OCTOBER  2006

Welcome to the October 2006 Edition of the Friends of Cancer Research monthly newsletter. As Friends celebrates its 10th Anniversary, we are working to improve the delivery, content, and style of our news updates to you. Please email us with any comments or suggestions at info@focr.org.

NIH FUNDING UPDATE

House and Senate Continue Work on NIH Appropriations Through Congressional Recess

Although the House and Senate have recessed until after the November 7 elections, several efforts are underway to increase the amount of funding available for the fiscal year (FY) 2007 Labor, Health and Human Services (HHS), and Education (Labor-HHS) Appropriations bill.  Right now, most of the federal government is functioning under a Continuing Resolution (CR) that provides funding through Friday, November 17.  The CR provides funding for the programs within the Labor-HHS bill at FY 2006 levels.  

The Senate Appropriations Committee approved the FY 2007 Labor-HHS Appropriations Bill on July 20.  The bill provides $142.8 billion in discretionary funding for FY 2007, an increase of nearly $1.27 billion (0.9 percent) over the current year's funding level. For NIH, the bill includes $28.46 billion, an increase of $220 million (0.8 percent) over FY 2006.  For NCI, the bill includes $4.79 billion, an increase of $9 million over FY 2006. 

Senator Arlen Specter (R-PA) and Tom Harkin (D-IA), the Chair and Ranking Member of the Senate Labor-HHS Appropriations Subcommittee, respectively, are attempting to get all the Senators who voted for their $7 billion amendment to the FY 2007 Budget Resolution to sign a letter to the Senate leadership seeking an additional $2 billion that was not included in the Labor-HHS Subcommittee’s FY 2007 allocation.  The letter is expected to be sent to the leadership in the next couple of weeks.  Right now, there are 56 Senators that have signed on to the letter. 

In the House, a group of 24 moderate Republican members sent a letter on September 27 that called on their leadership to fulfill a commitment made earlier this year to provide additional funding for the FY 2007 Labor-HHS Appropriations bill. The moderates, led by Representative Mike Castle (R-DE), reminded House Majority Leader John Boehner (R-OH) “of the agreement to provide no less than $7 billion above the Administration's request” for the FY 2007 Labor-HHS Appropriations bill.  This letter clearly states that the $7 billion is equal to the funding enacted in FY 2006 plus a 2 percent inflationary increase.  The House Appropriations Committee approved their FY 2007 bill on June 20 that provides $28.25 billion for NIH, a decrease of $306,000 from the current year's level.   

Both the House and Senate will take up their remaining FY 2007 appropriations bills when each body reconvenes after the election. 

If you have questions, or need more information, please contact FOCR Director of Government Affairs Jeff Coughlin at (202) 944-6643 or jcoughlin@focr.org.  

NIH Reauthorization Bill Approved by House

House Approves NIH Reauthorization Bill

On September 26, the House of Representatives overwhelmingly approved the National Institutes of Health Reform Act of 2006 (HR 6164) that reauthorizes the agency through fiscal year (FY) 2009, provides the authorization for a 5 percent annual increase in NIH funding, and creates a Common Fund to support trans-NIH research that involves more than one of the agency's institutes or centers.  The bill passed by a vote of 414-2, with only Representatives Edward Markey (D-MA) and Jesse Jackson, Jr., (D-IL) not voting in favor of the bill. 

House Energy and Commerce Committee Chairman Joe Barton (R-TX) made reauthorizing the National Institutes of Health (NIH) one of his priorities after taking over as chairman of the committee in 2004.  In the summer of 2005, the Chairman circulated several drafts of a reauthorization bill to the medical research community.  In the intervening months, his staff has been working with stakeholder groups to reach a compromise on a bill that reforms NIH but is still acceptable to the research community.  The Energy and Commerce Committee approved the bill on September 20 and it was brought to the House floor for a vote shortly thereafter.  Congress last reauthorized NIH in 1993.

Overall, the bill focuses on the organization and function of the Office of the Director of NIH and its relationship to the individual NIH institutes and centers by providing enhanced authorities for strategic planning (through the establishment of the Division of Program Coordination, Planning, and Strategic Initiatives) and support of trans-institute initiatives.  The bill creates a new electronic reporting system of all NIH research activities with a standard format, and requires the Director to compile an annual report on the research activities of the agency. 

Moreover, the bill establishes a Common Fund to provide a permanent funding mechanism for trans-NIH research projects identified through the Division of Program Coordination, Planning, and Strategic Initiatives.  The bill proposes that the Common Fund will grow to 5 percent of the total NIH budget, by splitting any annual appropriation increase for NIH in half—with 50 percent placed in the Common Fund and the other 50 percent for new or ongoing research priorities at the institutes and centers.

However, the legislation does not specify individual line item authorizations for any of the NIH institutes and centers and the bill limits the overall size of NIH to the current 27 institutes and centers.

 It is unclear whether the Senate will take up HR 6164 in the Congressional session that is scheduled to begin after the November elections.  Senate jurisdiction for NIH reauthorization would be in the Senate Health, Education, Labor and Pensions (HELP) Committee.  The HELP Committee has several other issues to consider during the November session, so the Committee may not have time to debate the idea of NIH reauthorization.   

 

If you have questions, or need more information, please contact FOCR Director of Government Affairs Jeff Coughlin at (202) 944-6643 or jcoughlin@focr.org.

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Coalition for a Stronger FDA

Friends of Cancer Research Joins Coalition for a Stronger FDA

Friends of Cancer Research is a member organization of the newly formed Coalition for a Stronger FDA.  At a recent press conference, Friends Chair Dr. Ellen Sigal joined coalition co-chair and former HHS Secretary Tommy Thompson, as well as other representatives from coalition member groups, in announcing its formation. The new group is a coalition of patient groups, consumer and public health advocates, along with innovative companies that formed to work together to increase public support for the Food and Drug Administration. “We have enormous expectations. We do not fund them," said Dr. Sigal.  Jim Greenwood, president of the Biotechnology Industry Organization and a former Republican congressman from Pennsylvania, agreed in saying, “[The] problem is that the FDA has been given more responsibilities over time and less resources.” Secretary Thompson referred to FDA as the poor stepsister of other federal agencies and commented that “with the doubling [of the NIH budget] will come a flood of new discoveries and technology.  Without sufficient resources at FDA…the agency could become a bottleneck.”    The coalition is planning a multi-year effort to advocate for increased resources for FDA and improve public confidence in the agency. 

 <Coalition for a Stronger FDA – Press Release>

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Institute of Medicine (IOM) Report

IOM Report on Drug Safety Released

 The Institute of Medicine (IOM), a division of the National Academies of Science, recently released a report entitled “The Future of Drug Safety: Promoting and Protecting the Health of the Public”.  The report was requested in order to assess the current drug safety system at the Food and Drug Administration (FDA).  The IOM committee formulated a number of recommendations aimed at enhancing drug review, safety surveillance at the Center for Drug Evaluation and Review at FDA.    The committee also made recommendations to improve resource for the agency and public communication.  This report received a great deal of attention from, congress, advocates, FDA, industry and the national news media.  Dr. Ellen Sigal and Dr. Steven Burakoff, Director of the New York University Cancer Center, formulated an op-ed response to an editorial appearing in The New York Times.  Please see the links below for our op-ed response and a brief summary of the IOM Report.

 <FOCR Op-ed: Seeking Reason on Drug Safety>

<IOM Report in Brief>

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Biomarker Consortium

Biomarker Consortium

The Foundation for the National Institutes of Health (FNIH), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) today announced the launch of a major public-private biomedical research partnership, The Biomarkers Consortium, to search for and validate new biological markers ─biomarkers─ to accelerate dramatically the delivery of successful new technologies, medicines, and therapies for prevention, early detection, diagnosis, and treatment of disease.

Ellen Sigal, Ph.D., Chairperson of Friends of Cancer Research and Chair of the public-private partnership committee of the FNIH describes the collaboration as, "a seminal public-private partnership bringing together multiple sectors of the health enterprise as never before to work together on the development and qualification of biomarkers. The financial and logistical challenges of this work require a truly multi-sector approach that includes all relevant stakeholders, including government, private industry, and advocacy and non-profit organizations. This collaboration will accelerate the scientific discovery of new technologies, medicines and therapies that can be used to better detect, diagnose, and treat disease. The public health impact of this consortium will be enormous."

Biomarkers are molecular, biological, or physical characteristics that indicate a specific, underlying physiologic state. Biomarkers can be used to identify risk for disease, to make a diagnosis, to assess severity , to identify the organs involved, and to guide treatment. Biomarkers can also be used in clinical research studies to assess whether a drug is safe and effective as well as learn more about health and disease.

The initial focus of the consortium will be the validation and advancement of promising new imagining techniques in non-Hodgkin’s lymphoma and non-small cell lung cancer.  It will also support studies to identify treatment response biomarkers in depression and diabetes.

The Foundation for NIH will manage The Biomarkers Consortium under direction of its Consortium Executive Committee, with guidance from leading scientists within and outside the member organizations, and with input from public representatives and funding partners. The foundation actively seeks additional funding partners to both help support the consortium’s operational activities and for individual research projects, each of which has the potential to emerge as a distinct scientific initiative under the consortium’s administrative umbrella.

For more information please contact Friends of Cancer Research at 202-944-6710 or see related links below: 

<Biomarker Consortium Audio News Release>

<Biomarker Consortium Background>

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FRIENDS EVENTS

 

Friends co-hosts THINK PINK Luncheon with Tysons Corner Saks Fifth Avenue and DC Magazine
 

Pictured above from lef to right: Penny Eastman, Catherine Stevens (wife of Senator Ted Stevens), Marlene Malek (President of Friends), Jan Smith (journalist and wife of FOCR Board Member Sam Donalson, Ellen Sigal (Chairperson and Founder of Friends), Peter Abrahams (Publisher of DC Magazine), and Sandy Heilner (VP - General Store Manager).
 

Saks Fifth Avenue’s annual “Key to the Cure” weekend was held from October 12-15, 2006, with a percentage of proceeds from purchases made at the Saks Fifth Avenue Tysons Galleria donated to Friends of Cancer Research.  “Key to the Cure” was founded by Saks Fifth Avenue in partnership with the Entertainment Industry Foundation’s Women’s Cancer Research Fund, which is Chaired by Rita Wilson, Tom Hanks, Kate Capshaw and Steven Spielberg, along with Founders Kelly Chapman Meyer, Anne Douglas, Quinn Ezralow, Marion Laurie, and Jamie Tisch.

To kick off this special weekend, Friends of Cancer Research held an educational luncheon on October 12 that was sponsored by Saks Fifth Avenue and DC Magazine.  With Susan Dentzer from The NewsHour with Jim Lehrer as moderator, guests at the luncheon had the opportunity to hear about new directions in cancer research, prevention, early detection, and treatment from panelists Dr. Anna Barker, Deputy Director for Advanced Technologies and Strategic Partnership at the National Cancer Institute, and Dr. Jocelyn Rapelyea, Associate Director of Breast Imaging and Intervention at The George Washington University Medical Center.

Friends of Cancer Research would like to thank Saks and DC Magazine for their generous sponsorship of this event, as well as our panelists and moderator, for enabling us to raise awareness and provide education to the public on the latest in cancer research.  As Dr. Barker said, “The more informed you are, the better questions you can ask [of your doctor].”  Dr. Rapelyea spoke about the latest imaging techniques to detect breast cancer at the earliest possible stage.  She recommends getting yearly digital mammograms beginning at age 40 and regular mammograms starting at age 50.

Dr. Barker explained that the mapping of the human genome is leading to exciting new research discoveries in cancer development at the National Cancer Institute.  As more is discovered about how gene abnormalities lead to cancer, both panelists stressed that knowledge of your family medical history will be increasingly important in assessing risk factors and monitoring for the development of certain cancers. 

Above from left to right: Dr. Rapelyea, Susan Dentzer, Dr. Anna Barker, Marlene Malek, and Ellen Sigal holding up this year's Key to the Cure t-shirt designed by Oscar de la Renta.

Following the panel discussion, audience members has the opportunity to address follow-up questions to panelists in a Q&A session.  Dr. Sigal started out the questions, asking how limited federal funds have impacted cancer research.  Jan Smith, who is a journalist and wife of Friends Board Member Sam Donaldson, followed by asking whether trials in the pipeline will be delayed due to a lack of funding.  Dr. Barker responded that, unfortunately, trials are already being delayed due to lack of funding and this will end up causing the US to fall behind as a leader in scientific research.  In addition to stressing the importance of federal funding, Dr. Barker also emphasized the need for more public-private partnerships. 

One audience member wondered whether there is a hereditary risk for inflammatory breast cancer among families.  (Inflammatory breast cancer is an aggressive disease that accounts for 1 to 5 percent of all breast cancer cases and is diagnosed in younger women compared to non-IBC breast cancer, according to the National Cancer Institute website.)  Dr. Rapelyea described the symptoms of this cancer, which include redness, swelling, and tenderness of the breast without a specific lump, and emphasized that family history of breast cancer is found in approximately one-fourth of all cases of breast cancer.  If you are diagnosed with breast or any other type of cancer, Dr. Rapelyea always recommends, even to her own patients, getting a second opinion to confirm the diagnosis.  “If your doctor does not suggest you get a second opinion, get another doctor,” explaining that doctors should welcome second opinions as they foster collaboration and encourage the sharing of medical expertise.

 Another attendee asked whether there are any new vaccines for cancer in the pipeline that are similar to the new HPV vaccine for cervical cancer.  Dr. Barker spoke about a possible vaccine for melanoma, but emphasized that it is unique for a cancer to be caused by an infectious disease and we are only starting to understand this connection in other cancers. 

 For more information on this topic, please email info@focr.org

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Friends Announces Plans for Special Benefit Celebrating 10^th Anniversary

Friends of Cancer Research is planning a special benefit evening at the Four Seasons on November 15th celebrating its 10^th Anniversary.  Honorees will include prominent members of Congress, the Administration, and the entertainment industry who have demonstrated steadfast leadership and support in their work for cancer research. 

 Honorees include:

Lifetime Achievement Award
Andrew von Eschenbach, M.D., Acting Commissioner of the Food & Drug Administration, and The Honorable Arlen Specter (R-PA)

Cancer Leadership Award
The Honorable John Dingell (D-MI), The Honorable Dianne Feinstein (D-CA) invited, The Honorable Deborah Pryce (R-OH)

Research Advocacy Award
Lucy Fisher & Douglas Wick, Red Wagon Entertainment (Award-winning movie producers whose credits include Gladiator, Stuart Little, Working Girl, and Memoirs of A Geisha), and Janet & Jerry Zucker, Zucker Productions (Award- winning producers and director whose credits include Ghost, My Best Friend’s Wedding, Airplane, Rat Race, The Naked Gun, and First Knight)

For more information and sponsorship opportunities, please call: (202) 413-9348 or visit:
www.focr.org/GeneralInfo.html

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