Why the Health Research Funded by the Pentagon is Unique and Valuable

Walter Pincus’s latest article published by the Washington Post criticizes the health research funding in the defense appropriations bill as both earmarked funding and unneeded duplicative funding. He is wrong.

It Isn’t Earmarked Funding

The defense health programs don’t come close to meeting the Administration’s own definition of an earmark.

The Office of Management and Budget (OMB) defines earmarks as “funds provided by the Congress for projects or programs where the congressional direction (in bill or report language) circumvents the merit-based or competitive allocation process, or specifies the location or recipient, or otherwise curtails the ability of the Administration to control critical aspects of the funds allocation process.”

The fact that President Obama does not request funding for important health research programs does not make them “earmarks” if Congress chooses to fund them.

All funding through the Congressionally Directed Medical Research Programs (CDMRP) is competitively awarded. Research proposals go through a two-tier review process of scientific peer review, followed by a programmatic review that includes basic researchers, clinicians, consumers, and military members.

To qualify, CDMRP research must have relevance to service members and their families. The research potentially helps to decrease the more than $1 billion that the Department of Defense (DoD) spends on cancer care each year.

The Research Isn’t Duplicative

Back in 2007, COL Harris, testified before the House Defense Appropriations Subcommittee about the Congressionally Directed Medical Research Programs. In answering how the CDMRP research is different than that of research funded by the National Institutes of Health (NIH) and the National Cancer Institute (NCI), COL Harris explained that “[t]wo hallmarks of CDMRP are innovation and inclusion of survivors in decision-making processes. CDMRP strives to recognize and fund innovative research, which can ‘leap frog’ scientific advances towards achieving the goals of the programs. This focus can be high risk, yet can yield high gains. CDMRP funds research that may be considered too risky or preliminary for the NIH/NCI to support.”

The CDMRP supports high-quality medical research, concentrating its resources on research mechanisms which complement rather than duplicate the research approaches of the major funders of medical research in the United States. Although the diseases included in this program are diverse, the research on these disease types is often synergistic. For example, investigators increasingly look at the molecular profiles of cancer, often finding connections across cancers affecting different body sites. Advances or progress related to one cancer fuels the research on the other cancers in this program, and treatments initially approved for one cancer are routinely found to be effective in others. For example, treatments approved initially for kidney cancer have proven effective in other solid tumors outside the scope of this program. Monoclonal antibodies, designed to target specific molecules on the surface of cancer cells, were first used in the treatment of non-Hodgkin lymphoma. They are now the most widely used form of cancer immunotherapy, with clinical trials in progress for almost every type of cancer.

It’s A Good Investment

Advocacy groups and members of Congress have been strong champions of Pentagon-conducted research because Defense Department researchers get results with minimal tax-payer investment.

Funding for the CDMRP is an opportunity to advance the best research to eradicate diseases and support the warfighter for the benefit of the American public. These research programs target diseases that impact directly the welfare of the American military, their families and the public. The CDMRP supports medical research on several forms of cancer (breast, blood, colorectal, melanoma, pediatric, brain, lung, ovarian, and prostate) and other diseases (like neurofibromatosis, bone marrow failure, and tuberous sclerosis complex) that have led to breakthroughs on nerve regeneration and traumatic brain injury. The CDMRP also funds research on Gulf War Illness, psychological health, spinal cord injury, and hearing and vision loss (which comprise a significant portion of current battlefield injuries). Other activities target diseases and conditions such as Lupus, Multiple Sclerosis, Scleroderma, ALS, and Autism, conditions that can have a devastating effect on the families those in service leave behind.

Funding Successful and Innovative Research

Cancer research performed by the Pentagon is unique in that it funds high-risk, high-reward projects that may yield nothing or a spectacular breakthrough. Many of these projects have gathered enough data to receive funding from the National Cancer Institute, taking the research even further. The Pentagon’s annual budget for ovarian cancer research is only $12 million, but it has yielded multiple discoveries that benefit women with the disease. One example is the OVA1TM test, which helps physicians determine whether a pelvic mass is benign or malignant. Another breakthrough is a compound that slows ovarian cancer growth.

The DoD Prostate Cancer Research Program, through its sponsorship of Phase I/II trials through the Prostate Cancer Clinical Trials Consortium, has helped to bring to market 3 new medicines for men with advanced prostate cancer that were approved by the FDA in 2010-11: namely, PROVENGE® (sipuleucel-T) – Dendreon Corporation, XGEVA™ (denosumab) – Amgen Inc, and ZYTIGA™ (abiraterone acetate) – Johnson & Johnson were all made possible through DoD support of a comprehensive clinical trials network of 13 US centers of excellence for prostate cancer research. Also, more than 2,700 patients have had access to 83 clinical trials since 2005 through the DoD’s Prostate Cancer Clinical Trials Consortium.

Research funded by the Tuberous Sclerosis Complex Research Program (TSCRP) has led to the development of animal models of tuberous sclerosis complex (TSC) and clinical trials, resulting in the first drug specifically to treat TSC being approved by the FDA in 2010.  These same animal models are shedding light on the consequences and potential treatment for traumatic brain injury.

The ALS Research Program has led to the identification and development of new chemical compounds which are now being developed for potential treatments for ALS, a fatal disease for which there currently is no effective treatment. The program also has enabled the parallel development of many new approaches to therapies for ALS, increasing the chances of finding a meaningful treatment for all people with the disease, including our heroes serving in the military who are twice as likely to die from ALS as the general public.

Dr. Carlos Alvarez at the Research Institute at Nationwide Children’s Hospital, Dr. C. Couto at Ohio State University, and Dr. Kun Huang at Ohio State University recently received funding for an innovative research proposal identifying genetic pathways that are affected in cancer risk and disease progression by studying military working dogs.

Colorectal cancer is the second leading cause of cancer death in America. As Congress moves forward with the fiscal year 2012 appropriations bills I hope it will continue to fund proven research programs that have the potential to reduce the billions of tax-payer dollars we spend on cancer care.

– Nancy Roach was a member of the FY10 PRCRP Integration Panel responsible for the programmatic review of grant applications submitted to the program for funding through the Department of Defense.  Ms. Roach is a founder of both Fight Colorectal Cancer (formerly the C3: Colorectal Cancer Coalition) and the Colon Cancer Alliance. She currently serves as the Chair of the Board of Directors for Fight Colorectal Cancer. Ms. Roach also serves on the Executive Committee of the FDA-Duke Clinical Trial Transformation Initiative. In her role as a patient advocate, Ms. Roach also serves on a number of advisory boards for the National Cancer Institute.