dmcanzi@watserv1.waterloo.edu (David Canzi) (03/22/90)
Medical News for Week ending March 18, 1990
Copyright 1990: USA TODAY/Gannett National Information Network
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March 12, 1990
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AIDS `PROJECT INFORM' UNDERWAY:
The federal Food and Drug Administration has given its approval to San
Francisco-based AIDS group Project Inform to resume its trials for the
experimental AIDS drug Compound Q. This is the first time the FDA has given
complete control over a clinical trial to a community group rather than to a
medical research group.
PROBLEMS WITH NEW AIDS TREATMENT:
Six AIDS patients taking the experimental drug DDI have died of
pancreatitis, reports the Los Angeles Times. Pancreatitis is a toxic side
effect attributed to the drug. Most of the patients were among the eight-
thousand receiving the drug as part of the Food and Drug Administration's
expanded access program.
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March 13, 1990
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AIDS STARTS TO DECLINE:
According to the Journal of the American Medical Association, the AIDS
epidemic in the United States has peaked and will start to decline. Findings
indicate that AIDS peaked in 1988, reports Drs. Dennis Bregman and Alexander
Langmuir of the Department of Preventive Medicine at the University of
Southern California, Los Angeles.
AIDS UP IN SAN FRANCISCO:
A study in the Journal of the American Medical Association projects that
San Francisco will experience between 12,349-17,022 cases of AIDS through June
1993, with 9,966-12,767 cumulative deaths. The incubation period of AIDS makes
the numbers difficult to arrive at. The median incubation period is 11 years.
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March 15, 1990
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SEX, LIES AND MORE LIES:
Do not believe everything you hear. Thursday's New England Journal of
Medicine says of 422 sexually active college students, 34 percent of men and
10 percent of women, have lied to have sex. And 47 percent of men and 60
percent of women have been lied to for sex. Experts say no matter what someone
says, you should still practice safe sex.
AZT APPROVED BY FDA:
The Food and Drug Administration has approved the use of AZT to treat
patients in the early stages of AIDS. The approval is expected to enlarge the
market for the drug, which is the only approved drug for treating AIDS. AZT
has been shown to significantly slow the progression of AIDS in those infected
with the disease.
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Food & Drug Administration News
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Expanded Labeling for AZT
P90-16 Food and Drug Administration
FOR IMMEDIATE RELEASE Brad Stone - (301) 443-3285
March 2, 1990 (Home) -- (703) 892-0468
The Food and Drug Administration has approved new labeling for
zidovudine, or AZT, to include people who are infected with the AIDS virus but
have not yet developed the full-scale disease, HHS Secretary Louis W.
Sullivan, M.D., announced today.
The expanded labeling reflects the results of two studies sponsored
by the National Institute of Allergy and Infectious Diseases that indicate the
drug slows the progression of the disease when used at early stages of
infection.
HHS Secretary Sullivan said, "The studies and the change in labeling
mean that better treatment can now be offered to thousands of people at
earlier stages of infection with the AIDS virus before their health
deteriorates critically."
HHS Assistant Secretary for Health James O. Mason, M.D., Dr.P.H.,
noted that today's action follows recent agency approval of a new lower dose
for zidovudine, and the sanctioning of a Treatment IND protocol which allows
widespread distribution of the drug to children at advanced stages of
infection with the AIDS virus.
He said, "Today's action underscores the government's commitment to
widen the treatment options available against AIDS. It also underscores the
great deal of scientific cooperation between the government and the private
sector in the efforts against this disease."
Zidovudine, the only drug proven effective against the AIDS virus, was
approved by FDA in March 1987 for treating people with more advanced stages of
infection. These are patients who have had either an episode of Pneumocystis
carinii pneumonia -- an infection that commonly strikes people with AIDS -- or
who are symptomatic and have CD4 helper cell counts of 200 or less. CD4
helper cells are white blood cells important in the immune system that are
destroyed by the AIDS virus. Healthy individuals normally have CD4 helper
cell counts of 1,000 or more.
Earlier this year FDA approved a labeling change for zidovudine which
lowered the recommended dose for the long-term regimen to 600 milligrams a day
-- half the previously recommended dose. The reduced dosage not only lowers
the frequency of side effects, thereby allowing more patients to continue
zidovudine therapy, but also dramatically reduces the cost of zidovudine
treatment for many patients.
The expanded labeling approved today will include use of zidovudine in
people with CD4 helper cell levels of 500 or less.
NIAID protocol 016 involved 713 patients with early AIDS-related complex
including conditions such as oral thrush, chronic rash or intermittent
diarrhea, as well as CD4 cell levels between 200 and 500. The other NIAID
study, protocol 019, involved more than 1,500 people infected with the AIDS
virus who had not yet developed any symptoms of AIDS. In both studies,
zidovudine appeared to significantly slow the progression of the disease.
On Jan. 30, FDA's Antiviral Drug Products Advisory Committee reviewed data
from both these studies and recommended that FDA approve expanded labeling
indications. The committee, made up of outside experts, also considered
evidence from animal studies that zidovudine is carcinogenic in rodents. The
group recommended that the potential risk for cancer should be investigated
further, including any possibly unique effects on women, fetuses and children.
Nevertheless, the committee believed that on balance, the benefits of
zidovudine's use in those at earlier stages of infection with the AIDS virus
outweigh any potential risk.
Zidovudine can inhibit the production of red blood cells, requiring
treatment for anemia. The drug can also reduce white blood cell counts to the
extent that the drug's use has to be discontinued.
The supplemental application that was approved today was submitted by the
drug's sponsor, Burroughs Wellcome of Research Triangle Park, N.C., Oct. 31.
It applies to both the capsule and syrup forms of the drug.
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Center for Disease Control Reports
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[The following articles are not about AIDS, but are included because
they contain recommendations for people infected with HIV to (1) get
tested for tuberculosis and (2) get a flu vaccination.]
Morbidity and Mortality Weekly Report
Thursday March 15, 1990
Update: Tuberculosis Elimination -- United States
In April 1989, CDC's Advisory Committee for the Elimination of
Tuberculosis (ACET) published A Strategic Plan for the Elimination of
Tuberculosis in the United States (1). This plan established the goal of
tuberculosis (TB) elimination (i.e., a case rate of 0.1 per 100,000 persons)
by the year 2010, with an interim goal of a case rate of 3.5 per 100,000
population by the year 2000.
CDC, in collaboration with state and local health departments, uses three
sources to monitor progress toward these goals: 1) an individual-case
surveillance system, 2) TB mortality data from CDC's National Center for
Health Statistics (NCHS), and 3) program performance data collected on cases,
contact follow-up, bacteriologic conversion of sputum, continuity of drug
therapy, completion of therapy, and preventive therapy. This report updates TB
elimination efforts based on the most recent data from these three sources.
Case Surveillance
In 1988, the last year for which individual-case data are available,
22,436 TB cases (9.1 per 100,000 U.S. population) were reported, a 0.4%
decrease from the 22,517 cases reported in 1987. If the 6.7% average annual
decline between 1981 and 1984 had continued through 1988, an estimated 14,768
fewer cases would have been expected during 1985-1988 (Figure 1).
When compared with 1985, the number of reported TB cases in the 25-44-year
age group in 1988 increased by 961 cases; however, in other age groups, cases
declined (Table 1). In all age groups, reported cases increased among non-
Hispanic blacks and Hispanics but decreased among non-Hispanic whites,
Asians/Pacific Islanders, and American Indians/Alaskan Natives (Table 1). In
the 25-44-year age group, cases among non-Hispanic blacks increased by 22.6%
(from 2898 in 1985 to 3552 in 1988);Hispanics, by 34.5% (from 1153 to 1551);
and non-Hispanic whites, by 2.3% (from 1520 to 1555). Increases in cases
occurred among both males and females. In 1988, TB case rates for
racial/ethnic minorities were approximately fourfold to ninefold higher than
for non-Hispanic whites (Table 1).
NCHS Data
Final TB mortality data from NCHS for 1987 indicate that 1755 persons died
from TB in the United States--a 1.5% decrease from the 1782 deaths reported in
1986.
Program Performance Data
Case register and contact follow-up reports contained information on
approximately 75% of cases reported during 1988. As of December 31, 1988, 76%
of the patients receiving two or more TB drugs were current with their
chemotherapy regimen. Up-to-date bacteriologic information was available for
57% of patients; for 84% of these patients, contacts were identified, and 93%
of these were examined. Of contacts who were examined, 23% were infected.
Preventive therapy was prescribed for 89% of infected contacts less than 15
years of age and for 59% of those greater than or equal to 15 years of age.
Approximately 1% of the contacts examined had clinically apparent TB.
Data on the bacteriologic conversion of sputum were known for 17,868 (79%)
of the 22,517 cases reported during 1987. Sixty-one percent of patients with
positive sputum were known to have become negative (bacteriologic conversion)
within 3 months after starting chemotherapy; 20% remained positive beyond the
third month of chemotherapy; and 7% died within 3 months of being reported. No
information was available on the remaining patients.
Data on drug therapy were known for 14,072 (63%) of the cases reported
during 1987. Medication was taken continuously during the first 6 months of
therapy by 86% of patients. Six percent interrupted their therapy; 2% stopped
taking their medication; and 9% died within the first 6 months of treatment.
Approximately 75% of patients for whom reports were available completed
therapy within 12 months: 9%, within 6 months; 27%, within 7-9 months; and
39%, within 10-12 months. Approximately 11% of patients died within 1 year of
diagnosis.
More than 95,000 persons with tuberculous infection at risk for clinical
disease were reported to have begun preventive therapy during 1987; 66%
completed 6 continuous months of treatment. Contacts of TB patients had a 72%
completion rate. Recent converters and other infected persons had completion
rates of 70% and 64%, respectively.
Reported by: State and local health departments. Div of Tuberculosis Control,
Center for Prevention Svcs, CDC.
Editorial Note: The number of newly reported TB patients meeting the CDC case
definition (2) represents greater than 90% of patients under treatment
supervision by state and local health departments (CDC, unpublished data), and
this percentage has remained stable since 1984. However, the public health
burden of TB is only partially reflected by the number of new cases reported
annually. In 1987, this burden included the more than 115,000 persons under
treatment for TB ( greater than 20,000 new patients plus greater than 95,000
high-risk persons who began preventive therapy). In addition, 1755 persons
died from this curable disease.
The trends for race/ethnicity primarily reflect the increasing occurrence
of TB in persons infected with human immunodeficiency virus (HIV) (3). Because
the HIV-infection status of TB patients is not collected on the TB case report
form, the precise impact of HIV infection on TB morbidity trends in the United
States cannot be determined. Nevertheless, HIV infection is an important risk
factor for developing clinically apparent TB among persons already infected
with the tubercle bacillus (4). Accordingly, CDC recommends that all HIV-
infected persons be screened for TB and latent tuberculous infection and, if
infected, offered curative or preventive therapy (5). Similarly, persons with
TB and known tuberculin-positive persons should be evaluated for HIV infection
so that appropriate counseling and treatment can be undertaken (5).
Approximately 1% of the estimated 10 million persons in the United States
who are infected with the tubercle bacillus (CDC, unpublished data) were
identified and treated in 1988. Identification and treatment of all 10 million
infected persons is not necessary to substantially reduce the burden of TB.
Instead, ACET has emphasized focusing on high-risk populations (1). The
proportion of infected persons represented in high-risk groups is unknown.
However, the percentage of infected persons who are screened and treated for
TB annually must increase substantially beyond 1% if TB is to be eliminated by
the year 2010. These patients must also be carefully monitored for compliance
and adverse drug reactions (6).
Use of program performance reports allows state and local health
departments to measure their progress toward TB elimination. The reports
indicate that noncompliance with prescribed therapy is the greatest remaining
obstacle to elimination (7). Ideally, 90% of patients should complete therapy
within 12 months. Program and research strategies that may be effective in
addressing noncompliance include the use of outreach workers to administer and
directly observe therapy and provide incentives to enhance compliance (8);
education programs for health professionals; studies of compliance predictors
and enhancers; and research targeted toward reducing the duration of therapy
and number of drug doses required. Careful monitoring of all patients for
compliance and the more widespread use of compliance-enhancing strategies is
essential for eliminating TB.
References
1. CDC. A strategic plan for the elimination of tuberculosis in the United
States. MMWR 1989; 38(no. S-3).
2. CDC. Public Health Service recommendations for counting reports of
tuberculosis cases: procedural guide. Atlanta: US Department of Health,
Education, and Welfare, Public Health Service, 1977.
3. Bloch AB, Rieder HL, Kelly GD, Cauthen GM, Hayden CH, Snider DE. The
epidemiology of tuberculosis in the United States. Semin Respir Infect
1989;4:157-70.
4. Selwyn PA, Hartel D, Lewis VA, et al. A prospective study of the risk of
tuberculosis among intravenous drug users with human immunodeficiency virus
infection. N Engl J Med 1989; 320:545-50.
5. CDC. Tuberculosis and human immunodeficiency virus infection:
recommendations of the Advisory Committee for the Elimination of Tuberculosis
(ACET). MMWR 1989;38:236-8, 243-50.
6. Bass JB, Farer LS, Hopewell PC, Jacobs RF. Treatment of tuberculosis and
tuberculosis infection. Am Rev Respir Dis 1986;134:355-63.
7. Addington WW. Patient compliance: the most serious remaining problem in the
control of tuberculosis in the United States. Chest 1979;76(suppl):741-3.
8. Division of Tuberculosis Control, South Carolina Department of Health and
Environmental Control/American Lung Association of South Carolina. Enablers
and incentives. Columbia, South Carolina: American Lung Association of South
Carolina, 1989.
Perspectives in Disease Prevention and Health Promotion
Influenza Vaccination Coverage Levels in Selected Sites -- United
States, 1989
In 1988, the Congressionally mandated Influenza Vaccine Demonstration
Project awarded demonstration grant funds for the 1988-89 and 1989-90
influenza seasons to nine geographic areas, including states and counties.
Goals of this project were to determine 1) the cost-effectiveness of Medicare
coverage of influenza vaccination and 2) whether Medicare reimbursement and
other measures to enhance vaccine delivery result in increased influenza
vaccination levels among Medicare Part B beneficiaries (i.e., persons aged
greater than or equal to 65 years or persons of any age with a disability or
who have end-stage renal disease). Each area includes an intervention site,
where influenza vaccine is a benefit provided to these beneficiaries, and a
comparison site, where the benefit is not provided. Intervention sites were
chosen based on their ability to support promotional intervention efforts to
increase vaccine coverage, and comparison sites were chosen on the basis of
similar demographic and health service utilization characteristics. Annual
surveys in the nine areas will assess changes in influenza vaccine coverage.
This report summarizes preliminary results of the first survey, conducted
from May through July, 1989.* Because vaccine distribution was limited during
the project's first year, the data reported here are considered baseline.
A telephone survey was conducted using the September 1988 update of the
Medicare statistical data file to select a stratified probability sample of
noninstitutionalized Medicare Part B beneficiaries from each demonstration
site. The age-sex-race distribution of the sample at each intervention site
was replicated for its comparison site. Telephone numbers were available for
approximately 65% of selected beneficiaries. Respondents were asked about
vaccination status for the 1987-88 and 1988-89 influenza seasons, source of
influenza vaccination, presence of an underlying medical condition, and
factors influencing influenza vaccination status (e.g., concern about side
effects). Data from this survey are self-reported.
For each of the intervention and comparison sites, at least 940
respondents were surveyed. The 17,643 respondents represented a 60% completion
rate. The overall influenza vaccination coverage estimate for
noninstitutionalized Medicare beneficiaries for the 1987-88 influenza season
was 41% (95% confidence interval (CI)=39.9-41.3), and for 1988-89, 43% (95%
CI=42.7-44.1) (Table 1, page 165). Coverage in intervention sites tended to be
slightly higher than coverage in comparison sites.
The lowest reported vaccination level was among persons aged less than or
equal to 65 years with a disability or who had end-stage renal disease (30%
(377/1259)). In comparison, among persons aged 65-75 years and greater than 75
years, coverage was 42% (4352/10,310) and 48% (2931/6074), respectively.
Vaccination levels for males (44%) and females (43%) were similar; the level
for races other than white (31%) was substantially lower than for whites
(44%). Among persons with and without an underlying medical condition,
vaccination levels were 48% and 39%, respectively.
Of 7660 persons vaccinated, 62% reported receiving vaccine from a private
physician. Among the 9983 (57%) persons not vaccinated, at least 91% were
candidates for vaccination based on recommendations of the Immunization
Practices Advisory Committee (ACIP) (1). The most commonly (54%) cited reason
for not being vaccinated was that persons considered themselves healthy and
not in need of vaccination. Additional reasons cited included: concern about
side effects (30%), concern about illness associated with the vaccine (30%),
and lack of a physician's recommendation for vaccination (15%).
Reported by: Div of Health Systems and Special Studies, Office of Research and
Demonstrations, Health Care Financing Administration. Div of Immunization,
Center for Prevention Svcs, CDC.
Editorial Note: The public health impact of epidemic influenza is dramatic:
influenza accounted for greater than or equal to 10,000 excess deaths during
each of 19 epidemics that occurred in the United States from 1957 to 1986 (1).
In three of these epidemics, more than 40,000 excess deaths occurred. However,
because influenza vaccine is up to 75% effective in preventing complications
and death from influenza among high-risk older persons residing in
institutions (2), much of this health burden is preventable.
Influenza vaccine is recommended annually for persons with chronic
cardiopulmonary disorders; residents of nursing homes and other chronic-care
facilities; healthy adults greater than or equal to 65 years of age; adults
and children with metabolic diseases (including diabetes mellitus), renal
dysfunction, hemoglobinopathies, or immunosuppression; children and teenagers
receiving long-term aspirin therapy; health-care personnel caring for high-
risk patients; and home-care and household contacts of high-risk persons. In
addition, vaccination should be considered for persons with human
immunodeficiency virus infection, travelers to countries where influenza is
likely to occur, persons providing essential community services, students or
other persons in institutional settings (e.g., schools and colleges), and
persons who wish to reduce their risk of acquiring influenza infection
(1,3,4).
Findings from this survey suggest that influenza vaccination coverage
among older persons may be higher than documented in previous surveys. For
example, the most recent national coverage estimate (from the 1985 U.S.
Immunization Survey) for persons aged greater than or equal to 65 years was
23%. For 1987, the Behavioral Risk Factor Surveillance System estimated
influenza vaccination coverage among persons aged greater than or equal to 65
years to be 32% (5); state-specific estimates ranged from 24% to 41%. Finally,
in 1987, the number of doses of trivalent influenza vaccine distributed was
greater than 24 million** (CDC, unpublished data), the highest number of doses
distributed in any year since 1976.
The results of this study are based on nonrandomly selected sites and
cannot be generalized to the entire U.S. population of noninstitutionalized
persons greater than or equal to 65 years of age for at least two reasons.
First, vaccination status of nonrespondents and the 35% of Medicare Part B
beneficiaries for whom telephone numbers were not available could not be
determined and could result in bias of unknown direction and magnitude.
Second, sites that offered to participate in the project as intervention sites
may have been more likely to have ongoing active adult immunization programs
(6,7). Thus, vaccination levels in the survey areas may be higher than in
other areas.
Because the project was implemented late in the 1988-89 influenza season,
adequate data are not yet available to conduct a cost-effectiveness
evaluation. The demonstration sites will be monitored for the success of
intervention efforts in increasing influenza immunization levels. At the
completion of the project, if Medicare coverage is determined to be cost
effective, influenza vaccine will become a covered benefit for all Medicare
Part B beneficiaries.
The high proportion of vaccinees reporting a private physician as their
source of vaccination and the substantial group reporting lack of a
physician's recommendation as a reason for not being vaccinated underscore the
influence of health-care providers in the decision to be vaccinated (8,9).
Educational and promotional campaigns may help dispel concerns among patients
regarding the benefits, safety, and efficacy of influenza vaccine. Health-care
providers should use every opportunity to assess patients' immunization status
and recommend influenza vaccine and all other vaccines (hepatitis B, measles,
mumps, rubella, and pneumococcal vaccines, and diphtheria and tetanus toxoids)
appropriate for adults (1,3,4).
References
1. ACIP. Prevention and control of influenza: part I, vaccines. MMWR
1989;38:297-8,303-11.
2. Patriarca PA, Weber JA, Parker RA, et al. Efficacy of influenza vaccine in
nursing homes: reduction in illness and complications during an influenza A
(H3N2) epidemic. JAMA 1985; 253:1136-9.
3. ACIP. Adult immunization: recommendations of the Immunization Practices
Advisory Committee (ACIP). MMWR 1984;33(no. 1S).
4. American College of Physicians Task Force on Adult Immunization/Infectious
Disease Society of America. Guide for adult immunization. 2nd ed.
Philadelphia: American College of Phy sicians, 1990.
5. CDC. Influenza vaccination levels in selected states--Behavioral Risk
Factor Surveillance System, 1987. MMWR 1989;38:124,129-33.
6. CDC. Allegheny County 1986-87 influenza vaccination program--Pittsburgh,
Pennsylvania. MMWR 1987;36:617-9.
7. McKee P. Oklahoma's Influenza Demonstration Project. In: Proceedings of the
Twenty-third Immunization Conference. San Diego: US Department of Health and
Human Services, Public Health Service, CDC, 1989:83-9.
8. Williams WW, Hickson MA, Kane MA, Kendal AP, Spika JS, Hinman AR.
Immunization policies and vaccine coverage among adults: the risk for missed
opportunities. Ann Intern Med 1988;108:616-25.
9. CDC. Adult immunization: knowledge, attitudes, and practices--DeKalb and
Fulton counties, Georgia, 1988. MMWR 1988;37:657-61.
*A second survey will be conducted in the summer of 1990. The project is
expected to continue for 1991 and 1992.
**Previous estimates of 27 million (5) were based on provisional data.
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Volume 3, Number 9 March 19, 1990
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