[Congressional Record Volume 150, Number 124 (Tuesday, October 5, 2004)]
[Senate]
[Pages S10440-S10442]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD (for himself and Mr. Bond):
  S. 2892. A bill to amend the Public Health Service Act to reauthorize 
and extend certain programs to provide coordinated services and 
research with respect to children and families with HIV/AIDS; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. DODD. Mr. President, I rise today to introduce the Children and 
Family HIV/AIDS Research and Care Act of 2004. This bipartisan 
legislation will address the special needs of children and youth with 
HIV/AIDS--needs that are too often overlooked, both domestically and 
internationally. This legislation recognizes the simple fact that when 
it comes to HIV prevention, research, care, and treatment, children and 
youth are not just small adults. To give them a chance for a healthy 
future, we must ensure that their unique needs are met.
  I want to begin by thanking my good friend Senator Bond of Missouri 
for joining me in introducing this important legislation. Senator Bond 
has provided crucial support for children and for children's health. 
Over the years, he has been a leader in the fight to protect children 
from birth defects and developmental disabilities. He has also done a 
great deal to ensure that our nation's children's hospitals and 
community health centers have the resources they need to continue to 
provide essential care to children and families. I am very pleased to 
work with him to move this legislation forward.
  Children's growing bodies are especially susceptible to the rapid 
advancement of HIV infection. Because their immune systems are still 
immature, the disease typically progresses more rapidly and differently 
in children than in adults. For example, children with HIV infection 
are more prone to neurological abnormalities and certain opportunistic 
infections than adults. In addition, because children's bodies are 
growing and developing, HIV/AIDS can have profound effects on 
children's physical growth and ability to reach developmental 
milestones such as crawling, walking and learning to talk.
  While research has definitively shown that initiating drug treatment 
in children in a timely manner promotes normal growth and development, 
and prolongs life, treating children with HIV/AIDS presents particular 
challenges. Appropriately formulated and dosed HIV/AIDS drugs are 
urgently needed to ensure that children receive optimal care. 
Currently, liquid formulations that young children can swallow are not 
always readily available. In addition, pediatric dosing and safety 
information for these powerful drugs is often lacking, particularly for 
younger children. This lack of information puts children at risk; too 
much medication can be toxic and too little will not effectively 
suppress the virus. Over time, under-dosing can lead to drug 
resistance, a particularly serious concern for children who will need 
to use these medications for years, if not decades.
  Appropriate HIV/AIDS care and treatment for children and youth also 
requires that special attention be paid to their social development 
needs. Children and youth have unique concerns regarding disclosure and 
stigma that may be exacerbated by frequent absences from school and 
social activities, and the onset of sexual maturity. Working with 
schools and other social and community institutions is imperative to 
promoting a sense of normalcy. Because children are not typically 
medical decision-makers, developing long-term care partnerships with 
parents and other caregivers is also crucial to successful care and 
treatment. At the same time, maximizing each child's own ability to 
take active participation in different aspects of his or her own care 
can increase a child's sense of ownership over treatment, improving 
adherence and overall health.

  By reauthorizing and expanding Title IV of the Ryan White CARE Act 
this legislation will help to ensure that the unique care and treatment 
needs of children are addressed. This program is a lifeline for more 
than 53,000 women, children, and youth affected by HIV/AIDS served 
annually by Title IV-funded projects. Through 91 grants in 35 states, 
the District of Columbia, Puerto Rico and the Virgin Islands, Title IV 
projects provide medical care, case management, support services, 
mental health, transportation, child care, and other crucial services 
to families affected by HIV/AIDS. Title IV is the smallest of the four 
main titles of the Ryan White CARE Act, yet reaches the highest 
proportion of minorities.
  Key to the success of Title IV projects is the model of ``family-
centered care.'' This model of care treats the whole family as the 
client, whether several family members are infected by HIV, or just a 
parent or child. The family-centered care model is crucial to 
developing strong partnerships between consumers and providers, leading 
to better health outcomes for women,

[[Page S10441]]

children, and youth. By allowing affected family members to receive 
services, as well as the infected individuals, Title IV projects 
promote health at the family level, thereby prolonging life, improving 
quality of life, and saving money by keeping people out of the 
hospital.
  I would like to take a moment to recognize the work done by the 
Children, Youth and Family AIDS Network of Connecticut, which provides 
Title IV services to more than 500 children, youth, women, and families 
affected by HIV/AIDS in my home state. I have heard from many of these 
individuals about just how important these services are to their 
quality of life.
  While recommitting the Health Resources and Services Administration 
(HRSA) to family-centered care and the unique work of Title IV, this 
legislation will also expand the innovative strategies Title IV 
projects have used to prevent mother-to-child HIV transmission. Since 
1994, when the administration of preventive drug interventions was 
shown to significantly reduce perinatal HIV transmission, the number of 
newborns infected with HIV has decreased dramatically. Yet mother-to-
children transmission does continue to occur, largely due to missed 
opportunities for identifying HIV-positive pregnant women and providing 
the supportive services needed to ensure adherence to recommended 
treatment regimens. We propose to fund demonstration grants to assess 
the effectiveness of two strategies in reducing mother-to-children 
transmission: (1) Increasing routine, voluntary HIV testing of pregnant 
women and (2) increasing access to prenatal care, intensive case 
management, and supportive services for HIV-positive pregnant women.
  In addition, this bill will encourage research into key care and 
treatment questions affecting the pediatric populations. These include: 
the long-term health effects of preventive drug regimens on HIV-exposed 
children; the long-term health, psycho-social, and prevention needs for 
children and adolescents perinatally HIV-infected; the transition to 
adulthood for HIV-infected children; and safer and more effective 
treatment options for infants, children, and adolescents with HIV 
disease.
  Since history suggests that a vaccine may prove to be the most 
effective, affordable, long-term approach to stopping the spread of 
HIV, this legislation will also ensure that children are not an 
afterthought when it comes to the development of an HIV vaccine. 
Currently, some of the populations hardest hit by the pandemic--infants 
and youth--are at risk of being left behind in the search for an 
effective vaccine. Because we cannot assume that a vaccine tested in 
adults will also be safe and effective when used in pediatric 
populations, it will be important to ensure that promising vaccines are 
tested in infants and youth as early as is medically and ethically 
appropriate. Failure to begin planning for the inclusion of these 
groups in clinical trials could mean significant delays in the 
availability of a pediatric HIV vaccine, at the cost of countless 
thousands of lives. This legislation will ensure that we begin now to 
address the logistical, regulatory, medical, and ethical issues 
presented by pediatric testing of HIV vaccines so that children can 
share in the benefits of any advances in vaccines research.
  I want to thank several organizations for lending their expertise to 
the development of this legislation, in particular the Elizabeth Glaser 
Pediatric AIDS Foundation, the AIDS Alliance for Children, Youth and 
Families, and the American Academy of Pediatrics, all of whom support 
this bill. I would also like to note that the AMS Vaccine Advocacy 
Coalition is endorsing this legislation. I would ask unanimous consent 
that three letters of endorsement be printed in the Record.
  HIV/AIDS is the single greatest health care catastrophe facing the 
world today. We need to do much more to seek effective treatments and, 
eventually, a cure for this horrible illness. This legislation is by no 
means sufficient to reach that goal, but it is a step towards ensuring 
that children are not left behind as we make progress, and then when we 
do finally eradicate HIV/AIDS once and for all, children and youth are 
able to benefit immediately. I urge all of my colleagues to join us in 
support of this legislation.
  There being no objection, the letters were ordered to be printed in 
the Record, as follows:

                                       AIDS Alliance for Children,


                                           Youth and Families,

                                  Washington, DC, October 5, 2004.
     Senator Christopher J. Dodd,
     Subcommittee on Children and Families,
     Senator Christopher S. Bond,
     Subcommittee on Aging,
     Washington, DC.
       Dear Senators Dodd and Bond:
       As the national non-profit organization dedicated to women, 
     children, youth and families affected by HIV/AIDS, we would 
     like to extend our sincere gratitude for you introduction of 
     the Children and Family HIV/AIDS Research and Care Act of 
     2004. We greatly appreciate your leadership on this issue.
       The Children and Family HIV/AIDS Research and Care Act 
     provides many important services to some of the most 
     vulnerable populations of HIV-positive people: women, 
     children, infants, youth and male caregivers. This bill 
     reauthorizes Title IV of the Ryan White CARE Act, strengthens 
     the model of family-centered care, reinforces other 
     provisions in the CARE Act serving these groups, expands 
     efforts to prevent mother-to-child HIV transmission (MTCT), 
     and ensures that biomedical research efforts in the fight 
     against HIV--especially the search for a preventive vaccine--
     take into consideration the special needs of pediatric 
     populations.
       Title IV of the Ryan White CARE Act is a lifeline to more 
     than 53,000 women, children, youth, infants and male 
     caregivers served each year. Through grants to 91 
     organizations across 35 states, the District of Columbia, 
     Puerto Rico and the U.S. Virgin Islands, grantees and 
     hundreds of subgrantees provide medical care, support 
     services, case management, outreach and other services to 
     thousands of families affected by HIV/AIDS. Title IV saves 
     lives by providing treatment and care, improves quality of 
     life by keeping people healthier, and saves money by reducing 
     hospitalization. Title IV projects have also led the way in 
     reducing MTCT from more than 2,000 babies born HIS-positive 
     each year to fewer than 300. It is essential this program be 
     reauthorized and expanded, and we appreciate your support.
       In addition, biomedical research on a potential HIV vaccine 
     and other research into antiretroviral treatment, 
     psychosocial and prevention needs, and transitioning from 
     pediatric into adult health care settings are all complicated 
     research issues that must pay special attention to the needs 
     of children. Children and youth are not merely ``mini-
     adults'' for whom the same treatment, care and prevention 
     regimens apply. In terms of both physiological and 
     psychosocial development, children and adolescents have 
     different needs than adults, and research efforts must be 
     attuned to these concerns. This bill would address those 
     issues by developing a pediatric HIV vaccination testing plan 
     and expand other research efforts relevant to infants, 
     children, and youth affected by HIV/AIDS.
       We fully endorse this legislation, and again thank you for 
     your efforts to introduce and support it. We look forward to 
     working with our offices to promote this bill and see its 
     provisions enacted into law.
           Sincerely,
     Ivy Turnbull,
       President.
     David C. Harvey,
       Executive Director.
                                  ____

                                        Elizabeth Glaser Pediatric


                                              AIDS Foundation,

                                  Washington, DC, October 5, 2004.
     Hon. Christopher J. Dodd,
     U.S. Senate,
     Washington, DC.
     Hon. Christopher S. Bond,
     U.S. Senate,
     Washington, DC.
       Dear Senators Dodd and Bond:
       On behalf of the Elizabeth Glaser Pediatric AIDS 
     Foundation, I would like to commend your leadership in 
     introducing the Children and Family HIV/AIDS Research and 
     Care Act of 2004. We applaud your attention to the needs of 
     children with HIV/AIDS and offer our strong endorsement of 
     this bipartisan legislation.
       The Foundation was created more than 15 years ago to help 
     children with HIV/AIDS and is now the worldwide leader in the 
     fight against pediatric AIDS and other serious and life-
     threatening diseases affecting children. While we have made 
     great strides in caring for children with HIV/AIDS since the 
     early days of the pandemic, it is an unfortunate fact that 
     their unique needs are still too often overlooked. As we have 
     learned firsthand, children with HIV/AIDS are not small 
     adults. To give them the best possible chance for a healthy 
     future, it is essential that their specific prevention, care 
     and treatment needs are met.
       The Children and Family HIV/AIDS Research and Care Act of 
     2004 will address those needs by reauthorizing Title IV of 
     the Ryan White CARE Act and expanding its focus on reaching 
     and caring for adolescents with HIV/AIDS. To further reduce 
     mother-to-child transmission of HIV, this legislation will 
     also promote routine, voluntary prenatal HIV testing and 
     intensive care management for HIV-positive pregnant women. In 
     addition, because children are at risk of being left behind 
     in the search for an effective HIV vaccine, the bill will 
     require federal agencies funding and regulating HIV vaccine

[[Page S10442]]

     research to develop plans and guidelines for including 
     pediatric populations in clinical trials as quickly as is 
     medically and ethically appropriate. This legislation will 
     also encourage research on key remaining pediatric research 
     questions, including how to provide safer and more effective 
     treatment options for children with HIV/AIDS.
       Thank you again for your commitment to ensuring that the 
     unique prevention, care and treatment needs of children with 
     HIV/AIDS are met. We appreciate the opportunity to join you 
     in helping children to reap the benefits of the very best 
     that science and medicine have to offer and look forward to 
     working with you toward passage of this critical legislation.
           Sincerely,

                                                   Mark Isaac,

                                     Vice President, Public Policy
     and Communication.
                                  ____



                              AIDS Vaccine Advocacy Coalition,

                                    New York, NY, October 5, 2004.
     Hon. Christopher Bond,
     U.S. Senate,

     Hon. Christopher Dodd,
     U.S. Senate,
     Washington, DC.
       Dear Senators Bond and Dodd: On behalf of the AIDS Vaccine 
     Advocacy Coalition, I would like to express our strong 
     support for the Children and Family HIV/AIDS Research and 
     Care Act of 2004. We applaud your efforts to provide 
     coordinated services and research with respect to children 
     and families with HIV/AIDS.
       Founded in 1995, AVAC is an internationally recognized non-
     profit organization committed to accelerating the ethical 
     development and global delivery of vaccines against HIV/AIDS. 
     We are committed to a broad, sustainable response to manage 
     the long haul from basic science, to product development, 
     through multiple clinical trials and, eventually and most 
     importantly, to a safe, efficacious, accessible and 
     affordable vaccine in use for the people and communities that 
     need it most.
       Unless issues surrounding the testing of vaccine candidates 
     in relevant pediatric populations are addressed now, they 
     likely won't have timely access to an effective vaccine when 
     one is developed and licensed. That would not only deny young 
     people of an important HIV prevention tool, but it would 
     severely hamper global efforts to stop the AIDS pandemic.
       We, therefore, strongly endorse your effort to enact 
     legislation that prioritizes this critical research issue and 
     calls for a plan of action to move forward. We appreciate the 
     opportunity to join you now to ensure that the research and 
     development process delivers treatment and prevention to the 
     populations that need it most and look forward to working 
     with you toward passage of this legislation.
           Sincerely,
                                                  Mitchell Warren,
                                               Executive Director.

  Mr. BOND. Mr. President, currently, more than 3,700 children and 
youth under the age of 13 are living with HIV or AIDS in the United 
States and of the more than 40,000 Americans newly infected with HIV 
each year, half are young people under the age of 25 years old. When we 
think about this devastating virus we do not often associate it with 
children, especially infants or newborn babies, but the fact is this 
disease does not discriminate on the basis of age. It affects children 
in very specific and very different ways than adults.
  For instance, the medical experience of children with HIV/AIDS can 
differ significantly from that of adults. Because children's immune 
systems are still immature, the disease typically progresses more 
rapidly in children than in adults and can have different 
manifestations. For example, the majorities of children with HIV have 
neurological abnormalities and are more susceptible to certain 
opportunistic infections than adults. In addition, because children's 
bodies are growing and developing, HIV/AIDS can have profound effects 
on children's physical growth and ability to reach developmental 
milestones such as crawling, walking and learning to walk.
  Medication for young children living with HIV/AIDS can also be very 
different than that of an adult living with HIV/AIDS. For example, 
children of certain ages cannot swallow pills and require liquid 
formulations of life-saving HIV/AIDS drugs that are not always readily 
available. In addition, dosing and safety information for these 
powerful drugs are often strikingly different for children and adults, 
and for younger children, this information is typically completely 
missing. This lack of information puts children at risk by requiring 
health care providers to estimate correct dosing. Too much medication 
can be toxic, and too little will not effectively suppress the virus. 
Over time, under-dosing can lead to drug resistance.
  Children are not just small adults and their growing bodies are 
especially susceptible to the rapid advancement of HIV infection. Early 
awareness that a child has HIV infection, combined with good care and 
support, can enhance survival and quality of life, which is why I am 
introducing, with my colleague Senator Dodd, The Children Family HIV/
AIDS Research and Care Act of 2004. This legislation will address those 
needs of children and adolescents living with HIV/AIDS by reauthorizing 
Title IV of the Ryan White CARE Act and expanding its focus on reaching 
and caring for adolescents with HIV/AIDS. Moreover, this legislation 
will continue to work to reduce mother-to-child transmission of HIV, by 
promoting routine, voluntary prenatal HIV testing and intensive care 
management for HIV-positive pregnant women. In addition, because 
children are at risk of being left behind in the search for an 
effective HIV vaccine, the bill will require federal agencies funding 
and regulating HIV vaccine research to develop plans and guidelines for 
including pediatric populations in clinical trials as quickly as is 
medically and ethically appropriate. This legislation will also 
encourage research on key remaining pediatric research questions, 
including how to provide safer and more effective treatment options for 
children with HIV/AIDS.
  For a young person living with HIV or AIDS there is no cure and there 
is no remission. It is with them at home, on the playground, in the 
classroom, and at a Friday night sleepover. It will be with them as 
they enter high school, go to college and get their first job. For a 
person born with this virus it is a permanent part of their life. This 
bill will help to ensure that the needs of infants, children, and 
adolescents living with HIV/AIDS are not overlooked.
                                 ______