A Strategic Plan for the Elimination of Tuberculosis in the United
States Message to the Readers of Morbidity and Mortality Weekly
I am pleased to provide you with "A Strategic Plan for the
of Tuberculosis in the United States" describing actions necessary
achieve the goal by the year 2010, with an interim target of a case
rate of 3.5 per 100,000 population by the year 2000. At a national
conference in 1984, Dr. James O. Mason, then Director of the
for Disease Control, challenged the public health community to
a strategy to eliminate tuberculosis from the United States. This
was developed by the Centers for Disease Control/Department of
and Human Services' Advisory Committee for Elimination of
Many experts from both within and outside the Department played a
significant role in its development. We are grateful to all those
participated in the process.
I am pleased to report that the House of Delegates of the American
Medical Association and the Governing Council of the American
Health Association have passed resolutions in support of the plan,
the American Lung Association and the American College of
Medicine have also endorsed the goal. We thank these organizations
their support and anticipate that other organizations will take
actions in the near future.
We must commit ourselves to the objective of eliminating
and making that objective widely known so others can join in this
effort. The Centers for Disease Control is identifying activities
short- and long-term implementation. The plan is being distributed
wide variety of public and private organizations with the
recommendation that they take similar action.
The goal of eliminating this disease and its tragic consequences
the United States is achievable, and we believe it will be broadly
supported by all sectors of our society.
Walter R. Dowdle, Ph.D.
Centers for Disease Control
In 1987, the Secretary of the U.S. Department of Health and Human
Services established an Advisory Committee for Elimination of
Tuberculosis* to provide recommendations for developing new
applying prevention and control methods, and managing state and
tuberculosis programs targeted at eliminating tuberculosis as a
health problem. After review and feedback from numerous interested
people and organizations, this plan was completed.
The committee urges the nation to establish the goal of
elimination (a case rate of less than one per million population)
the year 2010, with an interim target of a case rate of 3.5 per
population by the year 2000. The U.S. case rate for 1987 was 9.3
Three factors make this a realistic goal: 1) tuberculosis is
into geographically and demographically defined pockets; 2)
biotechnology now has the potential for generating better
treatment, and prevention modalities; and 3) computer,
telecommunications, and other technologies can enhance technology
transfer. Therefore, a three-step plan of action was developed:
more effective use of existing prevention and control methods,
especially in high-risk populations
2.the development and evaluation of new technologies for treatment,
diagnosis, and prevention
3.the rapid assessment and transfer of newly developed technologies
into clinical and public health practice
The committee brings this plan to the attention of the medical
community and the public to stimulate positive, constructive
and action, to increase the public's level of awareness of
tuberculosis, and to encourage a commitment to the elimination of
tuberculosis. In the past, the United States has spent hundreds of
millions of dollars annually on tuberculosis treatment and control
activities. Unless alternative action is taken, large and
expenditures will continue indefinitely. Expenditures on
treatment may increase over the next few years because of high
morbidity rates among people infected with the human
virus (HIV), the homeless, the foreign-born, the elderly, and
minority groups. Furthermore, tuberculosis has the potential for
spreading more widely in the community.
The mission of all tuberculosis control programs should now be to
eliminate this disease by the year 2010. Strategies for eliminating
tuberculosis are set out in this document. These strategies are
on the needs and responsibilites of the various groups of people
involved in this effort (Appendix). The committee realizes the task
will not be an easy one; it will require considerable commitment at
levels. The challenge to carry out this plan is a test of our
willingness and ability as a society to respond to a very serious
health problem that disproportionately affects its disenfranchised
members. A great nation such as ours can carry out this plan. It is
time to commit to a tuberculosis-free society!
Tuberculosis is a communicable disease caused by bacteria
(Mycobacterium tuberculosis complex) that are usually spread from
person to person through the air. When people with tuberculosis of
respiratory tract cough, airborne infectious particles are
these bacteria are inhaled by other people, they cause an infection
that spreads throughout the body. Most individuals who become
do not develop a clinical illness because the body's immune system
brings the infection under control; however, infected people do
a positive reaction to a tuberculin skin test. The infection can
persist for years, perhaps for life, and infected persons remain at
risk of developing disease at any time, especially if the immune
becomes impaired. Although the disease usually affects the lung, it
occur at virtually any site in the body.
Despite the great strides that have been made in the control of
tuberculosis, the disease continues to be a public health problem
the United States. There remain isolated and potentially dangerous
enclaves of this preventable, but frequently severe and
fatal, disease. If more aggressive action is not taken, thousands
preventable cases and deaths will continue to occur in the United
States each year until well into the next century. This document
been prepared to identify the steps necessary to eliminate
Ongoing analyses of tuberculosis morbidity data continue to
the magnitude and extent of the problem. These data have important
implications for the control and elimination of tuberculosis in the
From 1953 through 1984, the number of tuberculosis cases reported
decreased an average of 5% annually (1). However, in 1985, the
of tuberculosis cases remained stable and, in 1986, cases increased
2.6% (2,3). This increase was, at least in part, caused by the
occurrence of tuberculosis among persons infected with HIV (2-4).
infection appears to have increased the incidence of tuberculosis
causing immunosuppression, which allows latent tuberculous
progress to clinically apparent disease. Therefore, tuberculosis
screening and prevention efforts will need to be targeted to
with, or at risk for, HIV infection.
Although tuberculosis case rates have progressively declined for
races over the past two decades, the decrease has been much less
nonwhites than among whites. Nearly two-thirds of cases now occur
blacks, Hispanics, Asians, and Native Americans (5-10). Although
specific data are not available, the higher risk in these minority
populations may be related primarily to socioeconomic conditions,
as poor housing and nutrition. Thus, prevention and control
should be formulated in consultation with, and targeted toward,
high-risk minority populations.
Tuberculosis is also common among immigrants, refugees, and migrant
workers from countries where the disease is prevalent (10). In
patients, organisms responsible for disease are frequently
commonly used antituberculosis drugs, especially isoniazid (INH).
not recognized and managed appropriately, drug-resistant disease
infection may lead to failure of treatment or preventive measures.
Almost half the cases among immigrant Asians occur within the first
years of arrival in the United States. Specific control efforts
thus be directed at recent immigrants before or shortly after their
arrival. Over two-thirds of cases in foreign-born persons occur in
those who are less than 35 years old at the time of arrival in the
United States (10). These cases are potentially preventable.
More than 80% of childhood cases occur in minority groups.
cases are geographically focal. Less than 12% (363) of U.S.
reported one or more tuberculosis cases among children in 1986 (CDC
unpublished data). Using childhood cases as sentinel health events,
health departments can target certain populations for preventive
Among all racial and ethnic groups and both sexes, tuberculosis
rates are highest among the elderly. Although case rates are higher
among the 5% of the elderly living in nursing homes, the majority
cases occur among 95% of the elderly who live in the community.
Good epidemiologic surveillance data are essential for an effective
tuberculosis- elimination effort. These data target the populations
geographic areas experiencing the problem and provide clues as to
to deal with it. Additional data are needed to define the extent to
which correctional institution populations, homeless people, lower
socioeconomic groups, and others are at increased risk. While
of national data are useful, analyses of state and local data will
even more important for targeting elimination efforts.
STEP 1 -- MORE EFFECTIVE USE OF EXISTING PREVENTION AND CONTROL
The emphasis in this section is on currently available prevention
control strategies not being fully utilized and on new strategies
existing technology. Although new technologies will be needed to
eliminate tuberculosis (see Step 2), much can be achieved through
efforts to improve existing tuberculosis control programs. Detailed
recommendations for diagnosis, prevention, treatment, and program
management are included in various American Thoracic Society and
statements and in CDC's Tuberculosis Policy Manual. Our
are quite general and will need to be adapted at the state,
and individual level. They are meant to serve as guidelines and not
establish rigid standards of practice or to discourage creativity
Priorities for Step 1 include adequate and appropriate treatment
all persons with tuberculosis, identification of high-risk
groups within each geographic area, and the use of preventive
in the appropriate members of these groups. Strategies are
terms of surveillance, prevention of disease and infection,
of disease, and program evaluation and assessment.
The identification and reporting of tuberculosis cases, suspected
cases, and contacts is often slow or incomplete, thus delaying
treatment and preventive intervention. Some cases are not diagnosed
reported, and contact investigation is not done. This is more
occur among the poor, the elderly, the homeless, drug users, and
By January 1, 1991, systems should be in place to assure that: 1)
persons with signs and symptoms suggestive of tuberculosis receive
appropriate diagnostic evaluation within 2 weeks of initial contact
with a health-care provider; 2) suspected or diagnosed cases are
reported to health departments within 3 days of the time the
is made or suspected, or a positive laboratory result is obtained,
that contacts can be identified and examined; 3) active
population-specific casefinding, screening, and preventive
programs are established and maintained by health departments; and
achievement of the above objectives is measured and assessed.
Health departments, medical and nursing schools, schools of
health, volunteer agencies, professional societies, and minority
advocacy groups should educate health-care providers and high-risk
groups in the community about the signs and symptoms of
and the methods of diagnosis, treatment, and prevention.
2.To speed up case reporting and make it easier for health-care
providers to report, health departments should initiate telephone
reporting systems for reportable infectious diseases, including
tuberculosis, as a replacement or supplement to written
This system should include a telephone answering machine to record
off-hour reports. Computer-to-computer reporting using
telecommunications systems should be developed to further improve
3.Physician, laboratory, and hospital reporting of cases to health
departments should continue. Pharmacy reporting of persons who
a supply of antituberculosis drugs should be undertaken on a pilot
basis to determine whether additional cases are found.
4.Health department staffs should routinely monitor the time
the diagnosis of tuberculosis and the date the case is reported to
health department. Delays of more than 3 days should be
and action taken to prevent similar delays in the future.
5.Health department staff should conduct periodic reviews of
records systems (e.g., laboratory reports, pharmacy reports, AIDS
registries, and death certificates) to validate the surveillance
and to detect any failures to report cases.
6.Clinicians and public health officials should identify groups of
people in the community among whom tuberculosis and transmission of
infection are occurring. This may require collection and analysis
data (e.g., residence, occupation, socioeconomic-status indicators,
HIV-antibody status) not now included on the individual case-report
form. These data are necessary to identify high-risk populations
areas in which active casefinding and preventive intervention
should be conducted. Members of high-risk groups and their health-
providers should be apprised of the problem and involved in the
implementation, and evaluation of casefinding and prevention
Improving Case Prevention
Preventable tuberculosis cases continue to occur in the United
By definition, preventable cases include all those for whom one or
of the currently recommended interventions should have been
but were not. These interventions include contact identification
examination, preventive therapy for infection, prompt diagnosis of
disease, prompt reporting, isolation of persons with suspected and
diagnosed tuberculosis, adequate ventilation of buildings, the use
ultraviolet lights in high-risk areas of buildings, chemotherapy
disease, and directly observed therapy. Some of these interventions
(e.g., isolation) are designed to prevent transmission of infection
among residents and staff of high-risk institutions such as
nursing homes, correctional institutions, and shelters for the
homeless. Other interventions (e.g., preventive therapy) are
to prevent disease among those already infected. INH preventive
reduces the risk of tuberculosis by more than 90% among persons who
complete a full course of treatment.
To prevent infection among persons potentially exposed to an
case of tuberculosis and to prevent tuberculosis among contacts and
other infected persons for whom preventive therapy is recommended,
following methods should be implemented by January 1, 1991.
All U.S. residents should have the results of at least one
tuberculin skin test in their medical records, and those whose test
result is positive should be evaluated and counseled regarding
risk of developing tuberculosis.
2.Each health department should assess the prevalence, incidence,
sociodemographic characteristics of cases and infected persons in
community. On the basis of these data, health departments should
initiate tuberculin screening programs specifically targeted to
community's high-risk groups. Screening may be done to identify
suspects, undiagnosed cases, diagnosed cases lost to follow-up, and
infected persons in need of preventive therapy. At a minimum,
departments should ensure that such programs are extended to
with symptoms compatible with tuberculosis, all foreign-born
(and their families) from high-prevalence areas, high-risk minority
groups, the homeless, migrant workers, persons being admitted to
nursing homes, people entering correctional institutions, and
known to be infected with HIV. In addition to their prevention
screening programs have the potential for providing publicity and
generating goodwill for the tuberculosis program.
3.Tuberculin skin-testing programs should be conducted annually
the staffs of tuberculosis clinics, mycobacteriology laboratories,
shelters for the homeless, nursing homes, substance-abuse treatment
centers, dialysis units, and correctional institutions. The staffs
hospitals, mental institutions, and home health- care agencies
be tested annually if the prevalence of infection exceeds 5%.
4.Consideration should be given to installing and properly
ultraviolet lights in high-risk facilities such as jails, prisons,
shelters for the homeless (10-13).
5.Hospitals that admit untreated tuberculosis patients or persons
suspected of having tuberculosis should have proper facilities and
procedures for instituting respiratory isolation.
6.Consideration should be given to routinely obtaining sputum for
mycobacterial smear and culture from symptomatic nursing home
thought to have a lower respiratory infection.
7.Tuberculosis patients and persons suspected of having
should be interviewed within 3 days after the health department
receives the case report by a person who has had specific training
8.Close contacts should be examined within 7 days after the index
9.Infected contacts should be placed on preventive therapy if there
no evidence of clinical disease.
10.A child whose skin test shows no evidence of infection and who
close contact of someone with infectious tuberculosis should be
on preventive therapy until repeat skin testing (3 months after
is broken) confirms the absence of infection.
11.All persons identified with HIV infection should be tuberculin
tested. Those with positive tuberculin reactions or a history of a
positive tuberculin reaction (without active disease) should be
considered for preventive therapy, regardless of age.
12.All other recognized high-risk, infected persons should be
considered for preventive therapy regardless of age. This includes
recently infected persons (i.e., persons who had negative skin-test
results who have converted to positive test results), persons with
chest radiographic findings consistent with past tuberculosis, and
those with medical risk factors known to substantially increase the
risk of tuberculosis (e.g., silicosis, below ideal body weight,
gastrectomy, immunosuppressive therapy).
13.Screening of refugees, immigrants, and entrants from
countries should be continued and infectious persons with
excluded until they become noninfectious. These groups should also
screened for tuberculous infection (without disease). Unless
contraindicated, those with infection (without disease) should be
started on preventive therapy either before, or within 2 months
their entry into the United States.
14.Infected persons placed on preventive therapy should complete a
course of treatment.
15.Twice-weekly, directly observed preventive therapy should be
whenever necessary to ensure compliance, especially if the number
persons on daily supervised preventive therapy would overextend the
personnel resources assigned to the program.
16.Patients on INH preventive therapy must be carefully monitored
monthly basis for compliance and signs and symptoms of toxicity.
testing of urine for INH metabolites is highly recommended when
cannot be observed directly. If signs or symptoms of toxicity
therapy should be stopped immediately and the patient reevaluated.
more than a 1-month supply of medicine should be dispensed at any
17.BCG vaccine should be considered in those rare situations in
other control measures cannot be applied and uninfected children
exposed to infectious persons who remain untreated.
Improving Disease Containment
Many tuberculosis patients do not complete a recommended course of
therapy. More than 25% of sputum-positive patients are not known to
have converted from positive to negative sputum culture within 6
months. In addition, almost 12% of patients are not known to be
currently receiving therapy, and more than 17% of tuberculosis
do not take their medication continuously (14).
Beginning immediately, all patients with tuberculosis should
treatment with an appropriate regimen.
For each new case of tuberculosis in the United States, a
health department employee should be assigned the responsibility
held accountable for ensuring the education of the patient about
tuberculosis and its treatment, ensuring continuity of therapy, and
ensuring that contacts are examined. The health-care worker should
visit the patient within 3 days of diagnosis to identify contacts
possible problems related to compliance with therapy.
2.For each new infectious case, a specific treatment and monitoring
plan should be developed within 4 days of diagnosis. This plan
include drugs to be used (doses, duration, and frequency of
administration), assessment of toxicity, and methods to be used to
assess and ensure compliance.
3.Appropriate antituberculosis drugs, laboratory services, contact
investigations, contact examinations, and other necessary services
should be provided to patients by health departments without regard
the patients' ability to pay.
4.Incentives may be necessary to enhance compliance. To be most
effective, incentives should be tailored to the individual needs
desires of the patients. An incentive may be as simple as offering
cup of coffee and talking with a patient while he or she is waiting
the clinic, or as complex as providing food and housing for a
patient. Particular attention must be given to ensuring that
have transportation to the clinic.
5.Twice-weekly, directly observed therapy should be used whenever
needed. Specific funding for outreach staff should be encouraged at
federal, state, and local level. Alternatives to federally funded
outreach staff might include, for example, appropriately instructed
home health-care workers or maternal and child health staff to
6.Quarantine measures, including temporary institutionalization,
be used in those instances when an infectious patient refuses to
with self- administered or directly observed therapy. State and
laws and regulations should be modernized to facilitate the cure of
persons with infectious tuberculosis. For example, court-ordered
compliance with directly observed therapy should be available.
Program Assessment and Evaluation
In many areas, there is incomplete assessment of community
control problems and inadequate evaluation of community prevention
control efforts. As a result, programs do not function as
and efficiently as they should.
By January 1, 1991, a system should be in place to achieve an
effective assessment of the tuberculosis problem and evaluation of
activities being performed at all levels for the control and
elimination of tuberculosis.
The Federal Government and state and large metropolitan health
departments should annually evaluate their progress toward the
elimination of tuberculosis. This evaluation should include an
of morbidity and mortality data, case reporting, case finding,
treatment, and prevention activities. Annual evaluations could be
in collaboration with interested constituencies such as lung
associations, minority organizations, and professional societies.
Regional meetings to share information among states are encouraged.
2.Expert assessment should be conducted annually for local health
departments by the state, CDC, or the American Lung
Association/American Thoracic Society and for state health
by CDC or the American Lung Association/American Thoracic Society.
similar assessment of federal tuberculosis prevention and control
activities should be conducted by the CDC Advisory Committee for
Elimination of Tuberculosis or other outside consultants.
3.Priority for continued federal funding of state and local
should be, at least in part, contingent upon improved program
performance and productive activities in high-risk populations.
4.A prototype computerized record system should be developed by CDC
use by local programs for case reporting, patient management, and
program assessment. CDC should provide microcomputers, with
software and training, to state and major city health department
tuberculosis control programs in high-incidence areas.
5.Each state and major metropolitan area should develop and publish
annual community tuberculosis summary and program plan (including
objectives, methods, a discussion of program progress or failure,
corrective action needed).
6.Health departments should review each new tuberculosis case and
death from tuberculosis to determine if the case or death could
been prevented had the American Thoracic Society/CDC
been followed. Based on these reviews, new policies should be
and implemented to reduce the number of preventable cases.
Implementation of Step 1 of this plan will require strong
the national, state, and community levels. State and local
advisory groups, with broad representation from public, private,
voluntary medical groups, should develop and help implement Step 1
strategies appropriate for the state or community.
STEP 2 -- DEVELOPMENT AND EVALUATION OF NEW PREVENTION, DIAGNOSTIC,
In June 1985, CDC, the National Institutes of Health, the American
Thoracic Society, and the Pittsfield Antituberculosis Association
cosponsored a conference in Pittsfield, Massachusetts. The
this conference was to identify areas for research that would lead
improved technologies for eliminating tuberculosis from the United
States. The complete report of this conference was published in the
August 1986 issue of the American Review of Respiratory Disease
Consequently, only selected priority projects are mentioned here.
The five headings under which research projects and activities are
listed represent critical objectives for eliminating tuberculosis.
are presented in priority order. These projects should also be
in terms of type of research, i.e., basic, applied, and
epidemiologic/operational (Table 1). Basic research is intended to
obtain a better understanding of structure, processes, and
of tuberculosis. While the findings from this research can often be
applied for some clinical or public health purpose, basic research
not proceed with a specific application in mind. As already
applied research has as its goal the application of knowledge to
solution of a particular clinical or public health problem.
Epidemiologic studies are designed to assess the magnitude,
distribution, and determinants of disease in a population.
research studies assess the actual impact of interventions on
outcomes in the population.
Improving Methods for Preventing Disease in Infected Persons
The vast majority of new cases of tuberculosis arise in persons who
have had a latent period of infection. The most critical element in
tuberculosis elimination is the detection and treatment of infected
persons before disease emerges. At present, INH is usually
for 6-12 months for preventive therapy. However, this approach has
major deficiencies. These include the expense of treating and
monitoring patients for such a long time, noncompliance with
therapy of long duration, and the occurrence of drug toxicity,
The first-priority objective of Step 2 is to develop shorter,
more effective and more economical means of preventing the
clinical disease from the infected state.
Areas of research to be pursued are as follows:
A drug that is more effective and less toxic than INH should be
identified. This will require research at several levels.
a.The mechanisms by which current antituberculosis drugs act are
understood. Consequently, studies of microbial metabolism, with
identification of target sites for drug activity, should be
to develop new approaches to preventive therapy.
b.In vitro models of drug efficacy, especially those allowing
assessment of the interactions of drug, phagocyte, and organism,
be developed to help select drugs for in vivo studies.
c.Animal models for studying preventive therapy of latent infection
should be developed.
d.Based on present and developing knowledge, candidate drugs should
evaluated in high-risk groups both in the United States and in
2.Alternatives to daily INH preventive therapy regimens (e.g.,
multi-drug regimens, rifampin alone, twice-weekly INH) should be
3.Because hepatotoxicity is a major limitation to the use of INH
preventive therapy, research efforts should be encouraged that a)
contribute to the understanding of the mechanisms of INH-hepatitis,
contribute to the understanding of the mechanism by which INH acts,
which will in turn facilitate the development of congeners that
antimicrobial potency while eliminating sites of hepatotoxic
c) investigate the cytoprotective effects of agents that may block
interfere with the toxic effects of INH, and d) identify more
risk factors, other than age, for the development of INH-hepatitis.
4.High priority should be given to the development of a
vaccine to boost the specific immune response.
5.Modification of the host immune response to M. tuberculosis
should be evaluated as a supplement to chemoprophylaxis to boost
immune response and increase destruction of intracellular
Improving Methods for Identifying Infected Persons at Risk of
The use of the Mantoux test with tuberculin, purified protein
derivative (PPD), to identify persons infected with M. tuberculosis
well established. However, the test suffers from a lack of
and specificity. In addition, the test is difficult to interpret in
serial testing programs because of the "booster effect." In
with the skin test, epidemiologic factors and patient
have been used to identify persons at high risk of developing
The risk of developing clinically apparent tuberculosis is
recently acquired infection, young adulthood, leanness, and disease
states in which T-lymphocyte function is disturbed (16). Despite
knowledge, we currently have a very limited ability to predict
infected persons are most likely to develop disease.
Preventive therapy would be a much more efficient intervention for
reducing tuberculosis morbidity if there were better methods for
identifying persons infected with M. tuberculosis (i.e., those who
at risk of developing disease). Ideally, a test is needed that is
capable of specifically differentiating those who harbor living
tubercle bacilli from those who do not.
Genes that code for species-specific epitopes of mycobacteria
be identified and characterized. This should permit amino acid
and synthesis of epitopes which may be useful for serologic or
2.T-lymphocytes are the key responding cellular elements of the
response to M. tuberculosis. These cells should be studied to
subpopulations of T-lymphocytes that influence progression or
containment of infection.
3.Genetic differences, such as those related to histocompatibility
complex antigens, between infected persons who develop disease and
those who do not should be sought.
4.The absolute and relative risk of disease among persons infected
both the tubercle bacillus and HIV should be determined.
5.Socioeconomic status, immunodeficiency status, stress (both
and psychological), body weight, nutrition, and environmental
(e.g., incarceration, sunlight, ventilation) should be investigated
risk factors in prospective or case-control studies.
Improving Methods for Preventing Infection or the Establishment of
Infection in Various Body Sites
Transmission of M. tuberculosis infection usually occurs via the
airborne route. Current methods for preventing the transmission of
infection to uninfected persons include early identification,
isolation, and treatment of infectious source cases; environmental
control to reduce the number of airborne infectious particles
the use of nonrecirculated ventilation to the outdoors and
light; and drug therapy of uninfected persons who are exposed to
infection sources. Vaccination with BCG does not prevent infection
may limit the spread and complications of the disease (17). Each of
these measures has certain drawbacks, and transmission of infection
still occurring at unacceptable levels. Therefore, more reliable
methods are needed for preventing infection and for limiting its
within the body.
Source case factors
a.Patient characteristics that influence infectiousness should be
2.Environment- or bacteria-oriented factors
a.Research on systems for better air disinfection should be
b.Studies that would increase our understanding of the
M. tuberculosis and how this may affect infectivity and virulence
should be pursued.
3.Studies on the host's native resistance
a.Host factors (e.g., nutritional state, genetic makeup, level of
stress) that affect susceptibility and resistance to tuberculous
infection should be identified.
b.More refined epidemiologic methods for identifying groups and
at risk of becoming infected should be investigated.
c.In vitro studies of the immune and nonimmune macrophage's ability
handle virulent and avirulent strains of M. tuberculosis should be
undertaken to identify factors that affect the macrophage's ability
destroy these organisms.
a.Studies to identify protective immunogenic component antigens of
tuberculosis should be undertaken and procedures for large-scale
production, purification, and synthesis of these antigens should be
b.Different immunization techniques, with and without biological
response modifiers, should be evaluated.
5.Populations in which a vaccine trial could be carried out should
6.Studies should be done to determine if persons or groups differ
regard to infectibility and whether this could be altered in some
Improving Methods for Treating Disease
Current drug regimens are effective, well tolerated, and can be
with minimal effects on the patient's mode of living. Nevertheless,
major problems remain. With current drugs, a minimum of 6 months of
multi-drug therapy is necessary to achieve a high probability of
(18). There are at least four obstacles to achieving a cure: 1) the
failure of patients to comply with regimens of long duration, 2)
drug-resistant organisms, 3) adverse reactions that require
interruption and modification of the original, and usually optimal,
drug regimen, and 4) the cost of the most effective regimens.
The following steps should be taken to develop more effective
approaches to therapy for tuberculosis.
All new antimicrobial agents should be routinely evaluated in
for antimycobacterial activity. In addition, drug combinations
be examined for synergy.
2.Classes of compounds that should receive high priority in the
for better treatment regimens are beta-lactam compounds,
sulfones and sulfonamides, rifamycins, and 4-quinolones.
3.Improved delivery systems--including longer acting drug-release
systems, such as injectable suspensions, implantable rods, and
membrane-enclosed drugs-- should be sought.
4.Research to define enzyme targets for antituberculosis drugs
be carried out. This information will facilitate the design of new
drugs with higher affinity for these target enzymes, or indicate
rational modifications of existing drugs for the same purpose. High
priority should be placed on finding rapidly effective,
agents that affect mycobacteria in all metabolic states.
5.Because mycobacteria within macrophages are not readily
many drugs, a knowledge of drug transport mechanisms should be
to allow modification of drugs to facilitate uptake.
6.Pharmacologic agents that activate T-lymphocytes and macrophages
should be identified and evaluated in patients with mycobacterial
7.Manipulation of the microenvironment in the phagosome should be
attempted to improve the efficiency of the microbicidal activity of
8.Effective compliance enhancers or incentives should be identified
psychometric and other tests should be developed to identify
for whom various enhancers are likely to be most effective.
Improving Methods for Diagnosing Disease
Current techniques for diagnosing tuberculosis are beset by a
serious limitations and problems. Available techniques are slow,
resource intensive, and not ideally sensitive and specific.
One objective of this program is to develop better diagnostic
techniques that will rapidly identify persons with current disease
distinguish them from persons with past disease or infection
High priority should be placed on the search for genus- and
2.DNA probes specific for M. tuberculosis should be produced and
3.Similarly, genus- and species-specific monoclonal antibodies
be produced and evaluated for their ability to rapidly detect and
identify M. tuberculosis and other medically significant
4.Studies to detect free mycobacterial antigens with appropriate
antibodies or probes in clinical specimens should be undertaken.
5.Systems that would assay material produced by the diseased host's
lymphocytes or macrophages might be useful for diagnosis. A related
area to be explored is the study of the T-lymphocyte antigen
There is an urgent need for competent investigators to submit
well-designed proposals for all of the above studies. CDC should
continue to work with the National Institutes of Health, the Food
Drug Administration, state and local health departments, private
industry, academia, volunteer agencies, foundations, and other
to encourage the funding and conducting of this research. A report
federal and private research funding agencies should be submitted
annually to the Secretary's Advisory Committee for Elimination of
Tuberculosis detailing progress made in achieving these research
STEP 3 -- TECHNOLOGY ASSESSMENT AND TRANSFER
This step of the elimination plan focuses on the actions necessary
facilitate the adoption of new tools, procedures, and ideas into
clinical and public health practice. (This has been called
transfer or translation.) Because we are generally discussing the
assessment and transfer of technologies not yet developed, it is
possible to be as specific in this section as in the preceding two
Technology Assessment and Transfer in General
Impediments to the technology and assessment transfer process must
identified and strategies devised to resolve them. Problems arise
the new technology requires retraining, additional resources, or a
change in habits. Problems also arise if cost-effectiveness data on
new technology are not available or if cost savings from a new
procedure do not accrue to those who spend the resources to adopt
It is important to ensure the widespread, rapid, and efficient use
new technologies for tuberculosis control in field operations.
Technologies for transfer should be chosen on the basis of their
potential impact on the tuberculosis-elimination effort. Before a
program is initiated to "sell" a new technology, it is crucial to
develop a consensus on its appropriateness, identify persons who
be using the new technology, enlist their aid, identify potential
resistance points to the introduction of new technologies and
innovations, and develop strategies for overcoming the resistance.
Methods to be used in specific sectors are as follows:
The Federal Sector
a.Lead responsibility for setting standards for technology transfer
should rest with CDC through its ongoing work with the American
Thoracic Society's Scientific Assembly on Microbiology,
and Pulmonary Infection; the American Academy of Pediatrics
LP*RedbookLP' Committee; and other expert groups. These groups
critically assess information about new technologies and make
recommendations about further evaluation and implementation.
b.The involvement of other federal agencies (including the National
Institutes of Health, the Food and Drug Administration, the Health
Financing Administration, the Health Resources and Services
Administration, the Veterans Administration, and the Immigration
Naturalization Service) on an Interagency Task Force will be
in the technology assessment and transfer process.
c.CDC Public Health Advisors and their state and local counterparts
should continue to translate national recommendations into local
practice. Public Health Advisors should be assigned the
control program of each state and big city requesting such
These programs should be encouraged to develop their own
program-management capacity to transfer new technology.
d.When available, federal grant funds should continue to be used as
seed money for implementating new tuberculosis technology,
demonstration projects, and technology assessments. States and
localities should continue to fund ongoing community tuberculosis
control efforts and eventually assume the cost of each new
as its advantages become apparent.
e.CDC should explore with the Health Care Financing Administration
possibility of Medicare and Medicaid reimbursement for tuberculosis
control services such as directly observed therapy, nursing
translation services, transportation services, and halfway housing
tuberculosis patients. Resources to provide these services to
not covered by Medicare or Medicaid must also be sought.
f.CDC should continue to disseminate information about new
to as wide an audience as possible. Current vehicles for this
information exchange include the Morbidity and Mortality Weekly
articles and editorials in peer-reviewed medical and nursing
training courses (such as "TB Today!"), and national tuberculosis
conferences. These should be supplemented with new educational
such as videotapes, satellite teleconferencing, computerized
boards, and programmed instruction packages.
g.The Division of Tuberculosis Control, Center for Prevention
CDC, should continue to work with national organizations (e.g., the
American Hospital Association, major health maintenance
and nursing home organizations) to assist in establishing policies
h.The mycobacteriology laboratory at CDC should continue to play an
important role in the assessment and transfer of technology in the
diagnostic and laboratory areas through premarketing and
evaluation of new technologies and scientific publications.
i.The Division of Quarantine, Center for Prevention Services, CDC,
should apply new technology for controlling tuberculosis among
immigrants, refugees, and other entrants.
The State and Local Public Sector
a.Technology-assessment and -transfer activities of state and local
tuberculosis control programs should complement those of the
sector. Strengthening state and local health department
(noted in Step 1) will enhance the implementation of new
b.The American Public Health Association, Association of State and
Territorial Health Officials, the Council of State and Territorial
Epidemiologists, the National Association of County Health
the U.S. Conference of Local Health Officers, the Association of
and Territorial Public Health Nursing Directors, the Association of
State and Territorial Laboratory Directors, state and local
committees, and other similar organizations can play a vital role
recommending the adoption of the elimination plan and new
and control technologies.
c.State and locally funded evaluations of new technologies through
demonstration programs will be important to their adoption locally.
d.Promulgation of information on new technologies through state and
local public health newsletters can help to spread new technologies
through the public sector and into the private sector as well.
e.This sector should link with the academic institutions to educate
private medical sector about new technologies in tuberculosis. This
might involve making telephone calls or personal visits to
who report and/or manage cases and providing them with current
The Volunteer Sector
a.Since the turn of the century, the American Lung Association has
our nation's efforts to establish effective public health programs
deal with the problem of tuberculosis. Continuation of these
educational and advocacy activities, including support of local
American Lung Association/American Thoracic Society educational
activities, will be essential to the technology- transfer effort.
enhance its effectiveness, the American Lung Association should
continue to form national, state, and local coalitions with other
groups, such as the American Public Health Association and the
Academy of Pediatrics, to urge that resources be made available for
b.Advocacy groups representing populations with high rates of
tuberculosis can play an important role in technology transfer when
they are involved in decision-making and in the education of their
constituents and health care providers who serve them.
c.Foundations can serve in technology assessment and transfer by
providing funding for demonstration projects and educational
Professional Medical Societies and the Private Medical Sector
a.Some medical specialty groups, such as the American Thoracic
and the American College of Chest Physicians, have assisted in the
transfer of new technology through the preparation and
authoritative statements on tuberculosis, educational programs, and
consensus conferences. In the future, these and other professional
groups (including the American Academy of Pediatrics, the American
Medical Association, the National Medical Association, the American
College of Physicians, the Infectious Diseases Society of America,
American Academy of Family Physicians, the American Osteopathic
Association, the Society of Hospital Epidemiologists, the
of Practitioners of Infection Control, and the American Nurses
Association) should increase their educational efforts in
and produce and distribute written, audio, and video programs on
various new tuberculosis control techniques.
b.Selected physicians who are respected in their communities will
as opinion leaders in technology transfer. Such persons must be
out and their assistance requested for educational programs.
c.Health-maintenance organizations, occupational health clinics,
hospitals, and other health-care groups can assist in technology
transfer by holding seminars and conferences on new technologies in
tuberculosis, incorporating new technology into routine
patient-management protocols, and by distributing educational
on tuberculosis to employees in their institutions.
d.Important audiences to reach with education messages are
infection-control nurses, medical and nursing educators, medical
nursing students, and house staff. These groups must be mobilized
informed action in any elimination campaign.
The Business Sector
a.Health-insurance providers can assist in technology transfer by
paying for treatment and prevention modalities shown to be cost
effective. Otherwise, the higher costs of less effective treatments
will be borne by the carrier. An example would be the provision of
twice-weekly, directly observed therapy that prevents unnecessary
hospitalization, drug resistance, and treatment failure.
b.Industry can serve a role in transferring new technology,
when it anticipates a profit in the adoption of the technology.
Industry might also fund demonstration projects, especially if a
successful outcome would lead to increased use of the technology
investigated. Pharmaceutical companies have assumed the important
of sponsoring conferences and seminars.
a.Articles on advances in the diagnosis, treatment, and prevention
tuberculosis should be published in newspapers and magazines to
the general public, thereby increasing support for tuberculosis
programs and increasing the demand for adoption of the new
Television news stories or public service announcements,
and posters will serve the same function.
Special Technology Transfer Issues
This section concerns specific recommendations about methods and
strategy for the transfer and implementation of specific new
technologies that have been developed, but not adopted, or that are
likely to be developed in the near future. The examples are divided
into the same categories under which research efforts were outlined
Step 2 of this plan.
Transferring Technologies for Preventing Disease in Infected
Because the largest number of cases arise from the pool of
infected in the past, highest priority must be given to the rapid
evaluation and implementation of new technology in this area. It is
likely that shorter (e.g., 2- or 3-month) preventive treatment
can be developed using currently available drugs.
2.To have a major impact on tuberculosis morbidity, newly developed
short-course preventive therapy must be widely implemented by the
private medical sector. This will require comprehensive education
programs aimed at all physicians likely to see patients with
tuberculosis. Professional organizations should assist in this
Increased emphasis on the prevention of tuberculosis in the
of medical schools and schools of public health should be
Cooperative agreement, grant, or contract funds might be used to
stimulate these educational efforts.
3.Health departments should begin now to develop registers
the names and addresses of untreated infected persons so that they
be readily identified, contacted, and treated when improved
methods are available.
4.Public education is important for creating a demand for this
Consumer groups and organizations representing populations
high rates of tuberculosis should be involved.
Transferring Technologies for Defining Infected Persons at Risk of
New diagnostic tests will probably be developed in the near future.
Before widespread adoption of the new tests, evaluation studies
needed to determine whether they have significant advantages over
PPD-tuberculin skin test.
Transferring Technologies for Preventing Infection
A reduction in the number of tubercle bacilli in the environment
achieved by the proper use of ultraviolet lights. Field studies of
technology in selected high-risk settings (e.g., hospital emergency
rooms, correctional institutions, nursing homes, and shelters)
be undertaken as soon as possible.
Transferring New Technologies for Treating Disease
Recent experiences with the slow diffusion of short-course,
observed, and intermittent therapy into clinical and public health
practice suggest that new approaches will be required in the future
promote more rapid and widespread adoption of new treatments.
2.A strong recommendation for a new therapy from the American
Society and the Advisory Committee for Elimination of Tuberculosis
be essential. Demonstration projects in selected states and
showing feasibility, patient acceptability, and improvement in
performance will speed acceptance of new approaches to treatment.
3.Federal support will be necessary for the wider application of
therapy regimens in the public sector. For the private sector,
incorporation of instruction on new tuberculosis therapies into
continuing medical education programs will be helpful. Such
could be funded by pharmaceutical companies that market the drugs
in the recommended treatment regimens.
Transferring and Assessing New Technologies for Diagnosis of
With the use of new DNA probes, it may soon be possible to make a
specific diagnosis of tuberculosis in several hours. Before the use
these new diagnostic tests is recommended, they should be carefully
assessed. Support for technology assessments might come from the
commercial firm developing the product, other private groups, or
Transfer of Communication Technologies
Improved communication is essential for transfer of
technology. The principal means by which this will be accomplished
frequent and timely telephone communication and on-line electronic
transfer of information. It will be essential to develop and
an electronic network in which the public and private sector can
and rapidly obtain current information about tuberculosis. CDC
standardize hardware and software requirements for this
network and, to the extent possible, assist state and local health
departments in obtaining hardware and software. The American
Association, the National Medical Association, and other
groups should be approached regarding communication with the
2.Computerization of health department data bases will enhance the
actions advocated in Step 1 of this plan.
Technology assessment and transfer in our society is a complex
involving many participants. Successful achievement will require
federal coordination and some federal funding but will depend
on the active participation of state and local officials, private
practitioners, private industry, and volunteer groups. The Advisory
Committee can function as a focal point for these interactions.
Centers for Disease Control. Tuberculosis in the United States,
1985-1986. HHS publication No. (CDC) 88-8322.
2.Centers for Disease Control. Tuberculosis--United States, 1985.
3.Centers for Disease Control. Tuberculosis, final data--United
1986. MMWR 1988;36:817-20.
4.Centers for Disease Control. Tuberculosis--United States,
the possible impact of human T-lymphotropic virus type
III/lymphadenopathy-associated virus infection. MMWR 1986;35:74-6.
5.Centers for Disease Control. Tuberculosis in minorities--United
States. MMWR 1987;36:212-20.
6.Centers for Disease Control. Tuberculosis in blacks--United
7.Centers for Disease Control. Tuberculosis among Asians/Pacific
Islanders--United States, 1985. MMWR 1987;36:493-5.
8.Centers for Disease Control. Tuberculosis among American Indians
Alaskan Natives -- United States, 1985. MMWR 1987;36:493-5.
9.Centers for Disease Control. Tuberculosis among Hispanics--United
States, 1985. MMWR 1987;36:568-9.
10.Rieder HL, Cauthen GM, Kelly GD, Bloch AB, Snider DE.
in the United States. JAMA (in press).
11.Centers for Disease Control. Guidelines for prevention of TB
transmission in hospitals. U.S. Department of Health and Human
Publication (CDC) 82-8371. Atlanta, Public Health Service, 1982.
12.Riley RL, Nardell EA. Clearing the air: the theory and
of ultraviolet air disinfection. Am Rev Respir Dis (in press).
13.Riley RL. Ultraviolet air disinfection for control of
contagion. In: Kundsin RV, ed. Architectural design and indoor
microbial pollution. New York: Oxford University Press, 1988.
14.Centers for Disease Control. Tuberculosis program management in
United States, 1985-1986. U.S. Government Printing Office, 1988
15.American Thoracic Society, Centers for Disease Control, National
Institutes of Health, Pittsfield Antituberculosis Association.
research in tuberculosis: prospects and priorities for elimination.
Rev Respir Dis 1986;134:401-20.
16.Rieder HL, Cauthen GM, Comstock GW, Snider DE. Epidemiology of
tuberculosis in the United States. Epidemiologic Reviews (submitted
17.Weigeshaus EH, Smith DW. Evaluation of protective potency of new
tuberculosis vaccines. Rev of Inf Dis 1989;11(S-2) (in press).
18.Girling DJ. The chemotherapy of tuberculosis. In: The biology of
mycobacteria, vol 3, clinical aspects of mycobacterial disease. C
Ratledge, J Stanford, JM Grange, Academic Press, London, San Diego,
1989, pp 285-323. Appendix: Planning Assumptions
The public needs:
1.current and accurate information about tuberculosis and progress
toward its elimination;
2.to be protected from infection with M. tuberculosis; and
3.if already infected, to be protected from disability and death
The public has a responsibility to:
1.insist that adequate resources be made available for tuberculosis
control and that those resources be used efficiently and
B.Tuberculosis patients need:
1.quality diagnostic, preventive, and curative medical care that is
available, accessible, and acceptable;
2.accurate and current information about the nature and risks of
disease and about the risks and benefits associated with treatment;
3.confidentiality to the extent possible.
Tuberculosis patients have a responsibility to:
1.prevent transmission of their infection to others;
2.assist in the identification of contacts;
3.take medicine as prescribed and to cooperate with necessary
radiographic, and sputum examinations; and
4.report problems with taking prescribed treatment, improvement or
deterioration of symptoms, and symptoms suggestive of adverse drug
C.Health-care providers need the following services from local
1.contact identification and evaluations;
2.regular follow-up of patients on treatment;
3.up-to-date patient-management guidelines and expert medical
4.antituberculosis drugs, laboratory services, and directly
therapy for their patients when needed.
Health-care providers have a responsibility to:
1.maintain a high index of suspicion for tuberculosis, especially
persons from high-risk populations;
2.report cases, suspected cases, and laboratory results to the
department within 72 hours;
3.treat patients and monitor their compliance and response to
and monitor for adverse drug reactions within accepted medical
4.promptly notify health departments when patients under their care
not take treatment as prescribed or do not return for necessary
5.update health departments at specified intervals about current
treatment (including degree of compliance), laboratory results, and
disease status of each patient; and
6.cooperate with the health department in:
a.contact identification and examination;
b.the screening of other high-risk groups for infection and
c.the application of preventive therapy in those groups.
D.State and local health departments need:
1.information from health-care providers to ensure that persons
diagnosed tuberculosis do not continue to spread the disease within
community and that persons with tuberculosis, suspected
or tuberculous infection are receiving appropriate examinations and
2.the resources and authority to carry out their responsibilities.
State and local health departments have a responsibility to:
1.establish guidelines for the identification, reporting,
and prevention of tuberculosis in the community;
2.ensure that patients with tuberculosis do not continue to
infection in the community;
3.provide rapid follow-up for persons diagnosed or suspected of
4.ensure that laboratory services, drugs, and the staff needed to
provide follow-up, contact examination, and directly observed
5.ensure that high-risk groups, including those under the
of other state agencies (e.g., prisoners), are identified and
for tuberculous infection and tuberculosis;
6.provide health education to the public;
7.appropriately use preventive therapy;
8.provide quality tuberculosis medical consultation for
9.provide outpatient and inpatient medical care for tuberculosis at
cost to the patient when such care is not available from other
10.rapidly transfer patient information from one jurisdiction to
another when a patient moves;
11.establish and maintain a records system (register) that is
for monitoring and evaluating the tuberculosis problem in the
12.coordinate all state and local tuberculosis control activities.
E.The Federal Government needs:
1.the resources required to carry out its responsibilities; and
2.accurate and timely reports from state and local programs (e.g.,
reports, reports of outbreaks).
The Federal Government has a responsiblity to:
1.establish goals and priorities and publicize guidelines and
2.provide expert medical and program consultation, program
public health education and training, and national morbidity and
3.conduct or support the basic and applied research studies,
developmental work, demonstration projects, and technology
necessary for the development of new technologies for prevention
4.ensure that aliens entering the United States are free of
or potentially infectious tuberculosis;
5.supplement, as necessary, local and state resources to carry out
elimination plan set forth in this document;
6.publicize progress made toward the elimination of tuberculosis in
7.assure that federal programs that provide direct or indirect
services to high-risk populations (e.g., Bureau of Prisons, Indian
Health Service) appropriately screen for and treat tuberculosis
infections and tuberculosis; and
8.direct health-care providers to coordinate patient care with
and local public health authorities.
F.Academic centers need to:
1.compete fairly for federal, state, and foundation funds for
tuberculosis education and research projects.
Academic centers have a responsibility to:
1.provide high-quality educational and tuberculosis control
for their students, staff, and affiliated hospitals;
2.provide high-quality care to tuberculosis patients; and
3.use grant and contract funds to carry out well-designed and
well-executed research studies and disseminate the results.
G.Private enterprise needs:
adequate return for its investments in tuberculosis prevention
Private enterprise has a responsibility to:
1.use its resources to develop more effective methods for
and control of tuberculosis.
H.The American Lung Association and other voluntary/professional
agencies should continue to:
1.be advocates for the appropriation of resources and the enactment
legislation to achieve elimination of tuberculosis;
2.support, and encourage the support of, medical research and pilot
3.provide public, medical, and professional health-worker
4.participate in developing standards for prevention, diagnosis,
5.form coalitions with other organizations to achieve the above
Finally, it is assumed that our society will continue to make
in ensuring that all citizens have access to adequate nutrition,
housing, and medical care.
The Advisory Committee membership is as follows: Dr. William C.
Banton II, Dr. George W. Comstock, Chairman, Dr. James L. Hadler,
Anthony P. Najera, Ms. Carol J. Pozsik, Dr. Robert J. Reza, Dr.
Sbarbaro, Dr. Margaret H.D. Smith, Dr. William W. Stead, Dr.
N. Whitley; Ex officio members: Dr. William A. Robinson (HRSA), Dr.
Darrel D. Gwinn (NIH), Dr. Sotiros D. Chaparas (FDA), Dr. Bruce
(IHS); Liaison members: Mr. Shane McDermott (ALA), Dr. Shirley
(AMA), Dr. Dixie E. Snider, Jr., Executive Secretary.
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