Biodefense System Overhaul Was Necessary, HHS Secretary Says

(Sep. 27) -Workers on a vaccine production line in 2009. U.S. Health and Human Services Secretary Kathleen Sebelius last week promoted an Obama administration plan to dramatically reform the nation's system for developing medical countermeasures for biological threats (William West/Getty Images).
(Sep. 27) -Workers on a vaccine production line in 2009. U.S. Health and Human Services Secretary Kathleen Sebelius last week promoted an Obama administration plan to dramatically reform the nation's system for developing medical countermeasures for biological threats (William West/Getty Images).

WASHINGTON -- A planned $1.9 billion revamp of the nation's medical countermeasure enterprise was overdue as government scientists were using decades old technology to confront new and emerging biological threats, a senior Obama administration official said here last week (see GSN, Sept. 24).

"We were working to squeeze every last bit of efficiency out of safe, but outdated, technology," Health and Human Services Secretary Kathleen Sebelius said Thursday. "It was like a car that you got tuned up but it still didn't accelerate fast enough when we needed it to."

Most notably, government researchers still used chicken eggs to grow vaccines, a process that dates back to the 1950s and can take up to several weeks to produce results, she said.

"Even if you yell at the eggs, they really don't grow a virus in a faster method," Sebelius joked, referring to an egg's ability to grow a vaccine.

Successful countermeasure development also has proven difficult because the private sector saw little financial benefit in producing biodefense medicines and vaccines for the government, according to Sebelius. The development process can be costly and there is little if any market for such products outside the public sector.

"For industry there's still too little incentive for private companies to produce medical countermeasures, for rare conditions like Ebola or radiation poisoning," she said during a biopreparedness conference organized by the University of Pittsburgh's Center for Biosecurity.

The planned changes were detailed in a report the department issued last month. The review was ordered in the wake of the government's response to the H1N1 influenza outbreaks in 2009, when development of a vaccine progressed much slower than expected.

Countermeasures are typically defined as drugs and vaccines that ward against chemical, biological, radiological and nuclear agents and emerging infectious diseases.

Of the initial $1.9 billion investment, $822 million would be spent on initiatives designed to decrease the amount of time the government needed to make pandemic flu vaccines, while the Food and Drug Administration would receive roughly $170 to enhance its regulatory efforts.

Another $678 million would go toward setting up one or more nonprofit organizations that could provide financial support to small firms working on new treatments, as well as provide the companies with new production systems and manufacturing of vaccines for times of high demand.

The department's Biomedical Advanced Research and Development Authority last week awarded what could amount to $100 million in contracts for initiatives intended to increase the speed with which agents and materials that counter biological threats are developed (see GSN, Sept. 22).

The government's countermeasure development pipeline, as set in 2004, starts with the National Institutes of Health conducting basic research on a drug or vaccine before transferring the materials to the biomedical authority at Health and Human Services.

The authority then provides financial and managerial support for companies to develop the treatments. The licensed end product would be purchased through the $5.6 billion Project Bioshield effort. The program purchases medicines designed to protect U.S. citizens from the effects of a WMD attack.

"The closer we looked at out countermeasure process, the more leaks, and choke points and dead-ends we identified," Sebelius told the audience.

Project Bioshield was nearly raided earlier this year by House appropriators who sought to remove $2 billion from its coffers in order to address unrelated budget issues (see GSN, Jul 23). The funds were later restored.

In comments that closely mirrored those she made when the report was unveiled last month, Sebelius said the ultimate goal of the revamp was a "nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat" including a naturally occurring, yet previously unrecognized, infectious disease.

"That's a pretty lofty goal but one, if we are committed to the security of Americans, that we have to take very seriously," she added.

September 27, 2010
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WASHINGTON -- A planned $1.9 billion revamp of the nation's medical countermeasure enterprise was overdue as government scientists were using decades old technology to confront new and emerging biological threats, a senior Obama administration official said here last week (see GSN, Sept. 24).