Monday, June 23, 2008

U.S. President's 2009 Biodefense Budget Proposal Calls for Overall Growth, But Some Cuts

U.S. President's 2009 Biodefense Budget Proposal Calls for Overall Growth, But Some Cuts

In 2001, 22 anthrax victims "wreaked havoc on hospitals up and down the East Coast," said Dr. Eric Toner, a senior associate with the Center for Biosecurity at the University of Pittsburgh Medical Center. Although only 11 of the 22 anthrax victims were afflicted by the most extreme form of exposure, resulting from inhalation, thousands of other patients had to be individually assessed in hospital emergency rooms.

Since then, hospitals have dramatically improved their ability to respond to biosecurity threats through better planning, drills and improved communications, according to Toner, a speaker at a 12 June Capitol Hill briefing organized by AAAS and the Congressional R&D Caucus.

Yet the number of hospital beds and emergency departments continues to decline, particularly in cities and at academic health centers, and many hospitals remain unprepared for either deliberate terrorist attacks or major disease outbreaks. "Unless we address the critical issue of hospital overcrowding, our ability to respond to any sort of biological attack is going to be severely limited," Toner cautioned.

Under U.S. President George W. Bush's proposed biodefense budget for fiscal year 2009, support for hospital preparedness would drop by 15%, or $60 million, according to Alan Pearson, director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Non-Proliferation.

The other "big loser" in the proposed budget, he said, would be state and local capacity-building efforts, which are recommended for an 18%, $140 million cut in biodefense funding. Pearson was the featured speaker at the Hill event planned by two AAAS program: the Center for Science, Technology and Security Policy, and the Center for Science, Technology and Congress.

Pearson later added that, according to the Bush Administration, these cuts reflect one-time adjustments to better align federal funding with state budget cycles, and further that funding would be unchanged compared with fiscal year 2008, when viewed on a month-to-month basis. "Funding for these activities has been slowly but steadily declining since FY2003," Pearson said. "It remains to be seen whether annual funding in FY2010 will return to the FY2008 level, or continue at the lower FY2009 level."

Across multiple agencies, however, the Bush Administration has recommended a big overall increase—an additional $8.97 billion for bioweapons, prevention and defense in 2009—equivalent to a 39% increase, compared with the congressional appropriation for 2008. The new funding would be devoted primarily for biodefense-related research, development, and medical countermeasures such as vaccines.

The proposed $8.97 billion includes $2.18 billion in BioShield funding, appropriated in 2004, but not available until 2009, Pearson explained. The Biomedical Advanced Research and Development Authority (BARDA), established within the U.S. Department of Health and Human Services, also is significantly increasing biodefense investments, and is likely to continue to do so, he added.

After the 11 September 2001 terrorist attacks triggered relatively rapid growth in U.S. federal funding for bioweapons, prevention and defense between fiscal years 2001 and 2009—for a total of $57 billion over those years, if the president's 2009 budget is approved, according to Pearson. Funds also are now being provided for Project BioShield, a 10-year effort to stockpile protection against biological, chemical, radiological and nuclear agents.

Within the president's proposed 2009 budget, Pearson said, the "winners," or categories of activity receiving the largest increases in funding would be research and development (R&D), which would rise by $330 million, or 10% compared with 2008; surveillance and detection, slated to go up by $114 million, representing a significant increase; and prevention efforts, which would jump by $32 million, or 15%. Funding for food and agricultural security also would increase, by $146 million, or about 35%.

But hospital preparedness and state and local readiness would see less support. "Particularly noticeable this year is a dramatic decrease in [proposed] funding for health professions training," he noted. This recommendation is "ironic" in light of a nursing shortage and requirements for pandemic and hazard preparedness, Pearson added.

Pearson also described a shift in funding emphasis, from "biodefense," or a focus on deliberate attacks, to "biosecurity," which also encompasses natural outbreaks of diseases, food contamination and other non-deliberate crises.

In addition to Pearson and Toner, four other leading experts took part in the 12 June briefing to provide perspectives on medical countermeasures, prevention strategies; agriculture and food defense; and public health preparedness.

Brad Smith, a senior associate at the Center for Biosecurity at the University of Pittsburgh Medical Center, addressed medical countermeasures—efforts to develop vaccines and other medicines to protect people from anthrax, smallpox and other biological agents.

Developing such treatments is time-consuming, expensive and often futile, Smith noted. He and his colleagues recently completed an analysis to determine how much it would cost to develop eight key medical products currently of interest to the government. By their estimate, it would cost $3.4 billion per year, every year, to have a 90%percent chance of successfully developing each of the eight needed medicines. By comparison, researchers have so far received $100 million per year for the past two years, through the Biomedical Advanced Research and Development Authority (BARDA).

"That's enough to support two of those [development] funnels with a 30% chance of getting products," Smith said. "If the government is going to get the products it says it needs to protect American citizens, the government will need to increase its investment across the board in developing new vaccines and medicines."

In the biodefense field, efforts to prevent new biological knowledge and technologies from falling into the wrong hands are inherently complicated, said Gerald Epstein, a senior fellow for science and security in the Center for Strategic and International Studies Homeland Security Program. That's because "biotechnologies are pervasively dual-use," Epstein noted. "The very technologies and capabilities we need to worry about are the capabilities we need to actively promote."

Epstein sees long-term scientific partnerships between nations as an important aspect of any strategies for preventing the misuse of biotechnologies.

While funding to prevent deliberate contamination of the U.S. food supply has increased since 2001, Pearson said, support for efforts to avoid accidental contamination of food has remained flat. Dr. James A. Roth, a veterinarian and director of the Center for Food Security and Public Health at Iowa State University, pointed out that food has been relatively cheap and abundant in the United States since World War II. But, he added, "that period is over, and internationally, food insecurity is becoming a huge and increasing problem."

Already in the United States, he said, corn has increased from $2 a bushel to $7 a bushel, and the food distribution system remains extremely vulnerable to any disruptions. In Iowa, for example, the largest egg-producing state, a single case of avian influenza would bring production to a halt, and within several days, eggs would disappear from grocery store shelves, restaurants and food processing plants.

Roth identified three defense-related food and agricultural areas in need of more funding: First, he said, efforts to combat zoonotic diseases deserve greater support. A new, $460million research facility is being built in Ames, Iowa, he said, but with insufficient support for operations and research. Second, Roth said, the pharmaceutical stockpile for protecting animals against major diseases is inadequate, which puts humans at risk, too. Third, Roth echoed Pearson's call for additional investment in the veterinary workforce.

"Only 26 states have vet colleges," Roth said. "We don't have nearly enough vets in rural areas, or to treat livestock." In the event of a disease outbreak affecting animals, he said, vets would be at the forefront of a rapid, critical response effort.

Dr. Georges Benjamin, executive director of the American Public Health Association, discussed public health preparedness. The public health system has made dramatic improvements in its capacity for dealing with bioterrorism, he said. The national stockpile of key medicines also has improved, along with systems for enhancing communications among states and agencies. Today, more epidemiologists are trained in biopreparedness, but Benjamin noted that too few professionals are focusing on chronic disease and maternal-child health issues. Further, low-income, elderly and other disadvantaged populations remain particularly vulnerable to biosecurity risks.

Moreover, Benjamin said: "The public really has not yet developed cultural awareness" of biosecurity risks. "We've not yet built this awareness that we need to have gas in the car, food in the fridge and an awareness of where our family members are and how we're going to communicate with them."

Looking to the future of biodefense, Pearson said that BARDA funding is likely to increase for the next few years. Support for medical countermeasures is shifting from agent-specific approaches to mixed strategies, he said. Further, policy-makers are beginning to recognize the need for efforts to prevent and prepare for natural disease outbreaks and food contamination as well as deliberate terrorism.

Ginger Pinholster
19 June 2008

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