Date: Mon, 12 Sep 1994 09:13:35 -0400 (EDT) From: "ANNE WILSON, CDC NAC" AIDS Daily Summary September 12, 1994 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 1994, Information, Inc., Bethesda, MD ************************************************************ "F.D.A. Debate on Speedy Access to AIDS Drugs is Reopening" "Credibility of Red Cross Doubted" "Africans Try to Break Silence on AIDS Even as Ailment Consumes Their Continent" "Women Suffer Most From AIDS, Conference Told" "Vatican Takes Low-Key Position on Contraceptives" "Bob Nelson Appointed Director of Public Policy and Advocacy for Catholic Charities" "AIDS: $35 Million in Carrots and Sticks" "HIV, TB Present Deadly Combination" "Directly Observed Therapy for Tuberculosis in New York City" ************************************************************ "F.D.A. Debate on Speedy Access to AIDS Drugs is Reopening" New York Times (09/12/94) P. A13; Kolata, Gina Three years ago, prodded by AIDS advocates, the FDA relaxed its approval process for new AIDS drugs so that they could enter the market faster. Although many researchers thought it unwise to waive the requirement that the drug be clinically proven, the FDA decision quickly resulted in available drugs, as the advocates had hoped. Now, some of these advocates say the policy is not working because testing is so inadequate that no one can tell if the drugs work. Other advocates urge that no unnecessary hurdles be imposed on new drugs, as efforts for change threaten hard-won past victories. All agree that the issue is timely because drug companies are starting studies on a new class of AIDS drugs known as protease inhibitors. The FDA will hold a meeting on Monday and Tuesday to allow researchers, statisticians, advocates, and drug companies to express their opinions, but the agency says it will not make a decision at the meeting. Accelerated approval of AIDS drugs allows the treatments to reach the patient faster, but critics say that definitive follow-up studies have never been done on the drugs. Others want the current policy to remain in effect but want the FDA to enforce adequate follow-up studies by the drug companies. "Credibility of Red Cross Doubted" Globe and Mail (09/08/94) P. A7; Picard, Andre Groups representing Canadian users of blood products say that the Canadian Red Cross has no place building a $150-million blood fractionation plant, if it cannot meet the U.S. and Canadian blood collection standards. "Fractionation is a highly technical and scientific operation and plants must adhere to the most stringent standards," says Derhane Wong-Rieger, president of the Canadian Hemophilia Society. The FDA has blocked shipments of some Canadian plasma to the United States for treatment after finding 19 violations of U.S. regulations at a Toronto transfusion center including inadequate screening of donors, mislabeling of blood units, sloppy record keeping, and poor quarantine methods for untested plasma. "Africans Try to Break Silence on AIDS Even as Ailment Consumes Their Continent" Los Angeles Times (09/11/94) P. A20; Dadson, Amba In Africa, where 10 million of the world's 16 million HIV infection cases have occurred, silence is helping the disease to spread. Many Africans cannot bring themselves to discuss AIDS because of powerful social forces, such as modesty and shame, which also keeps them from seeing their doctors. Now, in Ivory Coast, an almost unheard support group called "The Friends Club" has formed to break the silence and to offer hope to those infected with HIV. The meetings, drawing 35 to 40 people, are upbeat and positive and include honest conversations on all aspects of the disease. Ivory Coast is West Africa's most affected country, with over 18,000 documented cases of AIDS. "Women Suffer Most From AIDS, Conference Told" Reuters (09/09/94); Eltahawy, Mona AIDS activists accused the U.N. population conference on Friday of ignoring the increasingly devastating effect the disease is having on women around the globe. Women activists also told a non-governmental organizations panel discussion that family planning programs do not adequately inform women about ways to protect themselves from sexually transmitted diseases. International health organizations report that HIV is spreading faster among women than men, so far infecting over 7 million women worldwide. Elizabeth Reid, director of the HIV and Development Program of the United Nations Development Program, said than women in many traditional societies are unable to protect themselves from infection because they don't have the power to demand that their husbands practice safe sex. Simone Diniz, co-founder of a women's health collective in Brazil, said that family planning programs, "need to redefine their role, permitting themselves to further women's awareness and empowerment based on the understanding of who decides how, why, and when to have sexual intercourse." Diniz said many women partaking in family planning programs use the pill or implants--as opposed to condoms--because such choices don't involve the husbands' role in the decision. "Vatican Takes Low-Key Position on Contraceptives" Reuters (09/11/94); Pullella, Philip Although the Vatican assumed a low-key position on contraceptives at the U.N. population conference in Cairo, the Catholic Church says this does not indicate a change in its position prohibiting them. Vatican observers were surprised that, in pre-conference meetings, language that promoted condoms was not modified or formally contested. Holy See delegates said that their position had not changed, but that they had agreed to not block discussion by contesting the language. The delegates also said that they were putting contraceptive issues aside so that they could focus on its fight against abortion. "Bob Nelson Appointed Director of Public Policy and Advocacy for Catholic Charities" Business Wire (09/09/94) Catholic Charities of the Archdiocese of San Francisco announced the appointment of Bob Nelson as director of Public Policy and Advocacy in San Mateo, Marin, and San Francisco counties. Nelson has been at Catholic Charities for over seven years, most recently as manager of HIV Direct Services. He also sits on the Ryan White CARE Council, the Mayor and Board of Supervisors' Joint Task Force on HIV, and the National HIV Housing Coalition Board of Directors. "AIDS: $35 Million in Carrots and Sticks" U.S. News & World Report (09/12/94) Vol. 117, No. 10, P. 25 Although the U.S. government has put billions of dollars into AIDS research during the past decade, some critics claim these research dollars were imprudently spent. Last week, NIH, the nation's largest funder of AIDS research, announced a program that would fund research on highly experimental treatments. By 1998, NIH will give $35 million in grants to scientists and researchers under the condition that within two years of obtaining the grant, they start testing a new treatment in patients. If this provision is not met, the recipient will lose the grant. The NIH program has been well received by both industry representatives and AIDS activists. "HIV, TB Present Deadly Combination" American Medical News (09/05/94) Vol. 37, No. 33, P. 33; Pinkney, Deborah Shelton Experts at the 10th International Conference on AIDS warned that AIDS and TB could kill up to 15 million people during the next few years. Asia, which accounts for two-thirds of the world's TB cases, has an even bleaker outlook because it has experienced a large increase in HIV cases in the past year. Almost a third of the world's population is already infected with the TB bacilli, though most will never become sick, explained Arata Kochi of the World Health Organization." HIV-infected persons, however, are more likely to get sick with TB than individuals who are not HIV-infected. Those who go untreated can spread TB to 10 or 20 others within a year. "With over 50 percent of the adults infected with TB in many Asian countries, there is no end in sight for how bad the co-epidemic can get in Asia," said Kochi. "Directly Observed Therapy for Tuberculosis in New York City" Journal of the American Medical Association (08/10/94) Vol. 272, No. 6, P. 435; Klein, Susan J.; DiFerdinando Jr., George T.; Naizby, Brenda E. et. al. In a letter to the editors of the Journal of the American Medical Association, Drs. Klein, DeFerdinando, and Naizby address a previously published study conducted by Bloch et al. on drug-resistant tuberculosis and the current TB epidemic in New York City. Klein et al. call to attention the New York State Department of Health's directly observed therapy (DOT) treatment for TB patients, which involves offering anti-TB medications at various locations across New York City, minimizing access barriers to those infected. Bloch et al. respond by congratulating New York City's public and private health care providers and their success with TB patients over the last two years with the DOT program. "The use of DOT in NYC was not the only intervention," they caution. Bloch and his colleagues stress that DOT was part of an individualized patient treatment plan that also provided "accessible services, a reliable source of medication, treatment in a variety of settings, and social services, and an integrated system of follow-up." They summarize that "available evidence supports the recommendation that DOT be considered ... as part of optimal TB patient treatment."