Date: Fri, 13 May 1994 10:05:59 -0400 (EDT) From: "ANNE WILSON, CDC NAC" AIDS Daily Summary May 13, 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 "AIDS Coordinator" Associated Press (05/13/94); Recer, Paul The AIDS Coalition to Unleash Power (ACT-UP) and the National Association of People with AIDS are asking for the resignation of the White House's AIDS policy coordinator, but Kristine Gebbie says she has no intentions of relinquishing her position. "I'm not leaving," she stated. "I've got work to do." And she says she has President Clinton's support to do it. John Gurrola, a spokesman for Gebbie, was surprised by the campaign for the AIDS czar's resignation. He released a letter sent to Gebbie on April 29 that was signed by 10 national AIDS organizations, who praised her for "beginning a comprehensive HIV-AIDS planning process at the federal level." William J. Freeman, executive director of the National Association of People with AIDS, said his group supported Gebbie and worked hard with her for the past nine months. "But now we believe she is incapable of marshaling the support at the federal level," he explained. ACT-UP, which did not sign the April 29 correspondence, has opposed Gebbie since she assumed her position last August, according to Wayne Turner and Steve Michael, both of ACT-UP. The federal AIDS coordinator's job has "no power," and Gebbie "doesn't have the personality to make it something," Turner said. "Genelabs Reports Development Progress for AIDS Drug GLQ223 at Annual Shareholders' Meeting" Business Wire (05/12/94) Genelabs Technologies Inc., a worldwide biopharmaceutical and diagnostic company, has completed an analysis of data from a Phase II clinical trial of GLQ223, or alpha-trichosanthin, for treatment of patients with AIDS or AIDS Related Complex (ARC). The report says that previously reported findings, which were based on a primary endpoint that depended heavily on decreases in CD4 positive lymphocytes, were subjected to interference by the use of steroids that were prescribed to control the side effects of GLQ223. "Steroids are known to cause temporary drops in lymphocyte counts," explains Dr. Kenneth J. Gorelick, vice president of medical and regulatory affairs at Genelabs. "When steroid use is taken into account in the statistical analysis, GLQ223 shows encouraging evidence of drug activity in this study population." The company is informing the Food and Drug Administration of the findings, and will submit the complete study analysis to a peer-reviewed journal for publication. "We believe the results demonstrate that GLQ223 merits further evaluation to confirm these findings," says Irene Chow, Ph.D., president of the Genelabs biopharmaceutical division. "HemaCare Reports First-Quarter Results; Awaits Phase III Clinical Trial Approval on Experimental HIV/AIDS Treatment; Commences Stem Cell Rescue Program" Business Wire (05/12/94) Although HemaCare Corp.'s core blood products and service operations saw a profit in the first quarter of the year, the company's expenses associated with research and development of Immupath--its experimental treatment for AIDS--produced a loss. Immupath is a biopharmaceutical which borrows from the principle of passive hyperimmune therapy. HemaCare collects human plasma, rich in numerous anti-HIV antibodies, and infuses it into AIDS patients who can no longer produce enough antibodies to fight off the virus. Since 1990, HemaCare has been involved in a Phase I/II clinical trial to establish the safety and efficacy of the product. Results of that study showed that Immupath improved immune competence as measured by CD4 cell counts, and improved survival among certain patient groups. The company is currently awaiting approval from the Food and Drug Administration to conduct a Phase III clinical trial involving about 600 patients to determine long-term efficacy and safety of Immupath. "Baxter Receives FDA License to Market Solvent/Detergent-Treated Gammagard S/D" Business Wire (05/12/94) Baxter Healthcare Corp. of Glendale, Calif., says the U.S. Food and Drug Administration has licensed its Hyland division to market solvent/detergent-treated Gammagard S/D, Immune Globulin Intravenous, in the United States. Better known as "IGIV," the product is generally used to treat patients with life-threatening immune disorders, including HIV. In vitro studies suggest that the solvent-detergent purification process inactivated lipid-enveloped RNA viruses such as HIV types 1 and 2, Sindbis virus, and vesicular stomatitis virus. This viral inactivation procedure is used in conjunction with other plasma-derived products, and there have been no reports of HIV or hepatitis transmission in conjunction with the use of this product over a seven-year period. "Bill for AIDS "Manhattan Project" to Be Introduced" Reuters (05/10/94); Michael, Christopher The AIDS Cure Act, legislation that would authorize a "Manhattan Project" for AIDS research, is finally being introduced in Congress. "It's time to put a stop to the business-as-usual attitude toward finding a cure for AIDS," says Rep. Jerrold Nadler, who is pushing the measure. "The goal of the AIDS Cure Project is to recreate" the Manhattan Project, in which scientists collaborated in an intense, concerted effort during World War II to develop the atom bomb. As a campaign promise, President Clinton had vowed to authorize such a program. "My bill is an effort to remind him of that promise," says Nadler, "and to keep him to his word." The legislation would establish an agency independent of the National Institutes of Health, which currently coordinates most of the government's AIDS research. "The NIH has developed a certain stodginess," Nadler remarks. "The idea of the AIDS Cure Act is that every pathway of research is worth funding." Because it would provide "eminent domain," or the power of the government to assume the right to release promising treatments that patent holders refuse to discuss, Nadler says the bill would address the greatly criticized "profit-motive" in AIDS research. Activists say the "profit-motive" prevents potentially successful, but not profitable, treatments from being studied or released. "AIDS Patients on Life and Death" New York Times (05/13/94) P. C28; Holden, Stephen Of the many films surfacing that focus on people with AIDS, Juan Botas and Lucas Platt's "One Foot on a Banana Peel, the Other Foot in the Grave," is one documentary that approaches the issue with a stunning intimacy like no other. The film records the conversations of a group of male AIDS patients in their doctor's office, where they meet regularly to receive intravenous medication. Unlike other documentaries on AIDS, "One Foot," does not remain upbeat among the tragic circumstances. Botas, a well-known graphic designer, died of AIDS in August 1992, just three months after starting the film. "Medical Briefs: HIV Vaccine Enters Trial Phase" Advocate (05/03/94) No. 654, P. 33 Therion Biologics Corp. of Cambridge, Mass., will initiate Phase I clinical trials of an experimental recombinant vaccine known as TBC-3B. The vaccine is made from a live, restructured virus and aims to protect against HIV by triggering an immune response against the virus. Trials will be conducted at AIDS vaccine evaluation units in St. Louis; Rochester, N.Y.; Seattle; and Nashville, Tenn. "Home Healthcare Needs of Adults Living With HIV Disease/AIDS in New York City" Journal of the Association of Nurses in AIDS Care (03/94-04/94) Vol. 5, No. 2, P. 33; Hurley, Patricia M.; Ungvarski, Peter J. In the first study seeking to identify the home healthcare needs of adults with HIV/AIDS, Hurley and Ungvarski traced a retrospective chart review of a random sample of cases discharged from a New York City certified home health agency in 1991. They frequently observed symptoms such as weakness, fatigue and lethargy, pain, cough, skin lesions, and loss of memory. Other problems identified were inadequate nutrition, issues relevant to compliance with prescribed medications, inadequate in-home support systems, inadequate facilities or utilities in the home, financial worries, and lifestyles that included drug and alcohol abuse and tobacco use. Hurley and Ungvarski's findings suggest that the healthcare needs of HIV/AIDS patients in a home care environment is multifaceted, and not limited to the clinical manifestations of disease.