[Congressional Record Volume 153, Number 105 (Wednesday, June 27, 2007)]
[Senate]
[Pages S8615-S8616]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. CLINTON:
  S. 1712. A bill to amend the Public Health Service Act to improve 
newborn screening activities, and for other purposes; to the Committee 
on Health, Education, Labor, and Pensions.
  Mrs. CLINTON. Mr. President, today I am pleased to introduce the 
Screening for Health of Infants and Newborns Act, also known as the 
SHINE Act. This legislation is critical for the health of newborns and 
children because we know that public education and early detection are 
two of the greatest weapons we have in the battle against early 
childhood disorders.
  Each year in our Nation, at least 4 million newborns are screened for 
severe disorders, with 5,000 newborns diagnosed as a result. Although 
these numbers may seem small, these disorders are often life 
threatening and can cause serious mental and physical disabilities if 
left untreated. Early detection by newborn screening can lessen these 
illnesses, or completely prevent progression of many of these disorders 
if medical intervention can be started early enough.
  I am proud to say that New York has been a leader in newborn 
screening since 1960 when Dr. Robert Guthrie developed the first 
newborn screening test. Since then, more than 10 million babies have 
been tested. In 2004, New York expanded their newborn screening program 
from 11 conditions to encompass 44 conditions. These improvements were 
the result of a concerted effort by State officials and parent advocacy 
groups like the Save Babies through Screening Foundation and Hunter's 
Hope Foundation. They share a common goal, that every child born with a 
treatable disease should receive early diagnosis and lifesaving 
treatment so that they can grow up as healthy as possible. Today, we 
want to ensure that the great strides made by New York can be a model 
for all States and that New York can continue to make advancements that 
will benefit the children of New York and around the Nation.
  Newborn screening experts suggest States should test for minimum of 
29 treatable core conditions. However, as of today, some States only 
screen for seven conditions. Every child should have access to tests 
that may prevent them from a life threatening disease. This bill 
establishes grant programs so that States can increase their capacity 
to screen for all the core conditions. Grant funds are also available 
for States like New York to expand newborn screening panels above and 
beyond the core conditions by developing additional newborn screening 
tests.
  We should expect equity within newborn screening so that it does not 
matter where your baby is born. This legislation will establish 
recommended guidelines for States for newborn screening tests, 
reporting, and data standards. By tracking the prevalence of diseases 
identified by newborn screening within States, we will be able to meet 
these goals and improve the long-term health of our children.
  I hear from many parents how frightening it is to have a sick child 
and to not have a diagnosis. Many parents spend years trying to find 
out what is wrong with their child and feel helpless. This legislation 
will insure that current information on newborn screening is available 
and accessible to health providers and parents. The SHINE Act will 
provide interactive formats through the Maternal Child Health Bureau of 
the Health Services and Resources Administration so that parents and 
providers can ask questions and receive answers about newborn screening 
test, diagnosis, follow-up and treatment.
  Early treatment can prevent negative and irreversible health outcomes 
for affected newborns. We should be doing all we can to give every 
child born in our country the opportunity for a happy and healthy life.
  I ask unanimous consent to have printed in the Record letters of 
support.
  There being no objection, the material was ordered to be printed in 
the Record as follows:

                                                Hunter's Hope,

                                  Orchard Park, NY, June 25, 2007.
     Hon. Hillary Clinton,
     U.S. Senate,
     Washington, DC.
       Dear Senator Clinton: on behalf of the Hunter's Hope 
     Foundation, I respectively submit this letter as our full and 
     complete support for the bill titled ``Screening for the 
     Health of Infants and Newborns (SHINE Act)''.
       The Hunter's Hope Foundation was established in 1997 by Pro 
     Football Hall of Fame member and former Buffalo Bills 
     Quarterback, Jim Kelly, and his wife, Jill, after their 
     infant son, Hunter, was diagnosed with Krabbe (Crab a) 
     Leukodystrophy, an inherited, fatal, nervous system disease.
       The Foundation's mission is to: increase public awareness 
     of Krabbe disease and other leukodystrophies, support those 
     afflicted and their families, identify new treatments, and 
     ultimately find a cure.
       Since 1997, Cord Blood Transplant (CBT) has become a viable 
     treatment for Krabbe disease as well as a few other 
     leukodystrophies. But, CBT is only effective if the child is 
     treated before the disease inflicts irreversible damage to 
     the brain and nervous system. There are many other treatable 
     diseases that if not treated early will cause irreversible 
     damage. And, the number of such diseases continues to 
     increase with advancements in science and technology. We must 
     establish an infrastructure in our country that not only 
     addresses the immediate need, but also creates a system for 
     expansion. The SHINE Act will accomplish this.
       Hunter passed away August 5, 2005. Like thousands of other 
     children, if he had been screened at birth, he may be living 
     a healthy life today. Please help these children and their 
     families and pass this bill. We implore you to expedite the 
     passing and implementing of this bill. With each day that 
     passes, children are suffering and dying needlessly.
       Thank you from the bottom of our hearts.
           Sincerely,
                                                  Jacque Waggoner,
     Board of Directors, Chair.
                                  ____

                                    Save Babies Through Screening,


                                             Foundation, Inc.,

                                     Scarsdale, NY, June 25, 2007.
     Hon. Hillary Clinton,
      U.S. Senate,
     Washington, DC.
       Dear Senator Clinton: I am writing on behalf of the Save 
     Babies Through Screening Foundation to show our support for 
     the Screening for Health of Infants and NEwborns (SHINE Act). 
     As you know, our organization's mission is to improve the 
     lives of babies by working to prevent disabilities and early 
     death resulting from disorders detectable through newborn 
     screening. Our organization was founded in 1998 and is the 
     only organization solely dedicated to raising awareness in 
     regard to newborn screening.
       We believe that this bill will greatly enhance the 
     expansion of newborn screening throughout the United States 
     and will save the lives of thousands of babies--our tiniest 
     citizens. Additionally, this will spare Parents the agonizing 
     pain of watching their children suffer as I can attest to 
     firsthand. With the great expansion of newborn screening, 
     children will be able to live healthy and productive lives.

[[Page S8616]]

       We thank you for your vision and hard work. Nobody should 
     suffer the loss or impairment of a child when there are tests 
     and treatment available and this bill will put an end to 
     future suffering. Please feel free to contact me if we can be 
     of any assistance.
           Regards,
                                                  Jill Levy-Fisch,
     President.
                                  ____



                                     FOD Family Support Group,

                                        Okemos, MI, June 26, 2007.
       To Whom It May Concern: As Founder and Director of an 
     international Family Support Group for rare metabolic 
     disorders called Fatty Oxidation Disorders (many of which can 
     be screened for at birth, as well as many other metabolic 
     disorders), I strongly endorse the Screening for Health of 
     Infants and Newborns Act (SHINE Act of 2007) that Senator 
     Clinton originally introduced on February 15, 2007. It would 
     greatly enhance the lives of many families in our country.
       My family, and many others in our Group, has experienced 
     the tragedy of not having the awareness/education of, 
     screening for, and short- and long-term followup treatment 
     for an FOD. Our daughter, Kristen, died suddenly at the age 
     of 21 months. Fortunately, by the time our 2nd child was 
     born, we had become aware of these rare disorders and had 
     Kevin tested at birth--he is now a healthy, active, and soon-
     to-be college graduate. If it wasn't for the newborn 
     screening and follow-up treatment for MCAD, Kevin would have 
     died when he had his 1st illness at 6 months of age.
       I wholeheartedly endorse all parts of the bill that will 
     help educate and create awareness of these many disorders 
     (and more in the future) for families and professionals 
     across our country. Many aspects of the bill mirror our 
     Group's foundation and mission--to create awareness about 
     FODs, to educate the public, to network and support FOD 
     families and professionals around the world, to provide 
     ongoing education and information about metabolic disorders, 
     to inform families and the public of new developments in 
     screening, diagnosis, research and treatment (I also endorse 
     assisting in covering formulas, drugs, supplements etc), and 
     to advocate expanded universal and comprehensive newborn 
     screening and long-term follow-up treatment for FODs and 
     other related metabolic disorders.
       Please pass this bill for the benefit of many infants and 
     families!
           Take Care,
                                                    Deb Lee Gould,
     Director.
                                  ____

                                                    June 25, 2007.
     Hon. Hillary Rodham Clinton,
     U.S. Senate,
     Washington, DC.
       Dear Senator Clinton: We are pleased to write this letter 
     of support for the Screening for Health of Infants and 
     Newborns Act of 2007. We commend you for your leadership in 
     calling for a uniform and comprehensive national approach to 
     screening newborns for the full panel of core conditions 
     recommended by the American College of Medical Genetics and 
     endorsed by the American Academy of Pediatrics. If diagnosed 
     early, these disorders, including metabolic and hearing 
     deficiency, can be managed or treated to prevent severe 
     consequences.
       As a hospital which provides a wide array of services to 
     children with special health care needs, we know how 
     important early detection and treatment of conditions can be. 
     We were particularly pleased to see the provisions of this 
     legislation which provide for a Central Clearinghouse of 
     current educational and family support information, critical 
     to assuring a national standard of care.
       According to the latest March of Dimes Newborn Screening 
     Report Card, nearly two-thirds of all babies born in the 
     United States this year will be screened for more than 20 
     life-threatening disorders. However, disparities in state 
     newborn screening programs mean some babies will die or 
     develop brain damage or other severe complications from these 
     disorders because they are not identified in time for 
     effective treatment.
       At present, the United States lacks consistent national 
     guidelines for newborn screening, and each state decides how 
     many and which screening tests are required for every baby. 
     As a result, only 9 percent of all babies are screened for 
     all of the 29 recommended conditions. Clearly it is a wise 
     investment to take full advantage of the information 
     available to detect treatable conditions in children.
       We commend you for your leadership on this most important 
     issue and look forward to working with you and your 
     colleagues to secure passage of this legislation.
           Sincerely,
     Larry Levine,
       President.
     Judith Wiener Goodhue,
       Vice Chair, Board of Trustees, Chair, Government Relations 
     Committee.
                                  ____



                                               March of Dimes,

                                    Washington, DC, March 5, 2007.
     Hon. Hillary Clinton,
     U.S. Senate,
     Washington, DC.
       Dear Senator Clinton: On behalf of more than 3 million 
     volunteers and 1400 staff members of the March of Dimes, I am 
     writing to thank you for introducing the ``Screening for 
     Health of Infants and Newborns Act'' or the ``SHINE Act.'' We 
     understand the purpose of this legislation would be to 
     authorize grant programs to support state efforts to expand 
     the number of conditions for which newborns are screened and 
     to improve dissemination of educational resources to 
     healthcare professionals and the public.
       As you may know, the March of Dimes president served on the 
     steering committee that developed the American College of 
     Medical Genetics recommendation that every baby born in the 
     United States be screened for a `core' set of twenty-nine 
     treatable disorders, including certain metabolic conditions 
     and hearing deficiency. The March of Dimes has endorsed this 
     recommendation because early detection and treatment of these 
     disorders can avert lifelong disabilities (including mental 
     retardation), other serious illnesses and even death. Parents 
     are often unaware that the number and quality of newborn 
     screening varies from state to state and while newborns are 
     regularly screened and treated for debilitating conditions in 
     some states, in others, screening may not be required and 
     conditions may go undiagnosed and untreated.
       Federal guidance and incentives for states to improve their 
     newborn screening programs are sorely needed and the ``SHINE 
     Act'' will go a long way to enhancing the capacity of states 
     to expand their programs and to provide much needed 
     educational materials to families via the internet.
       We at the March of Dimes are sincerely grateful for your 
     leadership on this issue and we look forward to working with 
     you and others Members of Congress to expand federal support 
     for newborn screening.
           Sincerely,

                                              Marina L. Weiss,

                            Senior Vice President, Public Policy &
     Government Affairs.
                                  ____

                                               American College of


                                             Medical Genetics,

                                      Bethesda, MD, June 27, 2007.
     Re Screening for Health of Infants and Newborns (SHINE) Act.

     Hon. Hillary Rodham Clinton,
     U.S. Senate,
     Washington, DC.
       Dear Senator Clinton: I am writing in reference to the 
     SHINE Act, a bill that your office will introduce into the 
     Senate imminently to ensure the health and quality of life of 
     all newborns in the United States by providing resources to 
     further improve the capacity and quality of newborn screening 
     programs. The American College of Medical Genetics (ACMG), 
     which represents approximately 1400 medical geneticists who 
     comprise the workforce that cares for these patients and 
     their families, as well as houses the National Coordinating 
     Center for the Regional Genetic and Newborn Screening 
     Services Collaboratives, appreciates that you have 
     acknowledged our ongoing roles in the development of newborn 
     screening programs in the United States. ACMG is fully 
     supportive of the bill and recognizes the importance of each 
     of the areas it addresses. Newborn screening programs have 
     always represented a unique partnership between public health 
     and private healthcare and as such, they require a high 
     degree of coordination, collaboration and communication, as 
     recognized by this bill. Likewise, surveillance and data 
     collection are pivotal to harnessing new developments in the 
     areas of diagnostics and therapeutics.
       We are pleased that you have recognized this important 
     public health program and have sought positive activities to 
     improve it. If there is anything we can do to further the 
     goals of this legislation, please feel free to contact us.
           Sincerely,
     Michael S. Watson,
        Executive Director.
     Judith L. Benkendorf,
       Project Manager.
                                 ______