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American Pediatric Society & Society for Pediatric Research Public Policy Council |
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2004–2005 Activities Report |
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The
Public Policy Council, now in its 21st year, includes two
representatives from each of the three constituent societies,
the American Pediatric Society (APS), the Association of Medical
School Pediatric Department Chairs (AMSPDC) and the Society for
Pediatric Research (SPR). Members serve simultaneously as
representatives to the AAMC Council of Academic Societies and as
liaison and alternative representatives to the AAP Committee on
Federal Government Affairs (COFGA). The
Public Policy Forum is a loosely knit assembly of designated
representatives at each major academic institution represented
in AMSPDC; it serves as a communication network with the
membership of the three societies and with academic pediatrics
in general. Materials are distributed regularly to the Forum,
including periodic legislative updates as well as relevant items
on time-specific issues. These are supplemented by the Public
Policy Council's home page on the APS/SPR web site, which also
provides access to our Washington coordinators and to myself.
The Forum also serves as a vehicle for the annual legislative
briefing at the annual meeting. The legislative breakfast at
this year's PAS meeting in Washington, the forum's nineteenth,
was held Monday morning, May 16, and featured Anthony J.
Mazzaschi, Senior Associate Vice President for Biomedical and
Health Sciences Research, Association of American Medical
Colleges (AAMC) who discussed "The Politics of Stem Cell
Research". With passage of Proposition 71 in California,
reintroduction of legislation supporting and opposing stem cell
research in the U.S. Congress, and legislative action pending in
a number of states, this proved to be a very timely overview of
the current environment as seen from Washington. The
twelfth annual Public Policy Plenary Symposium, conducted by the
Public Policy Council in collaboration with the Public Policy
and Advocacy Committee of the Ambulatory Pediatric Association,
was held May 15. This year's Plenary Symposium was devoted to
discussion of proposed clinical trial registries with a panel of
internationally recognized authorities, including Kay Dickersin,
Director of the U.S. Cochrane Center and Prof. of Community
Health at Brown University, Christine Laine, Deputy Editor of
the Annals of Internal Medicine and Executive Secretary of the
International Committee of Medical Journal Editors (ICMJE),
Donald Lindberg, Director of the National Library of Medicine,
site for clinicaltrials.gov and David Schonfeld, Chair of the
AAP's Committee on Pediatric Research. Dr. Dickersin was
co-author with Drummond Rennie of one of the first proposals for
a mandated clinical trials registry (JAMA, 2003), a proposal
since adopted by the AMA's House of Delegates. As
a follow-up to last year's Public Policy Plenary Symposium, an
update was provided on the status of the National Children's
Study, an ambitious longitudinal study of 100,000 children from
birth through 21 years of age authorized by the Children's
Health Act of 2000, on Monday, May 16 following the SPR
presidential plenary session. PPC member, Elena Fuentes
moderated the session with an overview provided by Duane
Alexander, Director, National Institute of Child Health and
Human Development. Peter C. Scheidt, NCS
director, outlined the study plan and implementation
strategy joined later by Ruth A. Brenner, Senior Epidemiologist
at the NICHD and NCS Director of Protocol Development, and Alan
R. Fleischman, Ethics Advisor and Chair of the NCS Advisory
Committee will be available to respond to questions. Membership
on the Public Policy Council remained stable during the past
year with Christine Gleason and Elena Fuentes-Afflick from the
Society for Pediatric Research, Jimmy Simon and myself for the
American Pediatric Society and Russ Chesney and Jon Abramson for
AMSPDC. Karen Hendricks has continued her effective service as
the Public Policy Council's Washington Coordinator, assisted by
Kristin Butterfield, both working out of the Academy of
Pediatrics' Department of Federal and Government Affairs. The
societies have been well served by Ms. Hendricks over the past
dozen years. She is highly regarded as a central figure at most
of the Capitol's most significant and relevant health-research
advocacy groups. She has served on the steering committee of the
Ad Hoc Group for Medical Research Funding for a number of years,
is past president of the Coalition of Health Funding, a
consortium of voluntary health organizations, professional
societies and advocacy groups, past chair of Research!America's
Public Affairs Committee, and a pivotal figure in a number of
issue-specific coalitions. The effectiveness of the Public
Policy Council and our continued visibility in Washington is, in
many respects, a reflection of Ms. Hendrick's standing and her
efforts on our behalf. The
council's activities continue to be conducted primarily through
a monthly conference call supplemented by frequent mailings and
e-mail communications from the Academy's Washington office as
well as from the AAMC Council of Academic Societies. Conference
calls have frequently included Lolita McDavid, chair of the
APA's Public Policy and Advocacy Committee, in part to
coordinate plans for the PAS annual meeting, but increasingly to
coordinate policy initiatives, and Richard Behrman, executive
chair of the Pediatric Education Steering Committee for the
Federation of Pediatric Organizations, for input on pediatric
workforce and other issues. John Lewy, chair of the Academy's
Committee on Federal Government Affairs (COFGA) continues to
participate in conference calls prior to COFGA meetings.
Materials, including minutes of conference calls, are shared
routinely with the leadership of the three societies and thus
provide opportunity for input on specific issues. The semiannual
legislative reports prepared for the councils and AMSPDC
executive committee and testimony by Public Policy Council
members are routinely placed on the Public Policy Council web
site. Programs of the Public Policy Council continue to be
conducted from both the Academy's Department of Federal Affairs
and my office at Yale's Child Health Research Center. A
comprehensive legislative report, prepared in March, appears in
the program booklet for the annual meeting. The
Public Policy Council was engaged in a number of issues during
the past year, much of this reflected in the periodic
legislative reports prepared by our Washington staff. In concert
with the Ad Hoc Group for Medical Research Funding,
Research!America and other advocacy groups, the Public Policy
Council continued to advocate for sufficient increases in the
NIH budget to sustain the doubling initiative for the FY 2005
and FY 2006 budgets. In the face of sustained budget deficits,
approximately $500 billion, these efforts have met with modest
success. Thus, although the Public Policy Council, through these
coalitions, advocated a 10% increase in the NIH budget for FY
2005, or $30.6 billion, final numbers were $28.37 billion, or a
2.1% increase. The Administration's proposed budget for FY 2006
is virtually flat for the National Institutes of Health as well
as other public health agencies such as AHRQ and CDC. The Public
Policy Council is advocating a 6% increase for NIH for FY 2006
and significant increases in the budgets for AHRQ and CDC. While
efforts are underway to increase the overall allocations in the
FY 2006 budget resolution, much of the advocacy has been devoted
to eliminating proposed reductions in the Medicaid budget
submitted by the Administration and prospects for significant
increases for federal research agencies beyond the cost of
inflation are remote. The FY 2006 budget proposal calls for $60
billion in savings in Medicaid over ten years. To accomplish
this would require major changes in the Medicaid program such as
caps on the federal contribution or block grants to states. A
major advocacy effort on the part of AMSPDC with AAP and NACHRI
has been underway. While there has been favorable action in the
Senate, the outcome remained uncertain as of the preparation of
this report. Led
by PPC member Jon Abramson, the Public Policy Council, working
with the Academy of Pediatrics and other organizations, was
involved in efforts to improve the availability and safety of
medical devices used for children. Dr. Abramson provided
testimony on August 31, 2004 to an Institute of Medicine
committee studying the post-marketing surveillance of devices.
The statement included responses solicited through the Public
Policy Forum. The Academy submitted an extensive statement to
the FDA regarding the unmet device needs for the pediatric
population, the barriers to development of pediatric devices,
and recommendations on FDA action to stimulate age-appropriate
device development. One result of these activities is formation
of a private/public consortium that will be housed at Virginia
Tech, where there is already experience in development of adult
devices. The
Public Policy Council has been actively engaged in proposals for
a mandatory registry of clinical trials as recommended by the
AMA's Council on Scientific Affairs and the International
Committee of Medical Journal Editors (ICMJE) in a series of
editorials published simultaneously last fall. I have been in
close contact with congressional staff who have developed
legislation that has been introduced into both the 108th and
109th Congress - the Fair Access to Clinical Trials (FACT) Act.
This proposed legislation would expand the NLM administered
clinicaltrials.gov site to include a comprehensive database of
all publicly and privately funded clinical trial results. This
will be the topic for this year's Public Policy Symposium at the
PAS meeting. The
Public Policy Council has been actively monitoring federal
initiatives and proposed legislation dealing with embryonic stem
cell research, in particular increased federal funding for
creation and research on new stem cell lines and for support of
somatic cell nuclear transplantation (SCNT) for creation of
disease-specific cell lines and eventual so called
"therapeutic cloning". The Public Policy Council has
worked through a variety of coalitions, in particular the
Coalition for the Advancement of Medical Research (CAMR), AAMC,
FASEB and similar scientific coalitions. Finally,
the Public Policy Council has been actively monitoring ongoing
legislative and regulatory issues related to clinical research
in children. Staff monitors activities of the Secretary's
Advisory Committee on Human Research Protections (SACHRP), which
recently approved recommendations of a pediatric subcommittee on
refined definitions for various levels of pediatric research
that are codified in the Common Rule. There continues to be
interest in codifying some of the recommendations of the IOM
Committee on Clinical Research Involving Children, perhaps
through reauthorization of the Children's Health Act of 2000,
which established the Pediatric Research Initiative within NIH
and loan forgiveness programs for pediatric researchers. While
the PRI has not resulted in the desired increase in pediatric
research, the loan forgiveness program has had considerable
success with 298 awards in FY 2003. There have been discussions
with NICHD on creation of a NIH Pediatric Centers of Research
Excellence program, which has involved PPC member Russ Chesney.
While there is considerable interest within NICHD, the current
fiscal environment is not the most inviting for new initiatives.
The proposed program would complement the Child Health Research
Centers program, which evolved from Public Policy Council
advocacy nearly twenty years ago. AAP
Committee on Federal Government Affairs: COFGA, formerly the
AAP's Council on Government Affairs, includes eight members
appointed by the Academy plus liaison representation from the
three societies which form the Public Policy Council, the
Ambulatory Pediatric Association, Society for Adolescent
Medicine, the Academy's Committee on State Government Affairs,
and the Academy's senior and resident sections. John Lewy,
former chair of pediatrics at Tulane, is chair of COFGA while
Richard Bucciarelli leads the Academy's Task Force on Access to
Health Care, which functions as a subcommittee of COFGA. COFGA
met on two occasions over the past year, September 4-5, 2004 and
February 27-28, 2005. A major subject of both meetings has been
the promotion of legislation insuring increased access and
insurance coverage for children, in part through preservation of
the safety net as represented by Medicaid and S-CHIP and through
promotion of legislation (MediKids Health Insurance Act;
Rockefeller/Stark) and legislation introduced by Sen. Kerry
based on his 2004 presidential campaign "Kids Come First
Act of 2005". The latter would essentially federalize
Medicaid for those children below the federal poverty level in
exchange for increased state coverage of S-CHIP and children
between 100 and 300 percent of the poverty level. Prospects for
comprehensive coverage of children, however, remain virtually
non-existent in the current political and fiscal environment and
efforts have been concentrated on preserving the safety net
through expansion of S-CHIP and preservation of the current
federal/state Medicaid program. The Academy organized a
"fly in" in February of key Academy leaders and
members with close contact to Republican lawmakers which
legislative oversight on Medicaid. Preservation of Medicaid and
expansion of S-CHIP were the leading issue when COFGA met in
February and for the subsequent hill visits of COFGA members.
Also, in concert with NACHRI, the Academy has advocated for
maintenance of full funding for the Children's Hospital GME, for
which the Administration proposed a $100 million cut. The
Academy continues to promote creation of a Medicaid Payment
Advisory Commission, comparable to role of the Medicare Payment
Advisory Commission (MEDPAC). There has been increasing support
among Congress for creation of a Medicaid Commission as they
grapple with the proposed ten-year cuts in federal support. The
Academy and COFGA have been actively working to prevent
elimination of the Emergency Medical Services for Children (EMSC)
program within reauthorization of the Trauma Research and Access
to Urgent Medical Attention (TRAUMA) Act, which has been under
discussion in the House Committee on Energy and Commerce.
Legislation introduced in the 108th Congress would have
reauthorized TRAUMA programs under HRSA but eliminate the EMSC
program. Testimony and advocacy by the Academy has highlighted
the use of emergency services by children, only a small
proportion of which related to major trauma, and the importance
of emergency services for children in general as well as
children's hospitals. The Academy has similarly advocated for
emergency services for children for a forthcoming report of the
Institute of Medicine's Committee on the Future of Emergency
Medicine in the U.S. Health Care System, calling for increased
research, adequate reimbursement, and attention to the mounting
liability problems impacting emergency and trauma providers.
COFGA and the Academy continue to be engaged in support for
legislation that would enhance care coordination and the concept
of a medical home, especially for children with chronic illness
and special health care needs. Through COFGA, the Public Policy
Council members have emphasized the importance of adequate
residency training and development of subspecialists, which are
in increasing short supply in academic health centers. AAMC
Council of Academic Societies: The CAS is one of the three
principal components of the Association of American Medical
Colleges (AAMC) together with the Council of Deans and the
Council of Teaching Hospitals. The CAS now includes 94 member
societies of which four are pediatric - the three parents of the
Public Policy Council as well as the Ambulatory Pediatric
Association. The CAS provides an unparalleled opportunity for
interaction of pediatric specialists with leaders of other
professional societies as well as an opportunity for significant
input into development of AAMC policies and activities.
Pediatric participation in the CAS remains limited, although a
pediatrician and SPR/APS member, Robert Desnick, is the current
chair, however in his capacity as representative from the
Association of Professors of Human and Medical Genetics. Paul
McCarthy, representing the Ambulatory Pediatric Association, and
I previously served on the administrative board and as chairs of
the CAS. Russ Chesney has participated in the CAS Chairs Task
Force and CAS Chairs Objectives Panel. The
Council of Academic Societies, as usual, met on two occasions
during the academic year - November 8, 2004 in Boston as part of
the annual general meeting of the AAMC and March 10-12, 2005 in
Tucson, Arizona. The latter meeting was built around the theme
of "Tomorrow's Doctors, Tomorrow's Cures: Envisioning the
Future" with a focus on the continuum of medical education
and how the academic medical enterprise is evolving in response
to federal and state health expenditures, expansion of
scientific knowledge and current trends in physician and
non-physician workforce, in particular the now projected
physician shortage. I attended the annual meeting in November;
none of the Public Policy Council members were able to attend
the spring meeting, which is unfortunate as this is a prime
vehicle for interaction with other academic specialists. During
the course of the year the AAMC changed its official policy on
physician workforce issues, acknowledging the need to increase
medical school capacity and creation of new medical schools. A
CAS Task Force on Dual Degree Students, Programs and Faculty
issued its report at the CAS spring meeting and recommended that
existing databases be enhanced. The committee observed that the
number of medical students enrolled in dual degree programs is
relatively small and heavily concentrated in MD/PhD and MD/MPH
programs, though there is increasing interest in MD/MBA
programs. An MD/PhD program director section will be established
within the AAMC's Group on Graduate Research, Education and
Training (GREAT). Prompted by the pressures for "open
access" of NIH-sponsored research, the CAS also issued a
report on the characteristics of journals published by four CAS
member societies. Fifty-one of 98 member societies surveyed
published at least one scholarly journal with ISI impact factors
ranging from 0.409 36.278 and mean of 3.516. Within the AAMC at
large, a major legislative victory was dismissal of the Yung v.
AAMC et al suit involving the National Residency Matching
Program on the basis of legislation, sponsored by the AAMC,
which explicitly exempted NRMP from federal anti-trust
legislation. The AAMC has reinstituted its Clinical Research
Task Force and has created Institutes for Improving Clinical
Care and a new AAMC Institute for Improving Medical Education.
The AAMC, in cooperation with the Federal Office of Research
Integrity, has provided funds to support activities enhancing
the responsible conduct of research by member societies. As of
the 2004 annual meeting, $360,000 had been awarded. As
always, I encourage the PPC member societies to become more
active within the affairs of the AAMC, especially the Council of
Academic Societies. The AAMC is a major voice for academic
medicine and the CAS provides a significant vehicle for input by
faculty and chairs. The fall annual meeting of the AAMC will be
in Washington November 4-9, 2005. This event provides an
unparalleled opportunity for interaction with our colleagues in
other academic disciplines. Next year's CAS spring meeting,
always a highlight, will be held at the Intercontinental Hotel,
Miami, March 17-18, 2006. Operations
and finances: As noted last year, with my retirement as
associate dean and closure of the Office of Government &
Community Affairs at the Yale School of Medicine, activities of
the Public Policy Council are now managed separately, in part
through my office at Yale's Child Health Research Center. With
the support of the three parent societies I have been fortunate
to retain the part-time services of Eleanore Miller, who has
worked with me for many years. The ongoing arrangement with the
Academy of Pediatrics' Washington office remains unchanged. Submitted
by, Myron
Genel, M.D. |
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