Annual Incidence of TB Selected High Burden Countries, 2001

    36. Geographical Distribution of Notified Cases of TB, 2001

    38. Travesty Leading infectious cause of preventable death No “tumbling down” of death rate in developing world 1.5-2 million deaths annually despite 60+ years of effective therapy

    39. TB / HIV Co-epidemics

    45. Drug-resistant and Multidrug-resistant TB

    46. The Development and Spread of Drug- and Multidrug-resistant TB

    47. Introduction of Anti-TB Drugs Streptomycin 1943 Isoniazid 1952 Pyrazinamide 1956 Ethambutol 1960s Rifampin 1970s

    48. Drug Resistant Pattern Predicted by misuse of drugs over time Date drug first available for use in humans Penetration into local marketplace (changes in cost, duty, regulatory approval) Evolution of NTP regimen Introduction of free-of-charge Tx by NTP

    53. The Russian TB Epidemic: Key Features TB case notification more than doubled from 34/100,000 in 1991 to 92 per 100,000 in 2001 Rooted in political changes, economic crises, and social disruption Reported case rates > 3,000 per 100,000 prisoners in several oblasts in 1999 TB again a major cause of young adult deaths Primary and acquired drug resistance common

    56. Causality? “Re-emergence” of TB due to HIV and MDR TB are not biologic phenomena but social phenomena Those falling ill continue to be the marginalized, homeless, prisoners, unemployed

    57. Immodest claims of causality “Non-compliance” with therapy Lack of knowledge Etiologic beliefs about health and TB Vs. Lack of commitment Lack of access to resources Lack of effective adherence strategies

    58. Sins of social scientists Conflating cultural difference with structural violence Social diseases “hide” amidst the poor population Minimizing the role of poverty Re-emergence was from the ranks of the poor Exaggerating patient agency Those least likely to comply are those least able to comply Romanticizing folk healing Unfair distribution of world’s medical resources

    59. Which social forces? Poverty, racism, gender inequality? Homelessness, injection drug use? Structural violence? The World Health Organization?

    60. WHO and MDR TB Through 1998, WHO policy was to treat all relapsed cases of MDR with Regimen 2 – adding Strep to 4-drug regimen WHO, and some current experts, argue against treating MDR TB; that DOTS for TB will take care of MDR problem The poor “at risk” not only to develop MDR TB, but “at risk” of not finding adequate therapy

    61. Tailoring a time-bomb MDR TB being cultivated even in the face of an effective TB program (Peru) Enrollment of patients into standard treatment algorithms Amplification in “hot spots” MDR TB only seen in places where inequality is entrenched Cannot eliminate TB without also dealing with problem of drug-resistance

    62. Arguments against not treating MDR TB Clinical – No expertise, diagnosis is complex DOTS will fail to treat drug-resistant TB Epidemiologic – Treating MDR will destabilize DOTS No data showing DOTS will lower MDR case rates where it is already established Without treatment, transmission of MDR will continue Social Analysis – Too expensive to treat Or too expensive NOT to treat? Moral – Poor countries cannot handle the challenges Treatable in the US, but not in Russia? Differential valuation of life? Victims are the poor.

    63. Social diseases cannot be eradicated or eliminated without a social response

    64. Social approach Determine the mechanisms by which social forces promote or retard the transmission of TB Identify and rank the barriers preventing those afflicted from having access to the best care available Become engaged in multidisciplinary trials Expose the mechanisms that entrench medical inequities

    65. Global TB Control

    66. Global TB Control Global control of TB is a leading health priority DOTS WHO global strategy National case management of populations March 1997, declared to “represent the most important public health breakthrough of the decade, in terms of the lives which will be saved” To tell class the main objectives for this lectureTo tell class the main objectives for this lecture

    67. WHO DOTS Strategy for TB This cartoon illustrates the 5 elements of the DOTS strategy. First, is the government commitment to consider TB control a priority, along with necessary resources for the program. Second is the reliance on microscopy-based sputum examinations as the basis to diagnose the presence of this infectious organism. Third is the use of standardized rifampin-based short-course chemotherapy under direct observation (at least during the first two months of treatment). Fourth is assuring an uninterrupted supply of quality anti-TB medicines. Fifth is the creation of a record-keeping system and training for program supervision, monitoring, and evaluation.This cartoon illustrates the 5 elements of the DOTS strategy. First, is the government commitment to consider TB control a priority, along with necessary resources for the program. Second is the reliance on microscopy-based sputum examinations as the basis to diagnose the presence of this infectious organism. Third is the use of standardized rifampin-based short-course chemotherapy under direct observation (at least during the first two months of treatment). Fourth is assuring an uninterrupted supply of quality anti-TB medicines. Fifth is the creation of a record-keeping system and training for program supervision, monitoring, and evaluation.

    68. DOTS is Effective In Malawi, Mozambique, and Tanzania, DOTS led to cure rates between 86% to 90% In Beijing, China, DOTS led to a decrease of smear-positive TB from 127/100,000 to 16/100,00 in 11 years with cure rates > 90% In Bangladesh, DOTS led to cure rates > 80% In India, DOTS led to cure rates of ~75% to 80%

    70. DOTS Can Reduce the Burden of TB

    71. DOTS Can Reduce Drug Resistance

    74. In 1993, the World Bank determined that DOTS was one of the most cost-effective of any health care intervention

    77. Status of DOTS Globally, 2000 WHO Stop-TB partnership, significant momentum Countries implementing DOTS strategy, 155/210 (74%) All 22 high-burden countries have adopted DOTS 61% world’s population, including those in high burden countries, had access to DOTS Vietnam is the only high burden country meeting WHO target for case detection (75%) and cure (80%) Worldwide, DOTS programs will have to increase the number of additional patients enrolled annually by a factor of 2.5 to meet 2005 WHO targets

    78. Can TB Be Controlled Globally? Inadequate political commitment Incomplete DOTS coverage Impact of HIV on TB epidemiology Cost and management of MDR TB Slow development of new tools

    79. Expand DOTS coverage, especially in high burden countries Face challenges of HIV, MDRTB, and weak health systems and find solutions Ensure DOTS is patient-centered Build the necessary broad coalition to ensure control efforts are effective and sustained research is effective to identify new tools

    80. Beyond DOTS DOTS-plus treatment for MDR TB Screening and treatment of latent infection The prospects for new drugs and vaccines

    81. Working Group DOTS-Plus Formed in 1999 Composed of members of academia, civic organizations, donor agencies, bilateral donors, governments, UN

    82. Increase access to drugs for MDRTB Lower costs and increase control New, more effective, less toxic drugs needed Build technical capacity for “DOTS-Plus” - Ensure DOTS is fully in place “Hot Spots” require urgent attention Build Laboratory Capacity for DOTS-Plus Advocacy to mobilize resources

    83. Treating MDR TB (1) Rationale Patients with MDR TB are generally not cured by standard 4-5 drug short-course chemotherapy (the cornerstone of DOTS) Drug-resistant TB is present and increasing in many countries Significant transmission of MDR TB may still occur in DOTS-based countries The potential spread of MDR TB could be a threat to the success of DOTS

    84. Treating MDR TB (2) Feasibility In industrialized countries, treatment with expensive 2nd-line drugs is based on the use of individual DST Feasibility of these regimens in low and middle income countries unknown

    85. DOTS-Plus DOTS prevents drug resistance, but DOTS alone is not adequate in regions of high drug resistance Once solid DOTS program is in place, initiate projects to manage MDR TB Infrastructure development, capacity building Demonstration and pilot treatment projects Develop evidence base for global guidelines and recommendations Assess cost and sustainability

    86. Creation of DOTS-Plus Projects Decision to create DOTS-Plus Pilot Programs Case-management initiative designed to manage MDR TB within the DOTS strategy in low/ middle income countries Uses Individualized (ITR) and Standardized (STR) regimens Green Light Committee to assist in the procurement of low cost second-line drugs Requires evaluation of the cost, feasibility, and effectiveness of these regimens and projects Goal: To develop appropriate, evidence-based global policy for the treatment and management of MDR TB

    87. Strong DOTS programs Laboratory capacity for DST On-going drug resistance surveillance Advocacy - Maintain momentum - Increase visibility with public-private partnerships

    88. Green Light Committee Subgroup of Working Group on MDR TB Based on model for distributing meningitis vaccine Work with pharmaceutical companies to provide concessional prices for GLC-approved projects, enables a pooled procurement mechanism to buy 2nd line drugs Objectives are Review applications Evaluate the projects Report to WHO

    89. GLC Approach Determine category of drug Single negotiator (MSF) Drugs submitted for inclusion to the WHO Model List of Essential Drugs Direct negotiation strategy Advantages to suppliers highlighted Access to 2nd line drugs only given to those who meet DOTS-Plus criteria

    90. Effect on 2nd-line drug prices

    91. Examples of Countries Implementing DOTS-Plus Pilot Projects Peru (ITR/STR) Bolivia (ITR) Mexico (STR) Latvia (ITR) Estonia (ITR) Russia (various Oblasts, ITR) Philippines (ITR) South Africa (STR)

    92. Summary TB is a major global public health problem TB is a quintessential social disease that demands a social response HIV and drug resistance are seriously challenging global TB control efforts TB control efforts must be a global priority

    93. New Global Initiatives STOP TB Partnership Global Drug Facility Global Alliance for TB Drug Development Green Light Committee Global Fund Against AIDS, TB and Malaria

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