[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
PREMATURITY AND INFANT MORTALITY: WHAT HAPPENS WHEN BABIES ARE BORN TOO
EARLY?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
MAY 12, 2010
__________
Serial No. 111-121
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado STEVE BUYER, Indiana
LOIS CAPPS, California JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah JOHN SULLIVAN, Oklahoma
JANE HARMAN, California TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 2
Hon. Lois Capps, a Representative in Congress from the State of
California, opening statement.................................. 3
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 4
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 5
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 6
Hon. Janice D. Schakowsky, a Representative in Congress from the
State of Illinois, opening statement........................... 12
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 13
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 14
Hon. Christopher S. Murphy, a Representative in Congress from the
State of Connecticut, opening statement........................ 15
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, prepared statement......................... 16
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 16
Hon. Bruce L. Braley, a Representative in Congress from the State
of Iowa, opening statement..................................... 18
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, prepared statement.............................. 113
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, prepared statement.............................. 117
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 118
Witnesses
William Callaghan, MD, MPH, Senior Scientist, Maternal and Infant
Health Branch, Division of Reproductive Health, National Center
for Chronic Disease Prevention and Health Promotion, Centers
for Disease Control and Prevention............................. 19
Prepared statement........................................... 21
Answers to submitted questions............................... 155
Catherine Spong, MD, Branch Chief, National Institute of Child
Health and Human Development, National Institutes of Health.... 32
Prepared statement........................................... 35
Answers to submitted questions............................... 155
Alan R. Fleischman, MD, Senior Vice President and Medical
Director, March of Dimes Foundation............................ 61
Prepared statement........................................... 64
Answers to submitted questions............................... 157
Charles S. Mahan, MD, FACOG, Dean and Professor Emeritus, USF
College of Public Health, Lawton and Rhea Chiles Center for
Healthy Mothers and Babies..................................... 74
Prepared statement........................................... 77
Hal Lawrence, MD, Vice President, Practice Activities, American
College of Obstetricians and Gynecologists..................... 81
Prepared statement........................................... 83
Submitted Material
Statement of Craig Rubens of Seattle Children's Hospital,
submitted by Ms. Schakowsky.................................... 8
Letter of May 10, 2010, from Health and Human Services to the
House and Senate, submitted by Ms. Capps....................... 123
Articles by the American Association of Prolife Obstetricians and
Gynecologists.................................................. 127
Testimony of Dr. Paula Braveman.................................. 143
Prepared material of Dr. Nicholas Eberstadt...................... 147
PREMATURITY AND INFANT MORTALITY: WHAT HAPPENS WHEN BABIES ARE BORN TOO
EARLY?
----------
WEDNESDAY, MAY 12, 2010
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 3:05 p.m., in
Room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone, Jr. [Chairman of the Subcommittee] presiding.
Members present: Representatives Pallone, Green, Capps,
Schakowsky, Barrow, Christensen, Castor, Murphy of Connecticut,
Braley, Shimkus, Whitfield, Pitts, Murphy of Pennsylvania,
Burgess, Blackburn and Gingrey.
Staff present: Ruth Katz, Chief Public Health Counsel;
Sarah Despres, Counsel; Jack Ebeler, Senior Advisor on Health
Policy; Robert Clark, Policy Advisor; Stephen Cha, Professional
Staff Member; Alvin Banks, Special Assistant; Allison Corr,
Special Assistant; Camille Sealy, Fellow; Ryan Long, Minority
Chief Counsel, Health; and Aarti Shah, Minority Counsel,
Health.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. The meeting of the Health Subcommittee is
called to order, and today we are having a hearing on
``Prematurity and Infant Mortality: What Happens When Babies
Are Born Too Early.'' I will recognize myself for an opening
statement initially.
The consequences of premature births and infant mortality,
both the causes and consequences, need to be examined because
this is an important but complicated public health issue for
which much is still unknown. According to the Centers for
Disease Control and Prevention, each year more than a half-
million babies in the United States, or one in every eight, are
born prematurely. This statistic is up 20 percent from 1990 and
we are just starting to see a decline. Despite the recent
decrease, preterm birth remains a pressing health issue which
deserves ample attention as it is the greatest risk factor for
infant mortality and contributes to a host of acute and chronic
conditions.
While much advanced research has been conducted and
continues today, researchers are still trying to understand why
preterm labor occurs. However, we do know that there is a set
of factors that put women at higher risk of having a premature
baby. Some known factors include carrying more than one baby,
having a previous preterm birth, high blood pressure and
diabetes. In addition, we know that there are also external
factors that occur either alone or in combination with other
individual characteristics, and these include age, race,
poverty, marital status, stress, environmental chemicals and
many others. I am interested to hear from our witnesses today
how these factors intertwine and what we can do moving forward
to limit their effects.
While not directly linked to prematurity, I am particularly
interested to hear today about the prevalence of stillbirths
and sudden unexpected infant death, or SUID, within the infant
mortality rate in the United States. Like preterm birth,
stillbirth, there are some risk factors and causes such as
maternal medical conditions, fetal factors, umbilical cord
problems and placental abnormalities. However, despite these
known risk factors, there is no known cause for as many as half
of all stillbirths, leaving many parents without answers to the
reasons for these deaths. No parent should have to endure the
pain of losing a child, especially without knowing why that
child was taken from them so soon.
And I have introduced a bill called the Stillbirth and SUID
Prevention Education Awareness Act, which would improve data
collection and education so we can better understand the cause
of these deaths and help parents get the information and
answers they want to prevent. The bill would also fund
investigations to finally provide some answers by creating a
national registry to help researchers understand the scope and
impact of these tragedies. By understanding the causes of
death, we can prevent these tragedies in the future, and we
want every child to have the chance to grow up healthy.
In my opinion, infant mortality is a public health problem
that needs the attention of the subcommittee, so I would like
to thank all of our witnesses for being here today. I know
other members have raised this. This is not a legislative
hearing on my bill but an oversight hearing essentially to find
more about these issues and to determine whether or not we
should move forward with some legislation.
At this time I guess we will go to Mr. Whitfield. The
gentleman from Kentucky is recognized.
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Whitfield. Well, Mr. Chairman, thank you very much, and
I certainly want to thank the panel of witnesses for being here
today on this very important subject.
As the chairman said, half a million babies are born
preterm in the United States each year, and the Centers for
Disease Controls states that preterm births are the greatest
risk factor for infant mortality with over one-third of all
infant deaths being attributed to preterm births, and according
to the Institute of Medicine, there is no one cause of preterm
birth, rather, there are socioeconomic, biological and
environmental factors that all can lead to prematurity.
One area that I am particularly interested in and I think
it is very important that we explore is the reporting methods
used by different countries. I think it is important that we
all have the same reporting standards so that we can really
determine what the health statistics are as they relate to
infant mortality. According to the CDC, in 2005, the latest
year that the international ranking is available, the United
States ranked 30th in the world in infant mortality behind most
European countries, but there is not one consistent reporting
standard for many of these countries and I do feel it is
important that we establish a uniform standard.
I look forward to our witnesses today and the information
that they will provide us, and I yield back the balance of my
time.
Mr. Pallone. Thank you, Mr. Whitfield.
Next is our vice chair, Ms. Capps, the gentlewoman from
California.
OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mrs. Capps. Thank you, Chairman Pallone, for holding this
extremely important hearing, to our witnesses for being here
today, and to the fact that we have this bill being discussed.
We have quite a few health professionals in the audience and we
have a group on the Hill visiting of CARE, an international
organization with very strong ties to this legislation as well.
Many people would just assume that the United States being
as advanced as it is doesn't have significant infant mortality
rates or that everyone has access to high-quality prenatal
care, it is kind of a given, and that prevention of prematurity
or other complications is not a serious situation. But the
truth is, and that is why I am so thankful that we are having
this hearing today, the United States lags far behind other
industrialized nations in infant mortality rates, and I might
add, maternal mortality rates as well.
So why is this happening in our country? First and
foremost, we have a problem of access. Fortunately, we have now
new health reform law which puts into place several measures
that will improve the health of our mothers and of our infants.
This will happen through eventually universal coverage,
training of more health care providers, greater emphasis on
prevention and wellness through grants and other incentives but
there is always more than we can and should be doing to ensure
safe pregnancies and safe babies.
For example, I was proud to join in the recent Capitol Hill
launch of a new service called Text for Baby, and this is done
with the Congressional Caucus for Women's Issues, and Text for
Baby is a new, free mobile health information service designed
to promote maternal and child health among underserved
populations through simple text messaging, and I plan in my
Congressional district to find a way to allow some of my
constituents to see this program demonstrated, and I hope that
we will see more programs like this to get funded through the
new mandatory spending which are put in place for prevention
and wellness.
The other important need is to better gather data and
conduct further research so that we can develop a more
coordinated and comprehensive strategy. I am proud to cosponsor
two important pieces of legislation that do address infant
health research and education. One is the Birth Defects
Prevention, Risk Reduction and Awareness Act, and this is
sponsored by Rosa DeLauro, and then there is also your own
bill, Mr. Chairman, SID prevention, Stillbirth and SUID
Prevention Education and Awareness Act, sponsored by Chairman
Frank Pallone. Having a healthy pregnancy and a healthy baby
shouldn't be determined by the color of your skin, where you
live or how much money you earn.
I am eager to hear from our witnesses today to see what
steps we can take to reduce infant mortality and morbidity for
all families in the United States. I pledge my continued
support to make pregnancy and childbirth safe and healthy for
all moms and their newborns, and I yield back.
Mr. Pallone. I thank the gentlewoman.
The gentleman from Pennsylvania, Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. Thank you, Mr. Chairman.
As we will hear, prematurity is the number one risk factor
in infant mortality, and preterm birth rate in the United
States has been on the rise for the past few decades. Not only
is the potential for mortality a risk for preterm infant but
these babies could also face a wide range of health problems,
some lifelong, such as breathing and respiratory problems,
vision problems, increased susceptibility to infection and
intellectual disabilities, to name a few.
While we do not know precisely why more babies are being
born preterm, one thing we do know is that we need medical
professionals to care for women and their babies throughout
pregnancy, and this brings us to the issue of medical
liability. One of our witnesses on the second panel, Dr. Hal
Lawrence, is here representing the American College of
Obstetricians and Gynecologists, or ACOG. ACOG's 2009 survey on
professional liability sought to determine how medical
liability legislation and medical liability insurance issues
affect the practices of its members. Some of the survey's
statistics and conclusions are astounding. This comes from the
survey's executive summary: ``Of the survey respondents who
reported making changes to their obstetric practice because of
insurance portability or availability or both, 19\1/2\ percent
reported increasing the number of Cesarean deliveries.
Additionally, 21.4 percent decreased the number of high-risk
obstetric patients, 10.4 percent decreased the number of total
deliveries and 6.5 percent stopped practicing obstetrics
altogether.'' When survey respondents were asked about making
changes to their obstetric practice as a result of the risk or
fear of professional liability claims or litigation, here were
the results: 30.2 percent decreased the number of high-risk
obstetric patients, 29.1 percent reported increasing the number
of Cesarean deliveries, an additional 13.9 percent decreased
the number of total deliveries and 8 percent stopped practicing
obstetrics altogether.
Over my years in Congress, I have heard from multiple OB/
GYNs who due to medical liability climate could no longer
afford to practice in Pennsylvania and were either retiring
early, no longer delivering babies or moving their practices to
nearby Delaware. In just the city of Philadelphia and four
surrounding counties in southeastern Pennsylvania, where I am
from, 18 hospitals have closed their maternity wards since
1997, and a 19th will end obstetric services next month. Since
2001, southeastern Pennsylvania has lost 30 percent of its
practicing obstetricians, and according to the chief of
obstetrics at Hahnemann Hospital, Dr. Owen Montgomery, Lloyds
of London calls southeastern Pennsylvania the worst liability
market in the world.
Medical liability is a serious problem with direct
consequences for patients, particularly for mothers and their
unborn children, and in recently passed health care law, what
did we do to ameliorate this situation? We funded state
demonstration projects on medical liability. We have already
had two large and quite successful demonstration projects on
this issue. Their names are California and Texas. We don't need
more studies. What we need is real reform, and in this case the
new health care reform law does not deliver.
I yield back.
Mr. Pallone. I thank the gentleman.
Next is the gentleman from Texas, Mr. Green.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for holding the hearing
today on infant mortality.
According to the CDC, the United States ranks 28th among
developed countries in infant mortality with 6.9 deaths per
1,000 live births. Among the leading causes of infant mortality
in the United States, birth defects, preterm birth, low birth
weight, sudden infant death syndrome and respiratory distress
syndrome, preterm birth and low birth weight are the only
factors that haven't declined. According to the March of Dimes,
who we will hear from today, insurance plans for large
employers paid an average of $64,713 to cover the cost of
inpatient and outpatient medical care and prescriptions for one
preterm newborn and mother. That figure doesn't include the
cost of potential re-hospitalization and long-term care and
services. The Agency for Health Care and Research and Quality
estimated in 2005 that on a national scale private insurance
and Medicaid each paid about $7.4 billion to cover preterm
infants' inpatient hospital charges.
In Texas, Medicaid covers about half of all births
annually. The Texas Health and Human Service Commission reports
Texas Medicaid spent $408 million in 2007 on hospital costs
associated with preterm births. Texas and our district in
particular still leads the Nation in percentage of uninsured
residents. Texas also has the third highest rate of births to
teen mothers nationally at 63.1 per 1,000. From 1990 to 2006,
CDC National Center for Health Statistics showed the rate of
preterm birth in Texas increased 22 percent from 11.2 percent
of live births in 1990 to 13.7 percent in 2006. The State saw a
slight decrease from 2006, a 1 percent decrease from 2006-2007.
In Texas, 18.7 percent of live births to African American women
are preterm compared to 12.7 percent for Anglo women, 13.3
percent for Hispanic women and 11.3 percent for Asian women.
One cause that has been pointed to as a potential cause of
preterm birth is induced or cesarean births at 34 to 36 weeks
due to a miscalculation in the gestational age of the baby. At
the Tex Med Conference in 2009, the Texas Medical Association
and House of Delegates adopted a recommendation to support the
prevention of preterm births caused by delivering a baby early
by physicians and others who attend at the delivery of infants.
The recommendation presented by the TMA's committee on maternal
and prenatal health grew out of the March of Dimes' concern
that some premature births may occur without good medical
justification such as request or convenience of the mother or
because of incorrect calculation of the gestational age of the
fetus. I am hoping the witnesses today will address this topic.
Again, I want to thank all our witnesses for being here and
appreciate the time, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Green.
Our ranking member, Mr. Shimkus.
Mr. Shimkus. First of all, Mr. Chairman, thank you. I am
going to ask unanimous consent that all opening statements are
going to be submitted for the record. We have got competing
hearings, and I am not sure everyone is going to be able to
make it up.
Mr. Pallone. Without objection, so ordered.
Mr. Shimkus. I also want to apologize for not being here
punctually. The Appropriations Committee is dealing with some
testimony. Kristin Fitzgerald, who testified before our
committee, whose husband----
Mr. Pallone. Well, I was told you were here before me.
Mr. Shimkus. I was, but then I left. So that is my apology.
The last thing. I want it on the record, we asked for
someone to testify on the second panel, a Republican witness.
They did not get their testimony in on time. I have been very
hard on the Administration for not getting their testimony in
on time so I asked the chairman to disinvite the Republican
member of the second panel, which we ended up doing, and I
think that is appropriate and I just want to take all the
burden----
Mr. Pallone. It is going to make it harder for me. I am
going to have to make sure the Administration witnesses are on
time now.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. You have to lead by example. That is the key,
Mr. Chairman.
Thank you, Mr. Chairman. Any time a child a born is
special. Although preemie births make it challenging, I have
been able, just like many members, to go through hospitals and
see great facilities that are doing all they can to save the
lives of premature babies. We have passed the PREEMIE Act a
couple years ago, and so hence the analysis of data and the
follow-up that is occurring here.
We do have issues with making sure--no one is going to
dispute that we are not as good as we could be in this country.
We want to make sure we are comparing apples to apples versus
apples to oranges, and I do this in other committees. In
Telecom, I hate it when we are compared to Liechtenstein on
broadband access. So we just make sure that when we want to
compare apples to apples, we are doing--other countries may not
consider a live birth what we consider a live birth, and so let
us throw that out there and just get clear data so if we are
going to do some comparisons, we are going to do some
comparisons.
As always, I also want to make sure that as ranking member
I continue to stay on record calling for additional hearings on
the health care law. We just had a CBO report out this week. It
says oh, we made a mistake, there is $110 billion in additional
costs. That is all part of that calculation that we were told
that this was going to save money. So we know that those stats
were not correct. We think it is time to start talking about
this and we think it is time, especially on this issue, the
Medicaid issue for the poor, as we add 18 million more people
to the Medicaid rolls without funding, who gets left out? And I
think the very people we are talking about today, the poor
mothers with no care. Because what docs will do, in Illinois we
are $12.5 billion in debt. Medicaid is paying 30 cents on the
dollar 280 days late. Thirty cents on the dollar, 280 days
late. And the doctors who are servicing Medicaid patients, some
are just writing it off and some are going to start limiting
that access to care, and this is the issue that has also been
raised by the Administration and Secretary Sebelius when she
said we need more docs, we need more primary care physicians,
and guess what? This health care law does nothing to address
more providers. So we will continue the clarion call to say let
us have some hearings on the law.
I am going to end with this. An individual who recently
served in my staff left and went to Colorado and now has been
working in the private sector. She sent me an e-mail, and as a
direct result of the passage of this health care law, her
insurance company folded. Her child, who had a preexisting
condition, now has no coverage. As a direct result of this law,
she cannot purchase insurance for her family because of a child
with a preexisting condition. Now, folks, that is something we
can fix. We can have a hearing today. We can draft legislative
language tomorrow and we can move it to the floor next week.
Why do we accept a gap in this period of time when we are
allowing folks to not have coverage based on preexisting
conditions when we were promised that that would not be the
case?
So Mr. Chairman, hopefully you will raise this issue to the
full committee chairman. I know he is busy down in the
Oversight and Investigation hearing. But we will continue to
say I think it is time to start talking about the effects of
this health care law, and I yield back my time.
Mr. Pallone. Thank you.
The gentlewoman from Illinois, Ms. Schakowsky.
Ms. Schakowsky. Thank you.
First, at the request of our Energy and Commerce Committee
colleague, Jay Inslee, I ask unanimous consent to enter into
the record a statement from Seattle Children's Hospital.
[The information follows:]
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Mr. Pallone. Without objection, so ordered.
OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. Thank you.
The creation of the--oh, first let me say that fortunately
the health care bill that we passed does allow for children
with preexisting conditions requires that they be eligible for
health care and not be excluded.
The creation of the Millennium Development Goals has placed
significant attention on maternal and infant mortality rates
within the international community. The aim is to drastically
reduce these rates by 2015, and we have made visible, albeit
slow, progress toward these goals, but as we work with our
international partners to reduce infant and maternal deaths in
some of the most challenging places in the world, I am
constantly reminded that we face a health disparities crisis
right here at home. In fact, one out of eight U.S. babies is
born prematurely.
Gwen Moore, our colleague and vice chair of the
Congressional Caucus for Women's Issues, represents Milwaukee,
Wisconsin, and she often talks about the absolutely abhorrent
health disparities that are so evident in the infant and
maternal mortality rates in her district. Thirty-three out of
every 100,000 African American women died from pregnancy-
related complications in 2006 compared to fewer than 10 among
white women during that same period. There are studies showing
that even when researchers control for socioeconomic factors,
health risks like smoking or chronic disease and geographic
locations, a poor white woman is more likely to have a healthy
childbirth than a wealthy African American woman.
So most of our witnesses today have referenced this
disparity and have pointed to reasons why these statistics
might bear out the way that they do but what I am left with
when looking at the collective testimony is that it doesn't
seem that we really know why there is such a discrepancy in the
rates of premature births, birth defects and infant mortality
and maternal mortality across different populations. Is it an
access to health care issue? Is it culture? Is it socioeconomic
status or location or the number of children born to one
mother? Why is it that African American women are 1-1/2 times
more likely to deliver a preterm infant compared to a white
woman? I hope we will get some of those answers today.
While I am concerned about the plateau that we seem to have
hit in reducing infant mortality in this country in the 21st
century, I do know that there is a lot of interest and a lot of
collaboration aimed at bringing healthy pregnancies to healthy
term. Congresswoman Capps mentioned a very interesting and
innovative program, Text for Baby, which is a collaborative
effort among the Department of Health and Human Services, White
House Office on Science and Technology and seven major
corporations, a public-private partnership to work with at-risk
expecting moms. So you go to text baby, b-a-b-y or b-e-b-e, at
511411, and at-risk young women can receive text messages
reminding them to schedule a prenatal visit or get a flu shot
or avoid drugs and alcohol, et cetera. One small step.
I look forward to hearing the testimony today and I yield
back, and thank you, Mr. Chairman.
Mr. Pallone. I thank the gentlewoman.
The gentleman from Pennsylvania, Mr. Murphy.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman.
Years ago, before I ran for the State Senate, I practiced
as a psychologist at Magee Women's Hospital in Pittsburgh and
followed up infants in the newborn intensive care unit. There
was a moment when I was seeing one of the babies there, very
premature, very small, transparent skin, hooked up to all sorts
of equipment, probably not much bigger than my hand, and
another baby born addicted to crack cocaine, and I remember
saying to the nurse, I have had enough of this, I can't put up
with this anymore. She said well, are you going to run for
office and change the system, and I said sure. So here I am.
The system still has problems, and I want to point out how I
hope the scope of this hearing actually expands so we can deal
with these problems.
Some years ago when we looked at murder rates in this
country as declining, people looked upon that as a reason
either to give their community a pat on the back or a kick in
the rear because their murder rates were either going up or
down. One factor that was not computed into that was the access
to paramedics and a critical-care hospital, which was making a
difference in life and death and of course reducing rates of
murder because some people didn't die. It is important that
Congress at that time and this time does not misread statistics
and we get accurate information on a number of things and that
I suggest is not just mortality but long-term developmental
outcome. It is extremely important. I hope this is something
the witnesses can provide today with this.
We will take about a number of epidemiological issues and I
hope we don't just caught up in which nation wins the contest
of the lowest mortality rate because for me, that is not valid
information at all. We need accurate information of what
exactly happens. We need to know maternal factors, external
factors. Is it income, education, family issues? Is it other
factors such as maternal smoking, weight gain or loss,
nutrition, drug use, age, trauma, complications during
pregnancy, race? Are there medical issues we need to know
about? Is it infection rates, prenatal care, access to level 3
nurseries, access to developmental intervention, levels of
training of neonatologists, pediatricians, family physicians,
schools, other educational institutions and statistical
analysis to making sure that the definition of each one of
these is the same between communities and between nations.
I might add this, that over the years of the children that
I have seen born premature or very premature, it is interesting
to me now as I go through in going back to visit communities
and inevitably some parent will come up to me and introduce
their child to me who I took care of and who is--when they were
very, very young. In many cases the child is successful,
working, they introduce me to their own children. In addition
to not making me feel so young when I see that happening, it
also makes me very proud that when you surround people with
good quality medical care and tertiary care, good NSU care,
that is a very important factor.
I know the research I did on persistent pulmonary
intervention in newborns, of all the factors we looked at, what
was one of the most significant factors relating also to
seizure disorders and infarcts and developmental outcome, had
to do with where the child was cared for, how close they were
to a level 3 nursery and not just the other medical care
around. This is so extremely important. I want to make sure
that any funding that Congress looks at or any change of policy
directly addresses these issues. Rather than just saying let us
throw money at this issue and make sure we have some there, let
us make sure we are doing a critically good job, and I hope
that the witnesses will provide this Congress with this
information. We want to do it right but it is a matter of just
doing more than comparing us to other nations.
With that, I yield back, Mr. Chairman.
Mr. Pallone. Thank you.
The gentleman from Georgia, Mr. Barrow.
Mr. Barrow. I thank the Chair, but in the interest of the
witnesses' time, I will waive an opening.
Mr. Pallone. Thank you. The gentleman reserves.
The gentleman from Georgia, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. Mr. Chairman, thank you, and thank you for
calling this hearing. Obviously as a physician member of the
House, I am extremely interested in the subject, having
practiced and delivered babies for 31 years.
You know, what concerns me most when I hear that CDC report
going back to 2005 that ranks the United States 30th in the
world in regard to infant mortality, which as we all know is
the death of a child within the first year of life, and you
start scratching your head and say well, how could that be when
we spend two and a half times as much per capita on health care
in this country, and clearly with all corrections that need to
be done in making those comparisons, our prematurity rate and
our infant mortality rate is too high and we should make every
effort to do something about that, and I really look forward to
both panels of witnesses today to help us understand how we can
do that.
But when you compare our country to countries that count a
death in the first 24 hours of life as a miscarriage
essentially, that is not a fair comparison. Forty percent of
premature infants in our country, many of them immature, born
before 32 weeks, not just before 37 weeks, many of them are
going to die in the first 24 hours of life, in fact 40 percent.
So when some countries don't even count those as live births
and others say well, you know--I think France does this--any
child that is less than 500 grams is not considered a live
birth or other countries that say any child that is less than
30 centimeters in length is not considered a live birth. We
have got to as other colleagues have mentioned compare apples
to apples to get a true meaning and understanding, and I am not
going to say these statistics were necessarily used to make a
point that we need to have a universal health care system or
single-payer system or pass the Senate bill 3590 that we did
here just a month ago but let us use the right statistics. It
is very important that we do that.
As we look at matters related to obstetric and pediatric
care, I think we should not overlook the need to enact
meaningful tort reform to help address a shortage of OB/GYN
providers in markets all across the country. I believe that
Republicans and Democrats together can work on this issue, one
that I think most Americans support.
And Mr. Chairman, I want to make one last point. I realize
my time is up. But I want to welcome Dr. Lawrence from the
American College of OB/GYN, who is going to be on the second
panel. Dr. Lawrence as a practicing OB/GYN for more than 30
years, I am interested in hearing more about your MOMS
Initiative. It is my hope that efforts like yours might improve
both maternal and infant health in our country, and I would
like to find out ways that we can work together in this area.
Thank you, Mr. Chairman, and with that I will yield back.
Mr. Pallone. Thank you, Mr. Gingrey.
Next is the gentleman from Connecticut, Mr. Murphy.
OPENING STATEMENT OF HON. CHRISTOPHER S. MURPHY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF CONNECTICUT
Mr. Murphy of Connecticut. Thank you, Mr. Chairman, for
calling this hearing today.
I recently met with a constituent of mine, Arnold Goodman
of Avon, Connecticut, whose wife died during childbirth, and he
explained to me the causes of maternal mortality such as
multiple Cesarean sections, increased age and obesity that are
also risk factors for premature birth. He told me that the gaps
in the research and the lack of uniform reporting that
perpetuate both maternal mortality and premature birth and
infant mortality still persist, so I am interested here today
in learning more about the fact that maternal mortality and
prematurity rates are on the rise, the connections between the
two and what we can do on both of those issues, and just as Mr.
Shimkus is, I am also interested in the issue of access to
maternal and pediatric care for expectant mothers. I have no
doubt that the health care reform bill that extends coverage to
millions of women across this country is going to be able to
link them up with the care that they have not had previous to
today, but I also share Representative Shimkus's concern about
the rates that are paid under the Medicaid program and would
just remind this committee that at one time this Congress had
in place a system by which the federal government oversaw both
the rates for OB care and for pediatric care called the Born
amendment. That amendment was stripped out of the law in 1997,
and in the House version of the bill, we put back in that
federal oversight over obstetric rates and pediatric rates, and
I would be happy to work on a bipartisan basis to try to put
back into place some of the lost oversight that the federal
government has had to make sure that States do the right thing
when it comes to obstetric and pediatric rates. That issue of
access to care is made much, much better by the health care
bill but can be made even stronger with strong federal
oversight over Medicaid rates.
I am thrilled that the panel is here. I am very eager to
hear your testimony and again thankful for the opportunity to
listen.
Mr. Pallone. Thank you.
The gentlewoman from Tennessee, Mrs. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman, and welcome to our
witnesses. I want to thank you for the hearing.
In my district, Memphis, Tennessee, has one of the highest
prematurity and infant mortality rates in the entire Nation,
and it is a stat that impacts our neighborhoods, our State, and
we know the impact it has here in our country. Too many mothers
around the country just do not have, those young mothers don't
have the information that they need and the educational
resources that they need to keep their babies healthy. And DHS
has stated that children of mothers who receive no prenatal
care are three times more likely to be born at a low birth
weight and five times more likely to die than those who are
born to moms that get that necessary prenatal care.
And earlier this year, the Commercial Appeal, which is the
Memphis newspaper, reported that premature birth and low birth
weight are the biggest causes of those infant deaths in
Memphis, Tennessee. So we are watching those numbers very
closely. And since my days in the State Senate, this is an area
where we have watched this very closely. Indeed, Congressman
Cohen and I had legislation last year, had a resolution focused
on our concern with this infant mortality rate. We have some
great work that is being done in our State to address this. The
Porterly Children's Hospital, the March of Dimes, University of
Memphis and Memphis city schools all have programs, so we have
got a partnership that we are doing in the public not-for-
profit sector to help improve this rate. We have also got the
UT Health Sciences Center that has a grant, a $1.7 million
grant that they are working to expand the Blues Project, hoping
to reduce those rates, and we are focusing that on our TennCare
eligible moms.
So welcome. We are pleased to have you with us today. We
look forward to your testimony, and I look forward to working
with you on this issue and I yield back, Mr. Chairman.
Mr. Pallone. Thank you.
Next is the gentlewoman from Florida, Ms. Castor. I should
mention that Ms. Castor has done quite a bit of work on this
prematurity and infant mortality bill and also asked that we
have a hearing on this subject.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Well, thank you, Chairman Pallone, very much
for today's hearing so we can address infant prematurity and
mortality and some of my specific concerns about the rising
rates of elective preterm Cesarean deliveries in the United
States, and thank you for inviting Dr. Charles Mahan from the
University of South Florida, the founder of the Lawton and Rhea
Chiles Center for Healthy Mothers and Babies. I am honored that
he is here today. I would also like to extend a special welcome
to Dr. Fleischman, everyone at the March of Dimes and from the
American College of Obstetricians and Gynecologists.
The overriding message for pregnant mothers and families
and health providers in the United States has got to be taking
babies fully to term, to that 39 weeks, 40 weeks unless there
is an intervening medical reason. Researchers at the National
Center for Health Statistics just reported this week that the
high rate of premature births is the primary reason that the
United States has a higher infant mortality rate than other
industrialized nations. Preterm births are linked to
neurodevelopmental disorders and developmental delays. Let us
face it, brain development is the key to success for babies,
when they are young and even into their adult years.
Many premature babies grow up healthy but sadly many do
not. Some need lifelong constant care and have health problems
throughout their lives. Although the National Center reported
this week that preterm births have slightly declined in the
United States, the rates are still way too high and the rates
of preterm and low birth weight babies in my home State of
Florida are much higher and of great concern. Even with all the
great advances in science, technology, medicine, too many
babies are born prematurely and there are disturbing racial
disparities we must address. Nationally, the preterm birth rate
is 12.3 percent. In my home State of Florida, it is nearly 14
percent. The March of Dimes gave Florida an F grade on its 2009
premature birth report card, so I am committed to working with
you to bring that grade up.
And the Cesarean rate has risen across the country to 32
percent of all births as of 2008, and one factor in preterm
births may be this rising rate of elective C-sections. In
Florida, the C-section rate is even higher, accounting for
roughly 38 percent of all childbirths, and they think that in
Dade County, Miami, we are approaching 50 percent now where the
World Health Organization said it really should be half of
that. Elective C-sections prior to 39 weeks really put babies
at risk, so we need to understand these troubling numbers. The
data displaying the rise in C-sections is clear and speculation
about the potential overuse of these surgeries is strong. The
New York Times has featured several articles over the past 6 to
7 months reporting that late preterm births are the fasting
growing subgroup of premature births. Cesareans have become the
most common surgery in American hospitals, and ACOG has
recognized that the surgery is overused, and the March of Dimes
reports that C-sections accounted for 92 percent of all preterm
births in the United States from 1996 to 2004.
So I would really like to hear from our witnesses about
this. I think we need more data and research, so I am looking
forward to your testimony and the input of my colleagues moving
forward. Thank you.
Mr. Pallone. Thank you.
The gentlewoman from the Virgin Islands, Ms. Christensen.
Mrs. Christensen. Thank you, Mr. Chair. In the interest of
time, I am going to submit my statement for the record.
[The information was unavailable at the time of printing.]
Mr. Pallone. And Mr. Braley, the gentleman from Iowa.
OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF IOWA
Mr. Braley. Thank you, Mr. Chairman, for holding this
hearing on premature and infant mortality. It is important that
we examine the many risk factors and variables that relate to
these tragedies.
In Iowa, five mothers who each lost a daughter to
stillbirth or infant death got together in 2003 and founded
Healthy Birthday, a nonprofit organization dedicated to
preventing stillbirths and infant deaths through education,
advocacy and parent support. This group of friends including
State Representative Janet Peterson launched the Count the
Kicks campaign in June of 2009, which is a public health and
awareness effort to improve pregnancy outcomes. This campaign
is supported by the March of Dimes Iowa chapter and seeks to
reduce the number of preventable stillbirths by teaching
expectant parents how to self-monitor their babies' movements
and about the importance of tracking daily movements during the
third trimester of pregnancy. Less than a year after the
campaign's launch, 55 percent of OB/GYN clinics in Iowa and 56
percent of the birthing hospitals had begun using the program.
Research has shown that this type of education and awareness is
very effective.
A 2009 study conducted in Norway reported an overall
decrease in stillbirth rate by one-third when patients were
educated on monitoring fetal movements. If the United States
achieved the same level of success, we could save more than
8,000 babies every year. With one out of every 150 pregnancies
ending in stillbirth in the United States, it is hard to
understand why this issue hasn't gotten more attention, but I
believe that expanded awareness and education should be an
integral part of efforts to reduce stillbirths.
I commend Chairman Pallone for introducing the Stillbirth
and SUID Prevention, Education and Awareness Act. This bill
will improve the health of children, enhance public health
activities related to stillbirth and reduce the occurrence of
infant death. I am proud to be a cosponsor of this bill and I
encourage other members of the committee to support the bill,
and I yield back the balance of my time.
Mr. Pallone. Thank you, and I think that concludes our
opening statements by the members of the subcommittee, so we
will turn to our witnesses. I want to welcome you. Let me
introduce our first panel. On my left is Dr. William Callaghan,
who is the senior scientist for Maternal and Infant Health
Branch, Division of Reproductive Health, the National Centers
for Chronic Disease Prevention and Health Promotion of the
Centers for Disease Control and Prevention. And then we have
Dr. Catherine Spong, who is the branch chief for the National
Institute of Child Health and Human Development of the National
Institutes of Health. The drill is 5-minute opening statements,
and they become part of the record and then we may--well, you
actually on your own discretion if you like can submit
additional statements in writing afterwards, but if you would
start, Dr. Callaghan. We appreciate your being here.
STATEMENTS OF WILLIAM CALLAGHAN, MD, MPH, SENIOR SCIENTIST,
MATERNAL AND INFANT HEALTH BRANCH, DIVISION OF REPRODUCTIVE
HEALTH, NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND
HEALTH PROMOTION, CENTERS FOR DISEASE CONTROL AND PREVENTION;
AND CATHERINE SPONG, MD, BRANCH CHIEF, NATIONAL INSTITUTE OF
CHILD HEALTH AND HUMAN DEVELOPMENT, NATIONAL INSTITUTES OF
HEALTH
STATEMENT OF WILLIAM CALLAGHAN
Dr. Callaghan. Mr. Chairman, Mr. Shimkus and distinguished
members of the subcommittee, thank you for the opportunity to
participate in this hearing on preterm birth and infant
mortality. I am Dr. William Callaghan, acting chief, Maternal
and Infant Health Branch in the Division of Reproductive
Health, the Centers for Disease Control and Prevention. I am
also board certified in obstetrics and gynecology. Prior to
making the transition to public health in 2001, I spent 14
years in private practice caring for thousands of women during
their pregnancies. Today I will briefly outline the burden of
disease in the United States due to preterm birth and summarize
our current and continuing surveillance and research
activities.
Preterm birth is defined as being born at less than 37
weeks, that is, at least 3 weeks before the predicted due date
for the pregnancy. Today, more than half a million babies are
born preterm each year in the United States. Although a CDC
report released yesterday shows a very welcome and small
decline in the preterm birth rate for 2007 and 2008 down to
12.3 percent, levels still remain higher than at any point in
the 1980s and 1990s. Most of the increase prior to this recent
decline was among late preterm births, and those are births
from 34 to 36 weeks of gestation.
Preterm birth is an important risk for infant mortality.
More than one-third of infant deaths can be directly attributed
to preterm birth. Preterm birth and infant mortality are
particularly critical issues in the African American community.
African American women are one and a half times more likely to
deliver a preterm infant compared to white women, and the
infant mortality rate for black infants is more than twice that
of white infants. We also need to think beyond infant mortality
when we discuss prematurity. Preterm birth is the leading cause
of disability in children. Moreover, in 2005 it was estimated
the costs associated with preterm birth were $26.2 billion.
At CDC, our work addresses preterm delivery through three
basic mechanisms: surveillance, research and building public
health capacity. Surveillance is the core of CDC's work. We
monitor how many infants are born prematurely, analyze trends
and define risk factors. There are several important
surveillance systems that we use. The first is through
collection of birth certificates and death certificates by the
National Center for Health Statistics. The national statistics
for prematurity rates are compiled from information on birth
certificates. When birth certificate information is linked to
information on death certificates, we are able to look at the
causes of death for those babies who died during their first
year of life.
CDC's second largest surveillance system on maternal and
infant health is called PRAMS, the pregnancy risk assessment
monitoring system. PRAMS is an ongoing state-specific
surveillance system designed to identify and monitor maternal
behaviors and experiences before, during and after pregnancy
among women who had live births. PRAMS has served to expand the
information capacity of 37 States and New York City and this
unique surveillance system is now representative of
approximately 75 percent of all births in the United States.
CDC also provides resources to assist States in conducting
surveillance of major birth defects, which are important causes
of infant mortality.
In terms of research, we are working with partners to try
to understand some of the biology among women who delivered
preterm. These studies focus on the interactions among genes,
other biologic markers, race and ethnicity, and social and
economic exposures for women. We really don't know a lot about
why late preterm births increased and drove the overall preterm
birth rate during the last several decades. We are currently
involved in a study to review hospital medical records in order
to discover why and how late preterm births occur. In the area
of capacity building, CDC has 23 federal staff assigned to
State health departments providing technical support for
epidemiological research, public health surveillance and State-
based programs.
As we move forward, we will be investigating how the
quality of surveillance information can be improved and how we
can use it to inform programs and public health practice. A
society measures what it values, and we will strive to improve
the core public health function of surveillance. As new ideas
emerge about the reasons for and predictors of preterm birth
and about possible prevention interventions, we will continue
to synthesize evidence and attempt to fill in knowledge gaps
through research. We will continue to press forward with our
work in the area of understanding late preterm birth as this
group continues to comprise the largest proportion of preterm
births. As we learn more about causes and prevention, we
anticipate the result will be more healthy babies and healthy
families.
Thank you for the opportunity to speak today, and I would
be happy to answer questions.
[The prepared statement of Dr. Callaghan follows:]
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Mr. Pallone. Thank you, Dr. Callaghan.
Dr. Spong.
STATEMENT OF CATHERINE SPONG
Dr. Spong. On behalf of the Eunice Kennedy Shriver National
Institute of Child Health and Human Development at the National
Institutes of Health, I appreciate the opportunity to provide
the committee with information about our research programs on
preterm birth and infant mortality.
I am Dr. Catherine Spong, chief of the Pregnancy and
Perinatology Branch at the NICHD. The NICHD mission is to
ensure that every person is born healthy and wanted, that women
suffer no adverse harmful effects from reproductive processes
and that all children have the chance to achieve their full
potential for healthy and productive lives free from disease or
disability. As such, research on prematurity and its health
outcomes falls squarely within the Institute's mission.
As we have heard from your opening statements and as Dr.
Callaghan eloquently stated, preterm birth is a major public
health problem. In 2001, preterm birth became the leading cause
of death among newborns, and those who survive preterm birth
account for one in five children with mental retardation, one
of three children with vision impairment and almost half of all
children with cerebral palsy. Late preterm infants appear to be
at higher risk for sudden infant death syndrome and have higher
rates of neurological and developmental morbidities during
childhood. In adulthood, children born at low birth weight have
an increased risk for cardiovascular disease such as heart
attacks, strokes and hypertension and an increased risk for
diabetes.
The NIH is committed to understanding the causes and to
reducing the incidence of preterm birth, low birth weight and
infant mortality and their consequences. The NICHD was the lead
federal agency in planning and coordinating the surgeon
general's conference on prematurity prevention held in June of
2008. As I will describe, NICHD preterm research efforts
address these recommendations and range from basic work on the
mechanisms of labor, genetics and proteomics to research
regarding specific questions encountered in clinical practice
and the long-term implications on the infant, mother and
family.
While the NICHD supports the bulk of NIH research in this
area, other institutes and centers also contribute to the
overall NIH funding for infant mortality, low birth weight and
prematurity research projects. This totaled $278 million in
fiscal year 2009 including ARRA funds, the last year for which
we have complete data.
One of the most successful approaches for research related
to prematurity are the NICHE research networks, which allow
physicians and scientists across the country to coordinate
their work and share data. The Maternal Fetal Medicine Units
Network, composed of 14 sites across the country, conducts
clinical studies to improve maternal, fetal and neonatal
health. This network has a remarkable track record of
conducting high-priority clinical trials with its findings
incorporated into practice. The Neonatal Research Network
focuses on babies in neonatal intensive care units to improve
their health and outcome.
The NICHD recently has funded a study on women in their
first pregnancy, the Nulliparous Pregnancy Outcome Study. The
best predictor of preterm birth, pregnancy outcome, is not
available for these women yet they account for 40 percent of
all deliveries each year. The aim of this large multicenter
study is to identify markers early in pregnancy that will
identify women at the highest risk for preterm birth,
preeclampsia and stillbirth with the goal to ultimately develop
interventions and therapies.
To understand the biologic mechanisms underlying
spontaneous preterm births, the NICHD is supporting a wide
range of research including intrauterine infection, bleeding
and psychosocial stress. Another major emphasis is on
preeclampsia as it is the primary reason for medically
indicated preterm births. Research supported by NICHD has shown
that this disease is associated with an abnormal development of
the placenta. NICHD-supported research identified and
highlighted the significant complications associated with late
preterm births, those babies born between 34 and 37 weeks, that
account for 70 percent of all preterm births, these supported
practice guidelines affect changes in practice.
One aspect of research is to identify markers or predictors
of preterm birth. A short cervical length is a predictive
marker and was identified through NICHD research. In a blinded,
multicenter observational study of women with a prior preterm
birth, shortened cervical length in mid-pregnancy can predict
early spontaneous preterm birth. This has led to screening for
cervical length in women who are at risk for preterm delivery.
Ideally, the best outcome would be to prevent preterm birth
in the first place. A major advance in prevention was made by
the NICHD's Maternal Fetal Medicine Network studying women who
have had a previous preterm delivery and therefore were at risk
for a recurrent preterm birth. This trial compared progesterone
to placebo, and progesterone treatment lowered the risk of
preterm birth by one-third, the first successful preventative
therapy to reduce the risk of recurrent preterm birth and
improve neonatal outcomes. The impact of this treatment was
evaluated in a 2005 study, which estimated that 10,000 preterm
births could be prevented annually if all eligible pregnant
women received progesterone. The American College of
Obstetricians and Gynecologists has recommended the use of
progesterone to prevent preterm birth for women with a prior
spontaneous preterm birth.
In addition to studying preventative therapies, the MFMU
Network studies interventions during pregnancy to prevent
complications in preterm infants. Recently, the network
identified a therapy, magnesium sulfate, or Epsom salts, which
when administered to women who are at risk of delivering
preterm, reduces the risk of cerebral palsy in surviving
preterm infants by 45 percent.
The NICHD also supports research on how to manage and care
for preterm infants. One example is nitric oxide, a compound
that is used to treat infants with severe breathing problems,
but the safety and efficacy for premature infants has had mixed
results. To better understand the potential risks and benefits
of inhaled nitric oxide therapy, the NIH will convene a
consensus development conference in October of this year to
assess the available scientific evidence and form conclusions
about its clinical use in preterm infants.
Both preterm infants and infant mortality have dramatic
health disparities with higher overall rates in African
American women. NICHD-supported researchers are attempting to
identify the factors to explain these disparities, and in
August of this year the NICHD will hold a scientific workshop
focused on disparities in infant mortality, stillbirth and
preterm birth.
Given the implications of preterm birth on long-term health
and disease of the child and family and affecting over half a
million pregnancies each year, preterm birth truly is a public
health priority. Were we able to prevent preterm births, not
only would infant mortality improve, we would actually improve
the health of the Nation with less heart disease and diabetes
in the children and healthier mothers and families. This is our
goal.
Again, thanks to the committee for your time and interest,
and I am pleased to answer any questions that you may have.
[The prepared statement of Dr. Spong follows:]
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Mr. Pallone. Thank you, Dr. Spong.
What we do now is, we have questions from the members for 5
minutes or sometimes 8 if they didn't do an opening, and I am
going to begin with myself.
I will ask initially Dr. Callaghan, in your testimony you
discussed CDC's role in surveillance in terms of monitoring
infants born prematurely, analyzing trends, defining risk
factors and targeting prevention programs. I mentioned that I
sponsored H.R. 3212, the Stillbirth and SUID Prevention,
Education and Awareness Act, and I am particularly interested
in the collection of critical data to determine the causes of
stillbirth and sudden unexpected infant death. Can you tell me
what the CDC is doing to understand the causes and risk factors
associated with stillbirths, sudden unexpected infant death and
sudden unexplained death in childhood, and are there ways to
reduce those risks? And then secondly, how would better data
collection help reduce and prevent these deaths in the future,
if you could?
Dr. Callaghan. The National Center for Health Statistics
collects information on fetal deaths from fetal death
certificates. Fetal death certificates are not birth
certificates. A fetal death report is what it is called. So
they are able to--those are collected by States, sent to NHS
and NHS compiles those for the Nation. The quality of
information on fetal death certificates is not always what we
would hope it would be. These are filled out essentially in
real time at the bedside in the hospital and sent in, and there
is a fair amount of variability in how stringently people fill
those out. There is also a fair amount of variability on how
much each fetal death is investigated at the individual level.
To do this correctly, there needs to be fetal autopsy, there
needs to be fetal genetic studies. These aren't always done
consistently and so the amount of information that is
ultimately reported as to the cause of death can be variable,
which leads us to your statement that in many cases we are left
without a real good reason about why that happened. So efforts
to improve the quality of fetal death reporting at each
individual level at the time of each individual fetal death
would be important in terms of improving our information.
There is also some pilot work that is being done at CDC at
Atlanta in the National Center for Birth Defects and
Developmental Disabilities. There is Atlanta Metropolitan Birth
Defects Surveillance System and there is some pilot work being
tagged onto that to try to see if fetal death registration can
also be used with that same infrastructure. If that was
successful, that could be expanded to other birth defect
surveillance systems. Birth defect surveillance systems collect
much more nuanced information, almost through survey.
Lastly, about sudden unexplained infant death, we have done
a lot of work in this area, and we have learned that there is a
difference between the sudden unexplained infant death and
sudden infant death syndrome. Sudden infant death syndrome
means there is no plausible explanation for the cause of death.
It is truly unexplained. The more and more that people do death
scene investigations on the ground, again, in and around the
time of the infant death, the more and more people are finding
that there actually may be explanations. The good thing about
having an explanation, it doesn't bring a lot of relief to the
grief of parents, but if you have an explanation, now we have a
chance of prevention. So we are in the process of establishing
pilot registries for that.
Mr. Pallone. Thank you.
I am going to try to summarize this next one for Dr. Spong.
I think it is critically important that we do everything we can
to ensure that we have the right research infrastructure and so
I wanted to ask you three questions about the research network.
First, how many women are usually in the clinical trials
conducted by the network? I guess we are talking about the
Maternal Fetal Medicine Unit Network. And is there a diverse
population of women represented in the trials? Can you
elaborate on use of 17P to prevent prematurity and would you
discuss other interventions that have impacted patient care to
date?
Dr. Spong. Thank you, Mr. Chairman. The first question was
the number of patients enrolled in clinical trials?
Mr. Pallone. How many women are usually in them, yes, and
is there a diverse population of women?
Dr. Spong. So the number of patients enrolled in a given
trial depends on what the trial is looking at and what the
question is to be addressed, how big the effect needs to be,
how rare the outcome is. We have had trials that have included
few number of patients, for example, 200, 300, and we have
recently completed a trial that included over 10,000 women. In
addition, some of the observational studies have included, you
know, many, many more women than that. The diversity of the
population is assured when the network is openly and actively
recompeted every 5 years. As part of that recompetition, as
part of looking at who should be part of the network includes
geographic diversity and diversity in the patient population.
Your question about 17 alpha hydroxyprogesterone caproate
or progesterone for the use to prevent preterm birth, this was
a landmark study as the first preventative therapy identified
for women who had a prior preterm birth. As a clinician, I knew
that one of the very common things that you would see with a
patient who had come in for prenatal care who had had a prior
preterm birth, we would say that you are at very high risk for
another preterm birth but we had nothing to offer her. Now with
the use of 17 alpha hydroxyprogesterone caproate, we have
something that we can offer her that can reduce her risk of
another preterm birth by about one-third. That progesterone is
now being studied in other high-risk populations so women who
have had a prior preterm birth or are at high risk, women who
have multiple gestations are at high risk, and they have been
studied, both women with twins and triplets, and it was found
that progesterone did not reduce the rates of preterm birth in
that population, and I think that is very important to know,
that it is not a cure-all for all prematurity, it is for
specific conditions and it is currently being evaluated in the
setting of a shortened cervix in an asymptomatic woman.
There are a number of other studies that the network has
undertaken that have impacted practice. One example is the use
of antenatal corticosteroids which are given to women who are
risk of delivering preterm with the understanding that it will
improve outcome for the babies. It decreases their
complications such as breathing complications and bleeding
complications. The network undertook a study looking at
repeated doses of those steroids and found that in fact that
was not beneficial, so it was a change in practice from
repeating multiple doses of steroids.
Another example is one of magnesium sulfate being
administered to women who are at risk for preterm birth where
it significantly reduced the risk of cerebral palsy by about 45
percent. One of the unique factors from this network is that
when these trials are published, their findings are then often
incorporated into professional guidelines such as those by the
American College of Obstetricians and Gynecologists making
recommendations for how that should change and how that should
be implemented into practice. I can give a number of other
examples as well.
Mr. Pallone. No, I think we better stop there because I
made you go over. It is not your fault.
Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman.
I want to throw this out there. In the health care law,
either I am right that my constituent is denied the ability to
purchase insurance on the sole reason of a preexisting
condition of their child, or I am wrong, and I would ask
someone on the majority side to help me have a hearing on this
issue to see who is right. It is not a question. I am asking
for a hearing. I have a case of a former staffer who cannot get
insurance because of a preexisting condition of their child. My
colleague from Illinois said that is not true, and I think this
would be a good hearing to have on this issue of whether people
right now under this health care law are being denied access
because of preexisting condition. So I want to put that on the
record. My colleague is not here from Illinois, who rejected my
claim, but I throw that out as an issue.
I appreciate your testimony, and you say words I can't even
pronounce, but I do have a question, Dr. Spong. The mission of
the NICHD is to ensure that every person is born healthy and
wanted, and I am curious of why you have the word ``wanted''
there. What does that mean and what does that mean for what you
do? It is a curious word. Can you explain that?
Dr. Spong. Thank you for your question. The question is why
the NICHD mission includes the word ``wanted,'' and I will be
the first to admit that the mission was created before I
started working at the National Institute of Child Health and
Human Development so I do not have that information for you at
this time, but I would be happy to get back to you in written
testimony.
Mr. Shimkus. Yes, it is an interesting word. I mean, I
don't know what it means. So if you could get back to me.
Before we make conjectures and think things, I will just wait
for a response because I just don't know what that means.
Let me follow up with this question. If individuals change
their lifestyle, stop smoking and manage their weight, would
that reduce the risk of prematurity, Dr. Spong?
Dr. Spong. The risk factors that you stated were if they
lost weight and if they stopped smoking, would that reduce
preterm birth. Obesity itself--healthy lifestyles are good for
pregnancy. Obesity itself has a mixed message on whether or not
it actually causes preterm birth. There are studies that would
suggest that obesity is not in fact associated with preterm
birth. That said, starting out with a healthy weight is optimal
for pregnancy for a number of reasons regardless of preterm
birth, so we would certainly encourage all women to start
pregnancy at a healthy weight. Smoking itself is associated
with low birth weight or smaller babies, and clearly is one
major lifestyle change that people can make that can improve
the health of their children and remove the risk of low birth
weight.
Mr. Shimkus. Let me follow up, because Dr. Callaghan
mentioned that infection itself may not be the cause of
prematurity but rather the inflammation associated with the
infection. Do you agree with that?
Dr. Spong. The question regards to the role of infection
versus inflammation on preterm birth, and preterm birth is a
very complex condition, and I believe there are multiple
pathways that can lead to a preterm birth. One is going to be
an infectious pathway. Clearly, that can cause preterm birth
but the inflammation itself in the absence of infection can
also cause preterm birth.
Mr. Shimkus. And then are there contributing factors to
increased inflammation that could be avoided through a change
in lifestyle?
Dr. Spong. That is an excellent condition. Those are areas
that are currently getting teased out. It is likely that it is
not a single factor that causes much of preterm birth but a
constellation of events, so whether you have certain
environmental factors, certain genetics, certain inflammatory
markers and then certain lifestyle events that can ultimately
result in a preterm birth.
Mr. Shimkus. And I want to thank you. I am going to end. Of
course, on our side we have Dr. Gingrey and Dr. Burgess, who
are both obstetricians, and I am waiting for their follow-up
questioning as they are experts in the field, and I yield back
my time. Thank you, Mr. Chairman.
Mr. Pallone. Ms. Capps asked that we enter into the record
this letter from Secretary of Health and Human Services to the
Speaker and I guess to the Republican leadership, and it
basically goes into the different provisions in the health care
reform on adult and child coverage, preexisting conditions,
early retirement, reinsurance, rescissions, Medicare Part B
with a timeline.
Mr. Shimkus. That is correct. The point that Secretary
Sebelius has said please, insurance companies continue to cover
people, kids with preexisting conditions. The issue is they are
not, and so I would suggest that we have a hearing on this,
and----
Mr. Pallone. I am not just reading it.
Mr. Shimkus. I am just----
Mr. Pallone. You know what it is.
Mr. Shimkus. I am just----
Mr. Pallone. Effective beginning----
Mrs. Capps. The date September 23rd is there.
Mr. Pallone. And on March----
Mr. Shimkus. So right now people if they have no insurance,
they cannot get coverage with preexisting conditions. That is
the law.
Mrs. Capps. Because some insurance companies are operating
to do it----
Mr. Shimkus. So you are not disputing the fact that my
former staffer, this family cannot get health insurance right
now?
Mrs. Capps. It isn't required yet.
Mr. Shimkus. It is not required. Thank you for----
Mrs. Capps. But it will be very soon.
Mr. Pallone. But on March 29th it is required for children.
Mr. Shimkus. But it is now right now.
Mrs. Capps. September 23rd.
Mr. Shimkus. But it is not right now.
Mr. Pallone. It says on March 29th----
Mr. Shimkus. So my point is, we could pass a law tomorrow
to do this.
Mr. Pallone. Well, Mr. Shimkus, first of all, does anybody
have an objection to entering this into the record? I mean, the
only thing it says on preexisting conditions, it says,
``Effective for policies or plan year beginning on or after
September 23rd be prohibited from excluding coverage of
children.''
Mr. Shimkus. If the chairman would yield, my point is, I am
going to continue to raise issues that we ought to have
hearings on this law, and this is just another example of
people not having access to health insurance because of
preexisting conditions, and this is something we can fix.
Mr. Pallone. I don't think there is any question that the
law is the September date, but you can look at it.
Mr. Shimkus. And we could bring a bill to the floor
tomorrow and fix this. That is my point.
Mr. Burgess. Mr. Chairman, if I could just stand in
agreement with my colleague from Illinois. We handed an
enormous task to the Department of Health and Human Services to
create something out of whole cloth in this law that we passed
hurriedly a couple months ago and really it is incumbent upon
this committee to maintain the vigilance and oversight over HHS
and CMS as they come up with these rules and regulations that
are literally going to affect every American, not between today
and Election Day but for the next three generations. So I hope
you will consider Mr. Shimkus's request to hold the appropriate
hearings at this level.
Mr. Pallone. Let me just have that back.
Without objection, it is entered into the record.
The gentlewoman from California has the time.
[The information appears at the conclusion of the hearing.]
Mrs. Capps. Mr. Chairman, you may not wish to call on me
after all of that, but thank you. This has been a good
discussion. Back to the topic, but before I ask my question for
Dr. Callaghan, I want to just acknowledge that there are many
members of a non-governmental organization called CARE on
Capitol Hill today because they are very interested not only in
this hearing but in other topics having to do with preterm
delivery and birth, and one of them is a constituent of mine so
I want to welcome a particular group that was here. We had
nurses earlier as well. And I appreciate the testimony that
both of you have given us.
Dr. Callaghan, in your testimony you included some of the
surveillance mechanisms that the CDC uses to monitor the
pregnancy outcome and also infant health. Especially with
issues such as the ones we are discussing today, I believe it
is critical to have really accurate and robust surveillance and
data collection strategies. Now, you mentioned that only 37
States and New York City participate in what is called the
PRAMS program and that the survey is representative is 75
percent of all births. It is too bad we can't have closer to
100 percent. What are some of the barriers to implementation of
this participation in all States and for full representation so
that we really have a much more robust data collection?
Dr. Callaghan. The one thing I will say, and this is very
pertinent to your state, is California has a very complementary
system that does not participate in PRAMS. I could get the
precise name of it. I think it is called MEWA.
Mrs. Capps. So we do something different but you can't use
it in the national data collection?
Dr. Callaghan. No, we cannot use that in the national data
collection. That is parochial to California. It is a very good
system.
Mrs. Capps. The California system is good but it doesn't
help nationally?
Dr. Callaghan. It doesn't help nationally.
Mrs. Capps. I see. So that in of the barriers then?
Dr. Callaghan. It is a barrier because----
Mrs. Capps. And so maybe some kind of smart scientist can
figure--a number cruncher can figure out how to coordinate it
so it will be useful to California but also to the United
States.
Dr. Callaghan. Because then one of the other problems that
is left with some of the other smaller States is the births are
so small, and this is based on not a sampling of total births
but on a sample of births and so some very small States, it
becomes very difficult to get a sample that is representative.
Mrs. Capps. And you really want to have a large State like
California and all of New York, not just New York City
involved?
Dr. Callaghan. Right.
Mrs. Capps. That is useful. Thank you very much. It gives
me something to think about with my own State.
Here is another question. I am very excited to hear of the
move to modernize vital records systems. Maybe this is one
arena where we need to do this. But there seems to be more room
for data collection. Can you tell us more about what is
currently being collected on electronic records in light of the
many factors? Maybe we are not even asking enough questions
when we do data collection. In light of the many factors
associate with premature birth and infant mortality and
morbidity, what other data would be helpful to collect?
Especially with the kind of technology we have to collect and
sort data.
Dr. Callaghan. You are asking what other information could
we collect on birth certificates?
Mrs. Capps. Are we lacking----
Dr. Callaghan. We collect a lot of information on birth
certificates. We collect a lot of information about maternal
conditions during pregnancy. We collect information about
problems that occurred during labor and delivery. But one of
the things that we have seen over and over again when we go
back and do validation of that information is that it doesn't
do very well most of the time.
Mrs. Capps. So there is room for improvement?
Dr. Callaghan. There is room for improvement at the level
of data collection, and data collection occurs individually at
individual hospital level.
Mrs. Capps. So there might be some legislation that would
be useful to you to help with the CDC to do a better--to be
more equipped to do a better data collection?
Dr. Callaghan. I have always said that if there is anything
that I could do in career in public health is to improve vital
statistics because we have an infrastructure in place.
Mrs. Capps. Mr. Chairman, I am going to suggest, or just
suggest it to my fellow committee members that this is an area
that would seem to be the low-hanging fruit, if you will, for
some of the challenges that we face in this area, that if we
can put some bright heads together to figure out a better way
to collect data and use it in a proper way, that would be very
useful.
I am going to try one more question because I have 17
seconds. Dr. Spong, I appreciated your testimony as well. You
know, there are so many factors associated with preterm birth,
the health status of the mother, you know, issues like
diabetes, obesity, deficiencies of certain nutrients and so
forth, high blood pressure. Can you just say in a couple of
seconds more about the importance of preconception health? This
is such a huge issue that starts really prebirth with the one-
day mother, doesn't it?
Dr. Spong. Yes, preconception care is clearly important.
Women who start pregnancy healthy tend to have healthier
pregnancies. That said, I cannot point to research or data as
to what exactly needs to go into that preconception care that
will actually ultimately result in improved outcomes. But we do
know that women who have a healthy lifestyle, who are an
appropriate weight, who don't have habits such as smoking or
alcohol exposure tend to have healthier pregnancies.
Mr. Pallone. Thank you.
The gentleman from Pennsylvania, Mr. Pitts.
Mr. Pitts. Thank you, Mr. Chairman. First, I would like to
ask unanimous consent to enter into the record a couple of
articles and a list of studies that have found that women with
prior induced abortions are at increased risk for premature
birth and low birth weight.
Mr. Pallone. I am going to take a look at them but I don't
see a problem.
Mr. Pitts. The articles are by the American Association of
OB/GYNs.
Mr. Pallone. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. Thank you, Mr. Chairman.
Dr. Callaghan, you mentioned that the CDC had worked with
States to assist with smoking cessation programs during
pregnancy. Have any States used their master settlement
agreement funds to implement smoking cessation programs
targeted at pregnant women?
Dr. Callaghan. I really don't have the information at hand
to answer that question. I would be happy to do that and get
that information to you.
Mr. Pitts. All right. You mentioned that African American
women are more than, I think you said twice more likely than
white women to have preterm birth, one and a half times more
likely to have preterm birth, twice as likely to have very
preterm infants. Why is that the case?
Dr. Callaghan. That is one of the holy grails.
Understanding that is probably one of the holy grails in all of
perinatal health and perinatal medicine. These are disparities
that we have seen over and over and over again. They are
pernicious. When we adjust for almost anything that we can
think of, if we adjust for socioeconomic status, we adjust for
education levels, it doesn't go away. In fact, as was mentioned
previously in this hearing, these gaps are even greater when we
look at the difference between the most well-off African
American women and the most well-off white women, the gap is
even greater. As Dr. Spong mentioned, the paths to preterm
birth are likely very, very complex. This has been likened to
this other group of diseases that we call common complex
diseases like cardiovascular disease where at the end of the
day there is a preterm birth but there are a lot of different
ways to get there.
Our current kind of working hypotheses around these, that
there are genetic factors, that are environmental exposures,
environmental in most holistic ways such as stress, poverty,
all of which are interacting to result in whatever happens that
goes into spontaneous preterm birth. If we knew the answer to
that question and if we could fix that problem, our preterm
birth and our infant mortality rate would be dramatically
decreased in the United States.
Mr. Pitts. And in 2006, Congress passed the PREEMIE Act
authored by Mr. Upton in the House, and one provision of the
legislation called on HHS to award grants to public and private
nonprofit entities to conduct demonstration projects for the
purpose of improving the provision of information on
prematurity to help professionals and the public and improving
the treatment and outcomes for babies born preterm, and the
grants were to support programs to test and evaluate screening
for and treatment of infections, counseling on optimal weight
and good nutrition, smoking cessation, education, counseling,
stress management, appropriate prenatal care. How many grants
have been awarded under this program and what have been the
results of these demonstration projects so far?
Dr. Callaghan. We began receiving appropriations for the
PREEMIE Act in 2009, and we have continued to do work in
preterm birth as I outlined with regard to looking at late
preterm birth, with looking with factors associated with the
interactions that we are looking at in California, looking at
in Michigan, the interactions between preterm birth, race,
genetic factors and biologic markers. There are people at CDC
that are working in authorization and appropriations and I
would be happy again to have them get back in touch with you,
but as the scientific liaison for the branch that I work in,
that is information I am just not familiar with.
Mr. Pitts. OK.
Dr. Spong, I don't have much time. You mentioned genomic
research in the filed of prematurity. Can you further expand
about what we have learned about prematurity from genomic
perspectives?
Dr. Spong. There have been a number of smaller studies
looking at specific genes or specific alterations in genes to
try to identify why one group might be at higher risk of
delivering preterm, and they have identified certain changes in
alleles or changes in genes. However, we realize that really
that is not going to answer the question, looking at small
groups of people one gene at a time or one alteration in a gene
at a time. Because of that, the NICHD undertook launching a
network on genomics and proteomics of preterm birth to try to
really do a genome widescreen and really evaluate what are the
changes in the genomics and proteomics associate with
spontaneous preterm birth and indicated preterm birth, and that
network is ongoing and over the next couple of years I expect
we will have some findings from it.
Mr. Pitts. Thank you. My time is expired.
Mr. Pallone. Thank you, Mr. Pitts.
I guess we are going to the gentlewoman from Florida, Ms.
Castor.
Ms. Castor. Thank you very much for your testimony.
Dr. Callaghan, correct me if I am wrong, but I believe
there is no conclusive evidence that links rising C-section
rates to prematurity numbers or data that displays that
increases in C-sections are the reason that prematurity rates
went up from 1996 to 2007. However, the speculation is strong.
The March of Dimes reported that from 1996 to 2006, C-sections
accounted for 92 percent of all preterm births in the United
States. Can you please discuss the type of studies that must be
conducted to get to the bottom of this and what steps are
currently underway?
Dr. Callaghan. First of all, because I was a coauthor on
that paper, it is really 92 percent of the increase in preterm
births and not the total preterm birth rate. Still, that is a
very compelling number. The issue about this really hinges
around the word ``cause.'' During this time, 1996 through now
in fact, Cesarean sections have been rising for all comers and
pregnancy no matter what the gestational age, perhaps more
particularly in the late preterm births but it is going up. I
think that the issue around cause, and maybe we need to look at
this a little bit differently, is not so much as a Cesarean
section that is caused but might we expand that a little bit
more to say is it intervention because there are other
decisions that are being made around delivery. And I think that
is what we need to get at, what kinds of decisions are being
made. There are always two steps in this process. The first
step on a clinical basis is the physician and the patient
together in the best circumstances make a decision that
delivery should occur. So that is the first thing that happens
is should delivery occur. Next question is how delivery should
occur. So I think that first step, should an intervention take
place, is what we really need to get at. One of the things that
we are doing right now is, we have a pilot study in three
metropolitan Atlanta hospitals. We are going to identify
through vital records a group of infants that were born between
34 and 36 weeks, go to the medical records and see if it is
even possible by looking through the medical records to find a
reason why the birth occurred. We are also planning on doing
some key informant interviews in those hospitals, physicians,
nursing staff, et cetera, to try to get some more qualitative
information about what might be influencing those decisions
because I think what we really need to do is get at these
processes, and this is hard stuff because this isn't just
numbers, it is really getting around qualitative information
about what process goes on when decisions are made to deliver
prior to term and then how delivery should take place.
Ms. Castor. You know, ACOG and the March of Dimes have
probably the best recommendations on protocols for health
providers. It sounds like the study in Atlanta, something along
those lines so you support something like that on a broader
basis as well. Yes?
Dr. Callaghan. Yes.
Ms. Castor. Thank you very much.
Mr. Pallone. Thank you.
The gentleman from Texas, Mr. Burgess.
Mr. Burgess. Well, I am actually glad that subject Ms.
Castor brought up, that you are having that discussion. In 2006
when we reauthorized the National Institute of Health, there
was report language in the bill dealing with the concept of
doing a Cesarean suction study. Dr. Ken Leveno down at Parkland
where I trained had been concerned that there was a movement
toward elective Cesarean section. In my professional lifetime,
I saw rates go from 12 percent during my residency to probably
25 percent when I concluded active practice in 2003 and now I
suspect they are even higher still. Dr. Leveno's concern was,
we may reach a point where simply the indication for Cesarean
section is patient demand, and we really ought to have the data
before we reach that point because once we are there, it then
becomes very hard to walk back from patient demand on something
along those lines. So where are we with that? Are we looking
into the concept of Cesarean section rates and elective
Cesarean sections are the rates of late prematurity which are a
result of some iatrogenic influences either with Cesarean
section or planned induction of labor? Do you have data on
those issues?
Dr. Callaghan. Yes, that is exactly what we are trying to
get at now with these studies. There is also another study that
I am involved in peripherally through wearing my CDC hat in
Florida that is trying to look at that exact issue. There are
no national data on Cesarean section on demand.
Mr. Burgess. Again, it was Dr. Leveno's concern that we
ought to get that data before it becomes an established norm. I
would never be able to go back and randomly assign people to
groups. I mean, you know that. It becomes almost an impossible
study to construct, so we ought to be prospective about our
look at that.
Dr. Callaghan. And that would probably to do that on a
national basis to include all deliveries in the United States
would likely demand really changing our birth reporting forms
to have that as a check box, if you will, or questions on that
regarding the indications for Cesarean delivery. To the degree
that could be done, I would be in wholehearted support. I don't
know logistically if that is going to happen very quickly.
Mr. Burgess. Yes, it is expensive to do that type of study.
Honestly, it may be something that we need to look at in a
prospective fashion.
I represent a part of north Texas, the east side of Fort
Worth. Fort Worth is where the west begins, but I have the east
side. That is where the east levels out. We have some infant
mortality rates in some of my zip codes that are some of the
highest in the country, and if you look at African American
women and the infant mortality rates for African American
populations in those zip codes, it is astoundingly high, and
yet on the other side of the Trinity River in Dallas, their
mortality rates are much more benign and you don't see the
ratio of disparities. Both counties are large. Both have
significant urban populations. Both have a county hospital. The
difference between the two is the availability and the access
to what might be referred to as a community clinic or federally
qualified health center. And I have labored for that since 2005
when I began representing that part of Fort Worth, to get a
federally qualified health center there. We did not quite a
year so, so it will be a while before we see if it makes a
difference, but it really drove home to me that access may be a
problem, and that is something we need to pay attention to, but
arguably there is equal access in Dallas and Tarrant counties
because of the availability of a county facility even for
someone who lacks the ability to pay, and these are tax-
supported institutions. But utilization was hugely different
between Dallas and Tarrant County, and I think I attribute part
of that to the fact that the availability, the doctors weren't
where the people were, and that has been one of the
difficulties that I have sought to outcome. Do you guys have
any experience with looking at things like that?
Dr. Callaghan. We don't have a lot of experience with
looking at that particular thing although I think you are
probably referring to your home base, the Parkland experience
and the report that they have about reducing preterm birth and
infant mortality and it is an intriguing model where it is
almost doing prenatal care as I read that almost as community
outreach.
Mr. Burgess. And interestingly, back in the 1950s, Dr.
Prichard, looking at a map of Dallas and putting a pin in the
map, a very low-tech activity but a pin in the map every time
an out-of-hospital birth occurred, and that's where he set up
the clinic after he got a cluster of pins, and we as residents
would rotate through those clinics back in the 1970s. So they
have a longstanding robust outpatient clinic department that is
well accepted in the community because it has been there now
for almost 50 years. Again, on the other side of the Trinity,
we don't have--that is not an established part of what people
think about. When they think of John Peter Smith, it is because
it is the county hospital, not because there is a community
clinic that feeds into that. I just think, you know, we talk
about how we spend money, we have got to spend money wisely, I
just think that is one of the areas where we perhaps missed an
opportunity in this health care bill that we did. Well, we
missed a lot of opportunities, but an opportunity we missed in
this health care law was recognized in that.
Thank you, Mr. Chairman. You have been indulgent. I will
yield back the balance of my time.
Mr. Pallone. Thank you.
The gentlewoman from the Virgin Islands, Ms. Christensen.
Mrs. Christensen. Thank you, Mr. Chairman. I would like to
ask unanimous consent to insert into the record written
testimony from Dr. Paula Braveman, professor of family and
community medicine at University of California San Francisco.
Mr. Pallone. What is it that you are giving me again?
Mrs. Christensen. Written testimony that I would like to
insert into the record of today's hearing.
Mr. Pallone. Oh, OK, from----
Mrs. Christensen. Dr. Paula Braveman.
[The information appears at the conclusion of the hearing.]
Mr. Pallone. Without objection, so ordered.
Mrs. Christensen. Thank you. And just for the record, and I
know this is not NIH but it is really CDC, but I see no reason
why the territories' infant mortality, low birth weight and
preterm deliveries are not reported on because we have that
data, and I am proud to say that our infant mortality in the
Virgin Islands last quarter was 7.56, and I can say I am proud
because I know where we came from to get to 7.56, and that is
in a largely African American and Puerto Rican community.
Mr. Shimkus. Would the gentlelady yield for one second? I
think it would be good for the Administration, because she has
raised this a couple times that they better be prepared to
report on the territories when they come to this committee. We
are glad to have her on the committee.
Mrs. Christensen. Thank you.
Dr. Callaghan. I will be happy to take that back to
National Center for Health Statistics.
Mrs. Christensen. Thank you. And thank you, both of you,
for raising the issue of the disparities in African Americans
that I didn't have to do my opening statement.
Dr. Callaghan, what is puzzling and has been known for a
while is that even in African American women who are well off,
well educated, live in supportive surroundings, there is still
a higher low birth weight baby. They still have higher rates of
low weight babies. Is there research being done to determine
why this is and are you coming up with--this is sort of
following up on the other question, but this is low birth
weight babies, not preterm necessarily, not necessarily infant
mortality.
Dr. Callaghan. I came to CDC in 2001. Even prior to me
coming there, there has been a long history of CDC bringing
people together to look at this problem. A lot of the work in
what is the social context of pregnancy in African American
women and what is the context of African American women in the
United States and looking at the long-term effects of
institutionalized discrimination and institutionalized race and
how does that chronic stress, which is very difficult to
measure, there is not a blood test for it, but we know from
some qualitative work that that stress exists and we also know
that chronic stress plays itself out biologically. There is no
question about it. Stress is a biologic phenomenon. There are
pathways between what is going on in our brains and our brains
are connected to everything, and there has been the hypothesis
that some of these stress hormones actually regulate what has
been euphemistically called the placental clock, and that there
may be messages coming down that it is time to be born that are
not in the best interest of the woman or the baby but that is
what is going on. That being said, when we start drawing these
pathways, there are so many lines feeding back on to one
another that they are almost not even lines anymore, they are
this line going up, this line going down and all of a sudden
the line becomes a plane.
The more important thing perhaps might be not so much the
recognition that stress plays a part but then in the next step
so what do we do about this, how can we ameliorate the effects
of chronic stress, almost a bigger problem than trying to
understand that stress affects our biology. We have done----
Mrs. Christensen. Are you actually testing women in any way
to see what their level of stress is? You are talking about
people who are working in great jobs, have a decent education,
and I mean, everybody has stress.
Dr. Callaghan. Right, and in fact, when we look at least
epidemiologically, we see that women who like in PRAMS, for
example, they ask a lot of question about individual stress and
individual stress is much worse when you sort of overlay their
neighborhood context, for example, people who live in poor
neighborhoods have a more profound response to stress, at least
as it relates to preterm, than women who don't. I would like
also Dr. Spong to weigh in because NIH is doing a lot of that
fundamental work as well.
Mrs. Christensen. And before you answer, though, let me
just get my second question which is to you, Dr. Spong, and we
are glad to hear about the August conference that you are
having. In your answer, could you also tell me if the trials
with magnesium sulfate, progesterone or treatment of bacterial
vaginosis, if those trials are--the people in those trials, are
they diverse enough to be able to tell the impact on African
American and Latino or American Indian?
Dr. Spong. I thank you for both of your questions. I am
going to take the second question first. The diversity of the
patient population in the network is required by the open
recompetition every 5 years that the sites are geographically
diverse and the population is geographically diverse. And I
think one of the best examples is that progesterone was found
to be equally beneficial in both African American women and
non-African American women, which is so important given the
disparities associated, so yes, we do strive for that and we
are achieving that at least at this point.
I would like to bring to your attention one study that the
NICHD currently has underway called the community child health
research network, which is focused specifically on the question
you are asking about the African American community disparities
in preterm birth as well as infant mortality, and the goal of
this network is to involve the community itself along with the
academic sites to develop the interventions to try to see if we
can understand the disparities when measuring these markers of
stress and to try to see if we identify potential
interventions.
Mrs. Christensen. Thank you. Thank for your answers, and
Mr. Chairman, thank you. I yield back the balance of the time I
have left.
Mr. Pallone. I think that completes the questions for this
panel. Thank you very much. It was helpful in terms of what we
are trying to achieve and we appreciate it. We may send you
additional questions from some of the members within the next
10 days to answer in writing as well. But thanks.
I will ask the next panel to come forward. Let me introduce
the three of you. First on my left is Dr. Alan R. Fleischman,
who is senior vice president and medical director of the March
of Dimes Foundation. And next to him is Dr. Charles S. Mahan,
who is dean and professor emeritus of the USF College of Public
Health, the Lawton and Rhea Chiles Center for Healthy Mothers
and Babies. Thank you for being here. And finally, Dr. Hal
Lawrence, who is vice president for practice activities of the
American College of Obstetricians and Gynecologists. Thank you,
Dr. Lawrence.
As you know, we ask you each to speak for about 5 minutes
and then later if you want to submit additional materials in
writing, you can.
We will start with Dr. Fleischman.
STATEMENTS OF ALAN R. FLEISCHMAN, MD, SENIOR VICE PRESIDENT AND
MEDICAL DIRECTOR, MARCH OF DIMES FOUNDATION; CHARLES S. MAHAN,
MD, FACOG, DEAN AND PROFESSOR EMERITUS, USF COLLEGE OF PUBLIC
HEALTH, LAWTON AND RHEA CHILES CENTER FOR HEALTHY MOTHERS AND
BABIES; AND HAL LAWRENCE, MD, VICE PRESIDENT, PRACTICE
ACTIVITIES, AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS
STATEMENT OF ALAN FLEISCHMAN
Dr. Fleischman. Thank you, Chairman Pallone, Ranking
Shimkus and members of the subcommittee. On behalf of the 3
million volunteers and 1,400 staff members of the March of
Dimes, I want to thank the committee for your interest in the
public health crisis of premature birth.
As you know, the March of Dimes is a national voluntary
health organization founded in 1938 by President Franklin
Delano Roosevelt to prevent polio. Today, the foundation works
to improve the health of mothers, infants and children by
preventing birth defects, premature birth and infant mortality
through research, community services, education and advocacy.
After 3 decades of continual increases in the rate of
prematurity, the March of Dimes is heartened by the news that
the rate of preterm birth has finally leveled off and has begun
to decline. But now is not the time to rest on our laurels. The
life-threatening and lifelong consequences of prematurity as
well as its extraordinary costs in dollars can still be felt by
more than half a million babies and their families and each
year in the United States some 28,000 babies die before the
first year of life due to preterm birth. Prematurity is also
the number one cause of neonatal death and is the major
contributor to infant mortality. It is responsible for lifelong
disabilities.
We have also learned that the complications of being born
late preterm, just four to six weeks premature at 34 to 36
weeks' gestation are also significant since one-third of brain
growth and development occurs in the last 5 weeks of pregnancy.
Infants born just 4 to 6 weeks early are more likely than term
infants to have significant long-term deficits such as school
learning problems, disabilities and lower rate of college
education and lower net incomes.
In addition to the severe consequences, the costs of
prematurity are immense. The Institute of Medicine estimated
the annual societal economic costs associated with preterm
birth are at least $26 billion a year. Approximately half, or
48 percent, or hospital stays for preterm infants are financed
by Medicaid. In 2007, hospital costs for these babies averaged
$45,900 each.
In recent years, we have seen several effective
interventions to decrease preterm birth through comprehensive
quality improvement strategies. The Intermountain Health System
in Utah initiated prospective review of all elective inductions
and C-sections and were extremely successful with dramatic
decreases in early deliveries. Parkland Hospital in Dallas
universal access to culturally sensitive comprehensive
perinatal services over the past 15 to 20 years including high-
quality, evidence-based care with accountability and continuous
quality improvement has resulted in the lowest rates of preterm
birth among African Americans and indigent Hispanics in the
United States.
For the March of Dimes, the Cesarean section question is
simple. Every baby should be delivered at the right time for
the right reason. We applaud the guidelines and efforts of the
American College of Obstetricians and Gynecologists. Adherence
to their current guidelines and holding hospitals and
clinicians accountable to these standards of care through
quality and safety initiatives in hospitals can make a major
difference in the rate of preterm birth and is needed in every
hospital in the United States.
So we are beginning to see some progress, but to sustain
and to be truly successful in reducing the incidence of preterm
birth and infant mortality, we require the continuing
commitment of the federal government. That is why the March of
Dimes is seeking reauthorization of the 2006 PREEMIE Act to
support expanded research, education and demonstration
projects. My written testimony provides more specific
recommendations, but let me be clear: First, further research
is essential into the fundamental causes of prematurity, and as
the Institute of Medicine report and the surgeon general's
conference recommended, transdisciplinary research centers for
prematurity funded by the National Institutes of Health with
new dollars allocated for these activities will integrate a
wide range of disciplines and study this complex problem.
Second, we need to reauthorize and expand preterm activities at
the CDC Division of Reproductive Health to improve national
vital statistics and increase community-based intervention
programs, to impact on perinatal health disparities, and third,
we need to reestablish the federal interagency coordinating
counsel on prematurity and low birth weight to coordinate
federal efforts and keep Congress apprised of progress on the
issue of prematurity prevention.
Finally, we hope that one of the outcomes of this hearing
is that you will agree to work with us to draft and obtain
swift enactment of legislation reauthorizing and expanding upon
the progress made as a result of the PREEMIE Act, and I am sure
that each of you in the room join of all at the March of Dimes
who look forward to the day when every baby will be born
healthy and stay healthy. Thank you very much.
[The prepared statement of Dr. Fleischman follows:]
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Ms. Castor. [Presiding] Thank you, Dr. Fleischman.
Dr. Mahan.
STATEMENT OF CHARLES S. MAHAN
Dr. Mahan. Madam Chair and members of the committee, I
finished my OB/GYN residency 45 years ago, and practiced for
the first 20 years, and then morphed into public health and
directed the State health department in Florida for 8 years
before becoming dean.
I have been asked to speak to two areas by the committee.
One was disparities, and the other is some public health steps
that we could take immediately and in the fairly short term to
start turning this around. A lot of people have also spoken to
the disparities. The biggest problems are in African Americans.
In Florida, we have the most black births of any State in the
union, and our black-white infant death ratio has gone from 1.9
to 1 to 2.6 to 1, and last year we woke up our Hillsboro County
and Tampa and found that it was four times the white rate. I
have put some statistics there about maternal mortality again
which black women suffer much more heavily than white women,
and that has already been mentioned.
As far as the causes of infant mortality, there is a chart
on my testimony that shows sort of a flow chart that shows how
these things develop, and as Dr. Callaghan pointed out, there
is a very complex problem. You have root causes of which health
and health care are only two, and stress has been mentioned,
economics, education, family support, crime. All of these are
things that can lead to a problematic outcome of pregnancy. And
the two biggest factors that enter into preterm birth are
social issues and maternal health when the mother enters
pregnancy. By people smarter than I am, it has been predicted
that if we corrected and every African American woman got into
great health and great health care without addressing those
other issues, we may be able to nibble away at 30 percent of
this problem. But other countries that have passed us in this
area have dealt with the education, the jobs and the other
things that are important leading into this issue.
Now, depending on where you live, this isn't just a problem
in the black community. I am on the board of the Frontier
Nursing Service in Kentucky, and in Appalachia, which is mostly
white, we have terrible pregnancy outcomes there also. We have
different root causes. Twenty-five percent of our patients at
the Frontier Nursing Service are addicted to prescription
drugs, and there is very little treatment available and many
providers will not accept people that are addicted into their
practice.
The other issues that have been studied by Dr. Michael Lu
at UCLA and Flita Mass Jackson in Atlanta Morehouse are that
black women are victims of what is called weathering, and that
is that if you are a black mother that has a low birth weight
baby, your low birth weight daughter is more likely to also
produce a low birth weight baby and then they predict it may
take three or four generations of being upper income to
actually shed this weathering system which they think is mostly
due to stress. And adding to that, black women have the highest
rates of Cesarean of any group in the country.
Now, the second part I was asked is, what public health
interventions could we do to reduce prematurity. Well, one
thing you could do right now is pick up the phone, call CMS and
tell Medicaid to stop paying for elective inductions and
Cesareans at any stage of pregnancy, and I don't even agree
with ACOG's recommendation of 39 weeks, and we agree that that
may be arbitrary, but there is probably no reason a normal
woman should ever be induced no matter where she is. The second
thing is that in our studies in Florida, we find that women
that are agreeing to this, and national studies show that
generally when elective things are done, the doctor recommends
it, the patient generally does not bring up the subject. In
fact, national studies show that less than one-half of 1
percent of patients do. But they are quick to go along with
what the doctor recommends. So we have designed some informed
consent that is true informed consent showing that elective
procedures such as elective Cesarean are hazardous to the
health of the mother and the baby. They are not equivalent to
having a vaginal birth. And again, these are in low-risk women.
And those are part of the attachments you will get.
Unfortunately, you don't have them right now.
Vaginal birth after Cesarean has essentially disappeared
even though studies show that having a repeat Cesarean is
slightly more dangerous to the mother and the baby than having
a vaginal birth, so I would propose a new scale of payment for
Medicaid that would be something like $2,000 for a VBAC, $1,500
for a vaginal birth and $1,000 for a C-section, which takes
less time and effort. Those are immediate steps that could be
taken. In the short term, I would say in about a year, we can
encourage the development of new pregnancy provider models.
Most other countries have a midwife- and doula-based system for
primary care for normal women and pregnancy. That can even be
used for people that have high-risk problems comanaged with an
obstetrician. Although I would recommend, and this is just
coming from me, that we stop producing generalist OB/GYNs
because as ACOG has pointed out, the young folks coming out
today don't want to work on nights and weekends, and turn it
over to midwives backed up by an increased number of maternal
fetal medicine specialists working with groups of midwives,
which is a model that I have worked in in Gainesville over the
years. It is a wonderful lifestyle and way to work.
I also put in here pay midwives the same amount as
obstetricians get paid for taking care of normal people, but it
was pointed out to me that that is already in the new health
care bill, so forget that one.
I would encourage the movement to group prenatal care that
both ACOG and other groups have recommended instead of
individual prenatal care, especially for low-income women, so
that they can do some community support of each other.
Ms. Castor. Dr. Mahan, can you bring it to a close and we
will move on?
Dr. Mahan. Pardon?
Ms. Castor. Can you bring to a----
Dr. Mahan. Yes. I think develop quality standards, provide
preconception, interconception care, and then I have an
extensive session on the cost savings that this could have,
which would be to the tune of about $50 billion.
[The prepared statement of Dr. Mahan follows:]
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Ms. Castor. Thank you very much.
Dr. Lawrence.
STATEMENT OF HAL LAWRENCE
Dr. Lawrence. Thank you, Representative Castor and Chairman
Pallone and the distinguished members of the subcommittee. My
name is Dr. Hal Lawrence and I am an obstetrician/gynecologist
and ACOG's vice president of practice activities. I am here
today representing 53,000 physicians and partners in women's
health care.
Preterm birth is one of the most complicated and difficult
issues in obstetrics. As a Nation, we still don't know very
much about the risk factors, the causes or prevention of
preterm labor. We do know that preterm labor is the most common
cause of hospitalization before birth, that there is a link
between preterm birth and infant mortality, that the rate of
preterm births is a growing public health problem that cuts
across social, racial, ethnic and economic groups and that our
Nation must do better.
ACOG firmly believes that we can make a difference and we
are committed to leading the change and we are very clear that
deliveries before 39 weeks' gestation should only occur when an
accepted medical maternal or fetal indication for delivery
exists. We have been intimately involved in a number of efforts
over the years to improve research and practice guidelines to
reduce the rate of premature births in America.
ACOG is the nationally recognized source for clinical
guidelines and medical information that help shape maternity
care based on evidence-based peer-reviewed science and some
expert opinion. These include practical information on late
preterm births, management of preterm labor, assessment of risk
factors for preterm birth, use of progesterone to reduce
preterm birth and obesity in pregnancy. But where research has
not been conducted, clinical guidelines have to wait. Preterm
birth can occur in any pregnancy and our current clinical tools
cannot determine a woman's risk except for women, as you have
already heard, who have had previous preterm births, the only
clear risk factor. Even so, the ability to predict whether a
woman is at risk of preterm delivery has value only if an
intervention is available to reduce or eliminate that risk, and
right now we have very few effective interventions. Better
research can be translated into more complete clinical
guidelines and better care.
ACOG has been intimately involved in a number of other
efforts to advance our knowledge in this area including the
2006 Institute of Medicine report on preterm birth, the surgeon
general's 2008 conference on the prevention of preterm birth,
and the 2009 Symposium on Quality Improvement to Prevent
Prematurity that we did with the March of Dimes. These efforts
identified gaps in clinical knowledge and research, many of
which ACOG in our MOMS Initiative, and that stands for Making
Obstetrics and Maternity Safer, called on Congress to support,
and those include NIH research to reduce preterm births and the
focus on obesity, CDC's surveillance and research to assist
State maternity mortality reviews, modernized State birth and
death record systems, and improve the safe motherhood program,
the HRSA fetal and infant mortality review, which brings
together local OB/GYNs and health departments to reduce infant
mortality rates and improve the maternal child health block
grant, comparative effectiveness research into preterm birth
interventions and efficacy, disparities research, testing the
obstetric medical home to address the unique issues of
pregnancy and supporting quality improvement measures.
It is also impossible not to also mention the link medical
liability and the practice of obstetrics performing deliveries.
In the world of childbirth, a perfect pregnancy can turn
disastrous in a heartbeat, and through no fault or malpractice
of the obstetrician/gynecologist. Vaginal births after Cesarean
sections, VBACs, can seem perfectly normal until something goes
wrong. At that moment, one and sometimes two lives can be on
the line and seconds count. It is often in these scenarios that
OB/GYNs get sued and result in very large awards regardless of
the physician's care. The risk is really that great. ACOG
recommends exploring medical liability alternatives including
early offer programs, health care courts, alternative dispute
resolution and birth injury compensation funds, and I would
like to thank Representatives Pitts and Gingrey for your
attention to this important issue in your earlier comments.
I would also like to thank Representative Burgess, who
plans to introduce a bipartisan piece of legislation extremely
relevant to today's hearing. His legislation will provide for
research on birth defects and breast feeding to help educate
women on ways to reduce the risk to their babies and have
healthy pregnancies. Once introduced, I urge the subcommittee
to quickly take up this legislation.
I would also like to thank Chairman Pallone. ACOG has been
fortunate to be able to work with his staff and thank him for
his focus on stillbirth and sudden infant death, and we look
forward to offering support as that legislation goes forward.
Again, I would like to thank you for this opportunity to
provide this statement. A written statement of my comments has
been supplied, and we applaud your commitment and leadership on
this issue. We look forward to working closely with you and the
subcommittee. Thank you.
[The prepared statement of Dr. Lawrence follows:]
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Ms. Castor. Thank you, gentlemen. Your testimony was
outstanding.
Let me start by asking about a subject that you each very
briefly touched on, and that is the inaccurate gestational
dating. It seems like there is a concern out there about if the
recommendation is you go fully to term at 39, 40 weeks, how do
you really measure, especially in certain subgroups, that you
have an accurate due date, and then how do we--is it the same
based on socioeconomic factors and education or is there
something a little more concrete that we can get? I would like
to hear from all of you on that.
Dr. Lawrence. Thank you for that question. Obviously
whenever you have any recommendations on timing of delivery,
having accurate dates of that pregnancy is crucial, and we have
published guidelines on how you determine when somebody is at
least 39 weeks' gestation, and those guidelines clearly state
that you have to have had an ultrasound at least in the early
second trimester to confirm an estimated date of confinement,
or due date, so you are sure they are 39 weeks, or you have to
have had 36 weeks of pregnancy following a serum or urine
pregnancy test, or you had to be able to have documented fetal
heart tones for 30 weeks since they were first documented. All
three of those methodologies will confirm that somebody is at
least at 39 weeks' gestation. I know that there is discussion
about earlier first-trimester scanning. We think that that is
an interesting opportunity also. We have discussed this several
times and Dr. Fleischman and I have discussed this several
times. I know in Great Britain they do something called a
booking scan. But when our committees look at this and
carefully weigh the benefit and the costs of those ultrasounds
at that 16-, 18-, 19-week gestation, not only do you get a very
accurate gestational age calibration plus or minus seven to
nine days, you also get a good anatomy evaluation of that
fetus. So there is a whole lot more benefit found and so
because of that our committees have been unable to say we
should recommend two scans at this point in time.
Dr. Mahan. We had talked about this before we testified,
but the 39 weeks that ACOG recommends, I think we should look
at that again in the college because if a woman is entirely
normal, why should you even have the 39-week recommendation?
You know, Mother Nature tells you when term is because labor
starts, and the Institute for Health Care Improvement basically
recommends that we wait for labor to begin and see how labor
goes, again in normal people. You certainly have to count on
all the things Dr. Lawrence said for somebody who is high risk
if you are going to have to deliver them early.
Dr. Fleischman. We go back to the Institute to Medicine
report in 2006 that clearly recommended early ultrasounds in
the first trimester as the most accurate gestational dating,
which would, I think, give us combined with history a very
important public health program in order to assure that the
kinds of complex things that Dr. Lawrence is saying are the
appropriate ways if you don't have the earliest ultrasounds. I
think if we did that as almost every obstetrician in American
has in their office, the ultrasound machine, at the earliest
times to find the fetal viability as well as the fetal
gestational age, we would be making better decisions at the end
of pregnancy. We know time and time again from intervention
studies that if you put off at least until 39 weeks, and I am
not disagreeing with Dr. Mahan, but at least until 39 weeks you
run a very low risk of prematurity, and if you don't have
accurate gestational dating you increase the risk of premature
birth.
Ms. Castor. Mr. Shimkus.
Mr. Shimkus. Thank you, Madam Chair. I concur with you. It
is great testimony. One thing I really enjoy about this
subcommittee on health care, it is a caring profession. I mean,
everybody is doing it for the right reason, whether it is
adults, and this one of course on the unborn children. So with
all our fights and battles, it is really great to have people
who are very concerned.
Dr. Mahan, I really enjoyed your testimony. I have
questions for you. I am an old Army infantry guy, and you know,
we just keep it simple, and it seems like your testimony kind
of keeps it simple. God has created phenomenal human beings--
not your words, mine. The body tells us when. We shouldn't be
doing things that aren't natural unless we have to, I think if
I could summarize. And then there is ways to incentivize that
financially because we are a big payer. We are a third payer in
a lot of the health care delivery system. And so why not use
that tool? We did miss that opportunity, but then maybe there
are other opportunities to relook at that. I really enjoyed the
testimony.
Dr. Fleischman, you state that there are several factors
that have caused the increase in elective inductions, that is
kind of leading on this debate, and Cesarean deliveries. You do
mention in your statement about the litigious environment and
defensive medicine. Can you talk about that? I am from
Illinois. We have had a huge medical liability crisis. We had a
Supreme Court campaign turn on this, and even though that was
the primary reason because all our physicians were leaving the
State, it wasn't enough and then we have gone back to that. So
I know we don't like to talk about it, but it is in your
statement. Talk about that for me, will you?
Dr. Fleischman. Well, we are very sympathetic to the
obstetric practitioners concerning their concerns and fears
about the litigious environment. We believe the best way to
prevent lawsuits is to have the highest quality care, to set
standards, to set guidelines and to practice appropriately with
appropriate accountability. That protects both the patient and
the doctor, and I think we are moving in those directions. We
have the national quality forum and the joint commission and
others setting standards. We have CMS now to set standards
around perinatal health and quality measures. We think that
high-quality practice is the way for the obstetric community to
assure that they are actually able to protect themselves and
their patient.
Mr. Shimkus. And I appreciate that, but how do you tie that
in to the litigious--I get it. I mean, if we don't have
problems, then you don't have lawsuits, but how do you tie that
in to the courtroom drama that unfolds? Is it making sure--I
have been through this for years now as far as the public
policy guys, make people that say I am sorry. I mean, how do
you tie that to the courtroom? That is the issue?
Dr. Fleischman. Well, I think----
Mr. Shimkus. I mean, your words. I am not putting--you
talked about the litigious environment and defensive medicine.
Dr. Fleischman. Well, we can stand up tall if we practice
high-quality medicine based on ACOG guidelines and appropriate
care, and if we do that, then even if we make our way to the
courtroom, we can have a reasonable defense of good high-
quality practice and decrease the incentives on the part of
those who are bringing those lawsuits----
Mr. Shimkus. But you are not willing to talk about the
courtroom dilemma that they still face regardless of this.
Dr. Lawrence, do you want to weigh in on medical liability?
Dr. Lawrence. Thank you very much. Medical liability is
just a huge issue in our practice, and you all have heard this,
I am sure, before, but, you know, over 90 percent of practicing
obstetrician/gynecologists have been sued, and I would tell you
90 percent of anybody isn't doing bad things, and I think each
of you know that.
Mr. Shimkus. I always usually say in any organization, you
may have 10 percent who are bad actors. Unfortunately, we find
that here. I found that in the military. You find that in
schools. I would agree, 90 percent----
Dr. Lawrence. But not 90 percent.
Mr. Shimkus. I would have to agree, 90 percent, there is
something else going on.
Dr. Lawrence. And the thrust of your question, you know,
ACOG works hard to put forth guidelines enabling medical staffs
and local community hospitals to create practice parameters and
protocols to help take care of these patients. The problem for
us is that even when you do all that, even when you do it all
right, that does not guarantee a perfect outcome. Reproduction
has never been perfect. Sadly, reproduction will never be
perfect. There will always be adverse events. There will always
be situations that are not predictable. And somehow in this
process, if the providers are doing everything right, we should
not be held accountable for an adverse outcome that we could
not have prevented, and that is true in the VBAC situation that
I mentioned. It is true in many other situations in managing
patients whether they are high-risk patients or whether they
are deemed to be low risk and then all of a sudden there is a
cord prolapse or all of a sudden there is an abruption or all
of a sudden there is a vasa previa. I have been there. I have
jumped in and done those deliveries. And fortunately, they
usually go OK but not always, but if you do it right, somehow
the liability system has to recognize that and deal with this
other than within a tort arena.
Mr. Shimkus. Madam Chair, I am not going to follow up with
a question, but if I may just again thank you all, and I am
going to follow up with a written question on Medicaid
expansion and reimbursement rates and other things that I would
like to get into but time is not going to allow me to do that.
Ms. Castor. Thank you very much.
Dr. Christensen.
Mrs. Christensen. Thank you, Madam Chair.
Dr. Mahan, true informed consent, how do you define that
and how do you arrive at that?
Dr. Mahan. I think it needs to be based on--and I have
worked with the National Coalition to Improve Maternity
Services on this for the past year, especially for informed
consent for Cesarean, and we based all of our efforts on
science, evidence based, but what we were finding, and this is
among studies of upper-income people, upper middle-class
people, was that it was really a last-minute sort of glossed-
over thing that this is all going to be OK. So in the
attachments that you will get is a copy of the--it is called
the risks of Cesarean section, a checklist that women should be
given at about 32 weeks of pregnancy, not at term, so that she
and her partner can go through it, look at the differences----
Mrs. Christensen. Both sign?
Dr. Mahan. Pardon?
Mrs. Christensen. Are both supposed to sign it?
Dr. Mahan. I believe so, yes, and so is the care provider.
Now, this is just a suggestion. It has not been adopted except
by this particular group. But for instance, when the mother
looks at the section possible problems for my baby, my baby is
more likely to have breathing difficulties--this is after
Cesarean--it is normally best for labor to begin, so on and so
on and so on, and my baby is more likely to die than if it was
born vaginally, which is not a high chance but it is
statistically more likely to do that. The mother needs to know
that.
Mrs. Christensen. Thank you. And your third immediate
recommendation, I would ask you and Dr. Lawrence and perhaps
Dr. Fleischman as well, what is the data on outcomes in vaginal
birth after Cesarean, and does ACOG recommend that after the
first Cesarean that women go through vaginal delivery?
Dr. Lawrence. ACOG, in fact following the NIH consensus
conference that we just participated in, have a new practice
bulletin about discussing vaginal birth after Cesarean section,
and in there we do recommend that women be offered a trial of
labor after Cesarean section, assuming that that section was
for a non-recurring cause, assuming that there wasn't like she
had----
Mrs. Christensen. If it was a breech and----
Dr. Lawrence. Correct, like a breech, and we do recommend
that those patients be counseled and offered that procedure.
Institutions have to be able to provide the services to support
that procedure, and the problem with VBAC is where the risk of
a uterine rupture and spontaneous labor is low, it is less than
1 percent. If, however, it occurs, the same Dr. Lu that Dr.
Mahan used as a reference earlier has a study from Los Angeles
County that shows you have 12 minutes to get that baby born or
that baby will probably not survive, and if it does survive
will be severely handicapped. So because of liability concerns,
many institutions and many providers have said I am not willing
to put that baby at that much risk. At that same NIH consensus
conference on VBAC, one of the attendings from Parkland stood
up and gave a scenario of a perfectly managed VBAC, everything
was doing fine. In fact, this patient had delivered vaginally
after her previous Cesarean section, which puts her in a lower
risk. Everything was going great. The uterus ruptured, crash
Cesarean section, baby delivered. Baby did not do well. An
$11.5 million settlement against the institution and the
physicians. And that group no longer does VBACs. So that is the
scenario that vaginal birth after Cesarean section has placed
many obstetrical providers, and that is the reason that the
concern has been raised about that procedure.
Dr. Mahan. And I would follow up with that, and I agree,
and I think that was an excellent conference, but the issue
that we have to deal with now is that, you know, I think Dr.
Spong's studies that she has helped publish have shown that
VBAC is slightly safer for the mother and baby other than a
repeat Cesarean. You can lose babies and mothers with a repeat
Cesarean. The problem that we need to deal with, and it is tied
up with the liability issue, is that since so few hospitals are
providing VBAC--now, USF, we do do that in our practice group.
Women in communities that can't get it are turning to home
birth because they can't get it anywhere else and they had such
a bad experience with their first pregnancy that they don't
want to go back to the hospital and we are really worried about
that too. So it is another reason to deal with the liability
crisis.
Dr. Fleischman. I think the fundamental question, and I
agree with these gentlemen, but the fundamental question is,
how do we decrease primary Cesarean sections that are done
unnecessarily, and we know that if we induce a woman when she's
not ready to deliver, she is highly likely to result in a
Cesarean section, and then we put the woman in the position of,
you know, the question of vaginal birth after Cesarean. I think
that is the real challenge.
Ms. Castor. Thank you very much.
Mr. Pitts.
Mr. Pitts. Thank you, Madam Chairman.
Dr. Fleischman, you mentioned Institute of Medicine. The
Institute of Medicine recently published a 570-page resource
book entitled ``Preterm Birth: Causes, Consequences and
Prevention.'' On pages 517 and 518, abortion is noted as an
``immutable'' risk factor. However, the risk factor is
avoidable if women are given risk information prior to
pregnancy. I would like each of you to respond to this, and I
know of 59 studies that have found that women with prior
induced abortions are at increased risk for premature birth and
low birth weight. The question is two parts. Do your
organizations acknowledge abortion as a risk factor, and is it
included in your information searches? Are you aware of efforts
to inform women about such a risk factor? Each of you, please.
Dr. Fleischman?
Dr. Fleischman. At the March of Dimes, we continually
monitor those data that you have mentioned, and the most recent
data from modern techniques in termination do not give
convincing evidence of that as a significant risk factor for
preterm birth, and we do not raise that issue within our
materials.
Mr. Pitts. Dr. Mahan?
Dr. Mahan. I don't know the answer to that. I know that one
of my--I just read the executive summary of that report. One of
my problems with it was that it was a little behind the times
because it really wasn't dealing with the elective induction/
Cesarean issue. But one of the things I bring out in my
testimony that I hope you will read is that one of the key
things to improved maternal health and infant health in the
United States is interconception care and preconception care so
that--especially interconception care of women who have already
had a low-birth-weight baby. Right now essentially we just drop
them and we wait to see when they are going to have the next
pregnancy when we know that it would be help if we spaced their
pregnancy for at least two years and so I think following the
diabetic woman who just had a pregnancy, making sure she is in
good shape, following the woman who had a low-birth-weight
baby, trying to get her out there for 2 years before she gets
pregnant again, if we can provide--you know, in Florida we woke
up last year and the CDC told us that we are 51st of all the
States plus D.C. in providing reversible contraception to
women, and this is the 50th anniversary of the Pill. When the
Pill came out and I was a student in Chicago, the average
family size was six and a half, and now it is one and a half.
If we want to reduce abortion if it does cause this problem, we
have got to stop putting our heads in the sand about helping
people space their pregnancies.
Mr. Pitts. Dr. Lawrence?
Dr. Lawrence. Well, I would like to have a couple points.
First off, I am aware of the data. We do review that data. And
I also agree with Dr. Fleischman that more recent studies with
more recent technologies don't show a real correlation between
induced pregnancy termination and premature birth. I also think
that Dr. Mahan is right on target here, and I think one of the
benefits of the health care reform law is that now patients are
going to be able to have ongoing continual care, and as Dr.
Spong said earlier, the best way to have a healthy baby is to
have a healthy mommy and ongoing well women's health care
rolled in with contraceptive care, rolled in with preconception
care is a major factor in helping to reduce preterm birth and
improve maternal and infant outcomes.
Mr. Pitts. Thank you.
Dr. Fleischman, I didn't quite get your response. Do you
believe comprehensive medical malpractice reform would
potentially help providers stop practicing defensive medicine?
Dr. Fleischman. I guess the detail of what the
comprehensive medical malpractice reform means----
Mr. Pitts. Well, like they have in California or Texas.
Dr. Fleischman. Well, we have not taken a position on that
at the March of Dimes.
Mr. Pitts. OK. What about you, Dr. Mahan?
Dr. Mahan. Absolutely.
Mr. Pitts. And Dr. Lawrence?
Dr. Lawrence. I am in total support. If we get
comprehensive medical liability reform, it will help not only
OB/GYN but all areas of medicine.
Mr. Pitts. Dr. Mahan----
Ms. Castor. I am sorry.
Mr. Pitts. Oh, I am out of time.
Ms. Castor. We would like to get Dr. Burgess in before we
adjourn.
Mr. Pitts. Thank you. My time is up.
Ms. Castor. Dr. Burgess.
Mr. Burgess. We have a series of crucial votes and the
entire Nation hangs in the balance in 15 minutes, so we will
have to take off and do those. I appreciate you all being here
today. I appreciate you staying with us. Listening to your
testimony, your answers to some of the other questions is
certainly intriguing.
Dr. Fleischman, I am going to answer Mr. Pitts's last
question for you. Defensive medicine is learned behavior and
physicians are probably not likely to unlearn that behavior
overnight. There may be--certainly it will help but when I am
criticized by the President because we did liability reform in
Texas, and McAllen, Texas, is still a high-cost place to get
health care, you are not going to change it overnight even as
good as our law has been in Texas. I don't think there is any
question--you know, Dr. Mahan, you talk about VBACs, and I
remember the studies that came out of Los Angeles while I was
still in practice and I think they just absolutely threw up
their hands and stopped offering VBACs for a while because of
the liability issue, and certainly, Dr. Lawrence, your story of
what the group in Dallas got into the $11 million settlement,
if we are paying $1,000 more for a VBAC but we get hit with an
$11 million judgment, that is 11,000 VBACs we are going to have
to do to cover the cost of that $11 million judgment, and as
you guys know, the numbers just don't work out.
We do have to undertake a more sensible medical justice
system in this country. I don't know what it is. I like early
offer but what is happening in Texas now with a trifurcated cap
on non-economic damages seems to be working and it seems to be
working in a big way and not just holding down costs of
premiums for practicing physicians but holding down costs for
institution that self-insure for liability, allowing smaller
not-for-profit hospitals to have more money to invest in
capital improvements, nurses' salaries and the very things we
want our smaller nonprofit hospitals to do in our communities.
So I certainly stand behind what is happening in Texas. I would
have liked to have seen us do more in the health care law that
passed but unfortunately we didn't do it.
Now, Dr. Mahan, your discussion on Medicaid, you said for
Medicaid to stop paying for elective inductions and elective
Cesarean sections in any stage of pregnancy. That may be great
in theory but we have a problem back home where you can have a
hard time finding a doctor who will take a patient's Medicaid
because the reimbursement rates are so much lower than
commercial insurance, and as a consequence are we likely to
make it even tough for that woman to get prenatal care because
we have now created a more hostile environment within the
Medicaid system. The practicing physician is going to look at
it and say well, you know, maybe I was about to get over the
funding problem but I am darn sure not going there when they
are telling me how to practice.
Dr. Mahan. Well, I thought that too but we are working on
the issue in Florida now because we did study it and find an
association between the rising rates of Cesarean and the rising
rates of late preterm, and that will be published pretty soon,
and we found that our colleagues in obstetrics around the State
and they found this already ahead of us in North Carolina and
Ohio, that they understand that this is producing bad outcomes
in both women and babies that otherwise would have been normal,
but that they should not be delivered by Cesarean or induced if
they are normal people because the outcomes are worse, and I
think we are finding that most of the OBs as we approach them
on this and saying we are producing a lot of bad babies because
of this are extremely willing to listen to that and to change
their practice. And I agree that from State to State the
Medicaid rates are a problem but, you know, half of our births
are Medicaid and these are doctors taking care of them and they
seem to be willing to step in and reverse this thing.
Mr. Burgess. Now, in the health care law that just passed,
there was some protection for primary care that Medicaid rates
would be 75 percent of Medicare rates, but in your State are
OB/GYNs considered primary care?
Dr. Mahan. I don't think so.
Mr. Burgess. I don't think so either. And of course, in the
law we don't know because that is all up to the Secretary of
Health and Human Services and we are not having the types of
hearings that would allow us to get an idea of what their
thinking is over there so we are just all going to be surprised
one day. But even then, if there is a funding cliff that occurs
in 2 years' time and even if we were to get OB/GYNs designated
as primary care so that they would get 75 percent of the
Medicare rates, that funding cliff kicks in in 2 years' time
and we are back to the preexisting Medicaid. So all this
becomes terribly difficult and terribly complicated.
I guess just one last observation. Dr. Lawrence, you
referenced the medical home. That is what the generalist OB/
GYN, at least when I was practicing, that is what we were, and
Dr. Mahan says we shouldn't have those anymore, the generalists
are not helpful, let us go to midwives and perinatologists. But
you seem to see value in the medical-home model, and I would
just submit to you, the physicians of my generation, that is
what we were trained to do.
Dr. Lawrence. And I think we still train OB/GYNs to do
that. We are the care coordinators for well women's health care
essentially from the late teenage years up until early years to
years after menopause, and we definitely are the care
coordinators and providers for obstetrical patients, and we are
the ones who are able to intervene when those acute crises
occur.
Ms. Castor. Thank you, Doctor, very much.
We are going to have to bring the hearing to a close, but I
would like to ask Dr. Fleischman to help bring us to a close
and spend 1 minute on the implications for brain development
because you have a terrific visual exhibit here that I am
afraid they won't be able to see at home, but if you could
describe the difference in brain development from 35 weeks to
39 to 40 weeks to close us out for the hearing, I would
appreciate it.
Dr. Fleischman. We developed this visual for a project in
Kentucky to help women understand that one-third of the growth
and development of the brain occurs between 35 and 39 or 40
weeks, that all those neurons, all those nerve cells that
interact with each other are continually growing in those last
5 weeks and that that growth and development is critically
important to the fetus. It can happen outside the uterus but it
happens better inside a uterus if the fetus is not in any
jeopardy. And that has been very helpful both to help
clinicians understand what they can stay to women and it helps
women to not push hard for inappropriate early deliveries.
Ms. Castor. Well, thank you very much. You all have been
outstanding. All of the witnesses were just terrific today.
That concludes all the questioning.
In closing, I want to remind members that you may submit
additional questions for the record to be answered by the
relevant witnesses. The questions should be submitted to the
committee clerk within the next 10 days. The clerk will notify
your offices of the procedures.
Without objection, this meeting of the Subcommittee is
adjourned.
[Whereupon, at 5:40 p.m., the Subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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