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· Subject: HICN605 Medical Newsletter Part 1/6
------------- cut here -----------------
Volume 6, Number 5 March 8, 1993
+------------------------------------------------+
! !
! Health Info-Com Network !
! Newsletter !
+------------------------------------------------+
Editor: David Dodell, D.M.D.
10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA
Telephone +1 (602) 860-1121
FAX +1 (602) 451-1165
Compilation Copyright 1993 by David Dodell, D.M.D. All rights Reserved.
License is hereby granted to republish on electronic media for which no
fees are charged, so long as the text of this copyright notice and license
are attached intact to any and all republished portion or portions.
The Health Info-Com Network Newsletter is distributed biweekly. Articles
on a medical nature are welcomed. If you have an article, please contact
the editor for information on how to submit it. If you are interested in
joining the automated distribution system, please contact the editor.
E-Mail Address:
Editor:
Internet: david@stat.com
FidoNet = 1:114/15
Bitnet = ATW1H@ASUACAD
@NUMCALLS@@DLBYTES@@INCONF@@NUMTIMESON@@EXPDATE@@HOMEPHONE@@DATAPHONE@LISTSERV =
anonymous ftp = vm1.nodak.edu
Notification List/ftp = hicn-notify-request@stat.com
FAX Delivery = Contact Editor
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
T A B L E O F C O N T E N T S
1. Comments & News from the Editor
From the Editor: Scanner/OCR Fund & CDC MMWR Reports (new info) ...... 1
2. Centers for Disease Control - MMWR
[5-Mar-93] HIV Testing Services in Acute-Care Hospital Settings ...... 3
Comparison of Early and Late Latent Syphilis ......................... 5
Tetanus Fatality ..................................................... 8
Impact of Legislation on Needle and Syringe Purchase/Possession ...... 11
3. Dental News
License Granted to Dental Products that will Remineralize Teeth ...... 15
Dental Researchers Report Novel Approach Treating Arthritis .......... 17
4. AIDS News Summaries
AIDS Daily Summary Feb 16, 1993 to March 5, 1993 ..................... 19
5. Clinical Alerts from National Institues of Health
Alert: DDI and DDC for HIV infection ................................. 40
6. Announcements of Studies/Research
Tamoxifen Breast Cancer Prevention Trial Information ................. 44
7. General Announcments
Discussion List for Chronic Fatique Syndrome ......................... 79
Health InfoCom Network News Page i
Volume 6, Number 5 March 8, 1993
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Comments & News from the Editor
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Words from the Editor: Scanner/OCR Fund & CDC MMWR Reports
First, I would like to thank everyone who has sent in a donation for the
Mednews OCR/Scanner Fund. The total is now at $623. We are more than half
way to our goal.
For our new subscribers, I am trying to raise enough money to buy a good
flatbed scanner to scan in new articles and news releases for the newsletter.
Cost for a new scanner is approximately $1000. To prevent boring our old
readers, please write to david@stat.com if you have specific questions.
I have sent everyone individually thank you notes, but some email has bounced.
If you see your name below, but did not receive a thank you note, please drop
me a line.
If you would like to send in a contribution, mail a check to:
David Dodell
10250 North 92nd Street, Suite 210
Scottsdale, Arizona 85258-4599 USA
Thank you to the following individuals whose contributions I just received:
Chris Spirito
Louis Harris
William Landry
Judy Sproles
David Dorward
Laura Larsson
George Hazzard
Jack Cross
R.K. Wright
Edward Taxin
Kriss and Betsy Davis
Mark Dixon
Franz Piribauer
Clark University
Robert Robison
Health InfoCom Network News Page 1
Volume 6, Number 5 March 8, 1993
My source for the MMWR has finally arrived direct from the Centers for Disease
Control. Since I will no longer have to relay on a third-party source, the
MMWR should be back to a regular column of the newsletter.
Again, thank you for all the contributions sent so far.
David Dodell
Editor, HICNet Medical Newsletter
Health InfoCom Network News Page 2
Volume 6, Number 5 March 8, 1993
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Centers for Disease Control - MMWR
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
MMWR 42(08) March 05, 1993
Recommendations for HIV Testing Services for Inpatients
and Outpatients in Acute-Care Hospital Settings
=======================================================
CDC has published revised recommendations for human immunodeficiency
virus (HIV) counseling and testing of patients in acute-care hospital settings
(1).* These recommendations update previous CDC guidelines published in 1987
(2) and strengthen the recommendation for hospitals to assess the rate of HIV
infection among their patient populations and to develop HIV-testing programs
that assist infected patients in obtaining HIV-related treatment and
prevention services. The revision was prompted by information regarding both
the rates of previously unrecognized HIV infection among persons admitted to
some acute-care hospitals and the potential medical and public health benefits
of recognizing HIV infection in persons who have not developed acquired
immunodeficiency syndrome (AIDS).
CDC recommends that hospitals and associated clinics encourage health-
care providers to routinely ask patients in nonemergency settings about their
risks for HIV infection. Patients at risk should be offered HIV counseling and
testing services with informed consent obtained in accordance with local laws.
In addition, hospitals with an HIV-seroprevalence rate of at least 1% or an
AIDS diagnosis rate greater than or equal to 1.0 per 1000 discharges (3)
should strongly consider adopting a policy of offering such services routinely
to patients aged 15-54 years. These services should be structured to
facilitate confidential, voluntary patient participation and should include
pretest information about the testing procedures, appropriate posttest
counseling for infected patients and those at increased risk, and referral of
HIV-infected persons for medical evaluation. Persons who decline HIV testing
or who consent to testing and are found to be infected must not be denied
needed health care or provided suboptimal care.
The recommendations emphasize that HIV counseling and testing programs
should not be used as a substitute for universal precautions or other
infection-control techniques and underscore the importance of effective and
ongoing collaboration between acute-care providers and health departments to
improve HIV-related prevention and treatment services.
References
1. CDC. Recommendations for HIV testing services for inpatients and
outpatients in acute-care hospital settings and technical guidance on HIV
counseling. In: Recommendations and reports (January 15). MMWR 1993;42(no. RR-
2):1-6.
Health InfoCom Network News Page 3
Volume 6, Number 5 March 8, 1993
2. CDC. Public Health Service guidelines for counseling and antibody testing
to prevent HIV infection and AIDS. MMWR 1987;36:509-15.
3. Janssen RS, St. Louis ME, Satten G, et al. HIV infection among patients in
U.S. acute-care hospitals: strategies for the counseling and testing of
hospital patients. N Engl J Med 1992;327:445-52.
* Single copies of the recommendations will be available from the CDC National
AIDS Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003; telephone (800)
458-5231.
Health InfoCom Network News Page 4
Volume 6, Number 5 March 8, 1993
Comparison of Early and Late Latent Syphilis -- Colorado, 1991
==============================================================
Latent syphilis (i.e., the presence of serological evidence for syphilis
without clinical manifestations) is divided into early latent (EL less than
1-year's duration) and late latent (LL more than 1-year's duration) stages
(1). LL syphilis, which is often associated with low nontreponemal test (e.g.,
rapid plasma reagin RPR) titers and is presumed to have been acquired in the
distant past, is not routinely included in syphilis surveillance reports and
analyses. Although a separate classification of "unknown latent syphilis" has
been proposed (1), in practice, duration is unknown for nearly all syphilis
cases that are classified as LL. This report compares EL and LL syphilis cases
in Colorado during 1991 and demonstrates substantial overlap in their
characteristics.
Colorado EL and LL syphilis cases reported in 1991 were abstracted for
information on age, sex, racial/ethnic group, and serologic test results
(RPR). Persons aged greater than or equal to 60 years with RPR titers less
than or equal to 16 were not included among LL cases, because these are
usually closed administratively without investigation by disease-control
staff.
Serologic and demographic data were available for 33 (94%) of 35 EL and
92 (91%) of 101 LL cases reported in 1991. Females composed 17 (52%) EL and 35
(38%) LL cases. Blacks composed 13 (39%) EL and 28 (30%) LL cases; whites
composed seven (21%) EL and 28 (30%) LL cases; Hispanics composed 30% of both
EL and LL cases.
Of patients with EL syphilis, 27 (82%) had RPR titers greater than or
equal to 8; 40 (43%) patients with LL syphilis also had RPR titers greater
than or equal to 8 (Figure 1). The percentage of cases with RPR titers greater
than or equal to 32 was 42% for EL and 18% for LL. The median age group was
25-29 years for EL and 30-34 years for LL patients. Of patients with EL
syphilis, 28 (85%) were aged less than or equal to 39 years; 70 (76%) patients
with LL syphilis were also in this age range (Figure 2). Based on the
combination of both RPR titer greater than or equal to 8 and age less than or
equal to 39 years, 32 (35%) patients with LL syphilis were similar to the
majority of EL patients.
Reported by: KA Gershman, MD, HIV/STD Surveillance Program, RE Hoffman, MD,
State Epidemiologist, Colorado Dept of Health. Clinical Research Br, and
Surveillance and Information Systems Br, Div of Sexually Transmitted Diseases
and HIV Prevention, National Center for Prevention Svcs, CDC.
Editorial Note: The division of latent syphilis into early and late stages is
based on treatment and public health considerations; a previous study of
untreated syphilis indicated that most secondary relapses (mucocutaneous
lesions) occurred during the first year after infection (2). In the United
States, since the 1960s, the early latent stage has been defined as 1 year
Health InfoCom Network News Page 5
Volume 6, Number 5 March 8, 1993
from the onset of infection. In practice, latent syphilis is classified as EL
with evidence that a person acquired infection during the previous 12 months
based on 1) a nonreactive serologic test for syphilis or a fourfold rise in
titer from a previous serologic test for syphilis during the previous 12
months; 2) a history of symptoms consistent with primary or secondary syphilis
without a history of treatment in the previous 12 months; or 3) a history of
sexual exposure to a partner with confirmed or presumptive primary, secondary,
or early latent syphilis and no history of treatment during the previous 12
months. If none of these criteria are met, a case of latent syphilis is
classified as LL; the duration of infection is usually unknown.
Public health surveillance for syphilis is based on reported cases of
primary and secondary (P&S) or early (P&S plus EL) syphilis. Because a
substantial proportion of persons with infectious P&S syphilis do not seek
medical attention despite symptoms (3), reporting that includes EL cases
presumably reflects the true incidence of syphilis during the previous 12
months more accurately than does reporting of P&S syphilis alone. The findings
in this report that the age and serologic titer patterns of LL and EL syphilis
patients are similar suggest that a substantial number of LL case-patients may
have acquired infection during the previous 12 months, even though information
was inadequate to classify these cases as EL. Based on these findings, the
actual number of EL cases in Colorado could be more than twofold greater than
what is recognized.
Limitations in knowledge about the natural history of nontreponemal test
titers in untreated syphilis precludes use of these tests to assess duration
of infection. Although peak titers are reached during the first year of
untreated infection, data on their rate and variability of subsequent decline
are limited (4).
For monitoring morbidity trends and evaluating control programs, the
category P&S syphilis may be optimal, especially when focusing on patients
voluntarily seeking care with signs or symptoms (5). The detection of EL and
LL syphilis cases is more dependent on active case-finding conducted by STD
programs, including partner notification and serologic screening. Although the
division of latent syphilis cases into EL and LL stages has been useful for
treatment and partner notification, the findings in this report suggest this
classification is problematic for use in surveillance.
References
1. CDC. Case definitions for public health surveillance. MMWR 1990;39(no. RR-
13).
2. Sparling PF. Natural history of syphilis. In: Holmes KK, March PA, Sparline
PF, Wiesner PJ, eds. Sexually transmitted diseases. New York: McGraw-Hill,
1990:214.
Health InfoCom Network News Page 6
Volume 6, Number 5 March 8, 1993
3. Brown WJ, Donohue JF, Axnick NW, Blount JH, Ewen NH, Jones OG. Syphilis
and other venereal diseases. Cambridge, Massachusetts: Harvard University
Press, 1970:41.
4. Hart G. Syphilis tests in diagnostic and therapeutic decision making. Ann
Intern Med 1986;104:368-76.
5. CDC. Epidemic early syphilis -- Montgomery County, Alabama, 1990-1991. MMWR
1992; 41:790-4.
Health InfoCom Network News Page 7
Volume 6, Number 5 March 8, 1993
Tetanus Fatality -- Ohio, 1991
==============================
In August 1991, the Ohio Department of Health received a report of a
fatal case of tetanus. This report summarizes the investigation of this case.
On July 21, 1991, an 80-year-old woman sought treatment in the emergency
department of a hospital in central Ohio because of a stiff jaw and dysphagia.
On examination, she had slightly slurred speech and difficulty opening her
mouth but no difficulty breathing. A wood splinter from a forsythia bush had
been lodged in her left shin approximately 1 week; the wound site was
erythematous and draining purulent material. The emergency room physician
diagnosed tetanus and admitted the woman to the hospital. Treatment included
tetanus immune globulin (3000 units) and tetanus toxoid (0.5 cc) and
intravenous clindamycin because of a reported history of penicillin allergy.
The patient had no history of any previous tetanus vaccinations. She had
been treated at an undetermined time in the 1960s for an infected wound
associated with a fractured ankle. In addition, she had sought medical care
periodically for treatment of hypertension and other medical problems.
The patient's clinical status gradually deteriorated, and mechanical
ventilation was required because of increasing generalized rigidity. During
the ensuing 2-week period, she was treated for tremors, muscle spasms,
abdominal rigidity, apnea, pneumonia, and local infection from her leg wound.
Despite aggressive treatment, the patient died on August 5.
As a result of this case, a public health nurse, serving as part of the
Occupational Health Nurses in Agricultural Communities (OHNAC) project *,
instituted communitywide educational activities to increase tetanus
vaccination coverage among adults. Following these educational efforts, from
August 1991 through July 1992, the number of adults receiving tetanus
vaccination from the county health department increased 51% ** over the
previous 12 months (79 vaccinations compared with 52, respectively).
Reported by: M Fleming, Grady Memorial Hospital; A Babcock, Delaware County
Health Dept, Delaware; A Migliozzi, MSN, TJ Halpin, MD, State Epidemiologist,
Ohio Dept of Health. Div of Surveillance, Hazard Evaluations, and Field
Studies, National Institute for Occupational Safety and Health; Div of
Immunization, National Center for Prevention Svcs, CDC.
Editorial Note: The risk for tetanus is greater in older (aged greater than or
equal to 60 years) persons who lack protective levels of antitoxin (1,2).
Although tetanus is preventable through adequate vaccination, 117 cases of
tetanus were reported to CDC during 1989 and 1990 (3 ). Supplemental
information available for 110 of these cases indicates the case-fatality rate
was 24%. Of 109 persons for whom age was known, 63 were aged greater than or
equal to 60 years. Of the 37 persons in this age group for whom vaccination
status was known, 34 (92%) were inadequately vaccinated (CDC, unpublished
data, 1992).
Health InfoCom Network News Page 8
Volume 6, Number 5 March 8, 1993
Tetanus toxoid is a highly effective vaccine. Protective levels of serum
antitoxin are generally maintained for at least 10 years in properly
vaccinated persons (4). After completion of the primary vaccination series,
booster doses of tetanus toxoid, combined with diphtheria toxoid (as Td) every
10 years are recommended by the Advisory Committee on Immunization Practices,
the American College of Physicians, the American Academy of Family Physicians,
and the American Academy of Pediatrics.
This report and others underscore the consequences of missed
opportunities for vaccination (3). Although the patient in this report had
numerous prior contacts with the health-care system, she had no history of
vaccinations against tetanus. Of the 57 persons with tetanus in 1989 and 1990
for whom vaccination status was known, 45 (79%) reported ever having received
less than or equal to 2 doses of tetanus toxoid. In addition, of the 12 who
had sought medical care for their injuries and for whom tetanus toxoid was
indicated, 11 were not vaccinated (3).
Wounds such as that described in the patient in this report are common in
persons with tetanus and may not be considered sufficiently severe by the
person to warrant a visit to a health-care provider. In 1989 and 1990, only
27 (31%) of 86 persons with tetanus and a clear antecedent acute injury sought
medical treatment for their wounds (3). Therefore, internists, family
practitioners, occupational physicians and other primary health-care providers
who treat adults should use every opportunity to review the vaccination status
of their patients and administer Td and other indicated vaccines as
appropriate.
References
1. CDC. Tetanus--Rutland County, Vermont, 1992. MMWR 1992;41:721-2.
2. CDC. Summary of notifiable diseases, United States, 1991. MMWR 1992;40(no.
53):47.
3. Prevots R, Sutter RW, Strebel PM, Cochi SL, Hadler S. Tetanus surveillance
-- United States, 1989-1990. In: CDC surveillance summaries (December 11).
MMWR 1992;41(no. SS-8):1-9.
4. ACIP. Diphtheria, tetanus, and pertussis: recommendations for vaccine use
and other preventive measures -- recommendations of the Immunization Practices
Advisory Committee (ACIP). MMWR 1991;40 (no. RR-10).
* OHNAC is a national surveillance program conducted by CDC's National
Institute for Occupational Safety and Health that has placed public health
nurses in rural communities and hospitals in 10 states (California, Georgia,
Iowa, Kentucky, Maine, Minnesota, New York, North Carolina, North Dakota, and
Ohio) to conduct surveillance of agriculture-related illnesses and injuries
Health InfoCom Network News Page 9
Volume 6, Number 5 March 8, 1993
that occur among farmers and farm workers and their family members. These
surveillance data are used to reduce the risk for occupational illness and
injury in agricultural populations.
** The 51% increase in vaccinations may underestimate the total effect of this
intervention because it does not include persons who obtained vaccinations
from private physicians or from providers in neighboring counties.
Health InfoCom Network News Page 10
Volume 6, Number 5 March 8, 1993
Impact of New Legislation on Needle and Syringe
Purchase and Possession -- Connecticut, 1992
===============================================
Human immunodeficiency virus (HIV) and other bloodborne pathogens are
transmitted among injecting-drug users (IDUs) through the reuse and sharing of
contaminated needles and syringes (NSs) (1). Of the 689 acquired
immunodeficiency syndrome (AIDS) cases reported in Connecticut in 1992, 413
(60%) were associated with injecting-drug use. To help reduce IDUs' use of
contaminated NSs, Connecticut enacted laws effective July 1, 1992, that allow
the purchase without a prescription of up to 10 NSs at one time in pharmacies
and the possession of up to 10 clean NSs.* Before this date, purchase and
possession of NSs without a prescription had been illegal in Connecticut. This
report presents preliminary information from the first 5 months of an ongoing
evaluation to determine whether the new laws affected pharmacy-based NS sales,
IDUs' reported knowledge of the laws and places to obtain NSs, and law
enforcement officers' risk for needlestick injuries.
Investigation of Pharmacy-Based NS Sales
In June 1992, eight pharmacies in Hartford, a city of 139,739 (1990 U.S.
Census), were enrolled in a sentinel surveillance system to monitor pharmacy-
based NS sales. For 1992, the annual incidence of AIDS in Hartford was 86
cases per 100,000 residents. All sentinel pharmacies were located in
neighborhoods where injecting-drug use was reported to be prevalent. Monthly
prescription and nonprescription NS sales for each participating pharmacy were
monitored beginning July 1992.
By November 1992, six (75%) of the eight pharmacies were selling
nonprescription NSs. The number of nonprescription NSs sold by these
pharmacies increased steadily each month through October 1992 (480 in July;
856, August; 1143, September; and 1560, October).
In the two pharmacies not selling nonprescription NSs in November,
pharmacists reported they had sold nonprescription NSs when the law went into
effect, but cited IDU-related incidents (i.e., a used syringe was found on a
shelf and an IDU disrupted business) in their pharmacy as the reason for now
refusing to sell. IDUs' Knowledge of Laws and Places to Obtain NSs
During August-November 1992, staff members at three HIV counseling and
testing sites, two correctional facilities, and two drug-treatment centers in
Connecticut interviewed active IDUs using a standard questionnaire. Active
IDUs were defined as persons who reported using a needle or syringe to inject
drugs into their veins, into their muscles, or under their skin during June
1992 and who reported using injected drugs during the 30 days preceding the
interview. IDUs were asked about their knowledge of the new laws and NS-
purchasing practices during the 30 days preceding the interview and during the
30 days before the laws became effective.
Of 124 active IDUs, 68 (55%) reported they were aware they could both
Health InfoCom Network News Page 11
Volume 6, Number 5 March 8, 1993
purchase and possess clean NSs. An additional 26 (21%) IDUs were aware they
could legally purchase NSs but did not know they could legally possess them.
Thirteen (59%) of the 22 IDUs who were not aware of either law were men
interviewed in correctional facilities.
More IDUs reported purchasing NSs from a pharmacy during August-October
(51 41%) than during June (23 19%). This change included 27 IDUs who began
purchasing from a pharmacy and two IDUs who reported not purchasing from a
pharmacy after the new laws went into effect (p<0.001, sign test, matched-pair
analysis). Those purchasing NSs during June may have been IDUs with diabetes,
made illegal pharmacy purchases, or recalled inaccurately their purchasing
during that time. Fewer IDUs reported purchasing NSs on the street during
August-October (73 59%) than during June (92 74%); four IDUs reported they
began purchasing and 24 reported they did not purchase on the street (p<0.001,
sign test). However, of all methods to obtain NSs, purchases on the street
(59%) were reported more often than purchases from pharmacies (41%). The
prevalence of NS sharing was unchanged -- during both periods, approximately
36% of IDUs reported at least one episode of NS sharing.
In November 1992, four focus groups were held in Hartford with a total of
34 active IDUs to address issues regarding NS use and purchasing practices.
Participants reported that many IDUs changed their NS-purchasing practices in
July and began purchasing from pharmacies. Approximately two thirds of the
IDUs attending the meetings were aware that clean NS possession was legal and
reported they were now more likely to carry NSs with them on the street. Focus
group participants reported that NS-sharing episodes were less frequent after
the new laws went into effect.
Law Enforcement Officers' Risk for Needlestick Injuries
To determine whether Hartford police officers were at greater risk for
needlestick injuries after the new laws went into effect --because IDUs
reported that they were more likely to carry NSs on the street -- Occupational
Safety and Health Administration-mandated reports of occupational injuries and
illnesses were reviewed for reports of needlestick injury among police
officers. Needlestick injury rates among officers were similar during the 3
months before and after July 1 (two needlestick injuries in 423 arrests for
opium, cocaine, or NS possession versus one in 478 arrests, respectively).
Reported by: Hartford Dispensary; Regional Network of Programs; Chemical
Dependency Unit, Community Health Svcs; Hartford Police Dept; AIDS Program,
Hartford Health Dept. AIDS Program, Bridgeport Health Dept. AIDS Program,
Waterbury Health Dept. Health Svcs Div, Connecticut Dept of Correction. B
Weinstein, MPH, AIDS Section, JL Hadler, MD, State Epidemiologist, Connecticut
Dept of Health Svcs. Div of Field Epidemiology, Epidemiology Program Office;
Clinical Research Br, and Behavioral and Prevention Research Br, Div of
Sexually Transmitted Diseases and HIV Prevention, National Center for
Health InfoCom Network News Page 12
Volume 6, Number 5 March 8, 1993
Prevention Svcs; Office of HIV/AIDS, Office of the Director, CDC.
Editorial Note: In July 1991, the National Commission on AIDS recommended
removing legal barriers to the purchase and possession of NSs as part of a
strategy for reducing the spread of HIV among IDUs unable or unwilling to
enter drug treatment (2 ). Statutes in 44 states and the District of Columbia
place criminal penalties on the possession and distribution of NSs (drug
paraphernalia laws), and the sale of NSs without a medical prescription are
prohibited in 10 states and the District of Columbia (needle prescription
laws) (3). Although IDUs in some localities have begun to clean their NSs and
to decrease NS sharing in response to the AIDS epidemic (4,5), NS sharing
continues, reflecting the limited availability of NSs and the established
practices of injecting-drug use (5-7).
Because the number and proportion of HIV infections related to injecting-
drug use in Connecticut are high, efforts to prevent HIV infection among IDUs
and their sex partners have been broad and include street outreach and drug-
treatment-based education to encourage safer sex and injection practices,
comprehensive drug treatment, HIV counseling and testing, and legalizing the
availability of sterile NSs. In July 1990, the Connecticut legislature
legalized needle exchange in New Haven, and in May 1992, the legislature
approved and funded additional needle-exchange programs in Hartford and
Bridgeport. Connecticut legislators also amended the state's needle
prescription and drug paraphernalia statutes. Legalizing over-the-counter
purchase of up to 10 NSs potentially expanded IDUs' access to sterile needles
to include pharmacies in Connecticut that might choose to sell nonprescription
NSs. Allowing possession of up to 10 clean NSs might encourage IDUs to carry
their own NSs, thereby decreasing the likelihood of unsafe NS sharing.
A follow-up questionnaire survey of active IDUs is being conducted to
determine whether the behaviors reported in these preliminary findings have
changed and to better characterize NS-purchasing practices, NS ownership, and
patterns of NS usage as IDUs' knowledge of the new laws becomes more
widespread. One issue being explored is the discrepancy between questionnaire
results indicating that no change occurred in NS-sharing practices while focus
groups indicated that NS-sharing episodes decreased. The increase in the
number of nonprescription NSs sold by sentinel pharmacies in Hartford probably
reflects NS purchasing by IDUs but might also represent a shift from
prescription to nonprescription sales to persons with diabetes or those who
use NSs for medical purposes. To better define pharmacists' knowledge,
attitudes, and practices regarding nonprescription NS sales, pharmacists will
be interviewed in person and be surveyed by mail during 1993.
References
--------- end of part 1 ------------
· Subject: HICN605 Medical Newsletter Part 2/6
1. Schoenbaum EE, Hartel D, Selwyn PA, et al. Risk factors for human
immunodeficiency virus infection in intravenous drug users. N Engl J Med
Health InfoCom Network News Page 13
Volume 6, Number 5 March 8, 1993
1989;321:874-9.
2. National Commission on Acquired Immune Deficiency Syndrome. The twin
epidemics of substance use and HIV. Washington, DC: National Commission on
Acquired Immune Deficiency Syndrome, July 1991:10-1.
3. Gostin L. The needle-borne epidemic: causes and public health responses.
Behavioral Sciences and the Law 1991;9:287-304.
4. CDC. Coordinated community programs for HIV prevention among intravenous-
drug users -- California, Massachusetts. MMWR 1989;38: 369-74.
5. Selwyn PA, Feiner C, Cox CP, Lipshutz C, Cohen RL. Knowledge about AIDS and
high-risk behavior among intravenous drug users in New York City. AIDS
1987;1:247-54.
6. DesJarlais DC, Friedman SR, Sotheran JL, Stoneburner R. The sharing of drug
injection equipment and the AIDS epidemic in New York City: the first decade.
In: Battjes RJ, Pickens RW, eds. Needle sharing among intravenous drug
abusers: national and international perspectives. Washington, DC: US
Department of Health and Human Services, Public Health Service, Alcohol, Drug
Abuse, and Mental Health Administration, 1988. (NIDA research monograph no.
80).
7. Grund JPC, Kaplan CD, Adriaans NFP. Needle sharing in the Netherlands: an
ethnographic analysis. Am J Public Health 1991;81:1602-7.
* Connecticut General Statutes, Sections 21a-65, 21a-240, 21a-267, 1992. Under
the new laws, pharmacies are permitted, but not required, to sell NSs without
a prescription.
Health InfoCom Network News Page 14
Volume 6, Number 5 March 8, 1993
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Dental News
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
First License Granted to Produce Dental Products
that will Remineralize Teeth
-----
NIDR Research Digest by Roger Rensberger
The National Institute of Standards and Technology has granted a patent
license to a U.S. dental materials manufacturer to produce dentifrice products
using a new method to remineralize teeth. The method was developed by a NIST
researcher with support from the National Institute of Dental Research. The
manufacturer plans to use the remineralization method to develop toothpastes,
chewing gum, and other dental products that can help repair early cavities,
restore decalcified areas, and make teeth less sensitive to hot and cold.
The exclusive license to produce products with the patented remineralization
process was granted to Enamelon Inc., of Yonkers, N.Y., by the American Dental
Association Health Foundation (ADAHF) at the National Institute of Standards
and Technology
The remineralization method was invented by research chemist Dr. Ming S. Tung
of the Paffenbarger Research Center at NIST. The remineralization patent is
held by the American Dental Association Health Foundation, sponsor of the 64-
year-old Paffenbarger Research Center.
Use of Amorphous Calcium Phosphate
Dr. Tung's remineralization method uses amorphous calcium compounds, or a
carbonate solution, that crystallize to form hydroxyapatite, the primary
mineral in teeth and bone. The aim of remineralization is to disperse
hydroxyapatite into the tooth structure to prevent further tooth decay and
restore the tooth to its original form. Enamelon's products will contain the
amorphous calcium phosphate that causes the remineralization process to take
place.
In the past, commercialization of a solution for remineralization has been
prevented by problems such as instability, slow diffusion and reaction time,
and surface precipitation. The process patented by the ADAHF contains calcium
Phosphate that overcomes these problems and remineralizes the tooth rapidly.
FDA Approval Needed
The initial period of the exclusive license agreement with Enamelon will be
Health InfoCom Network News Page 15
Volume 6, Number 5 March 8, 1993
extended to a date three years after the manufacturer has demonstrated that
the remineralizing material has been physically and chemically stabilized for
storage and marketing, similar to other dentifrices or chewing gums.
Some of the materials will require clinical testing to receive Food and Drug
Administration approval for marketing the products to dental professionals and
the public.
The remineralization method developed by Dr. Tung is a prime example of how
dental materials research conducted at NIST supports the safe, efficient, and
economical use of materials for the benefit of consumers and practicing
dentists," said John A. Tesk, leader of the NIST Dental and Medical Materials
Group.
The NIST dental materials program is a cooperative activity involving
researchers from the institute's Polymers Division, research associates from
the ADAHF, NIDR, and industry, and guest scientists from leading dental
schools.
Health InfoCom Network News Page 16
Volume 6, Number 5 March 8, 1993
NEWS FROM NIDR - 03/07/93
-----------------------------------------------------------------
03/03/93
DENTAL RESEARCHERS REPORT NOVEL APPROACH FOR TREATING ARTHRITIS
Scientists have successfully treated arthritic rats by blocking the action of
molecule that regulates the body's response to infection or tissue injury.
The molecule is called transforming growth factor-beta (TGF-beta). When an
antibody that inhibits TGF-beta (anti-TGF-beta) was injected directly into the
animals' joints, arthritis symptoms were greatly reduced.
This finding could have applications for treating arthritis, periodontal
diseases, and other chronic inflammatory disorders, said Dr. Sharon Wahl of
the National Institute of Dental Research, who led the study. She cautioned,
however, that the use of antibodies for therapy has inherent problems, but
added that these studies serve as a prototype for local administration of
other TGF-beta antagonists currently under development.
TGF-beta is a multifunctional molecule that plays a pivotal role in switching
the immune system on and off. In the early stages of an infection, TGF-beta
is secreted by white blood cells and acts as a signal that attracts other
white cells and stimulates them to fight the infection. As the infection
subsides, TGF-beta reverses its role and suppresses the activity and
recruitment of white cells.
However, in chronic disease situations such as arthritis, the normal cycle of
events does not occur and TGF-beta continues to attract white cells. It is
the excessive accumulation of white cells that produces red, swollen joints
and eventually leads to tissue and bone destruction.
Scientists examined rats with experimentally induced arthritis to determine
the therapeutic effect of anti-TGF-beta, which specifically binds to TGF-beta
and blocks its activity. Rats were first injected with a bacterial cell
preparation that produces symptoms that mimic human rheumatoid arthritic.
Without additional treatment, the rats experience an acute form of arthritic
that appears within 24 hours and is characterized by swelling of the joints
and feet and redness of the overlying skin.
The acute phase subsides within several days, and after a period of two to
three weeks, the disease enters the chronic stage. This phase is identified by
joint deformity brought on by the gradual destruction of cartilage and bone
replacement with connective tissue containing large numbers of white bloods
cells.
Rats receiving a single injection of anti-TGF-beta into a hind ankle just
Health InfoCom Network News Page 17
Volume 6, Number 5 March 8, 1993
prior to injection with the bacterial cell preparation experienced a
significant reduction in both acute and chronic forms of arthritis. Acute
symptoms were reduced by over 75 percent and chronic symptoms by over 60
percent. Moreover, when anti-TGF-beta was administered only after the chronic
disease phase had begun, arthritis symptoms were still reduced by almost 70
percent.
According to Dr. Wahl and her associates, anti-TGF-beta works by interrupting
the cycle of white cell migration into the joints. The researchers feel that
this antibody and other TGF-beta inhibitors may provide a mechanism for
treating arthritis and other chronic inflammatory diseases.
The study was conducted by Drs. Sharon Wahl, Janice Allen, Gina Costa, and
Henry Wong of the National Institute of Dental Research in Bethesda, Maryland,
and Dr. James Dasch of Celtrix Pharmaceuticals, Inc. in Santa Clara,
California. The results were reported in the January 1993 issue of the
Journal of Experimental Medicine.
Health InfoCom Network News Page 18
Volume 6, Number 5 March 8, 1993
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
AIDS News Summaries
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
AIDS Daily Summary Feb 16, 1993 to March 5, 1993
AIDS Daily Summary
The Centers for Disease Control and Prevention (CDC) National AIDS
Clearinghouse makes available the following information as a public service
only. Providing this information does not constitute endorsement by the CDC,
the CDC Clearinghouse, or any other organization. Reproduction of this text
is encouraged; however, copies may not be sold. Copyright 1992, Information,
Inc., Bethesda, MD
=====================================================================
February 16, 1993
=====================================================================
"U.S. Starts Initial Human Tests on New Type of AIDS Vaccine" Los Angeles
Times (02/14/93), P. A7
On Friday, the federal government began preliminary human trials of an
AIDS vaccine, which researchers hope will protect against several strains of
HIV. The National Institute of Allergy and Infectious Diseases (NIAID) said
researchers would first give the vaccine to 36 healthy volunteers to test its
safety and the immune system response of the participants. The vaccine is
manufactured by United Biomedical Inc. of Hauppauge, N.Y. It is a so-called
"peptide vaccine," based on a laboratory-synthesized protein fragment, or
peptide. An agency AIDS researcher, Margaret Johnston, said, "Peptide
vaccines have two particular strengths: They are inexpensive and relatively
easy to modify, to include new mixtures of peptides and those from different
HIV strains." There are at least five genetically distinguishable strains
of HIV, according to research. The NIAID said United Biomedical eventually
wants to develop a vaccine involving a mix of peptides that would provide
protection against all strains of the AIDS virus.
=====================================================================
"New Research Shows HIV and Cancer Genes May Be Blocked" United Press
International (02/15/93)
Cleveland--A new drug may inhibit cancer and viral infections, including
HIV, according to recent research conducted by the Cleveland Clinic and the
National Institutes of Health, and published in the Monday issue of the
Proceedings of the National Academy of Sciences. The drug, 2-5A-antisense,
Health InfoCom Network News Page 19
Volume 6, Number 5 March 8, 1993
causes the breakdown of unwanted messenger RNA. Messenger RNA determines
which protein will be made in the cell. Therefore, when the unwanted RNA is
broken down, the gene cannot function. Dr. Robert Silverman of the Cleveland
Clinic's Cancer Biology Department said, "The research is in its very early
stages. But our results are exciting. This method takes a much more
targeted approach to treating viral infections and cancer." The approach
reported uses a modified "antisense," which is a piece of DNA that seeks out
and binds with messenger RNA. Attached to the antisense is an enzyme
activator, known as 2-5A. The antisense binds to the unwanted messenger RNA,
which is then killed by the activated enzyme. The report states, "In any
virus, the genes have a sequence unique in nature. In theory, we can make an
antisense that will bind only to the virus RNA without binding to human RNA,
thereby destroying the virus without harming the person." Silverman warns
that the findings have been in cell extracts, not within animals or people.
But he said the researchers still consider the results quite promising.
=====================================================================
"Unexplained Opportunistic Infections and CD4+ T-Lymphocytopenia Without HIV
Infection" New England Journal of Medicine (02/11/93) Vol. 328, No. 6, P. 373
(Smith, Dawn K., et al.)
The mysterious AIDS-like condition without evidence of HIV infection
that has recently been reported appears to be rare and not transmissible,
write Dr. Dawn K. Smith and colleagues of the Centers for Disease Control in
Atlanta, Ga. Researchers conducted investigations to determine the
demographic, clinical, and immunologic features of patients with idiopathic
CD4+ T-lymphocytopenia (ICL); whether the syndrome is epidemic or
transmissible; and its possible causes. The researchers reviewed 230,179
cases in the CDC AIDS Reporting System and performed interviews, medical
reviews, and laboratory analyses of blood specimens from adults and
adolescents who met the CDC definition of ICL. The patients' sexual
contacts, household contacts, and persons who had donated blood to them were
also tested. The researchers interviewed 31 of the 47 patients identified
with ICL, as well as 23 of their contacts. A total of 18 patients had one or
more risk factors for HIV infection: seven had hemophilia, six had engaged in
homosexual sex, six had received blood transfusions, and two had had
heterosexual sex partners who were at risk for HIV infection. The other 29
patients had no risk factors for HIV infection. When blood from 28 patients
was tested, eight were found to have T-cell counts of less than 300 cells
per cubic millimeter, and 6 had fewer than 250 T-cells per cubic millimeter.
The researchers determined that 10 sex partners, three household contacts,
and four children of the ICL patients, as well as six persons who had donated
blood to the patients, were immunologically and clinically normal.
Health InfoCom Network News Page 20
Volume 6, Number 5 March 8, 1993
====================================================================
February 17, 1993
====================================================================
"Effort to Manufacture Artificial Blood is Thwarted" Los Angeles Times--
Washington Edition (02/17/93), P. B7 (Maugh, Thomas H.)
The production of an artificial blood product has encountered an
unexpected hindrance that may seriously postpone its commercialization, said
a University of California--San Diego physician at a meeting of the American
Association for the Advancement of Science. While researchers from the four
companies conducting clinical trials on the artificial bloods have not
disclosed the preliminary findings from their trials, enough information has
been released to allow observers to figure out the cause of the difficulties,
said Dr. Robert M. Winslow, a professor of medicine at UC-San Diego who was
formerly in charge of the U.S. Army's efforts to develop an artificial blood.
Participants in the clinical trials of the artificial bloods have reported
various unexpected side effects, including chest pains, back pains, nausea,
and hypertension. What seems to be the cause is nitric oxide (NO), which
interacts with artificial blood, Winslow said. The hemoglobin in the
artificial blood is leaking out of blood vessels and into the surrounding
tissues, where it binds NO tightly, inhibiting its vasorelaxant properties,
said Winslow. Consequently, the blood vessels constrict, causing the
unusual symptoms. The problem could be very hard to solve because NO binds
with the hemoglobin at the same molecular location that oxygen does. Any
efforts to prevent the binding will most likely restrict hemoglobin's oxygen-
carrying capacity.
====================================================================
"Idiopathic CD4+ T-Lymphocytopenia--Immunodeficiency Without Evidence of HIV
Infection" New England Journal of Medicine (02/16/93) Vol. 328, No. 6, P. 380
(Ho, David D. et al.)
It remains undetermined whether idiopathic CD4 T-lymphocytopenia (ICL)
is new, transmissible, or acquired, write David D. Ho et al. of the Aaron
Diamond AIDS Research Center in New York, N.Y. Patients recently diagnosed
with severe CD4 T-lymphocytopenia but without evidence of HIV infection have
spurred a national surveillance network to investigate such cases. The
researchers examined 12 patients with CD4 T-lymphocytopenia who were referred
by three U.S. cities. The patients (10 men and 2 women) ranged in age from
30 to 69 years. A total of eight had risk factors for HIV infection. The
clinical conditions were heterogeneous: five patients had opportunistic
infections, five had syndromes of unknown cause, and two had no symptoms. Two
patients died from severe complications of their immunodeficiency. The
Health InfoCom Network News Page 21
Volume 6, Number 5 March 8, 1993
patients' lowest CD4 T-lymphocyte counts ranged from three to 308 per cubic
millimeter. Three patients had complete or partial spontaneous reversal of
the CD4 T-lymphocytopenia. Concomitant CD8 T-lymphocytopenia was found in
three patientsJand abnormal immunoglobulin levels were found in five.
Multiple virologic studies by serologic testing, culture, and polymerase
chain reaction were completely negative for HIV in all patients. The
researchers found that the 12 patients with ICL appear to be
epidemiologically, clinically, and immunologically heterogeneous. Although the
conditions experienced in the ICL patients resemble AIDS, HIV infection was
not detected. The cause of ICL is unknown, the researchers conclude.
====================================================================
"Projections of the Number of Persons Diagnosed With AIDS and the Number of
Immunosuppressed HIV-Infected Persons--United States, 1992-1994" Journal of
the American Medical Association (02/10/93) Vol. 269, No. 6, P. 733
The Centers for Disease Control recently released new estimates of the
number of persons in the United States who will initially be diagnosed with
an illness included in the 1987 AIDS surveillance case definition during
1992-1994. About 58,000 Americans had AIDS during 1991 as defined by the
1987 AIDS definition. Between 1992-1994, the number of persons who have
illnesses meeting these criteria is expected to rise by only a few percent
annually, with about 85 percent of those persons being reported to the CDC
with cases of AIDS. The rate of increase in reported AIDS cases in persons
who contracted HIV via heterosexual contact is expected to be higher than that
in persons who contracted the virus through homosexual/bisexual contact or
IV-drug use. The CDC predicts that, as of January 1993, an additional
120,000 to 190,000 Americans had HIV-related severe immunosuppression. Not
all of these persons were aware of their HIV infection, however, and of those
who know their HIV infection status, not all have had a T-cell count. If the
AIDS definition went unchanged, about 50,000 to 60,000 reported AIDS cases
would have been expected in 1993. The new definition of AIDS that includes
HIV-related severe immunosuppression should increase reported cases by about
75 percent. The effect of this expansion on the number of reported cases is
estimated to be smaller in later years because in 1993 many prevalent as well
as incident cases of immunosuppression will be reported as the expanded
surveillance case definition is used. Reported AIDS cases may decrease from
1993 through 1994, according to the CDC.
====================================================================
"Multicenter Clinical Trials of AIDS Vaccines Scheduled to Get Under Way in
Coming Months" Journal of the American Medical Association (02/10/93) Vol.
269, No. 6, P. 725 (Marwick, Charles)
Health InfoCom Network News Page 22
Volume 6, Number 5 March 8, 1993
HIV-negative volunteers at high risk of infection areJbeing recruited
for nationwide clinical trials of two AIDS vaccines. A total of about 320
male and female volunteers aged 18-60 years old will be involved. However,
some officials from the National Institutes of Health project that it will be
at least two more years before full-scale vaccine trials are conducted. The
two vaccines will be tested in five American centers: Johns Hopkins
University Center for Immunization, Baltimore, Md.; St. Louis (Mo.)
University School of Medicine; University of Rochester (N.Y.) Medical Center;
Vanderbilt University Medical Center, Nashville, Tenn.; and the University of
Washington School of Medicine in Seattle. The two vaccines have already
undergone safety testing, and do not appear to produce unwanted side
effects. The trials will test the ability of two recombinant proteins made
from the HIV envelope protein gp160 to boost protective antibodies and
possibly cytotoxic T-lymphocyte responses, says Daniel Hoth, MD, director of
the AIDS division at the National Institute of Allergy and Infectious
Diseases. Volunteers will be counseled to avoid high-risk behaviors linked
with HIV transmission. They will be assigned randomly to receive one of the
vaccines or a placebo. Three intramuscular injections will be given--an
initial injection and then two boosters at one and six months. One vaccine,
genetically engineered by Genentech Inc., uses the HIV-1 MN strain. The
other, made by Biocine, uses the closely related HIV-1 SF-2 strain. The two
vaccines are equipped with adjuvants to further potentiate an immune
response.
====================================================================
"TB Control Guidelines Cause Coast-to-Coast Confusion" American Medical News
(02/08/93) Vol. 36, No. 6, P. 1 (Voelker, Rebecca)
Due to the lack of a national plan to prevent tuberculosis transmission,
federal, state, and regional health officials have developed conflicting
respiratory-protection guidelines. The suggested measures range from
protective surgical masks to the cumbersome powered air respirators proposed
last year by the National Institute for Occupational Safety and Health. But
in its current draft guidelines, the Centers for Disease Control backs away
from the NIOSH-recommended respirators because of opposition from both health
professionals and hospital administrators. Despite the tighter facial fit of
the respirators, the CDC says, "There is not sufficient scientific evidence
to support" their routine use. The agency instead suggests that protective
surgical masks and valveless dust and mist respirators are sufficient for
minimum protection. CDC spokeswoman Kay Golan said, "NIOSH was required by
law to assess the risk and make recommendations so that no worker suffers.
They were prohibited from considering cost or feasibility when they made
their recommendations." But if the NIOSH recommendations are adopted in a
federal OSHA standard, they could become legally enforceable. Dr. Michael
Health InfoCom Network News Page 23
Volume 6, Number 5 March 8, 1993
Tapper, chairman of the AIDS/TB committee of the Society for the Hospital
Epidemiologists of America, attended a meeting at the CDC in Atlanta
concerning its first round of revisions to the 1990 guidelines for TB control
in health-care settings. He said that consensus based on science is
desperately needed to dispel the confusion.
======================================================================
February 18, 1993
======================================================================
"Drug Combination Stops AIDS Virus Reproduction" Washington Post (02/18/93),
P. A3
A drug strategy has been developed that inhibits HIV from reproducing in
a test tube, according to a report published in Thursday's issue of Nature by
researchers from the Massachusetts General Hospital and the Harvard Medical
School in Boston. The technique involves a combination of three drugs: AZT,
ddI, and a third compound called pyridinone. All three drugs attack a single
enzyme, called reverse transcriptase, which HIV needs to reproduce. If the
approach is found to also block the spread of HIV in people, a patient's
immune system might be able "to at least keep the virus in control for long
periods of time, and perhaps forever," said Martin Hirsh, one of the
researchers in the study. However, he and other researchers warn that it
will take experiments in humans to determine if the technique is actually
effective. HIV can mutate to produce subtle alterations in the enzyme that
yield resistance to individual drugs. Yung-Kang Chow, one of the
researchers, said the concept behind the "convergent combination therapy" was
that the virus would be unable to resist a triple attack. In addition,
thwarting the spread of the enzyme might prevent the virus from developing
drug-resistant strains, said Chow. The researchers infected blood cells with
HIV, then waited a week until HIV reproduction was at its peak. At this
point, they added the three-drug combination. After 35 days, the infection
was no longer detectable. After 49 days of treatment the drugs were
discontinued, and no HIV reproduction was evident for the next 45 days. The
three-drug combination will be tested in a study of people with advanced-
stage HIV infection beginning this spring. Related Stories: New York Times
(02/18) P. A1: Philadelphia Inquirer (02/18) P. A3
======================================================================
"TB Drugs" Associated Press (02/16/93) (Johnson, Linda A.)
Trenton, N.J.--Responding to a resurgence of tuberculosis cases that
resist therapy, federal health officials are reintroducing three drugs that
pharmaceutical firms stopped marketing. Bristol-Myers Squibb will introduce
the first anti-microbial drug, its injectable form of isoniazid, which should
be on the market within 10 days. The FDA asked the pharmaceutical
Health InfoCom Network News Page 24
Volume 6, Number 5 March 8, 1993
manufacturers to resume production of the three tuberculosis drugs because of
the public health threat that tuberculosis now poses. The companies stopped
selling the drugs in 1990, because they were not producing profits.
======================================================================
February 22, 1993
======================================================================
"Bill Seeks to Coordinate NIH Research on AIDS" Washington Post (02/22/93), P.
A4 (Brown, David)
The question of whether or not a more centralized AIDS research effort
would help put an end to the AIDS epidemic is currently being raised by
researchers. Last week, the Senate passed a bill that would give more power
to the National Institutes of Health's Office of AIDS Research (OAR) and make
its director, if not a "czar," then at the very least an official with
unprecedented authority over how the government spends money studying the
disease and searching for a cure. The bill requires the office to develop an
overall budget for AIDS research and eventually acquire major influence in
the decisions of what scientific questions will be most researched--and
funded. But many scientists are skeptical that central planning will lead to
better science and are fearful that a new AIDS coordinating office will add
another layer to the NIH bureaucracy and possibly slow the pace of research.
The proposal was written into the Senate version of the NIH Revitalization
Bill by Sen. Edward M. Kennedy (D-Mass.). A House subcommittee will consider
a similar bill on Tuesday. The Senate bill calls for the OAR to have a
full-time director with no other responsibilities at NIH and an advisory
council of scientists and lay people. The director would decide what is the
best balance of basic and applied research and how much should be done
inside and outside the NIH. The OAR director would have full authority over
the AIDS budget, which could not be altered by the head of NIH or the
secretary of Health and Human Services.
======================================================================
"Engineered Blood Factor for Clotting Passes Tests" Journal of Commerce
(02/22/93), P. 9A
A genetically engineered form of a blood clotting factor has been found
to be safe and effective in a long-term test of children with the most severe
type of hemophilia, according to a report published in Thursday's New England
Journal of Medicine. People who suffer from hemophilia A lack what is known
as factor VIII. Approximately 1 in 10,000 males are born with hemophilia A,
but females rarely suffer from the condition. Factor VIII has previously
been extracted from donated blood. But filtering out deadly viruses,
including HIV, has been difficult even though significant progress has been
made in attempts to distinguish blood-borne illnesses. The study shows that
genetically engineered factor VIII made by Miles Inc. was safe among infant
test subjects, a group selected because they had never received any treatment
Health InfoCom Network News Page 25
Volume 6, Number 5 March 8, 1993
for hemophilia. The safety and efficacy of the engineered factor VIII among
patients previously treated for hemophilia have been proven in earlier
studies. An additional 75 patients have now been treated and the entire group
has been followed for a longer period. The researchers examined 95
hemophiliacs given the genetically engineered factor VIII between Jan. 1 1989,
and July 1, 1992. The median age of the subjects at the time of first
treatment was about nine months. The treatment demonstrated its effectiveness
in every case with only three reports of minor side effects in the 3,315
times it was administered.
======================================================================
February 23, 1993
======================================================================
"Tortuous Route to an AIDS Vaccine" USA Today (02/23/93), P. 4D (Painter,
Kim)
Although there are several AIDS vaccines currently in clinical trials,
it could be 10 to 15 years before one could be used in large numbers of
people. Dr. Bernadine Healy, director of the National Institutes of Health,
said at a recent New York Symposium on AIDS vaccines, "I think it's fair to
say no one of these vaccines in early testing ... appears to stand out."
However, she says she is optimistic about the prospects for therapeutic
vaccines, which help people who are already HIV-positive. Most vaccines
being studied--for both preventative and therapeutic uses--are made with
pieces of HIV that cannot cause illness. These vaccines appear to be safe
and boost immune responses in volunteers. Yet no one knows whether these
responses can protect humans from actual HIV infection. Moreover, scientists
don't know what an effective response is. One promising method was tested in
a recent monkey study. Harvard Medical School researcher Ronald Desrosiers
gave healthy monkeys live simian immunodeficiency virus, the monkey form of
HIV, weakened by the removal of one gene. The monkeys contracted HIV but did
not become ill. Subsequently, they received massive doses of real SIV and
stayed healthy--indicating that the altered virus allowed their immune systems
to resist infection. While the finding may be promising, no other approach
is so risky. The worst-case scenario is that a live weakened virus could
quickly switch to a deadly form. Desrosiers is more concerned that weakened
viruses might cause cancer or a delayed form of AIDS several years after
vaccination. He said the first human trial would have to be small and might
take many years.
======================================================================
"AIDS and the Changing Face of Pneumonia" Washington Post (Health) 02/23/93),
P. 12 (Colburn, Don)
The AIDS epidemic has had a dramatic impact on the pattern of pneumonia
cases in hospital intensive care units. Pneumocystis carinii pneumonia
(PCP), once one of the rarest types of pneumonia, is currently the most
Health InfoCom Network News Page 26
Volume 6, Number 5 March 8, 1993
common AIDS-related condition. Frederick L. Ruben, a lung specialist at the
University of Pittsburgh School of Medicine and University Montefiore
Hospital in Pittsburgh, said, "Before, the only time it was seen was in
severely malnourished children or kidney transplant patients. Even
infectious disease specialists wouldn't see a case in five years. Now you
can't go a week without seeing a case." According to a recent study at a
community hospital in San Francisco, the AIDS epidemic "has profoundly
affected the spectrum of pneumonia in intensive care units." Of the 1,854
patients treated in the hospital's ICU over a three-year period, one out of
seven had pneumonia. Of those, 29 percent were HIV-positive. PCP accounted
for more cases--28 percent--than any other type of pneumonia in the San
Francisco ICU study, which was published in the Western Journal of Medicine
last December. In all 74 cases of PCP, the patient was also infected with
HIV. But four previous studies of pneumonia in ICUs during the 1980s had no
reported cases of PCP. The study demonstrated a sharp contrast in the age
pattern, also. Before the AIDS epidemic, fatal pneumonia struck mainly the
elderly or very young children. But in the San Francisco study, older
pneumonia patients had a much higher survival rate. The difference is the
direct impact of the AIDS epidemic, which affects mostly young and middle-
aged people.
======================================================================
"Two Firms Collaborate on Hemophilia Project" Baltimore Sun (02/23/93), P. 11D
(Bowie, Liz)
Genetic Therapy Inc. and CytoTherapeutics Inc. have signed an agreement
to collaborate on research to discover a new way to deliver a treatment for
hemophilia B. CytoTherapeutics has made a semipermeable polymer membrane
that could be implanted in a patient's body to deliver a drug. Genetic
Therapy has genetically modified cells that produce a protein called Factor
IX to treat hemophilia. The two companies seek to combine the technologies,
which will allow Genetic Therapy's protein to be slowly released through
CytoTherapeutics' membrane.
======================================================================
"In the Nation: 10 Sites Tentatively Set for New AIDS Therapy" Baltimore Sun
(02/23/93), P. 9A
Federal health officials announced yesterday that 10 research sites were
tentatively named to host human trials of the AIDS therapy which uses a
combination of three drugs to inhibit the spread of HIV. Research has
demonstrated that the therapy can block a key enzyme in the development of
HIV, although the treatment's safety and efficacy in humans is undetermined.
The sites being considered for the trials are Albert Einstein University in
Bronx, N.Y.; Cornell University in New York; the Harvard University
consortium of Boston, Mass.; Northwestern University in Chicago, Ill.; the
University of Alabama in Birmingham; the University of California--San Diego;
Health InfoCom Network News Page 27
Volume 6, Number 5 March 8, 1993
the University of Colorado in Denver; Florida's University of Miami; the
University of Minnesota in Minneapolis; and the University of Southern
California in Los Angeles. The National Institutes of Allergy and Infectious
Diseases said the trials are expected to begin in the spring.
======================================================================
February 24, 1993
--------- end of part 2 ------------
· Subject: HICN605 Medical Newsletter Part 5/6
Colorado Cancer Research Program
Denver, Colorado
Aurora Presbyterian Hospital . . . . . . . . . .303-360-3028
Presbyterian/St. Luke's Medical Center . . . . .303-869-2037
Porter Memorial Hospital . . . . . . . . . . . .303-777-6877
Rose Medical Center. . . . . . . . . . . . . . .303-320-7142
Saint Joseph Hospital. . . . . . . . . . . . . .303-866-8600
Swedish Medical Center . . . . . . . . . . . . .303-788-4636
CONNECTICUT
University of Connecticut
Hartford, Connecticut
Health InfoCom Network News Page 55
Volume 6, Number 5 March 8, 1993
Hartford Hospital
Hartford, Connecticut. . . . . . . . . . . . . .203-524-2193
Mount Sinai Hospital
Hartford, Connecticut. . . . . . . . . . . . . .203-286-4699
St. Francis Hospital and Medical Center
Hartford, Connecticut. . . . . . . . . . . . . .203-548-5323
Middlesex Memorial Hospital
Middletown, Connecticut. . . . . . . . . . . . .1-800-548-2394
New Britian General Hospital
New Britian, Connecticut . . . . . . . . . . . .203-224-5660
University of Connecticut Health Center
Farmington, Connecticut. . . . . . . . . . . . .203-679-4900
DISTRICT OF COLUMBIA
Georgetown University
V.T. Lombardi Cancer Research Center
Washington, D.C. . . . . . . . . . . . . . . . . .202-342-2400
DELAWARE
Medical Center of Delaware
CMC Research Office
Newark, Delaware . . . . . . . . . . . . . . . .302-731-8116
Beebe Hospital
Lewes, Delaware. . . . . . . . . . . . . . . . .302-645-8487
Nanticoke Hospital
Seaford, Delaware. . . . . . . . . . . . . . . .302-629-0260
St. Francis Hospital
Wilmington, Delaware . . . . . . . . . . . . . .302-421-4300
(press 1)
FLORIDA
Health InfoCom Network News Page 56
Volume 6, Number 5 March 8, 1993
Baptist Regional Cancer Center
Jacksonville, Florida. . . . . . . . . . . . . . .904-348-7073
South Florida Breast Cancer Prevention Trial
Miami Beach, Florida . . . . . . . . . . . . . . .305-674-2868
Florida Hospital
Orlando, Florida
(See Duke University, North Carolina). . . . . . .407-897-5763
GEORGIA
Atlanta Breast Cancer Prevention Program
at Northside Hospital
Atlanta, Georgia . . . . . . . . . . . . . . . . .404-303-3355
Atlanta Community Women's Health Project
Atlanta, Georgia
Atlanta Regional CCOP
Cobb Hospital and Medical Center. . . . . . .404-732-4640
Kennestone Hospital . . . . . . . . . . . . .404-429-7518
South Fulton Medical Center . . . . . . . . .404-669-4594
St. Joseph's Hospital . . . . . . . . . . . .404-851-7116
Emory University . . . . . . . . . . . . . . . .404-248-4617
Grady Hospital CCOP. . . . . . . . . . . . . . .404-616-6166
University of Kentucky Consortium/
Lexington Clinic
Morehouse School of Medicine
Atlanta, Georgia . . . . . . . . . . . . . . . . .404-752-1567
----------------------------------------------------------------------------
TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE
HAWAII - MICHIGAN
Health InfoCom Network News Page 57
Volume 6, Number 5 March 8, 1993
HAWAII
Cancer Research in Hawaii
Honolulu, Hawaii . . . . . . . . . . . . . . . . .808-586-2979
ILLINOIS
Carle Cancer Center BCPT
Champaign-Urbana, Illinois . . . . . . . . . . . .1-800-446-5532
Or
217-355-6817
Oncology/Hematology Associates of
Central Illinois
Peoria, Illinois . . . . . . . . . . . . . . . .1-800-793-2262
Central Illinois CCOP
Memorial Medical Center
Springfield, Illinois. . . . . . . . . . . . . .217-788-4444
Decatur Memorial Hospital
Decatur, Illinois. . . . . . . . . . . . . . . .217-875-3228
Illinois Cancer Center
Chicago, Illinois. . . . . . . . . . . . . . . . .312-986-7047
Evanston Hospital
Evanston, Illinois . . . . . . . . . . . . . . .708-570-2100
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois . . . . . . . . . . . . . . .708-654-1790
Lutheran General Hospital
Park Ridge, Illinois . . . . . . . . . . . . . .708-696-8650
McNeal Cancer Center
Berwyn, Illinois . . . . . . . . . . . . . . . .708-795-3195
Michael Reese-Humana Hospital
Chicago, Illinois. . . . . . . . . . . . . . . .312-791-3341
Health InfoCom Network News Page 58
Volume 6, Number 5 March 8, 1993
Northwestern University Cancer Center
Chicago, Illinois. . . . . . . . . . . . . . . .312-908-9068
Oncology Care Center
Belleville, Illinois . . . . . . . . . . . . . .618-236-1000
ext. 139
Rockford Clinic
Rockford, Illinois . . . . . . . . . . . . . . .815-968-0051
ext. 2345
St. John's Cancer Institute
Springfield, Illinois. . . . . . . . . . . . . .217-544-6464
ext. 5385
Swedish American Hospital
Rockford, Illinois . . . . . . . . . . . . . . .815-968-2500
University of Illinois at Chicago
Chicago, Illinois. . . . . . . . . . . . . . . .312-996-5949
Illinois Masonic Cancer Center
Chicago, Illinois. . . . . . . . . . . . . . . . .312-296-5338
Or
312-296-7236
Mercy Hospital and Medical Center
Chicago, IL. . . . . . . . . . . . . . . . . . .312-567-2600
St. Francis Hospital
Evanston, IL . . . . . . . . . . . . . . . . . .708-492-7115
Illinois Masonic Community Health Center
Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7454
Hispano Care, Inc.
Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7678
Masonicare, Inc.
Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7166
IMMC/Dept. of OB/GYN
Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7041
Health InfoCom Network News Page 59
Volume 6, Number 5 March 8, 1993
IMMC/Dept. of Ambulatory Care
Chicago, IL. . . . . . . . . . . . . . . . . . .312-296-7062
Piel BCPT
Chicago, IL. . . . . . . . . . . . . . . . . . .312-549-5400
Currie BCPT
Chicago, IL. . . . . . . . . . . . . . . . . . .312-288-3310
St. Elizabeth Hospital
Chicago, IL. . . . . . . . . . . . . . . . . . .312-278-2000
. . . . . . . . . . . . . . . . . . . . . . . . .ext. 5907
Loyola Medical Center
Maywood, IL. . . . . . . . . . . . . . . . . . .708-216-4762
University of Illinois
Chicago, IL. . . . . . . . . . . . . . . . . . .312-996-5162
Progressive Care
Chicago, IL. . . . . . . . . . . . . . . . . . .312-774-0042
Rush Medical College
Chicago, Illinois. . . . . . . . . . . . . . . . .312-563-2057
University of Chicago
Chicago, Illinois. . . . . . . . . . . . . . . . .312-702-3183
Or
312-702-0921
SEE INDIANA: Galesburg Clinic
SEE IOWA: United Medical Center
INDIANA
Hoosier Oncology Group
Indianapolis, Indiana. . . . . . . . . . . . . . .1-800-227-2345
Galesburg Clinic
Galesburg, Illinois. . . . . . . . . . . . . . .1-800-428-4963
WUMC - Barnard Cancer Center
St. Louis, Missouri. . . . . . . . . . . . . . .314-362-5252
Health InfoCom Network News Page 60
Volume 6, Number 5 March 8, 1993
IOWA
Cedar Rapids Oncology Project CCOP
Cedar Rapids, Iowa . . . . . . . . . . . . . . . .319-365-5241
United Medical Center
Moline, Illinois . . . . . . . . . . . . . . . .309-757-2000
University of Iowa
Iowa City, Iowa. . . . . . . . . . . . . . . . . .319-356-2778
SEE SOUTH DAKOTA: Sioux-Land Hematology Oncology
KANSAS
University of Kansas Medical Center
Kansas City, Kansas. . . . . . . . . . . . . . . .913-588-4092
Wichita CCOP
Wichita, Kansas. . . . . . . . . . . . . . . . . .316-268-8222
Or
316-268-5784
KENTUCKY
University of Kentucky Consortium/
Lexington Clinic
Lexington, Kentucky. . . . . . . . . . . . . . . .606-255-6841
ext. 4994
University of Kentucky Medical Center
Clinical Research Program
Markey Cancer Center
Lexington, Kentucky. . . . . . . . . . . . . . . .606-257-5207
University of Kentucky Consortium/
Lexington Clinic
King's Daughter Hospital
Ashland, Kentucky. . . . . . . . . . . . . . . . .606-327-4535
Or
606-327-4630
Health InfoCom Network News Page 61
Volume 6, Number 5 March 8, 1993
University of Kentucky Consortium/
Lexington Clinic
Graves Gilbert Clinic
Bowling Green, Kentucky. . . . . . . . . . . . . .502-781-5111
ext. 127
University of Kentucky Consortium/
Lexington Clinic, Cancer Care Center
St. Elizabeth's Medical Center
Edgewood, Kentucky . . . . . . . . . . . . . . . .606-344-5550
University of Louisville
Louisville, Kentucky . . . . . . . . . . . . . . .502-588-5245
Oncology Associates
Knoxville, Tennessee . . . . . . . . . . . . . .615-523-2024
The Tennessee Breast Center
Maryville, Tennessee . . . . . . . . . . . . . .615-984-9282
LOUISIANA
CCOP, Alton Ochsner
New Orleans, Louisiana . . . . . . . . . . . . . .504-838-3708
(Also has sites in Mississippi)
MAINE
East Maine Medical Center
Clinic for Cancer & Blood Disorders
Bangor, Maine. . . . . . . . . . . . . . . . . . .207-945-7481
MARYLAND
University of Maryland Medical Center
Baltimore, Maryland. . . . . . . . . . . . . . . .1-800-492-5538
Or
Health InfoCom Network News Page 62
Volume 6, Number 5 March 8, 1993
410-328-5224
Greater Baltimore Oncology Center
Baltimore, Maryland. . . . . . . . . . . . . . .410-828-3706
Johns Hopkins Hospital
Baltimore, Maryland. . . . . . . . . . . . . . .410-955-4765
Sacred Heart Oncology Clinic
Cumberland, Maryland . . . . . . . . . . . . . .301-759-5075
MASSACHUSETTS
Boston University Medical Center
Boston, Massachusetts. . . . . . . . . . . . . . .617-638-8260
Or
617-638-8261
Brockton Hospital
Boston, Massachusetts. . . . . . . . . . . . . .508-941-7979
Lahey Clinic
Burlington, Massachusetts. . . . . . . . . . . .617-273-8989
St. Ann's Hospital
Fall River, Massachusetts. . . . . . . . . . . .508-675-5688
University of Massachusetts Medical Center
Worcester, Massachusetts . . . . . . . . . . . .508-856-2424
or
508-856-3902
Dana-Farber Cancer Institute
Boston, Massachusetts. . . . . . . . . . . . . . .617-732-2177
Harvard Community Health Plan
Boston, Massachusetts. . . . . . . . . . . . . .617-421-1375
Faulkner Breast Center
Boston, Massachusetts. . . . . . . . . . . . . .617-732-2177
Miriam Hospital
Providence, Rhode Island . . . . . . . . . . . .617-732-2177
Health InfoCom Network News Page 63
Volume 6, Number 5 March 8, 1993
The Breast Health Center
New England Medical Center Hospital
Boston, Massachusetts. . . . . . . . . . . . . . .617-350-8159
Lawrence Memorial Hospital of Medford
Medford, Massachusetts . . . . . . . . . . . . .617-396-9250
ext. 1820
Southwood Community Hospital/Norwood Hospital
Norfolk & Norwood, Massachusetts . . . . . . . .1-800-458-0228
MICHIGAN
Michigan State University
East Lansing and Bay City, Michigan. . . . . . . .517-336-2616
CCOP Kalamazoo
Kalamazoo, Michigan. . . . . . . . . . . . . . .616-383-4823
University of Michigan
Ann Arbor, Michigan. . . . . . . . . . . . . . . .313-936-9943
Henry Ford Hospital
Detroit, Michigan. . . . . . . . . . . . . . . .313-876-1046
Saginaw Cooperative Hospitals
Saginaw & Bay City, Michigan . . . . . . . . . .1-800-541-3939
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan
Holland, Michigan
Battlecreek, Michigan
Traverse City, Michigan
Big Rapids, Michigan . . . . . . . . . . . . . .616-732-8889
Wayne State University
Detroit, Michigan. . . . . . . . . . . . . . . . .313-745-9590
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TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE
MINNESOTA - NORTH CAROLINA
Health InfoCom Network News Page 64
Volume 6, Number 5 March 8, 1993
MINNESOTA
Hennepin County Medical Center
Minneapolis, Minnesota . . . . . . . . . . . . . .612-347-4262
Metro-Minnesota BCPT Center
St. Louis Park, Minnesota. . . . . . . . . . . . .1-800-227-2345
Abbott-Northwestern Hospital
Minneapolis, Minnesota . . . . . . . . . . . . .612-874-4444
Fairview Riverside Medical Center
Minneapolis, Minnesota . . . . . . . . . . . . .612-371-6200
Fairview Southdale Hospital
Edina, Minnesota . . . . . . . . . . . . . . . .612-371-6200
Health One Mercy Hospital
Coon Rapids, Minnesota . . . . . . . . . . . . .612-336-6100
Health One Unity Hospital
Fridley, Minnesota . . . . . . . . . . . . . . .612-336-6100
Methodist Hospital
St. Louis Park, Minnesota. . . . . . . . . . . .612-932-5700
Health East Midway Hospital
St. Paul, Minnesota. . . . . . . . . . . . . . .612-221-2273
Health East St. Joseph's Hospital
St. Paul, Minnesota. . . . . . . . . . . . . . .612-221-2273
United Hospital
St. Paul, Minnesota. . . . . . . . . . . . . . .612-336-6100
Health East St. John's Hospital
Maplewood, Minnesota . . . . . . . . . . . . . .612-221-2273
North Memorial Medical Center
Robbinsdale, Minnesota . . . . . . . . . . . . .612-520-5155
Rice Memorial Hospital
Willmar, Minnesota . . . . . . . . . . . . . . .612-231-4570
The Duluth Clinic, Ltd.
Health InfoCom Network News Page 65
Volume 6, Number 5 March 8, 1993
Duluth, Minnesota. . . . . . . . . . . . . . . . .218-725-3456
Midelfort Clinic, Ltd.
Eau Claire, Wisconsin. . . . . . . . . . . . . .715-839-5296
Thunder Bay Regional Cancer Centre
Thunder Bay, Ontario . . . . . . . . . . . . . .807-343-1610
ext. 1675
MISSISSIPPI
See Louisiana, Ochsner Clinic
MISSOURI
Ellis Fishel Cancer Center
Columbia, Missouri . . . . . . . . . . . . . . . .314-882-8545
Midwest Cooperative Group Outreach Program
Kansas City, Missouri. . . . . . . . . . . . . . .816-932-3590
St. Luke's Hospital
Kansas City, Missouri. . . . . . . . . . . . . .816-932-2085
Kansas City Clinical Oncology Program
Baptist Medical Center
Kansas City, Missouri. . . . . . . . . . . . . .816-276-7834
Ozarks Regional CCOP
Springfield, Missouri. . . . . . . . . . . . . .417-885-6444
St. Louis/Cape Girardeau CCOP
Christian Hospital Northeast/Northwest
St. Louis, Missouri. . . . . . . . . . . . . . .314-355-2300
ext. 5733
Or
314-355-2500
ext. 5733
Depaul Health Center
St. Louis, Missouri. . . . . . . . . . . . . . .314-344-7995
St. John's Mercy Medical Center
St. Louis, Missouri. . . . . . . . . . . . . . .314-569-6540
Health InfoCom Network News Page 66
Volume 6, Number 5 March 8, 1993
St. Joseph's Hospital
St. Louis, Missouri. . . . . . . . . . . . . . .314-966-1659
Southeast Missouri Hospital
Cape Girardeau, Missouri . . . . . . . . . . . .1-800-455-4636
St. Francis Medical Center
Cape Girardeau, Missouri . . . . . . . . . . . .314-339-6886
SEE INDIANA: WUMC - Barnard Cancer Center
MONTANA
Montana Breast Cancer Prevention Group
Billings, Montana. . . . . . . . . . . . . . . . .406-259-2245
NEBRASKA
Creighton Cancer Center
Omaha, Nebraska. . . . . . . . . . . . . . . . . .1-800-858-7475
(RISK)
NEVADA
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada. . . . . . . . . . . . . . . . .702-384-5608
NEW HAMPSHIRE
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire . . . . . . . . . . . . . .603-650-5284
NEW JERSEY
SEE PENNSYLVANIA: Memorial Hospital of Burlington County
and Saint Francis Medical Center
NEW MEXICO
University of New Mexico Cancer Center
Health InfoCom Network News Page 67
Volume 6, Number 5 March 8, 1993
Albuquerque, New Mexico. . . . . . . . . . . . . .505-277-3839
NEW YORK
Central New York Breast Cancer Prevention Group
Syracuse, New York . . . . . . . . . . . . . . . .315-446-8205
Glens Falls Hospital
Glens Falls, New York. . . . . . . . . . . . . . .1-800-724-4425
Mary Imogene Bassett Hospital
Cooperstown, New York. . . . . . . . . . . . . . .607-547-3800
North Shore University Hospital
Manhasset, New York. . . . . . . . . . . . . . . .516-562-8255
Roswell Park Cancer Institute
Buffalo, New York. . . . . . . . . . . . . . . . .716-845-7667
or
1-800-767-9355
(ROSWELL)
Special Surveillance Breast Program
Memorial Sloan Kettering Cancer Center
New York, New York . . . . . . . . . . . . . . . .212-639-5877
Strang Cancer Center
New York, New York . . . . . . . . . . . . . . . .212-734-5625
St. Vincent's Hospital/Guttman
New York, New York . . . . . . . . . . . . . . . .212-229-9355
NORTH CAROLINA
Duke University Medical Center
Durham, North Carolina . . . . . . . . . . . . . .919-684-2995
Florida Hospital
Orlando, Florida . . . . . . . . . . . . . . . .407-897-5763
East Carolina University
Greenville, North Carolina . . . . . . . . . . . .1-800-722-3281
ext. 2391
Health InfoCom Network News Page 68
Volume 6, Number 5 March 8, 1993
Southeast Cancer Control Consortium, Inc.
Goldsboro, North Carolina. . . . . . . . . . . . .919-580-0000
Southeast Cancer Control Consortium, Inc.
Hickory, North Carolina. . . . . . . . . . . . . .704-324-9550
Southeast Cancer Control Consortium, Inc.
Greensboro, North Carolina . . . . . . . . . . . .919-379-4183
Southeast Cancer Control Consortium, Inc.
Asheville, North Carolina. . . . . . . . . . . . .704-253-0969
Southeast Cancer Control Consortium, Inc.
Raleigh, North Carolina. . . . . . . . . . . . . .919-783-3105
Southeast Cancer Control Consortium, Inc.
Winston-Salem, North Carolina. . . . . . . . . . .919-760-0122
Southeast Cancer Control Consortium, Inc.
Presbyterian Hospital
Charlotte, North Carolina. . . . . . . . . . . . .1-800-755-7563
Or
704-384-4111
Southeast Cancer Control Consortium, Inc. (SCCC)
Carolinas Medical Center
Charlotte, North Carolina. . . . . . . . . . . . .704-355-3789
University of North Carolina
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina. . . . . . . . . . . .1-800-862-8660
Cape Fear Valley Medical Center
Fayetteville, North Carolina . . . . . . . . . .919-323-6910
--------- end of part 5 ------------
· Subject: HICN605 Medical Newsletter Part 4/6
patients had used ZDV an average of 14 months, whereas those failing ZDV had
used it an average of 23 months. Approximately 66% of patients had a prior
AIDS diagnosis. The median CD4+ cell count of the enrolled patients was very
low, 37 cells per cubic millimeter. The use of concomitant medications at
baseline was similar in the two groups.
Results
Main Endpoint
Disease progression, including death, occurred in 156 ddI patients and 150 ddC
patients (rate per 100 person years: 92.3 for ddI vs 86.4 for ddC; relative
risk = 0.93, p-value = 0.56). Thus, there is no statistically significant
difference between the two treatments based on this endpoint. The ddI group
reported 100 deaths while the ddC group had 87 and the difference between the
groups is approaching, but does not reach, a statistically significant level
(relative risk 0.76, p-value = 0.072).
There were small, not statistically significant differences in several
characteristics with known prognostic value for progression of HIV disease and
survival: number of CD4+ cells, AIDS diagnosis and Karnofsky score. These
small baseline imbalances in important prognostic factors between the two
groups, especially for Karnofsky score, indicate that the ddC group may have
been, by chance, slightly more ill than the ddI group. It may be difficult to
distinguish the effect of the treatments under study from any inherent
differences in those baseline characteristics. Adjusted analysis is done in
order to make sure that any differences in outcome have not been influenced by
those random baseline differences.
When analysis of these results was performed adjusting for these prognostic
characteristics, the risk of progression of disease including death is in the
direction of favoring ddC, although still not statistically significant (p =
0.11). The adjusted risk of death alone, however, does indicate an advantage
for ddC (p = 0.002).
Health InfoCom Network News Page 41
Volume 6, Number 5 March 8, 1993
Disseminated Mycobacterium avium infection (MAI) infection was the most common
non-fatal first event in both treatment groups (ddI=24 vs ddC=27), with
Pneumocystis carinii pneumonia (PCP) and candidiasis following. Longitudinal
analysis of data on CD4+ cells show that the average change after 2 months for
those receiving ddI was significantly greater than for those receiving ddC.
Between months 2 and 18, CD4+ cell counts declined in both groups.
Toxicity
While on initial study drug, at least one adverse experience was reported by
67% of patients on ddI and 66% on ddC. Many patients had multiple adverse
experiences. Although the number and rates for patients with at least one
adverse experience were similar in the two groups, the nature of these
experiences were different. Peripheral neuropathy was seen significantly more
frequently in patients receiving ddC (32 on ddI vs 69 on ddC, p<0.001), while
stomatitis occurred only in ddC (8 patients). Pancreatitis was seen only in
patients on ddI (4 patients). Diarrhea (48 vs 9, p<0.001) and abdominal pain
(16 vs 7, p=0.030) occurred significantly more often in patients receiving ddI
than in those receiving ddC.
Conclusions
The findings of the ddI/ddC study may offer a new therapeutic option to
clinicians treating patients with advanced HIV disease. For patients in this
study, those who have failed or are intolerant of ZDV, ddC was found to be at
least as efficacious as ddI in delaying disease progression and death. The
results of this study suggest that ddC is an acceptable alternative
monotherapy to ddI in patients intolerant of or failing on ZDV; ddC
monotherapy delays clinical progression at least as long as ddI, and may
provide a survival advantage. Since the majority of patients (66 percent
overall) experienced disease progression with either treatment and the
differences in outcome are not large, the toxicity profiles of these two drugs
will be important to consider when choosing antiretroviral treatment for an
individual patient.
The results of this study, along with other recently released studies, provide
additional information on the choice of antiretroviral agents for treatment of
persons with HIV infection. The results of the CPCRA ddI/ddC study are not
intended to answer questions about the use of these therapies in previously
untreated patients, the relative benefit of nucleoside therapy versus no
nucleoside therapy in patients who have failed or are intolerant of ZDV, or
the use of either ddI or ddC in patients who tolerate or derive benefit from
ZDV. Other ongoing or recently completed studies address those questions. In
order to guide clinicians in the integration of the results of these studies
Health InfoCom Network News Page 42
Volume 6, Number 5 March 8, 1993
into their clinical practice, the Division of AIDS of NIAID will sponsor a
conference on the state-of-the art of antiretroviral therapy in HIV infection.
This conference is planned for summer 1993.
For more information about the CPCRA ddI/ddC study, please call
1-800-TRIALS-A.
Health InfoCom Network News Page 43
Volume 6, Number 5 March 8, 1993
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Announcements of Studies/Research
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Tamoxifen Breast Cancer Prevention Trial Information
============================================================================
Q and A About the Breast Cancer Prevention Trial (1/93)
Questions and Answers About the BCPT Trial (1/93)
1. What is the Breast Cancer Prevention Trial?
The Breast Cancer Prevention Trial or BCPT is a clinical trial
designed to see whether taking the drug tamoxifen (trade name
Nolvadex) can prevent breast cancer in women who are at an
increased risk of developing the disease. The BCPT will also
determine whether taking tamoxifen decreases the number of
heart attacks and reduces the number of bone fractures in these
women. Researchers with the National Surgical Adjuvant Breast
and Bowel Project (NSABP) are conducting the study in centers
across the United States and Canada. The study is funded by
the National Cancer Institute, the U.S. government's lead
agency for cancer research.
2. What is a clinical trial?
A clinical trial is a research study conducted with people.
There are many types of clinical trials. They range from
studies to prevent, detect, diagnose, and treat a disease to
studies of the psychological impact of the disease and ways to
improve a patient's comfort and quality of life.
3. Who is eligible to participate in the BCPT?
Two groups of women are eligible to participate in the study:
women 60 years of age and older are eligible based on their age
alone, while women between the ages of 35 and 59 will be
eligible if they are at sufficiently increased risk for
developing breast cancer.
Health InfoCom Network News Page 44
Volume 6, Number 5 March 8, 1993
4. Why are women 60 years of age or older eligible for the BCPT
based on age alone?
Many diseases, including breast cancer, occur more often in
older persons. The risk of developing breast cancer increases
with age, so it is more common to find breast cancer in women
over 60 years of age. The risk of heart disease also increases
with age, and tamoxifen may be of benefit in reducing risk for
developing this disease.
5. What determines increased risk of breast cancer for women
aged 35 to 59?
To participate in the trial, women 35 to 59 years of age must
have a risk of developing breast cancer within the next five
years that is equal to or greater than the average risk of a
60-year-old woman. This increased risk is determined in one of
two ways:
A woman must have other risk factors, in addition to her age,
that combine to place her at increased risk for breast cancer.
This risk is determined by a computer calculation based on the
following factors:
- number of first-degree relatives (mother, daughters, or
sisters) who have been diagnosed with breast cancer;
- whether a woman has any children and her age at the
first delivery;
- the number of times a woman has had breast lumps
biopsied, especially if the tissue was shown to have a
condition known as atypical hyperplasia; and
- the woman's age at her first menstrual period.
OR
A woman must have been diagnosed with the noninvasive breast
cancer, lobular carcinoma in situ, a condition that greatly
increases her chance of developing invasive breast cancer.
Health InfoCom Network News Page 45
Volume 6, Number 5 March 8, 1993
6. Are there other factors that affect eligibility for the
trial?
Certain existing health conditions may affect a woman's
eligibility for the trial. For example, women at increased
risk for blood clots are not able to participate. Also, women
who are taking hormone replacements for menopausal symptoms and
women using oral contraceptives cannot take part in the trial
unless they stop taking these medications. Those who stop
taking these hormones are eligible for the trial three months
after they discontinue the drugs.
7. Are pregnant women allowed to participate in this trial?
Women who are currently pregnant or who plan to become pregnant
are not eligible to participate. Premenopausal women partici-
pating in the BCPT must use some method of birth control other
than oral contraceptives ("the pill") while taking tamoxifen.
Oral contraceptives may change the effects of tamoxifen and may
also affect the risk of breast cancer.
8. Will every woman in the trial receive tamoxifen?
The 16,000 women who will participate in the BCPT will be
randomized (selected by chance) to receive either tamoxifen or
a placebo (an inactive pill that looks like tamoxifen). In a
process known as "double-blinding," neither the participant nor
her physician will know which pill she is receiving. Setting
up a trial in this way allows researchers to clearly see what
the true benefits and side effects of tamoxifen may be without
the influence of other factors.
9. What is the dose of tamoxifen and how long will it be given?
All women in the trial will take two pills a day for five
years, either a 20-milligram dose of tamoxifen (two 10 mg
pills) or a placebo.
10. How much will the tamoxifen cost?
Health InfoCom Network News Page 46
Volume 6, Number 5 March 8, 1993
There is no charge to participants for the tamoxifen or
placebo. The company that manufactures tamoxifen, ICI
Americas, Inc., Wilmington, Del., is providing both the
tamoxifen and the placebo without charge.
11. Are women required to have any medical exams?
Participants are required to have blood tests, a pelvic exam,
mammogram, and physical exam before they are accepted into the
study. Women 55 years of age and older will need to have an
electrocardiogram, or ECG (a test to measure the heart's
muscular activity), in addition to the other tests. These
tests will be repeated at intervals during the study.
12. Who will pay for these medical exams?
Physician or medical test costs will be charged to the partici-
pant in the same fashion as if she were not part of the trial;
however, the costs for these tests may be covered by a number
of insurance companies. For women over 55, the required
electrocardiograms will be done at no cost. Every effort will
be made to contain the costs specifically associated with
participation in this trial.
13. What are the responsibilities of a woman participating in
this trial?
Women entering the Breast Cancer Prevention Trial need to be
committed to it for at least five years. Throughout the course
of the study, participants will have several responsibilities.
Daily for five years, women need to take two pills. Partici-
pants must also report any side effects they experience to the
investigators, and must obtain periodic followup examinations.
At the time of these exams, participants also will be required
to complete some forms and questionnaires. Every effort will
be made to make followup appointments convenient and to ensure
that all the women who participate in the trial feel comfort-
able with their involvement.
14. How can women enroll in the trial?
Health InfoCom Network News Page 47
Volume 6, Number 5 March 8, 1993
Women who are interested in participating in the trial should
contact the center nearest to them. To locate the nearest
center in the United States, a woman can call the NCI's Cancer
Information Service at 1-800-4-CANCER (1-800-422-6237) or the
American Cancer Society's Cancer Response System at 1-800-ACS-
2345.
In Canada, participating centers can be located by calling: in
British Columbia and the Yukon, 1-604-879-2323; in Ontario, 1-
800-263-6750; in Quebec, 1-800-361-4212; and in other areas, 1-
416-387-1153.
---------------------------------------------------------------------------
Questions and Answers About Tamoxifen (1/93)
1. What is tamoxifen?
Tamoxifen is a drug, taken by mouth as a pill, that has been
used for almost 20 years to treat patients with advanced breast
cancer. Since 1985 it has also been recommended in the United
States for "adjuvant," or additional, therapy following
radiation and/or surgery for early stage breast cancer.
2. How does tamoxifen work in treating breast cancer?
One way that tamoxifen works in breast cancer is to interfere
with the activity of estrogen, a female hormone that promotes
the growth of cancer cells in the breast. Because tamoxifen
works against the effects of estrogen on breast cancer cells,
it is often called an "anti-estrogen." As a treatment, the
drug slows or stops the growth of these cancer cells. As
adjuvant therapy, tamoxifen has been shown to help prevent the
original breast cancer from returning.
3. Why is tamoxifen now being tested to prevent breast cancer?
Research has shown that taking tamoxifen as adjuvant therapy
for breast cancer may also prevent the development of new
cancers in the opposite breast. Evidence from these and other
Health InfoCom Network News Page 48
Volume 6, Number 5 March 8, 1993
studies suggests that tamoxifen may have beneficial prevention
qualities in healthy women who do not yet have breast cancer.
4. Does tamoxifen affect other parts of the body besides breast
tissues?
While tamoxifen acts against the effects of estrogen in breast
tissues, it acts like estrogen in other body systems. For
example, because it acts like estrogen, women who take
tamoxifen may have many of the beneficial effects of estrogen
replacement therapy, such as a lowering of blood cholesterol
and a slowing of bone loss that may lead to osteoporosis.
5. Can tamoxifen cause side effects?
Like most medications, whether over-the-counter medications,
prescription drugs, or drugs in clinical trials, tamoxifen may
cause side effects.
For example, in a recent NSABP breast cancer study where women
with breast cancer took either tamoxifen or a placebo, the side
effects experienced more often by women taking tamoxifen were
hot flashes and vaginal discharge. Women in both groups
reported sometimes having side effects--even though the placebo
itself would not cause any symptoms. The side effects that
some women in both groups reported included: vaginal dryness,
itching, or bleeding; menstrual irregularities; depression;
loss of appetite; nausea and/or vomiting; dizziness; headaches;
and fatigue.
Participants in the BCPT will have all their side effects
monitored and will receive periodic physical exams. Treatments
that may minimize or eliminate most side effects will be avail-
able.
6. Does tamoxifen cause a woman to begin menopause?
Tamoxifen does not cause a woman to begin menopause. In most
women taking the drug, the ovaries continue to function
normally and produce female hormones (estrogens) in the same or
slightly increased amounts. Because tamoxifen does not cause a
woman to begin menopause, there is a chance that pregnancy
Health InfoCom Network News Page 49
Volume 6, Number 5 March 8, 1993
could occur. This is why all premenopausal women participating
in this trial must use some method of birth control other than
oral contraceptives while taking tamoxifen.
7. Does tamoxifen cause blood clots?
Data from large clinical trials suggest that there is a small
increase in the number of blood clots in breast cancer patients
taking tamoxifen, particularly if they are also receiving other
anticancer drugs (chemotherapy). The total number of women who
have experienced blood clots while taking tamoxifen is small.
Women who have had blood clots in the past may not be eligible
to participate in this trial.
8. Does tamoxifen cause any other serious side effects?
Before a woman agrees to participate in the Breast Cancer
Prevention Trial, a health professional will fully discuss the
potential benefits and risks from the drug and medical
procedures that will be used.
The potential benefits and side effects of tamoxifen are
frequently due to its estrogen-like effects. Estrogens are
known to increase the risk of endometrial cancer, and there are
reports from several large clinical trials showing that breast
cancer patients taking tamoxifen have an increased risk of
endometrial cancer. Endometrial cancer frequently causes
bleeding and is usually diagnosed in its early stages--when
treatment by surgery alone is effective. The endometrial
cancers that have occurred during studies of women taking
tamoxifen have all been found in very early stages.
Because of some association between estrogens (particularly
oral contraceptives) and liver cancer, there has also been some
concern that tamoxifen may cause liver cancer. No liver
cancers have been reported in trials in which women took a 20
mg/day dose of the drug (the dose given in the BCPT). In
studies in which women took 40 mg of tamoxifen daily, there
have been two reports of liver cancer as well as a few reports
of liver complications. Based on the current available
information, tamoxifen has not been shown to be the cause of
the liver complications or the liver cancer. However, to
ensure the safety of the women who participate in the BCPT,
blood tests to check liver functions will be done at regular
Health InfoCom Network News Page 50
Volume 6, Number 5 March 8, 1993
intervals.
---------------------------------------------------------------------------
Other Important Questions About the BCPT (1/93)
1. Why is the Breast Cancer Prevention Trial so important?
This year, over 180,000 women in the United States alone will
be diagnosed with breast cancer, and more than 46,000 will die
of the disease. For many years, women at increased risk for
developing breast cancer have had no way to reduce their risk.
Women have to rely on examinations such as monthly breast self-
examinations, frequent checkups, and periodic mammograms to
detect breast cancer in its earliest stages. Doctors sometimes
suggest that certain women at very high risk have a preventive
(prophylactic) mastectomy, which is surgery to remove breast
tissue before cancer develops. The operation does not always
guarantee that breast cancer will be avoided, because it is
almost impossible to remove all the breast tissue.
If tamoxifen is successful in preventing breast cancer, women
at increased risk for developing the disease will have a choice
other than more frequent exams or major surgery. Tamoxifen may
be able to reduce by one-third or more the number of breast
cancers that occur in women at increased risk. In addition,
tamoxifen may decrease the risk of heart attacks by lowering
blood cholesterol. However, in order to give women this
choice, tamoxifen must be tested in a large clinical trial to
determine if the benefits outweigh any risk.
2. How could a healthy woman benefit from participating in the
BCPT?
The decision to take part in any clinical trial is an individu-
al one. Researchers hope that tamoxifen will prevent breast
cancer from occurring in those women receiving it in the trial.
Women will also benefit from regular mammograms and checkups,
which can help detect breast cancer in its earliest stages.
They will also benefit from the state-of-the-art medical care
they receive from the health professionals involved in the
Health InfoCom Network News Page 51
Volume 6, Number 5 March 8, 1993
trial. At each clinical center where women can be enrolled,
nurses and physicians will explain important information about
the trial and will discuss any questions a potential partici-
pant may have.
3. What is the National Surgical Adjuvant Breast and Bowel
Project?
The National Surgical Adjuvant Breast and Bowel Project is a
large group of cancer researchers who receive funding and
support from the U.S. National Cancer Institute. The more than
6,000 physicians, nurses, and other medical professionals in
the NSABP are located in over 250 medical centers throughout
the United States and Canada.
NSABP was founded in 1958 and has been a leader in breast
cancer research. The results of clinical trials conducted by
NSABP researchers have been the dominant force in altering the
standard surgical treatment of breast cancer from mastectomy to
lumpectomy plus radiation. This group was also the first to
demonstrate that adjuvant therapy could alter the natural
history of breast cancer, thus increasing survival rates.
To date, more than 30,000 women who have had breast cancer have
participated in treatment clinical trials conducted by NSABP
investigators. A clinical trial to prevent breast cancer is a
logical next step for this research group.
============================================================================
Tamoxifen Breast Cancer Prevention Trial Information
2. Breast Cancer Prevention Trial Referral Information (7/92)
The Breast Cancer Prevention Trial is being conducted at over 270
sites across the United States and Canada. Referral information
has been arranged alphabetically by state so that the closest
participating organization can be located.
Breast Cancer Prevention Trial (BCPT) with Tamoxifen
Telephone Contact List
Health InfoCom Network News Page 52
Volume 6, Number 5 March 8, 1993
MAIN TELEPHONE NUMBERS
United States. . . . . . . . . . . . . . . . . . .1-800-4-CANCER
Or
1-800-ACS-2345
Canada
British Columbia/The Yukon . . . . . . . . . . .604-879-2323
Ontario. . . . . . . . . . . . . . . . . . . . .1-800-263-6750
Quebec . . . . . . . . . . . . . . . . . . . . .1-800-361-4212
Other Regions. . . . . . . . . . . . . . . . . .416-387-1153
TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE
ALABAMA - GEORGIA
ALABAMA
Baptist Medical Center
Birmingham, Alabama. . . . . . . . . . . . . . . .1-800-421-2065
Or
205-581-9800
University of Alabama at Birmingham
Cancer Center
Birmingham, Alabama. . . . . . . . . . . . . . . .205-934-1338
University of South Alabama
Mobile, Alabama. . . . . . . . . . . . . . . . . .205-460-6474
ARIZONA
Arizona Cancer Center
Tucson, Arizona. . . . . . . . . . . . . . . . . .602-626-4100
Tucson Breast Center
Tucson, Arizona. . . . . . . . . . . . . . . . .602-326-6267
Greater Phoenix CCOP
Health InfoCom Network News Page 53
Volume 6, Number 5 March 8, 1993
Phoenix, Arizona . . . . . . . . . . . . . . . .602-239-6797
Maricopa Medical Center
Phoenix, Arizona . . . . . . . . . . . . . . . .602-267-5508
CALIFORNIA
Bay Area Cancer Control Consortium CCOP
San Francisco, California. . . . . . . . . . . . .1-800-283-9765
City of Hope National Medical Center
Duarte, California . . . . . . . . . . . . . . . .1-800-934-5555
Harbor-UCLA Medical Center Research
and Education Institute
Torrance, California . . . . . . . . . . . . . . .310-533-2217
Kaiser Permanente CCOP
San Diego, California. . . . . . . . . . . . . . .619-528-6325
Long Beach Memorial Breast Center
Long Beach, California . . . . . . . . . . . . . .1-800-638-1900
Saddleback Breast Cancer Center
Saddleback Memorial Medical Center
Orange County, California. . . . . . . . . . . .714-859-2660
Los Angeles Oncologic Institute at
St. Vincent Medical Center
Los Angeles, California
Other Sites: Los Angeles Intake Center
San Gabriel Valley Intake Center
Inland Empire Intake Center. . . . .1-800-499-5264
Or
213-484-7086
Norris Cancer Hospital
Los Angeles, California. . . . . . . . . . . . . .1-800-498-6666
Or
213-224-6929
San Joaquin Valley CCOP
Fresno, California . . . . . . . . . . . . . . . .209-221-5614
Health InfoCom Network News Page 54
Volume 6, Number 5 March 8, 1993
St. Mary Medical Center/Long Beach Community Hospital
Long Beach Community Hospital
Long Beach, California . . . . . . . . . . . . .1-800-554-2844
St. Mary Medical Center
Los Angeles County and Orange County, California1-800-377-7040
Stanford University Breast Cancer
Prevention Center
Palo Alto, California. . . . . . . . . . . . . . .415-723-8686
Sutter Breast Cancer Center
Sacramento, California . . . . . . . . . . . . . .1-800-524-7475
(RISK)
University of California, LA
Los Angeles, California. . . . . . . . . . . . . .310-825-9502
U.C. Davis Cancer Center
Sacramento, California . . . . . . . . . . . . . .1-800-547-2278
(BCPT)
COLORADO
--------- end of part 4 ------------
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∙HEADER:USENET
Path: channel1!uupsi!psinntp!rpi!gatech!asuvax!ennews!stat!david
From: david@stat.com (David Dodell)
Newsgroups: sci.med
Subject: HICN605 Medical Newsletter Part 4/6
Message-ID: <qHq5ZB12w165w@stat.com>
Date: Mon, 08 Mar 93 22:30:37 MST
Reply-To: david@stat.com (David Dodell)
Distribution: world
Organization: Stat Gateway Service, WB7TPY
Lines: 708
==============================================================================
Date: 03-10-93 (14:29) Number: 20974 Channel 1(R) Communica
To: ALL Refer#: NONE
From: DAVID DODELL Read: YES
Subj: HICN605 MEDICAL NEWSLETTE Conf: (1659) med
------------------------------------------------------------------------
· Newsgroup: sci.med
· Message-ID: <0iq5ZB14w165w@stat.com>
· Subject: HICN605 Medical Newsletter Part 6/6
------------- cut here -----------------
---------------------------------------------------------------------------
TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE
NORTH DAKOTA - TEXAS
Health InfoCom Network News Page 69
Volume 6, Number 5 March 8, 1993
NORTH DAKOTA
St. Luke's Hospital CCOP
Roger Maris Cancer Center
Fargo, North Dakota. . . . . . . . . . . . . . . .701-234-5842
OHIO
Columbus CCOP
Columbus and Springfield, Ohio
Community Hospital of Springfield
Doctors Hospitals
Grant Medical Center
Medical Center of Chillicothe
Mercy Medical Center of Springfield
Mount Carmel Hospitals
Park Medical Center. . . . . . . . . . . . . . .614-443-2267
Ohio State James Cancer Hospital
Columbus, Ohio . . . . . . . . . . . . . . . . . .614-293-8892
Riverside Regional Cancer Institute
Columbus, Ohio . . . . . . . . . . . . . . . . .614-566-4321
Northeast Ohio Breast Cancer Prevention
Trial Group
Cleveland, Ohio. . . . . . . . . . . . . . . . . .1-800-686-2278
(BCPT)
The Dayton Clinical Oncology Program
Kettering, Ohio. . . . . . . . . . . . . . . . . .513-296-7278
Toledo Community Hospital Oncology Program
Toldeo, Ohio . . . . . . . . . . . . . . . . . . .419-255-5433
University of Cincinnati
Cincinnati, Ohio . . . . . . . . . . . . . . . . .513-558-2278
(BCPT)
University of Kentucky Consortium/
Lexington Clinic
The Christ Hospital Cancer Center
Cincinnati, Ohio . . . . . . . . . . . . . . . . .513-369-2859
Health InfoCom Network News Page 70
Volume 6, Number 5 March 8, 1993
OKLAHOMA
Cancer Center of the Southwest
Baptist Medical Center of Oklahoma
Oklahoma City, Oklahoma. . . . . . . . . . . . . .1-800-327-2273
Or
405-946-2273
Saint Francis Hospital
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma. . . . . . . . . . . . . . . . . .1-800-695-9501
Or
918-494-4500
OREGON
Columbia River Oncology Program
Portland, Oregon . . . . . . . . . . . . . . . . .503-230-6853
SEE WASHINGTON: Kaiser Permanente
PENNSYLVANIA
Albert Einstein Cancer Center
Philadelphia, Pennsylvania . . . . . . . . . . . .1-800-355-8269
Or
215-456-3500
Bryn Mawr Cancer Center
Bryn Mawr, Pennsylvania. . . . . . . . . . . . . .215-526-3800
Fox Chase Network/Affiliates
Fox Chase Cancer Center
Philadelphia, Pennsylvania . . . . . . . . . . . .215-728-2792
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania. . . . . . . . . . . .215-284-8448
Memorial Hospital of Burlington County
Mount Holly, New Jersey. . . . . . . . . . . . .609-265-7555
Montgomery Hospital
Health InfoCom Network News Page 71
Volume 6, Number 5 March 8, 1993
Norristown, Pennsylvania . . . . . . . . . . . .215-270-2700
North Penn Hospital
Lansdale, Pennsylvania . . . . . . . . . . . . .215-361-4950
Paoli Memorial Hospital
Paoli, Pennsylvania. . . . . . . . . . . . . . .215-648-1636
Polyclinic Medical Center
Harrisburg, Pennsylvania . . . . . . . . . . . .717-782-6678
Saint Francis Medical Center
Trenton, New Jersey. . . . . . . . . . . . . . .609-599-5790
Saint Mary Hospital
Langhorne, Pennsylvania. . . . . . . . . . . . .215-750-5300
The Reading Hospital and Medical Center
Reading, Pennsylvania. . . . . . . . . . . . . .215-378-6512
Geisinger Medical Center - Breast Clinic
Danville, Pennsylvania . . . . . . . . . . . . . .1-800-622-2515
Lehigh Valley Hospital
Allentown, Pennsylvania. . . . . . . . . . . . . .215-778-2290
Grand View Hospital
Sellersville, Pennsylvania . . . . . . . . . . .215-453-4690
Norristown Regional Cancer Center
Norristown, Pennsylvania . . . . . . . . . . . .215-278-2500
Pottstown Memorial Medical Center
Pottstown, Pennsylvania. . . . . . . . . . . . .215-327-7480
Mercy Hospital
Scranton, Pennsylvania . . . . . . . . . . . . . .717-348-7673
Or
717-348-7940
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania . . . . . . . . . . . .1-800-777-8176
Western Pennsylvania BCPT Project
NSABP Adjuvant Therapy Center
Health InfoCom Network News Page 72
Volume 6, Number 5 March 8, 1993
Pittsburgh, Pennsylvania . . . . . . . . . . . .412-624-6221
Allegheny CCOP
Pittsburgh, Pennsylvania . . . . . . . . . . . .412-359-6190
RHODE ISLAND
SEE MASSACHUSETTS: Miriam Hospital
SOUTH CAROLINA
Greenville Memorial Hospital
Greenville, South Carolina . . . . . . . . . . . .1-800-998-9080
Or
803-455-3315
Southeast Cancer Control Consortium, Inc. (SCCC)
Greenwood, South Carolina. . . . . . . . . . . . .803-227-4457
Southeast Cancer Control Consortium, Inc. (SCCC)
Columbia, South Carolina . . . . . . . . . . . . .1-800-775-2287
Southeast Cancer Control Consortium, Inc. (SCCC)
Florence, South Carolina . . . . . . . . . . . . .803-667-2376
Or
803-678-5101
Southeast Cancer Control Consortium, Inc. (SCCC)
Charleston, South Carolina . . . . . . . . . . . .803-577-2276
Spartanburg CCOP
Spartanburg, South Carolina. . . . . . . . . . . .803-560-6810
SOUTH DAKOTA
Sioux Community Cancer Consortium
Dakota Midwest Cancer Institute
Sioux Falls, South Dakota. . . . . . . . . . . . .605-331-3257
Sioux-Land Hematology Oncology
Sioux City, Iowa . . . . . . . . . . . . . . . .712-252-3403
Health InfoCom Network News Page 73
Volume 6, Number 5 March 8, 1993
TENNESSEE
Southeast Cancer Control Consortium, Inc. (SCCC)
Kingsport, Tennessee . . . . . . . . . . . . . . .615-224-5592
Thompson Cancer Center
Knoxville, Tennessee . . . . . . . . . . . . . . .1-800-388-3313
Or
615-541-4966
Centennial Medical Center
Nashville, Tennessee . . . . . . . . . . . . . .615-342-3760
SEE KENTUCKY: Oncology Associates and The Tennessee Breast
Center
TEXAS
Baylor-Charles A. Sammons Cancer Center
Dallas, Texas. . . . . . . . . . . . . . . . . . .1-800-422-9567
M.D. Anderson
Houston, Texas . . . . . . . . . . . . . . . . . .713-792-8515
Scott & White Hospital and Clinic/
Texas A&M University School of Medicine
Temple, Texas. . . . . . . . . . . . . . . . . . .1-800-551-8858
Or
817-774-5888
University of Texas Health Science Center
San Antonio, Texas . . . . . . . . . . . . . . . .512-567-5750
---------------------------------------------------------------------------
TELEPHONE NUMBERS IN THE UNITED STATES - BY STATE
UTAH - WISCONSIN
UTAH
Utah Cancer Center
Salt Lake City, Utah . . . . . . . . . . . . . . .801-581-4048
Health InfoCom Network News Page 74
Volume 6, Number 5 March 8, 1993
Or
801-581-5052
VERMONT
Vermont Cancer Center
Burlington, Vermont. . . . . . . . . . . . . . . .802-656-4414
VIRGINIA
Massey Cancer Center
Medical College of Virginia Hospitals
Richmond, Virginia . . . . . . . . . . . . . . . .1-800-925-8821
James River Clinic
Newport News, Virginia . . . . . . . . . . . . .804-766-1905
Southeast Cancer Control Consortium, Inc.
Danville, Virginia . . . . . . . . . . . . . . . .804-793-0047
Southeast Cancer Control Consortium, Inc.
Martinsville, Virginia . . . . . . . . . . . . . .703-666-7827
WASHINGTON
Northwest CCOP/Virginia Mason CCOP
Northwest CCOP/Tacoma General Hospital
Tacoma, Washington . . . . . . . . . . . . . . . .206-594-1461
St. Joseph Hospital
Tacoma, Washington . . . . . . . . . . . . . . .206-627-4101
ext. 5524
St. Peter Hospital
Olympia, Washington. . . . . . . . . . . . . . .206-493-7281
Capital Medical Center
Olympia, Washington. . . . . . . . . . . . . . .206-754-5858
ext. 2433
Virginia Mason Medical Center CCOP
Seattle, Washington. . . . . . . . . . . . . . .206-223-6742
Health InfoCom Network News Page 75
Volume 6, Number 5 March 8, 1993
Kaiser Permanente
Portland, Oregon . . . . . . . . . . . . . . . .503-282-8421
Or
503-249-3315
Puget Sound Oncology Consortium
Fred Hutchinson Cancer Research Center
Seattle, Washington. . . . . . . . . . . . . . . .206-667-6544
WEST VIRGINIA
BCPT in West Virginia: Charleston and Morgantown
Charleston Area Medical Center
Charleston, West Virginia. . . . . . . . . . . .304-348-9523
Or
304-348-9541
West Virginia University
Morgantown, West Virginia. . . . . . . . . . . .304-293-3515
Or
304-293-4500
WISCONSIN
CCOP Marshfield Clinic
Marshfield, Wisconsin. . . . . . . . . . . . . . .1-800-358-3844
Or
715-389-3844
Milwaukee Breast Cancer Prevention Trial
Milwaukee, Wisconsin . . . . . . . . . . . . . . .414-283-6814
Wisconsin Comprehensive Cancer Center
Madison, Wisconsin . . . . . . . . . . . . . . . .1-800-622-8922
Or
608-262-5223
SEE MINNESOTA: Midelfort Clinic, Ltd.
TELEPHONE NUMBERS FOR CANADA
Health InfoCom Network News Page 76
Volume 6, Number 5 March 8, 1993
B.C. Cancer Agency
Vancouver, British Columbia. . . . . . . . . . . .604-822-7997
Cross Cancer Institute
Alberta, Canada. . . . . . . . . . . . . . . . . .403-492-8784
Tom Baker Cancer Centre
Calgary, Alberta . . . . . . . . . . . . . . . . .403-670-2492
Credit Valley Hospital
Mississauga, Ontario . . . . . . . . . . . . . . .416-820-4040
Hamilton Regional Cancer Center
Hamilton, Ontario. . . . . . . . . . . . . . . . .416-575-6348
Toronto Hospital
Toronto, Ontario . . . . . . . . . . . . . . . . .416-340-3196
Women's College Hospital
Toronto, Ontario . . . . . . . . . . . . . . . . .416-961-3433
Jewish General Hospital/St. Mary's Hospital
Montreal, Quebec . . . . . . . . . . . . . . . . .514-340-7562
St. Mary's Hospital
Montreal, Quebec . . . . . . . . . . . . . . . .514-342-5630
Royal Victoria Hospital
Montreal, Quebec . . . . . . . . . . . . . . . . .514-843-1572
Montreal General Hospital
Montreal, Quebec . . . . . . . . . . . . . . . .514-937-7813
Queen Elizabeth Hospital
Montreal, Quebec . . . . . . . . . . . . . . . .514-485-5134
University of Montreal
Hotel Dieu de Montreal
Montreal, Quebec . . . . . . . . . . . . . . . . .514-849-7346
(SEIN)
Or
514-843-2611
ext. 4951
Quebec BCPT Center
Health InfoCom Network News Page 77
Volume 6, Number 5 March 8, 1993
Quebec City, Quebec. . . . . . . . . . . . . . . .418-682-7394
Manitoba Cancer Treatment and Research
Foundation
Winnipeg, Manitoba . . . . . . . . . . . . . . . .204-787-4148
Or
204-787-4160
SEE MINNESOTA: Thunder Bay Regional Cancer Center
Health InfoCom Network News Page 78
Volume 6, Number 5 March 8, 1993
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
General Announcments
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Discussion List for Chronic Fatique Syndrome
From: "Roger Burns, CFS-MED Moderator" <BFU@CU.NIH.GOV>
Announcement
An Internet discussion list (CFS-MED) has been created to enable physicians to
discuss medical research and clinical issues regarding chronic fatigue
syndrome (CFS), usually known outside of the USA as myalgic encephalomyelitis
(ME). CFS/ME can be difficult to diagnose, and available treatments are not
widely known. Discussions on CFS-MED will hopefully increase knowledge within
the medical community about this important illness. The list is moderated.
CFS/ME is an illness characterized by debilitating fatigue and a variety of
flu-like symptoms. The illness is also known as chronic fatigue immune
dysfunction syndrome (CFIDS), and in the past it has been known as chronic
Epstein-Barr virus (CEBV).
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@NUMCALLS@@DLBYTES@@INCONF@@NUMTIMESON@@EXPDATE@@HOMEPHONE@@DATAPHONE@Roger Burn
Moderator, CFS-MED medical list
Editor, CFS-NEWS Chronic Fatigue Syndrome Electronic Newsletter
List-owner, CFS-L discussion
Health InfoCom Network News Page 79
· Subject: HICN605 Medical Newsletter Part 3/6
"Idiopathic CD4+ T-Lymphocytopenia--Four Patients With Opportunistic
Infections and No Evidence of HIV Infection" New England Journal of Medicine
(02/11/93) Vol. 328, No. 6, P. 393 (Duncan, Robert A. et al.)
Although lifelong suppressive therapy is recommended for many AIDS-
related conditions, it is unclear whether similar principles apply to patients
with idiopathic CD4+ T-lymphocytopenia (ICL), write Robert A. Duncan et al.
of Boston City Hospital and University Hospital Boston University School of
Medicine in Boston, Mass. Four patients without major risk factors for HIV
infection were examined, each of whom was presented with severe opportunistic
infections and was found to have ICL. The opportunistic infections
experienced by the ICL patients included Pneumocystis carinii pneumonia (PCP),
cryptococcal meningitis, and histoplasma-induced brain abscess. During 10 to
68 months of observation, none of the four patients had evidence of infection
with HIV type 1 or 2 or human T-cell lymphotropic virus type I or II on the
basis of epidemiologic, serologic, or polymerase-chain-reaction studies or
culture, nor was there any detectable reverse transcriptase activity. While
all of the patients had severe persistent CD4 T-lymphocytopenia (range 12 to
293 cells per cubic millimeter), the CD4 cell count progressively declined in
only one and was accompanied by multiple opportunistic infections. All four
patients had substantially reduced numbers of circulating CD8+ T cells,
natural killer cells, or B cells. These four patients had ICL with
opportunistic infections but no sign of HIV infection. Instead of the
progressive, selective depletion of CD4 T cells characteristic of HIV
infection, some patients with ICL have stable CD4 T cell counts accompanied
by decreases in the levels of several other lymphocyte subgroups, the
researchers conclude.
=====================================================================
February 25, 1993
=====================================================================
"Questions Raised About AIDS Case" Los Angeles Times--Washington Edition
(02/25/93), P. A6 (Cimons, Marlene)
A report published yesterday in the British journal Nature raised
questions about whether a Florida dentist who died of AIDS--accused in a
highly publicized case of infecting five patients with HIV--actually was the
source of transmission. Ronald W. DeBry, an evolutionary biologist in
Florida State University's department of biological science and one of the
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Volume 6, Number 5 March 8, 1993
researchers in the report, said, "We are not saying that the dentist did not
infect the patients--we're saying you really can't prove it one way or the
other." The case of Dr. David Acer was the only reported instance of HIV
transmission from an infected health professional to a patient since the AIDS
epidemic began in 1981. Officials from the Centers for Disease Control, who
conducted the first investigation and have concluded that Acer was the
source, criticized the Nature report, saying that it ignores significant
additional proof that points to the dentist. The CDC investigation indicated
that none of the five infected patients had any known high risk behaviors
that would have made them more vulnerable to infection. DeBry and his
colleagues used molecular sequencing techniques in the study and analyzed
viral samples obtained from all of Acer's infected patients. They also
compared these samples to known information about the strain that infected
Acer, even though they did not have an actual sample from the dentist. The
strains of HIV were then compared to "control" samples obtained from HIV-
positive individuals in Florida who had no known connection to Acer. They
discovered that "there is not enough difference between the dental group
sequences and the control sequences to prove that these [dental] sequences
are a separate set," said DeBry. Related Story: Baltimore Sun (02/25) P. 17A
=====================================================================
"Vestar Files for Approval of AIDS-Related Kaposi's Sarcoma Treatment" United
Press International (02/24/93)
San Dimas, Calif.--Vestar Inc. announced Wednesday that it has submitted
a new-drug application to the Food and Drug Administration for DaunoXome, its
drug that treats AIDS-related Kaposi's sarcoma. DaunoXome has been
distributed in Europe to individual patients by Vestar, but the company has
not yet received approval to market the drug. Among all of the cancers that
are associated with AIDS, Kaposi's sarcoma is the most common. The disease
causes lesions of the skin, mucous membranes, and lymph nodes, and often
progresses to internal organs, including the lungs and gastrointestinal
tract. Kaposi's sarcoma is experienced in approximately 15 percent or more of
AIDS patients.
=====================================================================
"Expanded European AIDS Case Definition" Lancet (02/13/93) Vol. 341, No. 8842,
P. 441 (Ancelle-Park, Rosemary et al.)
Because of the importance of having a common AIDS case definition in
Europe, all European countries should implement the new expanded AIDS case
definition, write Rosemary Ancelle-Park et al. of the Hopital National de
Saint-Maurice in Saint Maurice, France. The European Center for the
Epidemiological Monitoring of AIDS gathered experts in public health and
epidemiology participating in the AIDS Prevention and Control Research
Program of the European Community in Jan. 1993. The attendees discussed the
case definition of AIDS for surveillance purposes in Europe, following the
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Volume 6, Number 5 March 8, 1993
introduction of an expanded surveillance case definition in the United
States. The 1993 U.S. revised definition adds pulmonary tuberculosis,
recurrent pneumonia and invasive cervical cancer to its list of 23 conditions
defining AIDS. Also, it added HIV-positive people who have a CD4+ count
under 200 to the list. In 1991, European countries decided that HIV-positive
people should not be defined as having AIDS based on CD4 counts alone because
of concerns over the accurateness of AIDS surveillance based solely on the
degree of immunosuppression, biases that would be introduced in comparing
AIDS exposure categories, and possible negative psychological effects on
asymptomatic HIV-positive patients. Also, access to medical care in Europe
is not based on a person meeting an AIDS definition. After meeting with AIDS
surveillance representatives in 38 European countries, this position was
reconfirmed by the expert group. The possible inclusion of the three
opportunistic infections that the U.S. added to its AIDS definition were
examined. It was decided that the addition of these illnesses was valuable
for epidemiologic purposes.
=====================================================================
"Orogenital Sex and Risk of Transmission of HIV" Lancet (02/13/93) Vol. 341,
No. 8842, P. 441 (Spencer, Brenda)
Recommending to the public that orogenital sex is unsafe is without a
question theoretically correct, but the use/efficacy of a method depends not
only on its biological efficiency but also on its acceptability to the user,
writes Brenda Spencer of the Hopital de Bicetre in Le Kremlin-Bicetre,
France. In the Dec. 12 issue of the Lancet, correspondents report that HIV-1
has been detected in the pre-ejaculatory fluid, and conclude that this fluid
is therefore a potential vector for sexual transmission of HIV. But these
findings bring into question what the chance is that the presence of HIV-1 in
the mouth will result in infection of the receptive partner. One of the most
difficult things in health education is how to manage uncertainty about risk-
-as suggested by the confusion as to what defines safe sex. There have been
both extremes to the risk of oral HIV transmission. At the 1990 AIDS
conference in Montreal, one stand displayed a poster recommending to gay men
that they engage in oral rather than anal sex, whereas another ran a video
for adolescents advising that deep kissing may present a risk of infection.
The latter position neglects to consider the possibility that, faced with a
multitude of differing recommendations, the individual may fail to comply with
any. Some people have asked whether the belief that orogenital sex carries a
high risk of transmission yields an increase in unprotected anal sex. The
formulation of safer sex guidelines should consider psychological factors
along with any new laboratory discoveries, concludes Spencer.
=====================================================================
February 26, 1993
======================================================================
"As Their Life Expectancy Grows, So Do Needs of AIDS Patients" Washington
Health InfoCom Network News Page 30
Volume 6, Number 5 March 8, 1993
Times (02/26/93), P. A1 (Goldberg, Karen)
As a result of the longer life expectancy among AIDS patients, more
treatment, both physical and mental, is also required. Bob Howard, spokesman
for the Centers for Disease Control, said the life expectancy for HIV-
positive people has increased as a record number of HIV cases have developed
into full-blown AIDS. Many of the opportunistic infections that accompany
AIDS would have killed a patient much more quickly five years ago, according
to Dr. Robert Thomas, a Washington, D.C., physician specializing in HIV.
"When I was a resident [in 1987] people were looking at 18 months to live
after an AIDS diagnosis. Now I tell them three to five years." Aside from
medical services, longer-living AIDS patients need social, legal, and
psychological assistance. The District's Whitman Walker Clinic, the city's
main provider of services for AIDS patients, is having a difficult time
keeping its food bank stocked. Barbara Chinn, Whitman-Walker's deputy chief
program officer, said the food bank "is serving 600 clients a month now. This
time last year, it was 300. I'd say in another year it will be 900."
Approximately 2,000 volunteers work for Whitman-Walker--an all-time high.
The clinic has 30 support groups, nine housing facilities, and three
satellite offices, including the new Max Robinson Center. The CDC's Howard
said, "What we are seeing now is the maturing of the epidemic. More people
are presenting with AIDS, and that is a reflection of what went on eight
years ago. We have already seen a leveling off in that category
[homosexuals], but it is other areas like heterosexuals and IV-drug users, we
are still concerned about."
======================================================================
"Three Centers Plan Human Test of New AIDS Therapy" Reuters (02/24/93)
(Zengerle, Patricia)
Pittsburgh--Researchers from the University of Pittsburgh Medical Center
announced on Wednesday they were preparing to launch human trials of an
encouraging new three-drug AIDS therapy recently shown to inhibit HIV in a
test tube. The human trials will be funded by Merck & Co, which makes one of
the drugs being tested. The research sites include the University of
Pittsburgh, the University of Pennsylvania in Philadelphia, and Brown Miriam
Hospital in Providence, R.I. This trial will apparently precede by at least
several weeks the beginning of government-supported human testing of a
similar treatment this spring. The 24-week study in Pittsburgh will involve
30 to 40 individuals infected with HIV, who will be separated into two
groups. The first group will receive AZT initially. The other group will
receive AZT and a Merck drug called L-661. After two months of therapy, both
groups will also begin to receive the AIDS drug ddI. L-661 is part of a new
class of experimental drugs known as non-nucleosides, which have shown
promise in blocking the replication of HIV in test tubes when used in
combination with AZT and ddI. The University of Pittsburgh researchers said
Health InfoCom Network News Page 31
Volume 6, Number 5 March 8, 1993
their trial would start as soon as 30 to 40 volunteers, who must meet several
criteria, are enrolled.
======================================================================
"Cardiac Structure and Function in HIV-Infected Children" New England Journal
Of Medicine (02/18/93) Vol. 328, No. 7, P. 513 (Lewis, William and Dorn,
Gerald W.)
Toxicity from AZT may be related to the development of cardiomyopathy,
write William Lewis and Gerald W. Dorn of the University of Cincinnati
Medical Center in Cincinnati, Ohio. In the Oct. 29 issue of the New England
Journal of Medicine, Lipshultz et al. reported on cardiac dimensions and
function in HIV-positive children and concluded that progressive left
ventricular dilation occurred independently of any effect of AZT. However,
Lewis and Dorn disagree with that conclusion. Ejection performance was
normal in Lipshultz's patients at the start of AZT therapy but was depressed
after therapy. Ejection performance declined, but contractility was
unchanged. The causative factor appeared to be an increase in afterload
despite increased posterior-wall thickness and left ventricular mass. End-
systolic wall stress is related directly to end-systolic left ventricular
pressure and dimension and is related inversely to wall thickness. Because
end-systolic blood pressure was reported to be normal throughout the study,
end-systolic dimension must have increased. Since ejection performance, not
intrinsic myocardial contractility, is the primary determinant of clinical
status, the data suggest that AZT can worsen the development of dilated
cardiomyopathy in HIV-positive children. But no data from endomyocardial
biopsies were included. The lack of characteristic endomyocardial
morphologic changes would support the authors' thesis that AZT had no cardiac
toxicity, but no pertinent information was provided, conclude Lewis and Dorn.
======================================================================
"India: Zidovudine Production" Lancet (02/20/93) Vol. 341, No. 8843, P. 485
(Mangla, Bhupesh)
Indian pharmaceutical company Cipla Laboratories has begun manufacturing
and marketing a lower-cost AZT in 100 mg capsules with the brand name
Zidovir-100. The company is challenging Burroughs Wellcome's Retrovir
because its price is significantly cheaper. This is good news for developing
countries which can't afford the $3 per 100 mg capsule of Retrovir. A study
by the United Nations Development Program (UNDP) shows that the cost of
drugs will be a large determinant affecting the economic impact of AIDS in
developing countries. India may have to spend $1.6 billion on AIDS by the
year 2000. Cipla was able to make its drug cheaper with the help of the
Indian Institute of Chemical Technology (IICT) in Hyderabad. IICT, a
government-funded laboratory, has made the most of India's patent laws,
according to which pharmaceutical products can be granted only process
patents. Therefore, a drug enjoying a product patent outside India can be
Health InfoCom Network News Page 32
Volume 6, Number 5 March 8, 1993
manufactured in the country made by a process different from that used by the
original patent holder. Dr. A.V. Rama Rao, ICCT director, said, "Our aim is
to make the drug available at a low price to all the needy countries, whose
populace cannot afford the Burroughs Wellcome product. Quality wise there is
no difference between Burroughs and us. In the international markets, we all
have to meet the same standards." Drug companies in the United States have
been enraged by the fact that India can get hold of U.S. patents. But AZT
falls into a gray area--it was discovered originally, not by Burroughs
Wellcome, but by the U.S. National Cancer Institute as an anti-cancer
treatment.
======================================================================
"Rapid HIV Tests" Lancet (02/20/93) Vol. 341, No. 8843, P. 502 (Wannan, Gary
J. and Cutting, William A.M.)
Multiple uses of the HIV-CHEK test gave results as accurate as single
use of the test, write Gary J. Wannan and William A.M. Cutting of the
University of Edinburgh in Edinburgh, U.K. With the HIV-CHEK method, antigen
from HIV-1 and HIV-2 are incorporated in the membrane on the top of a small
block. Buffer is passed through the membrane followed by a serum or plasma
sample from the person to be tested, then by gold conjugate and a wash
solution. In positive cases a red-spot color reaction develops on the
membrane within 10 minutes. The researchers discovered that they could put
samples from at least 6 patients through the membrane before adding the gold
conjugate and wash solutions and still get a positive result if any subject
was infected. The researchers tested samples from 491 pregnant women and
revealed that multiple use was just as accurate as single use of the test. In
areas where the rate of HIV is low, it is possible to screen between 4 and 10
blood donors, pregnant women, or individuals in a population screening program
with a single HIV-CHEK. Because the HIV-CHEK tests cost about 3 pounds
sterling per test, in an area where the rate of HIV infection is less than 4
percent, the multiple sample screening method can save about 2,400 pounds
sterling for every 1000 individuals tested. Even though the findings are
encouraging, there still is a great need for an accurate and inexpensive test
to detect HIV antibodies, conclude Wannan and Cutting.
======================================================================
March 2, 1993
======================================================================
"Shalala Backs Reorganization" Science (02/12/93) Vol. 259, No. 5097, P. 889
(Cohen, Jon)
Secretary of Health and Human Services Donna Shalala recently expressed
support for a Senate bill addressing the reorganization of the National
Institutes of Health's Office of AIDS Research (OAR). The proposal has
incited opposition from some scientists and NIH officials who argue that it
Health InfoCom Network News Page 33
Volume 6, Number 5 March 8, 1993
would add another layer of bureaucracy to AIDS research. The Senate proposal
is designed to improve planning and coordination of AIDS research at the 21
NIH institutes by giving the OAR more authority over NIH's AIDS budget and
establishing a discretionary fund for the OAR director to use at his or her
discretion. Those who oppose the Senate bill include NIH directors, who on
Jan. 22 sent a memo to NIH Director Bernadine Healy addressing their fears
that the budget process would be "severely disrupted" by the proposed changes
which "may inadvertently be detrimental" to AIDS and non-AIDS research.
Healy sent the memo to Shalala, who subsequently showed it to members of the
House subcommittee on health and the environment. She told the subcommittee
that although she doesn't think "a reorganization alone will yield
improvements in science necessarily," HHS backs the bill because it hopes
that a strengthened OAR will elicit "a clearer view of where we're going."
She added that if the plan backfires and hampers AIDS research, "we will be
the first ones back here at this table to tell you that we have a structure
that doesn't work."
======================================================================
"Use of Evolutionary Limitations of HIV-1 Multidrug Resistance to Optimize
Therapy" Nature (02/18/93) Vol. 361, No. 6413, P. 650 (Chow, Yung-Kang et
al.)
Convergent combination therapy may be beneficial to the treatment of HIV-
1 infections and in post-exposure prophylaxis, write Yung-Kang Chow et al. of
the Massachusetts General Hospital and Harvard Medical School in Boston,
Mass. Certain drug combinations may prevent the co-existence of adequate
reverse transcription function and multi-drug resistance (MDR). Retroviral
drug resistance is conferred only by mutations in its own genome and is
limited by genome size. Therefore, combination drugs directed against the
same essential viral protein may thus prevent HIV-1 MDR, whereas the
conventional approach of targeting different HIV-1 proteins for combination
therapy may not. This is because genomes with resistance mutations in
different HIV-1 genes might recombine to develop MDR. The researchers tested
whether combinations of mutations giving rise to single-agent resistance
might further compromise or even abolish viral replication, and if multidrug-
resistant virus could be constructed. Certain combinations of mutations
conferring resistance to AZT, ddI, and pyridinone are incompatible with
viral replication. These findings suggest that evolutionary limitations
exist to restrict development of MDR. Furthermore, elimination of reverse
transcription by convergent combination therapy may also limit MDR, the
researchers conclude.
======================================================================
March 3, 1993
======================================================================
"Johnson and Johnson Belgian Unit in HIV Drug Trials" Reuters (03/02/93)
Health InfoCom Network News Page 34
Volume 6, Number 5 March 8, 1993
Brussels--American pharmaceutical firm Johnson and Johnson's Belgian
subsidiary Janssen Pharmaceutica, announced yesterday it had tested an AIDS
drug that stopped the replication of one strain of HIV in the test tube.
However, HIV developed resistance to the drug, alpha-APA, when used by
itself. Janssen said it began tests on HIV-positive patients and had
discovered that alpha-APA was well absorbed by the body and had few adverse
side effects. Other tests are being conducted to determine whether the drug
blocks the spread of HIV in the body. The alpha-APA compound inhibits the
action of reverse transcriptase, which can lead to the development of full-
blown AIDS. The drug company said that like similar agents, alpha-APA was
effective against the strain of HIV called HIV-1, but not against HIV-2.
Janssen is planning clinical trials to test the efficacy of combinations of
alpha-APA and other drugs. "These studies will indicate whether such
combinations of drugs will inhibit the multiplication of the virus for a
longer period and prevent resistance," said the company. Other companies
conducting similar studies have found that the virus developed resistance
when used with reverse transcriptase inhibitors. They subsequently used
combinations of inhibitor drugs and AZT to overcome the problem.
======================================================================
"HIV Vaccine Enters Clinical Trial Stage" American Medical News (03/01/93)
Vol. 36, No. 9, P. 25
The first large-scale clinical trial of an AIDS vaccine has been
launched in Sweden and will last six years. The trial will be testing VaxSyn
made by MicroGeneSys Inc. The therapeutic vaccine has exhibited its ability
to stabilize or reduce the amount of virus in an HIV-positive person, incite
an immune response, and stop the loss of CD4 cells. The trial in Sweden is
the last test MicroGeneSys must undergo before it can begin commercial
production of the vaccine.
======================================================================
"Cheaper Way to Make AZT" American Medical News (03/01/93) Vol. 36, No. 9, P.
25
A less expensive process for making AZT has been developed by a Japanese
company. The pharmaceutical company Kobayashi Koryo makes thymidine, a key
ingredient of AZT, using heat evaporation, a process that is up to 50 percent
cheaper than the current fermentation method, said company officials. The
trading concern Kanematsu Corp. expects to start selling thymidine to drug
companies in India and Brazil by the end of the year.
======================================================================
"HIV Clue Announced" American Medical News (03/01/93) Vol. 36, No. 9, P. 25
A chemical transformation in cells that helps explain how HIV spreads
has been discovered by researchers at the Webb-Warring Institute in Denver,
Colo. According to the scientists, HIV quells production of a vital enzyme
Health InfoCom Network News Page 35
Volume 6, Number 5 March 8, 1993
called superoxide dismutase. The researchers are testing human cell cultures
to elucidate if a drug can inhibit HIV's ability to suppress the enzyme. If
they are able to safeguard the enzyme's levels in cells, the time HIV stays
inactive could be prolonged.
====================================================================
March 5, 1993
====================================================================
"Hospitals Told to Test for HIV" Washington Post (03/05/93), P. A3
Hospitals with significant numbers of AIDS cases should offer HIV testing
to all persons admitted or treated in emergency rooms, federal health
officials announced yesterday. The Centers for Disease Control issued
guidelines that require voluntary testing for HIV to be routine in about 600
hospitals--11 percent of the nation's total--mostly in urban areas. The
results of the tests would be kept confidential and people could not be
denied care because they objected to being tested for HIV. Secretary of
Health and Human Services Donna Shalala said, "These recommendations will
help people learn of their HIV status and get early treatment. They will
also be able to take precautions to protect loved ones." A toll-free hotline
for physicians and other health care physicians will also be provided by the
HHS to answer questions about treating patients with HIV/AIDS. The new CDC
guidelines advise hospitals to offer voluntary testing to everyone between
the ages of 15 to 54 admitted to the hospital or treated in the emergency
room, clinics, or other outpatient departments. The agency encourages
testing in hospitals with rates of infection of at least 1 percent or in the
event that one in 1,000 discharged patients has AIDS. The tests would reveal
more than two-thirds of HIV-positive persons in those age groups hospitalized
for conditions other than HIV/AIDS, according to the CDC.
====================================================================
"Six More Sites Named for AIDS Therapy Test" Journal of Commerce (03/05/93),
P. 5A
Six additional locations where human trials of a new AIDS treatment will
be conducted were tentatively named yesterday by the National Institutes of
Health. The new sites are Indiana University in Indianapolis, Mount Sinai
Hospital in New York, the University of California--San Diego, the University
of Cincinnati, the University of North Carolina--Chapel Hill, and the
University of Pennsylvania in Philadelphia.
====================================================================
"A Shot in the Arm for TB Research" Science (02/12/93) Vol. 259, No. 5097, P.
886 (Watson, Traci)
Nearly a decade since tuberculosis began making its resurgence, the
government has started giving research into the disease a higher priority.
Health InfoCom Network News Page 36
Volume 6, Number 5 March 8, 1993
NIH Director Bernadine Healy intends to improve funding for TB research by
reallocating money among the NIH institutes. Healy told the Clinton
administration that this year, she will provide $12.5 million more than
planned for research on mycobacterium, including new diagnostic techniques
and treatments. About $9.2 million of the funding will come from cutting
other NIH programs. Although the increase will make the funding for TB
research $37 million in 1993, Healy also seeks to obtain emergency money from
Congress through lobbying efforts. She hopes increased congressional
spending on TB research will attract more scientists to study the disease.
However, congressional members said getting more money from Congress will
prove difficult with President Bill Clinton's pressure to cut governmental
spending. Healy claims additional funding is imperative because the number
of TB cases increased 18 percent between 1985 to 1991, and many of the new
cases are resistant to existing drugs.
====================================================================
"Triple Teaming the Deadly AIDS Virus" U.S. News & World Report (03/01/93)
Vol. 114, No. 8, P. 60 (Brink, Susan)
The recent finding that three drugs used in combination were effective
in attacking HIV in the test tube is encouraging for future research, even if
this method is not effective in humans. Yung-Kang Chow, a little-known AIDS
researcher, developed the three-drug approach, which is intended to force the
virus to profusely mutate until it destroys itself. Chow and colleagues at
Massachusetts General Hospital combined AZT and ddI with either pyridinone or
nevirapine. The chemical mix either overwhelmed the virus or forced it to
mutate so fast and furiously it couldn't replicate itself. By adding a third
agent--either pyridinone or nevirapine--to the AZT/ddI combination, Chow et
al. managed to compel HIV to mutate three times simultaneously in an attempt
to survive. Three quick mutations are more than the virus can tolerate in
the test tube. The new approach, called "convergent combination therapy," is
an extreme departure from the traditional method of treating HIV infection,
in which researchers have attempted to disable the virus at various stages in
the disease's development. But the researchers are cautious about the new
strategy's clinical potential, warning that any practical benefit from this
research could be years away. The National Institutes of Health is
currently forming clinical trials of the drug combination expected to begin
no later than July. Although the research is preliminary, it helps reinforce
the idea that AIDS might someday be controlled by a combination of drugs.
====================================================================
"Playing Chess With Reverse Transcriptase" Nature (02/18/93) Vol. 361, No.
6413, P. 588 (Richman, Douglas D.)
Scientists are researching the possibility of making the human
immunodeficiency virus (HIV) inviable by introducing mutations for drug-
resistance. Chemotherapy for HIV patients prolongs their disease-free
Health InfoCom Network News Page 37
Volume 6, Number 5 March 8, 1993
interval. However, this nucleoside treatment, using AZT, ddC, and ddI, only
reduces the virus replication but doesn't completely suppress it. These
drugs work by inhibiting the viral enzyme. The disease continues to
progress, which may result from emergence of viral mutants with less
susceptibility to the treatment drugs. A second class of possible inhibitors
of HIV-1 replication also stops reverse transcriptase (RT). Several
chemically distinct non-nucleoside compounds share properties, including low
toxicity, high potency, synergy with nucleoside agents, and excellent
pharmacokinetic properties. However, the resistant mutants of HIV indicate
that the non-nucleoside reverse transcriptase inhibitors may possess a weak
element when used as drugs. Although reducing the amounts of virus
replication and increasing CD4 lymphocyte counts, the drugs dissipated after
one month, which is about the same time as the appearance of the mutants.
======================================================================
March 4, 1993
======================================================================
"The Emergence of Drug-Resistant Tuberculosis in New York City" New England
Journal of Medicine (02/25/93) Vol. 328, No. 8, P. 521 (Frieden, Thomas R.
et al.)
AIDS patients are more likely to be infected with drug-resistant
tuberculosis and are more likely to die if infected with these organisms,
write Thomas R. Frieden et al. of the Centers for Disease Control in Atlanta,
Ga. The researchers gathered information on every patient in New York City
with a positive culture for Mycobacterium tuberculosis during April 1991.
Among the 518 patients with positive cultures, 466 (90 percent) had isolates
available for testing. A total of 33 percent of these patients had isolates
resistant to one or more antituberculosis drugs, 26 percent had isolates
resistant to at least isoniazid, and 19 percent had isolates resistant to
both isoniazid and rifampin. Among the 239 patients who had received
antituberculosis therapy, 44 percent had isolates resistant to one or more
drugs and 30 percent had isolates resistant to both isoniazid and rifampin.
Of the patients who had never been treated, the proportion with resistance to
one or more drugs increased from 10 percent in 1982-1984 to 23 percent in
1991. Patients who had never been treated and who were HIV-positive or
reported IV-drug use were more inclined to have resistant isolates. Among
AIDS patients, those with resistant isolates were more likely to die during
follow-up through January 1992. A history of antituberculosis treatment was
the strongest indicator for the presence of resistant organisms. Improvements
in TB-control programs and in social and economic conditions are greatly
needed and can promote the control of both TB and the emergence of drug-
resistant organisms, conclude the researchers.
======================================================================
"Dental HIV Transmission?" Nature (02/25/93) Vol. 361, No. 6414, P. 691
(DeBry, Ronald W. et al.)
Health InfoCom Network News Page 38
Volume 6, Number 5 March 8, 1993
The case of the Florida dentist who allegedly infected five of his
patients needs to be examined more closely with another dataset from some
other region of the HIV genome, write Ronald W. DeBry et al. of the Florida
State University in Tallahassee, Fla. Ou et al. recently reported that the
dentist did indeed transmit the virus to his five patients. Population
genetics indicate that a rapidly evolving marker can develop strong
geographical substructure. Therefore, an appropriate null hypothesis is that
the patients independently acquired similar variants within the local
community. The dental transmission hypothesis entails that a branch on the
viral phylogenetic tree lead to the dental group alone and not include any
controls. But in phylogenetic terms, the dental group must be monophyletic.
The null hypothesis would be rejected if a tree with a monophyletic dental
group is significantly better supported than any tree with controls
intermixed within the dental group. The researchers tested the hypotheses
using new sequences from the dental patients and a new set of regional
controls. This selection is justified: the dental group should be
monophyletic compared to any controls. In addition, the test is biased in
favor of accepting the dental transmission hypothesis because the controls in
both studies were obtained at clinics about 90 miles from the dentist's
practice area. The researchers conclude that the available data are
consistent with both the dental transmission hypothesis and the null
hypothesis and do not yet distinguish between the two.
Volume 6, Number 5 March 8, 1993
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Clinical Alerts from National Institues of Health
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CLINICAL ALERT
IMPORTANT THERAPEUTIC INFORMATION ON TREATMENT OF HIV INFECTION
Health InfoCom Network News Page 39
IN HIV-INFECTED PATIENTS WHO ARE INTOLERANT OF OR HAVE FAILED
ZIDOVUDINE THERAPY
Released February 1, 1993
Purpose of this Document
This document provides information on the results of a recently completed
clinical trial that compared ddI and ddC in HIV-infected patients who were
intolerant of or who had failed zidovudine therapy. Application of these
results beyond this specific patient population can not be supported by this
study. The study was conducted by the Terry Beirn Community Programs for
Clinical Research on AIDS (CPCRA), which is part of the National Institute of
Allergy and Infectious Diseases of the National Institutes of Health. This
information is provided to you, as a health care practitioner, to serve as
preliminary information while a manuscript is being readied for submission to
a peer-reviewed medical journal.
Introduction and Background
The CPCRA was established in 1989 to involve community physicians and their
patients in studies of treatments for HIV. A unique feature of this program
is its community-based focus for evaluating the effectiveness of a broad
spectrum of therapies and treatment regimens. The CPCRA is comprised of 17
research units, consisting of consortiums of primary care physicians and
nurses, located in 13 U.S. cities. These research units represent a
significant geographic, racial and risk group diversity. Through this
diversity, the CPCRA extends greater opportunity for participation in clinical
research to those persons underrepresented in traditional, university-based
HIV studies.
Study Design
The CPCRA ddI/ddC study was designed to answer the important clinical question
of which one of the currently available nucleoside analogues should be given
to a patient who can no longer tolerate or has failed ZDV therapy. The study
was an open-label comparison of ddI and ddC with progression of disease,
including death, and tolerance of the study drugs as the main endpoints.
The CPCRA ddI/ddC study opened in December 1990 and enrolled 467 patients by
Health InfoCom Network News Page 40
Volume 6, Number 5 March 8, 1993
September 20, 1991, exceeding target accrual three months earlier than
projected. All patients were followed for at least one year after the last
patient was enrolled. The protocol ended follow-up on September 20, 1992.
Study Population
Study Population: 230 patients were randomized to receive ddI and 237 to
receive ddC. Ten percent of the patients were women and two-thirds were
white. Nearly a quarter of the patients enrolled had a history of injection
drug use. The average age was 38 years. Approximately 63% of patients were
ZDV intolerant, 48% of them because of hematologic intolerance. Intolerant
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