Date: Tue, 11 Apr 1995 09:33:00 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com AIDS Daily Summary April 11, 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 ************************************************************ "AIDS Protein Discovery" "Inexpensive Vaccine" "Blood-Bank Software Recalled over Defects" "Across the USA: Oklahoma" "Liposome Technology, Inc. Vice President and Medical Director Richard D. Mamelok, M.D., Resigns" "Foes of Mandatory Maternal HIV Testing Fear Guidelines Will Lead to Reprisals" "Anergy Tests Draw Strong Reaction from Experts" "Cost of HIV Testing in the U.S. Army" "Employers Seeking Education Programs on AIDS" "Protease Inhibitor Consensus Statement" ************************************************************ "AIDS Protein Discovery" Washington Post (04/11/95) P. A6 Scientists have learned how an AIDS protein, called Vpr, forces its way into cells. Vpr enters the cell's nucleus more quickly than other proteins and makes the cell help do its job, found University of Pennsylvania pathologist David Weiner. Vpr hijacks a protein naturally present in human cells, one that moves specific steroid hormones through cells. Tests showed that some of these steroids activate HIV production and suppress immune cells, Weiner reported in the April 11 issue of Proceedings on the National Academy of Sciences. When Vpr was added, the protein used the steroids' cellular pathway to get to the nucleus and prompted steroid overproduction to help it produce HIV. Weiner found that the abortion drug RU-486, which is known to block steroid overproduction in other diseases, also blocked Vpr. HIV-infected cells treated with RU-486 produced 70 percent less virus than untreated cells, he found. Weiner warned, however, that it is still too early to know whether the drug would work in humans. Related Stories: Philadelphia Inquirer (04/11) P. B8; Washington Times (04/11) P. A8 "Inexpensive Vaccine" Washington Post (04/11/95) P. A6 Researchers at Texas A&M University and at the Roswell Park Cancer Institute in Buffalo, N.Y., have found that an inexpensive hepatitis B vaccine made from genetically engineered tobacco plants or potatoes may be as effective as commercial vaccines. The researchers discovered that compounds "virtually indistinguishable" from those in commercial products can be made by a tobacco plant that has been genetically engineered to contain proteins from the virus's surface coat. Mice injected with proteins extracted from the tobacco leaves had an immune response "qualitatively similar" to that produced by commercial hepatitis B vaccines, the scientists said. The researchers have also successfully engineered potatoes to generate the viral surface particles. Related Story: USA Today (04/11) P. 1A "Blood-Bank Software Recalled over Defects" Philadelphia Inquirer (04/11/95) P. B8; Meyer, Josh Following the discovery of programming flaws that could have allowed the unintentional release of contaminated blood, the Food and Drug Administration (FDA) has recalled computer software used by more than 200 United States hospital blood banks. FDA officials said the risk of the release of contaminated or unscreened blood through defects in Western Star Inc.'s LifeLine blood bank management system was "remote." Blood bank officials, however, said the recall emphasized the dangers of relying on complicated technology for such sensitive tasks. The FDA has cited Western Star for other problems with its blood bank software during the past three years. Western Star has voluntarily complied with the recall by informing its customers and ensuring that the programming defects have been corrected, according to the FDA. Both the FDA and Western Star officials emphasized that they were virtually certain that no blood was improperly released. Related Story: Los Angeles Times--Washington Edition (04/11) P. B3 "Across the USA: Oklahoma" USA Today (04/11/95) P. 4A Oklahoma authorities are attributing the statewide increase in tuberculosis (TB) cases to an increase in immigrants and to the growing number of AIDS cases. In 1994, 261 new cases of TB were reported, up from 209 in 1993. "Liposome Technology, Inc. Vice President and Medical Director Richard D. Mamelok, M.D., Resigns" Business Wire (04/10/95) Dr. Richard Mamelok, vice president and medical director of Liposome Technology, Inc. (LTI), has resigned from the company. Mamelok said, however, that he will delay his effective date of resignation to assist in the search for a successor and to help prepare the New Drug Application for AMPHOCIL, LTI's proprietary antifungal drug. Mamelok joined the company in October 1992, assuming responsibility for the company's DOX-SL and AMPHOCIL. In February, a Food and Drug Administration panel recommended that the agency approve DOX-SL under its accelerated approval system, which has been used for approving AIDS drugs including ddC, ddI, and d4T. "Foes of Mandatory Maternal HIV Testing Fear Guidelines Will Lead to Reprisals" Journal of the American Medical Association (04/05/95) Vol. 273, No. 13, P. 977; Voelker, Rebecca Although the discovery that zidovudine reduces the risk of maternal-infant HIV transmission by two-thirds was celebrated last year, this year the finding has been cause for protest. Activists fear that conservative legislators and policy makers will use the data to defend mandatory HIV testing or compulsory treatment for pregnant women. The U.S. Public Health Service's draft guidelines recommend that all pregnant women receive HIV counseling and testing. The guidelines repeatedly state, however, that HIV testing should be voluntary for women and their infants. Much of the controversy focuses on AIDS Clinical Trials Group (ACTG) protocol 076, the study which made the zidovudine discovery. Activists claim the data are incomplete and should not be a basis for federal guidelines. They want to know the effects of AZT on the infants and on the mothers. Wanda Jones of the Centers for Disease Control and Prevention acknowledges there are some questions left unanswered by the study, but said it is the only one ever to have demonstrated any effective method of preventing maternal-fetal transmission. "Anergy Tests Draw Strong Reaction from Experts" AIDS Alert (04/95) Vol. 10, No. 4, P. 47 Due to increasing controversy about its usefulness, the Centers for Disease Control and Prevention may change its current recommendation that all HIV-infected people at risk for tuberculosis (TB) be tested for anergy. A skin condition in which immunosuppressed people cannot react to a purified protein derivative (PPD) skin test, anergy is common in HIV-positive individuals. Anergy testing is common in many HIV and TB clinics throughout the United States. New data, however, indicates that testing is not an accurate diagnosis for infection. When studying intravenous drug users in Baltimore, Dr. Neil Graham of Johns Hopkins University discovered that the prevalence and incidence of anergy were higher among HIV-infected subjects than among those who tested negative for the virus. Graham also found high rates of change in anergy status in both groups. "This is a low-tech test," he commented. Graham said that using anergy testing "as the basis for [deciding whether to give] prophylaxis may not be ideal." If testing is no longer recommended, clinicians will have to rely on other diagnostic tools, such as patient history, CD4 counts, and community prevalence for evaluating possible TB infection in HIV-infected patients. "Cost of HIV Testing in the U.S. Army" New England Journal of Medicine (04/06/95) Vol. 332, No. 14, P. 963; Brown, Arthur E.; Burke, Donald S. In a letter to the editor published in the New England Journal of Medicine, Drs. Arthur E. Brown and Donald S. Burke of the Walter Reed Army Institute of Research summarize the cost per HIV test incurred by the U.S. Army since 1985. HIV testing in the Army costs less than $2.50 per serum specimen, compared to $15 for screening and $50 for confirmatory testing elsewhere in the nation. For testing active-duty soldiers and military applicants, there is an infrastructure for blood collection, processing, and shipment. The cost per specimen for testing--which includes the transport of specimens, enzyme-linked immunoabsorbent assays (ELISAs), confirmatory testing, and the reporting of results--was $4.41 in 1985 and 1986 and $2.43 in 1994. There is no infrastructure in the U.S. Army Reserve, and costs per specimen are three to four times higher. The Army's experience shows that large-scale HIV testing can be performed at a low cost. Such economic efficiency can also be achieved in the civilian sector, Burke and Brown believe. "Employers Seeking Education Programs on AIDS" Employee Benefits Report (04/03/95) No. 14, P. S11; Dauer, Christopher An increasing number of employers are turning to two national programs to educate themselves and their workers about AIDS. The Centers for Disease Control and Prevention's (CDC's) "Business Responds to AIDS/Labor Responds to AIDS" is a alliance between the CDC and business designed to develop AIDS education programs for employers, says Angie Hammock, director of the program. The program outlines five steps for employers to follow--develop a policy; educate the managers; educate the employees, who will educate their families; and community involvement. The National Leadership Coalition on AIDS (NCLA) has a similar partnership of business and labor interests to help employers address the AIDS epidemic. The coalition is a nonprofit organization of more than 200 businesses, labor organizations, and voluntary groups working "to stop the spread of AIDS through effective workplace education, policies, and practices," according to its mission statement. Several Fortune 500 companies have adopted the NCLA's educational programs, and "more and more" requests are coming in from small business owners, said Jerry Atchison, director of communications for the coalition. "Protease Inhibitor Consensus Statement" AIDS Treatment News (03/24/95) No. 219, P. 7 A group called the Protease Consensus Coalition has developed a consensus statement--signed by 61 organizations--stating that any attempt to withhold access to potential protease inhibitor compounds is contrary to the interests of HIV-infected people. Such action would be inconsistent with accelerated approval regulations, and is scientifically unnecessary, according to the statement. The long history of previous antiviral drugs illustrates that it is possible to continue conducting clinical trials of compounds, even after they have been approved for marketing. Organization that have signed the statement include ACT UP/New York Treatment and Data Committee, AIDS Project Los Angeles, AIDS Treatment News, National Association of People with AIDS, and the San Francisco AIDS Foundation.