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Biosecurity Experts Describe How Congress Can Help Prepare for Bioterrorism Attacks
Photo © and courtesy of Center for Biosecurity of the University of Pittsburgh Medical Center
Developers of medical countermeasures against biological agents are frustrated by a lack of sufficient product development funding and the slow, overly cautious federal contracting process, policy expert Brad Smith said at a congressional briefing organized by AAAS.
"Preparation matters," said Smith, listing pharmaceutical treatments and vaccines, public awareness and a health care system that can handle epidemics as essential components to managing a bioterrorism attack. "All of these things take a long time to put in place."
The 28 November briefing was organized by the AAAS Center for Science, Technology, and Security Policy.
Smith, a senior associate the Center for Biosecurity at the University of Pittsburgh Medical Center (UPMC), is among many policy experts who say the U.S. is not adequately prepared for biological assaults. Bioterrorism presents a different type of security threat compared to more traditional nuclear or radiological assaults, Kavita Berger, a project director for the AAAS Center, said after the event. Biological agents are readily available in nature and can multiply on their own. "Traditional arms control mechanisms are not helpful—it's a whole different beast," she said.
At the briefing, Smith explained how Congress can improve the development and acquisition of drugs for medical countermeasures against bioterror agents by appropriating funds that federal law has already authorized for biosecurity-related drug development expenses. Smith described a large gap between the amount of money authorized for such expenses and the amount of money that has been appropriated by Congress.
For instance, the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA) authorized Congress to spend $1.07 billion toward late-stage development of medical countermeasures for the 2006-2008 fiscal years. The act created the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS) to distribute funding for the development of medical countermeasures. Of the $1.07 billion in authorized funds, Congress had appropriated only $99 million to BARDA as of late November.
Similarly, the Project Bioshield Act of 2004 authorized $5.6 billion in funding to acquire medical countermeasures for the U.S. Strategic National Stockpile. However, given that estimates for the costs of developing new medical products range from $400-800 million or more, the $5.6 billion in the BioShield fund will likely cover only a handful of the needed medicines and vaccines.
"The biopharmaceutical industry sees this as a lack of appropriate scale of financial commitment by the government," said Smith, a molecular biologist by training. "Companies think that this can buy a few products, but when it's used up, then what happens? Is this really a long-term sustained commitment by the U.S. government?"
The development of medical countermeasures for bio-threats is further hindered by the daunting numbers: Only one out of every 5,000 compounds deemed a possible treatment makes it through clinical trials and into production. A new drug comes with at least eight to 12 years of development and a $400-800 million price tag.
Federal funds help companies develop drugs, but companies can find themselves in financially precarious situations if they have to put drug-development projects on hold while waiting for the government to award money. For instance, it takes an average of 25 months for Project BioShield to award a contract from the time when a threat is identified. "That can feel like an eternity for a company to tread water," Smith said.
On the other hand, federal agencies such as HHS—which oversees BARDA—may hesitate to allocate funds because of the high risk associated with drug development. HHS feels like it's in a "defensive crouch," Smith said, and that it can't have any more product failures after problems with a new anthrax vaccine resulted in the cancellation of the first and largest BioShield contract in December 2006.
"The point here is not that the government is going too slowly; rather, it's the realities of how government and private sectors work," he said. "Their timeframes don't mesh."
Congress can help the sectors mesh by acknowledging that product failures are an inevitable part of discovering useful drugs, Smith said. "If Congress made it clear that HHS has the freedom to operate then HHS can ease up on its overly conservative nature of running these programs," Smith said at the AAAS briefing.
Beyond discovering and producing medical countermeasures, the methods of getting the drugs to the public remain unclear as well, said Berger. "We don't have good distribution, and it's an essential part of the response. We really need to prepare and respond in a public health fashion."
Funded by the MacArthur Foundation, the AAAS Center for Science, Technology, and Security Policy promotes the integration of science into public policy. The Center focuses on science related to international and national security topics, including biosecurity, cybersecurity, and nuclear issues.
Read BARDA's strategic plan to obtain medical countermeasures.
12 December 2007