[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

                              ----------                              
                                                                   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.

                                  
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