The $4.18 billion National Cancer Institute budget request submitted by the Bush administration to Congress in April for fiscal year 2002 amounts to an 11.7 percent boost of $439 million over the current year's appropriation. The package, however, falls $850 million short of the amount NCI sought in its own "bypass budget" proposal.
NCI requested $5.03 billion, a whopping 34 percent boost of $1.27 billion. The bypass budget is so-called because, under the National Cancer Act of 1971, NCI's budget request is submitted directly to the president, bypassing approval by the National Institutes of Health and the Department of Health and Human Services (HHS) that is required of other NIH institutes and centers.
This bypass budget represents the cancer institute's "strategic planning," says John Hartinger, NCI's associate director for budget and financial management. The budget submitted to Congress by the president, he says, does not contain the same level of detail and is not organized in the same way as is the bypass budget. "Once we get a budget number back from Congress, then the director and the advisers will allocate it back to the bypass budget areas," Hartinger explains. "We will be able to 'cross-walk' it back" to specific program areas outlined in the bypass budget.
The increases requested in NCI's bypass budget are breathtaking by any measure. "The pace of discovery is continuing to accelerate" in all areas of cancer research, says NCI director Richard Klausner.
NCI will be riding the wave in Congress and the administration to double spending by the National Institutes of Health by fiscal year 2003.1 The institute also is benefiting from campaign pledges by George W. Bush to "renew the war on cancer" by increasing NCI's budget to $5.1 billion by fiscal 2003 and to fund "a medical moon-shot to reach beyond what seems possible today and discover new cures for age-old afflictions." In a campaign speech last September, then-candidate Bush declared that "one day, people might speak of cancer the way we speak of polio or smallpox."
The prospects for NCI's budget in Congress--including adding funds to bring funding closer to the bypass budget request--look good, especially given Congress' bipartisan support and propensity to award even more than an administration has requested in the past. In early April, the Senate voted 96-4 in support of a nonbinding amendment to support a $3.4 billion increase for NIH, a $700 million boost over Bush's $2.75 proposed budget increase. Given that sentiment, NCI may well benefit from congressional largesse.
"Both Congress and the administration for several years have been very supportive of doubling NCI's budget over a five-year period," says Ralph Tate, an NCI budget officer. "We are not anticipating a big fight between the president's budget and Congress' appropriation," he says. Adds a knowledgeable Hill source: "Support in Congress and in the administration is huge. You won't see anyone come out and say that NIH shouldn't get a hefty increase."
NCI's request for budget increases over fiscal year 2001 is divided into three main categories: (1) a core budget increase of $203.7 million that would continue research activities at the same level as the prior fiscal year accounting for inflation; (2) an infrastructure budget increase of $810.7 million that would support growth in eight infrastructure areas, including the National Clinical Trials Program, investigator-initiated research, and support for cancer centers, networks, and consortia; (3) a scientific priorities budget increase of $510.6 million to accelerate discovery in six areas possessing "extraordinary opportunities," including molecular targets for cancer treatment and prevention, cancer imaging, and defining signatures of cancer cells.
Core Budget Increase
Nearly $158 million or 78 percent of the $203.7 million increase in continuing operations is earmarked for research project grants (RPGs). For fiscal 2002, NCI wants to boost the success rate for competing grant applications to 40 percent from the present 29 percent in fiscal 2001. To accomplish this, the institute will continue its special exceptions process through which new investigators, including those who demonstrate particularly innovative and/or higher-reward projects, share the same success rate as more established applicants.
|Courtesy of National Cancer Institute|
NCI's budget request reflects strategic planning and increases in specific areas of research.
NCI will allocate up to 10 percent of competing RPGs for meritorious applications that fall outside conventional paylines. It also will continue its Accelerated Executive Review program to fund single projects in patient-oriented and basic research that are near the payline and for which reviewer criticisms can be addressed rapidly. The institute also will earmark 10 to 15 percent of funds to applications that target identified gaps and/or emerging opportunities including special needs in specific disease areas.
In addition to the proposed $158 million in RPGs, an additional $13.3 million is requested for intramural research, $9.1 million more for research support contracts, $5.6 million for additional clinical trials infrastructure, $4.6 million more for cancer centers, and $4.5 million additional for training and education grants.
Infrastructure Budget Increase
National Clinical Trials Program: More than 40 percent of the requested $810.7 million infrastructure increase is earmarked for the National Clinical Trials Program. This $328 million increase is needed because NCI has been able to initiate only about 30 Phase III clinical trials each year and there is a backlog of agents to enter the system. Planned improvements include increasing the overall number of trials as well as the number of participants by streamlining the way physicians communicate with and enroll patients in trials.
Over the next two to three years, NCI hopes to triple the number of promising new agents entering clinical trials, triple the annual patient accrual to early clinical trials of promising agents, quadruple accrual to pivotal or proof-of-principle early clinical trials, and double accrual to Phase III clinical trials.
Investigator-Initiated Research: NCI annually receives more than 8,000 mostly unsolicited research applications. An increase of $124.6 million here would fund an increase in "somewhat speculative" and "novel path" research proposals, expand transnational research, link basic, clinical, and population-based research. Funds also would be used to expand NCI's Quick-Trials program, which seeks to speed the transition from lab to early stage clinical trials by simplifying the grant application process. Also expanded would be the Phased Innovation Awards program to fund R&D in imaging technology.
Centers, Networks, and Consortia: An increase of $93.5 million would increase the number and broaden geographic distribution of NCI-designated cancer centers, expand the capacity of these centers to engage in new areas, expand activities of the Specialized Programs of Research Excellence, and develop a system to link and manage the entire research framework.
Other infrastructure increases would go towards improving information flow and informatics ($77.3 million increase); training, education, and career development ($68 million increase); and reducing cancer-related health disparities ($50.6 million increase).
Scientific Priorities Budget Increase
A total budget increase of $510.6 million is requested for six areas with good potential for scientific research. In 1996, NCI began to identify areas that are "ripe for investment" because they have "exceptional promise for achieving pivotal advances" in knowledge of cancer and in benefits for cancer patients and those at risk. For fiscal 2002, these areas include molecular targets of prevention and treatment, defining the signatures of cancer cells, cancer imaging, genes and the environment, tobacco-related research, and cancer communications.
Molecular Targets of Prevention and Treatment: An increase of $146.5 million is requested to exploit the convergence of advances in cancer biology, synthetic and biosynthetic chemistry, high-throughput screening, and medical imaging. Within this, $16.5 million would go toward identifying critically vulnerable sites within cells for cancer growth and anti-cancer agents. An additional $30.5 million is to synthesize or acquire molecules for use in drug screening efforts; $28.0 million to facilitate the steps to turn a promising compound into a drug; $41.5 million to facilitate partnering; $25.0 million to support special interdisciplinary initiatives.
Defining Signatures of Cancer Cells: An increase of $110.8 million would be used to generate a catalog of distinguishing molecular signatures of cells to develop new diagnostic and therapeutic approaches and predict response. The goal is to differentiate among tumors at the molecular level and devise treatments targeted at cellular subtypes of different cancers. Within this effort, $35.5 million is to expand the development and availability of molecular and analytic resources; $17.5 million to establish and make available tissue resources to researchers; $8.5 million to develop molecular signatures to study and validate animal models; $14 million to develop novel technologies for early cancer detection and determination of biomarkers; $13.3 million to validate molecular classification schemes of cancer and develop new diagnostics; and $18 million to characterize aberrant molecular interactions in cancer.
Cancer Imaging: An additional $90.6 million is to accelerate the discovery and development of imaging methods to predict the clinical course and response of cancerous or pre-cancerous cells to interventions. Most of these funds ($48.5 million) would go to develop and use imaging as an endpoint in clinical trials. Specifically, $30 million here would fund a large, randomized clinical study of spiral CT as a screening model for lung cancer detection. Another $9 million would continue funding clinical trials to evaluate possible benefits of digital mammography over conventional mammography.
Genes in the Environment: An additional $68.3 million would be used for large population studies and gene-environment interactions to discover genetic, environmental, and lifestyle factors and their interactions that define cancer risk. Specifically, $22 million would be used to identify environmental risk factors and susceptibility genes. Another $10.5 million would develop new ways to assess and measure environmental exposures; $4 million to identify and characterize gene variations; $8 million to identify cancer-predisposing genes in high-risk families; and $9 million to expand enrollment of genetically high-risk individuals into clinical protocols and conduct cancer susceptibility studies.
The two other areas of high-potential research are on tobacco and tobacco-related cancer, which would receive an additional $67 million in funding, and cancer communications, which would receive an additional $27.5 million.
"As a cancer biologist, I am most excited about defining the signatures of cancer cells and molecular targets," says Mary J. C. Hendrix, president of the Federation of American Societies for Experimental Biology (FASEB). As an organization, FASEB is "cautiously optimistic and hopeful, based on the president's strong endorsement of biomedical research, that the NCI and NIH will receive a respectable increase in their budgets for 2002," she says. "However, it is still too early to predict the outcome."
Hearings on NCI's budget request are scheduled for May 16 and 17 in the House and May 23 in the Senate.