[Senate Hearing 108-975]
[From the U.S. Government Publishing Office]
S. Hrg. 108-975
SCIENTIFIC AND MEDICAL ADVANCES IN THE FIELD OF IN UTERO SURGERY
=======================================================================
HEARING
before the
SUBCOMMITTEE ON SCIENCE, TECHNOLOGY,
AND SPACE
of the
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 25, 2003
__________
Printed for the use of the Committee on Commerce, Science, and
Transportation
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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
JOHN McCAIN, Arizona, Chairman
TED STEVENS, Alaska ERNEST F. HOLLINGS, South
CONRAD BURNS, Montana Carolina, Ranking
TRENT LOTT, Mississippi DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas JOHN D. ROCKEFELLER IV, West
OLYMPIA J. SNOWE, Maine Virginia
SAM BROWNBACK, Kansas JOHN F. KERRY, Massachusetts
GORDON H. SMITH, Oregon JOHN B. BREAUX, Louisiana
PETER G. FITZGERALD, Illinois BYRON L. DORGAN, North Dakota
JOHN ENSIGN, Nevada RON WYDEN, Oregon
GEORGE ALLEN, Virginia BARBARA BOXER, California
JOHN E. SUNUNU, New Hampshire BILL NELSON, Florida
MARIA CANTWELL, Washington
FRANK R. LAUTENBERG, New Jersey
Jeanne Bumpus, Republican Staff Director and General Counsel
Robert W. Chamberlin, Republican Chief Counsel
Kevin D. Kayes, Democratic Staff Director and Chief Counsel
Gregg Elias, Democratic General Counsel
------
SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE
SAM BROWNBACK, Kansas, Chairman
TED STEVENS, Alaska JOHN B. BREAUX, Louisiana, Ranking
CONRAD BURNS, Montana JOHN D. ROCKEFELLER IV, West
TRENT LOTT, Mississippi Virginia
KAY BAILEY HUTCHISON, Texas JOHN F. KERRY, Massachusetts
JOHN ENSIGN, Nevada BYRON L. DORGAN, North Dakota
GEORGE ALLEN, Virginia RON WYDEN, Oregon
JOHN E. SUNUNU, New Hampshire BILL NELSON, Florida
FRANK R. LAUTENBERG, New Jersey
C O N T E N T S
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Page
Hearing held on September 25, 2003............................... 1
Statement of Senator Brownback................................... 1
Witnesses
Armas, Alex, Parent, Villa Rica, Georgia......................... 4
Prepared statement........................................... 6
Armas, Julie, Parent, Villa Rica, Georgia........................ 3
Prepared statement........................................... 4
Clancy, Michael, Photographer, Roscoe, Illinois.................. 10
Prepared statement........................................... 11
Thorp, M.D., James A., Associate Director, Regional Perinatal
Center, Sacred Heart Women's Hospital and Clinical Professor,
Department of Obstetrics and Gynecology, University of Florida
at Pensacola................................................... 8
Prepared statement........................................... 9
Appendix
Lautenberg, Hon. Frank R., U.S. Senator from New Jersey, prepared
statement...................................................... 21
Response to written questions submitted by Hon. Frank R.
Lautenberg to:
James A. Thorp, M.D.......................................... 21
Michael Clancy............................................... 22
SCIENTIFIC AND MEDICAL ADVANCES IN THE FIELD OF IN UTERO SURGERY
----------
THURSDAY, SEPTEMBER 25, 2003
U.S. Senate,
Subcommittee on Science, Technology, and Space,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:38 p.m. in
room SR-253, Russell Senate Office Building, Hon. Sam
Brownback, Chairman of the Subcommittee, presiding.
OPENING STATEMENT OF HON. SAM BROWNBACK,
U.S. SENATOR FROM KANSAS
Senator Brownback. Good afternoon. The hearing will come to
order. I apologize for my lateness. I had another appointment
that I had to attend to before getting over here. Thank you all
for being here.
During the hearing today, I would like to examine some of
the most recent advances in the fields in utero surgery and
fetal medicine. In particular, we will hear the remarkable
story of a family who chose to undergo surgery for the benefit
of an unborn child, Samuel Armas. Samuel underwent fetal
surgery to treat spina bifida. Samuel is with us here today,
along with his parents, Alex and Julie.
The ability to treat and cure diseases for the benefit of a
young child who has yet to be born is an amazing advance that
will help alleviate the suffering of many young children, and,
in fact, is already doing so. These are advances that all
people, regardless of their political views, can embrace as a
positive step. I'm heartened by these advances and look forward
to hearing from the respective witnesses.
Let me also say that this hearing is not about abortion;
rather, it is about advances in therapeutic interventions that
are effectively treating people suffering from diseases before
they are born. There is little debate about whether the child
in utero is alive; but whether it is a life, a life worthy of
protecting, that is the debate, and we will continue to have
that on another day.
Today, I would like to focus primarily on the testimony of
the family that chose to undergo this remarkable intervention,
and the reasons they chose to do so given the risks associated
with a surgery of this nature, as well as the amazing results
of this intervention.
Finally, I would like to close by quoting from a recent
article that appeared detailing the advances in ultrasound
technology that show, quote, ``An unborn child can smile, yawn,
blink, suck his fingers, and cry as early as the 26th week of
pregnancy.''
We've got those blown up, and I'll submit into the record
an article that appeared in the Sunday Herald Sun, September
14, of a 4-D, four-dimensional, picture, sonograms, showing--
and this a child pictured at 24 weeks of age--and we'll have
those to hand out to people so that they can see. It's really
quite remarkable. You can't see it much in this detail of the
picture, but the smiling child here is really quite remarkable
to see.
[The information referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Senator Brownback. These advances are amazing. These new
scientific discoveries continue to help illuminate the public
policy debate on the importance of life when it begins.
Now I'd like to turn to our panel of witnesses. We have an
exciting set of witnesses here today with us. Mr. Alex Armas,
he's a parent from Georgia, delighted to have you here with us
today, parent of Samuel. And his wife, Julie, is here. Glad to
have you here, and, I think, expecting another one when?
Ms. Armas. Three weeks.
Senator Brownback. Three weeks. So just barely here and
able to travel well. Mr. Michael Clancy is a photographer that
was involved in taking some of the pictures that--they were
involved in this particular surgery. And Dr. James Thorp,
Medical Doctor, a Clinical Professor of Obstetrics and
Gynecology at the University of Florida, Pensacola, and
Associate Director of the Regional Perinatal Center at Sacred
Heart Women's Hospital, in Pensacola, Florida, who was involved
in these surgeries, as well. NIH is doing some initial reviews
of these surgeries and their efficacy. We will hear some about
that, as well.
But let's start with the witnesses and the testimony, and I
believe we'll start with Mr. and Mrs. Armas. If you'd be
willing to start in your testimony, we would certainly
appreciate that.
First, let me say thank you and welcome for coming. We had
to do some delays because of Isabel, it wasn't cooperating
quite as much, but delighted that you could still make it with
us here today.
STATEMENT OF JULIE ARMAS, PARENT, VILLA RICA, GEORGIA
Mrs. Armas. Good afternoon.
My name is Julie Armas, and I am honored to be invited here
today to tell you of our experience with fetal surgery.
In the spring of 1999, my husband and I were thrilled to
learn that after two miscarriages and numerous infertility
treatments, we were finally expecting a baby. By the 15th week
of my pregnancy, our unborn son was diagnosed with spina
bifida. The first words my doctor said were, ``Well, this is
really bad.''
We learned that the opening in our baby's spine caused
permanent nerve damage that could prevent him from walking and
using the bathroom normally. More importantly, the damage to
the spine had also caused his brain to begin forming in an
abnormal way, which could ultimately lead to hydrocephalus,
causing mental deficit, as well.
In light of this grim diagnosis, we were told that at least
half of all babies with spina bifida are aborted. But abortion
was never an option for us. Instead, we began educating
ourselves about spina bifida, and learned of an experimental
procedure to close the spinal lesion in utero, rather than
after birth, which is what is traditionally done. We were
excited that there was someone somewhere interested in
preventing some of the problems caused by spina bifida.
Despite the reservations of my physician, my husband and I
traveled to Vanderbilt University and underwent an intensive
two-day consultation with surgeons, social services, and
medical ethicists. We were immediately told that fetal surgery
was not a cure for our son, whom by now we had named Samuel.
Senator Brownback. I'm kind of partial to that name. I like
that one.
[Laughter.]
Mrs. Armas. The greatest potential benefit of surgery
before birth was that in many cases the brain malformation had
improved, thus decreasing the changes of hydrocephalus and the
subsequent mental issues.
We were asked why we would consider such a life-threatening
procedure when spina bifida itself is typically not life-
threatening. And our answer was that Samuel was not a
hypothetical; he was already a member of our family, our son,
and deserved our best efforts to improve his life.
After much prayer and support from family and friends,
Samuel and I had maternal fetal surgery at Vanderbilt on August
19, 1999. I was 21 weeks pregnant, and he weighed about a
pound.
Thankfully, no complications arose following the surgery,
and Samuel was born by scheduled Cesarean on December 2, 1999,
15 weeks after our surgery. He never went to the intensive care
nursery, and came home with me 4 days after birth. Today, he is
an active--as you may learn--walking three-year-old who attends
preschool, and is age appropriate developmentally.
In conclusion, I am grateful for the attention that this
Committee is giving to fetal surgery. Though it's not without
significant risk, it provided a ray of hope when we were in a
very dark place.
Thank you.
[The prepared statement of Mrs. Armas follows:]
Prepared Statement of Julie Armas, Parent, Villa Rica, Georgia
Good afternoon.
I am honored to be invited here today to tell you of our experience
with fetal surgery.
In the spring of 1999, my husband and I were thrilled to learn that
after two miscarriages and numerous infertility treatments, we were
finally expecting a baby. By the fifteenth week of my pregnancy, our
unborn son was diagnosed with spina bifida. The first words my doctor
said were, ``This is really bad''. We learned that the opening in our
baby's spine caused permanent nerve damage that could prevent him from
walking and using the bathroom normally. More importantly, the damage
to the spine had also caused his brain to begin forming in an abnormal
way, which could ultimately lead to hydrocephalus causing mental
deficits as well. In light of this grim diagnosis, we were told that at
least half of babies with spina bifida are aborted.
Abortion was never an option for us. Instead, we began educating
ourselves about spina bifida, and learned of an experimental procedure
to close the spinal lesion in utero, rather than after birth. We were
excited that someone, somewhere, was interested in preventing some of
the problems caused by spina bifida. Despite the reservations of my
physician, my husband and I traveled to Vanderbilt University and
underwent an intensive two day consultation with surgeons, social
services, and medical ethicists. We were immediately told that fetal
surgery was not a cure for our son, who by now we had named Samuel.
The greatest potential benefit of surgery before birth was that in
many cases, the brain malformation had improved, thus decreasing the
chances of hydrocephalus and subsequent mental issues. We were asked
why we would consider such a life-threatening procedure when spina
bifida itself is typically not life-threatening. Our answer was that
Samuel was not a hypothetical, he was already a member of our family,
our son, and deserved our best efforts to improve his life.
After much prayer and support from family and friends, Samuel and I
had maternal-fetal surgery at Vanderbilt on August 19, 1999. I was 21
weeks pregnant, he weighed about a pound. Thankfully, no complications
arose following surgery, and Samuel was born by scheduled Cesarean on
December 2, 1999, fifteen weeks after our surgery. He never went to the
intensive care nursery, and came home with me four days after birth.
Today he is an active, walking, three year old who attends preschool
and is age-appropriate developmentally.
In conclusion, I am grateful for the attention this committee is
giving to fetal surgery. Though not without significant risk, it
provided a ray of hope when we were in a very dark place.
Senator Brownback. Thank you, Mrs. Armas.
Mr. Armas, love to hear your testimony.
STATEMENT OF ALEX ARMAS, PARENT, VILLA RICA, GEORGIA
Mr. Armas. Good afternoon.
My name is Alex Armas, and I'm the father of a three-year-
old child with spina bifida who underwent corrective fetal
surgery at Vanderbilt University in 1999. Thank you for the
opportunity to be here today and to share with you the impact
that this fetal surgery process had on our family.
In early 1999, my wife and I learned that we were expecting
our first child. Although we were thrilled at the hope of
finally having a baby, our happiness was soon overshadowed when
we were told that our baby had spina bifida.
As it was initially explained to us, our baby would likely
suffer from brain malformations, hydrocephalus, which is excess
fluid pressure on the brain, incontinence, inability to walk,
learning deficiencies, and perhaps even problems swallowing or
breathing. The doctor painted a grim picture for us and stopped
just short of suggesting an abortion.
It is every parent's worst nightmare to learn that
something's wrong with your child, and we were initially
devastated. However, our view was that after years of trying to
conceive, this was the baby that God chose to give us. In our
mind, this was not a 15-week-old fetus; but, rather, was our
new son, Samuel Armas. Thus, abortion was never an option for
us. To the contrary, my wife and I set out to learn about spina
bifida and what options were available to us and Samuel.
We soon heard about the maternal fetal surgery program for
spina bifida that was offered at Vanderbilt University. After
being presented with details of the procedure, including past
successes, inherent risk of prematurity, my wife and I had a
difficult decision to make. After weighing the substantial
risks and the possible lifelong benefits, past surgery
successes, and after much prayer, we decided to go ahead and
have the surgery. In our minds, we would not have deprived an
already-born son of a similar life-improving procedure with
similar risks.
We were particularly struck during this process by those
who ethically challenged us on risking our baby's life for a
life-improving procedure, while we would have been supported
should we have elected to legally end his life.
When our son underwent fetal surgery, he was 21 weeks old
gestationally. His brain was not developing correctly due to a
Chiari malformation, and had enlarged ventricles due to
worsening hydrocephalus. Immediately after the surgery, the
hydrocephalus stopped increasing and started to slowly
decrease. By the time Samuel was born, 15 weeks later, his
brain malformation had reversed, and the hydrocephalus had
mostly disappeared. He did not require a shunt to drain fluid
from his brain, which is very common among children with spina
bifida. This was of considerable benefit to Samuel, because
shunts are commonly plagued with blockages, with infections,
and can require a child to have multiple brain surgeries in the
first year of life.
The benefit of the in utero procedure was that it allowed
continued development inside the womb, where conditions are
ideal for problems to stabilize, or, in Samuel's case, even
reverse, to some degree. This was particularly evident in
neurological benefit to Samuel.
We've learned that children with spina bifida have an
average shunt rate of approximately 70 to 95 percent, depending
on the level of the lesion. With corrective fetal surgery for
spina bifida, this average drops by half and is between 20 to
50 percent. Fetal-surgery children also exhibit less kidney
damage, lower bladder infection rates, and, in some cases,
improved leg function by up to two neurologic levels, or spine
levels.
Currently, the National Institute of Health is conducting
trials, as you mentioned, to evaluate corrective fetal surgery
for spina bifida. It's our hope that further clinical studies
will be supported so that future parents facing circumstances
such as we did will be better equipped to make educated
decisions about medical alternatives for birth defects.
Continued studies and increased awareness of intrauterine
surgical intervention will also increase acceptance among
insurance companies. We were fortunate, in that our insurance
provider, at the time, had investigated the economic benefits
of fetal surgery and had decided to cover all of our costs.
However, many other insurance companies are still reluctant to
cover fetal surgery. And, subsequently, this leaves an enormous
financial burden on families who are already struggling with
what to do with their pregnancy.
Increased awareness and supportive advances in fetal
surgery are critical to future families and their unborn
babies. Progress in this field is not only improving lives, but
it is also saving lives by representing an option, an
alternative, a hope for parents who may otherwise choose to end
their pregnancy. Most people think, ``This could never happen
to me.'' But it can, and it did for us. Having options like
fetal surgery can turn a family's initial perception of
hopelessness into an outlook of hope where the little victories
of life are celebrated. We've seen living proof of this in our
son.
Today, Samuel is nearly 4 years old and has not had to
endure the surgeries that are normally common for most children
with spina bifida. He is walking with leg braces, is
cognitively normal, and loves looking for bugs. We're very
grateful for his progress and for the obvious benefits that
he's had from fetal surgery.
We're also very thankful for the Subcommittee's
consideration of advances in this field and hope that it'll see
the true value in its progress.
Thank you.
[The prepared statement of Mr. Armas follows:]
Prepared Statement of Alex Armas, Parent, Villa Rica, Georgia
Good afternoon. My name is Alex Armas and I am the father of a 3
year old child with spina bifida who underwent corrective fetal surgery
at Vanderbilt University in 1999.
Thank you for the opportunity to be here today and share with you
the impact fetal surgery has had on our family.
In early 1999, my wife and I learned that we were expecting our
first child. Although we were thrilled at the hope of finally having a
baby, our happiness was soon overshadowed when we were told that our
baby had spina bifida.
As it was initially explained to us, our baby would likely suffer
from brain malformations, hydrocephalus (excess fluid pressure on the
brain), incontinence, inability to walk, learning deficiencies, and
perhaps even problems swallowing or breathing. The doctor painted a
grim picture for us and stopped just short of suggesting an abortion.
It is every parent's worst nightmare to learn that something is
very wrong with your child and we were initially devastated. However,
our view was that after years of trying to conceive, this was the baby
God chose to give us. In our mind, this was not a 15 week old fetus,
but rather was our new son, Samuel Armas. Thus, abortion was never an
option for us. To the contrary, my wife and I set out to learn about
spina bifida and what options were available to us, and Samuel.
We soon heard about the maternal-fetal surgery program for spina
bifida that was offered at Vanderbilt University. After being presented
with details of the procedure including past successes and inherit
risks of prematurity, my wife and I had a difficult decision to make.
After weighing the substantial risks, the possible life-long benefits,
past surgery successes and much prayer, we decided to have the surgery.
In our minds, we would not have deprived an already-born son of a
similar life-improving procedure with similar risks.
We were particularly struck by those who ethically challenged us on
risking our baby's life for a life-improving procedure, while we would
have been supported should we have decided to legally end his life.
When our son underwent fetal surgery, he was 21 weeks old
gestationally. His brain was not developing correctly due to a Chiari
malformation and had enlarged ventricles due to worsening
hydrocephalus. Immediately after surgery, the hydrocephalus stopped
progressing and started to slowly decrease.
By the time Samuel was born, fifteen weeks later, his brain
malformation had reversed and the hydrocephalus had mostly disappeared.
He did not require a shunt to drain fluid from the brain, which is very
common among children with spina bifida. This was of considerable
benefit since shunts are commonly plagued with problems such as
blockages and infections which may require multiple brain surgeries
during the first years of life.
The benefit of the in utero procedure was that it allowed continued
development inside the womb where conditions are ideal for problems to
stabilize, or as in Samuel's case, even reverse to some degree. This
was particularly evident in neurological benefit.
We have learned that children with spina bifida have an average
shunt rate of approximately 70 percent to 95 percent, depending on
lesion level. With corrective fetal surgery for spina bifida, this
average drops by half and is between 20 percent to 50 percent. Fetal
surgery children also exhibit less kidney damage, lower bladder
infection rates, and in some cases improved leg function by up to two
neurologic levels.
Currently the National Institute of Health (NIH) is conducting
trials to evaluate corrective fetal surgery for spina bifida. It is our
hope that further NIH studies will be supported so that future parents
facing circumstances such as we did, will be better equipped to make
educated decisions about medical alternatives for birth defects.
Continued studies and increased awareness of intrauterine surgical
intervention will also increase acceptance among insurance companies.
We were fortunate in that our insurance provider at the time had
investigated the economic benefits of fetal surgery and decided to
cover all of our medical costs. However, many other insurance companies
are still reluctant to cover fetal surgery. This leaves an enormous
financial burden on families who are already struggling with what to do
with their pregnancy.
Increased awareness and support of advances in fetal surgery are
critical to future families and their unborn babies. Progress in this
field is not only improving lives, but is also saving lives by
representing an option, an alternative, a hope for parents who may
otherwise choose to end their pregnancy. Most people think ``this could
never happen to me'', but it can, and it did for us. Having options in
fetal surgery can turn a family's initial perception of hopelessness
into an outlook of hope and a life where little victories are
celebrated and cherished.
We have seen living proof of this in our son. Today Samuel is
nearly 4 years old and has not had to endure the surgeries that are
normally common for most children with spina bifida. He is walking with
leg braces, is cognitively normal, and loves looking for bugs. We are
very grateful for his progress and for the obvious benefits he has had
from fetal surgery.
We are also thankful for the Subcommittee's consideration of
advances in intrauterine medical procedures and hope it will see the
value in its progress.
Senator Brownback. Well, I'm thankful for you to be here to
testify today, because hopefully you will help give hope to a
number of parents who are caught in a very similar
circumstance.
I'll have some more questions for you a little bit later
on.
Dr. Thorpe, would you describe for us the procedure that
we're talking about here and the nature of it and the progress
that's being made?
STATEMENT OF JAMES A. THORP, M.D., ASSOCIATE DIRECTOR, REGIONAL
PERINATAL CENTER, SACRED HEART WOMEN'S HOSPITAL AND CLINICAL
PROFESSOR, DEPARTMENT OF
OBSTETRICS AND GYNECOLOGY, UNIVERSITY OF FLORIDA AT PENSACOLA
Dr. Thorp. Senator Brownback, other Members of the
Committee, and members and guests, thank you very much for the
privilege of presenting my testimony in the U.S. Senate.
My name is Jim Thorp. I'm 50 years old. I am a maternal
fetal medicine specialist, and am privileged to have worked
with unborn children as my patients for many years. A maternal
fetal medicine specialist is an obstetrician/gynecologist who
has completed 2 to 3 years of additional formal education and
clinical experience with an American Board of Obstetrics and
Gynecology approved maternal fetal medicine fellowship. Members
of our Society for Maternal Fetal Medicine, SMFM, have advanced
knowledge of the obstetrical, medical, genetic, and surgical
complications of pregnancy and their effects on both the mother
and the fetus. My career has been focused on the child within
the womb as a patient.
I completed my fellowship in maternal fetal medicine in
1988, and began practice at St. Luke's Hospital of Kansas City,
affiliated with the University of Missouri, Kansas City. In
2001, I relocated to practice at Sacred Heart Women's Hospital,
affiliated with the University of Florida at Pensacola.
Now, my particular expertise involves what I would refer to
as closed maternal fetal surgical procedures. That is,
procedures that do not involve a major maternal surgery that
opens the womb. During my maternal fetal medicine career, I
have performed in excess of 250 such procedures, including
fetal blood samplings, fetal transfusions, decompressions of
certain bodily cavities, such as the urinary tract, among
others. I have also directed clinical research and published
extensively in my specialty.
The first fetal surgery should be and is credited to Sir
Albert William Liley in 1963. He developed the technique for
diagnosing and treating fetuses suffering from anemia as a
result of Rh disease. He is known as the ``Father of
Fetology,'' and was an ardent advocate of the rights of the
child within the womb. Dr. Liley said, ``As a doctor, I regard
the unborn child as my patient, and protect and respect his
life as I would the life of any other patient.'' From my
clinical experience, I am convinced that unborn children are
individuals and human beings who are capable of receiving and
responding to medical care and who should have legal
protection.
It is extremely difficult not to see the fetus as a child
before birth with the same value as a child after birth,
especially after one sees her smiling, grimacing, moving,
sleeping, yawning, urinating, stretching, sucking a thumb, as
well as responding to pain from needle sticks.
When a fetus is suspected of having severe anemia, the
operating team and I use an ultrasound to guide a needle
through the mother's abdomen, through the uterus, into the one
of the baby's small blood vessels. If severe fetal anemia is
confirmed by immediate blood testing within the operating room,
I will transfuse the baby with donor blood, specially prepared.
Without such a transfusion, the fetus will likely die or
deliver severely premature, with significant ramifications.
I've done this as early as 19 weeks gestation, with perfect
outcomes.
As endoscopic and laser technology increases, the surgical
correction of other problems, including twin-twin transfusion
syndrome, is now being performed and has been for some years.
The NIH is currently funding the so-called MOMS study, which is
a $25 million project at three centers, which is looking at the
repair of spina bifida, as Samuel had, in a controlled
prospective trial.
Another technique that is currently under investigation,
repair, includes diaphragmatic hernia, congenital defect in the
diaphragm, removal of many fetal tumors, and even balloon
angioplasty of certain valves within the fetus within the womb.
Near scar-free repair of cleft palate and lip can also be
performed.
Thomas Jefferson said, ``The care of human life, and not
its destruction, is the first and only legitimate object of a
good government.'' The United States is a world leader in
advanced medical study, and this includes research for the
youngest and the most innocent of our patients, those still
within the womb. I believe nations, societies, and governments
will ultimately be judged by the way that they treat their
weakest, their most vulnerable, their most innocent, including
the child within the womb.
I will close with a quote from just this past June 9, the
lead article in Newsweek by Claudia Kalb. And I quote, ``No
matter what legislatures, activists, judges, or even individual
Americans decide about fetal rights, medicine has already
granted unborn babies a unique form of personhood, as
patients.''
Thank you.
[The prepared statement of Dr. Thorp follows:]
Prepared Statement of James A. Thorp, M.D., Associate Director,
Regional Perinatal Center, Sacred Heart Women's Hospital and Clinical
Professor, Department of Obstetrics and Gynecology, University of
Florida at
Pensacola
Thank you very much for the privilege of presenting my testimony in
the United States Senate. My name is Jim Thorp and I am 50 years of
age. I am a Maternal-Fetal Medicine Physician Specialist and am
privileged to have worked with unborn children as my patients for many
years. A Maternal-Fetal Medicine specialist is an obstetrician/
gynecologist who has completed two to three years of additional formal
education and clinical experience within an American Board of
Obstetrics and Gynecology approved Maternal-Fetal Medicine Fellowship
Program. Members of the Society for Maternal Fetal Medicine (SMFM) have
advanced knowledge of the obstetrical, medical, genetic, and surgical
complications of pregnancy and their effects on both the mother and
fetus. My career has focused upon the child within the womb as a
patient. I completed my Fellowship in Maternal Fetal Medicine in 1988
and began practice at St. Luke's Hospital of Kansas City, affiliated
with the University of Missouri at Kansas City. In 2001 I relocated to
practice at Sacred Heart Women's Hospital, affiliated with University
of Florida at Pensacola. My particular area of expertise involves
closed maternal fetal surgical procedures, that is, procedures that do
not involve a major maternal surgery to open the womb. During my
Maternal Fetal Medicine career I have performed in excess of 250 such
procedures including fetal transfusions, urinary decompressions, fetal
blood samplings and others. I have also directed clinical research and
published extensively in my specialty.
The first fetal surgery is credited to Sir Albert William Liley in
1963. He developed the technique for diagnosing and treating fetuses
suffering from anemia as a result of Rh disease. He is known as ``the
father of fetology'', and was an advocate for the rights of the child
within the womb. Dr. Liley said, ``As a doctor I regard the unborn
child as my patient and protect and respect his life as I would the
life of any other patient. From my clinical experience I am convinced
that unborn children are individuals and human beings who are capable
of receiving and responding to medical care and who should have legal
protection.''
It is extremely difficult not to see the fetus as a child before
birth with the same value as a child after birth, especially after one
sees her smiling, grimacing, moving, sleeping, yawning, stretching,
sucking a thumb, as well as responding to pain from needle sticks. When
a fetus is suspected of having severe anemia the operating team and I
use an ultrasound to guide a needle through the mother's abdomen into
one of the baby's blood vessels. If severe fetal anemia is confirmed by
immediate blood testing in the operating room, I will transfuse the
baby with donor blood. Without such a transfusion, the fetus will die.
I have done this as early as 19 weeks gestation with perfect outcomes.
As endoscopic and laser technology increased, the surgical
correction of twin-to-twin fetal transfusion syndrome is now being
performed. The NIH is currently funding the MOMS trial, which is
investigating the repair of spina bifida within the womb. Another
technique that is currently under investigation includes repair of
diaphragmatic hernia, removal of fetal tumors, and even balloon
angioplasty of valves within the fetal heart. Near scar free repair of
cleft palate/lip may also be possible.
Thomas Jefferson said, ``The care of human life, and not its
destruction is the first, and only legitimate object of good
government''. The United States is the world leader in advanced medical
study and this includes research for the youngest and most innocent of
our patients, those still within the womb. I believe nations, societies
and governments will ultimately be judged by the way that they treat
their weakest, their most vulnerable and their most innocent, including
the child within the womb. I will close with a quote from the June 9th
Newsweek article by Claudia Kalb: ``No matter what legislators,
activists, judges or even individual Americans decide about fetal
rights, medicine has already granted unborn babies a unique form of
personhood-as patients.''
Senator Brownback. Thank you very much, Dr. Thorp. Powerful
testimony. I didn't realize we could do all those things and
those are taking place. I look forward to probing into those
various surgeries that are occurring now.
Mr. Clancy, you're a photographer. We don't usually have
photographers testify in front of the Senate, although----
Mr. Clancy. How about photojournalists?
Senator Brownback. Particularly photojournalists. But
you've got some interesting photographs that you wanted to
share with us.
STATEMENT OF MICHAEL CLANCY, PHOTOGRAPHER,
ROSCOE, ILLINOIS
Mr. Clancy. Well, like you said, my name is Michael Clancy,
and I appreciate having the opportunity to take part in the
legislative process of our great country.
As a veteran photojournalist in Nashville, Tennessee, I was
hired by USA Today to photograph a spina bifida corrective
surgical procedure. It was to be performed on a child 21 weeks
in utero, at Vanderbilt University Medical Center. At that
time, in 1999, 21 weeks in utero was the earliest that the
surgical team would consider for surgery. The worst possible
outcome would be that the surgery would cause premature
delivery, and no child born earlier than 23 weeks had survived.
The tension could be felt in the operating room as the
surgery began. A typical C-section incision was made to access
the uterus, which was then lifted out and laid at the junction
of the mother's thighs. The entire procedure would take place
within the uterus, and no part of the child was to breach the
surgical opening. The position of the child was adjusted by
gently manipulating the outside of the uterus.
The entire surgical procedure on the child was completed in
1 hour and 13 minutes. When it was over, the surgical team
breathed a sigh of relief, as did I. As the doctor asked me
what speed of film I was using, out of the corner of my eye I
saw the uterus shake, but no one's hands were near it. It was
shaking from within. Suddenly, an entire arm thrust out of the
opening and pulled back, until just the little hand was
showing. The doctor reached over and lifted the hand, which
reacted and squeezed the doctor's finger. As if testing for
strength, the doctor shook the tiny fist. I took the picture.
Wow. It happened so fast that the nurse standing next to me
asked, ``What happened?'' ``The child reached out,'' I said.
``Oh, they do that all the time,'' she responded.
The surgical opening to the uterus was closed, and the
uterus was then put back into the mother, and the C-section
opening was closed.
It was 10 days before I knew if the picture was even in
focus. To ensure no digital manipulation of images before they
see them, USA Today requires that film be submitted
unprocessed. When the photo editor finally phoned me, he said,
``It's the most incredible picture I've ever seen.''
When I first saw the picture I took that day, I said to
myself, ``I have captured the earliest interaction ever
recorded,'' proof that at 21 weeks in utero a child is a
reactive human being. Four years later, the story of Samuel
Armas has become legend and can no longer be ignored. The
picture originally known as ``Fetal Hand Grasp'' has been
renamed by the people as ``The Hand of Hope,'' hope for a
generation that will embrace the knowledge that new technology
brings, a generation that will demonstrate the courage to
acknowledge a living human being's struggle to survive.
Samuel Armas had made more of an impact on the world before
he was born than most of us make in a lifetime.
Thank you very much.
[The prepared statement of Mr. Clancy follows:]
Prepared Statement of Michael Clancy, Photographer, Roscoe, Illinois
``Story of The `Fetal Hand Grasp' Photograph''
As a veteran photojournalist in Nashville, Tennessee, I was hired
by USA Today newspaper to photograph a spina bifida corrective surgical
procedure.
It was to be performed on a child, twenty-one weeks in utero, at
Vanderbilt University Medical Center. At that time, in 1999, twenty-one
weeks in utero was the earliest that the surgical team would consider
for surgery. The worst possible outcome would be that the surgery would
cause premature delivery, and no child born earlier than twenty-three
weeks had survived.
The tension could be felt in the operating room as the surgery
began. A typical C-section incision was made to access the uterus,
which was then lifted out and laid at the junction of the mother's
thighs. The entire procedure would take place within the uterus, and no
part of the child was to breach the surgical opening. The position of
the child was adjusted by gently manipulating the outside of the
uterus. The entire surgical procedure on the child was completed in 1
hour and thirteen minutes. When it was over, the surgical team breathed
a sigh of relief, as did I. As a doctor asked me what speed of film I
was using, out of the corner of my eye I saw the uterus shake, but no
one's hands were near it. It was shaking from within.
Suddenly, an entire arm thrust out of the opening, then pulled back
until just a little hand was showing. The doctor reached over and
lifted the hand, which reacted and squeezed the doctor's finger. As if
testing for strength, the doctor shook the tiny fist. Samuel held firm.
I took the picture. Wow!
It happened so fast that the nurse standing next to me asked,
``What happened?'' ``The child reached out,'' I said. ``Oh, they do
that all the time,'' she responded. The surgical opening to the uterus
was closed and the uterus was then put back into the mother and the C-
section opening was closed. It was ten days before I knew if the
picture was even in focus. To ensure no digital manipulation of images
before they see them, USA Today requires that film be submitted
unprocessed. When the photo editor finally phoned me he said, ``It's
the most incredible picture I've ever seen.''
Senators, when I first saw the picture I took that day, I said to
myself, I have captured the earliest interaction ever recorded. Proof
that at twenty-one weeks in utero the child is a reactive human being.
Four years later, ``The Story of Samuel Armas'' has become legend, and
can no longer be ignored. The picture originally known as, ``The Fetal
Hand Grasp,'' has been renamed by the people as, ``The Hand of Hope.''
Hope for a generation that will embrace the knowledge that new
technology brings. A generation that will demonstrate the courage to
acknowledge a living human being's struggle to survive.
Samuel Armas had made more of an impact on this world before he was
born, than most of us make in a lifetime.
Thank you.
Michael Clancy,
Roscoe, Illinois.
Senator Brownback. That's beautiful testimony. Do you have
a picture, one of the pictures that you took?
Mr. Clancy. There's a poster in the--I have some right
behind you.
Senator Brownback. Was that the one that appeared in--I
remember, in USA Today, seeing a picture in----
Mr. Clancy. It's been in USA Today now four times. It was
in the June 9 issue of Newsweek. It's been around the world.
It's been on television shows. It's been embraced by the pro-
life community, the religious community. And----
Senator Brownback. And this is the picture?
Mr. Clancy. That's the picture. When I first took the
picture, most of the picture agencies said, ``It's too graphic
for the United States, but it'll be great overseas.''
[Laughter.]
Mr. Clancy. And that's kind of what's happened. It took 4
years for it to run in a secular publication, in Newsweek.
Senator Brownback. In the United States it took----
Mr. Clancy. It took 4 years for that picture----
Senator Brownback.--four years before anybody would run it?
Mr. Clancy. Right.
Senator Brownback. Why? They said it----
Mr. Clancy. Because of the story of Samuel. It has become
legend. People are e-mailing the story about Samuel reaching
out and squeezing the doctor's finger, and they're saying,
``You've got to see this picture.'' And it's like it can't be
ignored any longer. It has been amazing to me. I created a
website, because I felt that I needed to do the right thing
with this picture, it's so powerful. I give it to pro-life
groups, religious groups, and church groups. Anyway, it has
just been phenomenal.
In the last year, I've had 250,000 visitors to the Website.
I answer e-mails. Every night I go home, I have 20 or 30 e-
mails about the picture. People are asking me to come speak
somewhere. And I don't feel that I'm worthy to go speak
somewhere. I just promote the picture. It has just been an
amazing moment.
And I'm still in shock that at 21 weeks in utero, the child
was a reactive human being. And we see what we want to see. The
political climate just, you know, allows you to see what you
want to see and not do something about it. I think each person
has to take it into their own hand and do something about it.
Senator Brownback. When did this picture first appear in
publication, then, overseas?
Mr. Clancy. It was published January 7--January 9 in the
Tennessean and in USA Today. Then it ran overseas in October in
France. They ran a four-page layout in a French magazine. And
then it took off like wildfire, and you could see it go country
to country. It was pretty amazing.
It's gone around the world, like, three or four different
times. Whenever it hits a new country, I get e-mails in
languages I can't read.
[Laughter.]
Mr. Clancy. I go to translate.com. I cut and paste, and I
get a crude translation of what they're trying to ask me. Most
people are wanting a copy of the picture, how can they find out
more about it. It has just been an amazing thing for me.
Senator Brownback. That is an amazing picture.
Mr. Clancy. Thank you.
Senator Brownback. Let's see Samuel? Is he here? Is he
willing to come forward and testify?
Hi, Samuel. How are you today?
Samuel Armas. Fine.
Senator Brownback. Do you like to look for bugs?
Samuel Armas. Yes, sir.
Senator Brownback. I'll bet you're good at catching those.
And butterflies?
Samuel Armas. Caterpillars.
Senator Brownback. What's that?
Mrs. Armas. Caterpillars.
Senator Brownback. Caterpillars, yes. I'll bet you like
those. You don't eat them, do you?
Samuel Armas. No.
Senator Brownback. No. We don't want to do anything like
that. What do you like to play?
Samuel Armas. The cars.
Senator Brownback. With cars? Oh. And what do you have on
your shirt? You've got several things on your shirt there. What
do you have?
Samuel Armas. A butterfly.
Senator Brownback. Oh, that looks nice.
Samuel Armas. A grasshopper.
Senator Brownback. Oh.
Samuel Armas. A lunar moth.
Senator Brownback. A lunar moth. Well, we're going to get
scientific on me, aren't you.
[Laughter.]
Senator Brownback. You're not just going to let me slide
with a regular----
Mr. Armas. And that one, what's that one?
Samuel Armas. A spider.
Senator Brownback. And a spider.
Mr. Armas. Do we touch spiders?
Samuel Armas. No.
Senator Brownback. You don't touch any spiders? Why don't
you touch spiders?
Samuel Armas. They might bite.
Senator Brownback. Yes. Those can be pretty rough, can't
they? Now, how old are you?
Samuel Armas. Three.
Senator Brownback. You're three?
Samuel Armas. Yes, sir.
Senator Brownback. Oh. Have you seen this picture of you?
Samuel Armas. Yes, sir.
Senator Brownback. Well, you're offering a lot of hope to
people.
Mrs. Armas. Tell him about that picture.
Mr. Armas. Who's in that picture?
Samuel Armas. I'm Samuel.
Senator Brownback. And what did they do? What did they fix?
Samuel Armas. They fixed my boo-boo.
[Laughter.]
Senator Brownback. And you feel much better now that they
fixed your boo-boo?
Samuel Armas. Yes.
Senator Brownback. Thank you very much. Thank you very
much. That is remarkable.
And tell me, Dr. Thorp, you've been in this field for a
number of years now, what's the state of play in this field,
and what have you seen over the last 5, 10 years? What the
Armas's have done, is this a radical surgery now within the
field, or is this--or is it we're getting this one down and
it's moving on forward?
Dr. Thorp. Well, sir----
Senator Brownback. Pull that microphone up, if you would.
Dr. Thorp.--in my specialty, in the Society of Maternal
Fetal Medicine, what we've witnessed over the last 10 years is
unheralded incredible opportunities to treat the fetus in the
womb, as you've seen in front of you. I think that this is
still investigational, and that's why we're so grateful that
our government has provided such resources through the NIH to
actually do the study, where many children will actually be
randomized in utero before the surgery to either standard
after-birth repair versus the in utero repair. But the
opportunities in the future are unlimited for treating and
fixing the fetus in utero.
Senator Brownback. Now, tell me, where would Samuel be
today if they had not gone through the in utero surgery?
Dr. Thorp. Quite honestly, it's very difficult to say,
Senator, because we're looking at one case. He could be the
same, or he could be better, or he could be worse. And that's
why the NIH is conducting the trial that they're doing.
It's a moving target, Senator, because as time progresses
and institutions get more experienced, their control changes.
So to use a historical control is very dangerous in this type
of a situation where there's a moving improvement in outcomes.
Senator Brownback. But we generally think, in medicine, the
sooner you can catch something and deal with it, the better off
you are, and I don't know if that holds as well in in utero
surgery.
Dr. Thorp. Absolutely, it does. Theoretically, there's a
tremendous plasticity of fetal cells, in terms of inflamation
and scarring. The two-hit hypothesis with spina bifida is that
the initial problem that causes the defect is the initial
insult, but then the ongoing insult is the exposure to the
nerve cells of the brain and spinal cord to amniotic fluid,
which is thought to cause more damage. So the theory then is
that if that nerve tissue, the spinal cord, is protected and
closed in the uterus, then it won't take that second hit, the
so-called second-hit hypothesis. But that's yet to be proven in
prospective trials.
Senator Brownback. We had a witness in here--this has been
a couple of months ago--of a young man that was cured of sickle
cell anemia. He was 17 years old. What was his name? Keone
Penn. Keone Penn was a young man, 17 years old, and the
physician that was here claimed that if they can catch the
sickle cell anemia even in the womb, that they were going to
have a much greater chance of being able to deal with
developmental problems. Now, they didn't catch his until much
later, and he, of course, had a lot of developmental problems
because of the lateness that they caught it. But with umbilical
cord blood transfusion, he was cured of it.
Dr. Thorp. Yes, sir.
Senator Brownback. Are you familiar with those taking
place, as well?
Dr. Thorp. I'm familiar with those cases. And we're in the
embryonic stage. But you're absolutely correct. There are a
number of diseases that have the potential of being completely
cured by putting stem cells from cord blood into a fetus at 18
or 19 weeks, and that fetal immune system will actually empower
it to be part of itself and will grow clones of normal blood
cells throughout the life, instead of sickle cell. Also, a
similar type of disease with severe combined immunodeficiency
has also, I understand, been successfully performed.
Senator Brownback. At what age are we looking at for the
youngest treatment in the womb? What do you see? The child's
going to have to develop to a certain level before you can
detect and work on issues that come forward. I mean, you
mentioned angioplasties being done, and cleft palates being
fixed without a sign. What ages in the womb are we talking
about that will be probably the youngest age that we will get
to in performing different types of surgeries?
Dr. Thorp. I don't know that there will be a limit.
Technically, with ultrasound capability right now and with, for
example, the standard needles that I use in my surgery, I've
done a procedure as early as 19 weeks gestation successfully
that otherwise the baby would have died. Now, that's merely
limited by the physical size of the umbilical vessel and also
the size of the needle. But as new technologies,
nanotechnologies--there's a new da Vinci robotic device which
is being tested, I understand, in Tennessee--great potential to
lower that age.
Senator Brownback. That is amazing.
The Armas family, this was quite a thing for you to do.
When this first hit you that your child has spina bifida, and
you described that situation, how much information was
available to you that this surgery was a possibility at those
early steps?
Mrs. Armas. I am a labor and delivery nurse, and I live in
a large city. We live just outside of Atlanta, and we didn't
know anything about it. My mother stumbled across Vanderbilt's
website after we knew something was wrong. We didn't quite know
what it was. And my mother actually found their website, and
that's how we knew to ask about it. It wasn't something that
was commonly known to us.
Senator Brownback. So you just thought your options are to
go ahead and have the child, and the child will be born with
spina bifida, or abort the child, is the options that you
were----
Mrs. Armas. Yes.
Senator Brownback.--that you were generally provided at
that time?
Mrs. Armas. Yes, the traditional repair is done immediately
after birth.
Senator Brownback. Now, this is 3 years ago, going on four?
Mrs. Armas. August 19--was four years ago was the----
Senator Brownback. Four years ago.
Mrs. Armas.--surgery. Yes. Samuel will be four in December.
Senator Brownback. He was throwing me off, because I
thought he was four, and then when he said three.
What about the situation now? My guess is you get contacted
by a number of parents with similar problems. Are they getting
more information--what's available, what options are out there
for them?
Mrs. Armas. I think we are getting--and one of the reasons
we agreed to have USA Today in the surgical suite was that we
wanted to increase awareness of this surgery, because, like I
said, we didn't know anything about it, and we are getting some
contacts from people who have seen the picture, and then even
later found out they were carrying a child with spina bifida
and remembered it and called us.
But I still think, in talking to friends, it's not widely
accepted as a viable alternative.
Senator Brownback. Just not widely accepted as a viable
alternative?
Mrs. Armas. What I'm thinking of is, I have a co-worker who
was diagnosed with a child with spina bifida. He's less than a
year old. And she talked to me, and I told her about fetal
surgery. She came back, and she said, ``Well, my doctor doesn't
think that's a good idea.'' And, you know--and so she
subsequently didn't look into it any further.
In general, I think it's still considered very risky and
experimental, which is one reason we're very grateful that
they're conducting trials now to bring some validity to the
outcomes.
Senator Brownback. That would be the case, Dr. Thorp, on
spina bifida. What about these other issues, like cleft palate,
the angioplasty? My guess is you don't have a--there isn't
another option available when you're doing something like that
on a child in the womb.
Dr. Thorp. There are no clinical trials, sir. This is only
anecdotal, totally investigational, and it's very possible at
this point in time that we're doing more harm than good.
Senator Brownback. On an angioplasty or a cleft palate
repair?
Dr. Thorp. With all of these.
Senator Brownback. Because you just--you don't have the
standardized trials yet?
Dr. Thorp. Absolutely correct. And, you know, as Julie
mentioned, there are some significant drawbacks. She took
significant risk to herself to try to help Samuel within the
womb. Forty percent of the babies of the mothers that undergo
this surgery will actually deliver prematurely, before 32
weeks. And, in many cases, that could actually be detrimental
to the baby. So then not only will the baby have spina bifida
at birth, but it will also have a double hit with the
significant ramifications of extreme prematurity. So that's a
very serious thing.
So when we're looking at the risks, there's also
significant risks to mom. When you make a large incision in the
uterus, her uterus could rupture and put her life at risk, as
well. Not only for the last pregnancy, with Samuel, but also
with this pregnancy, with Ethan. So before--our government, our
NIH, our medical system is approaching this the right way,
absolutely correct, we don't want this widely available to
everybody until we know for sure that we are doing no harm.
Primum non nocere is part of our Hippocratic oath. That is,
first do no harm.
And it may that fetal surgery is here to stay and it's only
going to get better and better, but it may be that making a
large incision in the uterus is not the way to go because it's
so dangerous for mother and baby. It may be that when we are
developing our laser, our endoscopic technology, that this can
all be done through a scope. And, in fact, it is being done
investigationally at this time, attempted through a scope.
Senator Brownback. That would seem to me to be a way that
it would be likely that this would develop, because that big
incision in the womb is a----
Dr. Thorp. Very dangerous.
Senator Brownback.--dangerous procedure and dangerous thing
to do. Are we seeing that developing? The laparoscopic
surgeries?
Dr. Thorp. Yes, sir, absolutely. There is a laparoscopic
laser surgery that is now available for twin-twin transfusion
syndrome. And twin-twin transfusion syndrome, for those of you
who are not familiar with it, is a very common complication of
identical twins. In fact, 10 or 15 percent of identical twins,
as early as 15 to 20 weeks gestation, will have vascular
connections which will cause severe complications in both
twins. And there are at least, I believe, three centers that
are actually going in and actually lasering the vascular
connections between those two babies. Now, again, that's
controversial, it's investigational, but it's being done, and
done successfully.
Senator Brownback. Mr. and Mrs. Armas, when you first saw
the picture, how--I guess this was several days after the
surgery that you first saw the picture--what did you think?
Mr. Armas. Like Mr. Clancy, the first time we saw the photo
was a good bit later, weeks later. And, in fact, we were
planning, ``OK, tomorrow morning is the USA Today. You need to
get it at work.'' And I got a copy, and her parents and our
family got copies, and that's the first time we saw it. And we
were told that--basically what the picture entailed and about
the hand, but it--without too much detail, we didn't realize
what had been captured on film until we saw it in the
newspaper, and it was pretty significant to us.
Senator Brownback. What did you feel at that time when you
saw it? I mean, did you feel like this is a significant
picture, as what Mr. Clancy described, this has made it around
the world and touched lives and gave hope? I mean, you called
the picture ``The Hand of Hope.''
Mr. Clancy. Well, the people have kind of renamed it.
That's what it goes around now as an e-mail. It's kind of like
being mass e-mailed to people, and they titled it ``The Hand of
Hope.''
Mr. Armas. What I first thought was, ``That's my boy.''
Like we said, this was from very early on--we had wanted Samuel
for so long, and he was finally here, and we were going to have
him no matter what problems he came with. We were prepared, and
the Lord was going to help us deal with that. But there he was,
and that's my first thought, is, you know, not only have we
named him or come to know him or love him without even meeting
him yet, but there he was on the film. And it was pretty
amazing.
Sometimes we are taken aback--as we went through this
process, we got caught up in the process and kind of got used
to it, but every once in awhile we would step back and think,
``Can you believe we're having fetal surgery?'' And these are
things that we might see on TV or read about, but we were
actually participating in this. And the picture kind of brought
that home to us.
Do you have anything to add to that?
Mrs. Armas. No.
Senator Brownback. What did you think when you first saw
the hand of your child?
Mrs. Armas. I was at home, on bedrest. He's at work. My
family is out. And they're all calling me, telling me about the
picture, and I hadn't even seen it. I think it was sort of
surreal, because the whole process--like he said, we were, sort
of, concerned about our life and how it was going to change
with just this child with this special need. And then seeing
that I was put to sleep for this surgery, so, you know, there
wasn't a lot of that anxiety in the middle of the surgery. And
it was almost easy to pretend that I had had my tonsils out or
something. And then seeing that, you know, it was awesome.
Senator Brownback. Dr. Thorp, you mentioned you do a lot of
actions not breaching into the womb, but drawing blood, other
items, with the fetus. With a young child--what reaction do you
get from that young child when you stick it with a needle?
Dr. Thorp. Senator, there's no question that this is a
human baby in the womb. It does all the things that I said in
my testimony as early as 20 weeks. I will often have to
paralyze a fetus because if there's motion I will lose complete
visibility of the target that I'm putting the needle at. So I
will need to paralyze a fetus, much like you would be paralyzed
in an operating room so that a surgeon and anesthesiologist
could operate on you.
So it's very difficult to give that baby a shot. And I will
usually try to give the baby a shot in the buttock with a
smaller gauge needle. And it's the exact same reaction that--if
you have children or that Samuel has when they go to the
doctor's office and they have to get a shot. They pull away,
and then you have to chase them in the womb with the needle.
[Laughter.]
Senator Brownback. He's kind of----
Dr. Thorp. There's no question they feel it.
Senator Brownback. He's kind of confined in there. I mean--
--
Dr. Thorp. Yes, sir.
Senator Brownback.--you can catch him.
Dr. Thorp. There's absolutely no question. It's the same
way that you would expect a child, a newborn, in a doctor's
office. It's the same to me. It always has been. And to those
of us who see the ultrasounds, and to the parents--I would dare
say that Mr. and Mrs. Armas have absolutely no difference in
their perception of Samuel outside of the womb and Ethan, who
is in the womb. It's the same precious life.
Senator Brownback. Does it vary on age? When you're giving
that child a shot, does it vary on age or at any of the age
that you're operating in there, the same pull-back reaction,
pain being felt, sensations?
Dr. Thorp. The pull-back gets stronger beyond 19 weeks, but
the first--the earliest I've transfused a fetus is 19 weeks,
and I've gotten the same reaction. It's--that baby will move
away from the needle. It's painful, just like we don't like
needles.
Senator Brownback. Our two youngest ones are both five, and
we just did two shots to them for childhood diseases
prevention, and it took five of us holding, shooting, to get
all that done. I don't suppose you have five--maybe you have to
have five, but when you're in that type of situation that would
take a lot. But there's a pain sensation that's clearly there.
I want to thank all of you for coming and for presenting
this. This is a short hearing, but this is a powerful picture.
And just like pictures like Iwo Jima, others that have changed
the course of history when you see them, where they evoke a
powerful emotion within us, and I like to think they evoke that
powerful spirit within us that just says, ``This is
something,'' that it touches.
And I think, Mr. Clancy, what you're seeing with this is
just one of those. This is one of those powerful images that
touch, and it touches people everywhere.
And to the Armas family, thank you for being--for staying
in there. I'm sure you didn't think Samuel was going to be
quite this famous this early. Maybe later on, but maybe not
quite this early that he would be so famous.
Did anybody else have anything else they wanted to add?
Dr. Thorp?
Dr. Thorp. Sir, I would just say that Julie and Alex are
really heroes. They're really much--and Samuel--much like
astronauts doing a first thing. They took a lot of risk for
themselves, and they took a lot of risk, and it was the right
thing to do. And only by the risk that they took can the rest
of us be benefited, and they are to be congratulated and
thanked for that.
Senator Brownback. Absolutely. Absolutely. You're quite the
heroes. And I think of all the parents out there that would be
in a similar situation and looking for hope and now, you know,
here's a couple that have gone before them to give them hope.
We have five children, and my wife has had miscarriages,
too, and it's--you give a lot of people a lot of hope in
situations that they can look at as being pretty dark and
pretty difficult. So thanks for doing that. God bless you all.
Thank you all for joining us here today. I appreciate
particularly witnesses and the distances you've traveled and
what you've shared.
The hearing is adjourned.
[Whereupon, at 3:25 p.m., the hearing was adjourned.]
A P P E N D I X
Prepared Statement of Hon. Frank R. Lautenberg,
U.S. Senator from New Jersey
In utero surgery--also known as fetal surgery--provides a real
opportunity to improve the lives of children. Fetal surgery can offer
hope to women who might otherwise give birth to children with
potentially deadly or debilitating conditions such as spina bifida. It
can save lives.
Medical advances in fields such as fetal surgery are very positive
developments, especially when they help women who want to bear
children.
There are exciting developments in another field that, like fetal
surgery, could alleviate congenital birth defects and similar problems:
stem cell research.
That is why I have cosponsored Senator Feinstein's bill that would
prohibit human reproductive cloning--which just about everyone agrees
is abhorrent--but would allow therapeutic cloning--that is, the cloning
of cells for medical research, including stem cell research.
I hope that Congress will continue to support the development of
lifesaving treatments.
The best way for Congress to show its support is to keep increasing
the funding for the National Institutes of Health (NIH) by 8 to 10
percent each year, which is what the research community recommends.
Of course, that will become increasingly difficult now that we are
running budget deficits again but if we truly view the NIH and the
research conducted under its auspices as a national priority, we will
find a way to get it the money it needs.
______
Response to Written Questions Submitted by Hon. Frank R. Lautenberg to
James A. Thorp, M.D.
Background
Question 1. As fetal surgery becomes more routine and medical
technology continues to advance, there are concerns that doctors will
make the fetus a patient at the expense of the mother's autonomy. Thus
far, the pre-viable fetus has been deemed a patient according to the
woman's decision to continue a pregnancy to viability and thus, to
term. However, as medical technology makes the fetus more accessible to
pediatric surgeons, perceptions of the fetus may change as the fetus
begins to make serious claims for a right to nutrition, to protection,
and to therapy.
Should a fetus have the right to receive surgical treatment
independently of the mother's self-interest and legal rights?
Answer. NO, under no circumstances should a fetus have the right to
receive surgical treatment independently of the mother's self-interest.
A surgical intervention against the mother's desire should never be
done and in fact is considered a criminal offense (assault and
battery). Even if future studies show that some fetal surgeries are
life-saving (to the fetus) it will always involve risk to the mother.
For this reason no mother should ever be coerced into a fetal surgical
procedure that she refuses. Interestingly, even cesarean section to
save a normal fetus cannot be imposed upon a mother against her will.
It is my understanding that this has been tested in court.
Question 2. Does a mother have the right to refuse a surgery
because she is afraid of the risk such a surgery poses to herself?
Answer. YES. Absolutely and unequivocally YES. At the present time
the ``open maternal-fetal surgery'' which includes a large incision
into the pregnant uterus poses significant risk to the mother
(potentially life-threatening). In contrast, although the benefits to
the fetus are promising, they remain unproven. Indeed, the surgery also
poses significant risks to the fetus, including fetal death and
prematurity. About 40 percent of mothers undergoing ``open maternal-
fetal surgery'' will deliver 8 weeks or more premature, thus adding
additional risk. Thus, at the present time, many educated and wise
couples may elect NOT to have open maternal-fetal surgery.
______
Response to Written Question Submitted by Hon. Frank R. Lautenberg to
Michael Clancy
Question. Does the doctor who performed the surgery (Dr. Joseph
Bruner) share your account of the events that took place during the
surgery?
Answer. Thank you for your inquiry as to Dr. Bruner's comments
regarding the surgical procedure performed on Samuel Armas.
Dr. Bruner's first account of the events were published in the
Tennessean Newspapers Sunday January 9, 2000 Issues Section. http://
www.tennessean.com/sii/00/01/09/vandyfeta109.shtml
His statement:
``Depending on your political point of view, this is either
Samuel Armas reaching out of the uterus and touching the finger
of a fellow human, or it's me pulling his hand out of the
uterus . . . which is what I did.''
Three months later Dr. Bruner told Maj McKenna, (reporter) at the
Atlanta Journal Constitution:
``When Samuel's hand appeared in the uterine opening, I
impulsively reached out and lifted it,'' he said. ``It was a
very human thing to do, to reach out and take someone's hand.''
http://www.nrlc.org/news/2000/NRL05/sam.html (Could not access
the original article)
Dr. Bruner reportedly told Time magazine Europe that when his
finger was grasped it was the most emotional moment of his life, and
that for an instant during the procedure he was just frozen, totally
immobile: http://www.armybarmy.com/sam-hand.html (Could not access the
original article)
My credibility and integrity as a journalist has been severely
challenged by Dr. Bruner's comments, but my version of the event has
never changed.