February 8, 2005
February 8, 2005
HEADLINE
Administration Releases FY06 Budget
Proposal
Yesterday, the Administration released its budget proposal for
fiscal year 2006. As expected, the proposed FY06 budget cut funding
in many health programs.
While full details have yet to be digested, budgetary “gimmicks� that mask the true size of the budget proposal have yet to be accounted for, below is funding for key respiratory related federal programs.
National Institutes of Health
(in millions)
|
Program
|
FY04 Actual
|
FY05 Estimate
|
FY06 Proposal
|
%
|
| NHLBI |
2,878
|
2,941
|
2,951
|
0.3
|
| NIAID |
4,303
|
4,403
|
4,460
|
1.3
|
| NIEHS |
631
|
645
|
648
|
0.5
|
| NINR |
135
|
138
|
139
|
0.7
|
| FIC |
65
|
67
|
67
|
0.0
|
| NIH Total |
27,878
|
28,444
|
28,590
|
0.5
|
Centers for Disease Control and
Prevention
(in millions)
|
Program
|
FY04 Actual
|
FY05 Estimate
|
FY06 Proposal
|
%
|
| HIV, AIDS/TB/STDs |
964
|
960
|
956
|
-0.4
|
| NIOSH |
277
|
286
|
286
|
0.0
|
| Environmental Health |
146
|
148
|
147
|
-0.6
|
| Chronic Disease Prevention |
818
|
899
|
840
|
-6.6
|
| CDC total |
4,440
|
4,572
|
4,017
|
-12.1
|
Veterans Affairs
(in millions)
|
Program
|
FY04 Actual
|
FY05 Estimate
|
FY06 Proposal
|
%
|
| VA Research |
405
|
402
|
393
|
-2.2
|
| VA Medical Care* |
29,953
|
29,953
|
30,705
|
2.5
|
As the Washington Office delves deeper into the budget, we will share additional/revised information.
RESEARCH POLICY
Nabel Announced as New NHLBI Director
On January 26, the NIH announced that Elizabeth G. Nabel,
M.D., will be the new director of the National Heart, Lung, and
Blood Institute (NHLBI). Dr. Nabel, who is currently the Scientific
Director of Clinical Research in the NHLBI intramural program,
began her appointment on February 1, 2005.
A board certified cardiologist, Dr. Nabel received her medical education at Cornell University Medical College before moving to Brigham and Women's Hospital and Harvard University where she completed an internship and residency in internal medicine and a clinical and research fellowship in cardiovascular medicine. She joined the faculty of the University of Michigan in 1987 as an assistant professor of medicine, eventually rising to the position of director of the division of cardiology in 1997.
Dr. Nabel replaces Dr. Claude Lenfant who retired in 2003. As you know, the ATS Washington Office worked closely with Dr. Lenfant and Dr. Barbara Alving who had been the acting Director of NHLBI since Dr. Lenfant's retirement. The ATS Washington Office will continue to foster a great working relationship with Dr. Nabel during her tenure. For more information, please go the NHLBI press release:
http://www.nhlbi.nih.gov/new/press/05-01-26.htm
NIH Announces New Public Access To Research Policy
On February 3, the National Institutes of Health (NIH)
released its final policy regarding its open access to research
publication policy. The policy states that beginning May 2, 2005,
all NIH scientists are “requested,� but not required, to share a
copy of their peer-reviewed manuscripts that have been supported
fully or in part by NIH funds. Manuscripts will be posted on NIH’s
National Library of Medicine PubMed Central, a web-based
archive.
NIH claims the proposal will achieve the following goals:
- create a stable archive of peer-reviewed research publications resulting from NIH-funded studies to ensure the permanent preservation of these vital research findings;
- secure a searchable compendium of these research publications that NIH and its awardees can use to manage more efficiently and to understand better their research portfolios, monitor scientific productivity, and, ultimately, help set research priorities; and
- make published results of NIH-funded research more readily accessible to the public, health care providers, educators, and scientists
The policy gives manuscript authors the ability to select the period of time – from 0 to12 months - the manuscript will be posted on PubMed Central for public release. The policy further states that, “Authors and/or their institutions should ensure that their {PubMed Central} submissions are consistent with any other agreements, including copyright assignment that they may have, or enter into, with publishers or other third parties.�
The decision to make manuscript submission to NIH’s PubMed Central a “request� instead of a requirement has interesting legal and practical implications. From a legal stand point, by making it a “request� NIH has cleverly avoided issuing a federal regulation and hence complying with the Administrative Procedures Act, which sets forth conditions under which regulatory agencies issue regulations. NIH does not have statutory authority to issue federal regulations and the manner in which this policy was developed did not comply with the Administrative Procedures Act.
Also, by making it a “request,� NIH claims that it is not exercising a right to collect and distribute copyrighted information that is exchanged between author and publisher – although the policy states clearly NIH feels it has such a right.
From a practical standpoint, the policy may put authors in the uncomfortable position of wanting to please NIH by “voluntarily� making research manuscripts available to PubMed Central -- and hence to the general public shortly after publication and while still pleasing scientific journals who generally seek exclusive rights to the manuscript for a set period (generally 12 months).
The policy announced this week included changes from the previous iteration issued in September. The September proposal required authors of NIH-supported manuscripts to submit manuscripts and indicated that these would be made available to the public 6 months after publication. NIH also clarified that submitting manuscripts through this mechanism would satisfy the NIH progress report requirement.
The ATS, along with the publishers of several not-for-profit scientific journals, expressed significant concerns with the September version of the proposal, including that it would undermine the economic viability of many not-for-profit journals, essentially sets up a system of dual publication, is redundant and costly. The ATS is currently considering how to respond to the final version of the NIH publication policy.
For more information about the NIH public access policy, go to:
http://www.nih.gov/about/publicaccess/index.htm
NIH Announces New Ethics Policy
On February 1, the National Institutes of Health (NIH)
released its new ethics and disclosure policy. The new rules ban
NIH scientists from taking paid consultant work from biomedical
companies and forbid them from holding stock in such companies. The
new policy is in response to congressional hearings and inquiries
into possible conflicts of interests between NIH researchers and
outside companies.
Scientists still will be allowed to teach courses, write and give lectures. NIH scientists will have 30 days to sever consulting ties with pharmaceutical and biotech companies in order to comply with the new policy. For more information, please go to:
http://www.nih.gov/news/pr/feb2005/od-01.htm
ADMINISTRATION
Leavitt Confirmed as HHS Secretary
On January 26, the Senate confirmed former Administrator
of the Environmental Protection Agency and former Utah Governor
Mike Leavitt as the new Secretary of the Department of Health and
Human Services. Secretary Leavitt replaces Tommy Thompson who
announced his retirement in December 2004.
Nicholson Confirmed as VA Secretary
On January 26, the Senate confirmed former Republican
National Chairman Jim Nicholson to be Secretary of Veterans
Affairs. Secretary Nicholson replaces Anthony J. Principi who
retired in December 2004.
Before coming to the VA, Secretary Nicholson served as the U.S. Ambassador to the Vatican.
COPD
COPD Resolution Introduced
On January 4, 2005, Rep. Cliff Stearns (R-FL) introduced
a resolution supporting the establishment of Chronic Obstructive
Pulmonary Disease (COPD) awareness month. Rep. John Lewis (D-GA) is
a cosponsor. Similar legislation was passed in the summer of
2003.
The goal of the COPD Awareness Month legislation is to raise public awareness on the fourth leading cause of death in the United States and around the globe. The ATS Washington Office will continue to work with the U.S. COPD Coalition and the Congressional COPD Caucus to advance COPD awareness efforts in Congress.
ASTHMA
Asthma Education and Awareness Bill
Introduced
On January 5, Rep. Juanita Millender-McDonald (D-CA) introduced
the Asthma Awareness, Education and Treatment Act of 2005, H.R.
172. The legislation authorizes the Health and Human Services (HHS)
to carry out programs regarding the prevention and management of
asthma, allergies and related respiratory problems, and to
establish a tax credit regarding pest control and indoor air
quality and climate control services for multifamily residential
housing in low-income communities.
The bill authorizes the Secretary of HHS to provide $8 million in grant funding for health care organizations to provide screenings, educational materials and workshops in low-incomes area and $5 million for a national media campaign to provide public and health care providers information on asthma, allergies, and related respiratory problems, with priority given to the occurrence of such conditions in children.
The ATS Washington Office will continue to monitor the status of this legislation.
MINORITY LUNG DISEASE
New Report Outlining Minority Lung Disease
Released
On February 1, the American Lung Association released its Lung
Disease Data in Culturally Diverse Communities: 2005 report. The
report was created to raise awareness of lung disease in diverse
communities and provides relevant statistics about important lung
health issues such as asthma, smoking and clean air as they relate
to diverse communities.
According to Donald Woods, Vice President, Cultural Diversity for the American Lung Association, “in many instances, ethnic communities and communities of color are disproportionately affected by lung diseases.� The report finds that minorities have a disproportionately wide range of respiratory diseases, from childhood infections to occupational lung disease, asthma and cancer.
To read the full report, go to:
http://www.lungusa2.org/embargo/lddcdc/LDD.pdf
CLEAN AIR
EPA Staff Recommends Stricter Air Pollution
Standards
This week, EPA staff released a draft paper that
recommends stricter standards for exposure to fine particle air
pollution. The EPA staff paper noted that several studies have
shown significant adverse health effects – including increased
mortality, heart attacks, and emergency room visits - at levels
below the current 15 µg/m3 average annual standard and the 65 µg/m3
24-hour standard.
The EPA staff paper lays out a series of options for tightening the current clean air standard. The least strict standard proposed by EPA staff of 14 µg/m3 average annual standard and the 40 µg/m3 24-hour standard would designate 46 percent of all Americans as living in areas that have unhealthy air. The strictest standard proposed by EPA staff of 15 µg/m3 average annual standard and the 25 µg/m3 24-hour standard estimates that 86 percent of American live in areas with unhealthy air.
The EPA staff paper also recommends establishing stricter standards for course particle air pollution and visibility standards.
The EPA staff paper will be reviewed by the EPA Clean Air Scientific Advisory Committee in April. After the EPA Clean Air Scientific Advisory Committee has reviewed and made comments on the validity of scientific studies that unlie the staff recommendation, EPA staff will issue a final staff paper. EPA is expected to issue proposed new clean air standards by December 2005, with final implementation starting in December 2006.
Points of Contact
| Gary Ewart | Senior Director, Government Relations |
| Nuala Moore | Senior Legislative Representative |
| Joe Kirby | DC Office Administrator |
