Date: Mon, 18 Mar 1996 11:58:48 +0500 From: gharaghs{CONTRACTOR/ASPEN/gharaghs}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC AIDS Daily Summary 3/18/96 AIDS Daily Summary March 18, 1996 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 *********************************************************** "AIDS Therapy Study to Begin Among Patients" "Gilead Sciences Inc.: FDA Panel Clears Vistide; Stock Sinks on Testimony" "New York Helps 600 Retain Health Coverage" "FDA Put Off Making Its Decision on Drug for AIDS Wasting" "Case Hurts Green Cross Profit" "Assessing AIDS Research" "Guess What Kills More Women" "Avid Gets Option to License HIV Protease Inhibitor" "Neonatal Characteristics in Rapidly Progressive Perinatally Acquired HIV-1 Disease" "Growing Crisis in Paying for Care" ************************************************************ "AIDS Therapy Study to Begin Among Patients" Wall Street Journal (03/18/96) P. B5; Rundle, Rhonda L. Immune Response Corp., based in Carlsbad, Calif., is beginning a study of Remune, a controversial AIDS therapy designed to delay the onset of AIDS in HIV-infected individuals. The trial, one of the largest studies of an experimental AIDS treatment, will include 2,500 patients and will allow participants to continue taking their current medications. Remune, a therapeutic vaccine proposed 10 years ago by company founder Jonas Salk, is designed to slow the progression to AIDS by bolstering the immune system's attack on cells infected with HIV. A prior test in 300 patients was inconclusive, and some experts say Remune stimulates a weak response, but does not have a significant benefit for patients. "Gilead Sciences Inc.: FDA Panel Clears Vistide; Stock Sinks on Testimony" Wall Street Journal (03/18/96) P. B4 Although Gilead Sciences Inc.'s Vistide, a treatment for cytomegalovirus, was recommended for approval by a U.S. Food and Drug Administration advisory panel, testimony about the drug's potential side effects caused shares of Gilead to drop 23 percent to 26.75 on Friday. An FDA pharmacologist testifying at the hearing said Vistide had toxic side effects and had produced cancerous tumors in female rats. A spokeswoman for Gilead, however, said that the animal studies implicating Vistide as a carcinogen had been reviewed by both the FDA and the company and were deemed not applicable to humans. Related Story: Investor's Business Daily (03/18) P. A1 "New York Helps 600 Retain Health Coverage" Journal of Commerce (03/18/96) P. 7A Some 600 New Yorkers whose health insurance was threatened will not lose their coverage, thanks to a bill signed by Gov. George Pataki. The Empire Blue Cross and Blue Shield customers, many of whom have AIDS, were at risk of losing coverage because of a quirk in federal Medicare law and Empire's decision to discontinue the policy. The law said that Medicare recipients could not buy other policies to supplement their coverage. The new law orders Empire to continue to sell the policies to these patients. "FDA Put Off Making Its Decision on Drug for AIDS Wasting" Wall Street Journal (03/18/96) P. A13A The U.S. Food and Drug Administration has postponed its decision on whether to approve Serono Laboratories Inc.'s growth hormone to prevent AIDS-related wasting. While an FDA advisory panel voted on March 1 to recommend against approval, citing safety and efficacy concerns, AIDS activists have been pressuring the federal agency to approve the drug. Serono Laboratories, a subsidiary of Switzerland's Ares-Serono SA, said through its spokeswoman Gina M. Cella that it is in "ongoing discussions with the agency." Serono claims its drug has demonstrated effectiveness in preventing loss of lean body mass with few adverse side effects. "Case Hurts Green Cross Profit" Wall Street Journal (03/18/96) P. A14 Japanese pharmaceutical firm, Green Cross Corp., says it will charge a one-time loss of $47.4 million against results for the current quarter to settle a lawsuit filed by hemophiliacs who contracted HIV from the firm's blood products. The company noted it could have two annual losses due to the settlement. "Assessing AIDS Research" Washington Post (03/18/96) P. A16 This Washington Post editorial applauds the recently-released review of government-funded AIDS research, and the recommendations made by the panel of more than 100 independent experts. The panel expressed hope that AIDS will be treated as a chronic disease and that the HIV-infection of children may be prevented. The review found that researchers in non-AIDS areas may have been basing funding proposals on tenuous links to AIDS and that some projects are not worthy of funding. It suggested cutting back on drug development, reforming vaccine research, putting more focus on basic research, and supporting behavioral, social, and biomedical scientists working to prevent HIV infections. The editors conclude that the review process is beneficial because it reassures both the policy-makers and the public, as well as provides perspective and new insight for scientists. "Guess What Kills More Women" Washington Post (03/16/96) P. A16 In a Washington Post editorial, the authors urge countries and communities to actively work to stop the rapid spread of tuberculosis (TB), which kills more adults than malaria, other infectious diseases, and AIDS. The editors note that TB is inexpensive to treat, and curable with a directly observed treatment program. Antibiotics did rid the United States and other richer countries of TB in the past, but the disease--which is transmitted through the air--has resurged through travel, migration, and complacency. According to the editors, careful monitoring of drug programs are necessary because, if handled improperly, anti-TB drugs can produce drug-resistant strains of the disease and thus make the epidemic even worse. "Avid Gets Option to License HIV Protease Inhibitor" Philadelphia Inquirer (03/16/96) P. D3 Avid Corp. announced that it has received an exclusive option to license a second-generation protease inhibitor, called DMP-450, from DuPont Merck Pharmaceutical Co. The compound has completed early human testing. "Neonatal Characteristics in Rapidly Progressive Perinatally Acquired HIV-1 Disease" Journal of the American Medical Association (02/28/96) Vol. 275, No. 8 , P. 606; Mayaux, Marie-Jeanne; Burgard, Marianne; Teglas, Jean-Paul Among infants who are infected with HIV-1 by perinatal transmission, 10 percent to 15 percent have a significant immune deficiency and opportunistic infections during the first few months of life, and with encephalopathy, most die within five years. Other infants develop an immune deficiency gradually in a pattern similar to the disease progression in adults. Marie-Jeanne Mayaux et al. studied data from 267 children who had acquired HIV perinatally, to determine if markers could be identified to predict which infants would rapidly progress to AIDS. The researchers used data from the French Pediatric HIV Cohort, a network of 62 centers that keeps records of all infants born to HIV-positive mothers in the country. Opportunistic infections, cancers, and encephalopathy were used to measure the children's outcomes. The risk of developing the rapid, severe disease during the first 12 months of life was significantly higher in infants with adenopathies and/or spleen or liver enlargement at birth. The risk was also three times higher in infants who had a low percentage of CD4 cells at birth and who tested positive for HIV-1 during the first week of life. The authors recommend that children of HIV-positive mothers be tested early to identify those at risk. "Growing Crisis in Paying for Care" AIDS Treatment News (02/16/96) No. 241, P. 3; James, John S. The cost of AIDS treatment and monitoring is a central issue for patients, notes John S. James in AIDS Treatment News. As more drugs are used simultaneously, and protease inhibitors, which are more expensive than existing drugs, become available, treatment costs are increasing to an estimated $12,000 to $18,000 a year. Other costs, like hospitalization, should decrease as improved treatment prevents HIV-related illnesses. Fewer than 29 percent of people with HIV were covered by private insurance in 1994, and that percentage is decreasing. Fifty percent of AIDS patients are covered by Medicaid, but benefits--including prescriptions--are limited. For people whose income makes them ineligible for state Medicaid benefits, the only options are state AIDS Drug Assistance Programs funded under the Ryan White CARE Act, which are experiencing a funding crisis, or programs offered by the pharmaceutical companies. James contends that coalitions between AIDS service providers and pharmaceutical companies would be useful to alleviate the rising costs of AIDS care, as would grassroots support for government funding. More research is also needed for doctors to know how to prescribe drugs effectively. Other solutions that James proposes are better pharmaceutical company assistance programs and research into less expensive treatments.