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CRS — The President’s Emergency Plan for AIDS Relief (PEPFAR), U.S. Global HIV/AIDS, Tuberculosis, and Malaria Programs: A Description of Permanent and Expiring Authorities

October 1, 2013 Comments off

The President’s Emergency Plan for AIDS Relief (PEPFAR), U.S. Global HIV/AIDS, Tuberculosis, and Malaria Programs: A Description of Permanent and Expiring Authorities (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

Fighting HIV/AIDS, tuberculosis (TB), and malaria globally is a priority for Congress. The 108th and 110th Congresses enacted two pieces of legislation that have shaped U.S. responses to these diseases: P.L. 108-25, the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (Leadership Act), and P.L. 110-293, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (Lantos-Hyde Act). The Leadership Act authorized $15 billion to be spent from FY2004 through FY2008 on fighting HIV/AIDS, TB, and malaria. The Lantos-Hyde Act amended the Leadership Act to authorize $48 billion for fighting the three diseases from FY2009 through FY2013.

The Leadership Act (and the legislation that it amends) is the primary vehicle through which U.S. global assistance for fighting these diseases is authorized. The Lantos-Hyde Act mostly amends the Leadership Act, though it amends some other acts, such as the Foreign Assistance Act of 1961, and includes some stand-alone authorities. The Leadership Act and the Lantos-Hyde Act (primarily through amendments to the Leadership Act) created frameworks for how the funds should be spent, established program goals and targets, and established coordinating offices for managing government-wide responses.

The Leadership Act required the President to establish the Coordinator of the United States Government Activities to Combat HIV/AIDS Globally (known as the Global AIDS Coordinator) at the Department of State. Congress appropriates the bulk of global HIV/AIDS funds to the Office of the Global AIDS Coordinator, which leads the President’s Emergency Plan for AIDS Relief (PEPFAR). The Global AIDS Coordinator distributes the majority of these funds to U.S. federal agencies and departments and multilateral groups like the Global Fund to Fight AIDS, Tuberculosis and Malaria. The Lantos-Hyde Act amended the Leadership Act to establish the Coordinator of the United States Government Activities to Combat Malaria Globally (known as the Malaria Coordinator) at the U.S. Agency for International Development (USAID) to oversee implementation of related efforts by USAID and the Centers for Disease Control and Prevention. Some authorities within these Acts are enduring, such as those that created the Global AIDS and Malaria Coordinator positions (Leadership Act, as amended) and permitted U.S. participation in advance market commitments for vaccine development (Lantos-Hyde Act). Other authorities, however, are set to expire, such as language authorizing funding for global HIV/AIDS, TB, and malaria programs.

This report explains which authorities within the Leadership and Lantos-Hyde Acts are set to expire and which are permanent. Table A-1 in the Appendix A offers a side-by-side comparison of the Leadership Act in its original form and the Lantos-Hyde Act, which amends the Leadership Act and other legislation. A third column explains which sections are set to expire and summarizes language in S. 1545 and H.R. 3177 that amend the Leadership Act, as amended. The Leadership Act, as amended and Lantos-Hyde Act include comprehensive reporting requirements. Table A-2 in the Appendix A lists the reporting requirements and describes the extent to which the Administration has complied with the requirements.

Rather than revisit some of the contentious issues that dominated debate when crafting the Lantos-Hyde Act, House and Senate Members introduced legislation (H.R. 3177 and S. 1545) that is narrowly aimed at key priorities: enhancing oversight of U.S. global HIV/AIDS, TB, and malaria programs; authorizing appropriations for the Global Fund through FY2018; and allocating a portion of HIV/AIDS funds for orphans and vulnerable children (OVC) and for HIV/AIDS treatment and care. Table B-1 in Appendix B summarizes key amendments in the bills, entitled the PEPFAR Stewardship and Oversight Act.

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CRS — U.S. Global Health Assistance: Background and Issues for the 113th Congress

July 5, 2013 Comments off

U.S. Global Health Assistance: Background and Issues for the 113th Congress (PDF)
Source: Congressional Research Service (via U.S. Department of State Foreign Press Center)

Congressional support for global health programs has been increasing, particularly during the George W. Bush Administration. Combined global health funding from State-Foreign Operations, Labor-HHS and Defense appropriations rose from $1.7 billion in FY2001 to $8.9 billion in FY2012. The FY2013 Consolidated Appropriations Ac t (P.L. 113-6) includes approximately $8.4 billion for global health programs funded through State-Foreign Operations appropriations, up from $8.2 billion in FY2012. (FY2013 funding levels will likely change, however, due to sequestration.) These funds support global health programs implemented and managed by the U.S. Agency for International Development (USA ID), State Department and the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund)—a multilateral organization aimed at fighting HIV/AIDS, TB, and malaria worldwide. The act does not specify how much should be spent on global health programs through other appropriations.

Concern about infectious diseases, especially HIV/AIDS, has driven much of the budgetary increases. Excluding funding for the Global Fund, roughly 34% of the FY2001 U.S. global health budget was aimed at programs that address HIV/ AIDS. By 2012, about 57% of U.S. global health spending was aimed at fighting HIV/AIDS worldwide, and the FY2014 budget request calls for nearly 54% of global health spending to be aimed at the disease.

In the 112 th Congress, concerns about the strength of the U.S. economy and federal spending precipitated discussions about the role and effica cy of U.S. foreign aid, including global health programs. Critics began to push for U.S. global health programs to demonstrate impact and improve cost-efficiency. At the same time, supporters underscored the advances U.S. global health programs had made, the millions of lives saved in part with U.S. resources, and the promise of innovative health solutions. It is likely that this debate will continue in the 113 th Congress. Other issues the 113 th Congress may face include

  • deliberating funding levels for U.S. global health programs;
  • examining U.S. leadership of U.S. global health programs;
  • maintaining global HIV/AIDS commitments;
  • deliberating the reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) in FY2013; and
  • determining the appropriate mix of multilateral and bilateral spending for global HIV/AIDS, TB, and malaria programs.

President’s Malaria Initiative — Annual Report 2013

April 25, 2013 Comments off

President’s Malaria Initiative — Seventh Annual Report to Congress 2013 (PDF)

Source: USAID/CDC

The past decade has seen unprecedented progress in malaria control efforts in most sub-Saharan African countries. As countries have scaled up insecticide-treated mosquito nets (ITNs), indoor residual spraying (IRS), improved diagnostic tests and highly effective antimalarial drugs, mortality in children under five years of age has fallen dramatically. It is now clear that the cumulative efforts and funding by the President’s Malaria Initiative (PMI), national governments, The Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund), the World Bank and many other donors are working: The risk of malaria is declining. According to the World Health Organization’s (WHO’s) 2012 World Malaria Report, the estimated annual number of global malaria deaths has fallen by more than one-third – from about 985,000 in 2000 to about 660,000 in 2010.

The U.S. Government’s financial and technical contributions have played a major role in this remarkable progress. However, gaps in resources remain. If progress is to be sustained, committed efforts must continue. The theme for World Malaria Day 2013, and for the years leading up to the 2015 target date for the Millennium Development Goals, is “Invest in the future. Defeat malaria.” To this end, PMI and partners continue to build on investments in malaria control and prevention and respond to challenges, such as antimalarial drug resistance, insecticide resistance and weak malaria case surveillance.

CRS — U.S. Response to the Global Threat of Malaria: Basic Facts

June 19, 2012 Comments off

U.S. Response to the Global Threat of Malaria: Basic Facts (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

In 2010, malaria infected an estimated 216 million people and killed 655,000 people, most of whom were children under the age of five in sub-Saharan Africa. Despite the current burden of disease, malaria is preventable and treatable. Congress has increasingly recognized malaria as an important foreign policy issue, and the United States has become a major player in the global response to the disease. In its second session, the 112 th Congress will likely debate the appropriate funding levels and optimum strategy for addressing the continued challenge of global malaria.

Congress has enacted several key pieces of legislation related to global malaria control. These include the Assistance for International Malaria Control Act of 2000 (P.L. 106-570); the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (P.L. 108-25); and the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (P.L. 110-293). These acts have authorized funds to be used in the fight against malaria and have shaped the ways in which U.S. malaria programs are coordinated and managed, including through the creation of the U.S. Global Malaria Coordinator at the United States Agency for International Development (USAID).

In 2005, in response to growing international calls for global malaria control and to the success of the President’s Emergency Plan for AIDS Relief (PEPFAR), President George W. Bush launched the President’s Malaria Initiative (PMI), which aims to halve the burden of malaria morbidity and mortality in 70% of at-risk populations in sub-Saharan Africa by 2014. PMI brought significant new attention and funding to U.S. malaria programs and made the United States one of the largest donors for malaria efforts. While U.S. funding for global malaria programs has increased each fiscal year since FY2004, support for malaria interventions increased most precipitously beginning in FY2007 as PMI has expanded into new countries. President Obama has continued to support PMI through the Global Health Initiative (GHI).

There is evidence that the growing international response to malaria has had some success in controlling the epidemic. Since 2000, global malaria incidence has decreased by 17% and malaria mortality by 26%. Since 2000, 43 countries have reported a reduction in reported malaria cases of more than 50%, including eight African countries that have experienced 50% reduction in either confirmed malaria cases or malaria admissions and deaths. The decreases in each of these African countries are associated with intense malaria control activities. Despite these successes, several key issues pose challenges to an effective scale-up of the response to malaria.

First, increasing reports of drug-resistant malaria in Southeast Asia and insecticide-resistant mosquitoes, largely in Africa, threaten the success of malaria control programs. Second, weak health systems, including shortages in health care personnel and inadequate supply chain networks, have limited the delivery of essential commodities for malaria control. There is also debate within the global health community over whether malaria efforts should increasingly target areas where malaria elimination is possible or whether efforts should remain concentrated on malaria control. This report outlines basic facts related to global malaria, including characteristics of the epidemic and U.S. legislation, programs, funding, and partnerships related to the global response to malaria. The report will be updated as events warrant.

See also: U.S. Response to the Global Threat of Tuberculosis: Basic Facts (PDF)
See also: U.S. Response to the Global Threat of HIV/AIDS: Basic Facts (PDF)

Documents Uncovered by Judicial Watch Raise Concerns About Use of Drug for Military Personnel

May 4, 2012 Comments off

Documents Uncovered by Judicial Watch Raise Concerns About Use of Drug for Military Personnel
Source: Judicial Watch

Judicial Watch, the public interest group that that investigates and fights government corruption, announced today that it has uncovered documents from the Food and Drug Administration (FDA) detailing more than 2,000 episodes during the past 15 years in which people had serious adverse reactions caused by the anti-malaria drug, mefloquine hydrochloride, commonly known as Lariam®. Of 87 reported deaths associated with the drug, 39 were recorded as suicides and 12 were homicides.

The documents obtained by Judicial Watch pursuant to a March 26, 2012, request submitted to the FDA, include details from the agency’s Adverse Event Reporting System (AERS) identifying persons treated with mefloquine from November 4, 1997, through March 28, 2012, and the specific reported reactions to the drug. In addition to the reported deaths, reported reactions included hallucinations, panic attacks, depression, paranoia, anxiety, confusion, mental disorder, delusion, hemorrhaging, and numerous other serious disorders.

Long known for its severe neurological side effects, mefloquine was supposedly removed as the drug of choice in the treatment of malaria by the Department of Defense (DOD). In a September 2009 policy memorandum, the Defense Department stated that mefloquine was to be prescribed only in limited cases where other drugs, such as doxycycline and mallarone, were considered unlikely to be effective. Mefloquine was specifically prohibited in the treatment of patients with head injuries, and in particular, a TBI (traumatic brain injury). It is also contraindicated for patients with post-traumatic stress disorder.

Nonetheless, the documents obtained by Judicial Watch indicate clearly that mefloquine is still prescribed, even though its use has decreased since the September 2009 memorandum limiting its use was issued. In the field, medics apparently do not necessarily need to follow such policy recommendations by the U.S. Army and U.S. Central Command (CENTCOM).

+ Documents

Global malaria mortality between 1980 and 2010: a systematic analysis

February 6, 2012 Comments off
Source:  The Lancet
Background
During the past decade, renewed global and national efforts to combat malaria have led to ambitious goals. We aimed to provide an accurate assessment of the levels and time trends in malaria mortality to aid assessment of progress towards these goals and the focusing of future efforts.
Methods
We systematically collected all available data for malaria mortality for the period 1980—2010, correcting for misclassification bias. We developed a range of predictive models, including ensemble models, to estimate malaria mortality with uncertainty by age, sex, country, and year. We used key predictors of malaria mortality such as Plasmodium falciparum parasite prevalence, first-line antimalarial drug resistance, and vector control. We used out-of-sample predictive validity to select the final model.
Findings
Global malaria deaths increased from 995 000 (95% uncertainty interval 711 000—1 412 000) in 1980 to a peak of 1 817 000 (1 430 000—2 366 000) in 2004, decreasing to 1 238 000 (929 000—1 685 000) in 2010. In Africa, malaria deaths increased from 493 000 (290 000—747 000) in 1980 to 1 613 000 (1 243 000—2 145 000) in 2004, decreasing by about 30% to 1 133 000 (848 000—1 591 000) in 2010. Outside of Africa, malaria deaths have steadily decreased from 502 000 (322 000—833 000) in 1980 to 104 000 (45 000—191 000) in 2010. We estimated more deaths in individuals aged 5 years or older than has been estimated in previous studies: 435 000 (307 000—658 000) deaths in Africa and 89 000 (33 000—177 000) deaths outside of Africa in 2010.
Interpretation
Our findings show that the malaria mortality burden is larger than previously estimated, especially in adults. There has been a rapid decrease in malaria mortality in Africa because of the scaling up of control activities supported by international donors. Donor support, however, needs to be increased if malaria elimination and eradication and broader health and development goals are to be met.
Funding
The Bill & Melinda Gates Foundation.
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Free registration required to read full paper.

Is the current decline in malaria burden in sub-Saharan Africa due to a decrease in vector population?

August 26, 2011 Comments off

Is the current decline in malaria burden in sub-Saharan Africa due to a decrease in vector population?
Source: Malaria Journal

A longitudinal decline in the density of malaria mosquito vectors was seen during both study periods despite the absence of organized vector control. Part of the decline could be associated with changes in the pattern of monthly rainfall, but other factors may also contribute to the dramatic downward trend. A similar decline in malaria vector densities could contribute to the decrease in levels of malaria infection reported from many parts of SSA.

CRS — The Global Challenge of HIV/AIDS, Tuberculosis, and Malaria

May 24, 2011 Comments off

The Global Challenge of HIV/AIDS, Tuberculosis, and Malaria (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

The spread of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), tuberculosis (TB), and malaria across the world poses a major global health challenge. The international community has progressively recognized the humanitarian impact of these diseases, along with the threat they represent to economic development and international security. The United States has historically been a leader in the fight against HIV/AIDS, TB, and malaria; it is currently the largest single donor for global HIV/AIDS and has been central to the global response to TB and malaria. The 112th Congress will likely consider HIV/AIDS, TB, and malaria programs during debate on and review of U.S.-supported global programs, U.S. foreign assistance spending levels, and foreign relations authorization bills.

Over the last decade, Congress has demonstrated bipartisan support for addressing HIV/AIDS, TB, and malaria worldwide, authorizing more than $37 billion for U.S. global efforts to combat the diseases from FY2001 through FY2010. During this time, Congress supported initiatives proposed by President George W. Bush, including the President’s Emergency Plan for AIDS Relief (PEPFAR) and the President’s Malaria Initiative (PMI), both of which have demonstrated robust U.S. engagement in global health. Through the Global Health Initiative (GHI), President Barack Obama has led efforts to coordinate U.S. global HIV/AIDS, TB, and malaria programs and create an efficient, long-term, and sustainable approach to combating these diseases.

Despite progress in fighting HIV/AIDS, TB, and malaria, these diseases remain leading global causes of morbidity and mortality. Many health experts urge Congress to bolster U.S. leadership against these diseases and increase funding for such programs. In contrast, some Members of Congress have proposed cuts to these programs as part of deficit reduction efforts. This report reviews the U.S. response to HIV/AIDS, TB, and malaria and discusses several issues Congress may consider as it debates spending levels and priority areas for related programs.

Fraud and Abuse of Global Fund Investments at Risk without Greater Transparency

May 23, 2011 Comments off

Fraud and Abuse of Global Fund Investments at Risk without Greater Transparency (PDF)
Source: U.S. Senate Committee on Foreign Affairs (GOP)

DEAR COLLEAGUES: Through the President’s Emergency Plan for AIDS Relief (PEPFAR), the United States is providing both bilat- eral and multilateral assistance to disadvantaged populations to prevent and treat people with HIV/AIDS, tuberculosis and malaria. As of December 2010, U.S. investment in these programs totaled more than $32 billion. The U.S. provides its multilateral assistance through the Global Fund to Fight AIDS, Tuberculosis and Malaria, an independent entity which receives contributions from both countries and private organizations and provides medication and health services through nearly 600 grants in more than 140 countries. Although the Global Fund has demonstrated significant accomplish- ments and successes in saving lives through its antiretroviral drug programs and its prevention work, it has recently come under fire for mismanagement of grants in several countries. Following the release of several critical reports, some donors to the Fund have suspended their contributions until all mismanagement practices and abuses of funds can be rectified.

Many of the new Members of the Senate who have no direct experience with PEPFAR and the Global Fund have asked Com- mittee staff for a brief primer on these programs in anticipation of having to make funding decisions relative to the these global initiatives. I requested Senior Professional Staff Members Shellie Bressler and Lori Rowley to produce this primer. Their report examines the history and operation of PEPFAR and the Global Fund, the problems and initial improvements made to it, and the most recent challenges it faces. It also provides a series of recommenda- tions for implementation by both the U.S. Government and the Global Fund for strengthening existing systems for the distribution of supplies, medication and services in order to prevent further mismanagement and to ensure that the maximum number of peo- ple may benefit from the health prevention and treatment efforts of the Global Fund.

These tough recommendations run the gamut from withholding U.S. funds to the United Nations Development Fund (whose Development Program is a large recipient of Global Fund grants) until the organization’s internal procedures allow for greater access to their internal audit and investigation documents, to a recommendation for the development of an additional layer of protec- tion and an early warning system in those nations where insta- bility and/or government corruption are a concern.

I hope you find this report useful and that we may work together to reduce fraud, improve transparency and ensure maximum value for the U.S. investment in these global health programs.

Sincerely, RICHARD G. LUGAR, Ranking Member.

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