NIH seeks to sustain increased biological defense funding

U.S. health officials are hoping to sustain unprecedented funding for bioterrorism defense-related research in the coming years, following a sizable increase by Congress this fiscal year.

That goal may be hard to achieve, however, in the face of a tough fiscal climate and the stated determination by the White House budget office to scrutinize new research funding requests closely for "high payoff" and "maximum efficiency and effectiveness."

The National Institutes of Heath in fiscal 2003 was awarded $1.75 billion for biological defense-related work, an increase of nearly $1.5 billion over the previous year. The fiscal 2003 funding will be distributed roughly in thirds for drug and vaccine development and testing, for basic and clinical research, and for constructing four regional biological defense research centers, each with Biosafety Level-3 or -4 biological containment facilities.

NIH forecasts a $421 million decrease in required funding for such facilities from fiscal 2003 to fiscal 2006 as up to 10 are built, but is hoping to see a corresponding $497 million increase for research funding including at the new centers, according to long-range budget data provided by National Institute of Allergy and Infectious Diseases Director Anthony Fauci in a presentation last week.

Fauci, speaking at a conference on biological defense funding here, seemed optimistic, saying, "I think we're going to get reasonable increases from one year to another."

Fauci spokesman Gregory Folkers said the overall funding level would basically remain the same according to the NIH plan, but struck a note of caution about the outcome.

"Of course, we can't predict future budget levels, and numerous external factors may impact future funding. Thus, the numbers Dr. Fauci discussed are possible scenarios, based on assumptions that may or may not come true," he said.

Folkers said the biological defense funding plan was based on a careful assessment of what would be needed.

"The plan is designed to carefully balance and orchestrate the complex yet delicate interplay needed to successfully engage the best elements of academic and private sector research, to build and sustain research momentum, to identify and exploit research opportunities, to build and use critical research tools and infrastructure, and to make the optimum use of biodefense funds," he said.

Fauci, Folkers and other experts jointly wrote in an American Society of Microbiology News article in August, "There is a dearth of investigators involved in research on some of the most important pathogens that could potentially be used in a bioterrorist attack."

"Much of the 500 percent increase in funding will be wasted on research that lacks scientific merit, and thus has been unable to compete successfully for funding under previous standards for proposal review," Richard Ebright, a chemistry professor at Rutgers University, wrote in an e-mail.

"Worse, the 500 percent increase will significantly increase the number of institutions and persons with access to, and training in handling of, BW agents, and thus will increase the probability of future accidental or deliberate releases of BW agents," he said.

Biological Defense Given High Priority In the wake of the Sept. 11 attacks and subsequent anthrax attacks last year, the Bush administration has declared bioterrorism defense a high priority. Congress this year approved administration requests for approximately $600 million for Pentagon biological warfare defense research and $1.1 billion to strengthen state and local first response capabilities.

NIH says its biological defense research funds will be spent on expanding existing research on potential bioterrorist agents, developing new vaccines, therapeutic drugs and diagnostic tests, and expanding clinical research on newly discovered and developed products.

The new research facilities, called "regional centers of excellence for biodefense and emerging infectious diseases research," will "enable biomedical research efforts on pathogenic microbes, including potential bioterrorism agents," according to an NIH release describing its plan.

The centers also will be on hand to provide expert assistance to first responders in the event of a biological incident.

Tight Fiscal Climate

While the amount of money appropriated for biological defense research is dwarfed by the $400 billion national military budget this year, White House willingness to increase funding for biological defense research appears to remain an open question.

In two prominent documents, White House officials gave indications that additional funding requests for research and development in general in fiscal 2004 may be hard to come by.

In a May memo, Office of Science and Technology Policy Director John Marburger and Office of Management and Budget Director Mitchell Daniels encouraged agencies to "fund new, high priority activities by reallocating resources from lower-priority or recently completed activities."

The memo said requests for additional funding would require "a compelling rationale that the activity is important … and that funds from lower priority or recently completed programs cannot be substituted within the agency's guidance level."

Also, the administration's budget document for fiscal 2003 said the overall $2.4 billion requested for biological defense research work at various agencies was intended for "jump-starting" research and development.

Federal finances currently are tight particularly in light of the struggling economy, expected ramping up of the administration's 10-year tax reduction program, and significant funding increases for defense.

Fauci said he has had a number of discussions with senior administration officials, including Bush, inquiring into how the current level of funding would be spent.

Fauci said the message he took from those meetings is that research must be driven by defined goals and he said as a result greater emphasis will be placed within his institute on making basic research, the institute's "classic" work, applicable to specific challenges.

When how research money would be spent in the future, he said, "We're not going to skip over the basic research, but we are going to be very attentive to the basic research getting spelled out in definable endpoints."