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| Welcome to the October 2007
Friends of Cancer Research newsletter. To view the
entire edition online, please visit: http://www.focr.org/news/newsletter/recent.htm
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APPROPRIATIONS
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Continuing Disagreement on Funding for
2008
Since Congress did not pass any of the 12
Fiscal Year (FY) 2008 appropriations bills before the
end of FY 2007, Congress passed and the President signed
into law a continuing resolution to keep funding the
federal government at last year's levels until November
16, giving Congress extra time to finalize the FY 2008
appropriations bills.
First priority for
Democratic leaders in the Senate is the Labor, Health
and Human Services, and Education (LHHS) appropriations
bill, according to Senate Majority Leader Harry Reid
(D-NV). The House version of the bill has already been
approved, and the Senate will likely vote on its version
during the week of October 15. The House version
contains a 1.9% increase in funding for the National
Institutes of Health (NIH) over last year's level, while
the Senate version contains a slightly higher increase
for NIH at 2.8%. While both bills contain a much lower
increase than the 6.7% level for which the biomedical
community advocated, the Senate increase is preferable
to the House level.
The funding levels proposed
in both the House and Senate LHHS bills are higher than
the President's budget request, and the number that is
eventually agreed upon by the two legislative bodies in
conference will likely remain higher. The President has
threatened to veto appropriation bills that exceed his
budget, which puts the LHHS bill at risk. It is
probable, however, that the House and Senate would have
the votes necessary to override a presidential veto.
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DRUG
SAFETY
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Implementation of FDAAA to
Begin
On September 27th President Bush
signed into law the Food and Drug Administration
Amendments Act of 2007 (FDAAA). The success of the bill
is a result of great bipartisan efforts from members of
the House and Senate and is sure to bring monumental
changes to the US Food and Drug Administration (FDA).
(For a summary of important bill components, click here.)
The FDA is still
in the process of examining the legislation's
intricacies as planning for full implementation gets
underway. One provision that is beginning to take shape
is the establishment of the board of directors for the
newly created Reagan-Udall Foundation. The Foundation
was established as a part of the FDAAA to advance the
mission of the FDA through public-private partnerships
and to modernize product development, accelerate
innovation, and enhance product safety. The board of
directors will be comprised of diverse stakeholders
including academic experts, industry representatives,
patient and consumer advocates, and medical providers.
Nominees must be provided to the FDA by October 15, as
the bill requires establishment of the board of
directors by October 27.
More information:
Announcement in the Federal Register
(PDF)
Complete text of The Food and Drug
Administration Amendments Act of 2007 (PDF)
Friends' summary of FDAAA key
components
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SPECIAL
EVENT
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L-R: Marlene Malek; Ellen
Sigal; Sen. Sherrod Brown; Rep. Deborah Pryce; Dr. John
Niederhuber; Dr. Michael Caligiuri; Dr. Janet Woodcock;
Dr. Rainer Boehm; and Carl Stewart.
Standing
Room Only at Ohio State
Over
300 researchers, patients, health care professionals,
and other cancer research advocates piled into the
state-of-the-art Biomedical Research Tower at Ohio State
University on October 1 to hear discussion on the future
of cancer research. The public forum, which was
co-sponsored by the Ohio State University Cancer Center
and Friends, was moderated by Susan Dentzer, a highly
respected journalist and the health correspondent for
PBS's The News Hour with Jim Lehrer. The
distinguished panel included:
- Senator Sherrod Brown
(D-OH)
- Representative Deborah Pryce (R-OH)
- Dr. Michael Caligiuri, Director of the Ohio State
University Comprehensive Cancer Center
- Dr. John Niederhuber, Director of the National
Cancer Institute
- Dr. Janet Woodcock, Deputy Director and Chief
Medical Officer of the U.S. Food and Drug
Administration (FDA)
- Dr. Rainer Boehm, Sr. Vice President & North
American Region Head, Novartis Oncology
- Carl Stewart, cancer survivor
Ohio State
University President, Dr. Gordon Gee, opened the program
by addressing the audience and welcoming panelists to
the university to discuss important issues that impact
not only OSU, but the entire country.
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Ellen
Sigal and Marlene Malek discuss cancer research
with Senator Sherrod
Brown. | Throughout the
program many important topics were discussed. Senator
Brown discussed his commitment to public health and the
need to expand educational programs for smoking
cessation and other high risk factors. He also addressed
the challenges that the current budget environment has
created, specifically citing that the current debt is
causing programs that should be funded to be deprived of
necessary resources, such as the National Institutes of
Health (NIH) and expansion of the children's health
insurance program.
Rep. Pryce echoed the need for
a commitment to medical research and described a bill
that she recently introduced that would expand access to
clinical trials. She described how 60% of children
afflicted with cancer participate in clinical trials yet
only 3-4% of adult patients participate, and explained
that one reason for this discrepancy is the lack of
Medicare coverage of routine clinical costs for patients
enrolled in trials. Her bill would expand such coverage.
Dr. Niederhuber described innovative programs at
NCI and at research centers around the country that are
expanding knowledge about the development of all
cancers. The Cancer Genetic Markers of Susceptibility
(CGEMS) and The Cancer Genome Atlas Project (TCGA) are
two examples of NCI projects to help identify genetic
alterations involved with cancer.
Dr. Boehm spoke
about the important role that pharmaceutical and
biotechnology companies play in advancing cancer
research. He described the industry's role in a number
of groundbreaking scientific collaborations that will
help advance cutting edge science and lead to improved
patient outcomes.
Dr. Caligiuri
remarked
that the need for effective collaboration and
communication is paramount, especially with respect to
the challenges associated with the disease. He said that
one such challenge is the continued support for the next
generation of scientists. To illustrate his point, Dr.
Caligiuri asked all of the primary investigators in the
audience to raise their hands -- and to raise their
hands again if they had ever turned away incoming
graduate students from their laboratory due to financial
constraints. Virtually all investigators raised their
hands both times, anecdotally confirming the impact of a
flat budget at the NIH.
Dr. Woodcock discussed
the important role the FDA plays in the research
enterprise. She spoke about the FDA's Critical Path
Initiative, a project intended to modernize medicine and
provide new tools to evaluate scientific discoveries.
Given the expanding responsibilities of the FDA, federal
funding for programs like the Critical Path Initiative
is extremely important.
Cancer survivor Carl
Stewart described his emotional battle with the disease.
As a former patient of Dr. Caligiuri, Stewart recounted
how participation in a clinical trial saved his life,
and his story represented the hope that all
patients have for scientific discovery and the need for
continued collaboration from all
stakeholders.
The overwhelming theme of the
discussion was federal funding allocations for cancer
research, and the effects of the funding shortfall on
patients, researchers, and the economy. Each panelist
represented a unique component required for the
advancement of research and voiced his or her commitment
to the discovery of innovative cancer therapies.
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UPCOMING
EVENTS
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Town
Halls
Friends works with world class
cancer research institutes to host public symposia all
around the country. These events bring together
policymakers, researchers, patients, and health care
providers to discuss and learn from one another about
the amazing opportunities on the horizon in cancer
research and the ways we can work together to accelerate
innovation in cancer prevention, detection, and
treatment.
We welcome you to join us for our
next event:
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@ Yale University with Rep. Rosa
DeLauro
Monday, October 22,
2007 9:00AM -
11:00AM
Featuring: Dr. Edward Chu,
Deputy Director of YCC and Chief of Medical
Oncology; Dr. Daniel DiMaio, YCC Scientific
Director; Dr. Susan Mayne, YCC Director of
Prevention and Control; Dr. Andrew von Eschenbach,
Commissioner of the U.S. Food and Drug
Administration; Dr. Louis J. Denis, Clinical
Research & Development, Pfizer Oncology; and
Representative Rosa DeLauro (D-CT).
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For more information,
contact Heather Chaney at
hchaney@focr.org. |
OPINION
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Encouraging
Innovations, Preserving
SafetyMaintaining
a balance between access to new drugs and protecting
consumers
Cure, Fall Issue 2007 By Ellen Sigal,
PhD
As Capitol Hill prepared for a leadership
change following the 2006 elections, health policy
advisers were keenly focused on how the elections would
affect the anticipated debate surrounding drug safety.
Within the Washington Beltway, the Prescription Drug
User Fee Act (PDUFA) reauthorization was widely presumed
one of the most important pieces of legislation
to...
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SPECIAL
EVENT
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Friends' Chair Addresses Science and
Regulatory Leaders on Safety
Surveillance
On October 2 the PhRMA Science and
Regulatory Affairs (SRA) Section held its annual meeting
in Washington, DC. The focus of this year's meeting was
post-market drug safety assessment and patient outcomes,
and Friends' Chair, Ellen Sigal, provided the keynote
morning address to start the meeting with the patient
and research advocacy perspective.
Dr. Sigal
described the challenges and opportunities that the
biomedical community will face as steps are taken to
enhance the FDA drug safety system. She told the
audience of industry and academic leaders that while
patients want and deserve the safest possible
medication, they also need an innovative product
pipeline. Her focus was on the opportunities that will
be presented through the formation of the Reagan-Udall
Foundation and advanced science at the FDA. Dr. Sigal
described her high hopes for the future of drug safety,
anticipating a time when decisions will be based on
collaboration between diverse scientific bodies to
reshape current drug analysis through improved
biological markers of safety and efficacy, advanced
clinical trial design and inventive disease modeling.
Other speakers at the SRA annual meeting
included Dr. Andrew von Eschenbach, FDA Commissioner;
Dr. Janet Woodcock, Chief Medical Officer and Deputy
Director of the FDA; the Honorable Billy Tauzin, PhRMA
President and CEO; and leaders from the industry and
academic communities.
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FRIENDS
IN THE NEWS
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Familiar
Disagreements as Fiscal Deadline
Nears
By Robert
Pear September 24,
2007
[Excerpt] But Ellen V.
Sigal, chairwoman of Friends of Cancer Research, a
public education group, said: ''The uncertainty is very
difficult. It's devastating. Scientists are waiting to
know if they will receive research grants for innovative
ideas. The resolution of these questions can make a huge
difference to patients and researchers.''
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IN CASE YOU
MISSED IT
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The following appeared in the
news within the past month.
"Oversight of Clinical Trials" By
Edward J. Benz Jr., M.D. New York Times,
October 5, 2007
"Don't Short War On Cancer" By
Daniel DiMaio, MD, PhD The Hartford Courant,
September 27, 2007
"Drug Makers Seek Clues to Side Effects in
Genes" By Andrew Pollack New York
Times, September 27,
2007 | |
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