C3′s Grassroots Action Committee Chair Pam Seijo, Grassroots Action Committee Members Florence Kurttila, Arlene Murphy, and Ed Murphy, along with C3 advocates Patti Hollenback, Cindy Robinson, and Regan Weaver are all participating in the annual One Voice Against Cancer (OVAC) Lobby Day.

Follow us on Twitter @FightCRCAdvocacy for the latest updates from the hill.

During their meetings today, C3 advocates will be asking Congress to support the following funding requests for fiscal year 2011:

• $35.2 billion for the National Institutes of Health (NIH)
• $5.79 billion for National Cancer Institute (NCI)
• $240 million for the National Center on Minority Health and Health Disparities (NCMHD)
• $601 million for Centers for Disease Control and Prevention (CDC) cancer programs
• $50 million for CDC’s National Comprehensive Cancer Control Program
• $50 million for CDC’s Colorectal Cancer Screening, Education & Outreach Initiative
• $65 million for CDC’s National Program of Cancer Registries
• $2.857 billion for the Food and Drug Administration (FDA)

This year we have a unique opportunity to demonstrate the tremendous advances made in the fight against cancer thanks to recent increases in federal funding and urging Congress to build on this progress.  Want to help us?  Register today as a C3 advocate and we will keep you posted on future opportunities to make your voice heard in the fight against colorectal cancer.

C3′s Grassroots Action Committee Chair Pam Seijo, Grassroots Action Committee Members Florence Kurttila, Arlene Murphy, and Ed Murphy, along with C3 advocates Patti Hollenback, Cindy Robinson, and Regan Weaver will be heading to Capitol Hill tomorrow to talk to Congress about the importance of increasing federal funding for cancer research and cancer control programs.

Today, the advocates will be getting advice from former Representative Bud Cramer and from a number of Congressional health staff, including:

• Anne Morris, Professional Staff, House Committee on Energy and Commerce
• Jeremy Sharp, Legislative Director, Senator Christopher Dodd (D-CT)
• Adrienne Hallett, Professional Staff, Senate Appropriations Committee, Subcommittee on Labor, Health and Human Services

The training the advocates receive today will get them ready to take on Congress tomorrow during meetings with their Senators and Representatives.  C3 is participating in the OVAC Lobby Day along with numerous other cancer advocacy groups.  Interested in learning more about the OVAC coalition?  Check out their website.

Important Dates:

• May 12, 2010 – Last day to submit scholarship application
• May 24, 2010 – Last day to register for OVAC Lobby Day
• May 24, 2010 – Last day to reserve a hotel room at the special OVAC rate
• June 16, 2010 – Lobby Day begins at 12:00 PM
• June 17, 2010 – Lobby Day ends at 5:00 PM

Location: The Liaison Capitol Hill Hotel (415 New Jersey Avenue NW, Washington, DC  20001)

OVAC has negotiated a discounted room rate of $269 a night at the The Liaison Capitol Hill hotel, and all training sessions will be held at this hotel.

Register today for the OVAC Lobby Day.

During the Lobby Day, you will be going to the hill to ask Members of Congress to support increased funding for cancer research.  Specifically, you will be asking Members to support the following funding requests:

• National Institutes of Health (NIH) – $35.2 billion ($4.2 billion (13.5%) over FY 2010)
• National Cancer Institute (NCI) – $5.79 billion ($691 million (13.5%) over FY 2010)
• National Center on Minority Health and Health Disparities (NCMHD) – $240 million ($29 million (13.5%) over FY 2010)
• Centers for Disease Control and Prevention, Division of Cancer Prevention and Control (CDC) – $601 million ($126 million (26%) over FY 2010)
• CDC’s National Comprehensive Cancer Control Program – $50 million ($29 million over FY 2010)
• CDC’s National Program of Cancer Registries – $65 million ($14 million over FY 2010)
• CDC’s Colorectal Cancer Screening, Education & Outreach Initiative – $50 million ($5 million over FY 2010)
• Food and Drug Administration (FDA) – $2.857 billion ($500 million (21%) over FY 2010)

This year we have a unique opportunity to demonstrate the tremendous advances made in the fight against cancer thanks to recent increases in federal funding and urging Congress to build on this progress.  Register today to let your voice be heard regarding the importance of increased funding for cancer research.

Register today for the OVAC Lobby Day.

The registration deadline is May 24, 2010.  When you register, you will be asked to select a participant type.  You should select “OVAC Partners” and be sure to identify yourself as a C3 advocate.  If you have any problems with the registration form, or would like additional information about the OVAC Lobby Day please contact Catherine Knowles at Catherine.Knowles@FightCRC.org.

U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius issued the following statement of support,

“[u]nder this budget, we will provide the health and human services that Americans depend on more effectively, slashing waste and focusing programs on results.  And we’ll make many of the necessary investments our country has been putting off for years, including investments in fighting health care fraud, strengthening our public health infrastructure, and getting serious about health and wellness,” said Sebelius. “This budget is a big step toward a healthier, stronger America.”

The President’s budget includes $32.09 billion for the National Institutes of Health (NIH).  The proposed funding level for NIH would be an increase of $1 billion (3.2 percent) over last year to support innovative projects from basic to clinical research.  The increase in funding for the NIH will allow the agency to initiate 30 new drug trials in 2011, and double the number of novel compounds in Phase 1 – 3 clinical trials by 2016.  In addition, FY 2011 funding will support the completion of a comprehensive catalog of cancer mutations for the 20 most common malignancies, setting the stage for complete genomic characterization of every cancer as part of medical care within 10 years.

The NIH budget includes:

• $5.26 billion for the National Cancer Institute – an increase of $161 million (3.16 percent); and
• $219 million for the National Center on Minority Health and Health Disparities – a $7 million increase (3.5 percent).

The President’s FY 2011 budget proposal also provides $2.5 billion for the Food and Drug Administration (FDA) – an increase of $148 million (6.26 percent) over last year.  The funding increases for the FDA include increases to bring more lower cost generic drugs and generic biologics to market as well as funding to expand post-market safety surveillance of medical products, and to support FDA’s efforts to make safety data more comprehensive and accessible to patients, providers, and scientists.

That is the good news.

The bad news is the Centers for Disease Control and Prevention (CDC) budget.  The President’s FY 2011 budget proposal reduces funding for CDC cancer prevention and control programs, including the Office of Smoking and Health, by $19 million (3.9 percent) below last year’s funded level.  Specifically, the National Breast and Cervical Early Detection Program is cut by $4 million (2 percent) and the Office of Smoking and Health is cut by more than $3 million (3.2 percent).

The CDC’s Colorectal Cancer Screening, Education & Outreach program is funded at $45 million.  This is the same level the program was funded at for fiscal year 2010.

Two CDC cancer control programs are eliminated under the President’s budget.  The Geraldine Ferraro Blood Cancer Program, which received $4.7 million in FY 2010, and the Gynecologic Cancer and Education and Awareness (Johanna’s Law) Program, which received $6.8 million in FY 2010, are zeroed out under the President’s FY 2011 budget proposal.

We need your help to get Congress to continue to increase funding for colorectal cancer programs next year!  Register now to join us at the 2010 Call-on Congress, and continue reading for more details on fiscal year 2010 funding for cancer programs and research.

The conference report includes $74 billion for the Department of Health and Human Services – an increase of $6.3 billion or 8.5 percent over last year.

In addition to the $45 million in funding for colorectal cancer programs at the CDC, the conference report includes an increase of $30 million over fiscal year 2009 (8.8 percent increase) for CDC cancer prevention and control programs.

It includes $31 billion in funding for the National Institutes of Health (NIH).  The funding for NIH is a $692 million increase over fiscal year 2009 (22.3 percent increase).

The funding for NIH includes $5.1 billion for the National Cancer Institute, a 2.8 percent increase over fiscal year 2009, and $212 million for the National Center on Minority Health and Health Disparities, a 2.7 percent increase over fiscal year 2009.

Bill text is available online along with the manager’s statement (this is the part of the bill that includes earmark funding).

Yesterday evening, House and Senate appropriators met to consider a conference report.  The report is an omnibus package that includes six of the fiscal year 2010 appropriations bills.  It includes: (1) the Labor, Health and Human Services Appropriations bill (this is the bill that funds a number of cancer programs through NIH, CDC, and NCI); (2) the Commerce Justice Science Appropriations bill; (3) the Financial Services Appropriations bill; (4) the Military Construction and Veterans Affairs Appropriations bill; (5) the Department of State and Foreign Operations Appropriations bill; and (6) the Transportation and Housing Appropriations bill.  The bill text is available online along with the manager’s statement (this is the part of the bill that includes earmark funding).

The conference report includes nearly $450 billion in spending for fiscal year 2010, and could come to the floor for a vote in the House as early as tomorrow.

Although very large, this first conference report does not include the Department of Defense Appropriations bill.  A second package will be needed expected to complete consideration of the defense bill before the current continuing resolution expires on December 18.

House and Senate appropriators are scheduled to meet Thursday afternoon to consider this second conference report that will include fiscal year 2010 funding for the Department of Defense.  This second conference report is expected to include the funding C3 requested for a new peer reviewed cancer research program to focus on colorectal cancer research.  In addition to funding for the Department of Defense, this second conference report is expected to include a jobs package using TARP money, an estate tax fix, an extension of the highway trust fund, and an increase of the debt limit.

The second appropriations conference report will be considered on the floor in the House next week.

The Senate will take up both conference reports after the House passes them. This timetable will allow Congress to send the bills to the President and wrap up consideration of all the fiscal year appropriations bills before the end of the year.

A National Cancer Institute (NCI) working group has developed recommendations about how to engage advocates effectively in NCI research activities.  The recommendations are open to public comment until November 30, 2009.  Rather than go into detail about the recommendations, I will explain from my personal experience why I feel they are important and present C3’s feedback.

The recommendations fill an existing vacuum

The first time I was invited to participate in a research meeting as a research advocate, I was excited, but uncertain about my role and responsibilities.  I knew I was attending a research meeting  and understood the basics of research.  But I didn’t understand how the research organizations were organized (what the heck was CTEP anyway?), how they functioned, or why I was invited to the meeting.

I left the three-hour meeting feeling like a failure.  I’d sat in the room listening to researchers talk about colorectal cancer research ideas and had no idea what I was supposed to do.  I didn’t understand the difference between concepts, protocols, and active trials and couldn’t decipher the acronym-speak.  When I was asked if I thought patients would be interested in a specific trial, I had no way to evaluate the question.

Over time, I learned that my experience was not unusual.  Some groups welcomed advocates as full partners in the clinical research process, and some advocates helped shape meaningful research.  Other groups welcomed advocates to meetings but not in the nitty-gritty of research development, and other advocates spoke rarely if at all.  In other words, our role was frequently unclear to everyone including ourselves.

The lack of clarity meant that developing training and support was hard – if we don’t know what we’re supposed to do, how can we learn how to do it?  And if researchers don’t know why we are in the room, why would they be interested in our feedback?  After all, most of the researchers have advanced degrees in their specialties.  We are there because we, or someone we love, got sick.  Why should our opinions matter?

Time for change

In 2007, NCI Director John Niederhuber asked the NCI Director Consumer Liaison Group (DCLG) for recommendations on how to best involve research advocates in NCI activities.  The DCLG constituted the Advocates in Research Working Group (ARWG) and charged them to work with NCI’s Office of Advocacy Relations (OAR) to develop recommendations.

The six high-level recommendations provide a framework for identifying, involving and supporting advocates, and address issues such as training, compensation and support.  They were presented to the DCLG in October 2009. This PowerPoint presentation reviews the process and participants behind the ARWG, and sets out the recommendations in some detail.

C3’s response

C3, through my participation, was honored to be involved with this effort from the start, along with other advocates, researchers, NCI staff and OAR.  I frequently reached out to C3’s research advocates to get their individual and collective feedback on the issues.  Given that C3 helped shape the recommendations, it’s not surprising that we are pleased with the outcome.  We believe the recommendations will ensure that when advocates participate in research activities:

• Advocates will understand how to fulfill their role effectively
• Other participants will understand the value of advocate participation
• Over time, the value of advocate participation will be evaluated and thereby improved

Aspects of the recommendations which we strongly support include:

• Development of a trained advocate cadre which allows advocates to cycle in and out of activities, and promotes engagement of new advocates
• Clear articulation of conflict-of-interest principles
• Training and orientation for advocates as to their role in researchTraining and orientation for researchers as to the role of the advocates in research

Having said that, no doubt there are areas where the recommendations will evolve once theory hits reality.  For example, some of the recommendations could hold advocates to a different standard than the other players at the research table.  Recommendation 2.1 (slide 26) states that NCI will develop inclusion and removal criteria for the advocate cadre.  The intent behind the recommendation is aimed at identifying the knowledge and skills that advocates need for successful engagement.  For example, if an advocate needs human subject protection training prior to engagement, that could be one of the criteria. At the same time, researchers aren’t subjected to this kind of explicit vetting by NCI prior to engagement.  Should they be?  If not, should advocates?  We are comfortable with the intent behind the recommendation, and will watch the reality of implementation with great interest.

We believe that at this point, forward motion is the best way to identify and resolve problems.

Forward motion is where the real challenges will occur.  Implementation will take time, resources and a culture change, because substantive involvement of advocates in research can be unusual.  Personally, I’m always surprised by that, because I view advocates as the customers of cancer research – and who develops a product without involving customers?  However, our involvement with clinical research is more complex to figure out than our involvement in the development of a new car or toothpaste, and these recommendations are a step in the right direction.

C3 urges NCI leadership to accept these recommendations and provide the resources and support necessary to implement them.  Dr. Niederhuber, the current NCI Director, has been committed to these efforts.  We hope that if and when a new Director is appointed, he or she shows the same level of commitment to our effective involvement with the system.

As of July 2009, the National Cancer Institute has used ARRA funds to award 40 grants associated with colorectal cancer research, totaling $7,284,159. The grants support both ongoing and new colorectal cancer research.

Some of the NCl-supported colorectal cancer research projects that ARRA funds are moving ahead are working on speeding the translation of basic research findings into the prevention and early detection of colon and rectal cancer including:

• Two of NCI’s Specialized Programs of Research Excellence (SPOREs) focused on translational research in colorectal cancer.
• Two other SPOREs focused on the entire gastrointestinal system, which includes cancers of the colon, rectum, esophagus, and pancreas.
• The Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), a large-scale clinical trial taking place at 10 screening centers across the country, determining whether certain cancer screening tests reduce deaths from prostate, lung, colorectal and ovarian cancers.

NCI-supported projects in colorectal cancer research are dedicated to uncovering the causes and inner workings of colorectal cancer including critical research into understanding the altered genes contribute to cancer progression and exploring the roles of genetic mutations in cancer risk and initiation.

• The Tumor Microenvironment Network (TMEN) is a new NCI program focused on expanding our understanding of the role of the microenvironment in which a tumor originates. TMEN is looking at the critical role the microenvironment plays during tumor development, progression, and metastasis.
• One of the nine TMEN initiatives is studying the molecular and functional characterization of colon tumor cancer stem cells and their surrounding tissue.

NCI is also studying increased risk for colorectal cancer associated with family history, behavioral factors, and exposures in the environment.

• The Colon Cancer Family Registry (C-CFR), an NCI supported initiative, is an international research infrastructure for scientists interested in conducting population and clinic-based interdisciplinary studies on the genetic and molecular epidemiology of colon cancer and its behavioral implications. The C-CFR has information and biospecimens contributed by more than 11,300 families with a broad range of colon cancer risk matched with a control group of unaffected relatives and similar populations.
• Additionally, NCI’s Transdisciplinary Research on Energetics and Cancer (TREC) centers are collaborating to reduce cancer incidence, side effects, and deaths associated with obesity, low levels of physical activity, and poor diet. Two of the four TREC centers are focused on colorectal cancer.

NCI is optimistic that ARRA funds will support additional colorectal cancer research in the future. Watch for updates at the American Recovery and Reinvestment Act at NCI.

President Barack Obama

President Obama released his FY 2010 budget request. The budget requests $30.838 billion for the National Institutes of Health (NIH), a 1.4 percent increase ($443 million) over the FY 2009 level. This includes $5.15 billion for the National Cancer Institute (NCI) or $181 million more than the FY 2009 funding level.

The NIH funding request also reflects the request of $6 billion for “cancer research across NIH.” The budget summary says that the $6 billion request is “… the first year of an 8-year strategy to double cancer research by FY 2017. The FY 2010 request represents an increase of $268 million or 5 percent over the estimated FY 2009 level in this area.”

Senator Kay Bailey Hutchison (R-TX)

Senator Dianne Feinstein (D-CA)

Senators Dianne Feinstein (D-CA) and Kay Bailey Hutchison (R-TX) have authored a Senate Dear Colleague Letter in support of increasing the National Cancer Institute’s (NCI) budget to $6 billion in Fiscal Year 2010 and doubling NCI’s budget over the next five years.

“We ask that you lend your support to financing research that may lead to cures for cancer in our lifetimes.” The letter went on to say, “We are at a real turning point for cancer research, but whether we actually turn that corner will depend on available resources.”

We urge everyone to contact their Senators and ask them to sign onto this letter. The deadline for signatures is May 8th. Click here to find your Senators office number.