Kaisernetwork.org (Washington, DC)
25 July 2007
Global Challenges
Children Living With HIV/AIDS Need Access to Specialized Antiretrovirals, Treatment, Conference Delegate Says
[Jul 25, 2007]
Children living with HIV/AIDS in developing countries need access to specialized antiretroviral drugs and other treatments, Annette Sohn, an assistant professor at the University of California-San Francisco's pediatric infectious disease division, said on Wednesday at the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia, AFP/iafrica.com reports (Sands, AFP/iafrica.com, 7/25).
Delegates attending the conference, which ends on Wednesday, presented studies and discussed advances in HIV/AIDS prevention and treatment. The conference aims to improve understanding of HIV/AIDS, treatments for the disease and methods to prevent it from spreading worldwide (Kaiser Daily HIV/AIDS Report, 7/24).
According to Sohn, about 780,000 HIV-positive children worldwide need antiretroviral drugs but only 15% have access to them. Sohn urged pharmaceutical companies to focus on designing specialized antiretrovirals for children after a study -- which was conducted by NIH's National Institute of Allergy and Infectious Diseases and found that HIV-positive infants have a greater chance of survival if they are given immediate treatment -- was presented at the conference on Wednesday (AFP/iafrica.com, 7/25).
The NIAID study began in 2005 and was conducted in Cape Town and Soweto, South Africa. It examined 337 infants ages six to 12 weeks and initially aimed to determine whether early antiretroviral drug therapy over a limited time period would postpone HIV progression, Reuters reports. The study found that 96% of infants given immediate drug treatment were alive two years after birth, compared with 84% of the children given treatment later (Perry, Reuters, 7/24). An independent safety and monitoring board in London last month said that the study's results were so convincing that the study should be changed to allow all the infants to receive treatment and that the early results should be released (Foley, AP/South Florida Sun-Sentinel, 7/25).
Kevin De Cock, director of the HIV/AIDS Department at the World Health Organization, at the conference said the study is "obviously immensely important in its insight into pediatric treatment strategies," adding, "But the data will need to be looked at more before we really say what the implications are for treatment policy." Current WHO policy says that drugs should be administered only after children demonstrate signs of a weakening immune system. According to De Cock, "You can't scale up therapy or provide appropriate treatment to people if they don't know their HIV status." He added, "There's a need across the board to scale up HIV testing" (Foley, Associated Press 7/25).
Comments
"Children with HIV infection frequently show rapid disease progression within the first year of life due to their developing immune system and susceptibility to other serious infections," NIH Director Elias Zerhouni said Wednesday when releasing the study at the conference. He added, "This is the first randomized clinical trial that shows that infants treated before three months of age will do better than infants who have their treatment delayed."
Anthony Fauci, director of NIAID, said, "The results of this trial could have significant public health implications worldwide because these findings will cause experts to consider changes in standards of care in many parts of the world" (Reuters, 7/24).
Sohn on Wednesday said, "These findings have implications for guidelines on timing of antiretroviral therapy in early infancy and support the need for enhanced early diagnosis of infants and early effective transition into care." She added, "Research presented at this and other conferences have increasingly proven that we are waiting too long to treat HIV-positive children" in developing countries. According to Sohn, "Better generic pediatric antiretrovirals that are both potent enough to achieve sustained clinical and virological improvement and have limited long-term metabolic side effects are urgently needed."
Better diagnostic tools for health care workers working on pediatric HIV also are needed, Sohn added. "We are not identifying more HIV-positive women during pregnancy, and we lack the ability to diagnose their infants, so we don't know they're infected until they're already very sick," she said, adding, "By that time, it's often too late to prevent opportunistic infections and maximize the treatment benefits of antiretroviral therapy" (AFP/iafrica.com, 7/25).
Citric Juice, Microbicide Studies
Roger Short, a reproductive biologist at the University of Melbourne, at the conference Tuesday presented a study that found vaginal douching with citrus juice has no effect on the spread of sexually transmitted infections, including HIV, Australia's The Age reports (Leung, The Age, 7/24).
Short in 2002 told the Australian Broadcasting Corporation that a "few drops" of lemon or lime juice could protect women from HIV infection and unplanned pregnancies. He said he thought HIV, in addition to sperm, also might be affected by lemon juice because the virus is "extremely susceptible" to acidity. According to Short, laboratory tests, which did not include tests on humans or animals, indicated that the citrus juice killed HIV and sperm (Kaiser Daily HIV/AIDS Report, 10/11/02).
The recent study, conducted in collaboration with clinicians in the U.S. and Nigeria, examined the sexual health of almost 400 commercial sex workers in Jos, Nigeria. About one-fifth used lemon or lime juice to prevent STIs while the others did not. Tests for STIs -- including HIV, syphilis and hepatitis B and C -- found that there were no statistically significant differences in incidence between the groups, The Age reports. "Unfortunately, [lemon and lime juice] doesn't appear to have worked" in preventing STIs, Short said (The Age, 7/24).
Also at the conference, Jeremy Paull, a researcher at the Australian pharmaceutical company Starpharma, presented data from recent trials of an experimental microbicide, called VivaGel, that has been found to prevent the sexual transmission of HIV and genital herpes, the AAP/Sydney Morning Herald reports.
According to Paull, recent trials on animals have shown the gel to be between 85% and 100% effective at preventing the transmission of HIV and genital herpes. He added that the active ingredient in the gel is dendrimer, which is a molecule that binds to both viruses and prevents them from infecting healthy cells. Safety trials of the gel are under way among humans, the AAP/Morning Herald reports. According to Paull, the gel will be used by men who apply it before sex with women. Initial data presented at the conference indicate that the gel is safe and well-tolerated by healthy men whether or not they are circumcised (AAP/Sydney Morning Herald, 7/25).
In related news, conference delegates also discussed the risks people living with HIV/AIDS face as their lives are extended by the use of antiretrovirals, Business Day/AllAfrica.com reports. Physicians speaking at the conference warned that while HIV-positive people are living longer, they face a higher risk of age-related illnesses, including cardiovascular disease, osteoporosis and dementia (Kahn, Business Day/AllAfrica.com, 7/24).
Kaisernetwork.org serves as the official webcaster of the IAS conference. Individuals can sign up for a free daily update e-mail and find more information about conference webcasts online.
Video of the session that examines pediatric HIV/AIDS treatment is available online.
PBS' "The Charlie Rose Show" on Tuesday included a discussion about developments in HIV/AIDS research. Guests on the program included biochemist and Nobel Prize winner Paul Nurse; Seth Berkley, president and founder of the International AIDS Vaccine Initiative; Scott Hammer, a professor of medicine at Columbia University; Peter Kwong of the Vaccine Research Center at NIAID; and Judy Lieberman, director of the Division of AIDS at Harvard Medical School and senior investigator at the CBR Institute for Biomedical Research (Rose, "The Charlie Rose Show," PBS, 7/24) Video of the segment will be available online later this week.
BMS Launches New Approach to Expanding HIV Treatment Model
Bristol-Myers Squibb at the conference on Monday announced a new approach to expanding its Secure the Future initiative in developing countries. The new approach will replicate the initiative's HIV/AIDS treatment support programs in conjunction with governments, community groups and other funders. Secure the Future at the conference released a manual on establishing antiretroviral treatment programs that include community support to ensure that HIV-positive people receive assistance at home and in the community, as well as in clinics. The manual includes experiences from Botswana, Lesotho, Namibia, Swaziland and South Africa (BMS release, 7/23).
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Women in Papua New Guinea Being Tortured for Allegedly Practicing Witchcraft, Causing AIDS-Related Deaths
[Jul 25, 2007]
Some women in Papua New Guinea are being accused of practicing witchcraft to cause AIDS-related deaths among young people in the country, officials and researchers have said recently, AFP/France24 reports. A recent analysis released by the Centre for Independent Studies in Australia said, "Sorcery, witchcraft and other supernatural forces are widely blamed for causing HIV/AIDS" in Papua New Guinea. It added that "[a]ccusations of sorcery have resulted in torture and murder" of some women. Research fellow Miranda Tobias wrote in the analysis that there are "reports of women being tortured for days in efforts to extract confessions." Such forms of torture include being "beaten, stabbed, cut with knives, sexually assaulted and burnt with hot irons," Tobias wrote. According to the analysis, it is "estimated that there have been 500 such attacks in the past year."
Joe Kanekane of the Papua New Guinea Law and Justice Sector Secretariat said, "People believe a witch would behave in a certain way, would walk in a certain way," he said, adding, "That's all the basis that they have, and there's realistically no tangible substance to it." According to Kanekane, "They don't actually see the woman transform herself into a python or whatever it is (witches are reputedly capable of). Witchcraft is embedded in people's perceptions, embedded in their way of life."
Carol Kidu, Papua New Guinea's only female member of Parliament, said, "Sorcery permeates many societies in Papua New Guinea, and these young deaths from HIV/AIDS are unexplained, and so they attach it to sorcery, they make it witchcraft." Military doctor Roselyne Wia said the only way to stem this trend would be to "educate the village leaders and get the message down to the grassroots." According to a recent United Nations report, Papua New Guinea accounts for 90% of HIV cases in the Oceania region. High levels of sexual violence against women and inadequate access to sex education has contributed to the spread of the virus, according to the U.N. report. An estimated 60,000 people in the country were living with HIV in 2005 (Bartlett, AFP/France24, 7/23).
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Drug Access
WTO Announces That Rwanda Plans To Import Generic Antiretroviral From Canadian Drug Company
[Jul 25, 2007]
The World Trade Organization on Friday in a statement announced that Rwanda plans to override pharmaceutical patents and import 260,000 packs of Apo-triAvir, a generic HIV/AIDS medication made by the Toronto-based drug company Apotex, the New Times/AllAfrica.com reports. Apo-triAvir is a fixed-dose combination of the antiretroviral drugs nevirapine, lamivudine and zidovudine (Gahigana, New Times/AllAfrica.com, 7/22).
Under an August 2003 waiver to WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the "paragraph 6 system," developing countries with a public health crisis are allowed to import generic drugs when they cannot manufacture the drugs themselves, RNA/AllAfrica.com reports. According to WTO, Rwanda is the first country to use the waiver, which would allow it to import generic drugs that are manufactured under compulsory licenses in other countries (RNA/AllAfrica.com, 7/23). The TRIPS waiver submission was made last week by the Treatment and Research AIDS Centre. Rwanda plans to import the 260,000 packets during the next two years (New Times/AllAfrica.com, 7/22).
According to Reuters, Oxfam and other development campaigners have said that the TRIPS waiver is too burdensome because its reporting rules are cumbersome and it requires exporters of generic drugs to negotiate with patent holders for the right to sell the generic versions abroad.
Pascale Boulet, legal adviser for Medecins Sans Frontieres, said developing countries have been reluctant to use the waiver because of its difficult procedures. "It is important to keep in mind that this is just one shipment of one product for Rwanda," Boulet said. She added, "It is a system that works on a country-by-country and case-by-case basis. It may indeed respond to the needs of Rwanda for this specific medicine, but this is not a solution to the broader problem."
Celine Charveriat, head of advocacy for Oxfam, said that Rwanda's experience might determine the waiver's future. "We hope that Rwanda's action will lead to an increase in the number of poor people who can get antiretrovirals," Charveriat said, adding, "If found unworkable, the provision must be changed." WTO's 150 members have until December to ratify a decision to make the TRIPS waiver permanent, according to Reuters (MacInnis, Reuters, 7/20).
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Media & Society
HIV/AIDS Group Reacts to Pfizer's New Viagra Ad Campaign
[Jul 25, 2007]
The AIDS Healthcare Foundation has expressed concern over Pfizer's new television advertising campaign for its erectile dysfunction drug Viagra, Bloomberg/Arizona Republic reports. Pfizer on Monday launched the ad, which features a group of men in their 40s and 50s singing "Viva Viagra" to the tune of the Elvis Presley song "Viva Las Vegas," according to Bloomberg/Republic. Pfizer said the ad aims to make men less embarrassed about the condition. The ad, which premiered Monday during NBC's "Nightly News", will air during programs that have a 90% adult audience. Pfizer has not commented on how frequently the ad will run or how much it is spending on the campaign. "This disease is very stigmatized, and there are a lot of misperceptions," Ponni Subbiah, Pfizer's medical director for Viagra, said, adding, "Men are very willing to talk to their doctors about back pain or injuries but not ED."
Some advocacy groups and officials in the past have criticized Pfizer for its Viagra marketing methods. FDA in 2004 said that an ad featuring a man who grew devil horns while walking past a lingerie store was misleading and did not adequately warn of risks associated with the drug, and Pfizer had to withdraw the ad.
AHF earlier this year sued Pfizer for its Viagra marketing strategies (Bloomberg/Arizona Republic, 7/23). The lawsuit was filed in Los Angeles Superior Court against Pfizer for allegedly promoting recreational use of Viagra in ads. AHF said Pfizer's ads for the drug have increased risky sexual behavior, as well as cases of HIV and other sexually transmitted infections, among men. The suit asked that Pfizer stop running ads that promote Viagra as a lifestyle drug and that the company fund ads promoting awareness about the risks associated with Viagra and STIs. In addition, the suit asked that Pfizer forfeit profits gained from the ads and pay for AHF's costs of treating cases of HIV/AIDS and other STIs that it has linked to Viagra. AHF in December 2006 launched an ad campaign against Pfizer, saying the company's ads for Viagra promote recreational use. Pfizer at the time denied that the ads encourage recreational use of the drug and said that its advertising states that the drug does not protect against STIs (Kaiser Daily HIV/AIDS Report, 2/16). According to AHF President Michael Weinstein, the suit has been dismissed.
"Pfizer has been an outlier in shamelessly promoting Viagra as a party drug," Weinstein said, adding, "All those Sin City references, everything associated with Vegas, that is what they want the association to be. It's not about a medical condition; it's about performance anxiety." AHF has met with FDA in the past to discuss its concerns about Viagra, according to Weinstein.
Pfizer is examining new drug formulations and a possible nonprescription version of Viagra that could increase usage, according to Subbiah, who would not comment on specific research projects (Bloomberg/Arizona Republic, 7/23). AHF in February announced it will petition FDA to reject Pfizer's request to sell Viagra without a prescription (Kaiser Daily HIV/AIDS Report, 2/16).
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