From: david@stat.com (David Dodell)
Newsgroups: sci.med
Subject: HICN506 Newsletter (long)
Date: Sun, 20 Dec 92 09:32:19 MST
Reply-To: david@stat.com (David Dodell)
Distribution: world
Organization: Stat Gateway Service, WB7TPY

Volume  5, Number  6                                         December 20, 1992

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                         Editor: David Dodell, D.M.D.
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Compilation Copyright 1992 by David Dodell,  D.M.D.  All  rights  Reserved.  
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                       T A B L E   O F   C O N T E N T S


1.  Centers for Disease Control - MMWR
     [10 Dec 92] Population-Based Mortality Assessment, Somalia, 1992 .....  1
     Poliomyelitis Outbreak -- Netherlands, 1992 ..........................  5
     Knowledge of the Purpose of Community Water Fluoridation .............  7
     Tuberculosis Transmission in State Correctional Institution .......... 11
     Availability of Parenteral Isoniazid -- United States ................ 15

2.  Food & Drug Administration News
     FDA Approves Depo Provera ............................................ 16
     FDA Warns Against Hismanal Interaction ............................... 18
     New Food Safety Education Program for Nursing Homes .................. 19
     Sotalol Hydrochloride Approved For Ventricular Arrhythmia ............ 21
     FDA Advisory Committee Recommends Taxol For Ovarian Cancer ........... 23
     FDA Bans 415 Over-The-Counter Drug Ingredients ....................... 24
     PHS Advisory On Persistent Vaginal Fungal Infection .................. 29

3.  Columns
     Chronic Fatigue Syndrome Newsletter .................................. 31
     AIDS Daily Summary ................................................... 35

4.  Articles
     X-Ray Crystallography used to Track Down Viruses ..................... 43
     Sperm Homing Signal Discovered ....................................... 46






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::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
                      Centers for Disease Control - MMWR
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

                     Morbidity and Mortality Weekly Report
                               December 10, 1992
                 Courtesy of Karen S. Fleming, Epidemiologist
                    Infectious Disease Epidemiology Section
                     Arizona Department of Health Services


                              International Notes 
   Population-Based Mortality Assessment -- Baidoa and Afgoi, Somalia,  1992   

  Since 1990, Somalia has been the site of an intense civil war that has 
disrupted health-care services and food delivery to a substantial part of the 
country. A regional drought, in combination  with the ongoing civil 
disturbances, has further resulted in widespread famine. Multiple 
international government- and  nongovernment-aid agencies are involved in the 
relief effort for Somalia. However, security problems in most areas of Somalia 
have  prevented recent, systematic population-based assessments of the health 
and nutritional status of local Somali populations for use  in directing 
relief efforts. To characterize the mortality of  various Somali populations 
and to provide data on major population centers outside of the capital 
(Mogadishu), CDC, in collaboration  with the United Nations Children's Fund 
(UNICEF) and the U.S.  Agency for International Development, conducted a 
survey (1) of  urban populations in a central region of Somalia (Figure 1). 
This  report describes two pilot assessments performed during November 20-25 
and December 5-6, 1992, in the towns of Baidoa and Afgoi.  Baidoa 
     Baidoa is a regional center of the Bay Region of Somalia. Formal census 
data on this city were not available, and population estimates were provided 
by nongovernment-aid agencies. In early  August 1992, the estimated population 
of Baidoa was 37,000 persons;  by November 20, the town population had 
decreased to an estimated  21,000. On November 20, based on hut counts, the 
displaced population at two major camps for displaced persons (DPs) in Baidoa  
was approximately 5200 persons. An additional unknown number of DPs resided in 
the town itself.  
     For this mortality assessment, the DP-camp population was divided into 
seven areas of approximately equal populations (i.e., clusters), and survey 
starting points were randomly chosen in each of the seven areas. From the 
random starting point, residents in approximately seven consecutive huts in 
each cluster were selected to be interviewed. Interviewees were asked 
questions regarding deaths that occurred in the family (i.e., parents, spouse, 
or  children) from the first day following the Moslem holiday Ramadan (April 
3, 1992) to the day of the interview and deaths that  occurred during the 30 

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Volume  5, Number  6                                         December 20, 1992

days preceding the interview.  
     Mortality data were collected for 349 DPs who were alive on April 3 
(Table 1). From April 3 through November 21, 137 (39%) persons were reported 
to have died, resulting in an average daily  crude mortality rate (CMR) of 
16.9 deaths per 10,000 population. Among 63 displaced children aged less than 
5 years, 44 (70%) died  from April 3 through November 21 (aged less than 5 
years mortality rate [less than 5MR]=30.1 deaths daily per 10,000 population 
aged  less than 5 years). For all age groups, the most common reported causes 
of death based on a structured verbal autopsy were diarrhea (56% [9.4 deaths 
daily per 10,000]) and measles (23% [3.8 deaths daily per 10,000]). During the 
30 days preceding the survey, 16  (7%) of 228 persons died (average CMR=23.4 
deaths daily per  10,000), and among children aged less than 5 years, five 
(21%) of  24 died (less than 5MR=69.4 deaths daily per 10,000).  Of the sample  
population alive on November 20, 9% were children aged less than 5 years.  
     To measure mortality for the entire town of Baidoa, mortality 
surveillance data collected by the International Committee of the  Red Cross 
and the Somali Red Crescent Society were used. Each  morning, dead persons 
found in the city were counted after they  were transported by truck for 
burial. From August 9 through  November 14, 12,255 dead persons were 
transported for burial (37%  of the estimated August 9 Baidoa population).  
During this period,  an additional 3700 (10%) persons may have emigrated or 
have died and been buried without being counted. Deaths peaked in early 
September during concurrent epidemics of measles and multidrug-resistant 
Shigella dysenteriae (Figure 2). Afgoi 
     Afgoi is a town of approximately 35,000 persons that straddles  the 
Shabelle River 19 miles (30 km) west of Mogadishu. To  characterize health and 
mortality patterns in this town, 19 cluster  survey starting points were 
randomly chosen. On November 24-25 and December 5-6, eight consecutive huts or 
houses were visited in each  cluster. However, this survey was curtailed 
before the target  number of clusters were visited because of security 
concerns.  
     Mortality data were collected from 152 households for 1004  persons who 
were alive on April 3. Of the 767 long-term residents  of Afgoi and 237 
persons displaced from other areas who were included in the sample, 94 (9%) 
persons died from April 3 through  December 6 (average CMR=4.0 deaths daily 
per 10,000). The most commonly reported causes of death based on a structured 
verbal autopsy were measles (28% [1.1 deaths daily per 10,000]) and diarrhea 
(22% [0.9 deaths daily per 10,000]).  
     DPs were more than 1.5 times as likely to die than were residents during 
this period (DP average CMR=5.5 deaths daily per  10,000; resident average 
CMR=3.5 deaths daily per 10,000). As in Baidoa, children aged less than 5 
years were at highest risk for death (less than 5MR=9.4 deaths daily per 
10,000); moreover, during  this period, mortality rates for displaced children 
aged less than 5 years reached 12.8 deaths daily per 10,000.  
     CMRs during the 30 days preceding the survey remained elevated  (DPs=6.3 

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deaths daily per 10,000; residents=3.7 deaths daily per 10,000) compared with 
the average daily CMRs for the preceding 7 months (DPs=5.6 deaths daily per 
10,000; residents=3.5 deaths daily  per 10,000) (Table 1).  

Reported by: 

United Nations Children's Fund, Mogadishu, Somalia. Disaster Assistance 
Response Team, US Agency for International Development, Nairobi, Kenya. Div of 
Field Epidemiology,  Epidemiology Program Office; Div of Vector-Borne 
Infectious  Diseases, National Center for Infectious Diseases; Div of  
Environmental Hazards and Health Effects, National Center for Environmental 
Health; International Health Program Office, CDC.  

Editorial Note: 

Extreme mortality rates commonly occur in  famine-affected, internally 
displaced, and refugee populations (1).  During the 1984-85 famine in the Horn 
of Africa, average CMRs  exceeded 20 deaths daily per 10,000 persons (1). By 
comparison, the  reported annual CMRs in the Horn of Africa during nonfamine 
times  ranged from 20 to 24 deaths per 1000, which is equivalent to daily CMRs 
of 0.55-0.65 deaths per 10,000 persons (2). The findings in these 
investigations of mortality among DPs in Baidoa and both displaced and 
resident populations in Afgoi suggest that health  conditions are considerably 
worse in Somalia than they were during peak mortality periods of the 1984-85 
famine in Ethiopia and Sudan.  The CMRs reported in these villages in Somalia 
are among the highest ever documented by a population survey among famine-
affected civilians.  
     Because of two important limitations in these studies, the  findings 
cannot be generalized to the entire population of Somalia.  First, although 
these studies were designed as cluster sample-population surveys to assess 
nutritional status and vaccination coverage among children aged 6-59 months, 
too few  children were present in the sampled households to permit precise 
estimates of the prevalence of malnutrition in these populations.  Second, the 
Baidoa survey characterized the mortality history only of displaced persons, 
and the Afgoi survey results may not have  characterized all sections of the 
town because the survey was  interrupted.  
     Despite these limitations, these findings are a measure of the magnitude 
of the famine-related disaster in Somalia. These findings  are also consistent 
with assessments of previous emergencies that  have documented that children 
aged less than 5 years and DPs are at  highest risk for dying.  One indicator 
of the intensity of this disaster is that only 9% of the sample population in 
the Baidoa  study were aged less than 5 years compared with 20%-25% for most 
developing-nation populations.  
     Although the surveillance data based on body counts in Baidoa suggest a 
gradual improvement in mortality rates, the mortality  rates derived from 

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Volume  5, Number  6                                         December 20, 1992

surveys of Afgoi and DPs in Baidoa may not have decreased during the 30 days 
preceding the survey, despite the massive relief efforts. The CMR in Afgoi is 
more than two times  higher than the rate recorded for the nearby towns of 
Merca and  Qorioley from April 1991 through April 1992 (3). Anecdotal reports 
from other regions of Somalia (e.g., Bardera and Saco Uen) suggest that local 
mortality rates may be higher than in Baidoa or Afgoi.  
     Measles, diarrhea, dysentery, acute respiratory infections, and malaria 
are common but preventable causes of mortality among famine-affected 
populations. Feeding programs are critical for reducing protein-energy 
malnutrition; however, community health  programs that focus on the prevention 
of these infections can also have a major impact on mortality.  Community-
based measles  vaccination and oral rehydration programs should be given high 
priority during famine-related emergencies. In addition, routine vitamin A 
supplementation for all children aged less than 5 years  (and older children 
if malnutrition rates are high in older age  groups) may also reduce child 
mortality, especially measles-related  mortality (4). Surveillance efforts 
should include monitoring of trends in morbidity and mortality and evaluation 
of relief efforts.  

References

1. CDC. Famine-affected, refugee, and displaced populations: recommendations 
for public health issues. MMWR 1992;41(no. RR-13).  

2. United Nations Children's Fund. State of the World's Children,  1991. New 
York: United Nations Children's Fund, 1992.  

3. Manoncourt S, Doppler P, Enten F, et al. Public health  consequences of the 
civil war in Somalia, April 1992. Lancet 1992;340:176-7.  

4. Nieburg P, Waldman RJ, Leavell R, Sommer A, DeMaeyer EM. Vitamin  A 
supplementation for refugees and famine victims. Bull WHO  1988;66:689-97.













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Volume  5, Number  6                                         December 20, 1992

              Update: Poliomyelitis Outbreak -- Netherlands, 1992 

     The outbreak in the Netherlands of poliomyelitis among  unvaccinated 
persons who are members of religious groups that  generally do not accept 
vaccination is continuing (1). From  September 17 through December 5, 1992, 54 
cases of poliomyelitis were reported to the Netherlands' Office of the Chief 
Medical  Officer of Health (Figure 1). Of the 54 patients, 41 (76%) had 
paralytic manifestations of this illness; one neonate died, and 12 patients 
had aseptic meningitis. Fifty-one (94%) of the cases have been laboratory 
confirmed: 40 patients had wild poliovirus type 3  isolated from stool, and 11 
had IgM-specific antibody to poliovirus  type 3 suggestive of recent 
infection. All of the reported cases have occurred among unvaccinated (n=53) 
or inadequately vaccinated (n=1) persons belonging to a religious denomination 
that routinely does not accept vaccination. Patients ranged in age from less 
than 1 month to 56 years (mean age: 18.9 years). Of the 12 provinces in the 
Netherlands, seven have reported cases of poliomyelitis; the most severely 
affected provinces are South Holland and Gelderland.  

Reported by:

JK van Wijngaarden, MD, Div of Infectious Diseases, Office of the Chief 
Medical Officer of Health; AM van Loon, PhD, P Oostvogel, MD, MN Mulders, MSc, 
Laboratory of Virology, National Institute for Public Health and Environmental 
Protection; J  Buitenwerf, PhD, Laboratory of Virology, CF Engelhard, MD, Dept 
of Infectious Diseases, Municipal Health Svcs, Rotterdam, the Netherlands. 
World Health Organization, Geneva. Div of Immunization, National Center for 
Prevention Svcs; Div of Viral and  Rickettsial Diseases, National Center for 
Infectious Diseases, CDC.  

Editorial Note:

The poliomyelitis epidemic in the Netherlands  continues despite control 
measures initiated by the Dutch health authorities, including offering oral 
poliovirus vaccine to all previously unvaccinated persons belonging to 
affected religious  groups and to other previously unvaccinated persons aged 
less than 41 years and offering one dose of enhanced-potency inactivated 
poliovirus vaccine to persons who are incompletely vaccinated. Based on the 
ratio of cases of asymptomatic infection to paralytic disease for persons 
infected with poliovirus type 3 (at least  1000:1) (2), an estimated 54,000 
persons in the Netherlands may  have been infected with wild poliovirus type 3 
during this outbreak. Therefore, the risk for infection may be greater than 
previously assumed for unvaccinated or inadequately vaccinated travelers to 
the Netherlands. In addition, the potential for spread  of this poliovirus to 
other areas (including the North American  continent) by asymptomatically 
infected travelers from the Netherlands--even if not directly linked to a 

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Volume  5, Number  6                                         December 20, 1992

clinical case--also  may be higher than previously assumed.  
     To prevent transmission of imported polioviruses and cases of paralytic 
disease in the United States, increased efforts are  necessary to vaccinate 
all unvaccinated or inadequately vaccinated persons in the United States in 
accordance with recommendations of the Advisory Committee on Immunization 
Practices (3,4). Public health agencies and health-care providers should 
intensify outreach, especially to unvaccinated persons in these religious 
communities who do not routinely accept vaccination.  
     The risk for acquiring poliomyelitis while in the Netherlands is 
considered small because of the excellent sanitation in the country and 
because transmission of the poliovirus has been limited  primarily to 
unvaccinated religious groups. Nonetheless, the polio immunity of travelers to 
the Netherlands should be evaluated, and  persons with inadequate protection 
should complete a primary vaccination series with three doses of poliovirus 
vaccine before departure. For travelers with a completed primary series of  
poliovirus vaccine, it may be prudent to obtain one dose of poliovirus vaccine 
before departure, especially if extensive travel  in the Netherlands or 
contact with persons in the affected religious groups is anticipated.  

References

1. CDC. Poliomyelitis--Netherlands, 1992. MMWR 1992;41:775-8.  

2. Salk JE. Requirements for persistent immunity to poliovirus. Tr Ass Am 
Physicians 1956; 69:105-14 

3. CDC. Poliomyelitis prevention. MMWR 1982;31:22-6,31-4.  

4. CDC. Poliomyelitis prevention: enhanced-potency inactivated poliomyelitis 
vaccine--supplementary statement. MMWR 1987;36:795-8.















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                Effectiveness in Disease and Injury Prevention
      Knowledge of the Purpose of Community Water Fluoridation -- United
                                 States, 1990
   
Expansion of water-fluoridation programs in the United States has been based 
on the clear documentation of the caries-preventive benefits of fluoride (1), 
as well as resources made available since  the 1970s through the Fluoridation 
and Preventive Services Block grants administered by CDC. An estimated 135 
million persons in the  United States--approximately 61% of the population 
served by public  water supplies--have access to drinking water with 
clinically  important levels of fluoride (0.7 ppm or higher) for the 
prevention  of dental caries (2). Efforts to expand the implementation of 
community water fluoridation require dissemination and understanding of 
information about health benefits and purported health risks. This report 
summarizes results from the 1990 National  Health Interview Survey (NHIS) 
regarding public knowledge of the purpose and value of fluoridation of 
community drinking water.  
     Data for the NHIS were collected by CDC's National Center for Health 
Statistics through personal interviews with a representative  sample of the 
civilian, noninstitutionalized, U.S. population aged greater than or equal to 
18 years. The NHIS is conducted throughout  the year and has two parts: a 
basic health and demographic questionnaire (core) that is constant, and 
several specific  health-topic questions directed to adults in sample 
households. The  1990 NHIS included 41,104 respondents. Respondents were 
asked: "As you understand it, what is the purpose of adding fluoride to the 
public drinking water?" Interviewers coded responses as one of the following: 
"prevent tooth decay, protect teeth, or related response"; "purify the water 
or related response"; "other"; or "don't know." Analysis reflects adjustment 
for unequal probabilities of selection and for clustering introduced during 
sampling.  
     Almost two thirds (62%) of respondents correctly identified the purpose 
of fluoridation. Correct knowledge of the purpose of fluoridation was highest 
for persons aged 35-54 years (68%-70%), than for persons aged 18-24 years 
(49%) and aged greater than or equal to 75 years (40%) (Table 1).  
     Persons with more than a high school education were more than twice as 
likely than those with less than a high school education  (76% versus 36%) to 
correctly identify the purpose of fluoridation.  Among persons with a high 
school education, 61% answered correctly.  Among persons with less than a high 
school education, 30% believed the purpose of fluoridation was to purify 
water, compared with 36% who knew it was for preventing tooth decay.  
     Persons who were edentulous (i.e., had lost all of their  natural teeth) 
were less likely to know the correct purpose of fluoridation than were persons 
who still had their natural teeth (44% versus 64%). In addition, persons who 
visited the dentist 1-3 times during the preceding 12 months (66%-69%) were 
more likely to know the correct purpose of fluoridation than those who had not  

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Volume  5, Number  6                                         December 20, 1992

visited the dentist (50%).  

Reported by:

Disease Prevention and Health Promotion Br, Epidemiology and Oral Disease 
Prevention Program, National Institute of Dental Research; Musculoskeletal 
Disease Br,  Extramural Program, National Institute of Arthritis and  
Musculoskeletal and Skin Diseases, National Institutes of Health.  Div of Oral 
Health and Office of the Director, National Center for Prevention Svcs, CDC.  
Editorial Note: Dramatic declines in dental caries in the United States during 
the past half century that have been attributed largely to water fluoridation 
and other fluoride therapies reflect the public importance of fluoride 
exposure to human health (1). At the same time, continuing concerns have been 
raised about possible adverse health effects of fluoride.  
     Because more than one third of the U.S. adult population  cannot 
correctly identify the purpose of fluoridation, these persons may be less 
likely to make an informed decision when presented with conflicting 
information about the benefits and risks  of fluoridation during local efforts 
to fluoridate. The findings of  the NHIS suggest that misunderstanding of or 
resistance to fluoridation may be associated with the age and educational  
composition of a community. For example, because older populations have higher 
rates of edentulousness and are less likely to visit dentists, opportunities 
for reinforcement of the benefits of fluoridation are reduced (3).  
     Efforts to fluoridate water may be subjected to greater levels  of 
scrutiny than other public health interventions because fluoridation is a 
purposeful process to benefit individuals that must be instituted at the 
community level. For example, issues involving the relation between 
fluoridation and bone health and  osteoporosis are representative of the range 
of concerns raised  about potentially serious health effects of fluoridation. 
In the United States, approximately 250,000 hip fractures occur each year;  
osteo-porosis is an important underlying risk factor for this problem (4). 
However, based on reports from public health agencies,  the importance of 
results from some recent studies examining the relation of fluoride in 
drinking water to bone health and bone fracture susceptibility (5-10) appears 
to have been  overinterpreted.  
     To address concerns about the possible relation of bone health  to 
fluoride exposure, the National Institutes of Health (NIH)  convened a 
conference of experts to evaluate current public health practices regarding 
fluoride (11). The conference participants concluded that there was not an 
"adequate basis for making firm  conclusions relating fluoride levels in 
drinking water to hip  fracture and bone health" (11), and there were no 
recommended  changes in the Public Health Service policy regarding fluoride.  
     Since the NIH conference, two additional studies have been  reported 
regarding the relation of fluoride exposure to bone health  (9,10,12). An 
ecologic study involving three communities in Utah reported weak statistical 

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Volume  5, Number  6                                         December 20, 1992

evidence of increased risk for hip fracture in the exposed community (9); 
however, this study was constrained by a variety of methodologic limitations 
(10). The second study, conducted in Rochester, Minnesota, used a historical 
baseline incidence of hip fracture in a highly stable population;  in this 
study, there was no increased risk for hip fracture  following institution of 
fluoridation (12). The findings of these  additional studies do not alter the 
conclusions and recommendations  of the NIH conference.  
     The findings of the NHIS indicate a continuing modest level of knowledge 
of the purpose of fluoridation in the United States--  especially among young 
adults, the oldest adults, and the least  educated. These findings, coupled 
with conflicting information and possible misinterpretation about safety, may 
hinder efforts to expand fluoridation. Accordingly, health-care providers, 
public  health agencies, and schools should intensify efforts to educate the 
public, especially children and young adults, about the  benefits of 
fluoridation and maintaining oral health.  

References

1. Public Health Service. Review of fluoride benefits and risks: report of the 
ad hoc subcommittee of fluoride of the Committee to  Coordinate Environmental 
and Health Related Programs. Washington,  DC: US Department of Health and 
Human Services, Public Health  Service, 1991.  

2. CDC. Public health focus: fluoridation of community water systems. MMWR 
1992;41:372-5,381.  

3. National Institutes of Health. Oral health of United States adults, 
national findings. Washington, DC: US Department of Health and Human Services, 
Public Health Service, National Institutes of  Health, 1987; publication no. 
87-2868.  

4. Melton LJ III. Fluoride in the prevention of osteoporosis and fractures.  J 
Bone Miner Res 1990;5(suppl 1):S163.  

5. Riggs BL, Hodgson SF, O'Fallon WM, et al. Effects of fluoride treatment on 
the fracture rate in postmenopausal women with  osteoporosis. N Engl J Med 
1990;322:802-9.  

6. Kleerekoper M, Peterson EL, Nelson DA, et al. A randomized trial  of sodium 
fluoride as a treatment for postmenopausal osteoporosis. Osteoporosis 
International 1991;1:155-61.  

7. Sowers MF, Clark MK, Jannausch ML, Wallace RB. A prospective  study of bone 
mineral content and fracture in communities with different fluoride exposure. 
Am J Epidemiol 1991;133:649-60.  

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Volume  5, Number  6                                         December 20, 1992


8. Jacobsen SJ, Goldberg J, Brody JA, Stiers W, Rimm AA. Regional  variation 
in the incidence of hip fracture. JAMA 1990;264:500-2.  

9. Danielson C, Lyon JL, Egger M, Goodenough GK. Hip fractures and 
fluoridation in Utah's elderly population. JAMA 1992;286:746-8.  

10. Kleerekoper M. 'Please pass the roach poison again'  [Editorial]. JAMA 
1992;286:781-2.  

11. Gordon SL, Corbin SB. Summary of workshop on drinking water  fluoride 
influence on hip fracture [and] on bone health. Osteoporosis International 
1992;286:109-17.  

12. Jacobsen SJ, O'Fallon WM, Melton LJ III. Hip fracture incidence  before 
and after fluoridation of the public water supply:  Rochester, Minnesota, 
1950-1969. Am J Public Health (in press).




























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Volume  5, Number  6                                         December 20, 1992

                        Epidemiologic Notes and Reports 
       Tuberculosis Transmission in a State Correctional Institution --
                             California, 1990-1991 

During September and October 1991, active tuberculosis (TB) was diagnosed in 
two inmates and one employee of a California state  correctional institution 
(1991 average annual inmate population, 5421; employees, 1500).  This report 
presents findings from an  investigation by the California Department of 
Health Services  (CDHS), the California Department of Corrections (CDOC), and 
CDC to  determine whether ongoing transmission of Mycobacterium  tuberculosis 
was occurring in the institution. Case-Finding Among Inmates 
     A case of TB was defined by using the CDC surveillance case definition 
for clinically or laboratory-confirmed TB (1) in any  inmate diagnosed or 
treated for TB in the institution during 1991. Of 18 cases identified, 15 were 
culture confirmed. Of the 15 M.  tuberculosis isolates, 12 were susceptible to 
all drugs tested, and  three were resistant to a single drug (one to 
isoniazid, one to  streptomycin, and one to ethambutol). For 10 (56%) of the 
18 persons, onset of illness was recognized for the first time while they were 
in this institution during 1991, for an annual incidence of 184 per 100,000 
population in the institution. For the remaining  eight, seven had TB 
diagnosed before imprisonment, and one inmate  had TB diagnosed in 1990.  
     Restriction fragment length polymorphism analysis performed on  12 
available isolates revealed three distinct DNA patterns among eight M.  
tuberculosis isolates; the remaining four each had  different patterns.  
However, inmates with similar isolates were not  present at the institution at 
the same time and therefore could not  be linked epidemiologically.  
     Because of limited clinical evaluation and prolonged time to  sputum 
conversion, three case-patients may have been infectious for  a total of 7 
person-months during 1991. Other active cases were not  considered infectious: 
three were not culture confirmed, six were  diagnosed and the patients were 
started on adequate treatment  before they entered the correctional 
institution, two were in  persons who had no cough and had smear-negative 
pulmonary TB, and  four were in persons who had only extrapulmonary TB.  
     Of the 10 inmates whose diagnoses of TB were made while in the 
institution in 1991, two had negative tuberculin skin tests (TSTs) documented 
on entry to the correctional institution 8 months before  the diagnosis of TB. 
Neither patient had any known risk factors for  anergy; one was negative for 
antibody to human immunodeficiency  virus (HIV), and the other was not tested 
but did not report HIV risk behaviors.  Tuberculin Reactivity Among Inmates 
     The point prevalence of tuberculin positivity and the incidence of TST 
conversion among inmates were estimated from  inmate skin test results in 
November 1991 and correctional institution medical records. A positive TST was 
defined as a reaction of greater than or equal to 10-mm induration in response  
to 5 tuberculin units of tuberculin purified protein derivative administered 
by the Mantoux method.  

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Volume  5, Number  6                                         December 20, 1992

     Of 3070 inmates in the prison at the end of November 1991, TST  results 
were available for 2944 (96%). Of these, 873 (30%) were TST  positive: 549 had 
a history of a prior positive test and were not  retested in November 1991, 
and 324 tested positive for the first time at the prison in November 1991.  
     Of the 324 who tested positive at the prison, 155 had no  record of an 
earlier TST; for 21, results had been recorded as positive but the size of 
their TST reaction was not recorded. The  remaining 148 TST-positive inmates 
had documented skin test  conversions. Of these, 106 (72%) entered the state 
prison system with a negative TST and had skin test conversions while in the 
state prison system; for 97 of the 106, skin test conversion occurred within 
the previous 2 years. The remaining 42 persons who had skin test conversions 
spent some time outside the prison system  during the conversion intervals.  
Because of frequent inmate  movement between correctional institutions, 
conversions could not  be attributed specifically to the institution under 
investigation.  
     The 2-year conversion incidence was estimated to be 5.9 per 100 person-
years spent in the prison system. Case-Finding and Prevalence Among Employees 
     The employee identified as one of the three index case-patients was 
diagnosed with culture-negative pulmonary TB in  September 1991; the source of 
the employee's infection is  undetermined. This employee worked as a counselor 
on the prison's  HIV unit and recalled exposure to one of the three infectious  
inmates. The employee did not report any exposure to TB outside the  prison. 
The employee's most recent negative multipuncture skin test  for TB had been 
in May 1989, 1 year before employment at the prison.  
     Records regarding employees' current or past TST status were incomplete. 
However, two other employees had documented skin test conversions during the 
previous 2 years while working at the prison; one reported exposure to an 
inmate with possible TB. Neither reported any known exposures to M. 
tuberculosis outside the  prison.  

Reported by:

F Schwartz, MD, Marin County Health Dept, San Rafael; S Singh, PM Small, MD, 
Howard Hughes Medical Institute, Stanford;  D Cashman, MD, R Campbell, DO, N 
Khoury, MD, California Dept of  Corrections; S Coulter, S Royce, MD, R 
Roberto, MD, GW Rutherford, III, MD, State Epidemiologist, California Dept of 
Health Svcs. Div of Field Epidemiology, Epidemiology Program Office, CDC.  

Editorial Note: 

The incidence of active TB among inmates of this prison was more than 10 times 
the crude incidence of TB in California (17.4 per 100,000 population) for 
1991. In addition, the  number of incident cases was three times what would 
have been  predicted for a population of this size and demographic profile. 
Although the incident cases apparently were not linked, two  findings from 

Health InfoCom Network News                                            Page 12
Volume  5, Number  6                                         December 20, 1992

this investigation suggest that transmission of M. tuberculosis may have 
occurred in the prison: first, at least two  inmates with active TB may have 
become infected at the prison; and second, a substantial number of TST 
conversions were documented  among asymptomatic inmates. The prolonged 
infectiousness of the  three active cases in the prison illustrates the 
potential for M.  tuberculosis to be propagated in the prison system.  
     Although it cannot be proven that the 97 inmates who had TST conversions 
within the previous 2 years were infected while in prison, the 2-year 
conversion incidence of 5.9 per 100 person-years  in prison probably 
underestimates the risk for new M. tuberculosis infection. No information was 
available regarding the timing of  conversion and the potential for 
acquisition of infection in the state prison system for at least 155 inmates.  

     The findings in this report, as well as previous findings of  the 
potential for introducing multidrug-resistant TB into  correctional systems 
(2), emphasize the need to improve  infection-control practices in these 
settings. State health  departments can assist correctional system officials 
in  implementing control measures in correctional facilities (3),  including 
1) regular and systematic TB screening of inmates and  staff, with HIV testing 
and TB preventive therapy (PT) for those who test positive for TB and are 
eligible for PT; 2) rapid identification, isolation, and treatment of 
suspected cases of TB; 3) directly observed therapy and PT, and rigorous 
follow-up and recordkeeping to ensure completion of treatment; and 4) follow-
up  to assure continuity of care both inside and outside the correctional 
facilities.  
     Recent California legislation, supported by the CDOC, the CDHS, and state 
employee organizations, requires inmate and  employee TB skin testing, 
requires reporting of results to the CDHS, and designates that treatment for 
TB may be required as a  condition of parole for inmates with active TB. The 
CDHS and the CDOC are cooperating in implementing the mandates of the 
legislation. The CDOC is addressing infection-control issues in its 
facilities, and its staff members are participating on the California 
Tuberculosis Elimination Task Force and the Interagency Working Group on 
Tuberculosis.  

References

1. CDC. Case definitions for public health surveillance. MMWR  1990;39(no.  
RR-13):39-40.  

2. CDC. Transmission of multidrug-resistant tuberculosis among 
immunocompromised persons in a correctional system--New York, 1991.  MMWR 
1992;41:507-9.  

3. CDC. Prevention and control of tuberculosis in correctional institutions: 

Health InfoCom Network News                                            Page 13
Volume  5, Number  6                                         December 20, 1992

recommendations of the Advisory Committee for the  Elimination of 
Tuberculosis. MMWR 1989;38:313-20,325.











































Health InfoCom Network News                                            Page 14
Volume  5, Number  6                                         December 20, 1992

                               Notice to Readers 
             Availability of Parenteral Isoniazid -- United States 
   
Because parenteral isoniazid is unavailable commercially, a limited supply of 
this drug will now be made available through CDC under an investigational new 
drug agreement for the treatment of patients with active tuberculosis for whom 
the oral formulation of the drug cannot be prescribed.  Clinicians and other 
health-care  providers interested in obtaining this drug for their patients 
should contact CDC's Clinical Research Branch, Division of Tuberculosis 
Elimination, National Center for Prevention Services, telephone (404) 639-
2530.  
     The Food and Drug Administration is working with  pharmaceutical 
manufacturers to reestablish a supply of this drug; the drug is expected to 
become commercially available in the United States early next year.































Health InfoCom Network News                                            Page 15
Volume  5, Number  6                                         December 20, 1992



::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
                        Food & Drug Administration News
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

                           FDA APPROVES DEPO PROVERA
                           ------------------------

                    FDA News Release P92-31, Oct. 29, 1992
                   FDA Contact: Susan Cruzan, (301) 443-3285

  The Food and Drug Administration today announced the approval of Depo 
Provera, an injectable contraceptive drug.  

  The drug, which contains a synthetic hormone similar to the natural hormone 
progesterone, protects women from pregnancy for three months per injection. 
The hormone is injected into the muscle of the arm or buttock where it is 
released into the bloodstream to prevent pregnancy. It is more than 99 percent 
effective.  

  "This drug presents another long-term, effective option for women to prevent 
pregnancy," said FDA Commissioner David A. Kessler, M.D. "As an injectable, 
given once every three months, Depo Provera eliminates problems related to 
missing a daily dose." 

  Depo Provera is available in 150 mg. single dose vials from doctors and 
clinics and must be given on a regular basis to maintain contraceptive 
protection. If a patient decides to become pregnant, she discontinues the 
injections.  

  As with any such products, FDA advises patients to discuss the benefits and 
risks of Depo Provera with their doctor or other health care professional 
before making a decision to use it.  

  Depo Provera's effectiveness as a contraceptive was established in extensive 
studies by the manufacturer, the World Health Organization and health agencies 
in other countries. U.S. clinical trials, begun in l963, also found Depo 
Provera effective as an injectable contraceptive.  

  The most common side effects are menstrual irregularities and weight gain. 
In addition, some patients may experience headache, nervousness, abdominal 
pain, dizziness, weakness or fatigue. The drug should not be used by women who 
have acute liver disease, unexplained vaginal bleeding, breast cancer or blood 
clots in the legs, lungs or eyes.  

  The labeling advises doctors to rule out pregnancy before prescribing the 

Health InfoCom Network News                                            Page 16
Volume  5, Number  6                                         December 20, 1992

drug, due to concerns about low birth weight in babies exposed to the drug.  
Recent data have also demonstrated that long-term use may contribute to 
osteoporosis. The manufacturer will conduct additional research to study this 
potential effect.  

  Depo Provera was developed in the l960s and has been approved for 
contraception in many other countries. The UpJohn Company of Kalamazoo, Mich., 
which will market the drug under the name, Depo Provera Contraceptive 
Injection, first submitted it for approval in the United States in the l970s. 
At that time, animal studies raised questions about its potential to cause 
breast cancer. Worldwide studies have since found the overall risk of cancer, 
including breast cancer in humans, to be minimal, if any.

































Health InfoCom Network News                                            Page 17
Volume  5, Number  6                                         December 20, 1992

              FDA WARNS AGAINST HISMANAL (ASTEMIZOLE) INTERACTION
              ---------------------------------------------------

                    FDA News Release P92-30, Oct. 28, 1992
                  FDA Contact: Monica Revelle, (301) 443-3285

  The Food and Drug Administration today warned doctors against the use of the 
prescription antihistamine drug Hismanal (astemizole) in combination with the 
anti-fungal drugs ketoconazole or itraconazole or the antibiotic drug 
erythromycin.  

  Janssen Pharmaceutica, manufacturer of Hismanal, has agreed to send a "Dear 
Doctor" letter to physicians and other health professionals cautioning them 
about the risk of serious cardiac arrhythmias -- heart rhythm abnormalities -- 
in patients who used any of these drugs with Hismanal.  

  Hismanal is a nonsedating antihistamine prescribed for the treatment of 
seasonal allergies and hives. FDA in July had issued a warning about exceeding 
Hismanal's recommended dose of 10 mg (1 tablet) per day because of the 
increased risk of cardiac arrhythmias. Hismanal is known to cause cardiac 
arrhythmias when present at excessive levels in the blood.  

  FDA recently received reports of serious arrhythmias in two patients who 
took Hismanal with erythromycin, or erythromycin plus ketoconazole, alerting 
FDA to a possible interaction between Hismanal and these drugs, as a cause of 
arrhythmias. Subsequently, Janssen submitted preliminary information 
indicating that blood levels of Hismanal are greatly increased in patients 
taking ketoconazole. Itraconazole, recently approved by FDA, was included in 
the warning primarily because of its chemical and pharmacologic similarity to 
ketoconazole.  

  FDA issued a similar warning in July for other nonsedating antihistamine 
drug products, Seldane and Seldane-D.  

  "Because of the potentially serious nature of these interactions, we must be 
extremely cautious, and we urge doctors and patients to avoid combining these 
drugs," said FDA Commissioner David A. Kessler, M.D.  

  The new labeling for Hismanal includes the following boxed warning: 

  "Concomitant administration of astemizole (Hismanal) with ketoconazole 
tablets, itraconazole or erythromycin is contraindicated."



Health InfoCom Network News                                            Page 18
Volume  5, Number  6                                         December 20, 1992

              NEW FOOD SAFETY EDUCATION PROGRAM FOR NURSING HOMES
              ---------------------------------------------------

                    FDA News Release P92-34, Nov. 17, 1992
                    FDA Contact: Brad Stone, (202) 205-4144

  The Food and Drug Administration, the Centers for Disease Control and 
Prevention and the Health Care Financing Administration today announced the 
start of a new food safety education program for nursing homes to help reduce 
the incidence of serious and life-threatening foodborne diseases that can pose 
particular problems in the elderly.  

  The agencies are distributing two instructional videos that explain how to 
avoid foodborne illnesses, particularly among the elderly, by proper food 
handling and preparation. The videotape/training kits also provide information 
on the illnesses themselves.  

  A joint FDA-CDC study, "Foodborne Disease Outbreaks in Nursing Homes, 1975 
to 1987," published last year in the Journal of the American Medical 
Association, said that, while nursing home residents accounted for just 2.4 
percent of cases of foodborne illness in this country, they accounted for 19.4 
percent of the deaths from foodborne illness.  

  "A high proportion of nursing home residents may have weakened immune 
systems, so they have a greater susceptibility to these diseases and are 10 
times more likely to die from them than are younger adults," said HHS 
Assistant Secretary for Health James O. Mason, M.D., head of the U.S.  Public 
Health Service.  

  The new video package follows one developed three years ago by FDA and CDC 
showing how people infected with AIDS can protect themselves from foodborne 
illnesses. The current program expands this effort to the elderly and others 
in nursing homes.  

  The videotape series takes a two-tiered approach. One videotape is directed 
toward informing nursing home administrators and medical directors about the 
scientific aspects of foodborne illness, such as the causative agents of 
disease, symptoms and diagnosis. It also outlines methods for reducing the 
risk of outbreaks.  

  The other videotape is targeted to nursing home food service managers and 
workers. It instructs food service personnel on proper food storage, handling 
and preparation techniques, and is illustrated with case studies.  

  The videotapes and case studies are being provided to the agencies' field 

Health InfoCom Network News                                            Page 19
Volume  5, Number  6                                         December 20, 1992

offices throughout the country, and a limited number are also available to 
state and local public health agencies on a first-come, first-served basis.  
Nursing homes and others may order the videotape training kit directly for 
$39.00 plus $3.00 handling from: 

National Technical Information Service 5285 Port Royal Road Springfield, VA 
22161 Phone (703) 487-4650 

When ordering, refer to # PB92-780857.




































Health InfoCom Network News                                            Page 20
Volume  5, Number  6                                         December 20, 1992

           SOTALOL HYDROCHLORIDE APPROVED FOR VENTRICULAR ARRHYTHMIA
           ---------------------------------------------------------

                     FDA News Release P92-32, Nov. 5, 1992
                   FDA Contact: Susan Cruzan, (301) 443-3285

  The Food and Drug Administration today announced the approval of sotalol 
hydrochloride, a new drug for treatment of life-threatening ventricular 
arrhythmias (irregular heartbeats) which affect approximately 150,000 patients 
a year.  

  Like other anti-arrhythmic drugs, sotalol is not recommended for use in less 
severe circumstances because it can itself induce serious arrhythmias.  In 
patients with life-threatening arrhythmias, however, this risk is outweighed 
by the drug's benefits.  

  "The drug will provide an option for doctors to treat patients who have been 
diagnosed with serious arrhythmias," said FDA Commissioner David A.  Kessler, 
M.D. "It can also benefit people who have failed other treatments." 

  FDA's approval was based on the results of trials comparing sotalol with 
other anti-arrhythmic drugs in safety studies involving more than 3,000 
patients.  

  Studies of the drug's effectiveness involved a total of approximately 1,300 
patients who had life-threatening arrhythmias. In a small comparison study, 
conducted under controlled hospital conditions, sotalol proved about 30 
percent effective in preventing these arrhythmias -- somewhat better than 
procainamide, a widely used anti-arrhythmic drug. In a larger comparison 
study, conducted by the National Institutes of Health, sotalol was more 
effective in preventing recurrent arrhythmias, even over the long term, than a 
group of six other drugs.  

  Sotalol has two properties important to its therapeutic action: It decreases 
the effects of nerve impulses that excite the heart tissues, and it alters the 
way the heart conducts electrical signals that generate arrhythmias.  

  In studies of sotalol, one of the major adverse effects was a new life-
threatening arrhythmia called torsades de pointes. This was observed in about 
4 percent of patients who were treated for their life-threatening arrhythmias 
and more than 1 percent of patients treated for less serious arrhythmias.  

  Patients given sotalol must be carefully observed to ensure that the drug is 
having the desired effect but not the undesired ones. In addition, as the drug 
has no known benefit in patients with less serious arrhythmias, it should not 

Health InfoCom Network News                                            Page 21
Volume  5, Number  6                                         December 20, 1992

be used in such patients.  

  Some of sotalol's other adverse effects include labored breathing, worsening 
of existing congestive heart failure, fatigue and excessive slowing of the 
heart rate.  

  Sotalol will be sold under the trade name Betapace and marketed by Berlex 
Laboratories of Wayne, N.J.





































Health InfoCom Network News                                            Page 22
Volume  5, Number  6                                         December 20, 1992

          FDA ADVISORY COMMITTEE RECOMMENDS TAXOL FOR OVARIAN CANCER
          ----------------------------------------------------------

                    FDA News Release T92-56, Nov. 18, 1992
                   FDA Contact: Susan Cruzan (301) 443-3285

  We have had some media interest concerning the Nov. 16 recommendation by the 
FDA Oncology Drugs Advisory Committee that Taxol (paclitaxel) be approved for 
treatment of refractory ovarian cancer (cancer that is unresponsive to 
conventional therapy).  

  The committee, a group of outside experts, considered data presented by 
representatives of FDA, the National Cancer Institute (NCI) and Bristol-Myers 
Squibb Co., manufacturer of Taxol. The committee's recommendations were based 
on its conclusion that the data showed evidence of Taxol's effectiveness that 
is strong enough to allow its use in patients who have failed first line 
chemotherapy.  

  Clinical trials conducted by NCI at five centers around the country, plus 
multi-center trials in Europe sponsored by the manufacturer, were reported to 
have confirmed that Taxol shrinks tumors by at least one-half in 20 to 30 
percent of patients with refractory ovarian cancer, for an average of five 
months. In these studies Taxol, like many other cancer drugs, was associated 
with serious side effects including a decrease in white blood cells (which may 
cause susceptibility to infections), hair loss and numbness of the fingers and 
toes.  

  FDA has completed its initial review of information on Taxol, the agency is 
awaiting further data relating to manufacture of the drug and completion of an 
environmental assessment, required by law. Because taxol is obtained from the 
Pacific yew tree, this involves an assessment of the effect of yew harvesting 
on U.S. forests. The environmental assessment is being prepared in cooperation 
with the U.S. Forest Service.  

  NCI and Bristol-Myers Squibb are also working under a collaborative 
agreement to find new sources of the active ingredient and to further develop 
Taxol as an anti-cancer drug.








Health InfoCom Network News                                            Page 23
Volume  5, Number  6                                         December 20, 1992

                       FDA BANS 415 OTC DRUG INGREDIENTS
                       ---------------------------------

                    FDA News Release P92-27, Aug. 25, 1992
                  FDA Contact: Sharon Snider, (301) 443-3285

  The Food and Drug Administration today proposed banning 415 ingredients from 
seven categories of nonprescription drugs because they have not been shown to 
be safe and effective for their stated claims. The action affects a wide 
variety of nonprescription (OTC -- Over The Counter) products including 
remedies for digestive disorders, menstrual problems, fever blisters and 
poison ivy.  

  Use of most of the ingredients named has already been discontinued, but 
several products containing one or more of the ingredients remain on the 
market. Manufacturers will have to reformulate or remove such products from 
the market before the proposed rules are published in final form and become 
effective. "We are taking this action because no proof has been submitted to 
FDA that shows the ingredients are effective for the conditions claimed," said 
FDA Commissioner David A. Kessler, M.D.  

  The ban on some ingredients is not total, however; some ingredients banned 
for one use may be allowed for another. For example, salicylic acid is being 
banned as an external pain reliever in insect bite and sting treatment drug 
products but has been found effective for removal of warts, corns and 
calluses. In some cases ingredients known to be safe but which would not be 
allowed for certain claims could be used as inactive ingredients. For example, 
peppermint, while not effective as a digestive aid, could be used as a 
flavoring agent.  

  Most of the ingredients have been in use since before 1962, when a change in 
the law required that manufacturers submit proof of effectiveness for new drug 
products as well as drug products already on the market. To implement the part 
of the law dealing with nonprescription drugs, FDA set up a process to 
evaluate all ingredients contained in OTC drug products.  Since that review 
began, products and ingredients found harmful were removed from the market. 
Products believed safe, but for which evidence of effectiveness was lacking, 
were allowed to remain in use until proof of their effectiveness could be 
finally established or until final rules, such as the one that will follow the 
proposal announced today, become effective.  

  In recently announced similar actions, FDA banned 223 ineffective 
ingredients from 19 categories of products in November 1990, and 111 
ineffective weight control ingredients in August 1991.  


Health InfoCom Network News                                            Page 24
Volume  5, Number  6                                         December 20, 1992

  The agency began reviewing ingredients contained in an estimated 300,000 
nonprescription drug products sold in this country in 1972. Under the review, 
FDA evaluates reports prepared by advisory panels of outside experts together 
with comments from industry and the public. It then publishes a proposed rule 
with another comment period which includes an opportunity for a public 
hearing. Ultimately, FDA issues a final regulation (monograph) that is, in 
effect, a standard or recipe of acceptable ingredients, doses, formulations 
and instructions as well as permitted claims.  

  Comments on the current proposal, published in today's Federal Register, may 
be sent within 60 days to: FDA Dockets Management Branch (HFA-305), 12420 
Parklawn Drive - Room 1-23, Rockvile, Md. 20857.  

                      INGREDIENTS COVERED BY THIS NOTICE: 

       [ NOTE: If only one form of the ingredient is banned, this form ]
       [ appears in parentheses; i.e., "Myrrh (Fluid Extract)."        ]

(1) Digestive Aid Drug Products:

Alcohol, Aluminum hydroxide, Amylase, Anise Seed, Aromatic Powder, Asafetida, 
Aspergillus Oryza Enzymes, Bacillus Acidophilus, Bean, Belladonna Alkaloids, 
Belladonna Leaves (Powdered Extract), Betaine Hydrochloride, Bismuth 
Subcarbonate, Bismuth Subgallate, Black Radish Powder, Buckthorn, Calcium 
Gluconate, Capsicum, Capsicum (Fluid Extract), Carbon, Cascara Sagrada 
Extract, Catechu (Tincture), Catnip, Chamomile Flowers, Charcoal (Wood), 
Chloroform, Cinnamon Oil, Citrus Pectin, Cnicus benedictus (blessed thistle), 
Diastase, Diastase Malt, Dog Grass, Elecampane, Ether, Fennel Acid, Galega, 
Ginger, Glycine, Hectorite, Horsetail, Huckleberry, Hydrastis Canadensis 
(Golden Seal), Hydrastis Fluid Extract, Hydrochloric Acid, Iodine, Iron Ox 
Bile, Johnswort, Juniper, Kaolin (Colloidal), Knotgrass, Lactic Acid, Lactose, 
Lavender Compound (Tincture), Linden, Lipase, Lysine Hydrochloride, Mannitol, 
Mycozyme, Myrrh (Fluid Extract), Nettle, Nickel-Pectin, Nux Vomica Extract, 
Orthophosphoric Acid, Papaya (Natural), Pectin, Peppermint, Peppermint Spirit, 
Phenacetin, Potassium Bicarbonate, Potassium Carbonate, Protease, Prolase, 
Rhubarb Fluid Extract, Senna, Sodium Chloride, Sodium Salicylate, Stem 
Bromelain, Strawberry, Strychnine, Tannic Acid, Trillium, Woodruff.  

(2) Topical Antifungal Drug Products:

  A) General Use -

Alcloxa, Alum (Potassium), Aluminum Sulfate, Amyltricresols (Secondary), Basic 
Fuchsin, Benzethonium Chloride, Benzoic Acid, Benzoxiquine, Boric Acid, 
Camphor, Candicidin, Chlorothymol, Coal Tar, Dichlorophen, Menthol, 

Health InfoCom Network News                                            Page 25
Volume  5, Number  6                                         December 20, 1992

Methylparaben, Oxyquinoline, Oxyquinoline Sulfate, Phenol, Phenolate Sodium, 
Phenyl Salicylate, Propionic Acid, Propylparaben, Resorcinol, Salicylic Acid, 
Sodium Borate, Sodium Caprylate, Sodium Propionate, Sulfur, Tannic Acid, 
Thymol, Tolindate, Triacetin, Zinc Caprylate, Zinc Propionate.  

  B) Diaper Rash Drug Products -

Any ingredient(s) labeled with claims or directions for use in the treatment 
or prevention of diaper rash.  

(3) External Analgesic Drug Products:

  A) Diaper Rash Drug Products -

Any ingredient(s) labeled with claims or directions for use in the treatment 
or prevention of diaper rash.  

  B) Fever Blister and Cold Sore Treatment Drug Products -

Allyl Isothiocyanate, Aspirin, Bismuth Sodium Tartrate, Camphor, Capsaicin, 
Capsicum, Capsicum Oleoresin, Chloral Hydrate, Chlorobutanol, Cyclomethycaine 
Sulfate, Eucalyptus Oil, Eugenol, Glycol Salicylate, Hexylresorcinol, 
Histamine Dihydrochloride, Menthol, Methapyrilene Hydrochloride, Methyl 
Nicotinate, Methyl Salicylate, Pectin, Salicylamide, Strong Ammonia Solution, 
Tannic Acid, Thymol, Tripelennamine Hydrochloride, Trolamine Salicylate, 
Turpentine Oil, Zinc Sulfate.  

  C) Insect Bite and Sting Drug Products -

Alcohol, Alcohol (Ethoxylated Alkyl), Benzalkonium Chloride, Calamine, Ergot 
Fluidextract, Ferric Chloride, Panthenol, Peppermint Oil, Pyrilamine, Maleate, 
Sodium Borate, Trolamine Salicylate, Turpentine Oil, Zinc Oxide, Zirconium 
Oxide.  

  D) Poison Ivy, Poison Oak, and Poison Sumac Drug Products -

Alcohol, Aspirin, Benzethonium Chloride, Benzocaine (0.5 to 1.25 Percent), 
Bithionol, Calamine, Cetalkonium Chloride, Chloral Hydrate, Chlorobutanol, 
Chlorpheniramine Maleate, Creosote (Beechwood), Cyclomethycaine Sulfate, 
Dexpanthenol, Diperodon Hydrochloride, Eucalyptus Oil, Eugenol, Glycerin, 
Glycol Salicylate, Hectorite, Hexylresorcinol, Hydrogen Peroxide, Impatiens 
Biflora Tincture, Iron Oxide, Isopropyl Alcohol, Lanolin, Lead Acetate, 
Merbromin, Mercuric Chloride, Methapyrilene Hydrochloride, Panthenol, 
Parethoxycaine Hydrochloride, Phenyltoloxamine Dihydrogen Citrate, Povidone-
Vinylacetate Copolymers, Pyrilamine Maleate, Salicylamide, Salicylic Acid, 

Health InfoCom Network News                                            Page 26
Volume  5, Number  6                                         December 20, 1992

Simethicone, Sulfur, Tannic Acid, Thymol, Trolamine, Turpentine Oil, Zirconium 
Oxide, Zyloxin.  

(4) Internal Analgesic Drug Products:

Aminobenzoic Acid, Antipyrine, Aspirin (Aluminum), Calcium Salicylate, 
Codeine, Codeine Phosphate, Codeine Sulfate, Iodoantipyrine, Lysine Aspirin, 
Methapyrilene Fumarate, Phenacetin, Pheniramine Maleate, Pyrilamine Maleate, 
Quinine, Salsalate, Sodium Aminobenzoate.  

(5) Orally Administered Menstrual Drug Products:

Alcohol, Alfalfa Leaves, Aloes, Asclepias Tuberosa, Asparagus, Barosma, 
Bearberry (Extract Of Uva Ursi), Bearberry Fluidextract (Extract Of 
Bearberry), Blessed Thistle (Cnicus Benedictus), Buchu Powdered Extract 
(Extract Of Buchu), Calcium Lactate, Calcium Pantothenate, Capsicum Oleoresin, 
Cascara Fluidextract, Aromatic (Extract Of Cascara), Chlorprophenpyridamine 
Maleate, Cimicifuga Racemosa, Codeine, Collinsonia (Extract Stone Root), Corn 
Silk, Couch Grass, Dog Grass Extract, Ethyl Nitrite, Ferric Chloride, Ferrous 
Sulfate, Gentiana Lutea (Gentian), Glycyrrhiza Glabra (Licorice Root), 
Homatropine Methylbromide, Hydrangea (Powdered Extract) (Extract Of 
Hydrangea), Hydrastis Canadensis (Golden Seal), Hyoscyamine Sulfate, Juniper 
Oil (Oil Of Juniper), Magnesium Sulfate, Methapyrilene Hydrochloride, 
Methenamine, Methylene Blue, Natural Estrogenic Hormone, Niacinamide, Nutmeg 
Oil (Oil Of Nutmeg), Oil Of Erigeron, Parsley, Peppermint Spirit, Pepsin 
(Essence), Phenacetin, Phenindamine Tartrate, Phenyl Salicylate, Piscidia 
Erythrina, Pipsissewa, Potassium Acetate, Potassium Nitrate, Riboflavin, Saw 
Palmetto, Senecio Aureus, Sodium Benzoate, Sodium Nitrate, Sucrose, Sulferated 
Oils Of Turpentine, Taraxacum Officinale, Theobromine Sodium Salicylate, 
Theophylline, Thiamine Hydrochloride, Triticum, Turpentine (Venice) (Venice 
Turpentine), Urea.  

(6) Pediculicide Drug Products:

Benzocaine, Benzyl Alcohol, Benzyl Benzoate, Chlorophenothane 
(Dichlorodiphenyltrichloroethane), Coconut Oil Soap (Aqueous), Copper Oleate, 
Docusate Sodium, Formic Acid, Isobornyl Thiocyanoacetate, Picrotoxin, 
Propylene Glycol, Sabadilla Alkaloids, Sulfur (Sublimed), Thiocyanoacetate.  

(7) Skin Protectant Drug Products:

  A) Astringent Drug Products -

Acetone, Alcohol, Alum (Ammonium), Alum (Potassium), Aluminum Chlorhydroxy 
Complex, Aromatics, Benzalkonium Chloride, Benzethonium Chloride, Benzocaine, 

Health InfoCom Network News                                            Page 27
Volume  5, Number  6                                         December 20, 1992

Benzoic Acid, Boric Acid, Calcium Acetate, Camphor Gum, Clove Oil, Colloidal 
Oatmeal, Cresol, Cupric Sulfate, Eucalyptus Oil, Eugenol, Honey, Isopropyl 
Alcohol, Menthol, Methyl Salicylate,  Oxyquinoline Sulfate, P-T-Butyl-M-
Cresol, Peppermint Oil, Phenol,  Polyoxytheylene Laurate, Potassium 
Ferrocyanide, Sage Oil, Silver Nitrate,  Sodium Borate, Sodium Diacetate, 
Talc, Tannic Acid Glycerite, Thymol,  Topical Starch, Zinc Chloride, Zinc 
Oxide, Zinc Phenolsulfonate, Zinc  Stearate, Zinc Sulfate.  

  B) Diaper Rash Drug Products -

Aluminum Hydroxide, Cocoa Butter, Cysteine Hydrochloride, Glycerin, Protein 
Hydrolysate, Racemethionine, Sulfur, Tannic Acid, Zinc Acetate, Zinc 
Carbonate.  

  C) Fever Blister and Cold Sore Treatment Drug Products -

Bismuth Subnitrate, Boric Acid, Pyridoxine Hydrochloride, Sulfur, Tannic Acid, 
Topical Starch, Trolamine, Zinc Sulfate.  

  D) Insect Bite and Sting Drug Products -

Alcohol, Alcohol (Ethoxylated Alkyl), Ammonia Solution (Strong), Ammonium 
Hydroxide, Benzalkonium Chloride, Camphor, Ergot Fluidextract, Ferric 
Chloride, Menthol, Peppermint Oil, Phenol, Pyrilamine Maleate, Sodium Borate, 
Trolamine, Turpentine Oil, Zirconium Oxide.  

  E) Poison Ivy, Poison Oak, and Poison Sumac Drug Products -

Alcohol, Anion And Cation Exchange Resins (Buffered), Benzethonium Chloride, 
Benzocaine, Benzyl Alcohol, Bismuth Subnitrate, Bithionol, Boric Acid, 
Camphor, Cetalkonium Chloride, Chloral Hydrate, Chlorpheniramine Maleate, 
Creosote, Diperodon Hydrochloride, Diphenhydramine Hydrochloride, Eucalyptus 
Oil, Ferric Chloride, Glycerin, Hectorite, Hydrogen Peroxide, Impatiens 
Biflora Tincture, Iron Oxide, Isopropyl Alcohol, Lanolin, Lead Acetate, 
Lidocaine, Menthol, Merbromin, Mercuric Chloride, Panthenol, Parethoxycaine 
Hydrochloride, Phenol, Phenyltoloxamine Dihydrogen Citrate, Povidone-
Vinylacetate Copolymers, Salicylic Acid, Simethicone, Tannic Acid, Topical 
Starch, Trolamine, Turpentine Oil, Zirconium Oxide, Zyloxin.







Health InfoCom Network News                                            Page 28
Volume  5, Number  6                                         December 20, 1992

              PHS ADVISORY ON PERSISTENT VAGINAL FUNGAL INFECTION
              ---------------------------------------------------

                    FDA News Release P92-33, Nov. 16, 1992
                 FDA Contact: Monica Revelle - (301) 443-4177

  The U.S. Public Health Service today advised women that frequent or 
persistent cases of vaginal fungal infections known as "yeast" infections or 
vaginal candidiasis may sometimes be an early warning of HIV infection.  

  HHS Assistant Secretary for Health James Mason, M.D., who heads the Public 
Health Service, said most of the 13 million cases of vaginal candidiasis that 
occur annually do not have HIV as an underlying cause.  "Pregnancy, diabetes, 
contraceptive pills and antibiotics are commonly linked to these fungal 
infections," he said.  

  "But any woman at risk for AIDS," Dr. Mason continued, "should be aware of 
the possibility that recurrent or stubborn cases of vaginal candidiasis 
sometimes may be an early sign of infection with the human immunodeficiency 
virus, HIV, that causes AIDS -- and should check with a doctor. That is the 
purpose of this statement -- and of new labeling for nonprescription drugs for 
vaginal candidiasis." 

  According to recent studies, recurrent or stubborn cases of vaginal 
candidiasis are the most frequent initial clinical manifestation of HIV 
infection in women. One study showed that of women diagnosed with HIV-caused 
immunosuppression, 38 percent suffered recurring or persistent cases of 
vaginal candidiasis as their first symptom.  

  "Having this information in hand," said Food and Drugs Commissioner David A. 
Kessler, M.D., "the agency has requested that manufacturers of nonprescription 
drugs for vaginal candidiasis include a new label warning that women who may 
have been exposed to HIV infection and who experience recurrent or persistent 
cases of vaginal yeast infections seek professional medical attention 
promptly." 

  Miconozole nitrate, marketed under the name brand Monistat-7, and 
clotrimazole, marketed as Gyne-Lotrimin, Mycelex-7 and FemCare, are sold 
without prescription for treatment of vaginal candidiasis in patients who have 
had a previous episode of vaginal candidiasis diagnosed by a physician. The 
labeling of these products already states that recurrent infections may result 
from hormonal changes or use of oral contraceptives or antibiotics.  

  The additional warning will state: "In women with frequently recurrent 
vaginal yeast infections, especially infections that don't clear up easily 

Health InfoCom Network News                                            Page 29
Volume  5, Number  6                                         December 20, 1992

with proper treatment, the vaginal yeast infections may also be the result of 
serious medical conditions, including infection with HIV, that can damage the 
body's normal defenses against infection." 

  "Women should be made aware through all available sources that if they are 
experiencing recurrent vaginal yeast infections within a two-month period or 
if their infections don't clear up with proper medical treatment, they should 
see their doctor for professional diagnosis and treatment," Dr.  Kessler said. 
"In view of the growing epidemic of AIDS among women, it is important that 
they be alert to possible early HIV infection." 

  Women who need further information on risk factors for HIV infection or 
testing for HIV infection should contact their physician or the Centers for 
Disease Control and Prevention National AIDS Hotline at 1-800-342-AIDS. CDC 
hotline numbers are also available for Spanish speaking (1-800-344-7432) and 
for the hearing impaired, (TDD 1-800-243-7889).





























Health InfoCom Network News                                            Page 30
Volume  5, Number  6                                         December 20, 1992



::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
                                    Columns
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

 HHHHHH   HHHHHH   HHHHHH          H    H   HHHHHH   H     H   HHHHHH
 H        H        H               HH   H   H        H     H   H
 H        HHHHH    HHHHHH   HHHH   H H  H   HHHH     H  H  H   HHHHHH
 H        H             H          H  HHH   H        H  H  H        H
 HHHHHH   H        HHHHHH          H   HH   HHHHHH    HHHHH    HHHHHH


            Chronic Fatigue Syndrome Electronic Newsletter

 --------------------------------------------------------------------
 No. 10                   December 10, 1992             Washington DC
 --------------------------------------------------------------------

                         AMPLIGEN IN CANADA


        CONTENTS

 >>>1.  Ampligen in Canada
 >>>2.  Health policy talks with Clinton transition team
 >>>3.  Delay in Alberta drug study
 >>>4.  Medical publications update


 -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-

 >>>1.  Ampligen in Canada

The Canadian government has authorized, on an emergency basis, a very
limited distribution of Ampligen to patients with severe cases of
CFS, according to HEM Pharmaceuticals Corp. which developed and holds
the patent on Ampligen.  The government has also approved a clinical
trial of Ampligen in Canada.  Ampligen is a double-stranded
ribonucleic acid (RNA) compound which has shown promise in earlier
studies for treatment of CFS (see CFS-NEWS #9).  In Canada, CFS is
known as Myalgic Encephalomyelitis (ME).

To qualify for the emergency distribution, a maximum of 200 eligible
CFS/ME patients will undergo diagnostic evaluations at medical
centers to be selected jointly by the government and HEM.  The
identity of these centers will not be available before mid-January,

Health InfoCom Network News                                            Page 31
Volume  5, Number  6                                         December 20, 1992

and will then be published in CFS-NEWS.  The Canadian clinical trial
will be similar to the U.S. Phase II/III study that was authorized by
the FDA in October.  The medical centers which will conduct the
Canadian studies have not been selected yet, but will be located in
Montreal, Toronto and Vancouver.

[Information for this article provided by HEM Pharmaceuticals
Corporation of Philadelphia, Pennsylvania.]


 -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-

 >>>2.  Health policy talks with Clinton transition team

Members of the CFIDS Association's Public Policy Advisory Committee,
along with Dr. David Bell and lobbyist Tom Sheridan, are meeting this
week with President-elect Clinton's transition team in Washington to
discuss U.S. health care policy with respect to CFS.  The timing of
the meeting is fortuitous as the transition team is beginning to
focus on health issues.

[Information provided by Dave Patterson of the CFIDS Association.]


 -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-

 >>>3.  Delay in Alberta drug study

The drug trial undertaken by Dr. J. Van Aerde in Alberta, Canada for
a CFS remedy has been expanded and prolonged, and results are now
expected to be released in the spring or summer of 1993.   The trial
had previously been expected to yield results in November of this
year.  (An initial report about this study appeared in CFS-NEWS #3.)
The study has been expanded to include more patients.  The unnamed
drug is currently licensed to treat conditions other than CFS, and
Dr. Van Aerde will identify the drug when the full results of the
current study are released.  The study is being undertaken in the
city of Edmonton; previous news reports had mistakenly placed it in
Calgary.

[Information provided by the office of Dr. J. Van Aerde.]


 -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-


Health InfoCom Network News                                            Page 32
Volume  5, Number  6                                         December 20, 1992

 >>>4.  Medical publications update

[The following was contributed by Mr. Steve Clancy.  He is the sysop
of the Wellspring BBS which is a service of the Biomedical Library of
the University of California at Irvine.]

This CFS UPDATE is a review of the current medical literature  on
Chronic Fatigue Syndrome and is presented as a public service by the
Wellspring RBBS.  The presence or absence of any information in this
review should not be taken as  advocating one method of treatment
over another, and should not be construed as providing medical advice
or diagnosis.  The references may be taken from various  sources  and
should be used for educational purposes only.  Databases accessed may
include the MEDLINE online database produced by the National  Library
of Medicine, as well as other online and print  sources.  This
listing is NOT a complete review, but represents a selection.
Further information may be obtained from your local medical library.

 STEVE CLANCY, M.L.S., WELLSPRING RBBS (714) 856-7996
                                       (714) 846-5087
                                       (714) 725-2700
 ********************************************************************
 12/9/92


1. Murdoch JC.
     Chronic fatigue syndrome. A review from the general practice
     perspective.
   Australian Family Physician, 1992 Aug, 21(8):1205-6.

2. Prescott E; Norrgard J; Rotbol Pedersen L; Danneskiold-Samsoe B.
     Fibromyalgia and magnesia [letter].
   Scandinavian Journal of Rheumatology, 1992, 21(4):206.

3. Cho WK; Stollerman GH.
     Chronic fatigue syndrome.
   Hospital Practice (Office Edition), 1992 Sep 15, 27(9):221-4,
   227-30, 233-6 passim.

4. Sharpe M; Hawton K; Seagroatt V; Pasvol G.
     Follow up of patients presenting with fatigue to an infectious
     diseases clinic.
   Bmj, 1992 Jul 18, 305(6846):147-52.

5. Behan WM.

Health InfoCom Network News                                            Page 33
Volume  5, Number  6                                         December 20, 1992

     Muscles, mitochondria and myalgia [editorial].
   Journal of Pathology, 1992 Mar, 166(3):213-4.


 ===================================================================
 CFS-NEWS is an independent newsletter edited by Roger Burns in Wash
 ington D.C. and is distributed on the Fidonet CFS echo, on Internet
 and thru the USENET Newsgroup bit.listserv.cfs.newsletter.  Back
 issues are on file on the CFIDS/CFS BBS in Maine USA at telephone
 1-207-623-8486 in file area H.  Suggestions and contributions of
 news may be sent via Internet to CFS-NEWS@LIST.NIH.GOV, or via Fido
 NetMail to CFS-NEWS at 1:109/432, or post a message to the CFS echo
 or to newsgroup alt.med.cfs.  Patients should read the resource file
 CFS-RES.TXT available on the BBS mentioned above and elsewhere.
 Copyright (c) 1992 by Roger Burns.  Permission is granted to excerpt
 this document if the source (CFS-NEWS) is cited.  Permission is also
 granted to reproduce the entirety of this document unaltered.  This
 notice does not diminish the rights of others whose copyrighted
 material may be quoted herein.  Note that Fido and Fidonet are
 registered marks of Tom Jennings and Fido Software.
 ===================================================================

INTERNET users are encouraged to obtain the RESOURCE file and other
CFS files at the NIH file server.  To obtain the resource file, send
Internet e-mail to the address SERVER@CU.NIH.GOV with the subject
line GET FTP CFS.RESOURCE (the message text is ignored).  Or log in
via anonymous ftp to cu.nih.gov or 128.134.64.7 with password=guest,
directory=CFS, filename=RESOURCE.  Distribution of CFS-NEWS on the
Internet is sponsored by the NIH Computing Utility; however, this
independent newsletter does not represent the views of the National
Institutes of Health.  To subscribe, send the command SUB CFS-NEWS
<your> <name> to the address LISTSERV@NIHLIST.BITNET or @LIST.NIH.GOV
         CFS-NEWS is also posted to the CFS echo on Fidonet.
=====================================================================











Health InfoCom Network News                                            Page 34
Volume  5, Number  6                                         December 20, 1992

                         AIDS Daily Summary

The Centers for Disease Control (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.  Copyright 1992, Information, Inc., Bethesda, MD 


 "Argus Pharmaceutical Pursues 'Sneak-Attack' AIDS Drug" Journal of 
Commerce (12/07/92), P. 9A

     Argus Pharmaceuticals of Houston, Texas, has developed a patented 
biomedical agent that evades the body's defense mechanisms and  allows 
patients to combat AIDS or cancer.  The company uses its  biomedical 
technology to implant its potent drug inside the  body's lipids, which are 
organic compounds containing fats and  other substances found in the membrane 
of every cell.   

"Patient's Failure to Tell of AIDS Is Going on Trial as Fraud  Suit" Wall 
Street Journal (12/07/92), P. B6  (Lambert, Wade) 

     A lawsuit that could change the way health-care workers care for  AIDS 
patients is scheduled to begin today in state court in Los  Angeles, Calif.  
The lawsuit involves a surgical technician who  has accused a patient of fraud 
for not revealing that she had  AIDS before the technician was nicked by a 
scalpel that had been  exposed to the patient's HIV-positive blood.  While in 
recent  years public attention has focused on whether health-care workers must 
disclose their HIV-status to patients, this case is  apparently the first to 
argue that patients have a duty to inform their doctors and nurses.  


"Facility for AIDS, TB Patients Opens" Chicago Tribune (12/04/92), P. 1-7 

     Oak Forest Hospital of Cook County, Ill., has opened a 214-bed  facility 
specifically for the treatment of AIDS and tuberculosis  patients.  A total of 
84 long-term patients were moved to the new facility on Tuesday.  Cook County 
Board President Richard Phelan  said, "Once [the hospital] is fully 
operational, the new facility will enable the county to expand its capacity 
for treating AIDS  and TB patients.  This new facility will allow Cook County 
to  better manage these two serious diseases."  Oak Forest Hospital  is the 
only licensed chronic disease hospital in Illinois, and  plays an important 
role in caring for people with serious  long-term conditions.  

"AIDS Clinical Trial to Go Ahead" Science (11/20/92) Vol. 258, No. 5086, P. 

Health InfoCom Network News                                            Page 35
Volume  5, Number  6                                         December 20, 1992

1298  (Cohen, Jon) 

     The long-awaited trial of an immune preparation that may prevent  HIV-
positive women from transmitting the virus to their infants  is finally 
getting back on track.  The trial was originally  scheduled for July but was 
canceled when Abbott Laboratories--the sole manufacturer of HIV hyperimmune 
globulin (HIVIG)--insisted  that the company be completely protected from any 
lawsuits that  might emerge from the use of the treatment.  The threat of a  
lawsuit alleging violation of the contract caused Abbott to  relinquished its 
rights to HIVIG, and two other groups are  competing to supply material for 
the test.  The National  Institutes of Health and three dozen locations around 
the country had worked with Abbott for more than two years to design the  
HIVIG trial.  

 "Extreme Measures Needed to Curb Resurgence of Tuberculosis, Specialists Say" 
Baltimore Sun (12/08/92), P. 12A 

     Aggressive efforts are needed to deal with the recent nationwide 
resurgence of tuberculosis, said a panel of experts yesterday. Required 
measures could even include a mandatory quarantine for uncooperative patients.  
The disease, which was believed to be under control a decade ago, now 
threatens to become epidemic in the United States, the group said.  Certain 
populations, like immigrants, children, hospital patients, the homeless, AIDS 
patients, and prisoners, are at greatest risk of contracting TB.  

"Bombay--Epicenter of Disaster" Los Angeles Times--Washington Edition 
(12/08/92), P. A4 (Drogin, Bob) 

     The AIDS case rate in India is rapidly increasing dramatically, and could 
establish Bombay as the worldwide epicenter for the deadly disease.  Due to 
widespread prostitution, IV-drug use, and contaminated blood supplies, India 
has developed an AIDS epidemic that is virtually out of control, according to 
Dr. I.S. Gilada of the Indian Health Organization.  At least 35 percent of 
Bombay's prostitutes are HIV-positive, said the World Health Organization. 
That is up from 3 percent in 1988.  Currently, India has confirmed 10,730 HIV 
infections and 238 full-blown cases of AIDS. However, experts say that a far 
greater number of cases are misdiagnosed and unreported.  WHO and Indian 
officials publicly predict that 500,000 to 1 million Indians are HIV-positive 
and some experts put the figure much higher.  Also, the International Congress 
on AIDS in Asia and the Pacific reported last month that at least 3 million 
Indians will be HIV-positive and 179,000 will have AIDS by 1996.  By the end 
of the decade the number will more than double.  In India, the first AIDS case 
was not reported until 1986, whereas in Africa the disease was found in the 
early 1980s.  But an ambitious $100 million, five-year effort to fight AIDS in 
the country is just starting.  The plan is to develop a network of 1,000 

Health InfoCom Network News                                            Page 36
Volume  5, Number  6                                         December 20, 1992

centers across the country over five years to detect and treat AIDS patients, 
and to thwart the spread of the disease through coordinated public education, 
health care, and blood screening programs.  

 "AIDS Drug From Kenya to be Tested by NIH Unit" Washington Times (12/09/92), 
P. A1  (Barras, Jonetta Rose) 

     The controversial AIDS drug ImmuViron has received endorsements  from the 
American medical establishment to undergo clinical  trials.  However, it did 
not go unnoticed by Washington, D.C.'s  public health chief Dr. Mohammad 
Ahkter.  The National Institute  of Allergies and Infectious Diseases (NIAID) 
has decided to  develop a study for performing clinical trials of ImmuViron,  
which is known as Immunex and is a derivative of the drug Kemron, discovered 
in Kenya.  But unlike other AIDS drugs, the Food and  Drug Administration has 
not approved ImmuViron for mass  distribution, even though it can be legally 
imported for use by  individual patients.  Some say that ImmuViron does not 
cure AIDS  or provide the relief of AIDS-related symptoms claimed by those  
who have administered it.  Nevertheless, AIDS advocates and  researchers say 
the drug is worth being on the market even if can save just one life.  They 
contend that ImmuViron and Kemron have  been discriminated against because 
they are not drugs developed  by the "traditional white America" medical 
community.  A total of 15 physicians and researchers are scheduled to meet 
today to plan the FDA study.   

"More Experimental Drugs Will be Available Quickly" Philadelphia Inquirer 
(12/09/92), P. A4  (Vernaci, Richard L.) 

     The Food and Drug Administration announced yesterday that it  would soon 
make more experimental drugs available quickly if they exhibit promise of 
treating fatal or disabling diseases.   Therefore, the rules, under 
consideration for months, could be  enacted in about 30 days.  FDA 
Commissioner David Kessler said  yesterday, "Accelerated approval, conditional 
approval, these  were innovations built upon the agency's commitment to 
provide  access to experimental drugs for those dying of life-threatening  
disorders."  


"Insemination of HIV-Negative Women With Processed Semen of  HIV- Positive 
Partners" Lancet (11/28/92) Vol. 340, No. 8831, P. 1317   (Semprini, Augusto 
E. et al.) 


     Women who wish to become impregnated with their HIV-positive  partner's 
sperm can avoid infection, write Augusto E. Semprini et al. of the University 
of Milan Medical School in Milan, Italy.   The researchers found that previous 

Health InfoCom Network News                                            Page 37
Volume  5, Number  6                                         December 20, 1992

testing in our laboratory  showed that gradient centrifugation followed by a 
swim-up  procedure effectively removed HIV-1-infected cells from the semen of 
HIV-seropositive men.  

"High HIV Rate Found in Women in Florida District" Wall Street Journal 
(12/10/92), P. B6  (Chase, Marilyn) 

     A total of one out of every 20 pregnant women in a prenatal  clinic in 
rural Florida tested positive for HIV, producing an  alarmingly high infection 
rate that researchers believed stemmed  from heterosexual transmission.  The 
study is published in this  week's issue of the New England Journal of 
Medicine and was  conducted by Ted Ellerbrock of the  Centers for Disease 
Control,  John Witte of the Florida State Department of Health, and their  
colleagues.  The report emphasizes that growing numbers of AIDS  patients are 
women, especially young minority women.  

 "Federal Panel Approves Condom for Women; Orders Label Change" Washington 
Post (12/11/92), P. A2  (Gladwell, Malcolm) 

A Food and Drug Administration advisory panel yesterday approved for use in 
the United States  the female condom, the first birth control device for women 
designed to protect against sexually transmitted diseases.  The FDA obstetrics 
and gynecology devices  panel had announced in January that it would be 
willing to grant  approval of the device if its manufacturer completed 
clinical  testing of the product and modified its label.  But yesterday the 
panel ruled that if the company made modifications to the way it  explained 
the effectiveness of the condom in preventing disease  and pregnancy, the 
device should be available for market.  Final  FDA approval usually comes 
within weeks or months after the  advisory panel recommendation.  Officials at 
Wisconsin Pharmacal  Co., the condom's manufacturer, said they expected to 
have their  product on the market by next summer or fall at a cost of between 
$2.25 and  $2.50.  

"Potassium Hazard Seen in AIDS Drug" Science News (12/05/92) Vol. 142, No. 23, 
P. 398 

     A certain AIDS drug used to treat pneumocystis carinii pneumonia  can 
also elevate potassium in the blood, creating a condition  called 
hyperkalemia.  The drug trimethoprim (TMP) has caused as  many as 53 percent 
of hospitalized AIDS patients to develop mild  to moderate hyperkalemia.  
Michael J. Choi, Thomas R. Kleyman,  and Pedro C.  Fernandez of the Veterans 
Administration Medical  Center in Philadelphia report that they have 
discovered the  cellular mechanism that causes this side effect.  In addition,  
they have observed an AIDS patient treated with TMP whose  hyperkalemia 
reached the point of "medical emergency," said Choi. He suggests that this 

Health InfoCom Network News                                            Page 38
Volume  5, Number  6                                         December 20, 1992

case should make physicians aware of the  possible life-threatening 
consequences of using massive doses of  TMP to treat pneumocystis carinii 
pneumonia.  In general, TMP  does not elevate potassium concentrations to 
harmful levels.   However, a large number of AIDS patients already experience  
hyperkalemia caused by kidney failure or hormone deficiencies.   For such 
patients, treatment with TMP could increase the  potassium in their blood to 
dangerous levels, causing heart cells to fire erratically and even bringing on 
cardiac arrhythmia, said Choi.  

 "Hemophilia Drug Gains Government Approval" Journal of Commerce (12/15/92), 
P. 7A 

     The federal government last week granted approval of Genetics  Institute 
Inc.'s genetically engineered drug to treat hemophilia. The drug, called 
Factor VIII, is the blood-clotting protein that  is absent in 15,000 to 17,000 
hemophiliacs in the United States  with an equal number in Europe and slightly 
fewer in Asia.   Gabriel Schmergel, Genetics Institute president, said, "It 
has  taken us 11.5 years and $200 million to reach this day." 

"In the Nation: Experts Put AIDS Cost at $15 Billion by '95" Baltimore Sun 
(12/15/92), P. 8A 

     The cost of treating HIV-positive Americans could increase about  48 
percent, to $15.2 billion a year, by 1995, health experts told a Senate panel 
yesterday.  Fred Hellinger, a financing specialist with the U.S. Public Health 
Service, said, "The widespread use of expensive drugs has contributed to the 
high costs of treating  persons with HIV."  Approximately a million Americans 
are  infected with HIV and 250,000 have been diagnosed with AIDS.   Among 
those AIDS patients, 160,000 have died.  Hellinger said  that the number of 
newly diagnosed AIDS patients could reach  97,000 by 1995.  

"Britain--AIDS Virus" Associated Press (12/11/92)  (Epstein, Randi Hutter) 

     London--HIV can hide inside pre-ejaculatory fluid in men, as  well as 
infecting semen, according to two studies of HIV-positive men  published in 
the Dec. 12 Lancet.  Dr. Peter Schlegel, co-author  of one of the studies and 
associate professor of urology at New  York Hospital-Cornell Medical Center, 
said, "Many men believe  oral sex without ejaculation is completely safe.  
That is clearly not the case based on the potential infectivity of this 
fluid."   The second study was conducted by researchers at Harvard Medical  
School and Boston University's School of Public Health.  Both  studies do not 
suggest the risk of contracting HIV by contact  with pre-ejaculatory fluid.  
But author of the second study Dr.  Jeffrey Pudney of Harvard urged additional 
research.   Pre-ejaculatory fluid "is produced during sexual stimulation  
before intercourse, so placing a condom on the penis earlier may  be important 

Health InfoCom Network News                                            Page 39
Volume  5, Number  6                                         December 20, 1992

to prevent contact with this fluid, not just at the  time of intercourse," 
said Schlegel.  He added, "We're not  talking about a lot of fluid, but a 
small amount of it may be  important."  The Cornell researchers investigated 
pre-ejaculatory fluid from 14 men with AIDS and two men without the virus.  
They  discovered HIV and white blood cells in the fluid of six of the  14 men 
with AIDS.  Neither was present in the two HIV-negative  men.  Pudney examined 
12 samples of pre-ejaculatory fluid from  nine men with HIV and 11 samples 
from six uninfected men.  His  team discovered HIV in pre-ejaculatory fluid 
from six of nine  infected men but not in any samples from the uninfected men 
used  as controls.  

 "Program in Africa Curbs Spread of AIDS" Baltimore Sun (12/16/92), P.  8A 

     Health-care workers in Rwanda are controlling the heterosexual  spread of 
HIV by targeting young women with education and testing programs.  The effort 
could serve as a model for U.S. inner  cities.  Rwanda has one of the world's 
highest rates of AIDS.   According to researchers from the University of 
California--San  Francisco, nine out of ten deaths are caused by AIDS, and 
almost  one third of urban adults are HIV-positive.  In the study  published 
in today's Journal of the American Medical Association, the researchers 
examined 1,458 women ages 20 to 40 who enrolled  in  a prevention program in 
1988 in the Rwandan capital, Kigali.  The program offered confidential HIV 
testing, viewing of a  35-minute educational video, and group discussions 
afterward.   All of the subjects received regular physician examinations,  
condoms and spermicides, and invitations for male partners to be  tested and 
counseled.  As a result, condom use rose from 7  percent to 22 percent in one 
year among all of the women's  partners.  

"Heterosexually Transmitted Human Immunodeficiency Virus  Infection Among 
Pregnant Women in a Rural Florida Community" New England Journal of Medicine 
(12/10/92) Vol. 327, No. 24,  P. 1704  (Ellerbrock, Tedd V.  et al.) 

     An alarmingly high rate of HIV that most likely resulted from  
heterosexual transmission was found among several pregnant women  in a rural 
Florida community, write Tedd V. Ellerbrock et al. of  the Centers for Disease 
Control in Atlanta, Ga.  The researchers  interviewed and tested 1,082 of 
1,084 consecutive pregnant women  who registered for prenatal care at a public 
health clinic in  western Palm Beach County, Fla.  The rate of HIV infection 
was  5.1 percent (52 of 1,011 women).  Black women who were neither  Haitian 
nor Hispanic had the highest rate of infection.  Only 4  of 1,009 women (0.4 
percent) reported ever injecting drugs, and  all 4 were HIV-negative.  But 14 
of 43 users of "crack" cocaine  (33 percent) had HIV infection.  A total of 
131 of 983 women (13  percent) tested positive for gonorrhea, chlamydial 
infection, or  syphilis at prenatal registration.  Mulivariate  logistic-
regression analysis found HIV infection to be  independently associated with 

Health InfoCom Network News                                            Page 40
Volume  5, Number  6                                         December 20, 1992

having used crack cocaine, having  had more than two sexual partners, being 
black but neither  Hispanic nor Haitian, having had sexual intercourse with a  
high-risk partner, and testing positive for syphilis.  But 11 of  the 52 HIV-
positive women (21 percent) reported a total of only  two to five sexual 
partners and no known high-risk partners, had  never used crack cocaine, and 
had no positive tests for sexually  transmitted diseases.  The increasing rate 
of HIV and the  increasing prevalence of syphilis and use of crack cocaine  
indicate that other women may be at similar risk of contracting  
heterosexually transmitted HIV, the researchers conclude.  

"Chemical Briefs: Study Links AIDS, Failure of TB Drugs" Journal of Commerce 
(12/17/92), P. 7A 

     Several AIDS patients previously believed to be co-infected with  the 
drug-resistant strain of tuberculosis, may actually be unable to absorb the 
medicine, according to a study published in the New England Journal of 
Medicine.  Researchers from the National  Jewish Center for Immunology and 
Respiratory Medicine in Denver,  Colo., say they treated an man with AIDS 
whose TB reappeared  because he could not absorb the medicine, not because the 
TB had  become resistant.  Shaun E. Berning led the group and said that  
because intestinal disease is common among HIV-positive patients, the patients 
should be tested to ensure the dose of the drug is  high enough for the 
medicine to be effective.  


 "Simian Tests Raise AIDS-Vaccine Hope" New York Times (12/18/92), P.  A30  
(Altman, Lawrence K.) 

     An experimental vaccine has completely protected six rhesus monkeys 
against the simian form of HIV infection for more than three years, making it 
the strongest and longest lasting of any AIDS-related vaccine, according to a 
report published in today's issue of Science.  The research was led by Dr. 
Ronald C. Desrosiers of the New England Regional Primate Research Center in 
Southborough, Mass.  Federal health officials who funded the experiments 
considered the finding "a significant advance" in the search for a human 
vaccine to protect against HIV.  The monkey vaccine contains live simian 
immunodeficiency virus (SIV), the virus that causes an AIDS-like disease in 
monkeys, from which a key gene was removed.  The research involved the 
deletion of a gene known as nef from SIV and then injecting the virus in the 
monkeys.  The function of the nef gene is unknown.  When nef-deleted SIV is 
used in test tube experiments, the virus reproduces and harms cells.  But 
Desrosiers said he was surprised to find that injection of the nef-deleted SIV 
did not harm the monkeys.  The research led him to question whether nef-
deleted SIV could be used as a vaccine.  He began the research by injecting 
nef-deleted SIV into six monkeys who stayed healthy after two and a quarter 

Health InfoCom Network News                                            Page 41
Volume  5, Number  6                                         December 20, 1992

years.  Dr. Desrosiers said that the new findings could lead to the first 
safety tests of such a vaccine on human volunteers in two years.  Dr. Anthony 
S. Fauci, the head of the National Institute of Allergy and Infectious 
Diseases, said scientists at his institute are "extremely enthusiastic about 
the possibilities" of Dr. Desrosiers' findings.  Related Stories: Washington 
Post (12/18) P. A1; USA Today (12/18) P. 1A; Philadelphia Inquirer (12/18) P. 
A1; Los Angeles Times--Washington Edition (12/18) P. A1; Baltimore Sun (12/18) 
P. 1A; Washington Times (12/18) P. A8 

"AIDS: Sperm Washing" Newsweek (12/21/92) Vol. 120, No. 25, P. 8 

     An Italian physician has developed a new technique that may provide 
couples in which the male is HIV-positive with a chance to have a child with 
no risk of HIV transmission to the baby. Dr. Augusto Semprini of the 
University of Milan "washes" sperm by spinning cells in a  centrifuge: 
heavier, HIV-infected sperm settle at the bottom while HIV-free cells swim at 
the top. Already, 10 uninfected babies have been conceived through this 
process.  

"TB's Return" Time (12/21/92) Vol. 140, No. 25, P. 25 

     Due to the combination of the AIDS epidemic and breakdowns in public 
health services, the rate of tuberculosis has escalated 25 percent since 1984, 
when 22,000 cases were reported in the United States.  Physicians from the 
American Lung Association and the  Centers for Disease Control now suggest a 
series of more  aggressive countermeasures to thwart a general outbreak of TB,  
some new strains of which are particularly virulent.  They advise more 
extensive screening for TB infection among high-risk groups, including 
children, hospital patients, and the homeless.  Since  people with depleted 
immune systems are especially vulnerable to  TB, the physicians also recommend 
that anyone who lives in close  contact with a TB patient should also be 
tested for HIV  infection.  And as a last resort, the health experts recommend  
mandatory quarantine for those TB patients who neglect to  routinely take 
their treatment and, consequently, are a threat to their fellow citizens.











Health InfoCom Network News                                            Page 42
Volume  5, Number  6                                         December 20, 1992



::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
                                   Articles
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

                        In Search of Medical Victories
                                Fall 1992 - EDU
                    (c) 1992 Digital Equipment Corporation
                           Reprinted with Permission

One of the grand challenges of research in the 1990's is structural biology, 
which reveals basic and detailed information about the molecular structure and 
function of living systems.  

A key technique in structural biology, X-ray crystallography, allows 
researchers to study the X-ray diffraction patterns produced by tiny samples 
of crystalline proteins. Recent advances in radiation sources, biotechnology, 
controlled crystallization, and computer technology have spurred the more 
rapid elucidation of molecular structure by X-ray crystallography.  

Macromolecular crystallographers apply the technique of X-ray crystallography 
to study the structure and function of viruses as well as proteins and other 
biological macromolecules and assemblies. These studies explore the molecular 
origins of disease and provide a molecular basis for the design of therapeutic 
agents.  

                         From AIDS to the Common Cold

One of the world's leading research teams in this field is the macromolecular 
crystallography group of the Lucille P. Markey Center for Structural Biology 
at Purdue University, in West Lafayette, Indiana. Recognized internationally 
for its ground-breaking investigations, the group is also a training center 
for new generations of scientists and home to more than 50 researchers engaged 
in various projects. This research is conducted under the supervision of 
Michael G. Rossmann, Jack E. Johnson, Janet L. Smith, Jeffrey T. Bolin, 
Cynthia V. Stauffacher, Thomas J.  Smith, and Wladek Minor.  

Professor Rossmann has spent more than 25 years at Purdue exploring the world 
of viruses. A recent achievement of his team was the announcement of the 
molecular structure of the canine parvovirus, the first single-stranded DNA 
virus to be so described. This study could lead to a medical victory over a 
related virus known as B19, which attacks tissues in humans, sometimes 
fatally.  

Members of the group are now investigating the structure of the core antigen 
of the AIDS virus.  

Health InfoCom Network News                                            Page 43
Volume  5, Number  6                                         December 20, 1992


                             High-Speed Computing

In 1990, Professor Rossmann received a Smithsonian Institution award, "For 
Heroic Use of Information," in recognition of his use of computers in the 
crystallographic analysis of the structure of human rhinovirus-14, the cause 
of the common cold. This award recognizes that macromolecular crystallography 
would be impossible without efficient, high-speed computing capabilities. 
Acquiring and processing primary data, for example, are computationally 
intensive procedures, as are the complex procedures involved in atomic-
resolution molecular modeling.  

The multivendor computing network used by Purdue's Macromolecular 
Crystallography group includes two mainframes and 18 workstations running on 
ULTRIX from Digital Equipment Corporation.  

"The Digital workstations provide a very balanced system with their graphics 
capabilities and speed," explains Minor, software developer and research 
scientist. "The DECstation 5000's memory capacity is a distinct advantage." 

"We now operate 15 Digital workstations in the lab - some in the general area, 
and some as desktop devices for specific users," continues Minor. "We've been 
running on the ULTRIX operating system for more than two years." 

"A major advantage of the Digital workstation family is compatibility.  
Everything that works on the existing systems will work on a new system," he 
concludes.  

                       New Tools on RlSC-based Platforms

Currently, the scope and significance of both experimental research and 
software development in X-ray crystallography continue to expand dramatically.  

Using the RISC/ULTRIX-based workstations for biological research, the Purdue 
group also has developed software that takes advantage of the high rates of 
data acquisition achieved by new radiation technology.  
                                                                      
The Purdue group has also developed a family of instrument-independent 
software tools that promise to bring significant improvements to 
crystallographic data acquisition and processing. Today, both academic and 
government laboratories around the world use Purdue's crystallographic 
applications, as do the research facilities of many pharmaceutical companies.  

By developing software for interactive visualization, Purdue's scientists are 
giving researchers using platforms such as Digital's DECstation 5000 series 

Health InfoCom Network News                                            Page 44
Volume  5, Number  6                                         December 20, 1992

the tools for evaluating and controlling complex crystallographic experiments 
in conditions close to real time.  

                         Toward Life's Very Beginning

Purdue's research teams also are continuing the pioneering work that has long 
nourished major advances in structural biology, virology, crystallography, and 
gene evolution. Prof. Rossmann believes that when a sufficient number of 
molecular structures have been mapped in detail, scientists will identify a 
common ancestry among all viruses. Crystallographic analysis then should 
reveal the fundamental structure of all viruses and point toward answers to 
the most basic questions in biology.  

"There was some primordial structure whose function was very essential to 
biological function," explains Prof. Rossmann. "That structure would have been 
available at the very beginning of life."

Discovering "that structure" will answer to some of the basic questions of 
biology. Yet, as Prof. Rossmann has written: Answering one question usually 
raises other questions. Developing a technique means that new projects require 
for their solutions further technological answers." 

                             About the University

Purdue University, in Indiana, began in September 1874 with six instructors 
and 39 students. Now it has an enrollment of almost 60,000 students. With 
campuses in West Lafayette, Calumet, Fort Wayne, Indianapolis, and Westville
Purdue is one of the largest universities in the United States.

















Health InfoCom Network News                                            Page 45
Volume  5, Number  6                                         December 20, 1992

                        Sperm Homing Signal Discovered
                               from "interface" 
                 The Weizmann Institute of Science No 2, 1991

How does a sperm cell find its way to the female egg! A possible answer to 
that question has been provided by a Weizmann Institute study indicating that 
chemical signals released by mammalian ova might attract spermatozoa and that 
such chemical communication might be essential for normal human fertility.  
This finding may facilitate the development of new approaches for dealing with 
human infertility, particularly where the sperm signaling mechanism is faulty.  

It is now recognized that a large fraction of sperm cells entering the female 
reproductive tract remains motionless in storage sites until ovulation occurs, 
at which time the sperm movement resumes, enabling the male gamete to reach 
fertilization sites in the fallopian tubes within minutes. While the nature of 
the chemical signal triggering this movement is unknown, Prof. Michael 
Eisenbach, Head of the Weizmann Institute's Department of Membrane Research 
and Biophysics, in collaboration with Prof. David Garbers of the Howard Hughes 
Medical Institute, Nashville, Tennesse, initiated preliminary stuides to 
investigate whether chemical factors reieased by the egg might be responsible, 
Evidence to that effect has recently emerged from follow-up research by Prof, 
Eisenbach and Dr. Dina Ralt of the Weizmann Institute, in cooperation with 
Drs. Mordechai Goldenberg, Jehoshua Dor and Shlomo Mashiach of the Sheba 
Medical Center, Tel Hashomer.  

Prof. Eisenbach and his team found in test-tube experiments that follicular 
fluids extracted from women undergoing in vitro fertilization procedures 
attract human sperm cells. It is likely that the same factors that exist in 
the follicular fluid are released by the egg (or its surrounding cells) as it 
passes through the fallopian tube, thereby alerting sperm cells to its 
presence. Work is now under way to identify these sperm-signaling factors.  

This research was supported, in part, by grants from the Andrew W. Mellon 
Foundation, the U,S. National Institutes of Health, the Israel Ministry of 
Health, and the Yeda Fund.










Health InfoCom Network News                                            Page 46



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