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FILE No. 676 06/29 '95 18:35 ID:AMER ACADEMY PEDS.
1 202 393 6137
PAGE 2
American
Academy of
Pediatrics
June 26, 1995
PEDIATRIC
Department of Government
Representative Thomas J. Bliley Jr.
Lialson
U.S. House of Representatives
American Academy of Pediatrics
The Homer Building
2241 Rayburn House Office Building
801 Thirteenth Street, NW
Washington, DC 20515
Suite 400 North
Washington, DC 20005
202/347-8600
Dear Representative Bliley:
800/336-5475
Fax 202/393-6137
The American Academy of Pediatrics (AAP) was pleased to testify on May 11, 1995,
before the Subcommittee on Health and Environment on HIV testing of women and
infants. This is an extraordinarily complex and passionate debate -- one that has been
discussed extensively by the membership and leadership of our national organization,
which represents over 48,000 physicians. As Congress further contemplates this issue, it
is essential they understand the medical, as well as the social and behavioral components
of any legislative action.
The HIV/AIDS epidemic is increasing in women of childbearing age and spreading
beyond previously defined risk groups and geographic areas. This increase has been
reflected by a similar increase in children.
President
George D. Comerci, MD
There are now clear medical benefits of knowing the HIV status of pregnant women and
Vice President
newborns. Treatments are currently available to significantly reduce the HIV
Maurice E. Keenan, MD
transmission from mother to infant (zidovudine/AZT.) In fact, the study results which
Past President
Betty A. Lowe, MD
documented the value of AZT in pregnancy can save up to 1000 lives annually and
Executive Director
represents the most important medical breakthrough in recent years. In addition, the lives
Joe M. Sanders, Jr. MD
of the small percentage of infants not protected by the AZT treatment can be prolonged
infants by initiating medical care within the first months of life in order to reduce
Board of Directors
infections such as pneumocystis carinii pneumonia (PCP).
Gilbert L. Fuld, MD
Koono, Now I lampshire
It is essential that Members of Congress understand that both AZT and PCP medical
Louis Z. Cooper, MD
New York, New York
treatments for women and children require intensive, daily/regular. and prolonged
Susan Aronson, MD
dosages of medication. Compliance with medical care is likely to be greatest when the
Narberth, Pennsylvania
patient is fully informed and feels she has made an educated judgment regarding HIV
Joseph R. Zanga, MD
testing for herself or her infant. A relationship of respect and trust between women and
Richmond. Virginia
the health care system is critically important to the identification of women and infants
Robert E Hannemann, MD
who are IIIV-infected and their subsequent care and treatment.
Latayette Indiana
Hiomas F Tonniges, MD
Hastings. Nebraska
To comprehensively and compassionately address HIV infection in women and
Cardon Johnston, MD
infants, it is recommended that all pregnant women receive HIV education and
Birmingham. Alabama
counseling and that they be routinely tested with consent, as part of their part of
Donald E. Cook, MD
their prenatal care. For newborns whose mother's HIV status is unknown at
Greeley, Colorado
birth, it is recommended that they be tested with the consent of their mother.
Leonard A. Kulmk, MD
San Diego, California
FILE No. 676 06/29 '95 18:35 ID:AMER.ACADEMY PEDS.
1 202 393 6137
PAGE 3
Testing programs must be confidential, voluntary and accompanied by cultural and ethnically
appropriate information regarding HIV infection.
We support utilization of consent procedures that facilitate rapid incorporation of HIV education
and testing for women, and infants in the routine medical care setting. Consent may be obtained
in a variety of ways and may include documented patient education, with testing to take place
unless rejected in writing by the patient.
We caution Congress against imposing unrealistic and negative restrictions on women and infants.
We ask that you consider these recommendations as the debate over HIV testing continues in
Congress.
Sincerely,
Aleorge Comerci, MD
George D. Comerci, MD
President
F
TO:
Hillary Rodham Clinton
FROM:
Jennifer Klein
J.K.
DATE:
6/5/95
RE:
Letter to Editor on HIV Testing
The 25% that Dr. Arons refers to is the actual rate of transmission from mother to
child. If a woman is HIV positive, there is a 25% chance that her baby will be infected.
However, almost all babies born to HIV positive mothers test positive at birth because they
still have maternal antibodies. Therefore, the initial result is not an accurate test of the HIV
status of the baby.
The sentence that you underlined seems to suggest that all states or health care
providers be required to offer HIV counseling and testing. The American College of
Obstetrics and Gynecology will release guidelines in September that make voluntary
counseling and testing the "standard of care" for all pregnant women. This, according to
physicians, will effectively serve as a mandate because doctors fear that they will be held
libel in a malpractice suit if they do not follow professional guidelines.
cc:
Maggie Williams
TO:
Hillary Rodham Clinton
FROM:
Jennifer Klein J.K.
DATE:
6/28/95
RE:
HIV Testing of Pregnant Women and Newborns
Attached please find a memo from Patsy Fleming about the Coburn amendment that
we discussed yesterday. I wanted to highlight two things. First, Patsy notes that the Public
Health Service meeting on July 11 and 12 is expected to address "what policies are
appropriate when neither the mother nor the newborn has been tested voluntarily." Second,
the attached letter from the National Governors Association (NGA) points out that the
Coburn amendment is overly broad given the geographic concentration of AIDS.
According to the NGA, between 1993 and 1994, 63% of all pediatric AIDS cases occurred
in only three states; 89% of cases occurred in 15 states.
These two facts give us a solid foundation for pursuing mandatory testing of
newborns in "high risk" areas. Jeff Levi in our AIDS office agrees that this is an accepted
public health approach. We are working together to develop a strategy.
govl
cc:
Melanne Verveer
PHOTOCOPY
HRC HANDWRITING
CLINTON LIBRARY PHOTOCOPY
F y1
ARC
MAGGE
to len
bia Ignores
The Harm Infant H.I.V. Testing Can Do
es by Military
To the Editor:
Because the H.I.V. test at birth iden-
Re "AIDS Babies Deserve Help,
tifies maternal antibodies in the in-
Editor:
Now" (editorial, June 25) The Ack-
fant, the result would be a profile of
"Colombia Marvels at Drug
erman-Coburn plan you endorse
the mother's H.I.V. status. The pro-
pin: A Chain-Saw Killer, Too?"
would make AIDS funding to states
cess would thus amount to mandatory
vs article, June 21) You miss a
THE NEW YORK
contingent on human immunodefi-
testing of all mothers in two stages. If
point when you turn to Henry
ciency virus testing of all babies
aiza Ceballos's role with the army
they hadn't volunteered during preg-
whose mothers have not accepted
nd police in what has become
nancy, the result would be obtained
voluntary testing during pregnancy.
known as the Trujillo massacre, the
through their infant surrogate.
This would force states to choose
murder of 107 people in 1990.
Even without prenatal AZT, only
between violating the rights of preg-
These officers were- "corrupt."
about 25 percent of infants testing
nant and newly delivered women, or
But Maj. Alirio Urueña, who witness-
H.I.V. positive are truly infected.
losing funds for the majority of indi-
es say dismembered his victims with
Does that justify overriding the right
viduals with H.I.V.-AIDS who are not
a chain saw, was also a decorated
to informed consent for the remain
directly involved in this controversy.
officer promoted after the killings.
ing women who declined testing?
Far from "shocking" the Govern-
Using AZT, the perinatal transmis-
ment, the behavior of Major Urueña
sion rate has been reduced to &per-
Talk Radio's Roots
and his men was covered up until
cent. Thus, a better case can be made
international pressure marshaled by
to require testing of all pregnant
Colombian human rights groups
To the Editor:
women. Unfortunately, involuntary
forced authorities to agree to a com-
The Freedom of Speech Award to
testing could further cause women
mission to restudy the Trujillo case.
G. Gordon Liddy at the radio talk
hesitant to interact with the system
Only after this commission deliv-
show hosts convention should be con-
to avoid prenatal care altogetheric
ered its findings was Mr. Urueña
sidered an aberration (Chronicle,
It would be more constructive\to
dismissed.
June 26). For every Liddy on the far
mandate that every pregnant werm-
For the courts, it is far easier
right and every leftish host, there are
an be offered voluntary H.I.V. testing
to grasp the Scorpion for drug-traf-
hundreds of radio talkers who voice
with the assurance that if positive,
ficking than Mr. Urueña, shielded by
no political bent but who host pro-
she and her family would be entitled
an institutionalized esprit de corps
grams of community service and
to comprehensive medical, nutrition-
that defends even forced disappear-
sage advice. They are on 500-watt
al and social services before, during
ance - a secret arrest usually fol-
small-town stations as well as boom-
and after birth.
Not
lowed by execution - as an "act
ers, networks and syndicate.
Women are more likely to accept
of service." Until Colombia inves-
Talk radio started as "neighbor-
testing when persuaded that society
tigates, prosecutes and punishes
ing" in Iowa in the 1920's. Despite the
cares about them, rather than adis-
crimes committed by its own, cases
current in-your-face fad, honest con-
playing a punitive attitude that deval-
like Trujillo will remain the rule, not
tent remains a grass-roots ingredi-
ues the mother in the name of sawing
the exception.
ROBIN KIRK
ent of talk radio. ANNIE BREWER
the baby.
PAUL ARONS, MiD.
Research Associate
Dearborn, Mich., June 26, 1995
Medical Director, Leon County
Human Rights Watch-Americas
The writer edits Talk Shows and
Public Health Unit
Washington, June 21, 1995
Hosts on Radio, an annual directory.
Tallahassee, Fla., June 26, 1995
Even Before Medicare Cuts, Health Care System Has Changed
To the Editor:
(since these haven't occurred), but by
to beneficiaries - we should pay
Re your June 26 front-page news
dramatic changes in the purchasing
much closer attention to the changes
analysis on changes in the health
behavior of private employers, whose
that have occurred in response to the
care system as a byproduct of budg-
spending for employee coverage ac-
slowdown in private spending.
2011
et cutting: The important point you
counts for most of the remaining two-
In part because for two years all
make is that while the proposed
thirds of health care spending.
eyes were on the health care reform
slowdown in Medicare and Medicaid
Beginning in the late 1980's, large
debate in Washington, many of us
spending, which accounts for almost
private employers, looking to in-
have missed what's going on in our
one-third of total health care spend-
crease productivity and streamline
own backyards. PAUL S. JELLINEK
ing in this country, will probably
production costs (which include em-
Princeton, N.J., June 26, 1995
have a major impact on our health
ployee benefits), began aggressively
The writer is a vice president of the
care system, nobody is sure yet just
exercising their purchasing power in
Robert Wood Johnson Foundation,,
how that impact will play out.
the health insurance market, forcing
The point you miss is that the train
down premium costs and triggering
has already left the station. Profound
a transformation of the health care
Detention Under Study
delivery system into a bewildering
HRC HANDWRITING
PHOTOCOPY
changes in our health care system
are already under way, precipitated
array of new provider networks.
To the Editor:
not by changes in government policy
If we want to get some idea of how
Re "The Lessons of Esmor" (edito-
the proposed slowdown in Medicare
rial, June 21): You believe that the
and Medicaid spending might play
Attorney General should appointsa
Illegal Parkers
out - and how to minimize the risk
commission to study the Immigration
and Naturalization Service's deten-
To the Editor:
tion policies. Congress has already
Re Joyce Purnick's June 22 col-
done so; addressing detention "and
umn on illegal parking in New York
NYT)
removal policies are part of this com-
City: Doctors and reporters are lim-
mission's comprehensive mandate?
ited to parking at specially marked
In our first report to Congress
areas during working hours only. In
The New York Times
year "U.S. Immigration Policy
my neighborhood all the unticketed,
Company
storing Credibility," the bipartisan
illegally parked cars belong to police
United States Commission on Immi-
officers and judges: the people
229 West 43d St., N.Y. 10036
gration Reform recommended more
charged with enforcing the law.
effective policies for the removaliof
ARTHUR OCHS SULZBERGER. Chairman
Of course, they may not have
and Chief Executive Officer
criminal aliens. We are undertaking
Health and Hospitals Commissioner
LANCE R. PRIMIS. President
a review of other issues relatedvio
Maria Mitchell's connections and
LAURA J CORWIN Secretary
deportation, including detention of
have parking tickets dismissed (news
KATHARINE P. DARROW, Senior Vice President
aliens. The report will be available
article, June 25). This arrogance of
DAVID L. GORHAM, Senior Vice President
this year.
SUSAN MARTIN
power needs to be further investigat-
and Chief Financial Officer
Executive Director, United States
ed.
THOMAS L. FABRY, M.D.
RICHARD G. THOMAS, Treasurer
Commission on Immigration Reform
New York, June 26, 1995
Washington, June 23, 1995
CLINTON LIBRARY PHOTOCOPY
TO
94566244
P.01
JUN-27-1995 18:29 FROM WHITE HOUSE AIDS POLICY
OFFICE OF NATIONAL AIDS POLICY
EXECUTIVE OFFICE OF THE PRESIDENT
750 17th Street, N.W.
Washington, DC 20503
Phone: 202-632-1090
Fax: 202-632-1096
FACSIMILE COVER SHEET
TO: The First Lady
FAX NUMBER: 456-6244
FROM: Patricia Fleming
DATE: June 27, 1995
PAGES INCLUDING COVER SHEET:
COMMENTS:
JUN-27-1995 18:29 FROM WHITE HOUSE HIDS POLICY
TO
THE WHITE HOUSE
WASHINGTON
June 27, 1995
MEMORANDUM FOR LEON PANETTA
FROM:
Patricia Fleming
PF
SUBJECT: Amendment to the Ryan White CARE Act on Mandatory HIV Testing
cc:
The First Lady
Summary
The House Commerce Committee today postported full committee consideration of the
119
reauthorization of the Ryan White CARE Act On Tuesday bccause of controversy
surrounding a proposed amendment by Rep. Tem Coburn (R-OK) to require all states to
mandate HIV testing for certain newborns. Coourn's amendment would:
Endorse as the standard of care "mandatory counseling and voluntary testing of
pregnant women" (the policy recommended by the Public Health Service);
Require, as a condition of receiving certain Ryan White CARE Act funds, that each
State have a law requiring IIIV testing of newborns in cases where the HIV status of
the mother is unknown;
Forbid the use of HIV status to terminate or alter the terms of health insurance.
The amendment had broad support among Republicans on the Committee and may have been
supported by many of the Democrats. However, the National Governors' Association sent a
letter (attached) opposing the amendment on the grounds that this was an unfunded mandate.
This caused the delay in the markup. All the major AIDS organizations opposed the Coburn
amendment, as did the Association of State and Territorial Health Officials and the National
Alliance of State and Territorial AIDS Directors. It is quite possible that the Committee's
leadership will seek to delay consideration of Coburn's proposal while moving forward with
the Ryan White reauthorization.
Background
The Cobum amendment is part of a long-simmering debate over mandatory testing of
pregnant women and mandatory testing of newborns. As you know, in February 1994, NIH-
funded researchers reported the groundbreaking results that the use of AZT during
pregnancy, labor, and childbirth can reduce the risk of HIV transmission from mother to
child by as much as two-thirds. This is the first time we have been able to block
Memerandum for Leon Panetta
Page
transmission of HIV with & drug.
As a result of this finding, the Public Health Service, in consuitation with outside experts,
developed new guidelines recommending that doctors counsel all pregnant women to accept
voluntary HIV testing. Doctors should then offer pregnant women who are HIV-positive
treatment with AZT to lower the risk of transmission to their babies. The guidelines also
recommend that women who have given birth but who have not been tested should be
counseled and offered voluntary testing for themselves and their newborns before leaving the
hospital. These guidelines, issued in draft form for public comment, have drawn strong
support from medical, public health, and ethics groups. They will be issued in final form on
July 7th. One of the provisions in the Coburn amendment endorses the guidelines'
recommendation that prenatal HIV testing be voluntary.
Since all babies carry their mothers' antibodies at birth, a test of a newborn simply reflects
the mother's HIV status -- not the necessarily the newborn's own HIV-status. However, it is
possible to treat all babies whose mothers are HIV positive to prevent certain AIDS-related
conditions. In April 1995, CDC issued expanded guidelines that recommended antibiotic
treatment of all babies born to HIV-positive women to prevent Pneumocystis carinii
pneumonia, a major killer of HIV positive babies. Until April, the standard of care had been
to treat only those babies whose immune systems were compromised.
Coburn Amendment and Administration Policy
The intent of the Coburn amendment, developed with Rep. Gary Ackerman, is to assure that
newborns be tested when the HIV status of the mother is unknown. This proposal is less
extensive than one introduced earlier Ackerman, which would have unblinded the now-
suspended CDC seroprevalence study of newborns. It also rejects earlier calls for mandatory
testing of all pregnant women.
This support of voluntary prenatal testing makes it incumbent upon the Administration to
assure access to counseling and testing and to AZT therapy for pregnant women. My office
and the relevant HHS agencies have been working closely to develop a strategy that
integrates voluntary prenatal testing into all programs that reach women at risk for HIV.
Some of these steps are already in place. For example, HCFA has mandated the coverage of
AZT for HIV-infected pregnant women under the Medicaid program. Other efforts are
ongoing, such as the training of providers in proper counseling regarding HIV and AZT
therapy. Still other issues need to be resolved, as in Medicaid coverage of HIV counseling
and testing.
The Administration has taken no position on this amendment. The amendment is, however,
in part a strong endorsement of the voluntary approach to prenatal testing that is central to
the PHS guidelines. The PHS is sponsoring a meeting on July 11 and 12 of outside experts
Memorandum for Leon Panetta
June 27, 1995
Page Three
and community groups to discuss these issues in greater depth. Following that meeting, PHS
will develop recommendations for any additional steps to achieve voluntary prenatal testing,
and broader access to prenatal treatment with AZT. PHS will also grapple with the most
difficult part of the strategy, which is what policies are appropriate when neither the mother
nor the newborn has been tested voluntarily. It is at this point that the Administration will
have an opportunity to weigh in on this debate - in advance of final consideration of any
legislative action on this or related proposals.
JUN-27-1995
13:31
FROM
WHITE
HOUSE
HIDS
TO
94566244
JUN-27-1995
16:06
FROM
AIDS
ACTION
DC
TO
F.22
blown) - M.D.
C:
General of Venness
8
Hall of the -
Tommy C.
444 North Capirat Street
Governor of
Washington DC 20201-1512
Visa Chair
Telephone (202) 634-5300
June 26, 1995
Representative Themes Bilisy
Chairmen
Committee on Commerce
Room 2125
Rayburn House Office Building
Washington, DC 20515-6065
Dear Chairmen Billey,
8 behalf of the nation's Governors, I am writing to expecss our opposities to the proposed
amendment to HR. 1872 that will be offered by Congression Coburn tomorrow. Mr. Coburn's
amendment would make AJDS funding to states under the Ryan White Care Act contingent
upon passage of issue laws requiring the mandatory senting of all nowborns for HIV disume.
This interestment to anithetical to both the unitanded mandines legislation passed just several
months sgo and the Congressional trend toward a less prescriptive federal government.
Regarding the former, while the amendment is silent - funding for mandatory testing and
counseling, one must sesume that this will be paid either by the state directly or passed on to
insurers or individuals. If Congress is interested in establishing policy with financial impact, it
should be willing to pay the cost. If this is to be paid by CARE Act funds. significantly leas will
be available. for treatment of persons with AIDS.
This proposal is an important example of why broad Sedural prescriptions must be considered
carefully. According to the Conters for Disease Control and Prevention, between 1993 and
1994, 63 persent of all pedictric AIDS cases occured in only three states; 89 percent of cases
were in 15 - And while podicaria AIDS is # subset of HIV disease, we believe that HIV
discase has à nimilar distribution among states. This amendent chooses to somblish a national
screening and countring program with significant costs for all states when the problems appears
more focused in a much smaller sumber.
The National Governors' Association supports the resuthorization of the Rysn White CARE
Act; Bewever, this Association has no position OR mandatory testing for HIV. As such, this
letter should net be Interpreted as addressing the strengths or weaknesses of mandmory tenting
and counteling. However, decrying states accoss so important Inderal funds that are executive for
the care of persons with AIDS in order to ostablish a new faderal requirement is not good public
policy.
JUN-27-1995 16:06 FROM RIDS ACTION
LC
IU
F.B.)
Chairman Billey.
June 25, 1995
Page 2.
If you have any spections, please and the to contact Carl Volpe of # staff who would be happy
to answer say of your question.
Sincerely,
RACD
Raymond c. Scheppach
Resentive Director
our
Representative John D. Dingoil
Commissos Committee Members
TO:
Hillary Rodham Clinton
FROM:
Jennifer Klein
DATE:
6/28/95
RE:
HIV Testing of Pregnant Women and Newborns
Attached please find a memo from Patsy Fleming about the Coburn amendment that
we discussed yesterday. I wanted to highlight two things. First, Patsy notes that the Public
Health Service meeting on July 11 and 12 is expected to address "what policies are
appropriate when neither the mother nor the newborn has been tested voluntarily." Second,
the attached letter from the National Governors Association (NGA) points out that the
Coburn amendment is overly broad given the geographic concentration of AIDS.
According to the NGA, between 1993 and 1994, 63% of all pediatric AIDS cases occurred
in only three states; 89% of cases occurred in 15 states.
These two facts give us a solid foundation for pursuing mandatory testing of
newborns in "high risk" areas. Jeff Levi in our AIDS office agrees that this is an accepted
public health approach. We are working together to develop a strategy.
cc:
Melanne Verveer
JUN-27-1995 18:29 FROM WHITE HOUSE AIDS POLICY
TO
94566244
P.01
OFFICE OF NATIONAL AIDS POLICY
EXECUTIVE OFFICE OF THE PRESIDENT
750 17th Street, N.W.
Washington, DC 20503
Phone: 202-632-1090
Fax: 202-632-1096
FACSIMILE COVER SHEET
TO: The First Lady
FAX NUMBER: 456-6244
FROM: Patricia Fleming
DATE: June 27, 1995
PAGES INCLUDING COVER SHEET: 6
COMMENTS:
JUN-27-1995 18:29 FROM WHITE HOUSE AIDS POLICY
TO
94566244
P.02
THE WHITE HOUSE
WASHINGTON
June 27, 1995
MEMORANDUM FOR LEON PANETTA
FROM:
Patricia Fleming
PF
SUBJECT: Amendment to the Ryan White CARE Act on Mandatory HIV Testing
cc:
The First Lady
Summary
The House Commerce Committee today postported full committee consideration of the
reauthorization of the Ryan White CARE Act on Tuesday bccause of controversy
surrounding a proposed amendment by Rep. Tem Coburn (R-OK) to require all states to
mandate HIV testing for certain newborns. Coburn's amendment would:
Endorse as the standard of care "mandatory counseling and voluntary testing of
pregnant women" (the policy recommended by the Public Health Service);
Require, as a condition of receiving certain Ryan White CARE Act funds, that each
State have a law requiring IIIV testing of newborns in cases where the HIV status of
the mother is unknown;
Forbid the use of HIV status to terminate or alter the terms of health insurance.
The amendment had broad support among Republicans on the Committee and may have been
supported by many of the Democrats. However, the National Governors' Association sent a
letter (attached) opposing the amendment on the grounds that this was an unfunded mandate.
This caused the delay in the markup. All the major AIDS organizations opposed the Coburn
amendment, as did the Association of State and Territorial Health Officials and the National
Alliance of State and Territorial AIDS Directors. It is quite possible that the Committee's
leadership will seek to delay consideration of Coburn's proposal while moving forward with
the Ryan White reauthorization.
Background
The Coburn amendment is part of a long-simmering debate over mandatory testing of
pregnant women and mandatory testing of newborns. As you know, in February 1994, NIH-
funded researchers reported the groundbreaking results that the use of AZT during
pregnancy, labor, and childbirth can reduce the risk of HIV transmission from mother to
child by as much as two-thirds. This is the first time we have been able to block
Memorandum for Leon Panetta
transmission of HTY with & drug.
As a result of this finding, the Public Health Service, in consuitation with outside experts,
developed new guidelines recommending that doctors counsel all pregnant women to accept
voluntary HIV testing. Doctors should then offer pregnant women who are HIV-positive
treatment with AZT to lower the risk of transmission to their babies. The guidelines also
recommend that women who have given birth but who have not been tested should be
counseled and offered voluntary testing for themselves and their newborns before leaving the
hospital. These guidelines, issued in draft form for public comment, have drawn strong
support from medical, public health, and ethics groups. They will be issued in final form on
July 7th. One of the provisions in the Coburn amendment endorses the guidelines'
recommendation that prenatal HIV testing be voluntary.
Since all babies carry their mothers' antibodies at birth, a test of a newborn simply reflects
the mother's HIV status -- not the necessarily the newborn's own HIV-status. However, it is
possible to treat all babies whose mothers are HIV positive to prevent certain AIDS-related
conditions. In April 1995, CDC issued expanded guidelines that recommended antibiotic
treatment of all babies born to HIV-positive women to prevent Pneumocystis carinii
pneumonia, a major killer of HIV positive babies. Until April, the standard of care had been
to treat only those babies whose immune systems were compromised.
Coburn Amendment and Administration Policy
The intent of the Coburn amendment, developed with Rep. Gary Ackerman, is to assure that
newborns be tested when the HIV status of the mother is unknown. This proposal is less
extensive than one introduced earlier Ackerman, which would have unblinded the now-
suspended CDC seroprevalence study of newborns. It also rejects earlier calls for mandatory
testing of all pregnant women.
This support of voluntary prenatal testing makes it incumbent upon the Administration to
assure access to counseling and testing and to AZT therapy for pregnant women. My office
and the relevant HHS agencies have been working closely to develop a strategy that
integrates voluntary prenatal testing into all programs that reach women at risk for HIV.
Some of these steps are already in place. For example, HCFA has mandated the coverage of
AZT for HIV-infected pregnant women under the Medicaid program. Other efforts are
ongoing, such as the training of providers in proper counseling regarding HIV and AZT
therapy. Still other issues need to be resolved, as in Medicaid coverage of HIV counseling
and testing.
The Administration has taken no position on this amendment. The amendment is, however,
in part a strong endorsement of the voluntary approach to prenatal testing that is central to
the PHS guidelines. The PHS is sponsoring a meeting on July 11 and 12 of outside experts
JUN-27-1995 18:30 FROM WHITE HOUSE AIDS POLICY
TO
94566244
P.04
Memorandum for Leon Panetta
June 27, 1995
Page Three
and community groups to discuss these issues in greater depth. Following that meeting, PHS
will develop recommendations for any additional steps to achieve voluntary prenatal testing,
and broader access to prenatal treatment with AZT. PHS will also grapple with the most
difficult part of the strategy, which is what policies are appropriate when neither the mother
nor the newborn has been tested voluntarily. It is at this point that the Administration will
have an opportunity to weigh in on this debate -- in advance of final consideration of any
legislative action on this or related proposals.
JUN-27-1995
18:31
FROM
WHITE HOUSE AIDS POLICY
TO
94566244
P.05
JUN-27-1995 16:06 FROM AIDS ACTION
DC
TU
02/1000
&
Interent) - M.D.
# Schoppeak
If
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Mall of the I
Tommy C. Thousand
444 North Capital Senet
Governor of Winner
Washington DC 30001-1512
Visa Chair
Telephone (202) 634-5500
June 26, 1995
Representative Thomas Bilisy
Chairman
Committee én Commerce
Room 2125
Rayburn House Office Building
Washington, DC 20515-6065
Dear Chairmen Billey,
& behalf of the nation's Governors, I am writing to express our opposities to the propesed
amendment to H.R. 1872 that will be offered by Congression Coburn temorrow. Mr. Coburn's
amendment would make AJDS funding to states under the Ryan White Care Act consingent
upon passage of issue laws requiring the mandatory senting of all nowborns for HIV disense.
This massadment is amithetical to both the unfunded mandines legislation passed just several
months up and the Congressional trend toward a less prescriptive federal government.
Regarding the Former, while the amendment is silent on funding for mandatory testing and
counseling, one must cosume that this will be paid either by the state directly or passed on to
insurers or individuals. If Congress is interested in establishing policy with financial impact, it
should be willing to pay the cost. If this is to be paid by CARE Act funds, significantly less will
be available for treatment of persons with AIDS.
This proposal is an important example of why broad federal prescriptions arust be considered
carefully. According to the Centers for Disease Control and Prevention, between 1993 and
1994, 63 persent of all pediatric AIDS cases occurred in only three states; 89 percent of cases
were in 15 - And while podiatric AIDS is . subset of HIV disease, we believe that HIV
disease has à similar distribution among states. This amendment chooses to establish a national
screening and counseling program with significant costs for all states when the problems appears
more focused in a much smaller number.
The National Governors' Association supports the resuthorization of the Rysa White CARE
Act; however, this Association bee as position OR mindatory testing for HIV. As such, this
letter should not be interpreted as addressing the strengths or weaknesses of mandenery testing
and counteling. However, denying states access to important Inderal funds that are essential for
the care of persons with AIDS in order to establish a new faderal requirement in not good public
policy.
JUN-27-1995 18:31 FROM WHITE HOUSE AIDS POLICY
TO
94566244
P.06
JUN-27-1995 16:06 FROM RIDS ACTION
LC
1U
P.O.
Chairman Billey.
June 26, 1995
Page 2
If you have any questions, please feel the to contact Carl Volpe of my staff who would be happy
to answer any of your question.
Sincerely,
RAC
Raymond c. Scheppach
Executive Director
our
Representative John D. Dingell
Commissos Committee Members
TOTAL 9.00
TO:
Hillary Rodham Clinton
FROM:
Jennifer Klein
DATE:
6/26/95
RE:
Meeting with Dr. Koop on HIV Testing
Dr. Koop is coming in tomorrow to talk about HIV testing of pregnant women and
newborns. As you know, there are two major issues:
(1)
Should women be required to be tested during pregnancy or should they be given
routine counseling and voluntary testing?
Given the new study indicating that HIV transmission from mother to child can be
dramatically reduced through the use of AZT during pregnancy, it is clear that
pregnant women should know their HIV status. As you know, the Centers for
Disease Control (CDC) recommend routine HIV counseling and voluntary testing for
all pregnant women. (I have attached a summary of the CDC position.) Most
people, including (according to his staff) Dr. Koop, who have considered this issue
agree. The CDC and others support voluntary testing because: (1) in several studies,
it has proven effective; (2) unlike mandatory testing, it will not drive women from
seeking prenatal care; and (3) it helps establish a relationship of trust that is
necessary to ensure ongoing treatment.
(2)
Should testing of newborns be mandatory?
The more difficult question is whether newborns should be tested at birth.
The argument about mandatory testing of newborns began when Congressman
Ackerman introduced an amendment to "unblind" the CDC seroprevalence study.
The CDC study was designed to track the prevalence of HIV infection in women
(because a test of a baby indicates its mother's HIV status). Because the study did
not match the babies tested with their HIV test results, opponents charged that the
CDC was withholding data from mothers and babies who could get treatment if they
knew that they were HIV positive. The CDC responded by suspending the study for
further review.
Now, Congressmen Ackerman and Coburn intend to introduce an amendment that
would require all women who do not know their HIV status to have their infants
tested at birth. In other words, if voluntary counseling and testing did not work
during pregnancy, women would be forced to have their newborns tested. As you
can see from the attached op ed from yesterday's New York Times, they firmly
believe that we must mandate testing to ensure that babies do not go untreated.
The CDC and many advocates (including the American Academy of Pediatrics and
1
the Pediatric AIDS Foundation) believe that voluntary rather than mandatory testing
is the best approach at birth as well as during pregnancy. (I have attached an article
by the American Academy of Pediatrics recommending voluntary testing at birth.)
They argue that, as during pregnancy, voluntary testing works better. Women must
continue to bring their babies for treatment and to get treatment themselves, and will
be more likely to do this if they have consented to testing.
Dr. Koop's staff did not know his views on mandatory newborn testing. (At the
Pediatric AIDS Foundation event, he did note that he thought the CDC study was
unethical.) Once you have heard his position, you may want to ask the following additional
questions:
(1)
What impact might mandatory testing of newborns have on the doctor-patient
relationship? Does he think that it will erode trust between doctors and patients so
much that women will not get treatment? Does this depend on whether the test is
mandated at birth or during pregnancy?
(2)
If he supports mandatory testing at birth, does he think that testing should be
"purely" mandatory or that a woman should be allowed to "opt out" (i.e., be told that
this is done routinely but that she can refuse)?
(3)
Is HIV testing similar to other tests routinely performed at birth (e.g., syphilis, PKU)
or is HIV a completely different type of disease that requires different standards for
consent?
(4)
Does he think that confidentiality will be maintained if newborns are tested at birth?
cc:
Melanne Verveer
2
Perinatal Human Immunodeficiency Virus Testing
Provisional Committee on Pediatric AIDS
Continuing technologic and medical advances in
intravenous drug use as the primary exposure cate-
the detection, treatment, and prevention of pediatric
gory in women with AIDS. A significant proportion
human immunodeficiency virus (HIV) infection re-
of HIV-infected women are not aware of their own or
quire an ongoing assessment and review of recom-
partner's risk for HIV infection. Evaluation of na-
mendations relating to pediatric HIV infection, in-
tional data from publicly funded HIV counseling and
cluding issues that involve prenatal and perinatal
testing services from 1989 to 1990 indicates that 35%
HIV counseling and testing.
of women found to be HIV-infected do not report
Changes in the epidemiology of HIV infection in
risk factors that have been commonly associated
women require that prenatal testing recommenda-
with HIV acquisition, such as intravenous drug use
tions based on risk group and geographic prevalence
or having sex with a partner at known high risk for
be reconsidered. The following factors support the
HIV infection; 44% of black seropositive women did
importance of the evaluation of HIV infection status
not report these behaviors.4 Unprotected sexual in-
in reproductive-age women and newborns: the re-
tercourse may be the only high risk factor for HIV
cent finding that administration of zidovudine to
acquisition for these women.
some HIV-infected pregnant women and their new-
In geographic areas with low HIV seroprevalence
borns significantly reduced perinatal transmission of
among childbearing women, the ethnic distribution
HIV,¹ the requirement that prophylaxis to prevent
of HIV infection in women may differ substantially
Pneumocystis carinii pneumonia be initiated in the
from that observed in areas of the country with high
first few months of life for maximal efficacy, im-
HIV seroprevalence. A recent report from San Diego
provements in diagnostic confirmation of pediatric
County indicated that 34% of mothers with perina-
HIV infection in early infancy, and the recommenda-
tally infected infants were Caticasian.⁵ Similar to the
tion that HIV-infected women should not breast-feed
data cited above, heterosexual contact was the only
their infants if safe alternatives are available.
risk factor for HIV infection in 43% of mothers.
Because surveillance of AIDS cases detects only
CHANGING EPIDEMIOLOGY OF HIV INFECTION
infected individuals who have progressed to end-
IN WOMEN OF CHILDBEARING AGE
stage disease, use of AIDS case surveillance reports
The annual proportionate increase in cases of ac-
to detect population trends in HIV infection will
quired immunodeficiency syndrome (AIDS) in
reflect the scope of the HIV epidemíc 7 to 10 years
women currently exceeds that observed among
ago. However, anonymous HIV antibody seropreva-
men.² Although in 1982 only 6% of newly diagnosed
lence surveys provide estimates of HIV infection
AIDS cases involved women, in 1993 12.6% of new
trends that are independent of disease stage, and
cases were diagnosed in women. Currently, more
depict more recent patterns of HIV infection in
than 80% of women with AIDS are of childbearing
women. Serosurveys indicate that HIV infection, like
age, and the increasing rate of AIDS among adoles-
AIDS, has become widespread among women of
cent females portends a further increase among
childbearing age in nonurban areas of the country.6
women of childbearing age. The increase in the rate
It is evident that HIV infection in women has
of AIDS in women has been reflected by a similar
spread beyond previously defined risk groups and
increase in children; more than 95% of AIDS cases in
geographic areas.
children from birth to 4 years old are caused by
perinatal infection.
USE OF ZIDOVUDINE TO REDUCE PERINATAL
In addition to the increasing incidence of AIDS in
HIV TRANSMISSION
women, cases are no longer confined to urban areas
The risk of perinatal HIV transmission can be re-
of the United States; currently, more than 25% of
duced through the administration of zidovudine to
women with AIDS are from smaller cities and rural
HIV-infected pregnant women and their infants. In-
areas of the United States.³ Furthermore, behavioral
terim results have recently been reported from a
risk factors for HIV infection in women are shifting.
randomized, double-blind, placebo-controlled clini-
Since 1992, heterosexual contact has exceeded
cal trial, AIDS Clinical Trial Group (ACTG) Protocol
076, that evaluated the use of zidovudine adminis-
tered during pregnancy, labor, and to the newborn to
The recommendations in this statement do not indicate an exclusive course
reduce perinatal HIV transmission.¹ This trial en-
of treatment or procedure to be followed. Variations, taking into account
individual circumstances, may be appropriate.
rolled HIV-infected pregnant women with early
PEDIATRICS (ISSN 0031 4005). Copyright c 1995 by the American Acad-
stage HIV disease (CD4 count of 200 cells/mm³ or
emy of Pediatrics.
above at the time of entry into the study, who had
PEDIATRICS Vol. 95 No. 2 February 1995
303
received no antiretroviral therapy during their cur-
infant's HIV serostatus. PCP, however, continues to
rent pregnancy and had no clinical indications for
be the presenting manifestation of previously unrec-
antiretroviral therapy). Oral zidovudine was admin-
ognized HIV infection in nearly half of reported PCP
istered beginning between 14 and 34 weeks of ges-
cases. 10 In these children, HIV status was unknown
tation and was continued for the remainder of the
until the child developed PCP; this suggests that
pregnancy. During labor, a continuous intravenous
early identification of patients requiring prophylaxis
infusion of zidovudine was administered, followed
is incomplete. To adequately prevent the complica-
by the administration of oral zidovudine to the new-
tions of HIV disease, identification of an infected
born for 6 weeks. Analysis of data available through
child must be followed by the provision of appropri-
December 1993 demonstrated a two-thirds reduction
ate medical care. In addition, education of the par-
in the estimated rates of HIV transmission at 18
ents and other guardians regarding the need for
months of age, from 25.5% in placebo recipients to
close follow-up of these infants and instruction in
8.3% in those who received zidovudine; the differ-
administration of necessary medications is also
ence between the two groups was highly statistically
crucial for the prevention of PCP and other
significant (P = .00006). No significant short-term
complications of HIV infection.
side effects were observed from zidovudine use
Early identification of HIV-infected infants enables
other than mild, reversible anemia in the infants.
appropriate modifications and additions to the rou-
Although the short-term safety concerns appear min-
tine schedule of pediatric immunizations; early mon-
imal for the mother and child, the study has not yet
itoring of nutritional status and implementation of
provided information about the long-term risks for
aggressive nutritional supplementation at early
mothers and infants (both infected and uninfected)
stages of growth failure; initiation of antiretroviral
treated with the ACTG 076 zidovudine regimen.
therapy; careful monitoring of immunologic and
Although the ACTG 076 zidovudine regimen may
neurologic/neuropsychologic function to evaluate
not yield the same results in HIV-infected women
the need for change in antiretroviral therapy and the
who are severely ill with low CD4 counts, those who
need for special educational interventions; consider-
have been receiving zidovudine for an extended pe-
ation of other adjunctive therapies, such as intrave-
riod before pregnancy, or those who present very
nous immunoglobulin for the prevention of bacterial
late for prenatal care, it is possible that zidovudine
infections; screening and treatment for tuberculosis;
may be associated with some reduction in transmis-
appropriate management of communicable disease
sion in such situations. A variety of other therapeutic
exposures; and the provision of other needed
interventions to interrupt perinatal transmission of
services."
HIV are currently or soon to be under evaluation.⁷
With virologic diagnostic techniques such as HIV
The US Public Health Service recently published rec-
culture, polymerase chain reaction, and immune
ommendations regarding the use of zidovudine to
complex-dissociated p24 antigen, diagnosis of HIV
prevent perinatal HIV transmission.⁸ These recom-
infection can be made in almost 50% of infected
mendations cover a variety of clinical situations that
infants at birth and in more than 95% of infected
commonly occur in clinical practice, and highlight
infants by 1 to 3 months of age.¹² Unfortunately,
the factors to be considered by the woman and her
identification of HIV-infected infants at early stages
health care provider when making decisions regard-
of disease in the United States appears to be rela-
ing use of zidovudine to prevent perinatal transmis-
tively poor; data from a population-based study in
sion. The health care provider and mother need to
Massachusetts indicate that only 35% to 65% of peri-
discuss the potential benefits, unknown long-term
natally infected infants have been identified by the
effects, and gaps in knowledge relating to the wom-
health care system by 3 to 4 years of age.¹³
an's specific clinical situation to ensure that the
woman can make informed decisions about her
BENEFITS OF HIV TESTING IN THE PRENATAL
treatment.
AND NEWBORN PERIODS
There are now clear medical benefits for pregnant
DIAGNOSIS AND MANAGEMENT OF PEDIATRIC
women to know their HIV serostatus. In addition to
HIV INFECTION
the importance HIV testing has for early diagnosis
Early identification of infected infants is essential
and treatment of women,14 the availability of a treat-
for adequate medical management. Pneumocystis
ment capable of significantly reducing perinatal
carinii pneumonia (PCP) is the most frequent oppor-
transmission of HIV clearly provides an important
tunistic infection associated with pediatric HIV in-
impetus for all pregnant women to know their HIV
fection, occurs most commonly between 3 to 6
serostatus during early pregnancy.
months of age, is the most common initial disease to
Knowledge of HIV serostatus permits infected
occur in infants and children with previously unrec-
mothers to be counseled about the risk of HIV trans-
ognized HIV infection, and is associated with high
mission through breast-feeding. Because of the risk
mortality. Effective prophylaxis is available to pre-
of HIV transmission via breast milk, 15,16 women in
vent PCP, and in March 1991, the US Public Health
the United States who are known to be HIV-infected
Service issued guidelines for PCP prophylaxis in pe-
are advised not to breast-feed, since safe alternatives
diatric HIV infection.⁹
to breast milk are available."
Because of the age distribution of infants with
While evaluation for HIV infection during
PCP, PCP prophylaxis should begin in the first
pregnancy offers potential preventive as well as
months of life, which requires recognition of the
therapeutic benefits, when maternal serostatus is
304
PERINATAL HIV TESTING
unknown, HIV antibody testing of the newborn re-
counseling followed by a signature that affirms con-
mains important for therapeutic reasons. Knowledge
sent to testing; 2) provision of education followed by
of neonatal HIV serostatus permits early evaluation
a signature that either explicitly consents to or ex-
of the infant for HIV infection and immunologic
plicitly refuses testing; or 3) education followed by a
monitoring to evaluate the need for initiation of PCP
signature only to explicitly refuse the test. Each of
prophylaxis, antiretroviral, and other therapies.
these methods is an ethically acceptable way to
Human immunodeficiency virus infection in
respect the individual's decision whether or not to
women and children is often accompanied by HIV
be tested. Each method, however, has different
infection in other family members. Family members
associated dimensions.
should be offered the opportunity to undergo
Individualized counseling in conjunction with ob-
evaluation to determine whether they are HIV-in-
taining a signature on an informed consent form
fected and provided appropriate medical care and
requires significant health care resources. Patient ed-
follow-up if found to be infected.
ucation in written form or group settings followed by
a signature of consent or refusal may require less
RISKS OF HIV TESTING IN THE PRENATAL AND
intensive resources. In both of these methods of con-
NEWBORN PERIODS
sent, the provider may directly recommend the test.
Risks of prenatal/perinatal HIV testing include
Routine patient education accompanied by a signa-
those inherent to the identification of HIV infection
ture only to reject the test (right of refusal) implies
in any individual. Detection of HIV infection may be
that the test is recommended by the health care pro-
associated with anxiety and depression. Other risks
fessional and therefore will be performed unless the
include potential social stigmatization and discrimi-
patient signs the form, and may also result in the
nation. Also, because illicit intravenous drug use is
largest number of women being tested. Although
associated with HIV infection and may be used as a
some believe that right of refusal consent is inher-
basis to remove an infant from the mother's care,
ently coercive, documentation of appropriate patient
women who use illicit drugs may fear HIV testing. It
education and confidentiality reduce the likelihood
is possible if the benefits of HIV testing are not made
of such concern.
known to pregnant women, fear of the potential
Because the results of ACTG 076 indicate that
negative consequences may deter some women from
zidovudine has the potential to reduce perinatal
seeking prenatal care, particularly if testing is per-
transmission of HIV, there is now a compelling rea-
ceived as involuntary. However, in several settings
son for universal antepartum HIV education and
in which HIV counseling and voluntary testing have
routine testing with consent. Whichever method of
been routinely offered to all prenatal patients, no
obtaining consent is chosen, it is critically important
measurable decrease in women seeking prenatal care
that appropriate education regarding HIV infection
has been observed.
is provided to the individual before a decision
Human immunodeficiency virus seropositivity in
regarding testing.
a newborn measures maternally derived HIV IgG
Currently, the percentage of pregnant women be-
antibodies that, while not diagnostic of infection in
ing evaluated for HIV infection is regrettably small.
the infant, provide unequivocal evidence of infection
Therefore, testing programs for HIV infection should
in the mother. Human immunodeficiency virus an-
undergo periodic evaluation regarding the propor-
tibody screening of the newborn indirectly evaluates
tion of women being tested. Those programs in
maternal HIV infection status, and therefore has the
which a proportionately low number of women con-
same intrinsic risks as prenatal HIV testing.
sent to receive HIV testing should examine the rea-
sons for poor acceptance. Appropriate program
THE ISSUE OF CONSENT FOR HIV TESTING
modifications may need to be made to ensure that
A relationship of respect and trust between
women understand the benefits of testing and feel
women and the health care system is critically im-
comfortable undergoing testing.
portant to the identification of women who are HIV-
Because infant testing provides information im-
infected and their subsequent care and treatment.
portant to the well-being of the infant and also in-
Therefore, provision of education concerning the
formation regarding the infection status of the
benefits and possible risks of HIV testing is an
mother, the health care provider is obligated to ed-
important part of the process of HIV testing.
ucate the mother about HIV infection and to obtain
Documentation that information about HIV infec-
consent using one of the methods described above
tion has been provided and that consent for testing
when HIV testing of the infant is contemplated.
was obtained has generally been accomplished by
The purpose of HIV testing is to engage a woman
individual counseling followed by written or oral
in continuing care for herself and her baby, not to
consent. Alternative, less resource intensive, accept-
label a woman as being infected. Compliance with
able options to individualized counseling include
medical care is likely to be greatest when the patient
routine provision of education about HIV in written
feels she has made an informed judgment regarding
or video form or in group settings.
HIV testing for herself or her infant. Routine HIV
Some states have legal requirements for counsel-
education accompanied by offering HIV testing to all
ing followed by written consent for HIV testing.
pregnant women appears most likely to achieve this
Routinely used methods in medical practice to doc-
goal. Women need to be given sufficient information
ument consent or refusal for medical procedures
in a clear and understandable manner to appreciate
other than HIV testing include: 1) individualized
the benefits and risks of the proposed HIV test and
AMERICAN ACADEMY OF PEDIATRICS
305
the consequences of accepting or rejecting testing for
tested for HIV infection during the current
herself and her infant. This process is best performed
pregnancy, education about HIV infection and
within the context of a professional relationship
maternal HIV testing are recommended during
between the woman and her health care provider.
the perinatal period.
5. For newborns whose mother's HIV serostatus
CONCLUSION
was not determined during the recent preg-
Human immunodeficiency virus infection con-
nancy or the postpartum period, the infant's
tinues to spread among women of childbearing age
health care provider should educate the
in the United States, and is occurring in rural as
mother concerning the potential benefits of
well as urban areas. With the increasing heterosex-
HIV testing for her infant and the possible
ual spread of HIV, previously defined risk behav-
risks and benefits to herself of knowing the
iors for HIV infection incompletely identify
child's serostatus and recommend HIV test-
women found to be infected. The predominant risk
ing for the newborn.
behavior for HIV infection in many women is un-
6. In the absence of parental availability for con-
protected sexual intercourse. Perinatal HIV infec-
sent to test the newborn for HIV antibody, pro-
tion has mirrored the increases in HIV infection in
cedures need to be established to facilitate the
women. With the availability of an intervention to
rapid evaluation and testing of the infant.
reduce perinatal transmission of HIV, there is clear
7. The health care provider for the infant needs to
rationale for universal education and routine HIV
be informed of maternal HIV serostatus so that
testing of all women entering prenatal care. The
appropriate care and testing of the infant can be
persisting occurrence of PCP in young infants de-
accomplished. Similarly, if the infant is found to
spite the availability of effective prophylactic reg-
be seropositive when maternal serostatus is un-
imens indicates that the identification and treat-
known, the health care provider for the child
ment of HIV infection in infants at an early age
should ensure that information about the
remains inadequate. Testing programs for HIV an-
serostatus and its significance be provided to
tibody must be confidential, voluntary, and accom-
the mother and, with her consent, to her health
panied by cultural and ethnically appropriate in-
care provider. The mother should receive ap-
formation regarding HIV infection. Such programs
propriate referral to adult HIV-related services.
should be universally available.
8. Comprehensive, HIV-related medical services
should be accessible to all infected mothers,
RECOMMENDATIONS
their infants, and other family members.
9. The Academy supports legislation and public
1. On the basis of recent advances in therapy to
policy directed toward eliminating any form of
reduce the rate of perinatal HIV transmission
discrimination based on HIV serostatus.
and the continued occurrence of life-threaten-
ing illness in young infants with unrecognized
PROVISIONAL COMMITTEE ON PEDIATRIC AIDS,
HIV infection, the AAP recommends docu-
1994 TO 1995
mented, routine HIV education, and routine
Gwendolyn B. Scott, MD, Chairperson
Donna T. Beck, MD
testing with consent, for all pregnant women in
Alan R. Fleischman, MD
the United States. Documented consent for ma-
Lynne M. Mofenson, MD
ternal and/or newborn HIV testing may be ob-
Robert H. Pantell, MD
tained in a variety of ways, including by right of
S. Kenneth Schonberg, MD
refusal (documented patient education, with
Martin W. Sklaire, MD
testing to take place unless rejected in writing
Catherine Wilfert, MD
by the patient). The Academy supports utiliza-
LIAISON REPRESENTATIVE
tion of consent procedures that facilitate rapid
Martha F. Rogers, MD,
incorporation of HIV education and testing into
Centers for Disease Control & Prevention
the routine medical care setting.
CONSULTANT
2. Routine education about HIV infection and test-
James R. Allen, MD, MPH,
ing needs to be a part of a comprehensive pro-
American Medical Association
gram of health care for women, particularly for
women of child-bearing age.
REFERENCES
3. All testing programs for the detection of HIV
1. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant
infection should periodically evaluate the pro-
transmission of human immunodeficiency virus type 1 with zidovudine
portion of women who refuse HIV testing fol-
treatment. N Engl I Med. 1994;331:1173-1180
lowing HIV education. Those programs in
2. Centers for Disease Control. Update: acquired immunodeficiency syn-
which a proportionately low number of women
drome-United States, 1992. MMWR. 1993;42:547-551,557
receive HIV testing should examine the reasons
3. Ellerbrock TV, Bush TJ. Chamberland ME, Oxtoby MJ. Epidemiology of
women with AIDS in the United States, 1981 through 1990. JAMA.
for poor acceptance, with appropriate program
1991;265:2971-2975
modifications made as needed.
4. Centers for Disease Control. Characteristics of and HIV infection among
4. For women who are seen by a health care pro-
women served by publicly funded HIV counseling and testing servic-
fessional for the first time in labor and who
es-United States, 1989-1990. MMWR. 1991;40:195-197:203-204
5. Pratt RD, Hatch R, Dankner WM, Spector SA. Pediatric human immu-
have either not received prenatal care or have
nodeficiency virus infection in & low seroprevalence area. Pediatr Infect
previously tested negative, but have not been
Dis J. 1993;12:304-310
306
PERINATAL HIV TESTING
JUN-23-1995 17:33 FROM
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CDC HIV/ AIDS
CENTERS FOR DISEASE CONTROL
AND PREVENTION
PREVENTION
CDC Facuses on Preventing Perinatal Transmission
May 15, 1995 -- Helene Gayle, M.D., Associate Director of the Centers for
Disease Control and Prevention (CDC) Weshington Office and Acting Director of
CDC's National Center for Prevention Services, announced the agency's goals for
preventing mother-to child, or perinatal, HIV transmission. Dr. Gayle was one of
several witnesses testifying before the House Committee on Energy and Com-
meroe's Subcommittee on Health and the Environment hearing on HIV testing for
pregnant women and newborns held May 11, 1995.
In February 1995, the CDC released draft PHS Guidelines for HIV Counseling and
Voluntary Testing for Pregrant Women. These guidelines, which will be published
in June, were developed following a National Institutes of Health study (ACTG
076) that demonstrated that HIV-Infected pregnant women could reduce transmis-
sign to their infants by as much as two-thirds by taking zidovudine (AZT) during
pregnancy and delivery.
To give bables the best chance for a healthy life, free of the AIDS virus,
HIV-infected women must be reached as early in pregnancy as possible. In order
to achieve that, the guidelines recommend routine HIV counseling and voluntary
testing for all pregnant women. This strategy has already proven to be effective in
several communities nationwide and is the most effective way to identify women
and children in need of care. Unilke mandatory testing, voluntary testing doesn't
run the risk of driving women away from prenatal care. Instead it helps to
establish the relationship of Trust that Is essential for discussions about complex
medical issues.
TO
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As public health and medical professionals prepare to implement the guidelines,
CDC is taking steps to ensure that they are rapidly adopted and to evaluate their
effectiveness. Within the next few weeks, CDC will begin a process, assisted by
external expert consultants, to ensure that all pregnant women are offered HIV
counseling and voluntary testing and that they and their children are entered Into a
continuum of medical and support services. In addition, this planning process will
determine the best mechanisms for evaluating perinatal prevention efforts and for
monitoring the epidemic in women and children.
The future of one of CDC's current monitoring tools, the Survey of Childbearing
Women, will be assessed. This anonymous survey involves the "blinded" HIV
testing of newborn blood samples and has been the subject of recent media
reports as well as proposed federal and state legislation. According to Dr. Gayie,
"The Survey of Childbearing Women has provided critical information for monitor-
ing the epidemic in women and children. However, a lot has changed since that
survey was first developed. With the tremendous opportunity that we now have
to prevent most perinatal transmission, we must do everything possible to keep
our eye on the goal of preventing HIV infection in children. I am confident that the
planning process that CDC is beginning will provide us a strong foundation for
determining how best to achieve this goal."
Until this process is completed, State Health Departments have been asked In 8
letter from Dr. Phil Lee, Assistant Secretary for Health, to suspend the Survey of
Childbearing Women.
"with these recent advances," added Gayle, "CDC must re-evaluate how to best
combine prevention and surveillance strategies to meet these important chal-
lenges. We are eager to begin the planning process and move forward with the
task of Implementing and evaluating perinatal prevention efforts."
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CDC
HIV
/
AIDS
CENTERS FOR DISEASE CONTROL
AND PREVENTION
PREVENTION
CDC's Draft Guidelines for HIV Counseling
and Voluntary Testing for Pregnant Women
The Centers for Disease Control and Prevention (CDC) has released draft guidelines that call
upon medical professionals to provide HIV counseling and voluntary testing for all pregnant
women.
In 1993 (the most recent year for, which complete data are available), an estimated 7,000
HIV-infected women gave birth in the United States. The prevalence of HIV infection in women
giving birth was about 1.6 per 1,000, or about 1 in every 625. Assuming an HIV transmission
rate from mother to infam of about 15%-30%, about 1,000-2,000 HIV-infected infants were born
in the United States in 1993.
For HIV-infected women and their infants to benefit optimally from AZT and other medical
treatment, it is important for women to know if they are HIV-infected before or early in
pregnancy CDC's draft guidelines promote early HIV counseling and voluntary testing to help
women learn if they are infected This will enable women to seek and receive the care they need
for themselves and for reducing the chances of transmitting HIV to their infants.
Research Showed AZT Significantly Reduces Mother-to-Infant Transmission
In February 1994, the results of the National Institutes of Health (NIH) AIDS Clinical Trial 076
were announced, indicating that zidovudine (ZDV, or AZT) could reduce perinatal HIV
transmission by as much as two-thirds in some infected women and their babies. The results were
reported in the New England Journal of Medicine in November 1994. In August, the Food and
Drug Administration approved AZT use for pregnant women and the U.S. Public Health Service
issued guidelines on using AZT during pregnancy (MMWR 1994;43[RR-11]).
The finding of a 67.5% reduction in HIV transmission is promising, and there were no serious
short-term side effects observed in the study. But several questions remain unanswered. The trial
included a select group of women in the early stages of disease, who had not previously taken
AZT long-term, and who had access to prenatal care. The therapy may differ in effectiveness in
women who differ from these characteristics. Since researchers do not know exactly how the
therapy prevented transmission, they also don't know the effect of any therapy variations -- such
as using AZT only during labor or later in the pregnancy, or using it for a shorter time during
pregnancy. Moroover, scientists don't know about the long-term effects of AZT on both mothers
and infants Rescarchors continue to seek answers 10 these questions. NIH is continuing to
monitor the mothers and babies in the trial.
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Counseling for All Pregnant Women and Voluntary Testing Work
The combined strategy of HIV counseling for all pregnant women and voluntary HIV testing is
already proving effective in several communities. Voluntary testing means that after a woman
receives appropriate counseling from her health care provider, she is able to make an informed
decision about having a test for HIV. Studies show that when her health care provider talks with
a pregnant woman about the test and what it means for her and her baby, most women choose to
be tested and then to be treated at their doctor recommends. For example, in one inner-city
hospital in Atlanta, Georgia, 96% of women chose to be tested after being provided HIV
counseling and offered voluntary HIV testing as part of prenatal care.
Offering all women voluntary testing in the context of HIV counseling establishes the trusting
relationship between 8 woman and her health care provider that is essential for discussions about
care and treatment options.
Although AZT therapy is not 100% effective and the long-term risks to both the mother and her
child are not yet known, the dramatic reduction in HIV transmission in the trial dictates that every
HIV-infected pregnant woman should certainly be offered AZT therapy to reduce the risk of
transmitting the virus to her baby Because of the uncertaintics, a woman should make a personal
decision about taking AZT only after she discusses the benefits and potential risks for herself and
her child with her health care provider.
Finalizing the Recommendations
CDC is seeking public comment to ensure the final recommendations will promote the best care
possible for all pregnant women and their babies. After the public comment period, which runs
from February 23 through April 9, 1995. the draft guidelines will be modified as needed and
published in the Morbidity and Mortality Weekly Report (MMWR).
A notice of the public comment period for the draft guidelines appears in the February 23, 1995,
Federal Register. Printed copies of the draft guidelines and "Recommendations of the U.S. Public
Health Service Task Force on the Use of 2idovudine to Reduce Perinatal Transmission of Human
Immunodeficiancy Virus" (MMWR 1994;43[RR-11]) which has more information about AZT
treatment during pregnancy are available from the CDC National AIDS Clearinghouse (CDC
NAC). Printed copies may be ordered by calling the CDC National AIDS Hotline
(1-800-342-AIDS). The Hotline can also provide information about any AIDS-related issue. The
guidelines are also available clectronically through the CDC NAC On-line bulletin board as well as
through other HIV/AIDS bulletin boards, including the Internet.
For specific information regarding the 0-76 Clinical Trial or any other IIIV/AIDS clinical
trial, call the AIDS Clinical Trial Information Service (ACTIS) at 1-800-TRIALS A. For
information regarding treatment and care of IIIV infection and AIDS, including use of AZT in
pregnant women, call the HIVIAIDS Treatment Information Service (ATIS) at 1-800-448-0440.
February 1995
AIDS Babies Deserve Help, Now
Hundreds of babies infected with the AIDS
monitored and treated. Doctors have no way to cure
virus will continue to go undetected and untreated
these infected babies, but they can ward off many of
every year unless Congress or New York State deal
the infections that typically kill them, thus prolong-
with this vexing public health problem. The State
ing and improving the quality of their lives.
Legislature, immobilized by a fierce clash between
Although the medical solutions are in hand,
those who want mandatory testing of all newborns
they are not in fact being broadly applied. In New
and those who prefer a voluntary approach, has
York State, for example, clinics try, with widely
been unable to agree on a solution. Congress,
disparate vigor and success, to get women to agree
knocked off course when the same fierce clash
to be tested during pregnancy or at birth and to
stopped a Federal survey of infected babies, has yet
allow their babies to be tested. But surveys suggest
to take action.
most of the infected babies are missed. A more
Both bodies have a responsibility to get on with
vigorous effort is clearly needed.
the job. It is simply irresponsible to let newborn
Unfortunately, the State Legislature may be
babies go untreated while arguing over the mechan-
headed for another stalemate. The Senate has
ics of how to help them.
passed a bill to require mandatory testing of all
newborns and mount a more aggressive voluntary
testing program aimed at pregnant women. The
The need for a vigorous response is clear.
new voluntary approach would make it harder and
Women are becoming infected with the AIDS virus
less likely for women to decline testing. But the
in rising numbers, and about 7,000 of them give birth
Assembly has taken no action yet and has only four
each year. Many pass the virus on to their babies,
days before adjournment. Its leaders have tradi-
either in the womb or during birth. Some 1,000 to
tionally opposed mandatory testing but seem in-
2,000 babies are infected this way each year, with
clined to accept a more vigorous voluntary effort
New York State alone accounting for roughly a
for both pregnant women and newborns.
quarter of the total. Some of the infected babies are
Either approach would be better than the status
detected through voluntary blood tests on the moth-
quo. This page has long endorsed mandatory tests
ers or their newborns. The rest go undetected and
for newborns on the ground that the health of the
untreated until they become sick, when it is too late
baby is more important than any privacy risk to the
to offer them the best shot at a longer life.
mother. But there is virtually no political appetite
Medical science knows quite well how to allevi-
for imposing mandatory tests on pregnant women,
ate this damage. The best solution by far is to
so a strong voluntary approach is the only feasible
identify and treat the expectant mother before her
alternative.
NEW
child is born. One of the few bright spots in the battle
The best solution would be a national policy
against AIDS was the discovery last year that
insuring that all infected babies are identified for
treating a pregnant woman with the drug AZT can
monitoring and treatment. Representative Gary
THE
greatly reduce the chances that she will pass the
Ackerman, Democrat of New York, and Represent-
AIDS virus on to her child, saving most of the babies
ative Tom Coburn, Republican of Oklahoma, will
from infection.
unveil an amendment this week that would require
Unfortunately, large numbers of women never
states, as a condition for receiving certain Federal
come near a clinic for prenatal care and many of
AIDS funds, to test all newborns whose risk of
those who do come in for such care never get tested
infection has not been determined through volun-
for the AIDS virus. So a fallback solution is to
tary testing of the expectant mother. That approach
identify all infected newborns as early as possible,
would provide a needed incentive for the states to
through blood tests, so that they can be closely
identify and help these neglected babies.
Russia's Rancorous
Politics
The unruly state of Russian politics was cap-
tained period of political stability. So far neither
tured aptly the other day on a television talk show
President Yeltsin nor the Parliament has shown the
when Vladimir Zhirinovsky, the nationalist leader,
steady leadership to provide it.
tossed a glass of orange juice in the face of a
There is a need for responsible behavior in
reformist governor after he suggested Mr. Zhirinov-
Moscow. Instead of undermining each other, Mr.
sky had syphilis. Then there was the member of the
Yeltsin and the Parliament should be working to-
Russian Parliament who turned up in the Duma
gether to create an effective government, a stable
chamber toting a toy gun to protest Government
ruble and a civil society where public safety is
bargaining with Chechen fighters as a loss of Rus-
assured without sacrificing civil liberties. Instead of
sian honor. His fellow lawmakers agreed, approving
skirmishing over the war in Chechnya, they should
a nonbinding motion of no confidence in the Govern-
be cooperating to end a misadventure that has cost
ment of President Boris Yeltsin.
thousands
of
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DEG: BEFORE 96181168 VOA
" UN , PRIM I
9
2
Special request for Pla
Priday, June 9. 1995.
cusulative AIDS Cases for Voten
CDC AIDS Surveillance Data as of December 31, 1996
" STATE OF RESIDENCE AT AIDS DX
currentive
Desitative
87
Trequenty
Persent
Frequency
Parsent
simits
B4
0.0
a
0.0
Alabema
579
0.6
407
0.7
Arkanses
196
0.3
603
1.0
Arizona
265
0.6
866
1.5
Culifornia
4261
7.3
5087
1.7
colorado
D9
0.6
5326
9.1
Connecticut
1247
2.1
6573
11.2
Washington, D.C.
889
9.8
7432
12.7
Delevere
217
0.6
7649
13.1
Florida
E
13.6
19586
26.6
Deorgia
1443
2.3
10929
29.0
Smmil
70
0.1
16999
29.1
Jews
61
0.1
17060
29.2
take
A
9.0
17084
29.3
Illinois
5562
2.6
18621
31.9
Indians
212
0.4
18878
32.6
Kanses
0.2
18976
32.5
century
152
0.3
19126
32.8
Louisiana
644
4.9
19772
11.9
Wassachusetts
1201
2.0
27273
36.3
Haryland
1993
3.4
1566
39.9
Mains
67
0.1
23313
40.0
Richigan
m
1.5
84110
61.3
Mirements
He
0.3
24254
61.6
Missouri
347
0.4
34603
42.2
Mississippi
204
0.9
24957
62.6
Montana
10
0.0
24826
62.7
North Caroline
803
1.4
25689
44.0
North Datata
6
O.D
23073
44.0
Nebraska
49
0.1
29742
a4.1
New Harpshire
H
0.1
25800
66.2
New Jersey
6138
10.5
31934
54.7
New Mexico
17
0.1
31001
54.0
lieveds
190
0.3
38171
$5.2
New York
13943
27.3
48118
82.5
onso
338
0.9
48656
83.4
Oklahoma
165
0.3
48821
83,7
dragen
156
0.3
68977
as.0
Pennsylvania
1631
2.8
50608
86.8
Rhade Island
as
9,6
50033
57.2
Puerto Rice
2720
6.7
53575
91.8
soush Caroline
767
1.3
54340
93.2
south Dekove
?
0.0
36341
93.2
Ternessee
337
a.6
56706
93.8
Texes
2021
3.8
56925
97.6
Useh
H
0.1
57007
97.7
virginia
721
1.2
57725
99.8
Vermunt
26
0.0
57754
99.0
Washington
296
0,3
38030
99.5
wisconsin
208
0.6
36258
99.9
vast Virginia
38
0.1
$8316
100.0
vyeming
19
0.0
58327
100.0
NOTE: Total cumulative AIDS cases reported among woren thru 12/31/94 - 50,428.
The list above does #05 include the smaller
territories and cases
which have residence of report missing.
MEMORANDUM
To:
Jennifer Klein
From:
Karen Guss
Date:
June 14, 1995
Re:
HIV testing of newborns and pregnant women "tough issues"
The basic issue: a physician/patient relationship of trust
Effective prevention of HIV transmission and HIV treatment requires a great deal of
interaction between patients and health care providers and a serious commitment from the
patient: for example, stopping risky behaviors, taking multiple tests (women and newborns),
taking AZT several times a day (women and newborns), PCP prophylaxis, and adherence to a
changed immunization schedule. Many public health experts and physicians who treat the
populations of women most affected by HIV believe that mandatory testing of women or their
newborns will destroy any opportunity for creating this type of ongoing, engaged relationship
-- and cause more harm than good by driving them out of the health care system. These
experts and physicians recommend that counseling women to learn their HIV status and
voluntary testing is the best way to foster good relationships and motivate women to get
involved in treatment and prevention.
Others (e.g., Mark Rapoport, Commissioner of Health for Westchester County) disagree that
HIV testing would have a negative effect on the course of treatment of HIV positive pregnant
women and newborns. The two sides of this debate seem to have very different
understandings of how HIV positive women feel and how they would behave.
The CDC study is Tuskegee revisited.
The CDC "epidemiological surveillance" has been crucial to saving lives by telling public
health officials where they need to target their resources. For example, the creation of the
successful Harlem Hospital program was created after the CDC study revealed that African
American women were contracting HIV at a high rate. Blinded surveillance does not
foreclose instituting vigorous counselling and voluntary testing programs that can save lives -
but unblinding the study is the equivalent of mandatory HIV testing of post-natal women and
runs the risks discussed above.
We preform other tests for diseases on pregnant women and newborns as a matter of
course.
Yes, but many of these tests, at least in theory, are "routine" and not mandatory, which means
that women can choose to opt out of them. In addition, the mandatory tests are a holdover
from the days before public health understood the importance of involved, engaged patients.
Diseases like PKU, for which newborns are tested, are extremely rare and are not
concentrated in any particular population, much less one that may perceive mandatory testing
as a form of racial or socioeconomic discrimination. In addition, today none of the diseases
for which mandatory testing is the norm are invariably fatal or carry the threat of
discrimination and stigma that HIV/AIDS does. Accordingly, learning of a positive test result
for one of these diseases is not likely to have the devastating -- and counterproductive --
effect that learning of a positive HIV test may have.
What about women who don't get prenatal care?
According to Dr. Hermann Mendez, a member of the New York State AIDS Advisory
Council Subcommittee on Newborn HIV Screening, a pediatrician at SUNY-Downstate, and
the director of the Brooklyn Pediatric AIDS Network, "prenatal care" is a term of art, and one
defined differently by different people to mean a given quantity and quality of contact with
the health care system. Dr. Mendez believes that as many as 98 to 99% of pregnant women
have some contact with the health care system, and that health care providers must use each
contact to get pregnant women into counseling and voluntary testing. Women who still slip
between the cracks should receive counseling and the opportunity to get testing for themselves
and their newborn when the child is born. If a woman refuses testing for her newborn, her
doctor can tell her that because the infant's HIV status is unknown, she would like her to
bring the infant in frequently so that the infant's health can be watched. Each of these return
visits presents an opportunity to discuss HIV testing. Dr. Mendez claims that he has never
dealt with a mother who refused to bring in her infant for follow-up visits and eventually HIV
testing and/or PCP prophylaxis.
What about women who refuse to be voluntarily tested?
There is still a chance to reach these women when the newborn arrives (see above). The
people I talked to who are opposed to mandatory testing believe that the number of women
who would be driven away by mandatory testing overshadows the number of women who
would refuse testing for themselves and/or their infants. (I am expecting a study from Dr.
Louis Cooper of the American Academy of Pediatrics calculating the number of women who
would have to be driven out of prenatal care by mandatory testing to do more harm than
good.) Women who refuse testing seem more likely to be those women who are unwilling or
unable to follow the 076 or PCP prophylaxis regime in any event.
But women who don't know their HIV status because neither they nor their babies have
been tested could unwittingly transmit HIV by breastfeeding.
In reality, the vast majority of women with HIV do not breastfeed because their lives are too
chaotic. In addition, HIV test results do not arrive until at least two weeks after the test is
performed, so women who plan to breastfeed are already doing so by the time they get the
results. Moreover, women suspected of being HIV positive can be advised not to breastfeed
until they are tested and found to be HIV negative.
Voluntary, shmoluntary. There are voluntary testing programs in New York that have
had dismal results.
It is important to remember that in New York, HIV test counseling emphasizes the reasons
not to be tested, and fails to stress the advantages. Much HIV counseling is not done by the
physician who is attending to the other aspects of a woman's pregnancy and is likely to take
place in a different setting. (There are 24 pages in the New York State Code that dictate how
to perform HIV testing.) These features of HIV testing in New York can be very disturbing
and discourage testing. Voluntary testing seems to work best when it is embedded in a
process of prenatal care that emphasizes attending to other needs as well as to HIV testing,
such as in the Harlem Hospital program.
Should voluntary testing be a routine (opt-out) or an opt-in procedure?
That's a difficult question. Some people, like Dr. Cooper, believe that the test should be
routine so as not to scare women off with its strangeness. Others, like Dr. Mendez, believe it
should be an opt-in procedure. Dr. Mendez believes that in practice, opt-out tests become
mandatory because health care providers in effect drop the part of the discussion that
constitutes the opportunity to opt out. In addition, he believes that being HIV positive has
such a great impact on people's lives that it is psychologically important for them to have
taken affirmative steps to find out their HIV status.
People I contacted to discuss this issue:
Dr. Mark Rapoport, Commissioner of Health for Westchester County
914 593 5154
Troilby DeJung (sp?), New York State AIDS Institute
212 613 4364
Alan Brandt, Harvard School of Public Health
617 432 4365
617 495 3532
Dr. Robert Galen, Medpath Laboratories
216 932 1981
Dr. Louis Cooper, American Academy of Pediatrics
212 523 3365
Dr. Janet Mitchell, Harlem Hospital, obstetrician
212 939 4333
Dr. Hermann Mendez, Brooklyn Pediatric AIDS Network, pediatrician
718 270 3825
Mary Appplegate, New York State Board of Health
518 486 6065
Other possible sources of information:
Dr. Keith Krasinski, New York University Medical Center (in favor of mandatory testing of
newborns)
Eileen Tynan, New York State AIDS Institute (I spoke to her colleague (above) while Ms.
Tynan was on vacation)
Alan Fleishman, Director, Division of Neonatology, Albert Einstein College of Medicine
Paul Cleary, Department of Health Care Policy at Harvard
617 432 0174
Larry Gostin, Georgetown Law School
202 662 9373
Ron Bayer, Columbia School of Public Health (wrote anti-Hentoff op ed)
Michael Lindsay (sp?), Grady Hospital, Atlanta (Harlem Hospital-type program)
Kathy Wilford (sp?), Duke University Hospital (Harlem Hospital-type program)
PAGE
1
LEVEL 1 - 1 OF 1 STORY
Copyright 1995 The Washington Post
The Washington Post
May 20, 1995, Saturday, Final Edition
SECTION: OP-ED; Pg. A23
LENGTH: 798 words
HEADLINE: Another 'Tuskegee'?
BYLINE: Nat Hentoff
BODY:
After winning a Pulitzer Prize for commentary this year, Jim Dwyer of Newsday
was being interviewed on the New York affiliate of National Public Radio. The
host, Brian Lehrer, was puzzled -- indeed disturbed -- that part of Dwyer's
prize was due to a series of columns exposing the fact that although New York
State -- like 44 others -- has been testing all newborns for various conditions,
it does not disclose an infant's HIV status to either the mother or her doctor.
It is a "blind" test.
Dwyer considers this failure to inform -- with subsequent illnesses and early
death for thousands of children who could have been treated -- outrageous. The
interviewer, however, said to Dwyer: "You're considered a liberal columnist, but
on the HIV-testing of infants, you took the conservative position."
Such presumably liberal organizations as the ACLU, the National Organization
for Women and the Gay Men's Health Crisis do indignantly oppose the unblinding
of the test as an invasion of the privacy of the mother whose own infection will
be revealed if the child's is. Therefore, all privacy is somehow endangered.
Yet, Rep. Gary Ackerman (D-N.Y.) -- with a 100 percent ACLU rating --
introduced a bill, "The Newborn Infant HIV Notification Act," that compels any
state requiring infants' HIV tests to disclose the results to the mother. The
bill would apply to the anonymous tests that have been funded and conducted in
45 states by the Centers for Disease Control since 1988, for epidemiological
reasons.
Ackerman already had 220 co-sponsors -- more than half the House -- and the
ideological range is extraordinary. Ardent liberal Pat Schroeder (D-Colo.) is
allied with Robert Dornan (R-Calif.) who makes Pat Buchanan sound like a lyrical
moderate. Also on board is Nita Lowey (D-N.Y.), a leader of pro-choice issues in
the House, and Bill McCollum (R-Fla.) whose ACLU rating has been zero.
As the bill began to gather momentum, Ackerman was visited, he told me, by
Dr. David Satcher, head of the CDC, and Patricia Fleming, the White House
director of AIDS policy. The visitors wanted Ackerman to abandon his bill. One
of their arguments was that if mothers are told they and their children are
infected, they will panic and leave the health care system. There is abundant
evidence, however, that black and Latina mothers -- who tend to be often, but
hardly exclusively, at risk -- care as much about their children as do white
mothers and would not remove them from treatment.
PAGE
2
The Washington Post, May 20, 1995
Indeed, a recent poll by New York's Hispanic Federation -- an umbrella
organization of many Latino groups -- revealed that two-thirds of those polled
support mandatory HIV testing and disclosure for everyone, not only infants.
Gary Ackerman refused to withdraw his bill. He told me that the head of the
CDC said he might then consider withdrawing the "blind" tests altogether rather
than disclose the results.
Earlier, when the conversation was focusing on increasing criticism -- from
various quarters -- of the CDC's "blind test," Ackerman felt that the man from
the CDC appeared to be most troubled by the analogy between its study and the
Tuskegee "experiment."
From 1932 to 1972, some 400 illiterate black men with syphilis were observed
-- but not treated -- by Public Health Service physicians as they deteriorated
and eventually died, having been told only that they had "bad blood."
The Tuskegee reference entered the HIV-infant test debate through Dr. Arthur
Ammann, a distinguished professor of pediatrics at the University of California.
In Jim Dwyer's column, Ammann, referring to the CDC's anonymous testing of
infants for HIV, said: "The maintenance of anonymous test results at a time when
treatment and prevention are readily available will be recorded in history as
analogous to the Tuskegee 'experiment.' "
Suddenly, on May 10, the CDC announced it was immediately suspending its
HIV testing for newborns throughout the country. Instead it would focus on
encouraging women to engage in voluntary HIV-testing during and before
pregnancy. (CDC was silent on the fate of the sizable number of women who do not
appear for any prenatal treatment or counseling.)
Rep. Ackerman intends to get a majority of Congress to mandate that the CDC
resume the tests -- and from now on disclose the results as well as arrange for
counseling. Meanwhile, the American Academy of Pediatrics is "shocked and
dismayed" at CDC's total abandonment of its epidemiological tracking tests.
Those were the first to show the extent of AIDS among women.
The CDC could have continued the tracking, added disclosure of results, and
been free of the taint of the Tuskegee "experiment." But instead the politicized
CDC has chosen to fold -- extricating itself from accountability.
LANGUAGE: ENGLISH
LOAD-DATE-MDC: May 20, 1995
PAGE
1
LEVEL 1 - 2 OF 4 STORIES
Copyright 1995 The Washington Post
The Washington Post
May 26, 1995, Friday, Final Edition
SECTION: OP-ED; Pg. A27
LENGTH: 1313 words
HEADLINE: It's Not 'Tuskegee' Revisited: The false furor over HIV testing and
newborn babies.
BYLINE: Ronald Bayer
BODY:
For seven years state health departments across the nation, with support from
the federal Centers for Disease Control and Prevention, have conducted
epidemiological surveillance of HIV infection in the population by testing blood
samples drawn from hospital, clinic and emergency room patients after the
samples have been permanently stripped of all personal identifiers.
Those efforts have been crucial to our understanding of the geographic and
demographic pattern of HIV infection in the United States and to our
understanding of the future course of the AIDS epidemic. Now Congress is about
to consider ill-advised legislation to be introduced by Rep. Gary Ackerman
(D-N.Y.) that would prohibit the testing of blood samples, drawn from newborns,
that have been rendered anonymous. Faced with that legislative effort, the CDC
precipitously announced that it would suspend newborn surveillance pending
review. In so doing, it has interrupted the efforts of 45 states that have
tracked the number of babies being born to HIV-infected mothers.
Rep. Ackerman's proposal would permit only screening that would make possible
the notification of the mothers of babies who test positive. Republicans and
Democrats, liberals and conservatives have signed on to the Ackerman proposal,
demonstrating the appeal of legislation that, on its face, only seeks to protect
mothers and their children. The specter of the Tuskegee syphilis study -- the
notorious federal experiment that traced the course of syphilis in African
American men who were deprived of the knowledge that they had a treatable
sexually transmitted disease -- hovers over the debate.
Public health officials, on the other hand, are appalled at the prospect that
the Ackerman proposal will be enacted, depriving them of the capacity to obtain
knowledge crucial in the struggle against AIDS. They have a right to be
concerned. A serious misunderstanding of the public health and ethical issues
involved has permitted an unusual alliance to join hands in what may represent a
serious blow to the nation's effort to understand and combat AIDS.
If the Ackerman proposal is enacted, or if the CDC does not reverse its
decision, babies and their mothers will not necessarily be better off, but the
plug will have been pulled on the radar that tracks the progress of HIV
infection among childbearing women and their babies.
To understand the controversy, it is necessary to go back to the mid-1980s,
when the practice of testing blood samples after they had been stripped of
personal identifiers -- so called blinded seroprevalence studies -- was begun.
PAGE
2
The Washington Post, May 26, 1995
Soon after the licensure of the HIV antibody test in 1985, officials at the
CDC began to plan for large-scale HIV seroprevalence studies because they
understood that tracking cases of full-blown AIDS alone could not provide an
adequate picture of the epidemic's dimensions. AIDS cases were but the tip of
the iceberg: They told us about infections that had occurred up to 10 years
earlier.
However, mandatory testing of identifiable individuals was deemed neither
ethical nor politically acceptable. Studies that would rely on volunteers were
thought to be unrepresentative -- after all, there was no way of knowing whether
those who would agree to participate were more or less likely to be infected.
Therefore, the CDC elected to use, as the basis for its studies, blinded
seroprevalence studies based on blood samples already drawn for other clinical
purposes. Because such samples would be unlinked to individuals, no person could
be placed at risk of the kind of stigma and discrimination that surrounded AIDS.
No one's privacy would be violated. And thus it was unnecessary to obtain
informed consent before testing occurred.
The very process of eliminating identifiers, however, precluded the
possibility of notifying persons who were infected. Since there was little that
could be done for people with asymptomatic HIV infection, this was thought to
pose no problem. Moreover, none of this would prevent people who wanted to be
tested from seeking to learn their HIV status in settings that provided
confidential results.
The CDC's proposals for HIV surveillance were subject to searching ethical
and legal scrutiny. Did they violate the right of privacy? The right of patients
to be informed about their medical conditions? The Office for the Protection
from Research Risks at the National Institutes of Health found blinded
surveillance both ethical and legal. When a task force made up of ethicists,
lawyers, civil liberties advocates, gay rights proponents and public health
officials met at the Hastings Center -- a bioethics think tank -- to consider
the issue, there was not a single objection to such studies. A 1988 review of
the issue by a Canadian working group gave its stamp of approval to blinded
seroprevalence surveys. So too did the World Health Organization's Global
Program on AIDS.
Now that early clinical intervention for people with HIV infection has become
the standard of care, howev er, some people have begun to assert that ethical
considerations render blinded surveillance unacceptable. Infected individuals
need to know their status so that they can commence treatment. This, it is
claimed, is especially the case with regard to babies and their mothers. Is it
morally defensible to continue studies that by their very nature preclude the
possibility of notifying mothers that their babies carry the antibody to HIV --
and which also indicate that the mothers themselves are infected? Don't both
baby and mother have a right to that information? Is not the continuation of
blinded HIV surveillance studies analogous to the continuation of the Tuskegee
study, begun before the advent of penicillin, but which extended for years after
the treatment of syphilis became easy and effective?
The answer in each case is no. In the case of Tuskegee, individuals who were
known to be afflicted with syphilis were willfully deprived of that knowledge.
Indeed, every effort was made to prevent those impoverished African American men
from knowing about their situation or about the availability of therapy. The
PAGE
3
The Washington Post, May 26, 1995
situation is very different in the case of HIV.
What the enhanced prospects of therapeutic intervention for both babies and
their mothers require is not that we abandon critical surveillance studies but
rather that we undertake vigorous efforts to encourage voluntary HIV testing.
What blinded seroprevalence studies can do is help guide the necessary public
health efforts to identify the women and babies in need of care. They can tell
us about where we should expend the greatest efforts in developing the capacity
to provide voluntary testing and counseling.
Now that it appears that the risk of transmission of HIV from infected
pregnant women to their fetuses can be radically reduced by treatment with AZT
during pregnancy, such studies can tell us where to focus resources so that
women are encouraged to undergo testing before they give birth. Here there is a
chance for real HIV prevention.
Most important, it is crucial that we make certain that women and babies who
are identified through voluntary testing programs be provided with access to
needed clinical and social services.
To compare blinded surveillance for HIV infection to Tuskegee is to threaten
the interest of the mothers and babies who could benefit from carefully targeted
efforts to identify those in need of care. Clever political slogans about the
right of mothers to know about their babies' lethal infections should not serve
to justify an attack on studies that have proved so invaluable in the past and
that remain crucial today.
The writer is a professor at the Columbia University School of Public Health
and author of "Private Acts, Social Consequences: AIDS and the Politics of
Public Health."
GRAPHIC: Illustration, margaret scott
LANGUAGE: ENGLISH
LOAD-DATE-MDC: May 26, 1995
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LEVEL 3 - 20 OF 28 STORIES
Copyright 1994 The New York Times Company
The New York Times
June 27, 1994, Monday, Late Edition - Final
SECTION: Section A; Page 16; Column 1; Editorial Desk
LENGTH: 752 words
HEADLINE: AIDS Babies Deserve Testing
BODY:
All those concerned about babies infected with the virus that causes AIDS can
be grateful to Michael Dowling, New York's Commissioner of Social Services. He,
at least, has had the decency and common sense to guarantee that all
AIDS-infected babies in the foster-care system will DE identified and cared for.
But what about the larger number of AIDS-infected babies who are not in
foster care? Their fate now hinges on the outcome of a legislative battle that
pits the health needs of the babies against the privacy rights of the mothers.
The core issue is whether there should be mandatory testing and
identification of all newborns 50 that those infected with the AIDS virus can be
treated -- or simply mandatory counseling of all mothers to try to persuade them
to allow testing of themselves and their babies.
Each side in this clash claims its approach will be best for the children.
But from the evidence available, the likelihood that counseling alone will do
the JOB seems slight. The only sure way to identify these infants IS through
testing. The state already tests all newborns, anonymously, to track the
epidemic; it could use or enhance that program to identify the infected
infants who need medical monitoring and treatment.
The dispute arises because there is no way to Identify an infected newborn
without identifying the mother as infected; the babies contract the virus from
their mothers in the womb or at birth. Thus a mandatory test of any newborn
amounts to a mandatory test of the mother as well, subjecting her to possible
discrimination if her disease status becomes known. Under current state law,
neither the mother nor her child can be tested without written, informed
consent.
Commissioner Dowling avoided this dilemma because his agency has legal
responsibility For the babies in its care; in effect, he is their surrogate
parent. Thus he provoked no opposition when he pledged recently to require
routine testing of all children who enter foster care and appear likely to have
been exposed to the virus.
But Foster children account For only a minority of the several hundred
AIDS-infected babies born in New York State each year. Most of these babies
leave the hospital without being tested. They are thus robbed of any chance at
early treatment. Nothing is done for them until they come down with symptoms of
the Fatal illness.
Assemblywoman Nettie Mayersohn, of Queens, and State Senator Guy Velella, of
the Bronx, would rectify this neglect by disclosing the state's anonymous test
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The New York Times, June 27, 1994
results to the mothers. That may not go far enough. When individual lives are at
stake, the tests must be conducted more rigorously than those now performed for
statistical purposes. Still, done properly, such testing could identify
virtually every infected baby, and the mothers could then De counseled on the
importance of medical follow-up.
But leaders of the key health committees in the Legislature are pushing
bills, already approved in the Senate, that only call for mandatory counseling
of new and expectant mothers. They argue that this would capture the great
majority of infected children -- and that babies would get better care If their
mothers cooperated in treatment than If they were frightened away From the
medical system because of mandatory testing.
Unfortunately, there is scant evidence that the counseling approach would
work. The state already sponsors voluntary counseling programs for pregnant
women and new mothers in 24 hospitals in AIDS-impacted areas; they typically
fail to identify most of the infected babies. Counseling enthusiasts cite the
success of Harlem Hospital; some 90 percent of all infected babies born there in
1993 were identified through counseling and voluntary testing. But even the
founder of that program doubts its success could be replicated widely. And why
neglect even 10 percent of the babies?
Mandatory counseling could be Deneficial during prenatal care when doctors
can actually save many babies from infection by treating the expectant mother
with AZT. Since no one is seriously recommending that pregnant women be forced
to take an AIDS test, counseling the mother-to-be on the benefits of testing is
the only feasible approach.
But once a mother has delivered an infected baby, that infant deserves to be
identified and given the best possible care. By all means, counsel the mother on
the advantages of testing and treatment. But for the baby's sake, test the child
whether the mother approves or not.
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American Academy of Pediatrics
IIII AMERICAN FEDIATRIC
TESTIMONY
OF THE
AMERICAN ACADEMY OF PEDIATRICS
BEFORE THE
HEALTH SUBCOMMITTEE
OF THE
COMMERCE COMMITTEE
U.S. HOUSE OF REPRESENTATIVES
ON
PEDIATRIC HIV TESTING
Presented by:
Louis Z. Cooper, MD
May 11, 1995
Department of Government Liaison
The Homer Building
601 Thirteenth Street. N.W.
Suite 400 North
Washington, D.C. 20005
202-347-8600 / 800-336-5475 / FAX: 202-393-6137
1
Good afternoon. I am Louis Cooper, MD, Director of Pediatrics at St. Lukes Roosevelt
Hospital Center in New York and Professor of Pediatrics at Columbia University. I speak as
a member of the Board of Directors for the American Academy of Pediatrics (AAP), an
association representing over 49,000 pediatricians dedicated to promoting the health and well-
being of infants, children, adolescents and young adults. Thank you for the opportunity to
appear before you today to discuss the issue of perinatal HIV testing.
This is a passionate debate that knows no political boundaries. Democrats and Republicans,
liberals and conservatives, men and women all find themselves together on different sides of
the issue.
The development of our own policy statement was a long and deliberate process. The
discussions were sometimes tense, often emotional but always grounded in the principle that
the final policy must provide a child the most medically appropriate, ethical treatment
available to date. This is not a stagnant policy. It is one that will evolve as the epidemic and
treatment evolves and the Academy's policy will reflect the most current medical data
available.
This is an extraordinarily complicated debate. It is not an "either/or" issue, which some
would like to suggest. There is an effort to categorize the arguments surrounding HIV
testing of women and infants as either a "privacy of the mother" issue or one of "protection of
the child". The consequences are monumental on both sides.
This debate might better be categorized as an "IF-THEN" scenario. From a scientific point,
we know that IF a pregnant woman agrees to prenatal HIV testing and is found seropositive,
THEN she can choose to enter a program of treatment for herself and her unborn child. IF
she enters into the treatment plan, THEN she will significantly reduce the likelihood of
transmitting the HIV virus to her child. IF her child is born with HIV virus, THEN the child
can receive treatment to delay the onset of opportunistic diseases like pneumocystis carinii
pneumonia (PCP).
But this medical sequence does not reveal the complexities of getting a woman and child
proper treatment and counseling. The social components of the debate must be understood, as
well. It is critical that the epidemic be explored, within both the medical and social context.
BACKGROUND
Human immunodeficiency virus infection continues to spread among women of childbearing
age in the United States, and is occurring in rural as well as urban areas. In 1993, 12.6
percent of new AIDS cases were diagnosed in women -- up from 6 percent in 1982. (1,2)
With the increasing heterosexual spread of HIV, previously defined risk behaviors for HIV
infection incompletely identify women found to be infected. The predominant risk behavior
for HIV infection in many women is unprotected sexual intercourse. Perinatal HIV infection
has mirrored the increases in HIV infection in women. More than 95 percent of AIDS cases
2
in children from birth to 4 years old are caused by perinatal infection.
The persisting occurrence of PCP in young infants despite the availability of effective
prophylactic regimens indicates that the identification and treatment of HIV infection in
infants at an early age remains inadequate. (3)
AAP POLICY ON PERINATAL IMMUNODEFICIENCY VIRUS (HIV) TESTING
On the basis of recent advances in the therapy to reduce the rate of perinatal HIV
transmission and the continued occurrence of life-threatening illness in young infants with
unrecognized HIV infection, the AAP recommends: "Documented, routine HIV education
and routine testing with consent for all pregnant women in the United States."
A copy of the full AAP policy statement is attached.
It is critical to examine the Academy's policy statement in depth in order to understand how
the science and societal issues merge in this position.
Routing Testing: Testing needs to be viewed as standard of care for ALL pregnant women in
the United States, not just for those in targeted geographic, socio-economic or ethnic groups.
The vast majority of physicians in the United States target testing only to women they feel are
"at risk" or the woman is required to request the test from the provider, thereby having to
identify herself as being someone who has engaged in behaviors that society may not condone
(which many people may be reluctant to do). As a result, HIV testing has not been routinely
offered and recommended to ALL patients.
Testing programs for HIV antibody must be confidential, voluntary, and accompanied by
cultural and ethnically appropriate information regarding HIV infection. The purpose of
testing is not to label a mother or infant as infected but to engage the mother into appropriate
medical care for herself and her infant. This is the most likely to occur when the woman
feels she has been able to make an informed decision about her own health, including HIV
testing.
HIV is a chronic illness that requires long-term adherence to often multiple therapies for the
mother and child. While testing without patient knowledge or consent appears easier for the
health care provider, it would seem less likely to result in a patient that will understand and
adhere to chronic therapies for herself and her child.
The ACTG 076 zidovudine (AZT) regime is complex. It requires taking AZT five times
daily in the mother and administration four times daily for six weeks to the newborn infant.
Adherence to this regimen requires a patient who understands and is motivated to comply
with therapy. This is most likely to occur in the context of a trusting provider-patient
relationship, and appears unlikely to be facilitated by involuntary testing of a patient without
their knowledge.
3
High test acceptance levels (in the range of 94-97 percent) have been achieved without
mandatory testing in places that have initiated routine, universal voluntary testing programs.
Jackson Memorial Hospital in Miami, Florida reported in the first three months of 1995 that
96 percent of women counselled prenatally for HIV also agreed to testing. This was up from
92 percent in 1994 (4). Similar rates of acceptance were reported at Grady Memorial
Hospital in Atlanta, Georgia; and Harlem Hospital in New York (5).
Routine HIV Education: Routine education about HIV infection and testing needs to be a
part of a comprehensive program of health care for women, particularly for women of child-
bearing age. Detection of HIV infection may be associated with anxiety and depression.
Other risks include potential social stigmatization and discrimination. Also, because illicit
intravenous drug use is associated with HIV infection and may be used as a basis to remove
an infant from the mother's care, women who use illicit drugs may fear HIV testing.
Routine HIV education accompanied by offering HIV testing to all pregnant women appears
most likely to achieve the goal of engaging a mother in compliance with medical care for
herself and infant.
Women need to be given sufficient information in a clear and understandable manner to
appreciate the benefits and risks of the proposed HIV test and the consequences of accepting
or rejecting testing for herself and her infant. This process is best performed within the
context of a professional relationship between the woman and her health care provider. It is
possible if the benefits of HIV testing are not made known to pregnant women, fear of the
potential negative consequence may deter some women from seeking prenatal care. However,
in several settings in which HIV counseling and voluntary testing have been routinely offered
to all prenatal patients, no measurable decrease in women seeking prenatal care has been
observed.
Documented Testing With Consent: Because the results of ACTG 076 indicate that AZT
reduces perinatal transmission of HIV, there is now a compelling reason for universal
antepartum HIV education and routine testing with consent.
Documented consent for maternal and/or newborn HIV testing may be obtained in a variety of
ways including, but not limited to:
1)
Individualized counseling followed by a signature that affirms consent to testing;
2)
provision of education followed by a signature that either explicitly consents to or
explicitly refuses testing; or
3)
education followed by a signature only to explicitly refuse the test.
Each of these methods is an ethically acceptable way to respect the individual's decision
whether or not to be tested. The Academy supports utilization of consent procedures that
facilitate rapid incorporation of HIV education and testing into the routine medical care
4
setting. Whichever method of obtaining consent is chosen, it is critically important that
appropriate education regarding HIV infection is provided to the individual before a decision
regarding testing.
Individualized counseling in conjunction with obtaining a signature on an informed consent
form requires significant health care resources. Patient education in written form or group
settings followed by a signature of consent or refusal may require less intensive resources. In
both of these methods of consent, the provider may directly recommend the test. Routine
patient educations accompanied by a signature to reject the test (right of refusal) implies that
the test is recommended by the health care professional and therefore will be performed
unless the patient signs the form, and may also result in the largest number of women being
tested. Although some believe that right of refusal consent is inherently coercive,
documentation of appropriate patient education and confidentiality reduce the likelihood of
such concern.
TESTING NEWBORNS
Testing of a newborn is too late. The only true "life-saving" treatment is to prevent HIV
infection of the infant in the first place. The risk of perinatal HIV transmission can be reduced
through the administration of AZT to HIV-infected women and their infants. If we want to
attempt to prevent transmission by offering a mother AZT, one must know maternal infection
status and start treatment by mid-pregnancy. In times of limited dollars, resources should be
used to fund expanded prenatal HIV testing programs, not involuntary newborn testing.
For newborns whose mother's HIV serostatus was not determined during the recent pregnancy
or the postpartum period, the infant's health care provider should educate the mother
concerning the potential benefits of HIV testing for her infant and the possible risks and
benefits to herself of knowing the child's serostatus and recommend HIV testing for the
newborn.
The health care provider for the infant needs to be informed of maternal HIV serostatus so
that appropriate care and testing of the infant can be accomplished. Similarly, if the infant is
found to be seropositive when maternal serostatus is unknown, the health care provider for the
child should ensure that information about the serostatus and its significance be forwarded to
the mother and, with her consent, to her health care provider. The mother should receive
appropriate referral to adult HIV-related services.
Because infant testing provides information important to the well-being of the infant and also
information regarding the infection status of the mother, the health care provider is obligated
to educate the mother about HIV infection and to obtain consent using one of the methods
described above when HIV testing of the infant is contemplated. In the absence of parental
availability for consent to test the newborn for HIV antibody, procedures need to be
established to facilitate the rapid evaluation and testing for the infant.
5
CONCLUSION:
As noted, there are now clear medical benefits for pregnant women to know their HIV
serostatus. In addition to the importance HIV testing has for early diagnosis and treatment of
women, the availability of treatment capable of significantly reducing perinatal transmission of
HIV provides compelling rationale and motivation for all pregnant women to know their HIV
serostatus during early pregnancy.
Voluntary testing for HIV in pregnant women has been proven successful in numerous
instances. The Academy urges Congress to avoid well-intentioned efforts to intercede by
imposing federal restrictions and requirements on individuals -- whether they are adults or
infants.
We specifically oppose legislative efforts such as HR 1289, The Newborn Infant HIV
Notification Act. This bill would not reduce perinatal HIV infection in newborns but would
result in placing crippling constraints on the efforts of the Centers for Disease Control and
Prevention to obtain essential information related to the HIV/AIDS epidemic in the United
States.
The CDC-sponsored "HIV Survey in Childbearing Women" seroprevalence study is a critical
ingredient in the fight against HIV/AIDS for multiple reasons. It is the best tool we have for
tracking the epidemic across the nation. It serves as the critical "Gold-standard" by which we
must judge our programs of early detection and early treatment in pregnancy. Equally
important, it is the most reliable means of monitoring the effectiveness of programs for
reducing transmission of HIV infection in infants and for the early care for those who are
infected.
With adequate public health surveillance we may reach conclusions and shape our policies
based, not on speculation but on information which is both national and highly focused and
local in scope.
We urge Congress to encourage federal agencies to partner with private professional
organizations such as the American Academy of Pediatrics to expand on the existing successes
of voluntary testing with consent and to promote comprehensive HIV education and voluntary
testing of all women as a means to accomplish identification of infants at risk for transmission
of the HIV virus. It must be stated that this goal can not be accomplished unless education
and testing is coupled with support for programs which assure access to appropriate health
services for HIV-infected children and their families.
The Academy stands ready to evaluate its policy on Perinatal HIV Testing on an on-going
basis. The rapidly evolving research on HIV/AIDS provides us increased means of
controlling the epidemic. We are equally eager to insure our membership understands its
responsibility in educating parents and protecting children. Clearly, as further data becomes
available, Congress must continue to monitor and evaluate efforts to ensure the needs of these
6
populations are being met.
Thank you for the opportunity to share the Academy's policy with the Committee. I would
be pleased to answer any questions.
1.
Centers for Disease Control. Update: acquired immunodeficiency syndrome -- United
States, 1992. MMWR. 1993;42:547-551,557
2.
Ellerbrock TV, Bush TJ, Chamberland ME, Oxtoby MJ. Epidemiology of women
with AIDS in the United States, 1981 through 1990. JAMA. 1991;265:2971-2975
3.
Hsu HW, Moye J Jr, Kunches L, et al. Perinatally acquired human immunodeficiency
virus infection; extent of clinical recognition in a population-based cohort.
Massachusetts Pediatric HIV Surveillance Working Group. Pediatr Infect Dis J.
1992;11:941-945
4.
O'Sullivan, Jackson Memorial Hospital, Miami. 1994, 1995
5.
Lindsay MK, et al. Routine antepartum human immunodeficiency virus infection
screening in an inner-city population; Obstetrics and Gynecology. 1989;74:289-294
Attachment
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Centers for Disease Control
and Prevention (CDC)
Attants as you
MAY $0 1995
Mr. Vincent Carroll
Aditorial Page Editer
Denver Rocky Mountain News
400 W. Colfax Avenue
Denver, Colorado 80204-2694
Dear Mr. Carroll:
Recently, done people have proposed mandatory testing of every
baby born in the United States-for HIV, the virus that causes
AIDS. On the surface, this might seem like a good idea. If all
newborns were tested, parents or guardians could seek needed
medical care.
But testing newborn babies is too little too late to prevent HIV
infection and save babies' lives. Last year, a significant study
showed HIV-infected women could reduce the risk of transmitting
the virus to their babies by taking the drug AZT during
pregnancy, labor and delivery, and by giving the baby AZT for the
first six weeks after birth. For the first time--and the only
time we know of 50 far--we can prevent HIV infection with 8 drug.
To take advantage of this preventive treatment, women need to
know they're HIV-infected well bafore giving birth. Far too many
don't know, and far too many go through pregnancy without having
the opportunity to be tested,
That's why guidelines from the Centers for Disease Control and
Prevention (CDC) recommend routine counseling and voluntary HIV
testing for all pregnant women, as well as providing treatment
before, during, and after birth. If a woman hasn't been tested
during pregnancy, CDC recommends offering an HIV test for her
baby shortly after delivery and before they leave the hospital.
This individual prevention strategy is being confused with one of
the national surveillance tools CDC used to monitor the HIV
epidemic. This surveillance tool. the Survey of Childbearing
Women, has provided the clearest picture of the threat MIV poses
to women and children.
This is how the survey worked: Newborne! blood samples were sent
to state laboratories for routine metabolic tests. After those
tests were completed and the samples were no longer linked to
individual patients, some samples were tested for HIV, often
weeks or months after mother and child left the hospital. The
samples vere not and could never be individual patient diagnostic
tools. No one had the names of those who tested positive. But
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Page 2 - Mr. Vincent Carroll
the survey provided data that enabled State health departments
and CDC to predict trends in HIV infection among women and
children and helped direct prevention and research efforts.
with recent advances in the ability to decrease perinatal
transmission, CDC is now re-evaluating how best to combine
prevention and surveillance strategies to meet these important
new challenges. Assistant Secretary for Health Dr. Phil Les
asked all seate and territorial health departments to suspend the
Survey of Childbearing Women until those strategies are
developed
CDC has the responsibility to save lives and prevent disease. No
also have the responsibility to direct finite resources and
Dublic health afforts where they can do the most good. The best
way to accomplish those goals is to fully implement and evaluats
the CDC guidelines for routine counseling and voluntary HTV
testing during pregnancy and by continuing to monitor HIV and
AIDS trends to ensure that prevention afforts are working.
Sincerely,
David Satcher, M.D., Ph.D.
Director
2
Clinical Controversies
Mandatory
Newborn Screening for HIV
Long Overdue, but Not Nearly Enough
Mark S. Rapoport, MD, MPH; Westchester County, N.Y.
Key words: Human immunodeficiency virus (HIV) Transmission, HIV
The very fact that New York State and New York City
mother, potential location of other cases, especially the
have been actively grappling for more than a year with
child's father; education for prevention of additional
the question of mandatory HIV antibody screening of all
transmission by any and all recognized routes; and a
newborns tells a great deal: Multiple benefits accrue
broad range of social services (especially those available
from knowing that a baby is HIV-seropositive (with actual
via the Ryan White Care Act) for the family. None of
infection easily verifiable). These include better diagno-
these benefits are disputed.
sis of febrile and pulmonary illness; antibiotic prophy-
For most people, in New York State and elsewhere, the
laxis for pneumocystis infection and modified immuniza-
case for screening is straightforward and compelling. It
tion for the baby; counseling on the risks of breast
serves the HIV-seropositive baby's health for the data to
feeding and a host of other medical interventions for the
be known, and parents should want to do well by their
children. Parents should have this information. even if
Dr. Repoport is commissioner of health. Westchester County, N.Y.
they do not want it The headline on the cover of the Feb-
September/October 1994 The AIDS Reader 173
Z
81 ON
19118 5661 26 50
Newborn Screening
continued
ruary 21, 1994, issue of New York magazine may have cap-
our strategies and to bring AIDS care and AIDS policies
tured that feeling. It said, "Should It Be a Crime to Treat
closer to the norm for public health problems. Mandatory
This Baby for AIDS? The Rising Storm Over the Law That
newborn screening is one such step and is long overdue.
Keeps HIV-Positive Newborns from Early Treatment."
Having said that, we must address the ACTG 076 study
The view of the majority of people most deeply in-
showing the clear benefit of giving zidovudine prenatally
volved in AIDS policy and AIDS care, however, is very
andintrapartum to pregnant women, and then to the new-
different. While they agree that real benefits accrue to
born. The beneficial results are truly exciting. Taken to-
both baby and mother and from knowing a baby's
gether, the 3 interventions cut the rate of vertical trans-
serostatus, other considerations take precedence. First,
mission by about two-thirds, from 26% to 8%. If all
"coercion" is the key issue, with analogy sometimes
HIV-infected women received the entire "package," per-
made to testing Federal prisoners. Second, decade-old
haps 400 lives would be saved annually in New York State
fears arise of losing insurance, spouses, and jobs (al-
alone. There is a consensus that our emphasis now must
though the testing would be strictly confidential). Third,
bè to identify and treat infection in pregnant women at
there is the unsubstantiated fear that state-mandated test-
the earliest possible time. Further, there is widespread
ing would forever estrange HIV-seropositive women
agreement that a voluntary program would be the best
from their doctors and "the system," and "drive them un-
first effort I concur with this, since in the prenatal con-
derground."
=
text, we confront the likelihood that substantial numbers
I find none of these arguments convincing. The evi-
of women (especially those with the most risk-laden
dence for these fears being realized is very weak. Fur-
medical history and social circumstances) might be de-
thermore, all the perceived difficulties can be minimized
terred from seeking early prenatal care, or might be
by good counseling. good follow-up. and strong safe-
more likely to drop out of care. However, I believe that
guards on confidentiality. All of these things are possible
such a program would have to be well designed and con-
and are already being done to a substantial degree. The
tinually evaluated, with a mandatory prenatal testing pro-
record of the public health enterprise in maintaining con-
gram as a true alternative if a voluntary program did not
fidentiality is especially good.
achieve and maintain high rates of participation.
A strong sense of the history of discrimination (against
Although a prenatal effort at testing and treatment
women, people of color, and gay men) underlies many of
must be the first priority, the issue of testing newborns is
these fears. These sensibilities may be acknowledged,
by no means moot Some women will not seek prenatal
but should not be considered an eternal bar to progress
care, and women at highest risk for HIV infection are
in the ways we combat the plague of AIDS. AIDS is in
likely to be over-represented in that group. Also, some
many ways different from tuberculosis, hepatitis, and
women will refuse prenatal testing. What should our re-
syphilis, but it is also similar in many ways. All have some
sponse be to the needs of these women and their new-
stigma associated with them, nonetheless we have
borns? I believe that although the absolute number of in-
mounted credible efforts against them. In the course of
fected babies will be lower (hopefully, a great deal lower)
these efforts, we often encounter suspicion, distrust, and
than under present circumstances, society's obligation to
fears, but usually we can overcome them. This has direct
those babies remains unchanged. It is not difficult, I
relevance to the arguments relating to undermining the
think, to make a case for considering the refusal to accept
trust of women who are indirectly tested by a newborn
testing, and the attendant inability to act on the results of
screening program. I think we give these women too
that testing, a form of the true "medical neglect"
little credit if we assume that they will be unable to see
As a society, we do not tolerate medical neglect of
the benefits of screening (in retrospect, if not prospec-
children's needs in regard to conditions other than AIDS,
tively) and that this failure on their part will translate to a
many of which are not nearly as lethal We certainly need
distrust of and unwillingness to coopérate with their doc-
to develop a voluntary prenatal HIV program, incorporat-
tors, nurses, and social workers. The law would emanate
ing mandatory counseling and minimizing barriers to
from the state government, not the professional at the
participation; a mandatory testing program for the al-
bedside, and this distinction is not difficult to discern.
ready-born child would not be at odds with such a pro-
Mandating testing programs for hepatitis B and syphilis
gram. In fact, it would reinforce it, just as it would rein-
has not had the feared effects and I do not believe that an
force our commitment to valuing the life of every child,
HIV newborn-screening program would either. From our
and preserving and caring for those lives in the best way
efforts with these diseases, we should learn to improve
we know how.
174
Sentember/Ortober
1994
2
di
18 ON
16:18
26
FROM
Clinical Controversies
Mandatory
Newborn Screening for HIV
The Wrong Answer to the Wrong Question
Alan R. Fleischman, MD; Albert Einstein College of Medicine, Bronx, N.Y.
212-987-7281
Key words: Human immunodeficiency virus (HIV)
Transmission, HIV
Pediatricians responsible for the care of children infected
Clinical Controversies
with the human immunodeficiency virus (HIV) increas-
This exchange of opinions on the mandatory screening of
ingly voice concern that the earliest indication of HIV dis-
newborns for HIV antibodies is the first in an occasional se-
ease in a child is a fatal infection during the first months
ries of clinical controversies in HIV/AIDS care.
of life. Some of these health professionals believe that
early identification of children at risk for HIV infection
and the initiation of prophylactic therapies will greatly en-
portance of knowing their HIV status in order to reduce
hance the quality and quantity of children's lives. This
HIV transmission from one person to another? With par-
has resulted in the recommendation that the standard
ticular emphasis on women, how can we create a general
newborn screening test done on all babies right after
standard of medical practice so that every woman who is
birth, which currently identifies several genetic and
of reproductive age or is at her first prenatal visit is coun-
metabolic disorders, be utilized to find children who are
seled concerning the benefits of knowing her HIV status
infected with HIV. At first glance this recommendation
and offered appropriate comprehensive services for her-
seems both well-meaning and reasonable, in that the goal
self and her family?
of protecting children from unnecessary illness is cer-
A program of counseling and voluntary testing before
tainly laudable. However, there are many questions to be
or early in pregnancy can result in the identification of
raised about the basic assumptions upon which this rec-
women who would be offered the option of antiretroviral
ommendation is made, as well as serious concerns about
treatment in an attempt to block HIV transmission to the
the consequences of universal, nonconsensual screening
fetus. Even though all of the questions concerning the
of newborns for HIV.
use of ZDV in pregnancy have not been answered, the com-
Ironically, this debate is occurring at a time when excit-
pelling nature of the data demands that we make this op-
ing new data are emerging about the prevention of trans-
tion available to women who want this intervention.
mission of HIV from pregnant women to their fetuses
It is critically important that the testing of women be
through the administration of zidovudine (ZDV) to the
done with their permission and full understanding of the
woman during pregnancy and intrapartum, and to the
benefits and risks of the test. The health care establish-
newborn for 6 weeks after birth. The possibility of phar-
ment must foster an atmosphere of trust between pa-
macologic primary prevention of HIV transmission dur-
tients and their providers that can be translated into the
ing pregnancy creates a far more important question:
delivery of comprehensive services over a long period of
How can we educate the entire population about the im-
time. The treatment of HIV disease and the potential pre-
Dr. Fleischman is senior vice president at the New York Academy of
vention of transmission requires the full cooperation of a
Medicine and clinical professor of pediatrics, epidemiology, and social
knowledgeable and committed patient. Mandatory pro-
medicine at Albert Einstein College of Medicine, Bronx. N.Y.
grams based on coercion will only lead to greater distrust
172 The AIDS Reader September/October 1994
ON
16:20
FROM
Newborn Screening
and result in patients who are appropriately reluctant to
them voluntarily to learn their HIV status? If they are
favorably consider therapeutic options presented by well-
HIV-positive, how do we ensure that they receive needed
meaning health care professionals.
care for themselves and potential interventions to pre-
Knowing and accepting all of this, some legislators and
vent transmission to their fetus and, finally, that they pro-
health care leaders continue to press for mandatory
vide care for their infants? This can only be accomplished
screening of newborns for HIV. They argue that there is
through a new standard of medical practice that counsels
a need for a "safety net" to identify newborns whose
women on the importance and appropriateness of know-
mothers have not received prenatal care or who have re-
-ing their HIV status before, during, and after pregnancy.
fused to be tested. Of course, they realize that only a
Pregnant women should be counseled about the benefits
small proportion of the babies who test positive for anti-
and potential risks of HIV testing while receiving prenatal
body at birth actually will be infected (15% to 30%) while
care and at the time of delivery. Testing should be linked
100% of these infants' mothers will be infected. They also
to services and a positive test should result in referral to a
must be aware that the goal of a screening program is not
program that provides comprehensive care for families.
merely the identification and labeling of a potential pa-
Perhaps most critically important in the analysis of this
tient, but also the provision of needed services to that pa-
complex problem is the issue of trust and respect among
tient and family.
health care professionals, their patients, and the public at
It is incredible to me that some physicians and politi-
large. We need not create an atmosphere of fear and co-
cians would consider a program that would combine vol-
ercion when we have the opportunity to develop a pro-
untary testing during the prenatal period and mandatory
gram of screening and care that is both voluntary and
testing after birth. Can we, as professionals, in good faith
comprehensive and will likely benefit the vast majority of
counsel women about the importance of knowing their
those in need. We have available today a potential
HIV status during pregnancy and accept their voluntary
method to identify virtually all of the infants who are at
decision about testing, only to test them involuntarily af-
risk for HIV infection through mandatory counseling and
ter birth? This seems duplicitous and inappropriate. Of
encouraged testing of women. With appropriate re-
course, all women who have not been tested previously
sources given to education and health care delivery, the
should be counseled at the time of birth about the impor-
desired goal of early identification and treatment of HIV-
tance of testing, and we should encourage as many moth-
infected infants can be accomplished without mandatory
ers as possible to know their and their newborns' HIV
newborn screening. The right question is how to develop
status.
a trusting relationship in order to provide services to
We have the potential to ask the right question and cre-
those in need. The right answer is universal counseling
ate the right answer. The right question is: How can we
and voluntary testing.
offer appropriate counseling to all women and engage
S
81 ON
16:21
S661
FROM
MEMORANDUM
TO:
Jennifer Klein
FROM:
Zoë Neuberger 5n
DATE:
June 13, 1995
RE:
HIV Testing of Infants
You will find attached two pieces of information related to the
transcript of the Charlie Rose program on HIV testing of infants.
1) An article published in the New England Journal of Medicine
reporting the results of a study on PCP pneumonia prevention
in HIV positive infants. The study was conducted the CDC's
PCP Pneumonia Prophylaxis Evaluation Working Group.
2) An article that appeared in Newsday, which refers to the
lawsuit brought by the Association to Benefit Children, a
NYC-based child advocacy group, against Governor Pataki to
force the state to release test results. The librarian
located 24 other articles on the issue of mandatory HIV
testing of infants, but none of the titles suggest that they
would discuss the lawsuit. The law library has no
information on the case, since it is still pending. If you
would like further information, I could call the Association
to Benefit Children directly, but I will await your
instructions.
CC: Karen Guss
SENT BY PUBLIC AFFAIRS
: 6-12-95 : 1:06PM
CDC-
912024567431 # 2/ 6
The
THE NEW ENGLAND JOURNAL OF MEDICINE
March 23. 199'-
Michelle--
Vc
SPECIAL ARTICLE
CC
(if
PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA AMONG CHILDREN WITH
PERINATALLY ACQUIRED HUMAN IMMUNODEFICIENCY VIRUS INFECTION
Es
IN THE UNITED STATES
R.J. SIMONDS, MD, MARV Lou LINDECREN, M.D., POLLY THOMAS, M.D., DEBRA HAN3ON, M.S.,
yr
BLAKE CALDWELL M.D., GWENDOLYN SCOTT. M.D., AND MARTHA ROCERS, M.D.,
FOR THE PNEUMOCYSTIS CARINII PNEUMONIA PROPHYLAXIS EVALUATION WORKING GROUP*
Abstract Background. Pneumocystis carinii pneumo-
oped in 2.4 percent. Of 300 children with PCP diagnosed
he
nia (PCP) remains a common and ofton fatal opportunis-
from January 1991 through June 1993, 199 (66 percent)
ed
tic infection among children Infected with the human im-
Cr
had never received prophylaxis. and for 118 of those chil-
munodeficiency virus (HIV) HIV-infected infants between
in)
dron (59 percent) exposure to HIV was first identified 30
85
three and aix months of age are particularly vulnerable.
days or less before the diagnosis of PCP. Among 129 chil-
an
Current guidelines recommend prophylaxis in children
dren less than one year old, the CD1+ count doclined by
dr.
from birth to 11 months old who have CD4+ counts below
an estimated 967 cells per cubic millimeter (95 percent
int
1500 cells per cubic millimeter.
contidence interval. 724 to 1210 calls per cubic millime-
an
Methods. We used national surveillance data to OS-
ter) during the throe months before the diagnosis of PCP.
an
timate the annual incidence of PCP among children
Among infants In whom CD4+ counts were determined
RCI
less than one year old. We reviewed the medical rec-
within one month of the diagnosis of PCP, 18 percent (20
ords of 300 children given a diagnocic of PCP between
the
of 113) had at least 1500 cells per cubic millimeter, a level
'yr
January 1991 and June 1993 to determine why treat-
higher than the currently recommended threshold for pro-
blc
ment according to the 1991 guidelines for prophylaxis
phylaxis.
SCI
against PCP either was not given or failed to prevent the
Conclusions. In the United States the incidence of
mi
disease.
PCP among HIV-infected infants has not declined. If this
lut
Results. In our study the incidence of PCP in the first
infection is to be prevented, infants exposed to HIV must
to!
year of life among infants born to H/V-Infected mothers
be identified earlier, and prophylaxis must be offered lo
in
changed little between 1989 and 1992 Among 7080 chil-
de
more children than the guidolines currently recommend.
dren born to HIV infected mothers in 1992, PCP devel-
su
(N Engl J Med 1995;332:786-90.)
tal
M
OST cases of Pneumocystis carinii pneumonia
Low CD1+ cell counts were thought to identify the
(PCP) in children infected perinatally with the
be
HIV-exposed children who were at highest risk for PCP
for
human immunodeficiency virus (HIV) occur in infants
even early in life. when the available techniques were
int
between three and six months of age.¹ Because PCP is
unable to establish " diagnosis of IIIV infection. Rec-
the most common opportunistic infection classified as
ognizing that PCP occurs most frequently in early in
indicating the presence of the acquired immunodefi-
C.
fancy, the panel also stressed the need TO identify expo-
ciency syndrome (AIDS) in children,¹ because it is often
sure to HIV as soon as possible.
rapidly fatal,2 and because il can be prevented by
vic
Concern has been aroused about whether the recom-
int
chemoprophylaxis,3 clinicians and public health offi-
mended practices can adequately prevent PCP in chil-
cials emphaaize its prevention as part of the care of
dren born TO IIIV-infected mothers. 7-2 In one report
dr.
children exposed to IIIV and in setting priorities for
HIV exposure was often not identified in time for pro-
pr
5H
public health policy. In 1991. a paud of experts in pc-
phylaxis to be given during the peak risk period for
idi
diatric HIV infection issued guidelines that recom-
PCP in early infancy.⁷ Other small atudies have sug-
dr.
mended evaluating the ink of PCP in children born to
gested that monitoring CD4+ cell counts as recom-
I'e
HIV-infected mothers by measuring the CD11 cell
mended in the current guidelines may not be adequate
count and offering chemoprophylaxis if the count is
in
to determine the risk of PCP during the first year of
do
lower than an established age-specific threshold.+ The
life.8.9
ce
thresholds for prophylaxis were as follows: for children
lo evaluate the 1991 guidelines for prophylaxis, we
the
from birth through 11 months old, 2 CD4+ count be
estimated trends in the incidence of PCP among in-
frr
low 1500 cells per cubic millimeter; 12 through 23
to
fants born to IIIV-infected mothers between 1989 and
months nld, helow 750 cells per cubic millimeter;
1992. In addition, WC conducted a retrospective study
na
2 through 5 years old, below 500 cells per cubic milli-
of more than half the U.S. children given a diagnosis
in
meter; and 6 through 12 years old, below 200 celle per
of PCP in recent years in order in determine how
At
cubic millimeter.
often HIV exposure is identified before PCP is diag-
bil
nosed, how often the risk of PCP in such children is
From the Division of HIV/AIDS National Center for Infectious Diseases, Can
rere for Disease Control end Prevention, Atlanta (R.J.S., M.L.L. D.H., B.C.,
evaluated by means of CD4+ ccll counts, and whether
M.R.); the New York City Department of Health, New York (T.T.); and the De.
prophylaxia in initiated as recommended in the 1991
partinent of Rediatries. University of Miami School of Medicine, Miami (0.5.)
guidelines. In determine whether the currently recom-
Address reprint requests to Dr. 3imonds at the Division of HIV/AIDS. Centers
for Discase Control and Prevention. 1000 Clifton Rd., Mailstop b-45. Atlanta.
mended thresholds for prophylaxia and schedules fur
GA 30333.
monitoring are adequate to identify the children at
Other participants in the working group are listed in the Appendix.
greatest riak for PCP, we also analyzed data on CD++
SENT BY:PUBLIC AFFAIRS
: 6-12-95 : :06PM :
CDC-
912024567431 3/ 6
urch 23, 1993
Val. 332 No. 12
PROPHYLAXIS AGAINST PCP AMONG CHILDREN WITH HIV INFECTION
787
cell counts at the time of the diagnosis of PCP and CS-
able on the extent of adherence to prescribed prophylactic regiment.
timated the rate of decline in these counts.
W. determined whether the child WILL first evaluated for IIIV inform
tion more than 30 days before PCP was diagnosed, because the 1-w-
WITH
METHODS
2-month incubation period for PCP" suggests that this is the mini-
I
mal time needed for prophylaxis to be effective.
Estimation of the Incidence of PCP and AIDS In the First
Year of Life
Statistical Analysis
We used U.S. surveillance data on AIDS and data from the anon-
Wr: used the chi-square statistic with continuity correction to 1095
13,
ymous U.S. HIV Sernsurvey of Childbearing Women In calculate the
for differences in proportions between groups. A difference was con-
incidence of PCP and AIDS in the first year of life among children
sidered staristically significant if the P value was below 0.05.
with perinatally acquired HIV infection.
To estimate the decling in CD1+ cell counts before the diagnosis
AJDS is a reportable disease throughout the United States. Late at
of PCP, we used a robust, locally weighted, smoothed regression
diagnosed
health departments collect standardized data on each person report-
("lowers")." To 388053 the variability of this estimated decline during
ed 10 have AIDS and transmit these data to the Centers for Disease
the three months before the diagnosis of PCP. we used .1 bootstrap
66 percent)
Control and Prevention (CDC) without personal identifiers. Report-
technique for regression methods, Two hundred replicates WILL als.
: those chil-
ing of AMDS among adults and adalescents is estimated to be OVC)
cained by sampling with replacement from the residuals of the locally
dentified 30
H., percent complete*; no comparable estimate is available for cases
weighted, smoothed regression (the difference between the observe
ng 129 chil-
amount children For rhis analysis. wr included data on all U.S. chil-
and smoothed values for the CD4 cell count) and adding the sam-
declined by
then in whom AIDS was diagnosed in the first year of lite, whose IIIV
pled residuale to the amouthed values obtained from the observer
95 percent
infection was acquired perinatally, and who were born between 1989
data. The regression procedure was repeared for cash bootstrap sam-
bic millime-
and 1992 We used data reported to the CDC through March 1991
plc. The mean and standard deviation for the decline in CD4+ cell
sis of PCP.
and made adjustments in the number of cases to allow for delay* in
counts during the three months before POP was diagnosed were com-
determined
reporting."
pated from these 200 a catimates.
Since 1988, most state health departments have collaborated wills
percont (20
the CDC on an anonvmous program of testing for antibody to HIV
RESULTS
iter, a level
type 1 among women who Have birth: this survey USCR residual dried
The incidence of PCP in the first year of life among
hld for pro-
blood specimens collected from newborns for couine metubolic
children born to mothers with HIV infection changed
screening." For this analysis, we used the results of tests ol spect-
cidence of
mens collected from all participating states and the District of Co-
little between 1089 and 1992 (Table 1). Assuming a
this
lumbia 85 jurisdictions in 1989 and 44 in 1992). Tn estimate the to
mother-to-child IIIV-transmission rate of approximate-
must
tal number of children been each year 10 women with IIIV infection
ly 20 percent, we estimated the incidence of PCP in the
offered to
in the United States (excluding Puerto Rico and the territories), we
first year of life among HIV-inferred children born in
divided the number of children born to HIV-infected women in the
commend.
survey by the proportion of all U.S. COROR of ADS acquired perina
1992 to be approximately 12 percent; this was calcular-
cally that are reported from the participating areas."
ed 38 0.024 (The incidence of PCP among children born
We calculated the incidence of PCP in the hrst year of lile by di-
to HIV-infected mothers) ÷ 0.2 (mother-to-child trans-
entify the
viding the number of children born in each year and reported in have
mission rate) =0.12 (the incidence of PCP among mv
k for PCP
been given the diagnosis of PCP by one year of age (with adjustment
infected children). The overall incidence of AIDS in the
for delays in porting) by the estimated number of births to HIV-
(ues were
women that year. The incidence of AIDS in the first year of
first year of life also remained essentially unchanged
n.s. Rec-
life WIS calculated similarly.
between 1989 and 1992 (Table 1).
early in-
We collected retrospective data on 300 (61 percent)
Evaluation of Recent Сэсос of PCP
tify expo-
of the 172 U.S. children with permatally acquired HIV
From July 1993 through Ortober 1993, wr retrospectively re-
infection who were given a diagnosis of PCP between
the medical records of children with periontally acquired Itiv
C recom-
infection in when PCP was diagnosed for the Arst thre between Jan-
January 1991 and June 1993 (Fig. 1). This popularion
P in chil-
uary I, 1991, and June 30, 1993. We reviewed the records of 300 chil-
was made up of 197 (95 percent) of the 207 children
c report
dren with cases of PCP reported through July 1993 from three
with perinatally acquired HIV infection and POP who
for pro-
projects funded by the CDC: a program of population AIDS
were reported through the AIDS-surveillance pro-
tried for
"W illano conducted by health departments in New York City, Flor-
grams in New York City, Florida, and New Jersey; all
id.1. and New Jersey (areas with a high incidence of PCP among chil-
ave sug-
dreat. the Pediarric Sp cirum of Disease (PSD) project; and the
85 children with PCP enrolled in the PSD project (ex-
recom-
Permated AIDS Collaborative Transurission Studies (TACTS).
cluding those reported through the AIDS-surveillance
idequate
The P5D project conducts active surveillance for Hiv infection
program in New York City); and all 18 children with
year of
in chicken at seven sites: throughout the state of Massachusetts.
throughout Los Angeles County, California, and in educted mudical
centers in New York City, Washington, D.C., Pm 110 Rico, Texas, and
Table 1. Children Born to HIV-Infected Mothers.
axis, We
the San Francisco Bay area." Data are abstracted every six months
Those with PCP Diagnosed in the First Year of Life,
noug in-
from the medical records of all the children in each study area known
and Thoco with AIDE Diagnosed In the First Year
989 and
111 have been born to HIV-infrered mothers
of Life. According to Year of Birth.
10 study
PACTS is a group of Five collaborative prospective studies of peri-
tal HIV transmission and of the natural history of HIV infection
BORN TT)
PCP DIAGNOSES
IT'S
iagnosis
YIDER (W"
MIV-INM-CTED
IN FIRST THAR
IN FIRST VEN
hildren in New York City; Newark, NewJersey: Baltimore: and
Born
MOTHERS*
of LIMIT
or LIFE:
ne how
Adama. These studies small children of FllV-infected mothers at
is ding-
birth and record laboratory and clinical data on these children pro-
no.
number Inspect
spectively
Idren IS
1989
0400
For this study. we used a standardized form to collect data from
165 (26)
281 (4.1)
whether
existing data bases and medical records. For each child, we recorded
1990
6770
193 (2.9)
307 (4.3)
1C 1991
the date of birth the daw of death if the child had died, the dute and
1991
7030
157 (2.2)
129 (4.7)
recom-
method of diagnosis of PCP, the date when HIV exposure was first
1007
7080
(2.1)
301 (4.3)
ules for
whether the diagnosis of HIV intection in the child's
Iren at
mother 9.1% made before the child's birth, the dates and values for all
"Estimutes for the entire United States (excluding l'acito KICD and the
retermined, Dured III survey data 1000 " states in 1989. 1. in PART JIN
santable CDI cell counts, and the starting dure and type of pro-
15 in [99] and 1992.
CD4+
hylaxis 19 invoice PCP, if in was prescribed, No information was avail-
*Bused on AIDS Case reports. with adjustment for reporting delays
SENT BY:PUBLIC AFFAIRS
: 6-12-95 : 1:07PM
CDC-
912024567431 1/ 6
788
THE NEW ENGLAND JOURNAI OF MEDICINE
March 23. 1095
V
PCP who were enrolled in PACTS
studies or cared for in medical cen-
Prophylaxis before diagnosis of PCP
ters participating in PACTS (ex-
cluding those reported through
Unknown
AIDS-surveillance programs in New
Yes
No
12
Jersey and New York City).
89
199
The median ngr of the 300 chil-
dren at the time of diagnosis of PCP
Prophylaxis at time
was 5 months (5th and 95th percen
of diagnosis of PCP
tiles, 2 and 80 months); 222 children
Evaluation for
(71 percent) were less than I year
Yes
Unknown
HIV infection
old. PCP was diagnosed in 130 chil-
70
No
7
dren in 1991, 121 children in 1992,
12
and 16 children in January through
:-30 days
June 1993. PCP was definitively di-
before diagnosis
1-30 days
At time of
of PCP
before diagnosis
diagnosis
agnosed (on the basis of examina-
01
of PCP
H
of PCP
tion of bistologic UI cytologic speci-
58
r.
60
mens) in 219 children (73 percent),
F
of whom 171 (79 percent) were less
CD4+ count obtained
II
than one year old. A total of 123 (52
before diagnosis of PCP
M
percent) of the 236 children for
"
whom such information was avail
None
able had mothers known to have
1-30 days before
>30 days before
37
HIV infection before or at the time
diagnosis or PCP
diagnosis of PCP
16
28
of delivery. or the 300 children. 133
(11 percent) were reported to have
CD4+ count below
died by the time of the study. and 94
threshold for prophylaxie
(31 percent) died within two months
of the diagnosis of PCP. Death was
Yes
No
thought 10 be related to PCP in 89 of
8
20
the 116 children for whom this infor-
mation was available (77 percent).
Of rhe 300 children, 89 (30 per-
Figure 1. liming of Prophylaxis among 300 Children with Perinatally Acquired HIV
cent) had begun prophylaxis against
Infection in Whom PCP Was Diagnosed between January 1991 and June 1993.
PCP before PCP was diagnored,
and 199 (66 percent) had not; for 12 children (1 per-
had recognized IIIV intection (84 percent VS. 21 per-
cent) this information was not known (Fig. 1). Chil-
cent: relative risk, 4.9; 05 percent confidence interval,
dren whose mothers were known to bc infected with
3.0 to 8.0; P<0.001): these percentages did not change
HIV at or before delivery were more likely than other
significantly from 1991 through 1993.
children to receive prophylaxis before PCP was diag-
or the 81 children who did not receive prophylaxis
nosed (11 percent vs. 21 percent, P<0.01). Of the 89
and who WELL first evaluated for HIV infection more
children who had begun prophylaxis before PCP devel-
than 30 days before PCP was diagnosed, 53 (65 per
oped, 70 (70 percent) were apparently still receiving
cent) apparently had no CD4 cell counts performed
prophylaxis against PCP when the disease was diag-
at all or none more than 30 days before the diagnosis
nosed; however, 14 of those children (20 percent) had
of PCP. Of the 28 children for whom CD4+ cell counts
been receiving prophylaxis for no more than 30 days
were available more than 30 days before PCP was di-
before PCP was diagnosed. Prophylaxis at the time of
agnosed, 20 (71 percent) had no counts below the rec-
diagnosis consisted of trimethoprin-sulfamchorazale
ammended threshold for prophylaxis against PCP. Fif
for 51 children (73 percent), dapsone for 10 (14 per-
teen of these 20 children (75 percent) were less than
cent). aerosolized pentamidine for h (4 percent), and
one year old, and PCP was diagnosed definitively in 15
intravenous pentamidine for } (4 percent).
(75 percent).
Of the 199 children who did not receive prophylaxis
Including both children who had been given prophy.
against PCP before the disease was diagnosed, 60 (30
laxis against PCP and those who had not, 180 chil-
1
percent) were first evaluated for IIIV infection at the
drea had a total of 378 CD4+ cell counts performed
time of diagnosis of PCP, 58 (29 percent) were evalu-
before or at the time of the diagnosis of PCP. The CS-
ated 1 10 30 days before the diagnosis of PCP, and 31
rimated decline in the CD4+ cell count during the
(41 percent) more than 30 days before diagnosis (Fig.
three months before the diagnosis of PCP was 967 cells
1). The proportion of children who were first evaluated
per cubic millimeter (95 percent confidence interval,
for UIV infection no more than 30 days before the
721 10 1210 cells) among 129 children less than one
diagnosis of PCP was higher among children whose
year old (Fig. 2) and 15 cells per cubic millimeter (95
modiers WCIC not known to have HIV infection at or
percent confidence interval, 0 to 62 cells) among 51
before delivery than among those with mothers who
children at least one year old.
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No.
12
PROPHYLAXIS AGAINST PCP AMONG CHILDREN WITH HIV INFECTION
789
4000
ceive prophylaxis before PCP was diagnosed. Because
many of these cases might have been prevented hy pro-
phylaxia, they represent a failure of current strategies
CD4 + Count Icells/mm³)
3000
for identifying exposure to IIIV. evaluating the risk of
PCP, and initiating prophylaxis in the children with the
highest risk.
2000
The most prominent 3"1' in efforts to prevent PCP
III HIV-infected children remains the failure to recog-
1000
nize IIIV exposure SOUN enough In begin prophylaxis
before PCP develops. Over half the children in this
study who were not given prophylaxis before PCP de-
0
6
5
&
3
0
veloped were not recognized as having exposure to HIV
in time for prophylaxis to prevent the disease. More-
At time of
Months before Diagnosis of PCP
over, this proportion did not decrease over the 2½ years
diagnosis
Figure CD4+ Cell Counts during the Six Months before the
of the study. Not surprisingly, lack of knowledge of the
of PCP
Diagnosic of PCP in 129 Childron <.11 Months Old at the Time
mother's IIIV infection before birth was associated
60
of Diagnosis.
with late recognition of exposure TO HIV among the
Points indicate CD4 cell counts; the thin lines connect meas-
children in this study.
urementc in the samo child; the think line represents the locally
Some young children may not be protected by pro-
weighted, smoothed regression curve, and the clashed time rep-
resents the current threshold for prophylaxis against PCP in this
phylaxis because the length of time required to obtain
Age group (<1500 cells per cubic millimeter).
a CD4+ cell count in some communities may delay the
initiation of therapy until after the period of highest
risk for PCP (three 10 six months of age). In this study.
For 11 children (17 percent), the CD++ cell count
nearly two thirds of children whose exposure to HIV
was measured within one month of the diagnosis of
was identified but who were not given prophylaxis had
PCP (Table 2). Among the 113 of these children who
no record of CD41 all counts until 30 day 5 or less bc-
were less than one year old at the time of diagnosis, the
fore the diagnosis of PGP was made. Although some of
median CD1+ count was 552 cella per cubic millimeter
these children may have had measurements that were
(25th and 75th percentiles, 249 and 1250 cells). Among
not entered in the available medical records. it is likely
the 28 children who were at least one year old at diag-
that for others PCP developed before the CD4+ cell
nosis. the median CD4+ count was 29 cells per cubic
count was determined.
(25th and 75th percentiles, 7 and 401 cells).
Even among children whose CD++ cell counts were
Acquired HIV
June 1993.
of the 113 children less than one year old at the
evaluated 2% recommended. the established thresholds
diagnosis (18 percent) had CD1+ counts of
for prophylaxis may have caused many children at high
Lo00 or more cells per cubic millimeter. For 160 chil-
risk for PCP to be categorized 03 needing no prophy-
vs. 21 per-
dren, either the number or the percentage of CD4
laxis; this was especially true of those in the first year
ce interval,
cells was measured within one month of the diagnosis
at life, when the risk of POP is greatest,' for whom
not change
of PCP; 24 of 129 children less than one year old (19
the criterion for prophylaxis is a CD++ count of less
percent) and 7 of 31 children one year old or older (23
than 1500 cells per cubic millimeter. Moreover, because
prophylaxis
percent) did not fall below the recominended threshold
CDH cell counts in infants may decline rapidly, the
ction more
for initiating prophyluxis in terms of either CD1+ cell
monitoring of counts every three months, as recom-
33 (05 per-
counts or percentage of CD4+ cells (20 percent of total
mended in the 1991 guidelines, may not permit detec-
performed
hempliocytes for children of any age).*
tion of the drop early enough for prophylaxis 10 be use-
: diagnosis
ful. The estimated rate of decline of more than 300 cells
cell counts
DISCUSSION
per cubic millimeter per month before the diagnosis
CP was di-
Despite the publication in 1991 of guidelines for pro-
of PCP in infants less than one year old is much grear-
W the red
phylaxis against PCP' and even with continuing in-
or dhan the declines of fewer than 100 cells per cubic
L PCP. Pil-
urcases in the use of prophylaxis, 17,18 the estimated in-
millimeter per month reported among HIV infected
less than
cidence of PCP in the first year of life among children
ively in 15
with permatally acquired HIV infection in the United
Table 2. CU4H Cell Counts within One
(12 percent) has changed little in recent years
Month of the Diagnosis of PCP. According
in prophy-
The " virtually identical in the rate of 11.8 percent re-
to Age at Diagnocis.
180 chil-
ported among children prospectively followed in the
performed
European Collaborative Study, very few of whom had
CD4+ COUNT
AGEIND)
P. The C3-
received prophylaxis."
II 11
11 21
71
>72
uring the
Although limited by our reliance on data collected
: 967 cells
retrospectively, our evaluation of a large sample of U.S.
-15(k)
20
I
0
0
interval,
children with perinatally acquired 111V infection in
00-1499
29
I
,
1)
than one
whom PCP was diagnosed between January 1991 and
500-740
14
I
1
I
200
17
"
.
I
neter (95
june 1993 highlights several important factors contrib-
<:200
23
1
10
7
mong 51
ming 10 the continued substantial incidence of PCP.
T.4.11
113
+
1:
"
Host of the children we studied (66 percent) did not re-
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THE NEW ENGLAND JOURNAL OF MEDICINE
March 23, 199.
and uninfocted infants and older children in other
ices, Tallahassee: F. Laraque and J Beil, New Jersey Department of
studies and among older children in this study.
Health, Trenton: G. McSherry: University of Medicine and Dentistry
In some children, PCP may have occurred despire
of New Jersey, Newark; and M. Varquez, M, Kaluha, S. Davis,
J. Karon, and 1). Burgess, CDC. Atlanta.
prophylaxis; as many as 23 percent of the children with
PCP in this study may have been receiving prophylaxis
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1992:11233. abstruct.
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11. Karon JM. Buchler IW, Byer RH, a al, Projections of the number of per-
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and voluntary testing for HIV to all pregnant women
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PAGE
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LEVEL 1 - 1 OF 2 STORIES
Copyright 1995 Newsday, Inc.
Newsday
March 15, 1995, Wednesday, NASSAU AND SUFFOLK EDITION
SECTION: NEWS; Pg. A04
LENGTH: 601 words
HEADLINE: Panel Backs Giving Moms HIV Test Results
BYLINE: By Rebecca Blumenstein. ALBANY BUREAU
DATELINE: Albany
BODY:
Albany - Reigniting one of last year's most controversial legislative issues,
a state Senate committee yesterday approved a bill that would require that all
mothers be notified of the results of HIV tests on their newborns.
"I want to get this debate going,' said Sen. Kemp Hannon (R-Garden City), a
chief backer of the bill and the newly appointed chairman of the Senate's Health
Committee. The panel passed the measure yesterday.
The bill, vehemently opposed by AIDS activists and some Democratic
legislators, would "unblind" the HIV test now conducted anonymously at birth on
every newborn in the state to help state health officials track the epidemic.
Mothers would be required by law to be notified of the HIV status of their
child. For the estimated 1,800 mothers whose babies test positive every year,
the disclosure would mean that they, too, have the AIDS virus.
This year, pressure for a major confrontation over the bill already seems to
be building. Sponsored by Assemb. Nettie Mayersonn (D-Queens) and Sen. Guy
Velella (R-Bronx), the bill attracted the sponsorship of Gov. George Pataki when
he was a senator last year. He also supported it during his gubernatorial
campaign. And yesterday, a Manhattan-based child advocacy group, filed a lawsuit
against Pataki and other state officials to force the state to disclose the
results of the tests.
"It is the state's duty to acknowledge this public health crisis and help
children and their families with HIV," said Gretchen Buchenholz, executive
director of the Association to Benefit Children, which filed the suit in New
York State Supreme Court. There is "a public emergency of thousands of children
whose illness goes undetected until they come down with debilitating and often
fatal opportunistic diseases."
Opponents of the bill contend that mandatory testing would drive pregnant
women who don't want to know their HIV status away from the health care they
need. Instead, they favor a compromise measure, which the Senate at the last
hour failed to act on last year, that would mandate counseling to increase the
numbers of women who voluntarily consent to testing themselves or their babies.
Opponents say their position has been recently budyed by scientific research
that indicates a woman who receives the drug AZT during pregnancy will reduce
the risk of passing the HIV virus onto her child by two-thirds.
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Newsday, March 15, 1995
"If we can get women who are HIV positive into AZT programs, then we can
significantly reduce the passage from mother to child,' said Sen. Richard
Dollinger (D-Rochester), a member of the Senate's health committee. "I would put
the money into prevention and counseling."
Hannon argued more women would receive treatment with the mandatory testing.
"We know for sure if they are not notified, 100 percent won't come in," said
Hannon. "If you don't have the information you can't act on it."
Sen. Michael Tully (R-Port Washington), who chaired the Senate's health
committee before Hannon, said yesterday he was surprised such an emotional issue
was being introduced in the middle of budget negotiations. Tully said he remains
committed to the compromise bill he supported that mandates counseling instead
of testing.
Citing the new medicial evidence about the preventive effect of AZT, the
Centers for Disease Control last month released a new recommendation favoring
voluntary over mandatory testing of pregnant women and babies.
But advocates of mandatory disclosure claim that more of the medical
establishment is coming to their side, including the New York State Association
of Public Health Officials.
LANGUAGE: ENGLISH
LOAD-DATE: March 16, 1995
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LEVEL I - 25 STORIES
1.
attached
Newsday, March 15, 1995, Wednesday, CITY EDITION, NEWS; Pg. A19, 481
words, HIV Test of Tots Clears a Hurdle, By Rebecca Blumenstein. ALBANY BUREAU
Albany, ACQUIRED IMMUNE DEFICIENCY SYNDROME; TEST; CHILDREN; BIRTH; DISSENT;
LEGISLATURE; ISSUE; INFANT; KEMP HANNON; LAW; PROPOSED;;
2. Newsday, March 15, 1995, Wednesday, NASSAU AND SUFFOLK EDITION, NEWS; Pg.
attached
A04, 601 words, Panel Backs Giving Moms HIV Test Results, By Rebecca
Blumenstein. ALBANY BUREAU, Albany, ACQUIRED IMMUNE DEFICIENCY SYNDROME; TEST;
MOTHER; RESULT; NEW YORK STATE; INFANT; KEMP HANNON;
3. The New York Times, February 25, 1994, Friday, Late Edition - Final,
Section B; Page 4; Column 1; Metropolitan Desk , 910 words, AIDS Panel Urges
Tests for More Women, By MIREYA NAVARRO
4. Newsday, January 17, 1989, Tuesday, ALL EDITIONS, DISCOVERY; AIDS; Pg. 5,
1710 words, Testing Drugs on Babies, By Gail McBride. Gail McBride is a
free-lance writer.
5. Newsday, August 10, 1994, Wednesday, CITY EDITION, VIEWPOINTS; YOKOHAMA
AIDS WATCH; Pg. 30, 410 words, In the Interest Of the Child; Protect newborns
from HIV, EDITORIAL; CHILDREN; ACQUIRED IMMUNE DEFICIENCY SYNDROME; HEALTH CARE;
HEALTH; INFANT; HIV; TREATMENT; JAPAN; AZT; MEETING
6. Los Angeles Times, February 7, 1995, Tuesday, Home Edition, Life & Style;
Part E; Page 1; Column 2; View Desk, 1447 words, WHOSE LIFE IS IT?; WEIGHING THE
ETHICS OF KEEPING UNBORN BABIES SAFE FROM HIV, By PAMELA WARRICK, TIMES STAFF
WRITER
7. Newsday, January 17, 1995, Tuesday, NASSAU AND SUFFOLK EDITION, HEALTH &
DISCOVERY; AIDS PREVENTION; Pg. B23 Other Edition: Brooklyn25 City, 2171 words,
Stumbling Block To Progress; Shrinking funding and ethical concerns threaten a
major breakthrough in preventing the spread of the AIDS virus between mother and
child, By Laurie Garrett. STAFF WRITER, COVER; ACQUIRED IMMUNE DEFICIENCY
SYNDROME; MOTHER; INFANT; PREGNANCY; DRUG; AZT; RESEARCH; WORLD; MAP; ETHIC;
DANIEL TARANTOLA; QUOTE
B. Newsday, November 9, 1993, Tuesday, CITY EDITION, NEWS; Pg. 22 Other
Edition: Nassau and Suffolk Pg. 20, 544 words, Testing Newborns For AIDS Debated
By John Riley. ALBANY BUREAU, ACQUIRED IMMUNE DEFICIENCY SYNDROME; TEST;
CHILDREN; DEBATE; RIGHTS; NEW YORK STATE; PHYLLIS SHARPE; ELEANOR MITCHELL;
PHYSICIANS;
9. Newsday, June 28, 1994, Tuesday, CITY EDITION, VIEWPOINTS; ABOUT AIDS
TESTING; Pg. A28, 873 words, Myths Won't Save Babies' Lives, By Debra Cooper.
Debra Cooper is a spokesperson for the New York State Task Force on Women and
AIDS., OPINION; ACQUIRED IMMUNE DEFICIENCY SYNDROME; TEST; HEALTH; MEDICINE;
CHILDREN; TREATMENT; HEALTH CARE; REFORM
*
10. The New York Times, April 5, 1995, Wednesday, Late Edition - Final,
Section 8; Page 4; Column 1; Metropolitan Desk , 900 words, Senate Votes to
Require Telling Mothers of H.I.V. Results, By KEVIN SACK , ALBANY, April 4
11. Chicago Tribune, April 26, 1987 Sunday, FINAL EDITION Correction Appended,
SUNDAY MAGAZINE; Pg. 14; ZONE: C, 18907 words, CONFRONTING AIDS BLUNT FACTS
ABOUT AN INSIDIOUS KILLER AND WHAT YOU NEED TO KNOW TO PROTECT YOURSELF
By
©
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LEVEL 1 - 25 STORIES
Dennis L. Breo, special-assignments editor of American Medical News and a SUNDAY
contributing editor.
12. The Washington Post, April 9, 1994, Saturday, Final Edition, EDITORIAL;
PAGE A21; SWEET LAND OF LIBERTY, 774 words, When a Baby Is HIV Positive, Nat
Hentoff
13. Sacramento Bee, April 11, 1994, METRO FINAL, EDITORIALS; Pg. B13, 1200
words, "IT'S A BABY, NOT A STATISTIC', Nat Hentoff
14. The Denver Post, April 6, 1995 Thursday, 2D EDITION, Pg. E-01, 2416 words,
HIV tests inconsistent in pregnancies Researchers' findings not applied, Carol
Kreck, Denver Post Staff Writer
15. Rocky Mountain News, April 18, 1994, Monday, EDITORIAL; Ed. F; Pg.33A, 800
words, HIV-infected babies sacrificed for sake of mothers' privacy, Nat Hentoff;
Newspaper Enterprise Association
16. Newsday, February 3, 1995, Friday, NASSAU AND SUFFOLK EDITION, NEWS; Pg.
A56, 689 words, Test May Reduce HIV Infection of Newborns, By Laurie Garrett.
STAFF CORRESPONDENT, Washington, ACQUIRED IMMUNE DEFICIENCY SYNDROME; TEST;
INFANT; BIRTH; REDUCTION; TREATMENT
17. Time, July 4, 1994, U.S. Edition, MEDICINE; Pg. 60, 1182 words, Moms, Kids
and AIDS; Can testing and treatment before and after birth help thousands of
youngsters threatened by HIV?, By Christine Gorman; Reported by Sam Allis/New
York, with other bureaus
18. Newsday, August 25, 1993, Wednesday, CITY EDITION, NEWS; Pg. 15, 1282
words, FOCUS ON: Mandatory AIDS Tests; Pain of Knowing; Doctor, clinician
disagree on testing moms, newborns, By John Riley. ALBANY BUREAU, ACQUIRED
IMMUNE DEFICIENCY SYNDROME; TEST; INFANT; MOTHER; NEW YORK CITY
19. The Washington Post, April 08, 1995, Saturday, Final Edition, OP-ED; Pg.
A19, 797 words, Privacy That Kills
20. The New York Times, July 3, 1994, Sunday, Late Edition - Final, Section
1; Page 1; Column 3; Metropolitan Desk , 1604 words, Á BILL TO REQUIRE H.I.V.
COUNSELING BACKED IN ALBANY, By KEVIN SACK, Special to The New York Times ,
ALBANY, July 2
21. Los Angeles Times, November 14, 1994, Monday, Home Edition, Metro; Part B;
Page 6; Column 1; Editorial Writers Desk, 722 words, A GAIN AGAINST AIDS THAT
CARRIES ETHICAL QUESTIONS; SHOULD HIV-POSITIVE PREGNANT WOMEN FACE MANDATORY AZT
THERAPY?
22. The Washington Post, October 5, 1988, Wednesday, Final Edition, FIRST
SECTION; PAGE A1, 1200 words, AZT Tests Seek to Stem Fetal AIDS, Susan Okie,
Washington Post Staff Writer, NATIONAL NEWS
23. Newsday, March 31, 1994, Thursday, CITY EDITION, NEWS; Pg. A15, 1262 words
TFOUCUS ON: The AIDS Baby Bill; On a Crusade; Lawmaker's profile grows, By
Manuel Perez-Rivas. STAFF WRITER, Albany, NETTIE MAYERSOHN; PROFILE; ACQUIRED
IMMUNE DEFICIENCY SYNDROME; LAW; PROPOSED; INFANT; TEST
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24. Newsday, March 17, 1995, Friday, CITY EDITION, VIEWPOINTS; Pg. A36, 372
words, Infants' Rights; Tell mothers their HIV status, EDITORIAL; ACQUIRED
IMMUNE DEFICIENCY SYNDROME; HIV; INFANT; MOTHER; BIRTH; TEST; INFORMATION
25. Newsday, October 17, 1989, Tuesday, ALL EDITIONS, DISCOVERY; AIDS; Pg. 5,
1430 words, AZT Treatment for Babies; The drug is toxic, but infants born
infected with HIV are likely to develop disease quickly and die., By Laurie
Garrett
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