Date: Tue, 21 Nov 1995 09:40:18 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC AIDS Daily Summary 11/21/95 AIDS Daily Summary November 21, 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 ************************************************************ "FDA Gives Approval to Glaxo, Sequus to Market Separate AIDS Therapies" "Doctor Indicted Over Cancer Drug" "Across the USA: South Dakota" "Fighting the Death Sentence" "AIDS Researchers Meet to Brainstorm" "Moral Victories for Riley, Heat Players" "OncoRx Holds Patent Pending Rights to 3-TC For..." "Detection of Diverse HIV-1 Genetic Subtypes in the USA" "AIDS Watch: Talking about AIDS" ************************************************************ "FDA Gives Approval to Glaxo, Sequus to Market Separate AIDS Therapies" Wall Street Journal (11/21/95) P. B12; Langreth, Robert The U.S. Food and Drug Administration (FDA) has approved Glaxo Wellcome PLC's AIDS drug Epivir (3TC, lamivudine) for use in combination with AZT. The extraordinarily rapid approval comes only weeks after an FDA advisory committee recommended such action. Glaxo announced that the newly-approved drug will be available in about a week, and will be similarly priced to AZT, which can cost several thousands of dollars each year. Meanwhile, Sequus Pharmaceuticals Inc. has also received accelerated marketing approval for its Doxil, a treatment for AIDS-related Kaposi's sarcoma. The encapsulated form of edicine doxorubicin will be used by individuals who either do not respond to or cannot tolerate existing treatments. Under the accelerated approval system, both Sequus and Glaxo must undertake post-marketing studies to confirm the efficacy of their therapies. Related Stories: Washington Post (11/21) P. A3; New York Times (11/21) P. D2; Philadelphia Inquirer; USA Today (11/21) P. 4B; Washington Times (11/21) P. A3; Investor's Business Daily (11/21) P. A7 "Doctor Indicted Over Cancer Drug" Washington Post (11/21/95) P. A11; Schwartz, John Houston physician Stanislaw R. Burzynski was indicted Monday on 75 counts of mail fraud and violations of federal medical laws. U.S. Attorney Gaynelle Griffin Jones claims that Burzynski and the Burzynski Research Institute introduced an unapproved cancer-fighting drug called "antineoplastons" into interstate commerce, filed false and misleading claims with health insurers, and disobeyed a court order barring interstate trade of the drug without following U.S. Food and Drug Administration (FDA) regulations. Critics assert that the doctor played on the fears of cancer and AIDS patients, and that he charged his patients $40 million for the drug between 1988 and 1994. Burzynski's claims of curing seemingly hopeless cancer cases with his originally human urine-derived drug have been widely publicized, yet researchers have not been able to duplicate the doctor's findings, in part, because of his lack of cooperation. "Across the USA: South Dakota" USA Today (11/21/95) P. 9A South Dakota Gov. Janklow has declared Dec. 1 as AIDS Awareness Day in the state. A total of 95 cases of AIDS and 247 cases of HIV have been reported in South Dakota in the past decade. "Fighting the Death Sentence" New York Times (11/21/95) P. A21; Sullivan, Andrew In an op-ed column in the New York Times, Andrew Sullivan, editor of The New Republic, questions whether we are behind the times in terms of the HIV epidemic. The atmosphere around the disease, he claims, had often made hopefulness taboo. Although medical science has found not a cure, treatments are now available which can extend the lives of HIV-infected persons to a point when perhaps even better therapies will be available. In light of this new situation of increased optimism, Sullivan writes, two fundamental changes must occur. In addition to distributing safer sex information, Sullivan argues that more information should be spread about promising new treatments. He also states that anyone at risk for HIV who does not know their status should be tested both now and every six months. There will be no clear, defining instant when victory is declared--there is instead, a gradual beginning that we may not notice until it has already happened, Sullivan concludes. "AIDS Researchers Meet to Brainstorm" Houston Chronicle (11/20/95) P9. 7C; SoRelle, Ruth In the fifth such meeting in as many years, nearly 50 international AIDS researchers recently gathered in Houston to discuss methods of boosting immune systems that have been ravaged by HIV. The meeting was developed by Project Inform, and without it, many scientists say they would not have taken some dramatic steps that could bring about useful treatments for the disease. Martin Delaney, a founder of Project Inform, explains that the forum was developed because he thought researchers needed an opportunity to challenge and support one another and develop collaborations. "This should serve as a paradigm for researchers in all diseases," comments the University of Pittsburgh's Suzanne Ildstad, who is scheduled to perform a baboon-to-human bone marrow transplant next December. The meetings are attended by scientists, doctors, regulators from the U.S. Food and Drug Administration and the National Institutes of Health, as well as people with HIV and AIDS. "Moral Victories for Riley, Heat Players" Miami Herald (11/20/95) P. 1B; Jervis, Rick On Sunday, six members of the Miami Heat basketball team distributed turkeys to needy families and signed autographs at Miami's Ninth Street Mall. Meanwhile, across town, Heat coach Pat Riley shot baskets and chatted with 65 youths at South Beach's Shore Club Hotel as part of an event for Project Cradle--a University of Miami project that helps HIV-infected children. The outing, which was co-sponsored by Loews Hotel and the Community Alliance Against AIDS, featured such games as ring toss, putt-putt golf, and face painting. "We just want to get involved," said Riley. "It helps [the children] understand there are people here who care." "OncoRx Holds Patent Pending Rights to 3-TC For..." Business Wire (11/20/95) Exclusive rights to a U.S. patent application for anti-HIV and anti-HBV drug 3TC (lamivudine) are held by OncoRx Inc. for the treatment of hepatitis B virus. Yale University filed the patent application, but OncoRx licensed the exclusive rights from Yale in 1994 and has also licensed exclusive rights to other antiviral agents against HBV and HIV. "Detection of Diverse HIV-1 Genetic Subtypes in the USA" Lancet (11/04/95) Vol. 346, No. 8984, P. 1198; Brodine, S.K.; Mascola, J.R.; Weiss, P.J.; et al. Although HIV-1 subtype B prevails in North America and Europe, Brodine et al. detail in the British medical journal The Lancet the discovery of HIV-1 subtypes A, D, and E in five U.S. military personnel who acquired their infections during deployments overseas. According to the authors, these cases--the first non-HIV-1 subtype B ones to be documented in native U.S. residents and the first reported introduction of subtypes A and E into this country--evidence the predictable spread of various HIV-1 subtypes to areas of previously limited genetic diversity. This dispersal may have serious implications for the epidemiology of the AIDS epidemic and for the development and implementation of vaccine trials, Brodine et al. conclude. "AIDS Watch: Talking about AIDS" Men's Fitness (11/95) Vol. 11, No. 11, P. 28 AWARE: Positive Health Talk Radio is the only news and talk program in the United States that is devoted entirely to HIV-related issues. The program is broadcast in such cities as Chicago, St. Louis, San Diego, Philadelphia, and Provincetown, MA.