+------------------------------------------------+ ! ! ! Health Info-Com Network ! ! Medical 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 1994 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 biweekly. Articles on a medical nature are welcomed. If you have an article, please contact the editor for information on how to submit it. If you are interested in joining the automated distribution system, please contact the editor. E-Mail Address: Editor: Internet: david@stat.com Bitnet = ATW1H@ASUACAD LISTSERV = MEDNEWS@ASUACAD.BITNET (or internet: mednews@asuvm.inre.asu.edu) anonymous ftp = vm1.nodak.edu Notification List = hicn-notify-request@stat.com FAX Delivery = Contact Editor for information ---------------------------------------------------------------------- Date: Sun, 01 May 94 21:09:23 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR 29 Apr 94] Raccoon Rabies Epizootic Message-ID: Current Trends Raccoon Rabies Epizootic -- United States, 1993 Although the incidence of rabies is low among domestic animals in the United States, the recent increase in the occurrence of wildlife rabies has increased the risk for infection of humans. From 1991 to 1992, the number of reported cases of rabies in raccoons increased 40%, from 3079 to 4311. Of the 8644 animals reported rabid during 1992, a total of 3759 (43%) were raccoons in the mid-Atlantic and northeastern states (1). This report describes the continuing spread of the raccoon rabies epizootic in the mid-Atlantic and northeastern states. Connecticut. Rabies was first confirmed in raccoons in Connecticut in March 1991 and subsequently has been confirmed in raccoons in all towns but one west of the Connecticut River. Overall, the rabies epizootic in raccoons has involved six of eight counties and 129 of 169 towns. From 1992 to 1993, the number of confirmed cases of rabies in animals decreased 8% (from 831 to 762). Of the 1256 raccoons tested in 1993, 662 (53%) were positive for rabies. Since 1991, when the first case was detected in a raccoon, 1786 cases have been identified among animals, including 31 cases among domestic animals (22 cats, three dogs, three sheep, two horses, and one cow). Massachusetts. Rabies was first confirmed in raccoons in Massachusetts in September 1992 in Ashby, near the New Hampshire border and more than 60 miles north of the nearest cases of raccoon rabies in Connecticut. During 1993, cases were confirmed in animals in 175 (50%) of 351 towns and 10 of 15 counties; cases were not detected in the southeastern counties. Overall, from 1992 to 1993, the number of confirmed cases increased nearly 17-fold, from 42 to 698. Of the 1486 raccoons tested in 1993, 585 (39%) were positive for rabies. Since September 1992, although most (623) cases have occurred in raccoons, cases also have been detected in skunks (81), cats (14), woodchucks (11), foxes (eight), and cattle (three). New Hampshire. Rabies was first confirmed in raccoons in New Hampshire in April 1992 in Rumney in midstate. Cases subsequently have been detected in 48 towns in four counties in the southern region of the state. During 1993, 148 animals tested positive for rabies (103 [37%] of 278 raccoons, 32 skunks, five bats, three woodchucks, three cats, one pony, and one rabbit). At least one isolate from each species (except bats) was characterized as the strain associated with the raccoon rabies epizootic. One cat had received one dose of rabies vaccine 8 months before onset of illness. New York. Rabies was first confirmed in raccoons in New York in May 1990; since then, cases have been confirmed in animals in 50 of the 62 counties. In 1991 and 1992, rabies was confirmed in 666 and 1392 raccoons, respectively. In 1993, rabies was diagnosed in 2747 animals, comprising 17 species of mammals. Of the 4463 raccoons tested, 2369 (53%) were positive. From 1992 to 1993, the number of persons who received postexposure rabies prophylaxis increased from 1125 to 2905. In July 1993, a case of human rabies was attributed to a strain that characteristically infects silver-haired bats (2). North Carolina. Since 1990, three distinct epizootics of rabies have occurred in animals in North Carolina: during 1990, the skunk rabies epizootic from the Midwest entered two counties of northwestern North Carolina from Tennessee and Virginia; during 1991, the raccoon rabies epizootic from the Mid-Atlantic entered northeastern North Carolina from Virginia; and during 1992, the raccoon rabies epizootic from the Southeast entered from South Carolina into two regions of southcentral and southeastern North Carolina. Since 1990, rabies has been detected in terrestrial animals in 22 of 100 counties; rabies was confirmed in terrestrial animals for the first time in eight of these counties in 1993. The number of rabies cases more than doubled each year during 1991-1993: 24 cases in 1991, 50 cases in 1992, and 106 cases in 1993. During 1993, 71 (18%) of 386 raccoons tested were positive. In addition, the number of rabid domestic animals--eight cats and two dogs--was the highest annual total reported in North Carolina since 1959; none of these animals had been vaccinated against rabies. Reported by: ML Cartter, MD, GH Cooper, JL Hadler, MD, State Epidemiologist, Connecticut State Dept of Public Health and Addiction Svcs. M McGuill, DVM, A DeMaria, MD, State Epidemiologist, Massachusetts Dept of Public Health. MG Smith, MD, State Epidemiologist, New Hampshire State Dept of Health and Human Svcs. JG Debbie, DVM, DL Morse, MD, State Epidemiologist, New York State Dept of Health. JL Hunter, DVM, JN MacCormack, MD, State Epidemiologist, North Carolina Dept of Environment, Health, and Natural Resources. Viral and Rickettsial Zoonoses Br, Div of Viral and Rickettsial Diseases, National Center for Infectious Diseases, CDC. Editorial Note: Since the introduction of the raccoon rabies epizootic in the mid-Atlantic region in 1977, cases have been identified in 11 states and the District of Columbia (Figure 1). Cases were first detected in West Virginia (1977) and subsequently in Virginia (1978), Maryland (1981), the District of Columbia (1982), Pennsylvania (1982), Delaware (1987), New Jersey (1989), New York (1990), Connecticut (1991), North Carolina (1991), Massachusetts (1992), and New Hampshire (1992). During January-February 1994, the first cases in Rhode Island were detected in two raccoons and a fox. In the Northeast, only Vermont and Maine remain unaffected by the raccoon rabies epizootic. In 1990, raccoons surpassed skunks as the species in which rabies was detected most often in the United States, and the number of cases in raccoons continued to increase (Figure 2). Although the raccoon strain of rabies virus has been detected in many species, no known cases have occurred in humans. However, vaccination of dogs and cats remains important for the control and prevention of rabies because these domesticated species may serve as a link in rabies transmission between wildlife and humans. Rabies control in wildlife through oral vaccination is being evaluated in the United States (3); this approach has been successful in controlling fox rabies in parts of Europe (4) and in Canada (5). In April 1992, a program to administer vaccinia-rabies glycoprotein recombinant vaccine orally to raccoons was initiated in Cape May County, New Jersey. Similar programs are being planned that would target raccoons in areas of Massachusetts and New York, coyotes in Texas (6), and foxes in New York and Vermont. Additional field trials of the oral rabies vaccine should establish distribution methods, the minimum effective geographic area, bait density, frequency, and time(s) of year for vaccination. These assessments will help determine the cost-effectiveness and appropriate use of oral wildlife vaccination. Population reduction of wildlife rabies reservoirs is not a recommended or cost-effective method for rabies control (7). The costs of programs to prevent rabies have increased in parallel with the spread of the epizootic. For example, in New York, which in 1993 recorded the largest number of cases of rabies in wildlife ever reported by one state (1), the number of persons receiving postexposure rabies prophylaxis increased from 84 in 1989 to 2905 in 1993 (J.G. Debbie, D.V.M., New York State Department of Health, personal communication, 1994). In New Jersey, private and public expenditures associated with the raccoon rabies epizootic in two counties more than doubled from the pre-epizootic period ($405,565 per 100,000 population) to the epizootic period ($979,027 per 100,000 population) (8). Rabies prevention activities at the state and local levels have been aimed at reducing exposure to rabies-infected animals and insuring proper treatment when exposure occurs. For example, in some states, vaccination requirements for both dogs and cats have been statutorily mandated. Health departments, in collaboration with veterinary associations and animal-control and animal-welfare groups, have provided educational materials to the public about wildlife rabies, pet vaccination, and recognition of exposures to potentially rabid animals. Education efforts have targeted veterinarians and physicians because they often are the first to be informed of possible rabies exposures. State public health departments, state and local governments, CDC, and other federal agencies are collaborating to develop programs to control rabies epizootics (9). Information about rabies is available from state and local health departments and from CDC's Viral and Rickettsial Zoonoses Branch, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases; telephone (404) 639-1075. References 1. Krebs JW, Strine TW, Childs JE. Rabies surveillance in the United States during 1992. J Am Vet Med Assoc 1993;203:1718-31. 2. CDC. Human rabies--New York, 1993. MMWR 1993;42:799,805-6. 3. Rupprecht CE, Wiktor TJ, Johnston DH, et al. Oral immunization and protection of raccoons (Procyon lotor) with a vaccinia-rabies glycoprotein recombinant virus vaccine. Proc Natl Acad Sci U S A 1986;83:7947-50. 4. Brochier B, Kieny MP, Costy F, et al. Large-scale eradication of rabies using recombinant vaccinia-rabies vaccine. Nature 1991;354:520-2. 5. Rosatte RC, Power MJ, MacInnes CD, Campbell JB. Trap-vaccinate-release and oral vaccination for rabies control in urban skunks, raccoons and foxes. J Wildl Dis 1992;28:562-71. 6. Clark KA, Neill SU, Smith JS, et al. Epizootic canine rabies transmitted by coyotes in south Texas. J Am Vet Med Assoc 1994;204:536-40. 7. National Association of State Public Health Veterinarians. Compendium of animal rabies control, 1994. J Am Vet Med Assoc 1994;204:173-6. 8. Uhaa IJ, Dato VM, Sorhage FE, et al. Benefits and costs of using an orally absorbed vaccine to control rabies in raccoons. J Am Vet Med Assoc 1992;201:1873-82. 9. Spencer LM. Taking a bite out of rabies. J Am Vet Med Assoc 1994;204:479- 84. ------------------------------ Date: Sun, 01 May 94 21:10:39 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Deaths from Breast Cancer Message-ID: Current Trends Deaths from Breast Cancer -- United States, 1991 Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer death among women in the United States (1). For 1990, the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results Program (SEER) reported that the incidence of breast cancer was approximately 109 per 100,000 women (2). The annual incidence of breast cancer among women increased approximately 52% during 1950-1990, while the death rate increased 4% during the same period (2). This report summarizes epidemiologic information about deaths from breast cancer in 1991 and describes mortality trends during 1980-1991. Decedents for whom the underlying cause of death was breast cancer (International Classification of Diseases, Adapted, Ninth Revision, codes 174.0-174.9) were identified from public-use mortality data tapes (3). Denominators for rate calculations were derived from U.S. census population estimates (4,5). Rates were directly standardized to the age distribution of the 1970 U.S. population and were analyzed by state, age group, year, and race. To increase the precision of the rates presented, race was characterized only as "white," "black," and "other." In 1991, 43,583 women died from breast cancer; the overall death rate was 27.0 per 100,000 women (Table 1, page 279). The death rate for black women (31.9) was 19% higher than for white women (26.8). Rates for black women and white women were 2.6 times and 2.2 times higher, respectively, than that for women of other races (12.4). Since 1981, this rank order of death rates by race has been consistent. During 1980-1991, race-specific death rates for breast cancer among white women remained constant, increasing less than 1%. In comparison, from 1980 to 1991, rates for black women increased 21%, from 26.4 to 31.9 per 100,000 women, and rates for women of other races increased 29%, from 9.6 to 12.4. In 1991, death rates for breast cancer were 15-fold higher for women aged greater than or equal to 50 years (91.8) than for women aged less than 50 years (6.0) (Table 1, page 279). In both age categories, death rates were higher for black women than for white women and women of other races. Death rates varied from 17.6 in Hawaii to 35.9 in the District of Columbia (Table 2). Based on regional analysis, rates were highest in the Northeast. For white women, death rates ranged from 20.4 in Hawaii to 32.9 in New Jersey and for women of races other than white*, from 14.5 in Washington to 39.6 in the District of Columbia. For women aged less than 50 years, rates ranged from 2.8 in Alaska to 10.7 in the District of Columbia, and for women aged greater than or equal to 50 years, from 58.5 in Hawaii to 113.1 in New Jersey. Reported by: Cancer Surveillance Section, Epidemiology and Statistics Br, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC. Editorial Note: The findings in this report indicate that, in 1991, death rates for breast cancer varied substantially by race. These variations may reflect race-specific differences in stage of disease at diagnosis, survival rates, and prevalence of risk factors for breast cancer. For example, a SEER report for 1990** (the most recent year for which data are available) indicated substantial differences in the 5-year relative survival rate for white women (80.5%) compared with black women (64.1%). In addition, stage-specific data from SEER*** indicated survival among white women exceeded that for black women at all stages, and among white women breast cancer was more likely to be diagnosed at an earlier stage (2). Differences in state-specific death rates for breast cancer in 1991 may reflect factors that include racial composition, socioeconomic status, and access to and use of breast cancer screening and treatment. For example, for races other than white, the rate was highest in the District of Columbia, where 97% of the female residents in this combined category were black, and lowest in Washington, where 30% of the female residents in this category were black. Established risk factors for breast cancer include family history of breast cancer, history of benign breast disease, prior history of breast cancer, exposure to ionizing radiation, early age at menarche, late age at menopause, late age at first live birth, nulliparity, white race, and high socioeconomic status (1,6). Because many of these established risk factors are not alterable, secondary prevention is the current strategy for reducing mortality associated with breast cancer. Programs to reduce breast cancer mortality should emphasize the role of routine mammography screening to detect breast cancer at earlier, more treatable stages. The importance of this approach is underscored by findings from SEER indicating a 5-year relative survival rate of 93.2% for women with local disease compared with 18.2% for women with distant disease (2). Randomized clinical trials of breast cancer screening demonstrate an approximately 30% reduction in mortality for women aged 50-69 years; however, there has been no statistically significant decrease among women aged 40-49 years (7). For women aged greater than or equal to 50 years, routine screening with mammography and clinical breast examination has been recommended every 1-2 years (1,8). A national health objective for the year 2000 is to reduce breast cancer deaths to no more than 25.2 per 100,000 (baseline: 27.2 in 1987) (objective 16.3); specific age, racial/ethnic, and socioeconomic groups have been targeted for increases in screening (objective 16.11) (9). Recent results of the Behavioral Risk Factor Surveillance System indicate that in 1992, a median of 56% of women aged greater than or equal to 50 years reported having had a mammogram and clinical breast examination within the preceding 2 years (10). Based on the rapid increases in screening during the 1980s, breast cancer death rates could be reduced by the mid-1990s (2). References 1. American Cancer Society. Cancer facts and figures, 1994. Atlanta: American Cancer Society, 1994; publication no. 5008.94. 2. Hankey BF, Brinton LA, Kessler LG, Abrams J. Section IV: breast. In: Miller BA, Reis LAG, Hankey BF, et al, eds. SEER cancer statistics review, 1973-90. Bethesda, Maryland: US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, 1991:IV.1-IV.24; DHHS publication no. (NIH)93-2789. 3. NCHS. Vital statistics mortality data, underlying cause of death, 1980- 1991 [Machine-readable public-use data tapes]. Hyattsville, Maryland: US Department of Health and Human Services, Public Health Service, CDC, 1980- 1991. 4. Bureau of the Census. 1980-89 Intercensal population estimates by race, sex, and age [Machine-readable data files]. Washington, DC: US Department of Commerce, Bureau of the Census, nd. 5. Irwin R. 1990-92 Postcensal population estimates by race, sex, and age [Machine-readable data files]. Alexandra, Virginia: Demo-Detail, 1993. 6. Kelsey JL. Breast cancer epidemiology: summary and future directions. Epidemiol Rev 1993;15:256-63. 7. Fletcher SW, Black W, Harris R, Rimer BK, Shapiro S. Report of the International Workshop on Screening for Breast Cancer. J Natl Cancer Inst 1993;85:1644-56. 8. Volkers N. NCI replaces guidelines with statement of evidence. J Natl Cancer Inst 1994;86:14-5. 9. Public Health Service. Healthy people 2000: national health promotion and disease prevention objectives. Washington, DC: US Department of Health and Human Services, Public Health Service, 1991; DHHS publication no. (PHS)91-50213. 10. CDC. 1992 BRFSS summary prevalence report. Atlanta: US Department of Health and Human Services, Public Health Service, 1993. *Because of the small number of breast cancer deaths among women in other racial/ethnic groups and small populations of these groups in some states, the categories "black" and "other races" were combined for this state-specific analysis. **For women with breast cancer diagnosed during 1983-1989. ***For women with breast cancer diagnosed during 1983-1987. ------------------------------ Date: Sun, 01 May 94 21:11:29 MST From: mednews (HICNet Medical News) To: hicnews Subject: [MMWR] Vaccination Coverage of 2-year-old Children Message-ID: Current Trends Vaccination Coverage of 2-Year-Old Children -- United States, 1992-1993 The principal goal of the Childhood Immunization Initiative (CII) is to increase, by 1996, vaccination levels for 2-year-old children to at least 90% for the most critical doses in the vaccination series (i.e., one dose of measles-mumps-rubella vaccine [MMR] and at least three doses each of diphtheria and tetanus toxoids and pertussis vaccine [DTP], oral poliovirus vaccine [OPV], and Haemophilus influenzae type b vaccine [Hib]) and to at least 70% for at least three doses of hepatitis B vaccine (Hep B) (1). Since 1991, annual national estimates of vaccination coverage levels of preschool-aged children have been available through the National Health Interview Survey (NHIS) conducted by CDC (2,3). This report presents vaccination coverage levels of children aged 19-35 months for 1992 and provisional estimates of vaccination coverage for the combined first and second quarters of 1993 (Table 1). Vaccination coverage increased for three vaccines from 1992 to 1993: for three or more doses of Hib, from 28.0% to 49.9% (p <0.05); for three or more doses of poliomyelitis vaccine, from 72.4% to 78.4% (p <0.05); and for three or more doses of DTP/ diphtheria and tetanus toxoids (DT), from 83.0% to 87.2% (p greater than 0.05). Coverage with measles-containing vaccine decreased from 82.5% to 80.8% (p greater than 0.05). Among 19-35-month-olds, 12.7% had received three or more doses of Hep B. From 1992 to 1993, the proportion of children who had received a combined series of four or more doses of DTP/DT, three or more doses of polio vaccine, and one dose of MMR increased from 55.3% to 64.8% (p <0.05), primarily because of increased coverage with the fourth DTP/DT dose (from 59.0% to 71.1% [p <0.05]). Reported by: National Immunization Program; Div of Health Interview Statistics, National Center for Health Statistics, CDC. Editorial Note: In 1993, processing of the NHIS was modified to produce national vaccination coverage estimates for each quarter. The findings in this report represent the first provisional quarterly estimates and indicate substantial progress in efforts to attain the 1996 antigen-specific vaccination goals for DTP and polio vaccine. However, coverage with measles-containing vaccines has not improved since 1991, when 82.0% of 2-year-old children were reported to be vaccinated. Although the coverage levels for Hib and hepatitis B remain suboptimal, the levels described in this report may underestimate coverage because many children were born before the recommendations for universal infant vaccination that were promulgated in October 1990 (4) and November 1991 (5). Less than 1% of 19-35-month-old children surveyed during January-June 1993 were born after recommendations for universal infant vaccination against hepatitis B went into effect. Similarly, only approximately two thirds of the children aged 19-35 months included in this survey were born after October 1990--when Hib was approved for infants. Provisional results from NHIS for the first two quarters of 1993 indicate that the combined efforts of public and private health-care providers at local, state, and national levels have facilitated progress toward both the 1996 CII goal and the year 2000 national health objective to increase vaccination levels for 2-year-olds to 90% (objective 20.11) for the complete series of recommended vaccine doses against all nine diseases (i.e., four or more doses of DTP, three or more doses of OPV, three or more doses of Hib, one dose of MMR, and three or more doses of Hep B) (6). However, based on the reported 1993 coverage levels, approximately 1.25 million children require at least one dose of OPV, and 1.12 million require a dose of measles-containing vaccine; approximately 740,000 children have not received at least three doses of DTP/DT. These findings emphasize the need for public and private health-care providers and local, state, and national public health officials to collaborate on implementation of the CII to achieve higher levels of vaccination coverage among 2-year-olds. References 1. CDC. Reported vaccine-preventable diseases--United States, 1993, and the Childhood Immunization Initiative. MMWR 1994;43:57-60. 2. Massey JT, Moore TF, Parsons VL, et al. Design and estimation for the National Health Interview Survey, 1985-94. Hyattsville, Maryland: US Department of Health and Human Services, Public Health Service, CDC, 1989. (Vital and health statistics; series 2, no. 110.) 3. CDC. Vaccination coverage of 2-year-old children--United States, 1991- 1992. MMWR 1994;42:985-8. 4. ACIP. Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older--recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-1). 5. ACIP. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination-- recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-13). 6. 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. ------------------------------ Date: Sun, 01 May 94 21:12:28 MST From: mednews (HICNet Medical News) To: hicnews Subject: Taxol Approved for Breast Cancer Message-ID: ========================================================================= Food And Drug Administration Recalls, News, And Warnings ========================================================================= Taxol Approved for Breast Cancer We are receiving inquiries about the approval of Taxol for breast cancer when standard chemotherapy has failed. In December l992, FDA approved Taxol for treatment of ovarian cancer that has not responded to standard chemotherapy. The following may be used to answer questions. On April 13, l994, FDA approved a supplemental application for Taxol for treatment of metastatic breast cancer in patients who have not responded to first line chemotherapy or who have relapsed after chemotherapy. The approved label states that the drug is indicated for "breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated." Anthracycline drugs such as doxorubicin (Adriamycin) are among the drugs of choice for treatment of breast cancer. Although Taxol does not cure unresponsive breast cancer, several early studies and a large multicenter trial found it to be effective in shrinking tumors. In a multicenter randomized trial of 471 patients in Canada and Europe, Taxol decreased tumor size by one half in 26 percent of patients. These patients remained stable for an average of eight months from the start of treatment. The average survival time following treatment with Taxol was 11.7 months. While Taxol is beneficial in some cases, it has serious side effects. The more serious side effects include neutropenia -- a decrease in white blood cells which may increase susceptibility to infections -- hair loss, and numbness of the fingers and toes. Taxol (paclitaxol), extracted from yew tree bark, is currently marketed by Bristol-Myers Squibb of Wallingford, Conn. ------------------------------ Date: Sun, 01 May 94 21:13:57 MST From: mednews (HICNet Medical News) To: hicnews Subject: FDA Co-sponsors Meeting on Dietary Fiber Message-ID: FDA CO-SPONSORS MEETING ON DIETARY FIBER The Food and Drug Administration is co-sponsoring a conference May 12 and 13 in Arlington, Va., on what role dietary fiber plays in reducing the risk of certain forms of cancer and heart disease. Other conference sponsors are the Department of Health and Human Services, the Office of Disease Prevention, the National Cancer Institute, the Centers for Disease Control and Prevention, the National Heart, Lung and Blood Institute, the Congressional Research Service, the American Cancer Society, the American Heart Association, the Institute of Medicine, the American Medical Association, the Federal Trade Commission and the American Society of Clinical Nutrition. The meeting runs from 8 a.m. to 5:30 p.m. on May 12, and from 8:30 a.m. to 5 p.m. on May 13, at the Crystal Gateway Marriott Hotel, 1700 Jefferson Davis Highway, Arlington, Va. For more information about the scientific issues to be discussed contact Dr. James Tanner, Office of Special Nutritionals (HFS- 451), Food and Drug Administration, 200 C Street, S.W., Washington, D.C. 20204; telephone (202) 205-4168. Registration information may be obtained by contacting Tammy Lowry with the KRA Corporation of Silver Spring, Md., at (301) 495-1591. ------------------------------ Date: Sun, 01 May 94 21:14:57 MST From: mednews (HICNet Medical News) To: hicnews Subject: FDA Approves New Device for Paraplegics Message-ID: FDA APPROVES NEW DEVICE FOR PARAPLEGICS We are receiving inquiries about a new medical device that will for the first time enable some paraplegics to stand and take steps with a walker. The device, the Parastep I System, was approved by FDA on April 20. The following can be used to answer questions. Parastep I System triggers leg movement in certain paralyzed people with a battery-powered neuromuscular stimulator that sends computer-coordinated electrical signals through electrodes to leg muscles. The device, for use by some people with spinal cord injuries, provides limited mobility to individuals who otherwise must depend entirely on a wheelchair. It does not cure paralysis or provide normal walking, but it will enable some patients to stand and take steps with a walker. The device's microprocessor-stimulator unit is attached to the waist and connected to the legs and a walker with electrodes and cables. When activated, it stimulates leg movement and enables a person to stand safely and take steps while holding onto a walker. The user controls the stimulator unit through switches on the handlebars of the walker. Use of the device requires extensive training by a physical therapist. FDA approved the device based on a review of scientific data on its safety and effectiveness submitted by the manufacturer, Sigmedics Inc. of Northfield, Ill., and the recommendation of FDA's rehabilitation and orthopedics devices advisory panel. Clinical studies of 67 spinal cord-injured patients at 13 medical centers showed that with physical therapy training 59 of the 67 could stand and take steps with the walker. Of the 59, 20 could take steps without help, 2 required verbal assistance and 37 required physical assistance. However, only 8 of the 37 had completed the full course of training when the study concluded. The distance patients could walk ranged from 8 feet to 1,721 feet, with most people walking over 50 feet. Most patients in the study were able to increase their distance the longer they used the device. Parastep requires upper body strength and finger dexterity to be used safely and effectively. It should not be used by spinal cord-injured people who have epilepsy, cognitive deficiencies, osteoporosis, spasticity or other conditions that could interfere with its safe use. ------------------------------ Date: Sun, 01 May 94 21:16:15 MST From: mednews (HICNet Medical News) To: hicnews Subject: New Protein Preventing Viral Spread Discovered Message-ID: "Research" Nov 1993, No 30 Weizmann Institute of Science NEW PROTEIN PREVENTING VIRAL SPREAD DISCOVERED A natural protein that prevents the spread of viruses has recently been discovered by researchers at the Weizmann Institute. The material, named antiviral helper factor (AVH) was shown in human tissue-culture experiments to prevent virus budding, the release of viral particles from living cells by passage through the cell's outer membrane. Because many viruses-including those responsible for influenza, parainfluenza, AIDS, and the animal disease vesicular stomatitis are spread by this process, AVH may in the future prove useful for controlling some of these conditions. A report on the discovery of AVH appeared in a recent issue of the journal Science. It was authored by Prof. Menachem Rubinstein of the Institute's Department of Molecular Genetics and Virology and his coworkers Dr. Dina G. Fischer (of InterPharm Laboratories, Ness Ziona), Nathan Tal, Dr. Daniela Novick, and Sara Barak. A patent application covering the use of AVH in antiviral therapy has been submitted by Yeda Research and Development Co., which is responsible for commercial exploitation of Institute research. The discovery of AVH is an outgrowth of two decades of Weizmann Institute research into interferons- natural antiviral proteins, some of which are now used to treat systemic and dermatologic conditions caused by viruses. But because interferon injections are sometimes associated with side effects, including fever and flu-like malaise, biomedical researchers have been looking for alternative natural antiviral materials. Some time ago, Dr. Dina Fischer, then a member of Rubinstein's group, was studying the ability of interferon to protect cell cultures from vesicular stomatitis virus. This virulent pathogenic agent, which attacks cattle and sheep is used in interferon assays because it is not dangerous to laboratory workers. The researchers noticed that when human cells in culture were exposed to interferon they released a substance with a novel type of antiviral activity that was capable of protecting other cells from vesicular stomatitis virus. They therefore concluded that interferon, which is taken up by cells, stimulates the release of a soluble factor into the culture media, this factor being responsible for most of the total protection against vesicular stomatitis virus afforded by interferon. Preliminary characterization of the factor revealed it to be a soluble protein that was clearly not a member of the interferon family. Interferons induce major changes in cell physiology shifting the cell into an antiviral state that provides approximately 24 hours protection against viral takeover. AVH, however, is effective only while present in the cell media and has no extended effects; it must therefore operate by a completely different mechanism than that of interferon itself. The most surprising aspect of AVH was revealed only when sufficient quantities of the protein were obtained for structural characterization. The design and painstaking execution of a seven-step purification procedure provided 2 micrograms (millionths of a gram) of protein, enough material to show that the protein was pure and to identify its first 14 amino acid residues. A check of protein databases showed that AVH is identical to the external active site of a well-known cell-membrane protein, the low-density lipoprotein (LDL) receptor. This protein enables cells to take up LDL, commonly referred to as "bad" cholesterol, from the circulation. The LDL receptor has generated great interest because a genetic disorder, familial hypercholesterolemia, is caused by a mutation that inactivates this receptor. In such patients, cholesterol is not cleared from the blood, leading to arteriosclemsis, the blockage of blood vessels, and the appearance of heart attacks and stroke. Right now, says Rubinstein, we have no idea why a soluble fragment of the LDL receptor, which at first glance doesn't appear to be related to viral budding, has such a powerful antiviral effect. Rubinstein and his co-workers are now setting up a research program to solve this puzzle Soluble receptor fragments have recently received great attention in the scientific community. Some viruses cause infected cells to release such fragments in order to block the body's natural defense proteins from reaching their target membrane receptors **This viral defense scheme _ called the "the virus Star Wars campaign "** It now seems that cells themselves also prepare soluble forms of receptors - waging an antiviral Star Wars campaign of their own. Prof Rubinstein has already proven that AVH prevents the budding of vesicular stomatitis virus particles from infected cells He is now examining several other disease-causing viruses to see whether the new protein will be able to prevent their budding as well. "If things work out," he says, "AH either alone or together with interferon could provide an improved treatment for viruses that spread by budding However, much laboratory work remains to be done." This project, including the design of genetically engineered bacteria and cells that produce AVH, is being financed by InterLab Inc of Ness Ziona, under contract to Yeda Research and Development Co. ------------------------------ Date: Sun, 01 May 94 21:17:11 MST From: mednews (HICNet Medical News) To: hicnews Subject: AIDS Daily News Summary Message-ID: AIDS Daily Summary 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 1994, Information, Inc., Bethesda, MD Topics in this issue: - Aids Research Suffers Setbacks - Hospital Advises 4,100 Adult Ex-Patients to Get AIDS Test - CDC Study Launched to Track AIDS Treatment by Physicians - Breastfeeding Can Act as Transmitter of H.I.V. - Fighting Infectious Diseases With Blood Products - Study Finds Southern Europeans Die of AIDS Sooner - Scientists Find Compounds That May Block AIDS Virus - Megestrol Helps Enhance Appetite - FDA Approves Clinical Trial of Hyperthermia - Antiviral d4T to be Approved - Slower Heterosexual Spread of HIV-2 Than HIV-1 "Aids Research Suffers Setbacks" Financial Times (04/21/94) P. 17 (Griffith, Victoria) The past year doled out disappointment and dashed hopes to AIDS patients and scientists. Harvard researchers admitted that positive data on a cocktail of AZT-like drugs was faulty. Merck, which was working with one of the most promising of a new class of AIDS drugs known as protease inhibitors, discovered that its product staved off HIV only for 12 to 24 weeks before succumbing to infection. U.S. biotechnology firm Chiron suspended research for its candidate AIDS vaccine pending government funding for large-scale trials. And, in the latest setback, the Concorde study on AZT concluded that the drug has no value for asymptomatic HIV patients. Scientists are concerned that continued disappointment will lead the private sector to invest less money into HIV research. There are other disincentives to private research, according to Myron Essex, chairman of the Harvard AIDS Institute. "There is evidence that the number of people with AIDS in developed countries may be plateauing and even decreasing," he notes. "Most new AIDS cases are in developing countries, which may not be able to afford treatment even if it were available. Pharmaceutical companies don't usually invest heavily in researching drugs for declining markets." "Hospital Advises 4,100 Adult Ex-Patients to Get AIDS Test" Toronto Globe and Mail (04/20/94) P. A7 (Mickleburgh, Rod) More and more Canadian hospitals are now taking the time-consuming and expensive initiative to notify patients who received blood transfusions from 1978 to 1985, the critical period before donated blood was screened for HIV. Sunnybrook Health Science Center in Toronto is believed to be the first hospital in the country to launch a program expressly for contacting adult patients who may have received contaminated blood. On Tuesday, the facility mailed out 4,100 registered letters informing patients that they received blood that was not tested for the virus. The letter recommends that the patients undergo AIDS testing, if they have not already done so. Several other hospitals earlier took steps to track children and neonatal patients who received blood transfusions before HIV testing of blood was instituted in 1985. Advocates of the more than 1,000 Canadians infected through tainted blood have long called for such measures but, until recently, hospitals have resisted. For years, they depended upon broadly based public awareness campaigns to urge those who received donated blood in the critical period to take an AIDS test. "We're observing more and more hospitals trying to do something," said Carol Clemenhagen, president of the Canadian Hospital Association. "I guess we're learning that some people do not respond to that approach [public awareness campaigns]." "CDC Study Launched to Track AIDS Treatment by Physicians" AIDS Alert (04/94) Vol. 9, No. 4, P. 62 In September 1993, researchers launched a three-year effort to better monitor the changes in HIV/AIDS treatments and the evolution of the epidemic. "Because we are getting better at long-term survival, we need to study the changing history of infections to better understand how to focus our resources in the future," explains Dr. Steven Marlowe, principal investigator of the study, which is sponsored by the Centers for Disease Control and Prevention. "This is the first study to look at a broad spectrum of HIV patients being cared for by infectious disease specialists in a private-practice setting." The first part of the study involves tracking 4,000 or so HIV patients for three years. The researchers are gathering data to monitor trends in prophylaxis, treatment of opportunistic infections, and outcomes of care. The second vein of the study, which began in early April, will monitor treatment and outcomes of patients with pneumocystic carinii pneumonia. Researchers hope to answer questions about trends in the epidemic, such as which treatments effectively prolong life. "The investigators also hope to unlock other AIDS mysteries, including which drug or drug combination is most efficient in managing severe AIDS-related conditions and at what phase in the disease HIV patients are most vulnerable to infections. "Breastfeeding Can Act as Transmitter of H.I.V." New York Times (04/22/94) P. A26 (Mathur-Wagh, Usha; Roche, Natalie; Taha-Cisse, Ashaki H.) While generally in agreement that breastfeeding has its benefits, Roche et al. of Beth Israel Medical Center in New York warn that there is one circumstance in which the practice is potentially life-threatening. Although AIDS continues to be regarded as an almost exclusively male disease, Roche et al. say that the disease is now the leading cause of female mortality in New York City and New Jersey. As of 1991, they say, AIDS was the No. 1 killer of American women aged 15 to 44. The Beth Israel group cautions that it is crucial that women who are considering breastfeeding first undergo HIV testing. The virus is found in significant quantities in the breast milk of HIV-positive mothers. Like blood, semen, and vaginal fluids, breast milk is one of the bodily fluids through which HIV can be transmitted. Roche et al. realize that their recommendation may be viewed as an obstacle to encouraging women to breastfeed, yet feel that failure to issue such a warning would be a serious oversight from a public health perspective. Breastfeeding is best for babies whose mothers are HIV-negative, agree Roche et al., and every woman owes it to herself and her family to remain HIV-negative while breastfeeding, and beyond. "Fighting Infectious Diseases With Blood Products" Investor's Business Daily (04/21/94) P. A6 (Lau, Gloria) North American Biologics Inc. is leading the research effort into HIVIG, a product aimed at wiping out HIV infection in babies born to HIV-positive women. Mother-to-infant transmission of the virus can be interrupted by giving the newborn a dose of the blood component at birth to strengthen the immune system, says David Gury, the company's chairman, president, and chief executive. HIVIG is a preparation of antibodies called an immune globulin, taken from the blood of infected patients who remain healthy and still develop HIV antibodies. The compound is used to prevent and sometimes treat infectious diseases. "It takes a lot of antibody to make a product for an infant, but it takes a lot more product for an adult," says Gury, explaining why North American Biologics has not focused on perfecting the medication for adults. "Since this comes from people who already have AIDS, the availability of the product is very limited." "Study Finds Southern Europeans Die of AIDS Sooner" Reuters (04/21/94) AIDS patients in southern European nations died sooner than AIDS patients in the northern part of the continent, according to a study published in last Friday's issue of the British Medical Journal. Researchers studied 6,500 patients in 17 European countries who were diagnosed as HIV-positive between 1979 and 1989. "Survival of AIDS patients seemed to vary within Europe, being shorter in southern than central and northern Europe," the report concluded. Researchers did not determine what caused the regional differences, but speculated that the disparity may have been related to the "defining illnesses"--diseases common to AIDS patients--that first led doctors to diagnose AIDS. The report also found that patients treated with the antiviral drug AZT before being diagnosed with full-blown AIDS tended to die sooner. Researchers said this could be attributed to the fact that HIV infection was more advanced and the patients had a poor likelihood of survival anyway. In addition, older patients were found to have a lower survival rate. "Megestrol Helps Enhance Appetite" AIDS Alert (04/94) Vol. 9, No. 4, P. 61 Megestrol (Megace), a synthetic progesterone agent, has won approval for the treatment of anorexia, cachexia, and weight loss among AIDS patients. Two unpublished trials conducted from 1988 to 1991 found that AIDS patients gained between 10.7 to 11.2 pounds after 12 weeks of treatment with megestrol. At a dose of 800 mg a day, however, some patients experienced impotence, rash, or hypertension. Cutting the dosage in half may help impotence and other side effects, according to Isadore Pike, vice president of medical affairs for the Bristol-Myers Squibb Oncology-HIV Products Division. He recommends that the dosage be reduced from 800 mg to 400 mg when the patient has gained enough weight. Pregnant women should not take megestrol, and women who are not pregnant should use contraception when taking megestrol because of a potentially heightened risk of birth defects. "If you see somebody with AIDS, you see that his appetite really drops off, and there is no other obvious reason for that, that's the point you ought to consider instituting treatment" with megestrol, says Pike. "If the anorexia or weight loss appears to be a function of the disease itself, then I think [megestrol] becomes appropriate. But I don't think you need to wait to try it until they lose a tremendous amount of weight." It is not known through what mechanism the drug improves appetite. "Scientists Find Compounds That May Block AIDS Virus" Philadelphia Inquirer (04/26/94) P. A3 (Collins, Huntly) Scientists at the French laboratory of pharmaceutical giant Rhone-Poulenc Rorer have discovered a new class of compounds that appears to prevent HIV from invading human immune system cells in test tubes. The synthetic compounds, which are derived from betulinic acid found in the bark of the European plane tree, interrupt the viral life cycle at a very early stage and prevent HIV-infected cells from spreading to other cells. Although the mechanism is not fully understood, researchers say the compounds block the outer protein coat of HIV from bonding with the outer membrane of the host cell. Without this fusion, the virus cannot reproduce. According to the French team, the new compounds were effective against the most common strains of HIV-1, but were unable to inhibit so-called Zairean strains of HIV-1 found in sub-Saharan Africa, or HIV-2, which is prevalent in West Africa. This suggests that the virus may be able to build a resistance to the compounds. Jean-Francois Mayaux, head of the French team, warned that the finding was based on lab experiments and would have to be confirmed in clinical trials of humans. Rhone-Poulenc Rorer hopes to test the new agents in people sometime next year. "FDA Approves Clinical Trial of Hyperthermia" Washington Blade (04/22/94) Vol. 25, No. 16, P. 29 The U.S. Food and Drug Administration (FDA) on March 29 approved a clinical trial of a controversial HIV treatment known as hyperthermia. Within two months, IDT Corporation of Pittsburgh, Pa., is expected to begin a "feasibility study" testing hyperthermia in 10 patients. The treatment involves removing the blood from an HIV patient, heating it to about 110 degrees to kill the virus, then returning the blood to the patient. Officials at the National Institutes of Health (NIH) said there was no value in the treatment, and that no further research was necessary. But Sen. Frank Lautenberg (D-N.J.) says he has met with NIH and FDA officials to push for hyperthermia research. "Antiviral d4T to be Approved" AIDS Alert (04/94) Vol. 9, No. 4, P. 61 The antiviral d4T, a nucleoside in the same class of drugs as AZT, ddI, and ddC, is expected to be approved this year, reports Susan J. Yarin, spokeswoman for Bristol-Myers Squibb Co., which manufactures Zerit, a brand name version of the drug. Currently, d4T is available only as part of the Food and Drug Administration's Parallel Track Program for patients who cannot tolerate the drug, or for whom other therapies have failed. Nearly 11,000 HIV/AIDS patients have received d4T through the program at no charge; however, data on the trials will not be available until later this year, says Yarin. "Slower Heterosexual Spread of HIV-2 Than HIV-1" Lancet (04/16/94) Vol. 343, No. 8903, P. 943 (Kanki, Phyllis J.; Travers, Karin U.; Chung-Cheng, Hsieh et al.) Because HIV-2 has similar virological characteristics to HIV-1, this virus type was assumed to be just as infectious and capable of causing AIDS. Studies have identified significant rates of HIV-2 infection in West Africa, and surveys from other regions of the world indicate that HIV-2 infection continues to spread. Because the pathogenic potential of HIV-2 is considered to be lower than that of HIV-1, it is therefore important to recognize the transmission properties of HIV-2 and its contribution to the AIDS pandemic. Since 1985, Kanki et al. have studied 1,452 registered female prostitutes. The overall incidence of HIV-1 and HIV-2 was identical during the study; however, the annual incidence of HIV-1 increased substantially with a 12-fold increase in risk over the entire study period. The incidence of HIV-2, on the other hand, remained stable despite a higher prevalence of HIV-2. In Kanki et al.'s sample population, the heterosexual spread of HIV-2 is significantly slower than that of HIV-1, which strongly suggests differences in the viruses' infectivity potential. ------------------------------ End of HICNet Medical News Digest V07 Issue #15 *********************************************** --- Editor, HICNet Medical Newsletter Internet: david@stat.com FAX: +1 (602) 451-1165 Bitnet : ATW1H@ASUACAD