Kaiser Daily HIV/AIDS Report
'Campaign to End AIDS' Advocates Arrested During 'Die-In' Protest Outside White House
New Hampshire Public Radio Series Examines 'Building Wave' of Hepatitis C in State
Profit-Seeking in China's Health Care System 'Undermining' Government Efforts To Treat HIV-Positive Patients
PRI's 'The World' Profiles U.S.-Trained Ethiopian Resident Running 'Novel' HIV/AIDS Hotline
Public Health & Education
New York Times Examines Rapid HIV Testing, Debate Over OTC Use; Newsweek Profiles OraSure CEO, Oral HIV Test
Los Angeles Times Examines Research Surrounding Long-Term Effects of HIV on Brain Tissue
Politics and Policy
Aurobindo Receives Tentative FDA Approval To Produce Generic Oral Solution Version of Antiretroviral Epivir for PEPFAR
[Nov 08, 2005]
FDA on Friday granted tentative approval to Indian generic drug manufacturer Aurobindo Pharma to produce a generic version of GlaxoSmithKline's oral formulation of Epivir for inclusion in the President's Emergency Plan for AIDS Relief, Reuters reports. GSK's oral formulation of Epivir -- known generically as lamivudine -- is intended for use by HIV-positive children ages three months to 16 years in combination with other drugs (Reuters, 11/4). HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs to nations covered under PEPFAR. The expedited process is meant to encourage drug makers to produce generic medications to improve access to drugs in remote areas of severely affected countries and ensure the drugs' safety. The tentative approval designation means the generic drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements (Kaiser Daily HIV/AIDS Report, 7/11).
Across The Nation
'Campaign to End AIDS' Advocates Arrested During 'Die-In' Protest Outside White House
[Nov 08, 2005]
Twenty-nine HIV/AIDS advocates were arrested on Monday in front of the White House for protesting against the Bush administration's HIV/AIDS policies, the Associated Press reports (Associated Press, 11/7). The protest was organized by the Campaign to End AIDS, which earlier this month launched 10 caravans nationwide that held rallies in more than 100 cities. The caravans converged in Washington, D.C., on Saturday for "Four Days of Action to End AIDS," which included the March To End AIDS. C2EA is calling for a renewed commitment to the fight against the HIV/AIDS epidemic (Kaiser Daily HIV/AIDS Report, 11/7). Advocates on Monday "staged a peaceful 'die-in,'" in which they assembled a cemetery outside the White House by lying on the ground with tombstone-shaped signs reading, "Bush's war on AIDS," according to the Associated Press (Associated Press, 11/7). About 150 people stood across the street holding signs that read, "Stop Bush's War on AIDS," while chanting, "Bush is a jerk, condoms work," the AP/Washington Times reports (AP/Washington Times, 11/7). The protesters were arrested for demonstrating without a permit, a misdemeanor for which they received a citation that carries a $50 fine, according to U.S. Park Police Sgt. Scott Fear (Associated Press, 11/7). Twelve other advocates were arrested earlier in the day while protesting outside the offices of the Family Research Council (AP/Washington Times, 11/7).
New Hampshire Public Radio Series Examines 'Building Wave' of Hepatitis C in State
[Nov 08, 2005]
New Hampshire Public Radio's "NHPR News" last week aired a two-part series, titled "Hepatitis C: The Uncounted Disease," that examined a "building wave" of the disease that is hitting the state's health care system. NHPR requested from the New Hampshire Center for Public Policy Studies data on New Hampshire hospital discharges from 1996 to 2003. An analysis of the data found that the number of hospital visits by patients with hepatitis C increased an average of 24% annually and total hospital charges rose from less than $2 million annually to more than $17 million annually. New Hampshire is "one of only a handful of states" that does not track hepatitis C or require physicians to report newly diagnosed cases. The segment includes comments from Aydamir Alrakawi, a physician in the gastroenterology department at Dartmouth-Hitchcock Manchester; Tom Mock, director of ACORN, an HIV/AIDS counseling center in Lebanon, N.H.; New Hampshire state epidemiologist Jose Montero; and Gary Sobelson, president of the New Hampshire Medical Society (Greenberg, "NHPR News," NHPR, 11/2). A transcript of part one is available online. The complete segment is available online in Windows Media. N.H. Outreach 'Several Years Behind' Neighboring States
The second segment in the series examined how New Hampshire remains "several years behind its regional neighbors" in its hepatitis C outreach and early detection efforts. CDC estimates that the number of hepatitis C-related deaths will triple in the next decade, primarily because of infections that occurred 20 or 30 years ago. According to national statistics, 60% of new hepatitis C cases are transmitted through injection drug use. However, most of the large increase in hospital charges for patients with the disease in New Hampshire can be attributed to residents who received a blood product or transfusion before 1992, the first year that the blood supply was tested for the virus. Other states -- including Maine, Massachusetts and Rhode Island -- have launched public information campaigns to involve health care providers in identifying residents who might not be aware they are infected, while New Hampshire public health officials have focused their outreach and early detection strategies on injection drug users, HIV/AIDS clinics and prisons. The segment includes comments from Marie Gavin, a nurse who helps run the hepatitis program at the Manchester VA Medical Center; Paul Kuehnert, director of public health emergency preparedness for Maine; Paul Loberti, chief administrator of the Office of HIV/AIDS for the Rhode Island Department of Health; Montero; and Kevin O'Conner with CDC (Greenberg, "NHPR News," NHPR, 11/3). A transcript of part two is available online. The complete segment is available online in Windows Media. The complete table of New Hampshire hospital charge trends is available online.
Global Challenges
Profit-Seeking in China's Health Care System 'Undermining' Government Efforts To Treat HIV-Positive Patients
[Nov 08, 2005]
China's HIV/AIDS epidemic has "exposed how local profit-seeking" in the country's health care system is "undermining central government initiatives" to fight the disease, "reflect[ing] a broader crisis assailing the health care system," the Washington Post reports. Despite a program to provide no-cost antiretroviral drugs to HIV-positive people in China, patients are being forced to pay for their treatment because of a "relentless drive for profit within the Chinese health care system," according to the Post. Medical experts, government officials and patients say that Chinese doctors at local hospitals who are responsible for dispensing the antiretrovirals are "exploiting those in need, padding bills with unneeded drugs and dubious services," the Post reports. The government launched the antiretroviral drug program, which aims to supply 30,000 HIV-positive people with treatment by the end of 2005, using a $95 million grant from the Global Fund To Fight AIDS, Tuberculosis and Malaria. About 2,000 of the 19,000 patients who have received antiretrovirals through the program have stopped taking them because of side effects, including low blood pressure, insomnia and nausea, medical experts say. In addition, many doctors prefer to "prescribe expensive medicines than give away something for free," the Post reports (Goodman, Washington Post, 11/8).
PRI's 'The World' Profiles U.S.-Trained Ethiopian Resident Running 'Novel' HIV/AIDS Hotline
[Nov 08, 2005]
"The World" -- a co-production of BBC World Service, PRI and WGBH Boston -- on Monday profiled Sofnias Nega, a U.S.-trained Ethiopian who runs an HIV/AIDS telephone hotline in Addis Ababa, Ethiopia. Although such hotlines are "commonplace" in the U.S. and Europe, the idea is "novel" in Ethiopia, where approximately 1.5 million Ethiopians are estimated to be HIV-positive, PRI reports. Nega, who received his masters degree from the Johns Hopkins Bloomberg School of Public Health, manages a staff of 24 paid and volunteer counselors who field an average of 2,000 calls each day. The "pressures of the job are high," with counselors handling calls on topics ranging from suicide to the possibility of HIV transmission through infidelity, "but at least Ethiopians are now willing to discuss HIV and AIDS openly," according to PRI. The segment also includes an interview with Sister Benedict, a physician and mother superior of Sisters of Charity, which runs an HIV/AIDS clinic in Addis Ababa (Werman, "The World," PRI, 11/7).
 The complete segment is available online in Windows Media. A related slide show is available online.
Public Health & Education
New York Times Examines Rapid HIV Testing, Debate Over OTC Use; Newsweek Profiles OraSure CEO, Oral HIV Test
[Nov 08, 2005]
The New York Times on Saturday examined rapid HIV testing -- which has become the center of the U.S. strategy to prevent the disease and some say has "revolutionized" testing -- and the debate surrounding FDA's consideration of a proposal to allow over-the-counter access to the test. Prior to the approval of the two currently available rapid tests in 2002 and 2004, most federal programs focused on encouraging HIV-negative people to make behavioral changes to prevent HIV infection. With the availability of rapid testing, CDC is directing its prevention efforts at encouraging people to undergo HIV testing to determine their status early, before they spread the virus to others and when treatment is more effective, according to Ronald Valdiserri, acting director of CDC's National Center for HIV, STD and TB Prevention (Leland, New York Times, 11/5). An FDA advisory committee on Thursday heard testimony on a proposal to allow consumers to use OraSure Technologies' OraQuick Advance Rapid HIV 1/2 Antibody Test at home (Kaiser Daily HIV/AIDS Report, 11/4). Proponents of at-home HIV testing say it will reduce stigma and other obstacles to testing, and research shows people are less likely to spread the virus if they learn they are HIV-positive, the Times reports. Opponents of home testing say that along with the results, patients need education and counseling. FDA approved an at-home HIV test in 1996, but users mail a blood sample to a laboratory and access the results through a telephone hotline that has access to counselors (New York Times, 11/5). Newsweek Profiles OraSure CEO, OraQuick HIV Test
The Nov. 14 issue of Newsweek examined OraSure CEO Douglas Michels and the company's OraQuick test. FDA approved OraQuick for use in physicians' offices and laboratories in 2004 (Brant, Newsweek, 11/14). The test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the HIV result is negative, two appear if the result is positive (Kaiser Daily HIV/AIDS Report, 11/4). CDC has been purchasing OraQuick in bulk and distributing the test to clinics, and OraSure sells the test to developing countries for $5 each, or one-third of the price in the U.S. According to Newsweek, the percentage of people who obtain their test results has increased because of OraQuick. In New Jersey, for example, 34% of patients did not return for their test results with standard laboratory testing, which can take two weeks to return results. However, 100% of patients who were tested using OraQuick received their results (Newsweek, 11/14).
Science & Medicine
Los Angeles Times Examines Research Surrounding Long-Term Effects of HIV on Brain Tissue
[Nov 08, 2005]
The Los Angeles Times on Monday examined research into the long-term effects of HIV on brain tissue (Brink, Los Angeles Times, 11/7). A study published in October in the Proceedings of the National Academy of Sciences found that HIV can continue to damage some types of brain tissue even when patients are receiving highly active antiretroviral therapy. Paul Thompson, a researcher at the David Geffen School of Medicine at the University of California-Los Angeles, and colleagues from the University of Pittsburgh used a 3D magnetic resonance imaging technique on the brains of 26 people diagnosed with AIDS and 14 HIV-negative people. The researchers found that the brain tissue of AIDS patients was 10% to 15% thinner in regions that control movement, language and feeling than the brain tissue of HIV-positive patients who had not developed AIDS. The tissue loss shown in the brain imaging of the AIDS patients correlated with motor and cognitive defects that the patients showed in multiple brain function tests. The extent of the tissue loss seemed to be related to patients' CD4+ T cell counts. AIDS patients who were taking HAART had no significant difference in tissue loss compared with AIDS patients who were not taking the therapy. "A protective blood barrier prevents drugs from entering the brain, transforming it into a reservoir where HIV can multiply and attack cells unchecked," Thompson said. According to the study, some areas of the brain were not affected by HIV. At least two in five people living with HIV/AIDS are expected to experience HIV-related cognitive injury, ranging from minor impairments to dementia (Kaiser Daily HIV/AIDS Report, 10/12). Researchers are unsure "how great a problem looms," but "even mild to moderate" cognitive impairments among a large percentage of HIV-positive people could become a "public health issue," the Times reports. Related Study
The National Institute of Mental Health is sponsoring a long-term clinical trial of brain function in HIV-positive people that will eventually include about 1,600 participants. David Clifford, head of the Neurologic AIDS Research Consortium at the Washington University School of Medicine in St. Louis, said that preliminary findings of the study show that about half of the participants have "subnormal performance" indicated by a variety of symptoms, including impaired motor or cognitive abilities. Clifford said, "The biggest concern is that this is the tip of the iceberg. We should not be complacent about the brain in HIV" (Los Angeles Times, 11/7).
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