Date: Tue, 5 Sep 1995 09:47:16 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC AIDS Daily Summary 09/05/95 AIDS Daily Summary September 5, 1995 The Centers for Disease Control and Prevention (CDC) National AIDS Clearinghouse makes available the following information as a public service only. Providing this information does not constitute endorsement by the CDC, the CDC Clearinghouse, or any other organization. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC Clearinghouse should be cited as the source of this information. Copyright 1995, Information, Inc., Bethesda, MD ************************************************************ "Roche Unit Seeks Approval of AIDS Drug" "Roche Suing Akzo over HIV Test Technology" "WHO Chief Warns of Women's Vulnerability to HIV" "Time to Legalize Syringe Sales?" "No Cover-Up Intended, Blood Official Says" "Lesbians Slip Through Health System Cracks--Expert" "Laos Launches AIDS Prevention Drive" "Bombay Blood Scandal Raises Question of Safety" "Smear Campaign" "AIDS Drugs by Mail" "FDA Announces Public Workshop and Advisory Subcommittee Meeting on Current Issues in AIDS Clinical Trials" ************************************************************ "Roche Unit Seeks Approval of AIDS Drug" Wall Street Journal (09/05/95) P. B2; Langreth, Robert Hoffmann-La Roche Inc., a division of the Swiss drug and chemical maker Roche Holding Ltd., has filed an application with the U.S. Food and Drug Administration (FDA) to market its protease inhibitor Invirase. In clinical tests, most patients taking Invirase in conjunction with other drugs did not develop viral resistance to the drug for at least one year. FDA officials have pledged to review Roche's submission within six months, an extremely rapid review. Other pharmaceutical companies, such as Merck & Co. and Abbott Laboratories, are in the early stages of testing their own protease therapies. "Roche Suing Akzo over HIV Test Technology" Investor's Business Daily (09/05/95) P. A30 Switzerland's Roche Holding AG has announced that it is suing Organon Teknika NV, a division of Dutch drug maker Akzo Nobel NV, because a diagnostic technology used for HIV detection allegedly violates an existing Roche patent. A company spokesman said that Organon Teknika's NASBA technology is "very similar" to Roche's PCR, or polymerase chain reaction. "We want the court to order them no longer to produce NASBA until questions are settled," the spokesman added. Akzo Nobel, however, claims that Roche's product is "essentially different" from the NASBA disease detection system. "WHO Chief Warns of Women's Vulnerability to HIV" Reuters (09/05/95); O'Neill, Mark According to the World Health Organization (WHO), women face the disheartening reality of being infected with HIV more rapidly than men, in part because of their economic dependence on males. "The bleak reality is that the sexual and economic subordination of women fuels the HIV/AIDS pandemic," WHO stated in its position paper at the Fourth United Nations World Conference on Women in Beijing. WHO said that by the year 2000, there will be 14 million HIV-infected women and about 4 million women will have died from the disease. "The number of infected women with HIV is increasing more rapidly than men in Africa, in southern Asia," noted WHO director-general Hiroshi Nakajima. It is essential, therefore, to provide women--particularly young women--with the skills and confidence to reject sex when they do not want it. Women at a grassroots forum near Beijing, however, said WHO was following the wrong methods to fight the disease. These women advocated the rapid development of microbicides that women could use to fight HIV, rather than relying on men to use condoms. "Time to Legalize Syringe Sales?" New York Times (09/05/95) P. A16 Encouraging evidence in the war against AIDS comes from a Connecticut study which shows that a small change in drug laws may significantly reduce the spread of HIV among injection drug users, write the editors of the New York Times. In 1992, Connecticut adopted laws which allowed pharmacists to sell and individuals to possess as many as 10 non-prescription needles at a time. New studies from the Centers for Disease Control and Prevention and the Connecticut Department of Health show that by 1993, more than 80 percent of the state's pharmacies were selling needles over the counter and more drug addicts were obtaining their needles from pharmacies than on the streets. In addition, the users report a nearly 40 drop in needle-sharing. These findings suggest, the editors say, that other states should consider changing their needle-selling and possession laws, which were originally designed to prevent drug abuse. Changing these laws appears to be a relatively cheap and effective way to fight AIDS, the editors conclude. "No Cover-Up Intended, Blood Official Says" Toronto Globe and Mail (09/01/95) P. A1; Nasrulla, Amber A senior member of the Canadian Blood Committee said on Thursday that the committee destroyed tapes and documents related to the country's blood supply as a matter of housekeeping, not because it was trying to cover up something. At the inquiry into Canada's tainted blood scandal--in which thousands of Canadians became infected with HIV and hepatitis C--Dr. Wayne Sullivan, the committee's former Nova Scotia representative, said the audio tapes were used only to accurately transcribe the minutes of the meetings, and that once they were approved, they were erased. However, Mr. Justice Horace Krever press asked Sullivan and two other former committee members to clarify their explanation. "You want me to believe that there is no connection between the decision to destroy this information and the realization that if you didn't destroy it, it might be available to someone who might resort to the freedom of information act?" he asked. "Lesbians Slip Through Health System Cracks--Expert" Reuters (09/01/95); O'Donnell, Lynne Western health care systems are missing lesbians, a U.S. expert said on Friday. "Lesbians are slipping through the cracks," said Ellie Emanuel of the University of Wisconsin at Stout's School of Education and Human Services. "Women think that if they don't have sex with men they don't have to worry about annual check-ups that would detect disease." At the Non-Governmental Organizations women's forum in a Beijing suburb, participants heard that lesbians often do not believe they are at risk for sexually transmitted diseases. "There is a growing recognition that women and lesbians are at risk of getting AIDS through sexual behavior and needle-sharing," said one Swedish participant. She estimated that more than 20 percent of lesbians in the United States had sex with a high-risk partner, and that between 1 and 2 percent of all women with AIDS were lesbians. Emanuel urged lesbians to be identified in the community and instructed about issues related to their personal health. "Laos Launches AIDS Prevention Drive" Reuters (09/01/95) Laos has launched a campaign to stem the spread of HIV in the Southeast Asian country, the United Nations (UN) reported on Friday. In a statement, the UN Development Program (UNDP) said that it had given the Lao Ministry of Health $252,000 for an 18-month campaign which will involve reorganization of the country's AIDS control body and the promotion of AIDS awareness. The UNDP also said, "Only 59 HIV positive cases, resulting in 10 AIDS deaths, have ever been reported in Laos," compared to significantly higher rates in such countries as Thailand, Burma, and Cambodia. "Bombay Blood Scandal Raises Question of Safety" Lancet (08/26/95) Vol. 346, No. 8974, P. 566; Kumar, Sanjay Recent reports of contaminated blood and alleged theft at the Red Cross Society Blood Bank in India have emphasized the issue of blood safety in the country. Media reports based on leaked documents claim that the blood bank provided at least 15 bags of HIV- or hepatitis B-contaminated blood to several Bombay hospitals between 1992 and 1994. Other documents reveal that hundreds of bags of blood missing in official reports during much of that time were "adjusted" in the monthly summaries. One bank official says that blood meant to be thrown out may have been stolen for sale. Those aware of the scandal are not surprised. "Hardly much has changed since the Fergusson report," says H.D. Shourie, director of the consumer rights group Common Cause, referring to the 1990 health ministry study on the blood banking system. The Indian Health Organization, which has taken up several issues raised by the scandal, reports that more than half of the country's blood supply is not screened for HIV, and that 75 percent of the World Bank's $84.5 million loan to fight AIDS has not been spent over the last three years. "Smear Campaign" POZ (08/95-09/95) No. 9, P. 83; Horn, Tim For people with HIV, particularly women, yeast infections can be recurrent problems and are frequently associated with disease progression. A yeast infection often found in HIV-infected people is thrush, or candidiasis, which often manifests itself in the mouth, esophagus, digestive tract, and vagina. Risa Denenberg, a family nurse practitioner who specializes in the care of HIV-positive women, says, "Cultures, or smears, should be obtained during regular six-month checkups." Denenberg also warns that the yeast infections "can often be obscured by the symptoms of HIV infection." There are several treatments to chose from, including Monistat-7, Gyne-Lotrimin, and Femstat. Oral treatments, such as fluconazole and ketaconazole are also available for the treatment of recurrent or severe yeast infections. In addition, it is important to distinguish whether repeated yeast infections are individual recurring infections, or if they treatment failures--which Denenberg says occurs when an infection fails to clear after a full seven-day course of treatment. Preventative measures that may reduce the likelihood of new infections include low-dose oral antifungal drugs, reduced sugar intake, and the consumption of yogurt containing Lactobacillus acidophilus. "AIDS Drugs by Mail" Pharmaceutical Representative (09/95) Vol. 25, No. 9, P. 4 A new mail-order pharmacy will provide low-cost medications to AIDS patients within 24 to 48 hours of ordering. MedExpress, which was recently introduced by the National Association of People with AIDS, will offer all medications approved by the Food and Drug Administration, as well as nutrients and supplements. The service will also assign each patient a "member advocate," who will provide data on prescription interactions and side effects, stress management, and nutrition. "FDA Announces Public Workshop and Advisory Subcommittee Meeting on Current Issues in AIDS Clinical Trials" U.S. Centers for Disease Control and Prevention () The U.S. Food and Drug Administration is holding a public workshop on current issues in HIV clinical trials on Sept. 6 and 7, 1995. At the workshop--to which registration is required--members of the industry and the public will be able to discuss issues regarding the design and conduct of clinical trials of drugs for the treatment of HIV, as well as propose strategies for overcoming known obstacles. A major challenge to developers of HIV treatments is the successful design and conduct of clinical confirmatory trials, which are needed to provide the data used to confirm the clinical benefit of drugs that have received accelerated approval. The workshop will be followed by a joint meeting on Sept. 9 of subcommittees of the Antiviral Drugs Advisory Committee and the National Task Force on AIDS Drug Development. The subcommittees will hear summary presentations from the workshop, and will discuss recommendations on the scientific design of future HIV clinical trials. For more information, call the AIDS Clinical Trial Information Service at (800) 874-2572.