Download The Acquired Immunodeficiency Syndrome (AIDS) and Infection with

POSITION
PAPERS
The Acquired lmmunodeficiency Syndrome (AIDS) and Infection with the
Human lmmunodeficiency Virus (HIV)
HEALTH
AND
INFECTIOUS
PUBLIC
POLICY
DISEASES
SOCIETY
COMMITTEE*,
IN 1986, the American College of Physicians and the Infectious Diseases Society of America jointly published a
policy statement on the acquired immunodeficiency
syndrome (AIDS)
( 1) . The statement that follows expands
and updates the previous one, based on knowledge and
experience gained in the last 2 years, evolution of professional and public attitudes and beliefs, and recognition of
unmet needs. Particular issues emphasized include an explicit acknowledgment
of the ethical imperative to care
for all patients; recognition of the low but definite risk for
transmission of human immunodeficiency
virus (HIV) in
the health care setting and of the need for observation of
universal precautions to minimize this risk; expanded
recommendations
for routine testing of high-risk patients; recognition of the other ethical duties that may
conflict with the need for confidentiality; and recognition
of a national leadership gap in public education and public policy development.
Background
The acquired immunodeficiency
syndrome was first described in the United States in 1981 (2). By the end of
1987, more than 46 000 cases of AIDS were reported
(3), and estimates from the Public Health Service suggest that the total number of cases will reach or even
exceed 270 000 in 199 1 (4, 5). The disease has been reported throughout the world and is particularly prevalent
in central Africa (6).
The lethality of AIDS has been its most impressive and
dismaying feature (7). The mean number of months
from diagnosis to death is less than 24 (8), and more
than 80% of all persons in the United States who have
* This paper was authored by Theodore C. Eickhoff, M.D., and was developed for the Health and Public Policy Committee and the Infectious Diseases Society of America by the Health Promotion Subcommittee: Charles E.
Lewis, M.D., Chairman; Frank M. Calia, M.D.; Edward W. Hook, M.D.;
Willis C. Maddrey, M.D.; Robert H. Rubin, M.D.; Lynn B. Tepley, M.D.
Members of the Health and Public Policy Committee for the 1987/1988
term include Richard G. Farmer, M.D., Chairman; F. Daniel Duffy, M.D.;
Donald L. Feinstein, M.D.: Paul F. Griner. M.D.: Joseph E. Johnson III.
M.D.; Charles E. Lewis, M.D.; C. S. Lewis, Jr., M.D.; Michael A. Nevins,
M.D.; Steven A. Schroeder, M.D.; Quentin D. Young, M.D. Members of the
Council of the Infectious Diseases Society of America for the 1987 to 1988
term include Jack S. Remington, M.D., President; Vincent T. Andriole,
M.D.: Herbert L. DuPont. M.D.: David J. Drutz. M.D.: Pierce Gardner.
M.D.: King K. Holmes, M.D.; Richard B. Hornick, MD; Calvin M. Kunin, M.D.; Robert C. Moellering, Jr., M.D.; Merle A. Sande, M.D.; P. Frederick Sparling, M.D. Principal staff support was provided by Linda Johnson
White. This position paper was adopted by the Council of the Infectious
Diseases Society of America on 28 December 1987 and by the Board of
Regents on 15 January 1988.
I
460
Annals
of Internal
Medicine.
1988;108:460-469.
AMERICAN
OF AMERICA;
COLLEGE
Philadelphia,
OF PHYSICIANS;
and
the
Pennsylvania
been diagnosed as having the disease for 3 years or more
have died (9). One chemotherapeutic
drug, zidovudine
(azidothymidine,
AZT),
has some beneficial effect ( 10,
11) and has been licensed by the Food and Drug Administration (FDA),
but the degree to which this drug and
others currently under study will alter the natural history
of AIDS remains uncertain.
The retrovirus that causes AIDS, the human immunodeficiency virus (HIV), was described in 1983 (12, 13).
It is now clear that there are other human immunodeficiency retroviruses that may occasionally cause less virulent disease, but it is belived that the first such virus identified (HIV- 1) is the cause of most of the cases of AIDS
(14-16).
The first cases of AIDS were described among homosexual men, and a mistaken perception arose that AIDS
is a “gay disease.” This misperception is at the root of
many civil rights issues and societal concerns that have
arisen in relation to HIV-infected
persons. The risk
groups for HIV infection have proved to be remarkably
stable since their delineation by the Centers for Disease
Control in 1982 (17, 18). Approximately
65% have been
homosexual or bisexual men, 8% have been both homosexual or bisexual and intravenous drug abusers, and
16% have been intravenous drug abusers only; others affected include heterosexual contacts of bisexual men and
intravenous drug abusers, infants born to HIV-infected
mothers, and before the introduction of HIV screening
tests, recipients of multiple blood transfusions or blood
components, such as patients with hemophilia. In 3% to
5% of patients with AIDS, no risk factors have been
identified.
The human immunodeficiency
virus has been isolated
from blood, semen, bone marrow, tears, saliva, cervical
secretions, cerebrospinal fluid, brain tissue, lymph node
tissue, urine, and feces. To date, however, the disease is
known to have been transmitted only by sexual contact,
by shared contaminated
needles, by infected blood or
blood products, by infected organ or tissue transplants,
and from mother to infant across the placenta or during
delivery ( 19). There is one case of probable mother-to-infant transmission through infected breast milk (20).
It is important to emphasize that all other human interpersonal behaviors are not believed to transmit HIV
infection ( 19, 21). These behaviors include touching,
talking, sneezing, hand-shaking,
and sharing air space,
eating and drinking utensils and toilets. Nonsexual transmission in household settings has not occurred, except
Q 1988
American
College
of Physicians
when there was additional exposure to contaminated
blood. Donating blood does not transmit HIV infection
to the donor, although many people still believe otherwise. Blood, tissue, and genital secretions are the only
known vehicles of HIV transmission. There is no epidemiologic evidence that insects such as mosquitoes transmit HIV. Similarly, there is no evidence that vaccines or
human globulin preparations transmit HIV infection. All
blood components
prepared since screening was introduced in April 1985 have used seronegative blood only.
The precise number of HIV-infected
persons in the
United States is unknown. Based on screening data from
the military, blood banks, and the geographic prevalence
of AIDS cases, the Centers for Disease Control has estimated that there are now 1.0 to 1.5 million HIV-infected
persons in the country, most of whom are unaware that
they are infected (22).
The natural history of HIV infection has not been
clearly defined. Studies carried out in risk groups known
to have been infected with HIV for 5 or more years suggest that 30% or more develop definite AIDS; 10% to
15% develop AIDS-related conditions such as lymphadenopathy, diarrhea, and wasting; and 10% or more develop chronic neurologic disabilities (23, 24). Furthermore,
the rate of conversion from asymptomatic status to symptomatic AIDS or AIDS-related
complex
has been a
steady 6% to 8% per year in such infected cohorts, suggesting that eventually 60% or more of HIV-infected persons will progress to symptomatic
disease (25, 26). It
must be emphasized, however, that our knowledge of the
natural history of HIV infection is based largely on studies done in homosexual or bisexual men and intravenous
drug abusers and may not accurately predict the experience in heterosexual, nondrug-abusing
populations. Cofactors that may predispose to or promote the development of symptomatic
expression of HIV infection are
largely unknown.
Nonetheless, the estimated 1.0 to 1.5 million HIV-infected persons constitute the reservoir that will likely
yield at least 200 000 new cases of AIDS by 1991 (4).
These estimates are midrange and vary from a low of
150 000 total cases to a high of 700 000 total cases, reflecting differing assumptions about the rate of progression to symptomatic disease.
The projections also take into account some underreporting of AIDS. Some of the underreporting is based
on technical problems, and some is due to a rather narrowly construed case definition of AIDS, which was purposely designed to meet strict criteria of case definition
primarily for epidemiologic
purposes (18). The Centers
for Disease Control has recently revised its surveillance
case definition for AIDS and broadened it so that virtually all cases now believed to represent AIDS or AIDS-related conditions are included (27). This should help to
minimize underreporting in the future, and is estimated
to increase the number of cases reported by 10% to 20%.
The economic impact of AIDS is only beginning to be
appreciated. An early study by Hardy and colleagues of
the first 10 000 patients with AIDS estimated the lifetime
inpatient costs at $147 000 per patient (28). Subsequent
studies indicated that the costs have declined significantly, primarily due to lower rates of hospital utilization.
Current projections suggest a lifetime direct health care
cost of $40 000 to $60 000 per patient (29). Because of
the large number of patients, however, projections of the
total cost per year are striking. Public Health Service
estimates range from a total of $8 to $16 billion per year
by 1991 (4, 30).
Funding for AIDS research has been given high priority, and for this action the federal government is to be
commended. For fiscal year 1988, Congress is expected to
appropriate close to $950 million for AIDS research and
services. These funds will be used for basic research on
HIV, elucidating the pathogenesis and natural history of
HIV infection and HIV-related
illness, epidemiologic
studies, and drug and vaccine development and testing,
including large-scale clinical trials of both vaccines and
antiviral agents, as well as research on long-term therapy.
Although the federal government has taken the lead in
funding AIDS research, the same cannot be said for its
role in public policy development and public education.
With the singular exception of Surgeon General C. Everett Koop, who has spoken out with vigor and candor
(3 1)) the Federal government has failed to take an effective leadership role in public policy development and in
public education, and it appears that the present administration is unable to agree on how best to approach AIDS
public policy issues. Religious and civic organizations
and communications
media that have articulated the
threat of HIV infection and the means of prevention
should be commended for their actions.
Much work needs to be done to address the serious
social, ethical, and public health implications of this catastrophic and ultimately fatal disease. For persons with
HIV infection, these implications include lack of confidentiality, loss of job, ostracism from the community,
denial of insurance, eviction from housing, exclusion of
children from school, refusal of morticians to prepare
bodies for burial, and efforts by hospital unions and even
some health care professionals to exclude persons with
AIDS from medical care. In the absence of effective leadership from the federal government, individual states are
beginning to articulate their own positions and to legislate their own solutions to these issues. Some of these are
appropriate responses, but some of them are misguided,
and in the longer term, counter-productive.
There is a compelling need for a national program emphasizing prevention and coordinated services that can be
managed at the local level. This program should focus on
preventing infection through education
and behavior
modification.
Efforts in primary prevention should include the education of adolescents and young adults regarding the transmission of HIV, the encouragement
of
abstinence or monogamous
sexual relationships,
and
ways to reduce the risk of transmission through use of
condoms and avoidance of shared needles and drug paraphernalia. Secondary prevention for those already infected with HIV should focus on educational efforts to minimize their risk of transmitting the virus to other persons.
The American College of Physicians and the Infectious
Position Papers
461
Diseases Society of America support such educational activities and urge physicians to take a leadership role in
putting an end to the increasing and often unfounded
public anxiety associated with this disease.
the very nature of the patient-physician
relationship,
makes a mockery of our professional heritage, and violates the very essence of being a physician.
Positions
urged to become
2. Physicians
1. The American
College
of Physicians
tious Diseases Society of America
other health care professionals,
ed to provide
including
competent
patients
patients
with
The denial of appropriate
condiunrelated
care to pa-
tients for any reason is unethical.
Physicians who have the primary responsibility for patients’ well-being must provide high-quality,
nonjudgmental care without regard to their own personal risk,
real or perceived. Physicians and nurses alike are charged
by the ethics of their healing profession to treat patients
with all forms of sickness and disease. It is inappropriate
for any health care professional to compromise the treatment of any patient, including those with transmissible,
lethal diseases such as AIDS, on the grounds that such
patients present unacceptable medical risks. This fundamental principle of medical ethics cannot be compromised.
The obligation to provide care to all patients, regardless of personal risk, whether real or perceived, is deeply
rooted in medical history and medical ethics. Observance
of this ethical imperative by the medical profession in the
past, however, has been inconsistent at best (32). Many
physicians are known to have fled from the Black Death
in Europe during the 14th century, and from the Great
Plague of London in the 17th century. Nonetheless, in
the last 100 years, physicians have unhesitatingly cared
for patients whose diseases were known to place them at
personal risk; well-known examples include typhoid fever, yellow fever, tuberculosis, poliomyelitis,
pandemic
influenza, and hepatitis B. Since the advent of antibiotic
agents, however, virtually an entire generation of physicians has grown accustomed to providing patient care in
an environment essentially free of personal risk for serious infectious disease.
A patient-physician relationship is established by a patient choosing a physician and the physician agreeing to
provide care. The physician thereby incurs a moral responsibility to provide the best care possible. If a physician feels inadequate or incapable of providing such care
for established patients in a given circumstance, the physician is ethically bound to refer the patient to a competent colleague who is able and willing to provide such
care (33). Refusal of a physician to care for a specific
category of patients, such as patients who have AIDS or
who are HIV-positive, for any reason, is morally and ethically indefensible.
The practice of medicine is a societal trust and carries
with it a societal responsibility. If medicine wishes to retain its respected status as the healing profession, we
must continue to provide the best possible care to our
patients, regardless of personal risk. To do less threatens
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economic
and to take appropriate
patients and
steps to min-
include the risk of HIV
problems,
are
risks and prob-
in caring for HIV-positive
imize them. Such problems
care to all patients,
and AIDS-related
tions as well as HIV-infected
medical problems.
patients with AIDS
and hospitals are obligat-
care professionals
fully aware of potential
lems encountered
believe that physicians,
and humane
with AIDS
and the Infec-
and other health
and personal
trans-
psychology
stresses.
Epidemiologic
data suggest that the risk of transmission of HIV infection from patients to health care workers is very low, but not zero. Three prospective studies to
determine the risk of documented percutaneous or mucous membrane exposure to blood or body fluids of HIVinfected patients have been carried out in the United
States (34-36).
Of the more than 1300 exposed health
care workers evaluated in these studies, 4 became positive
for HIV antibody; three of the seroconversions occurred
in persons who had no other documented risk factors for
infection. These three seroconversions
occurred
after
needle-stick injuries; no seroconversions
occurred after
approximately 400 mucous membrane exposures. Thus,
the risk of HIV transmission after percutaneous exposure
appears to be on the order of 0.5% ( 19). The risk of
infection with this virus from such exposure is thus very
low, in marked contrast to the risk of hepatitis B virus
infection (6% to 30%) after similar kinds of exposures.
Three cases of apparent HIV transmission to seronegative health care workers through non-needle-stick percutaneous exposure or mucous membrane exposure were
reported in the Spring of 1987 (37). The occurrence of
these three cases reemphasized the importance of regarding all blood and body fluids as potentially infectious.
Guidelines from the Centers for Disease Control (38)
and the American Hospital Association
(39) reemphasize the principle of universal precautions, that is, the use
of gloves for any anticipated direct contact with blood,
mucous membrane, or other body fluids of all patients;
the use of masks when aerosolization of blood-contaminated body fluids is anticipated; and the use of protective
eye-wear when blood splashes are anticipated.
These
guidelines also reemphasize the precautions to be taken
with needles and sharp instruments, the use of equipment
to minimize the need for mouth-to-mouth
resuscitation,
and appropriate sterilization and disinfection procedures.
These kinds of barrier techniques that interrupt the
transmission of blood-borne
infections have been in use
for many years. Although there are no concrete data
about the effectiveness of such barrier techniques in preventing the transmission of HIV, substantial data indicate their effectiveness in preventing transmission of hepatitis B ( 19). Use of barrier techniques has the added
benefits of protecting patients from other kinds of nosocomial infections and protecting health care workers
from other blood-borne
diseases (40). It is self-evident
that, to be effective, universal precautions must be applied in all health care settings, not only hospitals and
3
emergency rooms, but also ambulatory care centers and
physicians’ offices.
Potential economic
problems in caring for patients
with AIDS and HIV infection should be recognized.
Many patients with AIDS, as their diseases progress, lose
their jobs, health insurance coverage, and in some instances, all of their financial assets. Such circumstances
must not be allowed to compromise patient care. That
patient care not be refused because of inability to pay is
another historic principle in medical ethics and must not
be compromised in caring for patients with AIDS (33).
The whole issue of financing the care of patients with
AIDS awaits broad solutions involving a coordinated response of both the public and private sectors (30).
Health care workers may also be reluctant to care for
patients with AIDS because of the stressful psychological
and emotional dimensions. In the long term, these patients do poorly despite optimal care, or they develop
new infections as soon as one is successfully treated. Hospitalizations are often prolonged,
and legitimate questions can be raised about the cost-benefit ratio of procedures that physicians may begin to view as futile. These
patients are typically young and critically ill. Many
health care professionals find it difficult to discuss the
relevant issue of foregoing life-sustaining treatment, such
as intubation or cardiopulmonary
resuscitation,
with
such patients.
The stress of caring for these patients can be alleviated
as the clinically achievable goals of medical therapy are
clearly defined and communicated
both to the patient
and among the staff. Professional support groups, often
interdisciplinary
in nature and composed of physicians
and other professionals involved in caring for patients
with AIDS, have also been very useful in this regard.
When treatment no longer provides therapeutic benefit,
supportive care, including control of pain and other
symptoms of discomfort,
should be provided. Hospice
and nursing home care should be encouraged. Attention
to patients’ needs for supportive care can relieve much
anxiety and reluctance on the part of health care professionals who are caring for patients with AIDS.
3. Elected
ganizations,
prison
fully
leaders, employers,
officials, and school
informed
infection,
semination
lic policy
and
to
housing
service
or-
authorities,
officials are urged to become
educate
and particularly
mechanisms
community
welfare agencies, public
to
others
understand
about
HIV
the limited
by which the virus can be transmitted. Disof such knowledge
development,
those who become
should serve to guide pub-
to alleviate discrimination
infected
against
with the virus, and to limit
the further spread of infection.
Persons in positions of public responsibility such as
those outlined in position 3 must understand the basic
concepts of transmission of HIV and then educate their
constituents accordingly.
Transmission of HIV appears
to require parenteral, open skin, or mucous membrane
contact with contaminated blood or body fluids. Good
evidence shows that even close and prolonged familial
exposure to persons infected with HIV will not transmit
the virus (21). Because HIV appears not to be transmitted by casual contact, there is no justification for restricting social or professional relations with HIV-infected patients when transmission of body fluids is not likely.
Children with HIV infection who attend school or daycare centers may present additional risks for transmission
due to their immaturity and to the uncontrollable nature
of physical contact among children. The Centers for Disease Control, the American Academy of Pediatrics, and
the National Education Association have advocated that
children who lack control over their body secretions or
excretions, who are prone to biting, spitting, or vomiting,
or who have open skin lesions should be placed in a restricted school environment (41, 42). However, school
children with HIV infection who do have control over
bodily functions should be allowed to attend class in a
normal setting. The American College of Physicians and
the Infectious Diseases Society of America support this
policy as one that protects school children without unnecessarily discriminating against all young persons with
HIV infection.
The approach to patient care, employment, housing,
institutionalization,
and education should be based on
knowledge of the actual risks of infection and not on
speculation or unwarranted fears. Thus, the education of
persons in positions of public authority or responsibility
is of paramount importance. Strong leadership from the
Federal government would be a major help toward realization of that goal (43). Once fully informed, persons in
positions of public responsibility will be able to educate
their own constituents, and those likely to come into contact with HIV-infected persons will be able to respond in
a humane fashion without jeopardizing their own health
and safety. This point is particularly important for police,
firemen, emergency medical technicians, and other persons in similar positions.
Social prejudice against HIV-infected persons is a public problem that threatens the very fabric of society and
should evoke concerned responses from all sectors of society. The health care professions have a special responsibility to ensure that such prejudice does not occur in the
health care setting.
4. Testing for HIV
antibody
it will benefit the patient
should be used only when
or contacts
may have been transmitted,
to whom
or for protection
the virus
of the pub-
lic health.
The enzyme immunoassay to detect antibody to HIV
was licensed in March 1985. Because the goal of such
testing was to screen HIV-positive
blood out of the nation’s blood supply, the tests were designed to be as highly sensitive as possible. This purpose has been served, and
transfusion-associated
HIV infection has occurred only
in rare instances of blood donated during the “window”
of time between HIV infection and the appearance of
HIV antibody as detected by enzyme immunoassay (44).
However, the large number of false-positive results from
Position
Papers
463
enzyme immunoassay requires great caution in interpreting positive results in low-risk populations (45).
The sensitivity of the currently licensed enzyme immunoassay tests is at least 99% when they are done under
optimal
laboratory
conditions.
Under these circumstances, the probability of a false-negative test is very low,
except during the first several weeks after infection before
detectable
antibody
is present. A small number of
infected people may not develop detectable antibody for
several months or more after exposure (46); the potential
infectivity of such persons before they have developed
antibody is not known.
The specificity
of the currently
licensed
enzyme
immunoassay test is approximately 99% when repeatably
reactive tests (that is, two consecutive positive tests) are
considered. To increase the specificity even further, a
confirmatory
test, most often the Western blot test, is
used to validate repeated reactive enzyme immunoassay
results. The Western blot test is highly specific when
strict criteria are used to interpret the test results.
Thus, the full testing sequence consists of repeatably
reactive enzyme immunoassay tests, coupled with a positive confirmatory
Western blot test. This testing sequence, if positive, is highly predictive of HIV infection,
even in a population with a low prevalence of infection.
In contrast, the predictive value of even repeatably reactive enzyme immunoassay tests alone, without confirmatory Western blot testing, in a population with an HIV
prevalence of 0.2%, is little better than 28%. As the
prevalence of infection in the population under study increases, the predictive value of repeatably reactive enzyme immunoassay tests alone increases to 98% in a population with an HIV prevalence of 20%. The point to be
emphasized, however, is that in a low-risk population,
with a prevalence of HIV infection of less than 0.5%,
fully half or more of all repeatably reactive enzyme immunoassay tests will represent falsely positive tests. The
more specific Western blot testing is, therefore, crucial to
identify true HIV infection. It is important to understand
the sensitivity and specificity of the currently available
tests when considering issues of HIV testing and population screening, and when notifying patients of positive
test results. A patient should not be considered infected,
nor informed of a positive test result until the full test
sequence, including the Western blot test, is completed
and confirmed to be positive.
A new generation of diagnostic tests that will have significant impact is under development (47-49). The new
tests may minimize the problem of false-positive enzymeimmunoassay tests, perhaps to provide prognostic information unavailable with current tests, and to detect HIV
antigen during the period between infection and development of antibody. We encourage the rapid development
and introduction of tests that show improved performance.
There are many possible reasons for testing, but the
overriding reason is to enable physicians to provide counseling directed at behavior change in seropositive persons
to prevent transmission of the virus. Other justifiable reasons for testing include medical diagnosis, therapeutic de464
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cision-making,
reassurance for worried healthy persons,
and large-scale anonymous testing to define the extent of
asymptomatic HIV infection in the population (22).
Three levels of testing should be clearly distinguished;
these are mandatory testing, routine testing, and voluntary testing.
Mandatory testing is the testing of certain individuals
or groups specified by law or regulation. In the United
States, all military personnel are now required to be tested. Regulations are being developed for mandatory testing of federal prisoners and immigrants. There is uniform
testing of blood donors, and donors of organs, tissue, and
semen. The American College of Physicians and the Infectious Diseases Society of America support these existing testing programs, but we do not believe that further
expansion of mandatory testing in low-risk populations is
appropriate. Because of strong evidence that HIV cannot
be transmitted by casual contact, it is not in the public
interest to require the testing of persons whose social or
sexual lifestyles render them unlikely to have been exposed to the virus. Thus, we believe that it is inappropriate to require health care employees, food service workers, or personal service workers such as barbers or manicurists to be tested serologically for HIV infection as a
condition of employment. Similarly, widespread mandatory premarital testing is unlikely to be cost-effective, and
we believe it is inappropriate.
Mandatory testing of high-risk populations might seem
appropriate; it is widely believed, however, that such an
approach would only drive potentially HIV-infected persons away from the health care system. We do not, therefore, believe that increased mandatory testing would be
productive.
Routine testing is the testing of certain individuals or
groups recommended
by health care providers and consented to by the person to be tested after counseling. We
believe that such routine testing should be increasingly
recommended, particularly in populations known to be at
higher than baseline risk (22). Specific examples might
include persons who may have sexually transmitted diseases, intravenous drug abusers, persons who identify
themselves as at risk, women of childbearing age with
identifiable risks for HIV infection, persons who received
blood transfusions between 1978 and April 1985, and
persons planning marriage in which one or both partners
may be at increased risk. Testing for diagnostic purposes
should be encouraged
in persons undergoing medical
evaluation with selected clinical signs and symptoms
such as generalized lymphadenopathy;
unexplained dementia; chronic unexplained fever, diarrhea, or weight
loss; or with diseases such as tuberculosis. Testing is also
useful in many instances to aid in therapeutic and management decisions.
We do not believe that all persons admitted to hospitals should be tested on a mandatory or routine basis. We
do support, however, the concept of increased routine
testing for HIV antibody in high-risk populations. It may
be appropriate, therefore, for hospitals in certain geographic, high-prevalence areas to consider routine testing
3
of selected subpopulations shown to have an increased
prevalence of HIV infection.
Routine testing for HIV antibody in any health care
setting raises a number of significant concerns, all of
which must be addressed. First, the patient must be appropriately informed of the potential consequences
of
testing before being asked to give consent to be tested.
Second, testing must be inextricably linked to and accompanied by appropriate counseling for confirmed seropositive patients, provided
by properly
trained persons.
Third, care must not in any way be conditional on consenting to be tested or on the results of the test; in other
words, care must be provided in a nondiscriminatory
fashion. Finally, confidentiality
safeguards must be in
place to limit knowledge of the test results to those directly involved in the care of infected patients, to contacts
who may have been exposed, or as required by law or
regulation. Confidentiality
and antidiscrimination
measures should, in fact, be guaranteed by law.
Voluntary testing, which is defined as a person wishing
to be tested for HIV infection, should be made available
to any such persons, including health care professionals.
Some health care professionals have advocated serologic testing of patients when exposure to large amounts of
patients’ blood may be anticipated. Specific examples include those patients having major operative procedures
and those being treated in critical care units, especially if
there is uncontrolled bleeding (38, 40). Decisions about
the desirability of establishing such testing programs
should be made by individual institutions, with physician
input, and testing may be done if the patient consents. If
such testing programs are carried out, however, negative
test results must not be allowed to convey a false sense of
security, because the enzyme immunoassay test will not
be positive during the incubation period of HIV infection.
It is important to reemphasize that identification of
HIV-infected patients in the health care setting must not
result in denial of needed care or in the provision of suboptimal care. Adherence to universal blood and body fluid precautions, recommended for the care of all patients,
will minimize the risk of HIV transmission from patients
to health care personnel. The added benefit to universal
precautions of knowing a patient’s HIV status if any, is
unknown, and in any case, such information is not likely
to be available in emergency or outpatient settings.
Health care workers who sustain accidental percutaneous puncture or direct mucous membrane exposure to
blood or body fluids from a known patient source present
an ethical dilemma if the patient refuses to consent to an
HIV-antibody
test; the accidentally exposed health worker has a legitimate interest in the HIV-antibody
status of
the source patient. A few states have enacted legislation
that permits an HIV test to be done without individual
informed consent in such situations; some hospitals in
states in which individual informed consent is not mandated have incorporated
into their general consent for
admission and treatment a provision indicating that, in
the case of accidental exposure, the patient’s blood may
be tested for both hepatitis B and HIV infection. The
American College of Physicians and the Infectious Dis-
eases Society of America believe that, in situations of accidental exposure (with formal documentation
of the incident), the patient’s’ blood may ethically be tested for
HIV infection without individual informed consent; the
patient should, of course, be counseled and informed.
Transmission of HIV from infected health care professionals to patients has not been reported but is a theoretical possibility. Transmission
of hepatitis B virus from
health care professionals to patients has been documented in rare situations in which the involved health care
professionals had very high concentrations of hepatitis B
virus in their blood (much higher than those that occur
with HIV infection)
(50, 5 1). Additionally,
the health
care professionals sustained deep puncture wounds while
doing invasive procedures or had exudative lesions that
allowed the virus to contaminate instruments or open
wounds of patients.
Since transmission of HIV from infected health care
professionals doing invasive procedures to their patients
has not been reported and would be expected to occur
only rarely, if at all, the American College of Physicians
and the Infectious Diseases Society of America do not
recommend routine testing of health care professionals to
prevent transmission of HIV. The observance of universal blood and body fluid precautions by HIV-positive
health care professionals, including physicians, will serve
to further minimize any risk of transmission of HIV to
patients. The same principle of confidentiality applies just
as much to HIV-infected
health care workers as to any
other person. We believe that HIV-infected physicians, if
otherwise able to care for patients (for example, do not
have evidence of cognitive impairment due to brain infection), present virtually no risk of HIV transmission to
their patients.
5. Counseling and educational efforts, rather than policies promoting physical restriction or quarantine, are appropriate methods for controlling the spread of HIV infection.
Individual counseling and public education about the
ways in which HIV infection can be transmitted are appropriate ways to control its spread. The behaviors that
are known to transmit the virus, such as sexual contact
and the sharing of intravenous needles, are usually consensual and voluntary, and many persons can be persuaded to change their behavior if adequately informed and
counseled. Effective health education regarding the hazards of engaging in high-risk activities is at present the
single most important approach to controlling the epidemic spread of this disease. Public education requires
leadership at the local, state, and federal levels. Individual counseling is clearly the responsibility of health care
professionals. For that reason, it is important to reemphasize that testing and appropriate counseling must always be directly linked. In addition to describing behaviors known to minimize risks of transmission, counseling
of HIV-positive patients must also outline behaviors that
present no risk of transmission, including normal interPosition Papers
465
personal, social, and professional or occupational behavior.
The quarantine of persons with AIDS or persons who
have been exposed to HIV and presumed capable of
transmitting the virus, is an invasion of individual liberty
and privacy. Such a policy would, in all likelihood, result
in the nonreporting of many AIDS cases, and the loss of
cooperation of risk-group members that is critical to further understanding of HIV-related diseases. Quarantine
has been advocated in some states for the very small
number of persons with HIV infection who persistently
refuse to curtail sexual activity or the sharing of intravenous needles, or who otherwise persist in behavior that
poses the risk of transmission to others. Although such a
policy may occasionally be effective in preventing transmission in specific situations, it certainly cannot effectively control a virus that is frequently transmitted by persons who are unaware that they are carriers. The judicial
system will ultimately decide whether persistent behavior
by a person known to be HIV-infected
that exposes another to the risk of HIV transmission represents a criminal offense. Such proceedings in this hitherto unknown
area of law have already begun.
6. The confidentiality
should
be protected
of patients
infected
with HIV
to the greatest extent possible,
sistent with the duty to protect
con-
others and to protect
the
public health.
Health care professionals
caring for patients with
AIDS and testing persons for antibody to HIV should be
sensitive to the individual patient’s needs for confidentiality and to his or her right to privacy. Patients with AIDS
risk societal ostracism, and in many cases, loss of jobs
and housing if their disease is known. Homosexuals and
intravenous drug abusers believed to have infectious diseases may evoke condemnation of their lifestyle by others
and may find themselves discriminated against and socially isolated.
Great public misunderstanding
about the significance
and predictive value of the HIV-antibody
test remains.
The scientific community generally accepts that persons
whose results are reproducibly
seropositive,
and confirmed by a Western blot test, have been infected with
HIV, those persons are also believed to be infectious.. The
test does not predict, however, which infected persons are
at risk for developing AIDS or other clinical diseases
caused by the virus. The potential discriminatory impact
of public knowledge of a person’s HIV seropositivity is,
therefore, enormous. Thus, the American College of Physicians and the Infectious Diseases Society of America
believe that physicians and hospitals have the obligation
to maintain confidentiality of their medical records and
not disclose information to outside sources without the
patient’s consent.
There are, however, situations in which the health and
welfare of other persons may take precedence over the
duty to maintain confidentiality (33, 52, 53). There is a
concurrent duty to warn or to inform, and this duty extends to present or recent sexual contacts, to persons with
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whom an HIV-positive
person has shared intravenous
needles, and to any other persons who are likely to have
had contact with the infected person’s blood or body fluids. In many instances, HIV-infected patients will recognize the responsibility
to inform their sexual or other
contacts and will do so voluntarily. Indeed, counseling
should reinforce the concept that the HIV-infected
patient is obligated to inform his or her contacts. If the
HIV-infected
patient refuses to inform others, however,
the physician must consider his or her responsibility to
protect the health and welfare of the patient’s spouse or
other contacts. Clear guidelines on this sensitive issue do
not exist, but it is clear that, under some circumstances,
the duty to inform will take precedence over the duty to
protect confidentiality. In some jurisdictions in which reporting positive tests for HIV antibodies is mandated by
law, public health authorities will assume this responsibility; in these instances, the physician’s responsibility is
discharged by appropriate reporting to the relevant public health jurisdiction.
When a physician acts in good
faith under the law to disclose test results for the protection of contacts, he or she should be protected against
legal challenge by the seropositive person.
A number of state health authorities now require reporting of confirmed HIV seropositive tests, and other
state health authorities as well as the Centers for Disease
Control are moving in this direction. The American College of Physicians and the Infectious Diseases Society of
America
support such reporting to local authorities.
Disease reporting for public health purposes is well established in American public health and has included infection and disease surveillance; identification of at-risk persons in populations;
epidemiologic
analysis by time,
place, and person; intervention strategies appropriate to
the epidemiologic
pattern of transmission; health education; skillful contact tracing in selected circumstances;
and utmost care in the confidential management of sensitive information.
These established public health techniques should prove useful in limiting HIV infection, but
a major expansion of resources in most public health departments for these activities will be necessary to accomplish the goals.
Insurance carriers have, for obvious reasons, great interest in the results of HIV tests of persons they insure or
are considering insuring, whether for health insurance or
life insurance. We recognize the economic implications of
AIDS for the insurance industry. Insurance carriers may
have legitimate interests in the HIV-antibody
status of
persons applying for life insurance, particularly in highrisk geographic areas of the country, and if they are single men between the ages 20 and 40, for example, and are
seeking insurance for large sums. Confidentiality
concerns within the insurance industry must be adequately
addressed, particularly in instances of employee group
insurance, either for health or life insurance. Access to
HIV-seropositivity
data in insurance industry data banks
must be carefully controlled. The issue of health insurance is somewhat more complicated, and its ultimate resolution depends heavily on decisions yet to be made on
how the enormous health care cost of AIDS is to be paid.
3
One suggested approach is to treat HIV-positive persons
as a shared risk pool, with all health insurance carriers as
well as the federal, state, and local governments participating in the coverage of that pool (30). Reported instances of health care insurers revoking coverage after
learning that an insuree was HIV-positive are deplorable.
Health care insurers have an obligation to continue coverage to persons already insured.
7. Physicians should incorporate into their practices
standard procedures for taking complete sexual histories
of their patients and should assume responsibility for
candid communication with and education of persons
known to be at risk for HIV infection. The need to modify sexual practices to prevent transmission of infection
should be stressed. In addition, physicians are urged to
take a major part in educating the public to eliminate
misconceptions about AIDS.
AIDS represents a prime example of the hazards of a
health information gap, as evidenced by the unprecedented (in recent times) public and professional
anxiety
toward a disease. In earlier years, some appropriate apprehensions were aired because many important facts
about the disease were unknown.
In 1988, however,
many of the previously
unanswered
questions about
AIDS have been answered, and it is incumbent on physicians to provide this information to their patients in a
timely and accurate manner. Because of the complex nature of the disease and the regular emergence of new information, physicians must make special efforts to keep
well informed, even if they do not have patients with
AIDS or AIDS-related
conditions in their practice. Important areas to consider include an understanding of the
basic concepts of infection transmission in general; the
nature of HIV transmission; the significance of a positive
test for HIV antibody; and the guidelines for risk reduction, including the concepts of “safe sex,” that currently
are being promoted within risk groups (31, 54).
Physicians are often reluctant to discuss the sexual
preferences and practices of their patients. However,
AIDS, as a predominantly
sexually transmitted disease,
now emphasizes the importance of learning the sexual
history of patients, particularly new patients. To be less
than explicit with patients at risk for AIDS and to avoid
discussing the consequences of their behavior is to neglect
seriously the physician’s responsibility
to educate patients. The infectious nature of the disease, its causes, and
the steps to be taken to prevent transmission must be
discussed candidly with each patient known or suspected
to be at risk regardless of how the physician views the
subject.
Guidelines on “safe sex” are widely available, particularly within risk groups. These guidelines generally encourage the following:
1. Avoidance of sexual contact with persons suspected
of having AIDS or a positive HIV-antibody
test.
2. Avoidance of receptive anal intercourse.
3. Avoidance
of sexual contacts with multiple partners.
4. Avoidance of sexual contact with people who use
intravenous drugs.
5. The use of condoms during sexual intercourse.
6. Avoidance
of oral-genital
contact
and openmouthed, intimate kissing.
These guidelines are reasonable and sensible, and are
believed, but not generally proven, to minimize the risk
for HIV transmission (55, 56). It should be noted, however, that the use of condoms
during intercourse is
known to reduce but not totally eliminate the risk of HIV
transmission (57, 58). “Safe sex” is certainly safer sex,
but it is not wholly free of risk.
Further guidelines recommend that any man who has
had sex with another man since 1977 should not donate
blood, plasma, body organs, other tissue, or sperm (59).
In addition, seropositive women should not breast-feed
their babies. Other precautions include advising persons
against practices such as being shaved or tattooed or having their ears pierced in places where proper sterilization
of equipment is not assured.
The very title “doctor,”
from the Latin docere, to
teach, implies a responsibility to share knowledge and
information. Physicians must be explicit with their patients about AIDS.
Proper education
regarding the
known risks of contracting or transmitting infection is
the responsibility of the physician, not only for his or her
patients, but also for the persons with whom that patient
may have contact.
In addition to individual patient education, physicians
are encouraged to offer their services to public educational activities so that accurate information can be provided.
Examples of such activities include community forums,
public service announcements on television and radio, the
production of brochures and other written materials, and
telephone hotlines. It is particularly important to inform
adolescents and young adults before they begin sexual
activity about HIV and its transmission, and ways to
minimize risks.
As the number of persons with AIDS continues to
grow, biomedical researchers will receive further encouragement to bring a scientific solution to this problem.
The concerns of society for the means of controlling the
spread of the virus will probably increase as well. If so,
there will be a growth in the prevalence of proposals for
inappropriate
testing and restrictions
of individuals’
rights. During this period, well-informed physicians will
be in a key position to prevent irrational societal responses, to comfort those most concerned,
and to care for
those infected with the AIDS virus.
8. The American College of Physicians and the Infectious Diseases Society of America encourage continued
research into the causes, prevention, and treatment of
AIDS and AIDS-related conditions. In addition to biomedical aspects, research into psychosocial and economic
issues related to AIDS shouId be increased. Studies of the
effectiveness of various types of educational interventions
on behavior modification are critically important.
Position
Papers
467
The explosive growth in knowledge about AIDS, its
clinical manifestations and natural history, about HIV
infection and its natural history, and about the virus itself
in the past 7 years is nothing short of astonishing. The
virus has been identified and its molecular structure and
function are known, at least in part. Many of its genes
have been cloned and inserted into other expression vectors to define function and to facilitate vaccine development. A new generation of diagnostic tests is under development, including a test for HIV antigen, and is expected
to appear in the next several years. These new tests
should diminish the problem of false-positive results and
perhaps yield prognostic
information.
An enormous
amount of information has been collected and published
relating to the disease itself and to its many manifestations. Epidemiologic studies have defined major routes of
transmission and the natural history of HIV infection is
known, although not yet with great precision. Knowledge
gained about HIV infection will have profound application in human biology, specifically with regard to human
retroviruses and oncogenesis. The response of the biomedical research community to the challenge of AIDS,
and the leadership roles of the National Institutes of
Health and the Centers for Disease Control, should be
acknowledged
and commended.
All of this new knowledge notwithstanding, it is apparent that most of the task
remains to be completed, and that considerable research
must yet be done before this disease is fully understood
and controlled.
Highest priority should be given to prevention, that is,
steps to minimize further spread of HIV infection in the
uninfected population. Educational efforts and vaccine
development are presently the most promising avenues
toward that goal. Thus, a major effort is needed to develop and evaluate educational and marketing techniques
that will result in behavioral modification
to diminish
high-risk behavior and thus limit the spread of HIV infection in the community. Particularly important are the
development of techniques for promoting safer sexual
practices and for limiting illicit drug-related activities,
particularly among adolescents, young adults, and hardto-reach minority populations.
Several candidate vaccines are under development, and
one is undergoing phase 1 clinical trial. Field trials of
potential HIV vaccines present difficult technical as well
as social and ethical problems, but nonetheless must be
carried out. Although there has been rapid progress in
the development of potential vaccine candidates, most
authorities believe that an effective HIV vaccine is still at
least 10 years away.
The second priority is to develop an efficient and responsive system to provide care to all patients with
AIDS. A major research effort is needed to explore all
aspects of the care of patients with AIDS, not just the
purely clinical care of the hospitalized
patient with
AIDS. Long-term efforts to understand and favorably influence the sociologic, psychiatric, and economic consequences of AIDS and AIDS-related illness are also needed. The emphasis should be on out-of-hospital
care that
maintains the patient with AIDS as a productive person
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within the community for as long as possible and then
provides a supportive environment with an emphasis on
comfort and human dignity when productivity is no longer possible. By necessity, there must be both increased
public and private sector funding to provide social and
home services, housing, hospice care, and continuing
health care to persons with AIDS. In addition, efforts to
evaluate the most effective means of accomplishing
these
tasks must be carried out.
The third priority is improved therapy for patients
with AIDS. Although substantial strides have been made
in the development of effective chemotherapy, and zidovudine (AZT)
has now been released, the development
of more effective and safer chemotherapeutic
agents remains a major priority. The optimal time in the course of
HIV infection and development of AIDS at which to begin chemotherapy must be clearly defined. Similarly, improved therapies for the many opportunistic
infections
that occur in patients with AIDS, and therapies that can
safely and effectively be provided on an ambulatory basis
or in the home need to be developed and evaluated.
Medical schools, postgraduate training programs, and
continuing medical education programs are challenged to
educate present and future physicians to care for patients
who have HIV infection and AIDS with compassion, understanding, and a thorough knowledge base. Sexual history taking and counseling must be given major emphasis.
The charge to all of us, then, is clear. Continued study
of all aspects of AIDS and HIV infection is necessary if
this disease is to be controlled. Support from both the
public and private sectors is needed for basic and applied
research, health services research and delivery, and education. Federal, state, and municipal governments are encouraged to fill the existing leadership gaps in this area,
so that persons in positions of public responsibility at all
levels of government may effectively educate their constituents. The American College of Physicians and the
Infectious Diseases Society of America recognize that the
resources and skills of all segments of our society will be
required if the plague of AIDS is to be controlled. Such
an effort will require the investment of billions of dollars
and the expertise of many disciplines. To do less, however, will risk catastrophic consequences for society.
b Requests
for reprints should be addressed to Linda Johnson White, Director; Department of ScientificPolicy, American College of Physicians, 4200
Pine Street; Philadelphia, PA 19104.
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Position Papers
469