The material below from extracted from HICN volume 5, number 4, which appeared in sci.med. From: ddodell@stjhmc.fidonet.org (David Dodell) Date: 20 Apr 92 00:27:24 GMT Organization: St. Joseph's Hospital/Medical Ctr, Phoenix, AZ Volume 5, Number 4 April 19, 1992 +------------------------------------------------+ ! ! ! Health Info-Com Network ! ! Newsletter ! +------------------------------------------------+ Editor: David Dodell, D.M.D. 10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA Telephone +1 (602) 860-1121 FAX +1 (602) 451-1165 Compilation Copyright 1992 by David Dodell, D.M.D. All rights Reserved. License is hereby granted to republish on electronic media for which no fees are charged, so long as the text of this copyright notice and license are attached intact to any and all republished portion or portions. The Health Info-Com Network Newsletter is distributed weekly. Articles on a medical nature are welcomed. 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Martin Wehlou (Bitnet: WEHLOU@BGERUG51) ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Medical News ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Medical News for March 9, 1992 to April 19, 1992 Copyright 1992: USA TODAY/Gannett National Information Network Reproduced with Permission --- March 12, 1992 --- BLOOD-TESTING WARNING ISSUED: Devices used to draw blood to test for such diseases as hepatitis B may actually spread the virus if used improperly, suggests a study in New England Journal of Medicine. Failing to change the disposable platform on the devices led to a recent hepatitis outbreak in California. Likewise, nondisposable devices can transmit disease if not properly disinfected. --- March 13-15, 1992 --- AIDS-RELATED CANCER STUDIED: A Japanese drug may hold promise for AIDS patients with Kaposi's sarcoma, a rare skin cancer, suggests a report in Friday's Science. The Japanese drug SP- PG was shown to shrink similar tumors in mice. Research also suggests that Kaposi's sarcoma may develop from an infectious agent other than the AIDS virus, British researchers report in Friday's Lancet. --- March 16, 1992 --- CAPSULE MAY TREAT ORAL FUNGUS: A capsule with a tiny hole may prove a more effective treatment for an oral fungus, say dental researchers at UC San Francisco. Saliva, passing through a membrane, causes an internal layer to expand, pushing out medication. The capsule, known as Mucosal Oral Therapeutic System, lasted longer and worked better than conventional methods of treating oral candidiasis. --- March 18, 1992 --- TEENAGERS ARE AT RISK: Four in 10 teenagers have had sex in the past three months and half of them didn't use a condom, increasing their danger of hepatitis B infection, according to a survey by the U.S. Centers for Disease Control. Almost 90% of sexually transmitted diseases occur among people age 15-29, according to the CDC, and hepatitis B is the second-most commonly reported sexually transmitted disease. --- March 19, 1992 --- HIV ATTEMPTS UNSUCESSFUL: After failing to find HIV-infection among patients of Dr. David K. Hobart, who died of AIDS in 1989, University of Cincinnati Medical Center officials said Tuesday they would be unlikely to recommend such investigations again. The center spent eight months and nearly $300,000 to find and test patients of the Cincinnati doctor. Of 1,140 patients, 704 responded and 554 were tested. --- April 1, 1992 --- STUDY DONE ON CANCER COSTS: Families can spend as much as $20,000 in just three months to care for a cancer patient, new research shows. Insurance may cover hospital and doctor bills, but other costs mount once the patient is sent home. A three-month study of 190 middle-class cancer patients and family care-givers, shows average out- of-pocket expenses were $659 per family; the range was $60 to $3,380. MAJORITY DEPLETED SAVINGS: The average loss of income from time taken off work in caring for a cancer patient was $363; range, zero to $13,592, a Michigan State University survey shows. Average total family costs were $4,571; range, $60 to $20,754. That includes $10 an hour for time spent taking care of a patient. Also, sixty percent of family care-givers depleted their savings. SOME AIDS PATIENTS NOT COUNTED: A government study in Wednesday's Journal of the American Medical Association suggests that for every person officially listed as an AIDS patient by the federal government, two more are getting medical care for illnesses caused by the AIDS virus. Many are seriously ill, despite not having an infection recognized as a sign of full-blown AIDS. --- April 10-12, 1992 --- DRUG APPROVAL PROCESS ANNOUNCED: A new process would cut in half the average 10-year schedule now used by the Food and Drug Administration to approve drugs, Vice President Dan Quayle announced Thursday. The process would be aimed at promising new drugs for serious conditions like AIDS, cancer and Alzheimer's disease. A consumer group that monitors the FDA called the announcement "nothing new." PROVISIONS OF DRUG PROPOSAL: Some drugs for life-threatening illnesses will gain Food and Drug Administration approval with only short-term data - as the AIDS drug DDI did recently - under a plan proposed Thursday by Vice President Dan Quayle. The plan also provides for wider access for drugs that have been tightly controlled, the hiring of outside experts to do routine work and international cooperation. --- April 13, 1992 --- AIDS AMONG YOUTH INCREASING: The past two years have seen a 77% increase in the number of AIDS cases among people 13-to-24 years, with thousands more likely to be HIV-infected and millions more at risk, according to a congressional report. Cited: 68% of girls and 86% of boys have sex before age 20, while fewer than half report condom use. Each year 3 million teens contract a sexually transmitted disease. --- April 17-19, 1992 --- STUDY UPHOLDS AZT BENEFITS: The AIDS drug AZT can delay the onset of AIDS and help HIV-infected men live longer reports this week's New England Journal of Medicine. The study is expected to outweigh an earlier study that involved fewer patients and found no long-term survival benefits from the drug. However, further research is needed to determine when is the best time to begin AZT treatment, say researchers. ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Center for Disease Control - MMWR ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Morbidity and Mortality Weekly Report Thursday April 16, 1992 Current Trends Public Health Uses of HIV-Infection Reports -- South Carolina, 1986-1991 In the United States, public health officials use acquired immunodeficiency syndrome (AIDS) surveillance data to monitor trends, manage resources within communities, and identify specific needs of special populations (1). In addition to AIDS surveillance, 24 states require confidential reporting by name of HIV-infected persons to the local/state health department (Figure 1). This report summarizes public health uses for HIV-infection report data by one of these states--South Carolina Department of Health and Environmental Control (SCDHEC)--in guiding prevention and treatment programs. AIDS has been reportable to the SCDHEC since 1982; cases of HIV infection have been reported to SCDHEC since February 1986. SCDHEC uses HIV-infection reports to 1) target health education/risk reduction and early intervention programs; 2) provide counseling, testing, referral, and partner-notification services; 3) offer testing for CD4+ T-lymphocytes and screening for other diseases; 4) expand HIV surveillance data collection; and 5) assist legislators and policy makers in targeting resources. In South Carolina, although 93% of AIDS cases among hospitalized persons have been reported (2), the completeness of HIV testing and reporting is not known. As of December 31, 1991, SCDHEC had received 5787 HIV reports and 1599 AIDS reports. Of all reported cases of HIV infection in South Carolina in 1991, 52% were from SCDHEC counseling and testing sites and clinics, and 48% were from other sources. Targeting Health Education/Risk Reduction and Early Intervention Programs To identify groups in need of HIV/AIDS services, SCDHEC compared HIV- infection and AIDS reports for the state and the United States by person's sex, race/ethnicity, and HIV-transmission category (Table 1). During 1990, a higher percentage of persons with HIV infection were women and blacks than were persons reported with AIDS. From 1986 through 1990, the proportion of HIV-infection reports (from all sources) for women in South Carolina increased 4.5-fold (from 6% to 27%), while the proportion of health department testing of women increased less than twofold (from 28% to 54%). These data were used to target persons with high-risk behaviors with HIV-prevention messages through peer-directed health education and street outreach programs. Counseling, Testing, Referral, and Partner-Notification Services SCDHEC uses HIV-infection reports to target counseling and testing to persons with high-risk behaviors: following each HIV-infection report, either the patient or personal physician is contacted to develop a plan to counsel the infected person and for voluntary partner notification. Without disclosing the identity of the HIV-infected persons, named sex partners and/or persons with whom they shared needles during the previous 3 years are notified and offered counseling and testing. During 1990, of 1235 persons reported with HIV infection, SCDHEC attempted follow-up of 1139 (92%). Staff located 837 (73%) who named 1856 partners (mean: 2.2 partners named per index client); of the 1856 persons, 1336 (72%) were counseled and tested, and 263 (20%) persons with HIV infection were newly identified. CD4+ T-Lymphocyte Testing and Screening for Other Diseases Since March 1989, SCDHEC has offered an initial CD4+ T-lymphocyte test free to all persons newly identified as infected with HIV by SCDHEC counseling and testing sites or who were referred by personal physicians. In addition, subsequent CD4+ T-lymphocyte count monitoring is offered free to persons using health department services and for patients who were referred by personal physicians and who lack a source of payment for this test. From March 1989 through August 1991, the SCDHEC performed 4180 CD4+ tests for 2562 persons infected with HIV. SCDHEC uses CD4+ T-lymphocyte counts to determine the priority of referral of HIV-infected persons to physicians for care and to refer HIV- infected persons to entitlement programs (i.e., state Medicaid AIDS waivers require a CD4+ count less than 500 cells/uL). Persons are also offered screening for tuberculosis and syphilis, and during return visits for follow- up CD4+ T-lymphocyte counts, clients are counseled on risk reduction and behavior changes; clients have reduced high-risk behavior as a result of this counseling (3). From March 1989 through October 1990, SCDHEC evaluated a sample of persons newly identified as infected with HIV who had a CD4+ T-lymphocyte test performed within 90 days of their HIV-antibody-positive test results; of 422 persons, 12% had CD4+ less than 200 cells/uL, and 46% had less than 500 cells/uL. These findings were used to assess the need for prophylaxis for Pneumocystis carinii pneumonia and zidovudine treatment. Expanding Surveillance for HIV Infection and AIDS In collaboration with CDC, SCDHEC is obtaining additional health-related information from persons newly reported with HIV infection or AIDS in urban (Charleston County) and rural (Edisto Health District) areas of the state. Persons who consent to be interviewed provide information about their economic status, access to health care, reproductive history, and detailed sex and drug-use behaviors. Data from this supplemental surveillance are used to improve prevention and treatment services for HIV-infected persons. Assisting Legislators and Policy Makers SCDHEC uses HIV-infection surveillance data to assist legislators and policy makers in assessing the economic impact of the HIV epidemic and in targeting funds for prevention activities and medical services. For example, for each person newly identified with HIV infection (approximately 100 reported per month) in South Carolina, an estimated $50,000 will be expended for HIV-related health-care costs (4). Based on these projections, the partner-notification program during 1990 could result in an estimated cost savings of $13 million if program efforts prevented transmission of HIV to one other person during the lifetime of each of the 263 persons newly identified with HIV infection. Reported by: L Kettinger, MPH, J Jones, MD, State Epidemiologist, South Carolina Dept of Health and Environmental Control. Div of HIV/AIDS, National Center for Infectious Diseases; National Center for Prevention Svcs, CDC. Editorial Note: The activities of the SCDHEC illustrate how states can use HIV-infection reports to strengthen efforts to prevent HIV infection and enhance access to services for persons infected with HIV. Although HIV reports may not be representative of all HIV-infected persons, they provide a minimum estimate of those in need of health care and services. The findings in this report (i.e., a higher proportion of HIV infections among women and blacks in South Carolina during 1990) are consistent with trends reported for AIDS cases in South Carolina and HIV seroprevalence and AIDS data for the United States (5-7). South Carolina has used these data to target priority geographic areas within the state and direct the funding for education, prevention, and early intervention activities. Although these activities can occur in the absence of HIV reporting, states with confidential HIV reporting by name can ensure that treatment services are offered to eligible persons with high-risk behaviors. For example, the findings in this report show the effectiveness of targeting counseling and testing to persons at high risk for HIV infection (e.g., named partners of HIV-infected persons); 20% of partners who were counseled and tested were HIV-antibody-positive compared with a 3% seropositive rate among all HIV-antibody tests in South Carolina county health departments in 1990. Some of the other states that have implemented HIV surveillance use these data in similar ways. For example, in Missouri, approximately 25% of persons infected with HIV who were reported to the health department had been enrolled in a state-funded case-management plan that offers CD4+ testing, a medical evaluation, and zidovudine and other medications. Patients reported by personal physicians are offered care-coordination services and, for those who are eligible, provided insurance co-payments. In Minnesota, all persons reported with HIV infection are offered counseling and partner-notification assistance by the health department; in addition, funding for education and prevention services targeted to adolescents has resulted directly from HIV- report data that demonstrated the need for intervention among this age group. Similarly, in Arizona, services available through the health department to HIV-infected persons include counseling, psychosocial and physician referrals, and zidovudine treatment. States also use HIV-infection reports in combination with AIDS case reporting and seroprevalence surveys to monitor the epidemic and are collaborating with CDC to develop a standardized HIV surveillance system (8). To maintain confidentiality, state health departments have implemented various measures to ensure the security of personal data maintained through HIV/AIDS surveillance (9). For HIV-infected persons who are identified in either public or private health-care settings, HIV reporting provides the opportunity for health departments to offer counseling, medical referrals, and partner-notification and prevention services. Health departments can also use HIV-infection report data to develop public health strategies that link surveillance with prevention and treatment services. References 1. Public Health Service. Healthy people 2000: national health promotion and disease prevention objectives--full report, with commentary. Washington, DC: US Department of Health and Human Services, Public Health Service, 1991; DHHS publication no. (PHS)91-50212. 2. Jones JL, Rion P, Hermann P, et al. Improvement in AIDS case reporting, South Carolina (letter). JAMA 1991;265:356. 3. Wykoff RF, Jones JL, Longshore ST, et al. Notification of the sex and needle-sharing partners of individuals with human immunodeficiency virus in rural South Carolina: 30-month experience. Sex Transm Dis 1991;18:217-22 4. Conway GA, Colley-Niemeyer B, Burt S, et al. Costs of AIDS and HIV-related disease in South Carolina: a comprehensive study (abstract). Vol 2. IV International Conference on AIDS. Stockholm, June 12-16, 1988. 5. CDC. AIDS in women--United States. MMWR 1990;39:845-6. 6. CDC. The HIV/AIDS epidemic: the first 10 years. MMWR 1991;40:357-63,69. 7. St. Louis ME, Conway GA, Hayman CR, et al. Human immunodeficiency virus infection in disadvantaged adolescents. JAMA 1991;266:2387-91. 8. CDC. Update: public health surveillance for HIV infection--United States, 1989 and 1990. MMWR 1990;39:853,859-61. 9. Torres CG, Turner ME, Harkess JR, Istre GR. Security measures for AIDS and HIV. Am J Public Health 1991;81:210-11. Current Trends Update: Serologic Testing for Human T-Lymphotropic Virus Type I -- United States, 1989 and 1990 Human T-lymphotropic virus type I (HTLV-I)* is a retrovirus that has been identified as a cause of human T-cell leukemia/lymphoma and tropical spastic paraparesis; HTLV-II is closely related to HTLV-I but has not been linked to human illness. Both viruses can be transmitted through blood transfusion and injecting-drug use; therefore, accurate and reliable HTLV-I-antibody test results are essential to diagnose HTLV-I infection, conduct public health surveillance and prevention programs, and improve the safety of blood and blood products collected for transfusion (1). During 1989, CDC expanded its Model Performance Evaluation Program (MPEP) to assess the performance of laboratories that conduct HTLV-I-antibody testing and to identify potential problems in the testing process (2). This report summarizes findings of CDC's laboratory performance evaluation surveys. The approximately 300 laboratories enrolled in the MPEP that perform HTLV-I-antibody testing participated in CDC's HTLV-I-antibody testing surveys conducted during October 1989 and April and July 1990. Participating laboratories reported results to CDC after testing coded panels of eight undiluted HTLV-I/II-antibody-negative and HTLV-I/II-antibody-positive samples. The antibody-positive samples were obtained from five persons infected with HTLV-I and 11 infected with HTLV-II. CDC previously had determined the HTLV- I/II-antibody reactivity of these samples through composite testing by using enzyme immunoassay (EIA) kits licensed by the Food and Drug Administration (FDA) and by Western blot (WB) and radioimmunoprecipitation assay (RIPA) antibody tests using the interpretive criteria of the Public Health Service Working Group (1). Approximately 98% of the laboratories that participated in each of the three surveys reported EIA results; approximately 10% reported WB test results, and less than 2% reported indirect immunofluorescence or RIPA results (Table 1). Laboratories that performed HTLV-I-antibody testing were classified into five types: blood bank, hospital, independent, health department, and other (i.e., test-kit manufacturer, sexually transmitted disease clinic, and research, drug-toxicology, and military laboratories). Of the laboratories that returned test results, approximately 80% were from blood banks and hospitals (Table 2). Laboratory performance was described in terms of analytic sensitivity (i.e., of positive specimens, the proportion that were reactive), analytic specificity (i.e., of negative specimens, the proportion that were nonreactive), and overall analytic performance (i.e., for all specimens tested, the proportion for which test results were correct). Enzyme immunoassay. In each survey, greater than 80% of the EIA results were reported by blood bank and hospital laboratories. The FDA-licensed Abbott** HTLV-I EIA kit was used by approximately 75% of the laboratories reporting EIA results. From the October 1989 survey to the July 1990 survey, overall EIA analytic sensitivity declined from 99.4% to 96.7% (Table 3). Although the analytic sensitivity for HTLV-I-antibody-positive samples ranged from 99.8% to 100% during all three survey periods, the analytic sensitivity for HTLV-II-antibody-positive samples declined from 99.2% in October 1989 to 95.1% in July 1990. The EIA analytic specificity was more than 98% during all three survey periods. The decline in overall analytic performance from greater than 99% in October 1989 to 97.3% in July 1990 reflected changes in the EIA analytic sensitivity. Western blot. Approximately 70% of the WB test results were reported by hospital, independent, and other laboratories. The WB tests manufactured either by Biotech or prepared by participating laboratories were used by approximately 70% of the laboratories reporting WB results. In all three surveys, the WB analytic specificity was greater than 97%, while the overall WB analytic sensitivity was less than 65%. The analytic sensitivity for HTLV- I-antibody-positive samples declined from 100% in October 1989 to 94.8% in July 1990. However, because the analytic sensitivity for HTLV-II-antibody- positive samples was less than or equal to 50% in the three surveys, the overall WB analytic performance was less than 76%. Reported by: Model Performance Evaluation Program, Laboratory Performance Evaluation Section, Laboratory Practice Assessment Br, Div of Laboratory Systems, Public Health Practice Program Office, CDC. Editorial Note: Although HTLV-II has not been clearly linked with any disease (3), a high prevalence of HTLV-II infection has been reported among HTLV- seropositive U.S. injecting-drug users (91%-93%) (4,5) and HTLV seropositive U.S. blood donors (50%) (6). Because HTLV-I and HTLV-II are closely related, the genome of HTLV-II encodes viral proteins similar to those of HTLV-I causing extensive serologic cross-reactivity. FDA-licensed viral-lysate-based EIAs for HTLV-I do not distinguish HTLV-I from HLTV-II infection; therefore, many repeat-reactive HTLV-I EIA specimens submitted for WB supplemental testing are positive for HTLV-II antibody. Additionally, available but unlicensed HTLV-I WB test kits and reagents cannot distinguish HTLV-I from HTLV-II infection, and HTLV-II-antibody-positive samples frequently are interpreted as WB indeterminate. Depending on the sensitivity of the particular WB kit for envelope reactivity, HTLV-I-antibody-positive samples also may be interpreted as WB indeterminate. The findings in this report for HTLV-I-antibody-positive samples by WB indicated high antibody reactivity to p19, p24, gp46, and/or gp61/68 and were consistently interpreted as seropositive. Because WB kits/reagents available for use during 1989-1990 often did not detect antibody to HTLV-II viral antigens, particularly envelope glycoprotein antigens, indeterminate interpretations were frequently reported for the HTLV-II-antibody-positive samples. Although most laboratories performed well in testing the performance evaluation samples by EIA, the basis for decline in analytic sensitivity during the three survey periods is unknown; CDC is further analyzing the reported data to identify factors that may have contributed to the decline. In addition, the findings in this report indicate that the unlicensed WB assays used by the laboratories lack sensitivity and specificity in detecting HTLV-II antibody and in discriminating between HTLV-I and HTLV-II infections. However, recent reports indicate that new but unlicensed WB kits containing recombinant envelope antigens demonstrated 100% sensitivity for detecting envelope antibody (7). Also, both type-specific synthetic peptides and recombinant proteins recently became available for differentiating HTLV-I from HTLV-II infection (8,9); these test kits are not licensed by the FDA. Because of the clinical importance of HTLV-I, the high prevalence of HTLV-II in high-risk behavior groups (1), and the need for precise medical diagnosis of HTLV-infection status for patient counseling, laboratories need licensed WB assays that are more sensitive and specific to detect HTLV-II antibody and to discriminate between HTLV-I and HTLV-II infections. References 1. CDC. Licensure of screening tests for antibody to human T-lymphotropic virus type I. MMWR 1988;37:736-40,745-7. 2. CDC. Performance evaluation program: testing for human immunodeficiency virus infection. MMWR 1987;36:614. 3. Rosenblatt JD, Golde DW, Wachsman W, et al. A second isolate of HTLV-II associated with atypical hairy-cell leukemia. N Engl J Med 1986;315:372-7. 4. Lee H, Swanson P, Shorty VS, Zack JA, Rosenblatt JD, Chen ISY. High rate of HTLV-II infection in seropositive IV drug abusers in New Orleans. Science 1989;244:471-5. 5. Kwok S, Gallo D, Hanson C, McKinney N, Poiesz B, Sninsky JJ. High prevalence of HTLV-II among intravenous drug abusers: PCR confirmation and typing. AIDS Res Hum Retroviruses 1990;6:561-5. 6. CDC. Human T-lymphotropic virus type I screening in volunteer blood donors- -United States, 1989. MMWR 1990;39:915,921-4. 7. Lillehoj EP, Alexander SS, Dubrule CJ, et al. Development and evaluation of a human T-cell leukemia virus type I serologic confirmatory assay incorporating a recombinant envelope polypeptide. J Clin Microbiol 1990;28:2653-8. 8. Lal RB, Heneine W, Rudolph DL, et al. Synthetic peptide-based immunoassays for distinguishing between human T-cell lymphotropic virus type I and type II infections in seropositive individuals. J Clin Microbiol 1991;29:2253-8. 9. Lipka JJ, Santiago P, Chan L, et al. Modified Western blot assay for confirmation and differentiation of human T-cell lymphotropic virus types I and II. J Infect Dis 1991;164:400-3. *HTLV-I is not closely related to human immunodeficiency virus type 1, does not cause depletion of CD4+ cells, is not associated with immunosuppression, and does not cause acquired immunodeficiency syndrome (1). **Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services. -- ------------------------------------ Jack Hamilton jfh@netcom.com