Maternal and Child Health Library
This and past issues of the MCH Alert are available at http://www.mchlibrary.info/alert/archives.html.
February 16, 2007
1. Curriculum Focuses On Ensuring Access To Oral Health Services
For Young Children with Special Health Care Needs
2. Report Examines State Children's Health Insurance Program Trends,
Experiences, and Issues Within and Across States
3. Paper Suggests Priority Areas for Increased Federal Funding to
Support Children
4. Report Explores Recent Changes Affecting Maternal
Mortality Data
5. Authors Assess Economic Returns of Clinical Trials Performed
Under FDA's Pediatric Exclusivity Program
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1. CURRICULUM FOCUSES ON ENSURING ACCESS TO ORAL HEALTH SERVICES FOR YOUNG
CHILDREN WITH SPECIAL HEALTH CARE NEEDS
Special Care: An Oral Health Professional’s Guide to Serving Young Children
with Special Health Care Needs, is a Web-based continuing education (CE) course
that provides oral health professionals (dentists, dental hygienists, and dental
assistants) with information to ensure that young children with special health
care needs have access to health-promotion and disease-prevention services
that address their unique oral health needs in a comprehensive, family-centered,
and community-based manner. The Web-based curriculum was prepared by the National
Maternal and Child Oral Health Resource Center at Georgetown University and
designed by the Center for Advanced Distance Education at the University of
Illinois at Chicago with support from the Maternal and Child Health Bureau.
Topics include (1) an overview of children with special health care needs and
oral health, (2) the provision of optimal oral health care, (3) oral health
supervision, (4) oral disease prevention, and (5) behavior management. Four
CE credits through the Indian Health Service or through the American Dental
Hygienists’ Association will be awarded upon successful completion of
the course. The course is free of charge and is available at http://www.mchoralhealth.org/SpecialCare.
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2. REPORT EXAMINES STATE CHILDREN'S HEALTH INSURANCE PROGRAM TRENDS, EXPERIENCES,
AND ISSUES WITHIN AND ACROSS STATES
Children's Health Insurance: State Experiences in Implementing SCHIP and Considerations
for Reauthorization addresses trends in the enrollment and current composition
of the State Children's Health Insurance Program (SCHIP) across states, states'
spending experiences under SCHIP, and considerations for SCHIP reauthorization.
The report presents testimony of the U.S. Government Accountability Office before
the U.S. Senate Committee on Finance and is based on prior work, analysis of
the Current Population Survey conducted by the U.S. Census Bureau (2003-2005),
information from states' annual SCHIP reports (2002-2005), and SCHIP enrollment
and expenditure data from the Center for Medicare and Medicaid Services. Contents
include background information on SCHIP allotments to states, design choices,
and coverage of adults. Figures provide data on SCHIP enrollment, the percentage
of children who are uninsured, state SCHIP design choices, SCHIP eligibility
for children and adolescents ages 6-18, and types of cost-sharing under SCHIP.
Tables provide information on the basis of coverage for states with separate
child health programs, premium-assistance programs in nine states, states covering
adults in SCHIP, selected SCHIP program characteristics of shortfall and non-shortfall
states, and SCHIP enrollment in states using SCHIP funds to cover adults. The
full report, including the scope and methodology,
is available at http://www.gao.gov/cgi-bin/getrpt?GAO-07-447T.
Report highlights are available at
http://www.gao.gov/highlights/d07447thigh.pdf.
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3. PAPER SUGGESTS PRIORITY AREAS FOR INCREASED FEDERAL FUNDING TO
SUPPORT CHILDREN
Cost-Effective Investments in Children examines options for investing additional
resources in children as part of an overall federal-deficit-reduction plan. The
paper, one in a series of papers on budget choices published by the Budgeting
for National Priorities project at the Brookings Institution, is based on a review
of benefit-cost evidence. The author identifies four areas of investment in children
where there is sufficient evidence of positive outcomes and sound benefit-cost
ratios to merit expanded federal funding. These areas include (1) high-quality
early childhood education programs for children ages 3 and 4, (2) nurse home-visiting
programs to promote prenatal care and the healthy development of infants and
toddlers, (3) school reform with an emphasis on programs in high-poverty elementary
schools that improve the acquisition of basic skills for all students, and (4)
programs that reduce the incidence of adolescent pregnancy. For each of the four
areas, the paper reviews the social science evidence regarding program effectiveness
-- particularly cost effectiveness -- and outlines a specific proposal with a
budgetary estimate. Summary tables and conclusions are also presented. The paper
is available at
http://www.brookings.edu/views/papers/200701isaacs.pdf.
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4. REPORT EXPLORES RECENT CHANGES AFFECTING MATERNAL MORTALITY DATA
"In the NVSS
[National Vital Statistics System]
, maternal deaths
increased with the introduction of the ICD
[InternationalClassification of Disorders]
-10 and when the separate pregnancy status question switched from being supplemental
information available from some state certificates to an item expected to be
included on all state
certificates," state the authors of Maternal Mortality and Related Concepts.
In the NVSS, deaths of pregnant or recently pregnant women are identified according
to the information reported on the women's death certificates. As alternative
data sources have been developed and research groups have focused on maternal
mortality in greater detail, there has been interest in improving the information
available from the death certificate. A growing number of states have made efforts
to improve vital-statistics-data quality by including a separate question on
recent pregnancy history on death certificates. The report summarizes processing
of maternal mortality in the NVSS, describes recent changes affecting NVSS data,
and discusses the impact of these changes on statistics on deaths of pregnant
and recently pregnant women.
The data presented in the report, published by the National Center for Health
Statistics, is based on information from death certificates filed in the 50 states
and the District of Columbia that are subsequently compiled into national data,
also known as the NVSS. States were divided according to whether the state death
certificate
included any form of a separate pregnancy question.
The authors found that
- Maternal mortality fluctuates from year to year but was 12.1 deaths per
100,000 live births in 2003.
- The implementation of the ICD-10 in 1999 resulted in about a 13% increase
in the number of deaths identified as maternal deaths between 1998 and 1999.
- The rate increased again between 2002 and 2003 after a separate pregnancy
question became a standard item on the U.S. Standard Certificate of Death.
The authors conclude that "because most states have yet to adopt the standard
format of the separate pregnancy question, it is likely that maternal and late
maternal death rates in all states will continue to be subject to increases because
of the adoption of questions rather
than actual increases in maternal mortality."
Hoyert DL. 2007. Maternal mortality and related concepts. Vital Health Statistics
3(33). Available at http://www.cdc.gov/nchs/data/series/sr_03/sr03_033.pdf.
Readers: More information is available from the MCH Library's organizations resource
list, Maternal Morbidity and Mortality, at http://www.mchlibrary.info/action.lasso?-database=Organizations&-layout=Web&-response=/databases/OrgLists/orgs_matmort.html&-MaxRecords=all&-DoScript=auto_search_matmort&-search.
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5. AUTHORS ASSESS ECONOMIC RETURNS OF CLINICAL TRIALS PERFORMED UNDER FDA'S PEDIATRIC
EXCLUSIVITY PROGRAM
"The Pediatric Exclusivity Program has been a success from the perspective of
conducting trials for labeling in children," state the authors of an article
published in the February 7, 2007, issue of JAMA, the Journal of the American
Medical Association. Historically, only 25% of approved drugs marketed in the
United States have sufficient pediatric data to support approval of product labeling
by the U.S. Food and Drug Administration (FDA) for dosing, safety, or efficacy
in children. In 1997, Congress passed the U.S. FDA Modernization Act. Section
505A of this act, known as the Pediatric Exclusivity Provision, was designed
to give a financial incentive of 6 months of patent extension or marketing rights
to pharmaceutical companies that conduct studies requested by the FDA. The Best
Pharmaceuticals Act of 2002 extended the economic incentives provided by pediatric
exclusivity. This program has resulted in a substantial increase in pediatric
drug research. Nevertheless, critics of the program contend that it has provided
a "windfall" to the prescription drug industry. Several revised components of
the Pediatric Exclusivity Program legislation have thus been proposed. These
include disbanding the program altogether, varying the length of marketing protection
based on annual sales, and reducing marketing protection from 6 to 3 months.
The study described in this article sought to determine whether incentives provided
by the law are disproportionate to the cost of the studies
they affect.
The authors identified clinical trials performed for pediatric exclusivity for
which data were submitted between 2002 and 2004. During this period, data
from 59 drugs were submitted to FDA. Among these, 9 drugs that were granted pediatric
exclusivity were selected for the study, one in each of the following categories:
(1) allergy/immunology, (2) cancer, (3) central nervous system, (4) cardiovascular,
(5) psychiatry, (6) endocrine, (7) gastrointestinal, (8) infectious disease,
and (9) other. For each, the authors estimated the net economic return to industry
from participation in the exclusivity program and calculated the resulting net
return-to-cost
ratio.
The authors found that
- The median estimated cost of conducting each trial was $12.34 million.
The median cost for a single-dose pharmacokinetic study was $894,941, for
a multidose pharmacokinetic study was $2,297,250, and for an efficacy study
was $6,464,921.
- Median cash inflows were $140,447,244 assuming 6 months of exclusivity,
and decreased proportionately when the exclusivity period was reduced to
3 months.
- Median cash outflows were $10,362,062.
- Assuming 6 months of exclusivity, the median net economic benefit was $134,265,456.
Assuming 3 months of exclusivity, the median net benefit was reduced to $64,041,833.
- A very high rate of return was realized by blockbuster drugs (those with
yearly U.S. sales exceeding $1 billion); however, a much lower rate of return
was realized by most products in the overall 2002-2004 cohort.
The authors conclude that "from the policy perspective, our study shows that
the Pediatric Exclusivity Program overcompensates blockbuster products for performing
trials in children, while other products have more modest returns on investments
under this program." They continue, "Further understanding and modeling are necessary
to ascertain what constitutes adequate economic return to manufacturers for their
risk. Clearly, however, the greatest return of the exclusivity program is the
benefits derived in obtaining new information relevant and applicable toward
the care of children, and this benefit should not be
compromised."
Li JS, Eisenstein EL, Grabowski HG, et al. 2007. Economic return of clinical
trials performed under the pediatric exclusivity program. JAMA, the Journal of
the American Medical Association 297(5):480-488.
Abstract available at http://jama.ama-assn.org/cgi/content/abstract/297/5/480.
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