Date: Fri, 29 Dec 1995 09:39:41 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC AIDS Daily Summary 12/29/95 AIDS Daily Summary December 29, 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 ************************************************************ "Tracing the Trail of Tainted Blood" "Less HIV Found in Donated Blood" "Employee with AIDS Loses Award on Appeal" "Isis Drops Human Trials of a Genetic Drug" "Budget Talks May Continue into Weekend" "BFTI Receives Peruvian Naval Approval to Conduct Trials for Its Rapid Immunochromatographic Assay for Detection of the HIV 1/2 Viruses" "Treatment with Lamivudine, Zidovudine, or Both in HIV-Positive Patients with 200 to 500 CD4+ Cells per Cubic Millimeter" "Some Members of APHA Interested in Forming Caucus on AIDS" "Finding New Uses for Thalidomide" "No Thanks" ************************************************************ "Tracing the Trail of Tainted Blood" Philadelphia Inquirer (12/29/95) P. A1; Shaw, Donna Thousands of documents emerging in Canada's tainted-blood inquiry indicate that the plasma industry was reliant on high-risk blood donors than it had previously admitted. Specifically, these donors include prisoners, drug addicts, and poor people from the United States, the Caribbean, Central and South America, Asia, and southern Africa. Lawyers representing HIV- and hepatitis-infected hemophiliacs say that this reliance gave the industry a critical obligation to destroy viruses in blood-clotting products long before the first heat-treated medicines were approved in the United States. Today's plasma-based medicines are safer than ever, but blood experts admit that it is unrealistic to expect these medicines to ever be completely without risk. Factors related to this issue include the size of the plasma pool, the belief that paid donors are at greater risk for blood-borne diseases than volunteers, and the fact that the United States' method of viral inactivation does not eliminate all viruses. "Less HIV Found in Donated Blood" Boston Globe (12/28/95) P. 1; Saltus, Richard More accurate HIV tests and increased education of potential blood donors have made the risk of receiving an HIV-infected blood transfusion very low, according to a new report from the U.S. Centers for Disease Control and Prevention. Only 18 to 27 donations out of the 12 million given each year are tainted with HIV, the study found. To further improve the odds, the Food and Drug Administration (FDA) has ordered U.S. blood banks to implement a new HIV test that may detect some 10 more infected donations each year. The additional testing, which will cost the health care system about $65 million annually, will also "add additional complexity, increase the opportunity for error, and create more false-positive test results," said Dr. Christopher Howell, director of the blood transfusion service at Massachusetts General Hospital. An FDA spokesman, however, noted that the agency must safeguard public health, and that cost therefore was not considered when the FDA said last August that the test should be used. Related Story: Miami Herald (12/28) P. 6A "Employee with AIDS Loses Award on Appeal" Philadelphia Inquirer (12/29/95) P. B1; Lounsberry, Emilie The U.S. Court of Appeals for the Third Circuit in Philadelphia reversed on Thursday a $125,000 award to a SEPTA manager who said that his right to privacy had been violated when an administrator discovered he had AIDS by examining employee prescription claims. The court ruled that an employer's need for access to employee prescription records under its health-insurance plan is greater than a worker's interest in keeping such information confidential. "Such minimal intrusion, although an impingement on privacy, is insufficient to constitute a constitutional violation," wrote Judge Max Rosenn. Judge Timothy K. Lewis, however, dissented, saying that the appellate court should affirm the verdict and that he was disturbed by the "potential implications" of the majority's decision. "Isis Drops Human Trials of a Genetic Drug" New York Times (12/29/95) P. D2; Fisher, Lawrence M. Isis Pharmaceuticals has suspended clinical trials of a potential treatment for genital warts, an antisense compound known as Isis 2105, because it claims that the results and potential market do not merit further development. The company's shares dropped 37.5 cents to $13.25. According to analysts, the minimal decline reflects the company's attempts to prepare investors for a setback with the drug, as well as the promise of other Isis drugs currently being tested. These drugs include treatments for cytomegalovirus retinitis, for kidney transplant rejection, and for inflammation. Stanley Crooke, Isis chairman and CEO, said that although Isis 2105, when used with cryosurgery, had demonstrated antiviral activity, the drug was not strong enough and would likely need to be reformulated. "Budget Talks May Continue into Weekend" Washington Post (12/29/95) P. A1; Harris, John F.; Dewar, Helen President Clinton and Republican congressional leaders affirmed on Thursday their desire to restart budget negotiations, however both parties said they are not likely to reach an agreement in the next few days. The president also vetoed the authorization bill for defense appropriations. Aides report that Clinton objected to the GOP plan to establish a missile defense program that is said to violate the 1972 Anti-Ballistic Missile Treaty with Russia. Furthermore, Clinton termed "medically unwarranted" a provision in the measure which would require the discharge of HIV-infected service members. "BFTI Receives Peruvian Naval Approval to Conduct Trials for Its Rapid Immunochromatographic Assay for Detection of the HIV 1/2 Viruses" Business Wire (12/28/95) The Peruvian Ministry of Interior has approved Bio-Fluorescent Technologies Inc.'s (BFTI's) plan to conduct trials of its rapid assay test for the HIV 1/2 virus with the navy. The trials are the first part of the navy's requirements to qualify a product for sale. The navy department intends to provide HIV tests to all its personnel and their families. Sales in this sector of Peru alone could garner BFTI $4 million in 1996. "Treatment with Lamivudine, Zidovudine, or Both in HIV-Positive Patients with 200 to 500 CD4+ Cells per Cubic Millimeter" New England Journal of Medicine (12/21/95) Vol. 333, No. 25, P. 1662; Eron, Joseph J.; Benoit, Sharon L.; Jemsek, Joseph; et al. To determine the safety and activity of lamivudine plus zidovudine in the treatment of HIV-infection, as compared with either drug alone, Eron et. al. studied more than 360 patients with CD4 levels between 200 and 500 cells. During the double-blind, 24-week study, patients were randomly assigned to receive either lamivudine, zidovudine, or one of two dose levels of a combination lamivudine plus zidovudine. The researchers found that the low- and high-dose regimens of the combination therapy resulted in greater increases in CD4 cell counts and percentage of CD4 cells, as well as larger reductions in HIV-1 RNA plasma levels, versus zidovudine alone. The combination treatment was also more effective in reducing HIV-1 RNA levels and increasing CD4-cell percentages than lamivudine alone--benefits which were maintained through the 28-week extension phase of the study. The researchers concluded that such combination therapy was well-tolerated in the 52 weeks of study, and that it generates more immunologic and virologic improvement than either drug by itself. "Some Members of APHA Interested in Forming Caucus on AIDS" Nation's Health (12/95) Vol. 25, No. 11, P. 14 Members of the American Public Health Association (APHA) are considering the formation of a caucus that would focus on the group's future AIDS policies. "The worst thing we can do is become silent or complacent about the AIDS epidemic," said member Suzanne Keller. The APHA's AIDS policies, which were adopted in 1982, cover such topics as equality of care, infection control, and non-discriminatory practices. Some members say that new issues needing to be addressed include HIV home testing and sex education in schools. Tim Sankary, a member who works in the epidemiology department at the UCLA School of Public Health, says, "I'd like to know why condoms are not used even when students know about condoms and they know about AIDS. We have to look at the practical application of our AIDS education." "Finding New Uses for Thalidomide" Nature Medicine (12/95) Vol. 1, No. 12, P. 1230; Gershon, Diane Midtrial results of a Phase II, placebo-controlled study of thalidomide suggest that the drug is a safe and effective treatment for mouth ulcers in HIV patients. The placebo side of the study therefore has been shut down and all patients will now be able to receive the drug on an "open-label" basis. The two-part study, which was funded by the National Institutes of Allergy and Infectious Diseases (NIAID) and conducted through NIAID's AIDS Clinical Trials Group, found that 61 percent of the thalidomide recipients' mouth ulcers healed, compared to just 4.5 percent in the control group. The drug, which became infamous for the birth defects it caused in England and Germany, was never approved in the United States, though some AIDS patients are now unofficially obtaining it through buyer's clubs for the treatment of AIDS, ulcers, and HIV-related wasting. Thalidomide is also being used for other disorders in both Brazil and France. Despite the risks associated with thalidomide, women of childbearing age did participate in the NIAID study. "We felt strongly that women should be allowed equal access to a potentially beneficial therapy," said Jeffrey M. Jacobson, a chair of the study. The researchers imposed several safety precautions, however, to minimize the danger, including periodic pregnancy tests and requiring women to either abstain from sexual intercourse or use three methods of contraception at the same time. "No Thanks" Advocate (12/26/95) No. 697, P. 23; Gallagher, John Texas education commissioner Michael Moses recently rejected a $1.35-million federal grant on the grounds that it would have forced the state to discontinue its abstinence-based sex education program. Dianne Hardy-Garcia, executive director of the Lesbian Gay Rights Lobby of Texas, said, "There had been grumblings about the money, but nobody thought he'd send it all back." But Cecile Richards, executive director of the Texas Freedom Alliance, a coalition of moderate clergy and community leaders, noted that accepting the money would have meant confronting the religious right, which "has been very active in eliminating sex education in schools." The rejected funds came from a four-year Centers for Disease Control and Prevention grant used to finance HIV- and sexually transmitted disease-prevention training for teachers. Moses now says he will reconsider his decision, "provided the Centers for Disease Control and Prevention can furnish assurances in writing that Texas school districts will not be told how to teach sex education or health education." Carolyn Parker, executive director of the Texas AIDS Network, said that the state health education policy upon which Moses based his decision only requires that abstinence be part of the sex education curriculum, not the whole program. "There is nothing in [the code] that says we can't advance the discussion beyond abstinence," she observed. AIDS Daily News will not publish on Monday, January 1, 1996. Publication will resume on Tuesday, January 2.