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OCTOBER 2007
IN THIS ISSUE
Appropriations
Drug Safety
Friends at Ohio State
Upcoming Events
Friends in Cure
Friends at PhRMA
Friend in the News
In Case You Missed It
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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
APPROPRIATIONS

 
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.


If you would like to learn what you can do to encourage better NIH funding, please visit Research!America's website.

DRUG SAFETY

 
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

  • SPECIAL EVENT


    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.

    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.

    UPCOMING EVENTS


    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:


    @ 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).

    For more information, contact Heather Chaney at hchaney@focr.org.

    OPINION

     
    Ellen SigalEncouraging Innovations, Preserving Safety
    Maintaining 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...

    SPECIAL EVENT

     
    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.

    FRIENDS IN THE NEWS




    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.''

    IN CASE YOU MISSED IT


    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