Kaisernetwork.org (Washington, DC)
28 March 2008
Politics and Policy
FDA To Review Safety of GSK, BMS Antiretrovirals Abacavir, Didanosine
[Mar 28, 2008]
FDA on Thursday announced that it will review the safety of GlaxoSmithKline's antiretroviral drug abacavir and Bristol-Myers Squibb's antiretroviral didanosine, Reuters reports (Richwine, Reuters, 3/27). The agency said that data pooled from a recent study conducted among more than 33,000 HIV-positive people found that the antiretrovirals were linked to an increased risk of heart attack among some of the participants (AP/Wall Street Journal, 3/27).
Didanosine is a generic version of BMS's VIDEX, which was FDA-approved in December 2004. The drug is used in combination with other antiretrovirals for the treatment of HIV-1 infection. Abacavir is a second-line antiretroviral used to treat people living with HIV/AIDS who have developed resistance to first-line drugs (Kaiser Daily HIV/AIDS Report, 2/6). Abacavir is sold under the brand name Ziagen. GSK and BMS said their own evaluations have not found an increased risk of heart attack.
According to FDA, people taking either drug "had a greater chance of developing a heart attack than patients taking other medications." However, the risk did not increase over time and seemed to diminish after people stopped taking the drugs, the agency said. "The effect was not seen six months after stopping the drugs," FDA said. In a notice on its Web site, FDA said it is still evaluating the data and that the review "may result in the need to revise labeling for the products." The agency added that the current analysis of the study is incomplete, noting that researchers have not evaluated the risk of heart attack associated with Gilead Sciences' Viread and Emtriva. "Until this evaluation is complete, health care providers should evaluate the potential risks and benefits" of antiretrovirals their patients are taking, the agency said.
Marc Meachem, a GSK spokesperson, said the company has analyzed its own databases and "did not see any sign of an increased risk of heart attack." BMS spokesperson Sonia Choi said that the company has not "seen an increase of cardiovascular events in our studies of VIDEX or in our (company) safety database." FDA said that the results from analyses by GSK and BMS are inconclusive, according to Reuters. Mark Schoenebaum, an analyst for Bear Stearns, said in a research note that he believes safety concerns with GSK's abacavir "will drive increased switching to Gilead-based regimens" (Reuters, 3/27).
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Global Challenges
Number of HIV Cases in Asia Could Increase by 8M Unless Increased Action Is Taken To Address Virus, Report Says
[Mar 28, 2008]
The number of HIV cases in Asia could increase by more than 150%, or eight million cases, by 2020 unless more is done to prevent the spread of the virus, according to a report released Wednesday by the United Nations Commission on AIDS in Asia and the Pacific, Reuters reports. According to the report, about five million people are living with HIV/AIDS in Asia, and 440,000 people in the region are dying annually of AIDS-related causes. The report also found that the number of annual AIDS-related deaths could increase to 500,000 by 2020 without a bolstered response to the disease (Krauskopf, Reuters, 3/26).
The 238-page report was based in part on online responses from hundreds of representatives from community groups that are involved in HIV/AIDS-related work in Asia. The report found that Southeast Asia has the highest HIV prevalence in the region and that Indonesia has the fastest rate of growth (AFP/Google.com, 3/26). In addition, the report found that AIDS-related illnesses are the most likely cause of death and lost work days among people ages 15 to 44 (Reuters, 3/26). According to the report, the epidemic in Asia is characterized by high-risk behavior among commercial sex workers and their customers, injection drug users and men who have sex with men (Kyodo News, 3/26). The report noted that by 2020, the increase in the number of cases could be kept at three million if a response is adopted immediately. The commission recommended a minimum annual investment of 30 cents to 50 cents per capita on focused prevention programs (Reuters, 3/26). It added that an annual budget of $1 billion for prevention programs among high-risk populations could reduce new cases by 60%. According to the report, about $1.2 billion was available for overall HIV/AIDS programs in Asia in 2007, while the amount needed for an adequate response to the disease was about $6.4 billion (AFP/Google.com, 3/26).
Chakravarthi Rangarajan, chair of the commission, said that heads of governments should become directly involved in HIV prevention efforts to show leadership on the issue, which generally has been lacking. He added that prevention programs should promote the extensive use of condoms. The commission added that efforts to develop policies to fight the spread of HIV should involve the communities most affected by the disease and that governments need to change or abolish laws that incite HIV-related discrimination (Reuters, 3/26). The programs also should focus on protecting the wives of men who frequent commercial sex workers, as well as on providing sex education in schools and colleges, the report said (AFP/Google.com, 3/26).
Comments
UNAIDS Executive Director Peter Piot said the report "shows clearly that the response to the epidemic has to be tailored to Asian realities. ... There is not one Asian reality, there are many. The time is gone that with a blueprint for the whole world, we can stop this epidemic" (Reuters, 3/26). Rangarajan said, "The costs of inaction are simply too high," adding, "Without concerted and evidence-based responses, Asia can expect an economic (annual) loss of $2 billion" by 2020 (AFP/Google.com, 3/26).
U.N. Secretary General Ban Ki-moon in a statement said, "By implementing the recommendations of the commission, Asian countries can avert massive increases in infections and death, prevent economic losses and save millions of people from poverty." He added, "Such leadership is critical in Asia today" (Kyodo News, 3/26). Ban said, "We will never see equitable progress if some parts of the population are still denied basic health and human rights" (AFP/Google.com, 3/26).
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Globe and Mail Examines African Governments' Efforts To Increase Male Circumcision To Curb Spread of HIV
[Mar 28, 2008]
Toronto's Globe and Mail on Thursday examined the efforts of several African governments to provide male circumcision as a way of curbing the spread of HIV. According to the Globe and Mail, male circumcision could prevent "millions" of new HIV cases in Africa, where about 50% of men currently are not circumcised. Several African governments in response to recent studies about the procedure have implemented or are planning circumcision programs.
Swaziland hopes to offer the procedure to 200,000 men over the next five years; however, a shortage of doctors has complicated the government's efforts. The Family Life Association of Swaziland has "hundreds" of men on its waiting list for the procedure, and the clinic's one doctor performs about 10 circumcisions daily, the Globe and Mail reports. FLAS also has offered "Circumcision Saturdays" at clinics throughout the country. The procedure costs about $82 in the country, and the President's Emergency Plan for AIDS Relief is providing funds so the procedure can be offered at no cost.
Rwanda earlier this year also launched a campaign to increase male circumcision. The campaign is focusing on providing the procedure to military personnel, police officers and students. The country's Ministry of Health also is increasing efforts to circumcise infants. In addition, Kenya has decided to offer circumcision to all men in the country, and public health officials are examining ways to implement a safe and cost-effective program that recognizes cultural issues. Private urologists across Eastern and Southern Africa have reported an increase in the number of men requesting the procedure.
Peter Cherutich, who is leading the Kenyan team designing the program, said male circumcision campaigns are an "appropriate strategy from a scientific and public health perspective." He added that the campaigns "must be reconciled with the deep culturally embedded issues that define the procedure as a rite of passage, for circumcising communities, and more so as a mark of identity for noncircumcising communities."
According to the Globe and Mail, about 30 different pieces of research suggested a correlation between male circumcision and lower rates of HIV by the end of the 1990s, but a randomized, controlled trial was not conducted until after 2000. Daniel Halperin, an HIV/AIDS researcher at Harvard University, said such a trial was delayed because the "tendency" in HIV research is "to look for biomedical, technological solutions." Halperin added that although "circumcision is biomedical, in Africa, it's always been a traditional ... practice, so it has not been on the radar."
HIV/AIDS researchers had assumed that the procedure would be rejected in many traditional cultures that did not practice circumcision. According to Halperin, the challenge to increasing circumcision on the continent is to increase the number of medical workers who can perform the procedure and to provide the equipment to safely perform "hundreds of thousands, possibly millions," of circumcisions during the next few years (Nolen, Globe and Mail, 3/27).
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Progress Toward Meeting MDG Targets Slow in Some Areas
[Mar 28, 2008]
Progress toward meeting some key targets in the United Nations Millennium Development Goals -- which include curbing the spread of diseases such as HIV/AIDS, tuberculosis and malaria -- has been slow, according to reviews of U.N. documents and interviews with officials conducted halfway to the MDG deadline of 2015, the AP/Straits Times reports. "We are slow" and progress has been "too little, generally," U.N. General Assembly President Srgjan Kerim said, adding, "Whether the glass is half empty or half full ... depends from which angle you regard it."
According to the AP/Times, there has been some progress with farming, education, economic and health programs in places such as Africa, Haiti, Nepal and Vietnam. However, some diplomats and officials say that for all eight MDG targets to be met, the pace of progress must be drastically improved. "We're achieving them in some countries, middle-income countries, but we're not achieving them in Africa," British U.N. Ambassador John Sawers said. He added, "And at the present rate of progress, we will not have achieved them by 2015."
According to the AP/Times, progress toward meeting the MDGs is hindered by high energy and food prices, low food stocks, increasing costs from droughts and floods related to climate change, and the faltering world economy. "The stakes are high because maintaining strong economic growth ... is essential to generating the necessary resources to achieve" the MDGs, according to documents from Kerim's office.
Kerim said that although the challenge of meeting MDG targets is large, it still is "doable." He added, "We say we have three million more children survive every year. But then we say, on the other hand, we still have 72 million children still not in school. We say there are two million people now who receive AIDS treatment. Then we say half of the developing world lacks basic sanitation, which is again a gate for diseases." Kerim at the beginning of April is convening the 192-nation General Assembly to examine ways of reaching the MDGs by the 2015 deadline. The MDGs were "adopted by all the world leaders, so there cannot be an excuse," he said, adding, "We are not an institute. We are not here to offer people studies. Studies they have more than enough of. We are here to give policy recommendations" (AP/Straits Times, 3/27).
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Cuban Group Aims To Reach Women With STI, HIV Prevention Messages
[Mar 28, 2008]
A group of women in Cuba's Pinar del Rio province has been operating a peer education program to raise awareness among other women about sexually transmitted infections, including HIV, the Inter Press Service reports. Cuba's Ministry of Public Health recorded 7,739 HIV/AIDS cases in the country as of October 2007. Although most cases of the disease occur among men, the proportion of women who are HIV-positive in Pinar del Rio is 29.2%, compared with 19% nationwide, the Inter Press Service reports.
The program, coordinated by the Provincial Centre for Prevention of STIs and HIV/AIDS' Women's Project, designs educational strategies for towns and villages in the province. It also trains advocates who promote responsible sexual behavior among the local population. The program aims to raise awareness among women about the risk of STI transmission, as well as their understanding of factors that make them vulnerable. The program also aims to help women develop social skills that enable them to communicate better with their male partners and to negotiate things such as condom use, the Inter Press Service reports.
Project coordinator Gilma Gomez said, "Women in our province have a high level of knowledge about the nature of HIV and AIDS, and the main STIs, but they are not aware of specific factors that make them vulnerable and put them at risk." She added that traditional gender relations, the "inequality of communication between spouses" and other factors "put women in Pinar at a disadvantage with respect to HIV." Gomez said the program aims for women "to feel comfortable in the learning environment, so we promote a family atmosphere." She added that the idea is not to provide pre-packaged knowledge but to encourage a debate "on what women want and need to know about their situation with respect to HIV, as sexual beings and as educational agents transmitting information to other generations, using completely participative methods."
Martha Bermudez, the program's provincial coordinator for the University of Older Adults, said, "Our work is to explain all the problems related to" HIV/AIDS and STI "prevention, and also how women can become health promoters in their homes and neighborhoods." She added, "One of our main commitments is to take this message home with us. We have to talk to our children and their friends when they get together in our houses, but also to our neighbors and other community members, not just the young people" (Acosta, Inter Press Service, 3/26).
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TB Cases Among HIV-Positive People in Jamaica Increasing
[Mar 28, 2008]
The number of tuberculosis cases among HIV-positive people in Jamaica is steadily increasing, according to statistics from the Ministry of Health released on Wednesday during a symposium at the country's National Chest Hospital, the Jamaica Gleaner reports. Terry Baker, a consultant pulmonologist at the National Chest Hospital, said that six out of every 10 people living with HIV in Jamaica do not know that they have the virus, meaning that there likely are "many more" people with TB who are not included in health ministry data. HIV-positive people are at an increased risk of TB, so it is "important for them to get tested," he said. The health ministry statistics indicate that most cases of HIV/TB coinfection occur in St. James parish. Baker said this could be the result of the high number of commercial sex workers in the Montego Bay area.
Although the total number of TB cases in Jamaica seems to have remained steady, the Pan American Health Organization estimates that there are more cases than the recoded number, Mikael Tulloch-Reid, a senior medical officer at the National Chest Hospital, said at the symposium (Jamaica Gleaner, 3/27).
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Recent Releases
Study Examines Global Fund Financing Methods
[Mar 28, 2008]
"The 'Diagonal' Approach to Global Fund Financing: A Cure for the Broader Malaise of Health Systems?" Globalization and Health: The study examines how the "polarization" between "vertical" financing, or funding disease-specific approaches, and "horizontal" financing, which aims to improve overall health systems, has "obscured" the prospects offered by "diagonal" financing, which aims to reach disease-specific targets through improved health systems. According to the study, the Global Fund To Fight AIDS, Tuberculosis and Malaria in April 2007 agreed to consider financing comprehensive country health programs, and the new International Health Partnership will help low-income nations to develop such programs. This "combination could lead" the Global Fund to a "much broader financing scope," the study says. It adds that a "transformation" of the Global Fund into a "Global Health Fund is feasible, but only if accompanied by a substantial increase of donor commitments." According to the study, the transformation of the Global Fund into a diagonal, and perhaps eventually horizontal, financer "should happen gradually and carefully and be accompanied by measures to safeguard its exceptional features" (Ooms et al., Globalization and Health, 3/25).
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