Subject: CDC AIDS Daily Summary for Date: Wed Oct 3 11:31:01 PDT 2001 (327 lines) From: National AIDS Info Clearinghouse Copyright 2001, Information, Inc., Bethesda, MD The CDC National Center for HIV, STD and TB Prevention provides the following information as a public service only. Providing synopses of key scientific articles and lay media reports on HIV/AIDS, other sexually transmitted diseases and tuberculosis does not constitute CDC endorsement. This daily update also includes information from CDC and other government agencies, such as background on Morbidity and Mortality Weekly Report (MMWR) articles, fact sheets, press releases and announcements. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC HIV/STD/TB Prevention News Update should be cited as the source of the information. Contact the sources of the articles abstracted below for full texts of the articles. HEADLINES NATIONAL NEWS "FDA Panel to Vote on AIDS Drug" "Health Department Director Explains Grant Loss" "San Francisco Bans Filters in Libraries" INTERNATIONAL NEWS "Baby Born via Artificial Insemination Using Sperm of HIV- Positive Man" "South African Firm Begins Marketing AIDS 'Nutritional Supplement'" MEDICAL NEWS "Duke University Researchers Study Topical HIV Killing Compounds" EDITORIALS AND COMMENTARY "Caring for HIV Patients" NEWS BRIEFS "Mariners Notebook: Guillen Surgery a Setback" "Angola -Around 3.5 Percent of Population Suffers from AIDS" "Government Report -Richmond City Council" ************************************************************ NATIONAL NEWS ************************************************************ "FDA Panel to Vote on AIDS Drug" San Francisco Chronicle (10.03.01)::Tom Abate Today, a Food and Drug Administration (FDA) advisory panel will vote on whether to recommend approval of an AIDS drug for patients who have become resistant to other medicines. If the vote is favorable, as is expected, the FDA will also decide whether the new treatment will be a last resort drug or one sanctioned for use in early stages of the disease. The FDA usually follows the advice of its advisory committee, making the vote today one that may lift the last hurdle facing Gilead Sciences' AIDS drug Viread. Trading in Gilead shares was halted yesterday after the FDA posted a staff report so favorable that it suggested the real question was whether the drug would be a last resort or first-line AIDS treatment. Gilead hopes to have Viread on the market in November. "We're asking that it be labeled for all HIV infections," said Carol Brosgart, Gilead's vice president for clinical affairs. In support of Gilead, San Francisco's Project Inform's Martin Delaney said, "I'll be damned if we sit there and let them produce a narrow-label indication. This may well be the least toxic AIDS drug yet studied." In its largest study to date, Gilead tested Viread on HIV- positive patients who had been taking other AIDS drugs for at least five years. A majority of these patients were beginning to develop resistance to the medications. Their viral load was increasing and their CD-4 cell counts were declining, signs of immune system failure. The FDA staff report leaves little doubt that Viread reduced viral load by about 75 percent. Gilead's testing "provides clear evidence of [Viread's] antiviral activity," the report said. The FDA is expected to make a final decision on Viread by Nov. 1. If it decides that Viread should only be used as a last resort, Gilead is prepared to submit new studies to support its case for early use. "Health Department Director Explains Grant Loss" Associated Press (10.02.01) The director of the Arkansas Health Department said on Monday that the state missed out an a $725,760 grant to help AIDS patients because officials misunderstood federal grant law. The grant would have provided backup funding for medicines provided by pharmaceutical companies to about 100 patients in a state program. Dr. Fay Boozman said the companies could stop providing the medicines because of the declining economy. The controversy began when the Health Department filed away a July 20 letter from federal authorities notifying the state that its grant application had been denied and setting a July 29 deadline for a state response. But that deadline came and went without key state employees knowing that the letter had arrived. The letter's handling led to questions about whether the department was being run competently. There have also been accusations that federal officials applied federal rules unfairly, denying Arkansas' application while approving grants from other states in similar situations. Boozman, however, said this was not the case: "They did it uniformly." Arkansas was one of three states whose applications were not approved. To compensate for the missed money, Arkansas will use about $250,000 this fiscal year and a comparable amount next fiscal year, with the money coming from Gov. Mike Huckabee's portion of the state General Improvement Fund legislation. The Legislature also recommended $100,000 from its portion of that fund for the AIDS program, but whether revenue will be available for the allocation is uncertain, Boozman said. The missed money has caused disputes between legislators and the Huckabee administration. "San Francisco Bans Filters in Libraries" CNET.com (10.02.01)::Gwendolyn Mariano San Francisco officials have voted to ban Internet filters on computers in local public libraries, risking the loss of some $20,000 in federal funds. The San Francisco Board of Supervisors voted Monday unanimously to prohibit filters on city-owned computers used by the public, excluding Internet terminals designated exclusively for individuals under age 13. The ban rejects regulations governing federal funding of schools and libraries enacted last year under the Children's Internet Protection Act (CHIPA). The law requires schools and libraries to filter Web content or forgo federal funding. "There is no technology yet that can differentiate between what is harmful and what is not," said Supervisor Mark Leno, who sponsored the ordinance. "It's more important that the library along with parents teach our children how to use the Internet responsibly, and there's no filtering device that can substitute for that," he added. Leno maintains that filters would block information related to many health-related issues, such as breast cancer, AIDS, anorexia and sexuality. Maria Schneider, spokeswoman for the San Francisco Library, said the legislation passed by the board supports the library's current policy, which is not to use filters on public Internet terminals. ************************************************************ INTERNATIONAL NEWS ************************************************************ "Baby Born via Artificial Insemination Using Sperm of HIV- Positive Man" Agence France Presse (10.02.01) A Japanese woman has given birth via artificial insemination using sperm from her HIV-positive husband, with both mother and child confirmed infection-free, doctors said Tuesday. It was the first successful birth using HIV-infected sperm in Japan, according to Tasuku Harada, a gynecologist and lecturer at the medical department of Tottori University in Tottori. "Both the mother and baby have tested negative for the virus," he said. Harada, who led a team of doctors in the case, said he was aware of 250 babies born in Italy and several more in Spain through the same method. The mother, in her 20s, gave birth to the child at the university's hospital over the summer. Her husband, also in his 20s, is a hemophiliac who became infected with HIV after receiving contaminated blood products. Many hemophiliacs in Japan were infected with HIV between the late 1970s and mid-1980s after receiving transfusions of contaminated blood products. Doctors placed the husband's HIV-positive sperm into a centrifuge to separate the sperm from the virus. The sperm was then subjected to a "swim-up" method in which doctors remove only active sperm to further filter out the HIV virus. "According to one study, all but one of 4,000 copies of the virus may be removed through this method," Harada said. The sperm-rinsing procedure is widely available in Japan but there are few places to check if the rinsed sperm is virus-free. As of June 24, 2001, the Japanese health ministry had reports of 7,680 cases of full-blown AIDS or HIV-positive patients. This figure includes 1,432 people infected through contaminated blood products. At least 1,225 people have died of the disease. "South African Firm Begins Marketing AIDS 'Nutritional Supplement'" Associated Press (10.02.01)::Ravi Nessman A South African company is testing a nutritional supplement purported to help combat the effects of AIDS. Officials at Enerkom, a subsidiary of the government's Central Energy Fund, said they are running Phase II trials of Enerkom's supplement Oxihumate at a Tanzanian military hospital but that only a few of the participants are soldiers. Some scientists frown on the practice of using soldiers to test medicine because of the possibility that soldiers can be coerced to participate. The announcement of the study marks the second time this year that a South African company has reported testing AIDS drugs on soldiers in Tanzania. Oxihumate, derived from coal, boosts the immune system, fights inflammation and can help reduce the effects of AIDS, said Tony Surridge, acting CEO of Enerkom. The drug has been approved as a nutritional supplement, meaning no medical benefits have been proven and the company is prohibited from making medical claims about it, said Theo van de Venter, director of food control for South Africa's health department. Scientists running the trials emphasized that all 350 HIV-positive people in the Tanzania study gave informed consent, and most of them are civilians being treated at the military hospital. News reports on Oxihumate have harkened back to South Africa's Virodene scandal, when government officials put pressure on the country's Medicines Control Council to approve a locally developed AIDS drug. The council rejected Virodene, which is made from a toxic industrial solvent. Earlier this year, the Wall Street Journal reported that the company that owns Virodene was testing it in a military hospital in Tanzania. ************************************************************ MEDICAL NEWS ************************************************************ "Duke University Researchers Study Topical HIV Killing Compounds" Associated Press (09.25.01) A researcher at Duke University is addressing important unanswered questions about the use of topical microbicides intravaginally to prevent the sexual transmission of HIV. With a team of biomedical engineers, Dr. David Katz is studying crucial issues of whether candidate topical microbicides would reach the right tissues, adhere to them and remain in place over time. The hope is that women could someday shield themselves by applying such topical virus-killing chemicals in the vagina. But "objective, effective standards for evaluation of such proposed formulations do not yet exist," Katz said. The CDC estimates that between 120,000 and 160,000 adult and adolescent females in the United States now have HIV infections, rates that have increased over the last decade. Most were infected by heterosexual exposure to HIV. Katz's microbicide research is supported by multiple grants. These include funds from the Food and Drug Administration's Office of Women's Health and the Contraceptive Research and Development Program (a non-profit organization supported by the US Agency for International Development); as well as funds from the Gates Foundation; a $2.3 million grant from the National Institutes of Health; and a $90,000 award from the American Foundation for AIDS Research. Katz holds both the Nello L. Teer Jr. Professorship in Biomedical Engineering in Duke's Pratt School of Engineering and a professorship in the medical school's Department of Obstetrics and Gynecology. The research seeks to develop a base of knowledge about candidate topical microbicides by measuring candidate chemicals' viscosity and surface tension, and experimentally testing how they flow and adhere to surfaces similar to those in the vagina. Human studies are also being conducted with microbicide formulations in the vagina through a Duke Medical Center clinic using an endoscope-like instrument. This measures the coating of tissue surfaces and detects bare spots that might be particularly vulnerable to infection. "We plan to compare the results of our studies in the laboratory with the measurements of formulation deployment in women in the clinic. Our goal here is to develop understanding and confidence in the accuracy of our laboratory methods to predict features of microbicide deployment that occur in women in the body," Katz said. ************************************************************ EDITORIALS AND COMMENTARY ************************************************************ "Caring for HIV Patients" San Francisco Chronicle (10.03.01) "If it's true that a society is judged by how it cares for the elderly, the sick and the poor, the state's reputation for charity and compassion will be greatly impaired if a health care bill for HIV patients dies on the governor's desk. That's where AB937 has languished since leaving the floor of the Legislature on Sept. 13. Gov. Gray Davis has until Oct. 14 to sign the measure, which aims to guarantee reasonable care for HIV patients by providing reasonable pay for the doctors who treat them. "We receive more and more complaints from HIV patients and skilled HIV specialists about the lack of timely access, referrals and low reimbursement rates that nearly have bankrupted the limited number of California physicians who continue to treat HIV/AIDS patients," said author Assemblyman Paul Koretz (D-West Hollywood). "Among other things, the bill would require HMOs to reimburse HIV specialists at a rates that doesn't restrict patient's access to care. The bill would also require Medi-Cal to develop risk-adjusted rates for HIV treatment similar to the one it has for AIDS care. "As is, most HMOs use a 'capitation' scheme to pay doctors about $80 a month per HIV patient to cover the cost of specialists, emergency room and hospital care, and sometimes prescription drugs. Consequently, patients often go without care because fewer and fewer doctors can afford to serve them. "Predictably, the insurance lobby opposing the bill has been loud and strong, vehemently rejecting any option requiring the industry to increase payments. But AB937 is a no-nonsense, life-and-death measure of both our humanity and our commitment to fight this dreaded disease. Davis should sign the measure, which cleared both houses of the Legislature by wide margins." ************************************************************ NEWS BRIEFS ************************************************************ "Mariners Notebook: Guillen Surgery a Setback" Seattle Post-Intelligencer (10.03.01)::John Hickey Carlos Guillen's medical odyssey took another turn yesterday when the Seattle Mariners' shortstop underwent surgery to correct bleeding in his lung. The problem is thought to be an offshoot of the tuberculosis that sent Guillen to the hospital on Friday. In the operation, an artificial clot was inserted to control bleeding in the lung. Though the surgery was described as minor, it reinforces the probability that Guillen will miss the first round of playoffs. The original prognosis was for him to return to the field after a week. "We don't know anything until we get home," said Manager Lou Piniella. "Angola -Around 3.5 Percent of Population Suffers from AIDS" BBC (10.02.01) According to figures released at a recent national meeting on AIDS, about 3.5 percent of Angola's population of approximately 12 million have AIDS. Pregnant women and people with TB are the sectors of society at highest risk. The country's hardest-hit areas are border regions. "Government Report -Richmond City Council" Times-Dispatch (Richmond, Va.) (10.03.01) Among other actions taken at its Sept. 24 meeting, the Richmond City Council authorized $33,000 from the Virginia Commonwealth University Central Virginia HIV Care Consortium for the purpose of improving identification of persons who are at risk for or infected with HIV and other STDs; prompt identification of partners of HIV-infected persons; and improving the entry of persons with HIV into comprehensive HIV treatment programs.