 |
|
|
 |
| Government
and Public Affairs Bulletin Archive - 2002
Bulletin No. 1 - January 4, 2002 NIH
Funding Congress
completed its work on FY 2002 Labor Labor/HHS & Education
appropriations bill before Christmas.
The total bill allows for $123.1 billion in discretionary
funding for FY 2002, an increase of 10% over FY 2001.
For the NIH, the conference agreement provides for $23.3
billion, an increase of $2.99 billion (14.7%) over FY 2001.
However the conference agreement also mandates a $100 million
transfer to the Global AIDS-Malaria-TB Fund and a $297 million
transfer for the "evaluation tap" of other agencies. As a
result of these transfers, the net FY 2002 total for NIH is $22.888
billion, an increase of $2.787 billion (13.9%) over FY 2001. New
and other spending for NIH includes $112 million for the National
Institute of Biomedical Imaging and Bioengineering (up from $2
million in its first year of existence) and $110 million for
extramural facilities construction grants (versus $100 million last
year). The
FY 2002 Defense Appropriation includes bioterrorism provisions.
Including $85 million for NIAID to support bioterrorism
related research, $70 million for the construction of a level-4
biosafety laboratory at the NIAID, and $71 million for improving
laboratory security at CDC and the NIH. NIGMS
Pharmacogenetics Research Network The NIGMS
Pharmacogenetics Research Network has chosen the journal
Pharmacological Reviews to partner with the Network in publishing
summaries of data submissions to the Pharmacogenetics knowledge Base
(PharmGKB). In June
2001, the Network sought proposals for the journal partnership by
issuing a letter of invitation to interested journals. By
establishing the partnership, the Network wants to develop standard
print format reports that will help alert the scientific community
to the availability of new pharmacogenetic data sets. The
Pharmacogenetics Research Network determined that Pharmacological
Reviews best met the criteria of: readership and impact factor;
free, full-text access to journal content; journal longevity; and
whether the publisher is mission or profit-driven. The Editor in
Chief of Pharmacological Reviews (published by ASPET) is Darrell
Abernethy, M.D., Ph.D. PharmGKB data sets are expected to be published online in
Pharmacological Reviews in early 2002. USP
Announces Launch of Dietary Supplement Verification Program The
United States Pharmacopeial Convention (USP) is announcing the
availability of its Dietary Supplement Verification Program.
Based on USP's assessment of the manufacturer's capability to
produce a dietary supplement and testing to USP standards, USP will
issue a certification mark that can be used by the manufacturer on
the dietary supplement container label.
The presence of this mark on a dietary supplement product
container is an indication to the practitioner, consumer, retailer,
and other interested parties that the product contains the dietary
supplement ingredient in the designated amount, meets acceptable
limits of undesirable elements, and is manufactured appropriately. USP
is named in the Dietary Supplement Health and Education Act
amendments (DSHEA) to the Federal Food, Drug and Cosmetic Act as the
nation's official compendium for dietary supplement standards.
USP will work with participating manufacturers in the coming
months to conduct rigorous assessments that will allow the use of
the verification mark. The
program includes: laboratory evaluation of product samples and
regular monitoring; evaluation of manufacturer's quality systems by
means of an audit; and quality control and manufacturing data
review. The
DSVP Program does not address structure/function claims that were
created under DSHEA. The USP Council of Experts' (CoE) Dietary
Supplement Expert Committee will initially review all products
submitted for verification where safety concerns have been raised. Commission
Suggests Regulations and Incentives Could Spur Research on
Supplements The White House Commission on Complementary and Alternative Medicine suggested at a recent meeting that one way to quickly spur research on dietary supplements is to provide intellectual property protections and patent laws that encourage research in this field. The rationale is that if the government is going to regulate dietary supplements as drugs it should give them similar incentives. Industry has in the past been reluctant to the idea believing that such changes would not be effective. Industry maintains that it would be difficult to protect claims on dietary supplements the way claims protect new drugs because supplements are already in wide use. If a company finds a new use for Vitamin C and gains exclusive rights to a health claim, consumers would know that other Vitamin C products have the same benefit. If a supplement existed that was not sold on the market a company can put the supplement through the new drug approval process. Presumably Congress could amend DSHEA for such legislation but there is strong opposition by industry and among some key lawmakers to revisit DSHEA. Bulletin No. 2 - January 31, 2002 President’s
Budget Commits to Doubling, $3.7 billion for NIH in FY 2003 President
Bush will finish the five-year budget doubling cycle for NIH in
FY’03 with a proposed $3.7 billion increase to $27.3 billion.
This represents almost a 16% increase above the $23.6 billion
for FY 02. The
President's proposed FY’03 NIH budget includes $1.5 billion for
NIH bioterrorism research, up from $300 million budgeted for the
current fiscal year. It is not clear if this $1.5 billion is slated
entirely for NIAID or will be distributed among other institutes and
centers. The bioterrorism research includes the sequencing genomes of
bioterrorism agents, continued development of second-generation
anthrax vaccines, and improving diagnostics. The
budget proposes a 13% increase for NCI to $5.5 billion from $4.9
billion. NIDA Seeks Director
The National Institute of Drug Abuse is seeking a Director to direct a budget of approximately $900 million and a staff of 425 to support the research program on drug abuse and addiction. Interested and exceptionally qualified applicants may apply by April 8, 2002. To view the vacancy announcement, hit http://www1.od.nih.gov/ohrm/hrinfo/ses/vacancy/VacAnnc(NIDA).htm.
NIH and Bio-terror Funding Last
month President Bush recommended a $3.9 billion increase for the
NIH. As more details emerge from the budget it is clear that a
significant amount of money will be spent on bioterror-related
activities, other transfers of funds, and non-research funding. For
FY 2003, the total amount of spending on bioterrorism will be $1.75
billion. Of that amount, slightly over $500 million is to be spent on
vaccines with approximately one half ($250 million) of that amount
designated for anthrax vaccine procurement.
This has caused some concern since money spent on procurement
diverts funds from research. Another $521 million is designated for
health facilities construction.
This includes $371 million for intramural security upgrades,
including $80 million for specific security upgrades to the Bethesda
campus. Also included
is spending on construction and renovation of BSL level 3 and 4 high
containment facilities in Bethesda, Ft. Detrick and elsewhere. Research
on diagnostics to improve testing of pathogens, antibiotic/antiviral
research on new therapeutic agents for treatment of smallpox and
anthrax, and basic research on pathogens and the genomics of
pathogens is an additional $700 million. The
budget would also transfer out $49 million from NIH to DOD research
activities such as medical free electronic laser research, radiation
exposure research, and HIV clinical trial research.
A transfer of $100 million to the Global AIDS, malaria, and
TB fund is proposed. It is estimated that there are $490 million of taps,
transfers, and non-research related work in the President’s budget
that could otherwise fund biomedical research. EB’02
Public Affairs Highlights ASPET's
Public Affairs and Education Committees will sponsor a workshop on "Incorporating
Complementary and Integrative Medicine into Basic Science Teaching:
Why and Why Now?" The
workshop will be held on Sunday, April 21 from 12:15-1:45 pm in room
220 of the Convention Center. The
workshop will address the educational initiatives underway in
several medical schools to incorporate elements of Complementary and
Alternative Medicine (CAM) into the medical curriculum.
The presentations will focus on innovative approaches to
integrate CAM into various basic science courses at three different
institutions. In
addition, there will be discussion of specific strategies for
integrating the teaching of herbal medicine, botanicals and
nutraceuticals into medical pharmacology courses.
Speakers include: Aviad
Haramati (co-chair), Georgetown University School of Medicine; Gary
Rosenfeld, University of Texas-Houston Medical School;
David L. Felten, University of California at Irvine College
of Medicine; and Jeffrey Novack, Bastyr University. Topics
include: Approaches to Integrating CAM into the Teaching of
Physiology Incorporating Mechanisms of CAM into Basic Medical
Neuroscience and Immunology Courses, Strategies for Integrating
Herbal Medicine into the Teaching of Medical Pharmacology, How to
Cover Botanical Products and Nutraceuticals in a Pharmacology
Course. ASPET
and the American Physiological Society among other participating
societies are cosponsoring a half-day program on the workings of the
Institutional Animal Care and Use Committee (IACUC).
“Everything You Ever Wanted to Know About the IACUC But
Were Afraid to Ask,” is intended to address the concerns of
research scientists, provide useful information to those who serve
on IACUCs and those whose protocols require IACUC review. The
session will be held on Saturday, April 20 from 1-5 p.m.
ASPET
Ray Fuller Symposium and Short Course on Introduction to Ion
Channels ASPET’s
Ray Fuller Symposium on “The Neurobiology and Neuropharmacology of
Alzheimer’s Disease: Roads
to Treatment Strategies” will be held in New Orleans, Louisiana,
on April 19-20, 2002. This symposium is a satellite program to the Experimental
Biology 2002 and requires separate registration.
To register on line or to download the registration form,
please go to our website at: www.aspet.org/public/meetings/aspet_ray_fuller_symp_5.html
Also
in New Orleans, on Saturday, April 20, ASPET’s Short Course,
“Introduction to Ion Channels” will introduce participants to
the basic concepts of ion channels and a review of the field.
Topics include structural and functional techniques used to
study ion channels, an overview of potassium and voltage-and
ligand-gated ion channels, and an introduction to some of the
diseases associated with ion channels. For registration and additional information, please
contact Margie Arkin, Meetings Assistant at markin@aspet.org
or by telephone at 301-214-8831. Notice
of Official Satellite Meeting of the IUPHAR 2002 World Congress. The
10th International Symposium on Vascular Neuroeffector Mechanisms
will be held Friday-Monday, July 12-15, 2002 in Lake Tahoe,
California. The
scientific meeting will cover the latest advances in understanding
vascular neuroeffector function, including control of smooth muscle
contractility, encoding of calcium signals and function of alpha
adrenoceptor subtypes. Recent progress in neurotransmitter release
and integrative and clinical aspects will be discussed.
The symposium will also include a Tribute to John Bevan,
first organizer of this meeting. This is the tenth in a series of
International Symposia on Vascular Neuroeffector Mechanisms that
have been held as satellites to the IUPHAR meetings starting in
1969. Abstracts and registration are due April 1, 2002. Early
registration encouraged as the number of participants is limited.
For further information on registration and submission of abstracts,
please visit www.iuphar2002.org/vnem.
Ten Young Scientist Travel Awards are available.
Applications for these awards must be submitted by April 1,
2002. For further information contact: Sue Piper Duckles at spduckle@uci.edu. NIAID
Unveils Bioterrorism Research Agenda The
National Institute of Allergy and Infectious Diseases (NIAID) has
released the "NIAID Counter-Bioterrorism Research Agenda for
CDC Category A Agents", a document describing the Institute's
accelerated research plan for the most threatening agents of
bioterrorism. The
comprehensive plan includes short-, intermediate- and long-term
research goals and describes specifically how bioterrorism
countermeasures will be developed for each microbe.
The document also contains a copy of the "Strategic Plan
for Counter-Bioterrorism Research of the NIAID", which provides
a general overview of the Institute's broad plans for attacking the
full range of potential bioterrorism pathogens. The
"Research Agenda" describes two separate but necessary
arms of biomedical research. Basic
research will continue to provide the framework for scientific and
medical advances, and applied research will move laboratory
developments into products that can be used to protect the public
from disease. The
agenda divides research on each Category A microbe into six key
elements: --MICROBIAL
BIOLOGY. Increased
basic research will help scientists acquire comprehensive
information on the biology and disease-causing mechanisms of
potential bioterror pathogens.
Such information, which includes sequencing of each microbe's
genome, will provide the information needed to develop new drugs and
vaccines to combat possible bioterrorism-caused diseases. --HUMAN
IMMUNE RESPONSE. Increased
research on the basic components of the human immune system will
enable scientists to develop safe and potent vaccines, highly
accurate diagnostic tests, and broadly acting drugs that boost
overall immunity to a range of pathogens. --VACCINES.
Vaccines are one of the most effective ways to protect people
from infectious diseases, and accelerated research on new vaccines
is underway. New Ebola
and anthrax vaccines will soon enter human testing, and research on
improved smallpox and tularemia vaccines is ongoing.
Additional research has been conducted on ways to stretch
current smallpox vaccine stockpiles for the short term. --TREATMENTS.
The increase in antibiotic resistance among bacteria and the
relative scarcity of effective antiviral drugs make treatment
research imperative. Scientists
will use information gained from basic studies of a microbe's
biology and genetic makeup to develop compounds that specifically
destroy that organism or its toxins.
Research on new treatments for pathogens such as smallpox and
anthrax are currently underway. --DIAGNOSTICS.
An effective response against a bioterrorist attack requires
rapid, accurate identification of both natural and bioengineered
microbes. Information
on a pathogen's sensitivity to available drugs will also help
doctors quickly treat anyone who has become infected.
New early warning and diagnostic tests are a key part of
NIAID's bioterrorism research agenda. --RESEARCH
RESOURCES. Research on
the five general areas above requires a broad range of resources
including genomic information, novel reagents, animal models of
disease, and high-containment laboratories and clinical facilities.
NIAID will provide those resources in part by building the necessary
facilities, establishing collaborations with industry, and training
new scientists with varying expertise. Many goals presented in the
"Research Agenda" build on the results of ongoing NIAID
research. New smallpox,
Ebola and anthrax vaccines have been developed by NIAID researchers
or grantees and are now approaching clinical testing.
One of the first drugs to help treat smallpox was recently
submitted to the FDA for approval, and two recent studies identified
important biochemical features of two different anthrax toxins that
have provided promising leads for new anthrax drugs.
The "NIAID Counter-Bioterrorism Research Agenda for CDC Category A Agents" is available online at www.niaid.nih.gov/dmid/pdf/biotresearchagenda.pdf. Researchers can find information on bioterrorism-related research funding opportunities at www.niaid.nih.gov/dmid/bioterrorism. Bulletin - No. 4 - May 8, 2002 ASPET
Testimony Supports 15.8% Increase for NIH, Systems and Integrative
Biology, and Botanical Research ASPET
submitted its written testimony to the House Labor/Health &
Human Services Appropriations Subcommittee in support of the FY 2003
NIH budget. You can
read the written statement
at:http://www.aspet.org/public/public_affairs/pa_nih_fy03_support.html Senate
Confirms NIH Director
The
Senate confirmed by voice vote Dr. Elias Zerhouni as the 15th
director of the National Institutes of Health.
In his confirmation hearings, Dr. Zerhouni was asked about
the clinical potential of stem cells.
He responded that more study is necessary but that “If it
becomes evident through this research that there are pathways to
develop cures and so on, I am going to be the first one to assemble
that information, get the experts to provide established scientific
facts and share that with everyone."
Dr. Zerhouni also expressed that one of his priorities would
be to recruit new directors at the vacant NIH institutes and centers
that Zerhouni
indicated that one of his top priorities is to "re-establish
morale and momentum, vision and energy" to help recruit new
directors at several NIH institutes and centers that currently lack
permanent directors. Rats,
Mice and Birds The
research community has won its campaign to have rats, mice and birds
used in research excluded from Animal Welfare Act oversight. The
Senate version of the Farm Bill (H.R. 2646) included an amendment by
Sen. Jessie Helms (R-NC) that was adopted in the final version of
the bill worked out by conferees and passed by the House May 2.
Rats, mice and birds are part of a huge USDA authorization bill that
the President has said he will sign. Clinical
Scientist Awards in Translational Research The Burroughs
Wellcome Fund is offering awards to established independent
physician-scientists. These
awards provide $750,000 over five years and it is anticipated that
up to eight awards will be made.
Additional information is available by visiting the BWF web
site at www.bwfund.org. Application
deadlines for the 2003 award series is September 3, 2002.
Symposium on Herbal and Food
Interactions
The American
Society for Clinical Pharmacology & Therapeutics is holding a
two day educational symposium on the science of herbal and food
interactions, drug development and regulation from the perspectives
of government, industry, and academia.
Drug Interactions with Herbal Products and Food will be held
July 22-23 at the Hyatt Regency Bethesda Hotel in Bethesda,
Maryland. For
additional information, visit www.ascpt.org.
ASPET Public Affairs Bulletin, No. 5 ASPET Funding Survey ASPET is conducting an on-line confidential member survey to profile the funding source of ASPET member’s research grants. Simply hit the link below and tag the NIH institute or other research funding agency or organization and submit your confidential profile. Results will be published later. www.aspet.org/public/Public_Affairs/funding_survey.html Zerhouni Comments on Systems and Integrative BiologyDuring testimony (June 10) before the House Science Committee’s Environment, Technology and Standards Subcommittee, NIH Director Elias Zerhouni commented that the future of biomedical research is likely to move away from a “reductionist” approach that has been prevalent to one that pulls together all the “elemental pieces of information into an understandable whole.” Zerhouni stated that an integrative approach to research would be “an important trend for the NIH of the future.” The Subcommittee’s
hearing was not really related to integrative research but was focused
on the federal and regional response to homeland security. Zerhouni
was asked by one subcommittee member if the scientific community needs
more “generalist” scientists who can “make sense of all these
discoveries” among all the different specialized areas of research.
Zerhouni said this issue is an "important research strategy question
for the country." Hill Visits to Promote Systems and Integrative Biology In May we made several
visits to Senate and House offices to promote our appropriations
report language supporting systems and integrative biology that we
would like to see adopted in this year's appropriation bill reports.
Scientists met with delegations from Michigan, Nebraska, and
Massachusetts. Our visits were very well received and informative to
both Members and staff on the Hill as well as those scientists making
the educational visits. The report language is modified from last
year’s (that was included in the final Senate report but not the House
report) to more explicitly call for research support through all
available grant mechanisms as well as recommending that the NIH Center
for Scientific Review form integrative peer review panels.
ASPET Statement on the Use of Laboratory Animals in Biomedical ResearchApproved by ASPET Council, June 2002: “The American Society for Pharmacology and Experimental Therapeutics (ASPET) believes the use of laboratory animals is essential for biomedical research into the prevention and treatment of human and animal disease. Millions of people throughout the world are alive today because of the vaccines, drugs, surgical procedures, and other therapeutic methods that have been developed through animal research. While researchers continue to explore effective alternatives to animal models in testing new medicines and therapies, there are currently no suitable replacements for use of laboratory animals in many areas of research and testing. ASPET members help to ensure the judicious use of animals in laboratory research and take moral and legal responsibility to safeguard the welfare of laboratory animals. ASPET supports the privilege of biomedical researchers to use laboratory animals in a responsible and ethical manner, in full compliance with governmental regulations, policies, and guidelines as well as appropriate professional standards.”
Funding Opportunity NIAID Encourages Grant Applications In Biodefense, Emerging Infectious DiseasesA May 17 notice from the National Institute of Allergy and Infectious Diseases calls for grant applications on the prevention, detection, diagnosis, and treatment of diseases caused by potential bioterrorism agents and emerging infectious diseases. The request reflects more than $1 billion contained in the President's FY 03 budget request for NIAID to conduct such research. Awards will be released using the R01, R21, and P01 mechanisms. NIAID also hopes to announce other targeted research initiatives as requests for applications, program announcements and requests for proposals in the near future. These include basic research of microbial biology and the host response; applied research and development to create new diagnostics, therapeutics, and vaccines; infrastructure development; establishment of national resources and research training. Initiatives will span a broad range of scientific disciplines and include scientists at all career stages. ASPET Public Affairs Bulletin, No. 6 August 20, 2002
NIGMS Workshop on What is Training in
Pharmacological Sciences? August 8-9, NIGMS conducted a workshop on the status of training in pharmacological sciences. Over 150 individuals attended representing a broad spectrum of academic and industrial interests. Among the items discussed were training needed by students entering industry and academia, the balance between the reductionist and integrative approaches to pharmacology, how to increase the diversity of training within the pharmacological sciences training programs, and issues related to curriculum. Comprehensive reports of all sessions will soon be available on NIGMS’ web site. Bill Would Create Research Commission on Dietary SupplementsSen. Dick Durbin (D-IL) is drafting legislation that would create a commission for scientific research into the safety of dietary supplements. At a July 31 hearing, Durbin, chair of the Senate Governmental Affairs/Oversight Subcommittee, announced he was working on a measure "to develop a commission for scientific study to conclusively address the question of the safety of dietary supplements. "I believe as well that we need to establish an effective mechanism for banning the sale of dietary supplement products, particularly ephedra and ephedra-containing supplements, to minors," Durbin said. At the hearing much of the session focused specifically on evidence linking the herbal ephedra to adverse events. Durbin noted that more than 20 states have passed ephedra regulations more stringent than federal regulations. The FDA maintains it needs a stronger scientific foundation before it can determine whether ephedra poses a safety risk to consumers that merits stronger action. Funding NoticesPHARMACOLOGICAL APPROACHES TO ENHANCE NEUROMODULATION IN REHABILITATION (RFA-HD-02-023)
http://grants.nih.gov/grants/guide/rfa-files/rfa-hd-02-023.html ASPET Funding SurveyThis past summer, ASPET members were asked to participate in a survey of funding sources to provide a snapshot profile of our membership. While the survey is not scientific, it does provide an interesting view of where many of our members receive their grant money. The same survey was conducted five years ago and those figures (in percentages) are also provided. Each survey received over 400 responses:
NIDA 18% NIDA 18% NHLBI 15% NHLBI 14% NIGMS 14% NIGMS 9% NCI 10% NINDS 9% NINDS 9% NIDDK 8% NIMH 7% NIEH 8% NIAAA 6% NIMH 6% NIEH 6% NIAA 6% NIA 6% NIA 4% NIDDK 4% NICHD 4%
Foundation
Support: Industry:
National Health Organizations, Trade Associations, Miscellaneous:
ASPET Public Affairs Bulletin. No. 7 September 30, 2002
NIH Appropriations
|