"An effective biodefense will require a long-term strategy and significant new investment in the US health care system," Bush said in announcing the budget in February. "NIH will lead a partnership with industry, academia, and government agencies dedicated to understanding the pathogenesis of potential bioterrorism agents and to translating this knowledge into required medical products."
Most of NIH's increase is earmarked for the National Institute of Allergy and Infectious Diseases (NIAID), which will see its budget jump 57%, from $2.5 billion to nearly $4.0 billion. The next biggest increase is for the National Cancer Institute (NCI), which would grow by 12%, from $4.2 billion to $4.7 billion.
Anthony S. Fauci, NIAID director, says his institute has developed the following strategic plan to allocate the $1.7 billion in bioterror funding:
- Basic Research: About $441 million will go for basic research into the physiology and genetics (including genome sequencing) of potential bioterror agents, immune system function and response, and the pathogenesis of various microbes.
- Therapeutics, Drugs, Vaccines: About $592 million is designated to accelerate discovery, development, and clinical research of next-generation vaccines, therapies, and diagnostic tests, such as those using zebra chip technology (miniaturization technology to immobilize oligonucleotides or genes onto chips).
- Clinical Research: About $195 million will go for clinical trial components and pilot studies for diagnostics involving new vaccines and drugs.
- Facilities and Training: About $521 million is earmarked for construction and renovation of buildings and facilities, including establishing a series of extramural and intramural Centers of Excellence for Bioterrorism and Emerging Infections having biosafety level (BSL) 3 or 4 research labs. Funds for research training also are included.
But Where's the Balance?
NIH officials defend the emphasis on bioterrorism. "We have essentially what is almost a national emergency to get ourselves prepared against bioterrorism," Fauci says. "The other components of NIH are very worthy and deserving of increases. They are getting increases that in any other venue would be considered significant. They're just not as much as they would have liked." Adds Wendy Baldwin, deputy NIH director for extramural research: "I just don't think you can step back from Sept. 11 and our concerns over bioterrorism and try to make the world the place it was before that."
Reaction from the research community has been largely favorable. "We have no problem at all with the idea that there should be an increase for research in bioterrorism or an increase for cancer," says Robert R. Rich, president of the Federation of American Societies for Experimental Biology (FASEB). He also welcomed the effort to complete the budget doubling. But he warned against stopping the process and returning only to inflationary increases. "It's only a few years before you've squandered the momentum of that increase," Rich says, noting he doesn't foresee that happening as long as the budget increases at 7%-10%, the historical rate of growth prior to the doubling effort.
James P. Allison, president of the American Association of Immunologists, supported the NIH budget emphasis on bioterrorism through NIAID. "Immunologists and microbiologists have a special responsibility in this area," Allison said in a statement. "Immunologists seeking to understand and develop protections against bioterror agents will continue to need support from basic research in a variety of disciplines, including genomics and proteomics."
Health officials at the state and local levels are also generally pleased. "I'm personally very comfortable in spending additional dollars for bioterrorism. It will be money well spent," says Georges Benjamin, president of the Association of State and Territorial Health Officials and secretary of health for the state of Maryland. "There will be tremendous spin-off knowledge emerging from the bioterrorism research."
Larger and More Grants
The average cost of a new and competing RPG will be about $370,000, a 44% increase over 1998. This includes a 4% increase triggered by the Biomedical Research and Development Price Index. Noncompeting RPGs will contain increases for recurring direct costs of 3%, on average. Overall, intramural research expenses throughout NIH are forecast to increase 15% to more than $2.6 billion. The budget also asks to support 17,014 full-time training positions, 305 more than this year, and carrying a 4% increase in stipends for predoctoral and postdoctoral trainees.
Concern exists over what will happen to these RPGs after 2003 since most are multiyear commitments and it is doubtful the double-digit budget increases for NIH will continue.1 Fauci explains that next year's $1.5 billion increase, coupled with the existing $250 million for bioterrorism, will become part of NIAID's funding base for future years. The committed grants will continue to be funded, he says, regardless of the percentage of overall increases in the future.
Looking deeper into the numbers, another helpful sign emerges. More than one-third ($521 million) of the $1.5 billion in new funds for bioterrorism is designated for buildings and facilities (B&F) projects. This includes $150 million in NIAID to construct and renovate BSL 3 or 4 laboratories for the extramural Centers of Excellence for Bioterrorism and Emerging Infections. The other $371 million is to fund construction of BSL 3 or 4 intramural research labs at NIH's main campus in Bethesda and in Frederick, MD and to upgrade overall facility security.
When combined with an additional $434 million for other construction, the B&F expense totals $873 million. Factoring these capital expenses from NIH's $3.7 billion increase indicates the agency is in a better position than it would appear to deal with its commitment base should increases in future funding be scaled back.
The new budget requests $184 million to construct, repair, and secure CDC facilities as well as $159 million to upgrade scientific response capacity. This includes additional staff and equipment for the Rapid Response and Advanced Technology Lab at the National Center for Infectious Diseases. Also supported in the new budget is the Laboratory Response Network, a system of more than 80 public health labs equipped to rapidly identify possible bioterrorism pathogens. And an additional $400 million is earmarked for the National Pharmaceutical Stockpile and support costs for the 286 million doses of smallpox vaccine expected to be available later this year.
Biodefense spending throughout all government agencies totals $5.9 billion. Some of these other programs include: $420 million to the Defense Department to study the technology and tactics of bioterrorists and to devise countermeasures; $100 million to improve security at biological research labs; and $1.2 billion to boost state and local health delivery systems. This includes $518 million for a preparedness program for hospitals to improve infrastructure and communications and $200 million to increase state laboratory capacity to collect and identify potential bioterror agents.