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Report: Smallpox Vaccination Program Fell Short

CDC lost the public's confidence, review finds

THURSDAY, March 4, 2005 (HealthDay News) -- The U.S. government's smallpox vaccination program eroded the credibility of federal health officials while leaving no clear indication of how well prepared the nation might be against a bioterrorist attack.

So said Dr. Brian Strom, chairman of an Institute of Medicine (IOM) committee which released a report Thursday on lessons learned from the 2002 vaccination effort. The panel presented its findings in Washington, D.C.

While stopping short of calling the program a failure, the report did find what appear to be serious shortfalls in how the initiative was implemented. The report, titled The Smallpox Vaccination Program: Public Health in an Age of Terrorism, is the last of seven reports providing recommendations and guidance to the Centers for Disease Control and Prevention (CDC). Unlike earlier reports, however, this one was undertaken at the IOM's own initiative.

These lessons learned are important because "bioterrorism, unfortunately, continues to be a threat and it is likely that future programs like this will need to be initiated," said Strom, who is also chairman and professor of the department of biostatistics and epidemiology at the University of Pennsylvania School of Medicine.

Near the end of 2002, President Bush announced the smallpox vaccination program, which called for members of "Smallpox Response Teams" to voluntarily be vaccinated against the disease so they could be mobilized to assist in the event of an outbreak.

At the time, the U.S. government called for a two-phase, voluntary strategy for civilians. In the first stage, roughly 450,000 heath-care and emergency workers would receive the vaccine, followed by a second round covering up to 10 million other so-called "first responders" in the event of a bioterror attack.

According to a Feb. 18 article in the Toledo Blade, very few U.S. civilians -- just 40,000 health-care workers and others -- ended up volunteering for vaccination. Dr. David Grossman, health commissioner for Toledo and Luca County, Ohio, said the volunteer program never really gained momentum.

"We all agree it was a party no one came to," he told the Blade. "I doubt that 40,000 people in a nation of 300 million is enough."

The new report, which illustrates the inherent tension between national security and scientific integrity, is loaded with criticism, a main one being the failure of the scientific community to adequately answer scientific questions.

"The rationale for the policy and program structure was not explained clearly to the public health and clinical communities," Strom stated. "This was a vaccine that was known to have serious side effects, given in a setting where the disease had not existed for decades. Superficially, it didn't make public health sense. The public health rationale was never overtly explained."

This failure, in turn, contributed to trust problems at the main agency in charge of the initiative, the CDC, said Strom.

"There was a huge loss of credibility for the CDC on this issue at least," he said. "People began to have doubts about whether they should volunteer because they couldn't fully trust what they were hearing." And that would explain why the enthusiasm demonstrated for the program in its early days quickly waned, he said.

One lingering question was why the authorities changed their initial recommendation of vaccinating 20,000 individuals to 500,000 within 30 days and later 10 million members of the general public.

"Why was the number 500,000 chosen? Why within 30 days? Why 10 million?" Strom asked. "If they said 'national security,' that would have been acceptable rather than what seemed to be largely ignoring the public health and clinical communities then expecting them to take the risks of this vaccine."

Three different bodies asked for a pause of the vaccination program after Phase I and also after side effects were discovered. These recommendations were essentially ignored, Strom said.

"Scientific concerns were never addressed and, rather than proceeding with the pause, the response was that it would go right into Phase 2," he said. "The perception of the public health and clinical communities was that the CDC was not speaking from its usual sense of scientific authority, and that ultimately hurt the acceptability of the program as it proceeded."

In the end, Strom said, the nation is better prepared as a result of the program but exactly how much better is unclear. "We're unaware of the project's current status or any efforts towards a comprehensive assessment of smallpox preparedness," he said. "We need a better measure of preparedness so we'll know if the program fell short.

At its heart, the report at times seems a plea for free speech in a working democracy.

"We are acutely aware that the CDC is part of government and needs to follow the policy of government and that's appropriate. But in doing so, they need to speak from science and need to be allowed to speak for science," Strom said. "There certainly will be times that policy has to overrule what makes scientific sense. They just need to be allowed to say that."

More information

View the full report at the Institute of Medicine.

SOURCE: March 3, 2005, Washington, D.C., news conference with Brian L. Strom, M.D., chair, Committee on Smallpox Vaccination Program Implementation, Institute of Medicine of the National Academies, and chair and professor, department of biostatistics and epidemiology and director, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia
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