AIDS Daily Summary December 8, 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 ************************************************************ "F.D.A. Backs a New Drug to Fight AIDS" "On-Line Society Angered by Plan to Curb Content" "Across the USA: Texas" "Gay Ex-Cop Charges Discrimination on Miami Beach Force" "AIDS Ministry Lays Off Eight; Using Volunteers" "AIDS Victim Named Woman of the Year" "Schering-Plough Corp.: Intron A Melanoma Drug Cleared By FDA For Sale" " Preliminary Results From Phase III Trial of Doxil" "Prevention of SIV Infection in Macaques by (R)-9-(2-Phosphonylmethoxypropyl)adenine" "Coming Clean about Needle Exchange" ************************************************************ "F.D.A. Backs a New Drug to Fight AIDS" New York Times (12/08/95) P. B12; Hilts, Philip J. The U.S. Food and Drug Administration (FDA) approved on Wednesday saquinavir, the first of a new class of drugs called protease inhibitors. Drug manufacturer Hoffmann-La Roche Inc. of Nutley, N.J., pledged to have the anti-HIV drug, which will sell under the name Invirase, in pharmacies within 48 hours. The company also announced that as part of a new financial assistance program, it would provide the drug to patients who are waiting to be approved for coverage or reimbursement, and to some uninsured individuals. The wholesale price of one day's dose will be $15.89. The FDA, meanwhile, noted that this was the fastest approval process ever for a drug, taking just 97 days from the time Hoffmann-La Roche submitted an application. Research shows that saquinavir has been able to stem the reduction in CD4 cells, at least temporarily, and moderately increase their level with only relatively mild side effects. Two other drug companies--Merck & Company and Abbott Laboratories--are working on similar compounds, though neither has yet sought FDA approval for them. Related Stories: Wall Street Journal (12/08) P. B5; Washington Post (12/08) P. A3; Investor's Business Daily (12/08) P. A1; Washington Times (12/08) P. A3; Philadelphia Inquirer (12/08) P. A3 "On-Line Society Angered by Plan to Curb Content" Wall Street Journal (12/08/95) P. B5; Sandberg, Jared Wednesday's 17-16 House vote to make it illegal for anyone to deliberately display "indecent" material which can be seen by a minor on the Internet punishable by a fine and prison has sparked outrage among users of online services. Consultant Craig Johnson, for example, described Congress' move as "the age of electronic book burning," and worried that the word "indecent" might be applied to literary works, public health and medical exchanges, and discussions of AIDS. Currently, the American Civil Liberties Union is readying a court challenge to the action on the basis of the First Amendment. Online advocates are also urging the House to hold another vote to clarify what "indecency" means. Furthermore, online experts claim that this action could create serious problems with unintended results. Last week, America Online Inc.--in an attempt to eliminate vulgarity from members' online profiles--decided to exclude all uses of the word "breast," and in doing so erased profiles of many breast cancer patients. "Across the USA: Texas" USA Today (12/08/95) P. 10A The decision of Texas Education Commissioner Mike Moses to refuse nearly $2 million in federal grants for AIDS education has ignited anger among AIDS activists. Moses said he rejected the money because he did not want requirements for how local schools should teach sex education. "Gay Ex-Cop Charges Discrimination on Miami Beach Force" Miami Herald (12/07/95) P. 1B; De Valle, Elaine Pete Zecchini, an openly gay former officer with the Miami Beach Police Department, has charged the force with discrimination. Zecchini said that his difficulties began four years ago, when it became known that his lover was HIV-positive and others feared that he was as well. "The Miami Beach Police Department has presumed that since my lover has AIDS, that I have it also," commented Zecchini, who resigned Friday after six years with the department. Police Chief Richard Baretto denied any allegations of prejudice or discrimination, but Zecchini said that fellow officers were ostracized to the point that they would not defend him in risky situations. Also, when he once coughed during a training session, the instructor filed a worker's compensation injury report, claiming that Zecchini's saliva "came into contact with instructor's eyes and mouth." Zecchini's attorney, Loring Spolter, claims the Miami Beach officers are violating the Americans with Disabilities Act. "AIDS Ministry Lays Off Eight; Using Volunteers" Richmond Times-Dispatch (12/07/95) P. B3; Robertson, Gary Financial constraints have forced the Richmond (Va.) AIDS Ministry to layoff many of its employees this year, including eight workers within the last two weeks. The organization is now relying on volunteers to provide services to 16 AIDS patients in two residential facilities. A spokeswoman for the group said that the reductions were in part because the Ministry grew too fast, and also because "we have to anticipate the worst for the level of [federal] funding in 1997 and beyond." The federal government finances about half of the ministry's monthly budget. "AIDS Victim Named Woman of the Year" Toronto Globe and Mail (12/07/95) P. A4 Chatelaine magazine has selected as its Woman of the Year Rochelle Pittman, a woman who died of AIDS earlier this year after bringing much attention to the scope of Canada's tainted-blood tragedy. Mrs. Pittman became infected from her husband, who received infected blood during heart surgery. According to the magazine, she "rattled a paternalistic medical establishment to its core, challenged public perceptions of a stigmatized disease associated mainly with gay men and helped bring about a federal inquiry into the tainted-blood tragedy that left about 1,400 Canadians HIV-infected." Mrs. Pittman's story garnered attention in March 1994, when she was awarded some $515,000 in a lawsuit filed against her husband's doctor, Toronto Hospital, and the Canadian Red Cross. The court found the doctor liable for not informing Mr. Pittman that he was infected with HIV via a blood transfusion, and the Red Cross and the hospital shared some of the liability in failing to notify the doctor immediately of possible infection. "Schering-Plough Corp.: Intron A Melanoma Drug Cleared By FDA For Sale" Wall Street Journal (12/07/95) P. B4 The FDA has granted marketing approval to Schering-Plough Corp. for the anticancer drug Intron A. The drug is an auxiliary treatment to surgery for patients with malignant melanoma, and clinical tests have shown it to be effective in increasing patients' survival rates. Previously Intron A was approved for treatment of hairy-cell leukemia, AIDS-related Kaposi's syndrome, condylomata acuminata, and chronic hepatitis B and C. Shares of Schering rose $1.375 to $60.625 upon the news. " Preliminary Results From Phase III Trial of Doxil" Business Wire (12/06/95) SEQUUS Pharmaceuticals Inc. announced on Wednesday preliminary Phase III clinical trial results that indicated anticancer drug Doxil showed effectiveness in treating Kaposi's sarcoma in AIDS patients. The drug was compared to standard combination chemotherapy consisting of the drugs Adriamycin, Bleomycin, and Vincristine. No application for FDA marketing approval for Doxil as a first-line therapy has been filed, but Doxil was granted marketing clearance in November as a treatment for Kaposi's sarcoma in patients for whom conventional chemotherapy is not effective or well-tolerated. "Prevention of SIV Infection in Macaques by (R)-9-(2-Phosphonylmethoxypropyl)adenine" Science (11/17/95) Vol. 270, No. 5239, P. 1197; Tsai, Che-Chung; Follis, Kathryn E.; Sabo, Alexander; et al. Researcher Che-Chung Tsai of the University of Washington Regional Primate Research Center and his colleagues compared the efficacy of pre- and postexposure therapy with the antiviral compound (R)-9-(2-phosphonylmethoxypropyl)adenine, or PMPA, against the simian immunodeficiency virus (SIV) in 35 macaques. Subcutaneous does of the compound were administered either 48 hours before, 4 hours after, or 24 hours after injection with the virus. The monkeys were observed for 56 weeks, though treatment was stopped after just four weeks. All 25 PMPA-treated macaques were resistant to SIV infection and experienced no toxicity, while all 10 control animals became infected with the simian virus. According to the researchers, these findings indicate that PMPA prophylaxis could potentially be useful against some early HIV infections. "Coming Clean about Needle Exchange" Lancet (11/25/95) Vol. 346, No. 8967, P. 1377 Laws that prohibit the sale or possession of drug paraphernalia and those that keep drug addicts from obtaining clean injection equipment are detrimental to the public's health, according to the editors of The Lancet. The editors state that such laws should be eliminated, as should Public Law 102-394--a law which the Institute of Medicine (IOM) recently recommended be removed. Congressional opponents should consider not only data from the IOM, but equally convincing research from the U.S. General Accounting Office, the National Commission on AIDS, and the University of California/Centers for Disease Control and Prevention. Contrary to critics' claims, needle exchanges do not encourage or increase the number of drug addicts. What these programs do, the editors assert, is reduce the amount of needle sharing and dangerous sexual behavior among drug users. President Clinton should act immediately, in light of the tremendous evidence in support of needle exchange programs, the editors conclude.