By Rob Stein
Washington Post Staff Writer
Wednesday, December 2, 2009
Citing the balky swine flu vaccination campaign and other shortcomings in the nation's medical defenses, a top Obama administration official has announced a major review of the government's efforts to develop new protections against pandemics, bioterrorism and other health threats.
Health and Human Services Secretary Kathleen Sebelius said Tuesday that she ordered the evaluation in part because the H1N1 vaccine shortage had highlighted the nation's dependence on antiquated technology.
"We'll look for the fastest ways to move to new technologies that will let us quickly produce countermeasures that are more dependable and more robust," she told the American Medical Association's Third National Congress on Health System Readiness, which is being held in Washington. "Not just for flu and not just for infectious diseases, but for all the public health threats we face today."
The review will be led by Nicole Lurie, assistant secretary for preparedness and response, and will be complete by "early next year," Sebelius said.
"Today, we face a wider range of public health threats than ever before in our history," Sebelius said. "It could be anthrax delivered in an envelope. It could be a dirty bomb set off in a subway car. It could be a new strain of flu that our bodies have no immunity to."
The nation's ability to respond to such threats depends not only on having enough hospital beds, emergency rooms, doctors, and equipment such as masks and ventilators, but also on state-of-the-art diagnostic tests, medications and vaccines, she said.
"But the countermeasure that saves the day during a quick-hitting public health emergency can often take years to discover, develop, manufacture and distribute," she said. "Like a lot of countries, we've often failed to make the kind of long-term investments in countermeasures we need to stay safe."
Sebelius defended the government's response to H1N1, noting that the virus was identified quickly, diagnostic tests were produced and distributed rapidly, and the immunization program was started as soon as possible. At least 69 million doses of vaccine are now available. But the vaccine was produced much more slowly than officials predicted it would be, leading to long lines and frustration nationwide and heavy criticism in Congress. The lag is a clear example of the shortcomings of today's technologies, Sebelius said.
"We were fighting the 2009 H1N1 flu with vaccine technology from the 1950s. We could race to begin vaccine production, but there was nothing we could do if vaccine grew slowly in eggs. We could make deals with foreign vaccine producers ahead of time, but we still wouldn't have as much control over the vaccine as if they were based in the U.S.," she said.
"If we wanted to avoid these problems in the future, we needed to make some long-term investments in developing countermeasures that were just as safe and effective, but could be produced faster and more reliably," she said.
Progress has been made, she said. A new facility that can make flu vaccine using cells instead of eggs opened last week in Holly Springs, N.C., after Novartis received more than $400 million in federal funding. But that factory would still be able to produce perhaps only half the vaccine the nation would need in a pandemic, and that process is still prone to delays, she said.
"There are gaps at every stage in the process, from the laboratory to the factory floor, that are slowing or stalling the development of key countermeasures," Sebelius said, referring to the nation's reliance on research conducted at the National Institutes of Health and the Defense Department, which is often not focused on government priorities, as well as the lack of incentive for companies to invest in making new products for public health emergencies.
"In this age of growing public health threats against which countermeasures are often our best defense, that's dangerous," she said.
The review came as the federal Centers for Disease Control and Prevention urged Americans to continue to seek the H1N1 vaccine, even though the peak of the second wave appears to have passed. The virus is still spreading widely and a third wave could occur later this winter, said CDC Director Thomas R. Frieden.
"We are in a window of opportunity," he said. "We're going from a time when there was lots of disease and not enough vaccine to a time when disease is gradually decreasing and we're having a steady increase in the amount of vaccine available."