ACT NOW to Urge Full Funding of the BT Consortium

January 7, 2009

Brain tumor advocates began the new year by petitioning the National Cancer Institute (NCI) to reconsider a preliminary decision that would slash the funding for the Adult Brain Tumor Consortium by approximately one-half. Advocates urged the NCI Director to reverse his decision, which they believe could threaten the viability and effectiveness of the Consortium. The Phase I and Phase II brain tumor clinical trials group is being asked to meet ambitious research goals — of critical importance to brain tumor patients and researchers — with one-half of the budget originally promised to it.

The North American Brain Tumor Coalition is now shifting its efforts to the United States Congress, asking elected officials to communicate to NCI regarding this funding decision. A diagnosis of a brain tumor can be devastating to a patient and friends and family, and the hope for all is the development of new treatments that will offer longer and better life to brain tumor patients. In light of the tremendous needs of brain tumor patients and the promise held by research, a reduction in funding for brain tumor clinical research is unwarranted.

PLEASE JOIN US IN CONTACTING YOUR elected officials about funding for the Adult Brain Tumor Consortium. Encourage your Senators and Representatives to ask NCI to reconsider any reduction in funding for the Adult Brain Tumor Consortium.

The letter from brain tumor advocates to NCI explains the history of funding for the Adult Brain Tumor Consortium and the urgency of the request for restoration of funding. Please feel free to share it with your Senators and Representatives to help explain the critical importance of this Consortium to brain tumor patients and their families and friends.

If you have any questions about your Representatives and Senators and their contact information, please consult www.house.gov or www.senate.gov.

The letter from the North American Brain Tumor Coalition, the Brain Tumor Funders’ Collaborative, and other brain tumor organizations is included below.

January 5, 2009

Dr. John Niederhuber

Director

National Cancer Institute

Building 31, Room 11A48

Bethesda, Maryland 20892

Dear Dr. Niederhuber:

We are writing regarding the grant renewal for the Adult Brain Tumor Consortium (ABTC), a matter of great importance and urgency to the brain tumor advocacy community. We urge you to take immediate action to restore the funding for the ABTC so that it may continue to function effectively and in a manner that best serves brain tumor patients. The undersigned organizations are members of the North American Brain Tumor Coalition, members of the Brain Tumor Funders’ Collaborative, and other groups active in the brain tumor community. We share the common goal of improving treatments for brain tumors through research.

It has recently come to our attention that the funding that is set aside for the adult brain tumor clinical trials consortium may be as little as $2 million per year, a 50% reduction in funding from recent collective funding levels for the two adult brain consortia and less than the amount that the applicants understood would be available when the application process began. We are concerned that the reduction in funding will cripple the ABTC and have immediate negative effects on brain tumor patients who might otherwise choose to enroll in the Phase I and II trials conducted by the ABTC and all brain tumor patients who depend on the research and treatment advances fueled by the work of ABTC and its member institutions and researchers.

The request for applications for the adult brain tumor clinical trials consortium (RFA-CA-08-504) captures the importance of a strong consortium as well as the challenges facing such an organization. We quote the RFA:

An early clinical trials apparatus, focused on testing new agents in this medically challenging group of patients, remains an essential interface between early discovery mechanisms (e.g., Specialized Programs of Research Excellence [SPORE] programs, P01 program projects, R01 research projects, CTEP’s 1-2 new agent evaluation program, pharmaceutical industry new agents) and the late trials mechanisms typified by the NCI-supported Clinical Trials Cooperative Groups. The multi-center clinical trials conducted by the Consortia have advantages over single institution trials in efficiency and creditability. To improve the success rate of drug discovery, the new generation of Consortia studies will require an increased emphasis on pre-clinical correlations, pharmacokinetic/pharmacodynamic (PK/PD) relations, and evaluation of mechanistic endpoints based on tissue, imaging, and biomarkers.

The RFA also sets out the basic — and ambitious — standards for the consortium, including the ability to complete approximately six Phase 2 studies and two or three Phase I studies per year, enrolling a total of 250 to 300 patients per year. In addition to these basic criteria, the RFA describes the role of the consortium as a critical player in a public-private partnership to advance brain tumor research and therapies.

We are concerned that the consortium will not be able to meet these standards — appropriate and ambitious goals — if it receives only $2 million per year in federal funding. At risk is a system that has served brain tumor patients and researchers well for a decade and a half. Also at risk is the investment that the American people, through the National Institutes of Health (NIH), have made in a research infrastructure that focuses on brain tumors. More than 50,000 primary malignant and benign brain tumors are diagnosed in the United States each year. The five-year survival rate after diagnosis with a primary malignant brain tumor is approximately 30% (slightly lower than 30% for men and slightly above 30% for women.) More than 12,000 Americans will die this year from primary malignant brain tumors. Treatments for brain tumors remain woefully inadequate, although progress is being made. Now is not the time to reduce the federal commitment to brain tumor research and dismantle a critically important research system.

All of our organizations are painfully aware of the effects of the stagnation in NIH appropriations. We are actively engaged with others in the research community in advocacy efforts to boost the federal commitment to biomedical research. However, the decision about the ABTC cannot be delayed until we achieve success in that effort. We urge that you reconsider any action that would reduce the funding level for the ABTC. If this decision is not revisited, the brain tumor community would be asked to shoulder a heavy and disproportionate burden related to overall NIH and National Cancer Institute (NCI) funding constraints.

As you know, the adult brain tumor consortia have already taken decisive action to trim costs by merging into a single consortium. Additional budget trimming will affect vital activities of the consortium. As brain tumor advocates, we trust the leaders, researchers, and research institutions of the ABTC to use federal dollars efficiently and effectively to advance brain tumor research. They must not be doomed to failure with a budget that cannot support the goals and responsibilities of the grant.

We respectfully and urgently request your immediate and personal attention to this matter. We urge you to act without delay to restore the funding for the ABTC to the level that was set aside when the application process began, a level that will permit the grantee to fulfill the important goals of the grant.

Sincerely,

NORTH AMERICAN BRAIN TUMOR COALITION

American Brain Tumor Association

Brain Tumour Foundation of Canada

Children’s Brain Tumor Foundation

Michael Quinlan Brain Tumor Foundation

National Brain Tumor Society

Oklahoma Brain Tumor Foundation

Southeastern Brain Tumor Foundation

BRAIN TUMOR FUNDERS’ COLLABORATIVE

American Brain Tumor Association

Ben and Catherine Ivy Foundation

Brain Tumour Foundation of Canada

Children’s Brain Tumor Foundation

Goldhirsh Foundation

James S. McDonnell Foundation

National Brain Tumor Society

Sontag Foundation

The Tug McGraw Foundation

(Several groups participate in the North American Brain Tumor Coalition as well as the Brain Tumor Funders’ Collaborative.)

cc: James Doroshow, M.D.

Director

Division of Cancer Treatment and Diagnosis

National Cancer Institute

Building 31

Room 3A44

Contacts:

Jan McCormack

Chair

North American Brain Tumor Coalition

Elizabeth Goss

Policy Counsel

North American Brain Tumor Coalition

Elizabeth@turnergoss.com

Posted in Action Items, Advocacy Positions, Brain Tumor Research