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Biomedical subjects

Jim Yong Kim

Publications and source records attributed to Jim Yong Kim.

17 recordsLinked to original sources

Examining the production costs of antiretroviral drugs.

OBJECTIVES: To present direct manufacturing costs and price calculations of individual antiretroviral drugs, enabling those responsible for their procurement to have a better understanding of the cost structure of their production, and to indicate the prices at which these antiretroviral drugs could be offered in developing country markets. METHODS: Direct manufacturing costs and factory prices for selected first and second-line antiretroviral drugs were calculated based on cost structure data from a state-owned company in Brazil. Prices for the active pharmaceutical ingredients (API) were taken from a recent survey by the World Health Organization (WHO). The calculated prices for antiretroviral drugs are compared with quoted prices offered by privately-owned, for-profit manufacturers. RESULTS: The API represents the largest component of direct manufacturing costs (55-99%), while other inputs, such as salaries, equipment costs, and scale of production, have a minimal impact. The calculated prices for most of the antiretroviral drugs studied fall within the lower quartile of the range of quoted prices in developing country markets. The exceptions are those drugs, primarily for second-line therapy, for which the API is either under patent, in short supply, or in limited use in developing countries (e.g. abacavir, lopinavir/ritonavir, nelfinavir, saquinavir). CONCLUSION: The availability of data on the cost of antiretroviral drug production and calculation of factory prices under a sustainable business model provide benchmarks that bulk purchasers of antiretroviral drugs could use to negotiate lower prices. While truly significant price decreases for antiretroviral drugs will depend largely on the future evolution of API prices, the present study demonstrates that for several antiretroviral drugs price reduction is currently possible. Whether or not these reductions materialize will depend on the magnitude of indirect cost and profit added by each supplier over the direct production costs. The ability to achieve price reductions in line with production costs will have critical implications for sustainable treatment for HIV/AIDS in the developing world.

Anti-Retroviral Agents↗

Monitoring the scale-up of antiretroviral therapy programmes: methods to estimate coverage.

This paper reviews the data sources and methods used to estimate the number of people on, and coverage of, antiretroviral therapy (ART) programmes in low- and middle-income countries and to monitor the progress towards the "3 by 5" target set by WHO and UNAIDS. We include a review of the data sources used to estimate the coverage of ART programmes as well as the efforts made to avoid double counting and over-reporting. The methods used to estimate the number of people in need of ART are described and expanded with estimates of treatment needs for children, both for ART and for cotrimoxazole prophylaxis. An estimated 6.5 million people were in need of treatment in low- and middle-income countries by the end of 2004, including 660,000 children under age 15 years. The mid-2005 estimate of 970,000 people receiving ART in low- and middle-income countries (with an uncertainty range 840,000-1,100,000) corresponds to a coverage of 15% of people in need of treatment.

Adolescent↗

Limited good and limited vision: multidrug-resistant tuberculosis and global health policy.

Almost a third of the world's population is infected with Mycobacterium tuberculosis, the organism that causes tuberculosis disease. Most of those infected never fall ill, but individuals who do can recover if they have access to effective therapies. This paper discusses certain ethical and ethnographic issues raised by cases in which patients are infected with M. tuberculosis strains resistant to at least the two most powerful drugs on which therapy is usually based. In most poor countries, people with such multidrug-resistant tuberculosis (MDR-TB) were, until very recently, considered "untreatable." In addition to being consigned to a permanent state of ill health, they were also at risk of transmitting their resistant strain to others. In this paper we discuss the logic of "cost-effectiveness," which international health policy-makers utilized to make the case that treatment of MDR-TB is not feasible in resource poor settings. These analyses, which have held sway in public health policy for many years, are flawed, we argue, because they ignore and conceal the social determinants of access to health services and often rely on assumptions rather than evidence. We propose that policies based solely on analyses of cost-effectiveness of specific interventions for individual settings can be short-sighted and, because they do not pay sufficient attention to the social, political, economic, epidemiological and pathophysiological factors influencing the production of health, will ultimately hinder progress toward effective global TB control.

Cost-Benefit Analysis↗

Is the "3 by 5" initiative the best approach to tackling the HIV pandemic?

BACKGROUND TO THE DEBATE: The World Health Organization (WHO) and its partners aim to treat 3 million people infected with HIV in poor and middle income countries with antiretroviral treatment by the end of 2005. The ambitious "3 by 5" initiative has had its supporters and its critics since its announcement in 2002.

Antiviral Agents↗

Programmes and principles in treatment of multidrug-resistant tuberculosis.

Multidrug-resistant tuberculosis (MDR-TB) presents an increasing threat to global tuberculosis control. Many crucial management issues in MDR-TB treatment remain unanswered. We reviewed the existing scientific research on MDR-TB treatment, which consists entirely of retrospective cohort studies. Although direct comparisons of these studies are impossible, some insights can be gained: MDR-TB can and should be addressed therapeutically in resource-poor settings; starting of treatment early is crucial; aggressive treatment regimens and high-end dosing are recommended given the lower potency of second-line antituberculosis drugs; and strategies to improve treatment adherence, such as directly observed therapy, should be used. Opportunities to treat MDR-TB in developing countries are now possible through the Global Fund to Fight AIDS, TB, and Malaria, and the Green Light Committee for Access to Second-line Anti-tuberculosis Drugs. As treatment of MDR-TB becomes increasingly available in resource-poor areas, where it is needed most, further clinical and operational research is urgently needed to guide clinicians in the management of this disease.

Antibiotics, Antitubercular↗

Scaling-up treatment for HIV/AIDS: lessons learned from multidrug-resistant tuberculosis.

The UN has launched an initiative to place 3 million people in developing countries on antiretroviral AIDS treatment by end 2005 (the 3 by 5 target). Lessons for HIV/AIDS treatment scale-up emerge from recent experience with multidrug-resistant tuberculosis. Expansion of treatment for multidrug-resistant tuberculosis through the multipartner mechanism known as the Green Light Committee (GLC) has enabled gains in areas relevant to 3 by 5, including policy development, drug procurement, rational use of drugs, and the strengthening of health systems. The successes of the GLC and the obstacles it has encountered provide insights for building sustainable HIV/AIDS treatment programmes.

Acquired Immunodeficiency Syndrome↗

Community-based treatment of multidrug-resistant tuberculosis in Lima, Peru: 7 years of experience.

Programs implementing community-based directly observed therapy (DOT) have demonstrated success in the treatment of patients with tuberculosis. However, given complexities in the management and treatment of patients infected with multidrug-resistant tuberculosis (MDR-TB), the utilization of community-based DOT to treat MDR-TB patients has only recently been successfully attempted. We describe the first such program and highlight the crucial components and most critical challenges to creating a successful community-based MDR-TB treatment program.

Community Health Services↗

Community-based therapy for multidrug-resistant tuberculosis in Lima, Peru.

BACKGROUND: Despite the prevalence of multidrug-resistant tuberculosis in nearly all low-income countries surveyed, effective therapy has been deemed too expensive and considered not to be feasible outside referral centers. We evaluated the results of community-based therapy for multidrug-resistant tuberculosis in a poor section of Lima, Peru. METHODS: We describe the first 75 patients to receive ambulatory treatment with individualized regimens for chronic multidrug-resistant tuberculosis in northern Lima. We conducted a retrospective review of the charts of all patients enrolled in the program between August 1, 1996, and February 1, 1999, and identified predictors of poor outcomes. RESULTS: The infecting strains of Mycobacterium tuberculosis were resistant to a median of six drugs. Among the 66 patients who completed four or more months of therapy, 83 percent (55) were probably cured at the completion of treatment. Five of these 66 patients (8 percent) died while receiving therapy. Only one patient continued to have positive cultures after six months of treatment. All patients in whom treatment failed or who died had extensive bilateral pulmonary disease. In a multiple Cox proportional-hazards regression model, the predictors of the time to treatment failure or death were a low hematocrit (hazard ratio, 4.09; 95 percent confidence interval, 1.35 to 12.36) and a low body-mass index (hazard ratio, 3.23; 95 percent confidence interval, 0.90 to 11.53). Inclusion of pyrazinamide and ethambutol in the regimen (when susceptibility was confirmed) was associated with a favorable outcome (hazard ratio for treatment failure or death, 0.30; 95 percent confidence interval, 0.11 to 0.83). CONCLUSIONS: Community-based outpatient treatment of multidrug-resistant tuberculosis can yield high cure rates even in resource-poor settings. Early initiation of appropriate therapy can preserve susceptibility to first-line drugs and improve treatment outcomes.

Adult↗

From multidrug-resistant tuberculosis to DOTS expansion and beyond: making the most of a paradigm shift.

This review examines the paradigm shift around multidrug-resistant tuberculosis (MDR-TB). This shift has centered largely on the activities of institutions participating in the World Health Organization's Working Group on DOTS-Plus for MDR-TB. We review the important milestones since 1995, namely, the emergence of new evidence, the construction of new mechanisms, and the building of consensus to support new policy guidelines. This paper offers a case study of the construction of a model of good global governance that--if the opportunity is taken--can improve access to effective TB care through improving and helping to expand the WHO-recommended DOTS strategy.

Antitubercular Agents↗

Expanding tuberculosis case detection by screening household contacts.

OBJECTIVES: Tuberculosis (TB) case detection remains low in many countries, compromising the efficacy of TB control efforts. Current global TB control policy emphasizes case finding through sputum smear microscopy for patients who self-report to primary health centers. Our objective was to assess the feasibility and yield of a simple active case finding strategy in a high incidence population in northern Lima, Peru. METHODS: We implemented this pilot strategy in one health center's catchment area. Health workers visited household contacts of new TB case subjects to identify symptomatic individuals and collect sputum for screening. Neighboring households were screened in the same manner. Secondary analyses measured risk of TB by (1) sputum smear status of the index case subject, (2) compliance with testing, and (3) risk factors for disease detected through active contact tracing in contrast to self-report. RESULTS: The TB prevalence detected through combined active and passive case finding among 1,094 household contacts was 0.91% (914 per 100,000), much higher than with passive case finding alone (0.18%; 183 per 100,000; p=0.02). Among 2,258 neighbors, the combined strategy detected a TB prevalence of 0.22% (221 per 100,000) in contrast to 0.08% (80 per 100,000) detected through passive case finding alone (p=0.25). Risk factors for being diagnosed through active case finding in contrast with self-report included age >55 years (odds ratio [OR]=5.5; 95% confidence interval [CI] 1.2, 22.8) and female gender (OR=3.9; 95% CI 0.99, 22.3). CONCLUSIONS: Risk of active TB among symptomatic household contacts of active case subjects in this community is very high. Results suggest that contact tracing in such settings may be a powerful means of improving case detection rates for active TB disease.

Adolescent↗