AIDS Daily Summary August 22, 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 ************************************************************ "Upjohn, Pharmacia to Merge, Creating One of the World's 10 Largest Drug Firms" "Isolation Ends for Prisoner who Refused Testing for TB" "Chronicle: Deborah Harry in a Summer's-End AIDS Event" "Collins Won't Appeal Aide's Victory in Landmark AIDS Ruling" "Runners and Walkers Tackle the Grand Canyon "Rim to Rim Challenge" for Cancer and AIDS Research on Labor Day" "No Cheers for Baboon to AIDS Patient Xenotransplant" "Cancer Drug May Join the AIDS Arsenal" "Texas Compromise Salvages AIDS Prevention Education Program" "The Classification of AIDS Cases: Concordance between Two AIDS Surveillance Systems in Italy" "FDA Announces Public Workshop and Advisory Subcommittee Meeting on Current Issues in AIDS Clinical Trials" ************************************************************ "Upjohn, Pharmacia to Merge, Creating One of the World's 10 Largest Drug Firms" Journal of Commerce (08/22/95) P. 4B U.S.-based Upjohn Co. and Pharmacia of Sweden have announced that they will merge later this year, creating one of the 10 largest pharmaceutical companies in the world. The new company will be called Pharmacia & Upjohn Inc., and will have an annual revenue close to $7 billion and a market capitalization of $13 billion. "Through the merger, Pharmacia gains access to Upjohn's strong U.S. sales, marketing, and distribution infrastructure...while Upjohn gains additional sales and marketing support in Europe," explains Pharmacia's Jan Ekberg, the proposed chairman of the new group. The new company expects to release or extend 28 products during the next three years, including therapies for AIDS, Parkinson's disease, and cancer. "Isolation Ends for Prisoner who Refused Testing for TB" New York Times (08/22/95) P. B5; McKinley Jr., James C. A judge has decided that a murderer kept in solitary confinement for more than three years because he would not take a tuberculosis (TB) test should be returned to a normal cell at the Attica Correctional Facility. Prisoner Paul Jolly says that shortly after he began serving his life sentence, he converted to Rastafarianism--a religion which he claims prohibits him from taking a standard TB test. Because state prison doctors said his refusal to take the routine test could endanger other prisoners, however, Jolly was placed in "medical keeplock." Jolly then sued, alleging that his First Amendment right to practice a religion had been violated, and that his isolation represented cruel and unusual punishment. In his decision last Friday, the judge wrote, "The plaintiff, in choosing to undergo the conditions of medical keeplock for a period of over three and a half years, has shown remarkable conviction for what he was stated are his religious beliefs." "Chronicle: Deborah Harry in a Summer's-End AIDS Event" New York Times (08/22/95) P. B2; Steinhauer, Jennifer Singer Deborah Harry will appear in a Sept. 3 concert that will benefit an AIDS charity. Harry, who became famous in the late 1970s with punk-infused disco, says that although she is asked to do many benefits and auctions, she refuses all but the AIDS-related events. "One reason I am doing this," she adds, "is because it is the end of the summer. For everyone I know who is confronted with this illness, that season is symbolic because they have made it through another year." The concert will take place at the Provincetown, Mass., town hall and will benefit the Provincetown AIDS Support Group. "Collins Won't Appeal Aide's Victory in Landmark AIDS Ruling" Detroit News (08/18/95); Zagaroli, Lisa Rep. Barbara-Rose Collins (D-Mich.) has missed the filing deadline for an appeal in the case of a former aide who claimed he was fired because she thought he had AIDS. Because Collins has not appealed, Bruce Taylor will now receive compensation for more than seven months' back pay and attorney's fees. Jim Davison, a media services administrator for the House of Representatives, said he knew of no other instance in which a lawmaker had had a case before the Office of Fair Employment Practices. Taylor claimed his firing last December--two days after his homosexual partner died of AIDS--was in violation of the Americans with Disabilities Act. The law protects individuals who are perceived to be infected or have AIDS, as well as those who actually have the disease. According to Taylor, both Collins and her chief of staff repeatedly asked about his health prior to his dismissal. Although they deny the allegations, the judge ruled that Taylor was perceived to be infected and that Collins and her chief of staff had decided he "would require time off for health reasons." "Runners and Walkers Tackle the Grand Canyon "Rim to Rim Challenge" for Cancer and AIDS Research on Labor Day" Business Wire (08/21/95) On Labor Day weekend, 20 individuals will run or walk 23.5 miles in the Grand Canyon "Rim to Rim Challenge" to raise funds for the City of Hope National Medical Center and Beckman Research Institute in Duarte, Calif. The participants will start at the canyon's North Rim, descend 6,200 feet to the bottom of the canyon, go across, and up 4,000 feet to the South Rim. "This is another opportunity for me to test my personal limits while doing something to help City of Hope, a cause I believe in," says Tim Peterson, the event's organizer and leader. Peterson recently ran up and down the almost 14,000-foot-high Mt. Kilimanjaro for City of Hope, an organization that conducts research and treatment for such diseases as HIV/AIDS, leukemia, and diabetes. "No Cheers for Baboon to AIDS Patient Xenotransplant" Lancet (08/05/95) Vol. 346, No. 8971, P. 369; Thompson, Clare The xenotransplant of baboon bone marrow into an AIDS patient has several transplant scientists worried. The operation, they argue, is severely flawed and has little experimental justification. "The likelihood that this will work is extremely small," claims surgeon Hugh Auchincloss of Massachusetts General Hospital. "The difficult procedure will probably hasten [the patient's] death and not prevent it." The transplant is based on the assumptions that the baboon marrow is HIV-resistant, and that "facilitator cells" will allow engraftment without the development of graft-versus-host disease (GVHD). Suzanne Ildstad--one of the two scientists involved in the procedure--plans to isolate the facilitator, stem, and T cells from the baboon bone marrow; filter out the T cells, which are thought to be the cause of GVHD; repackage the stem and facilitator cells; and transplant them into the patient. The problem with the concept, however, is that Ildstad is the only one who has been able to identify the facilitator T cells. These and other technical questions should have been answered by animal experimentation, some opponents say. "Cancer Drug May Join the AIDS Arsenal" Journal of the American Medical Association (08/16/95) Vol. 274, No. 7, P. 523; Voelker, Rebecca The cancer drug hydroxyurea may not be a success in itself, but researchers claim it is particularly effective in fighting HIV when used in combination with the nucleoside analogue didanosine (ddI). Dr. Franco Lori, director of the new Research Institute for Genetic and Human Therapy (RIGHT) in Italy, is trying to determine why HIV-1 does not replicate in quiescent cells. According to Lori, his hypothesis that focused on the lack of deoxynucleoside triphosphates (dNTPs) was correct. "When HIV enters a quiescent cell, there is not enough food to survive," he explains. Research published in the journal Science later showed that in vitro anti-HIV activity is increased without additional toxicity when hydroxyurea is used with ddI. Lori thinks that hydroxyurea may reduce problems related to drug resistance. When used with ddI, he says, hydroxyurea lessens viral replication so significantly that there is less virus able to mutate, which could potentially delay the onset of ddI-resistance. In addition to Lori's trial, which has a U.S. counterpart that began testing last month, hydroxyurea research is also being conducted in France and other U.S. locations. "Texas Compromise Salvages AIDS Prevention Education Program" Nation's Health (08/95) Vol. 25, No. 11, P. 8 In April, the Dallas County Commission voted to discontinue a program in which condoms, bleach kits, and "explicit" AIDS prevention information were distributed. Now, however, the commission has reached a compromise that will restore the program by transferring a state grant from the county health department to a private agency. Following the April decision, the Texas Public Health Association and the American Public Health Association lobbied to reverse the decision. One key concern was the risk of losing a five-year, $1.2 million grant from the Centers for Disease Control and Prevention that funded an HIV/AIDS training program for Texas health professionals. The program was operated by the county health department, and would have been eliminated by the April vote. In June, however, the Commissioners restored the program, but forbade county employees from participating and said that any AIDS prevention information distributed by the county health department would have to be reviewed to guard against "explicit material." "The Classification of AIDS Cases: Concordance between Two AIDS Surveillance Systems in Italy" American Journal of Public Health (08/95) Vol. 85, No. 8, P. 1112; Serraino, Diego; Franceschi, Silvia; Dal Maso, Luigino et al. A new study compared how the Italian AIDS Registry--the country's national surveillance system--and the Italian Cooperative Group on AIDS-Related Tumors classified 725 AIDS cases. For both male and female injection drug users, gay men, and people infected with HIV through contaminated blood or blood products, there was a high degree of concordance in classification. There was reduced concordance among heterosexual men, particularly among those whose risk group was not identified. These discrepancies suggest the continued need for accurate monitoring of AIDS reporting by transmission category. "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) 243-7012.