Mar 11, 2005 (CIDRAP News) – Poor policy communication and a lack of clearly defined goals seriously hindered the smallpox preparedness program that the federal government launched in 2003, according to a report released by the prestigious Institute of Medicine (IOM) last week.
The Centers for Disease Control and Prevention (CDC) never fully explained the reasons for the vaccination program to the public health and healthcare workers at whom it was directed, and the result was poor participation, says the report by an IOM committee of experts.
Further, the report says the nation's level of preparedness for a smallpox outbreak remains unclear because the CDC has not spelled out what constitutes smallpox preparedness. The IOM's key recommendation is that the CDC define preparedness and set goals based on that definition.
Part of the IOM critique is that the CDC's communications about the program "seemed constrained by unknown external influences." CDC Director Dr. Julie Gerberding has flatly rejected that assertion and said the program has achieved major improvements in smallpox preparedness.
President Bush announced the plan to vaccinate military personnel and frontline civilian health workers in December 2002, and the civilian vaccination effort began in January 2003. The original plan was to vaccinate roughly 450,000 health workers in the first stage and several million additional healthcare workers and emergency responders later. At the time, the CDC urged states to complete the initial phase of civilian vaccinations in as little as 30 days.
However, few health workers volunteered for the shots, in part because the government initially offered no plan to compensate them if they suffered serious adverse reactions. By the end of January 2005, only 39,608 civilian health workers had been vaccinated, according to data on the CDC Web site. By contrast, the mandatory military vaccinations proceeded rapidly; more than 760,000 troops have received shots since December 2002, according to the Department of Defense.
Before the civilian vaccination program began, the CDC asked the IOM to assemble an expert committee to advise the agency on how to run the program. In response, the IOM committee, chaired by Brian Strom, MD, MPH, head of the epidemiology department at the University of Pennsylvania in Philadelphia, issued six brief reports over 19 months. The latest report adds four new chapters to the previous reports.
Naturally occurring smallpox was declared eradicated in 1980, but disease and security experts have been worried for years that stocks of the virus might have fallen into the hands of terrorists. Thus the IOM report says the vaccination program was "the result of an extraordinary policy decision: to vaccinate people against a disease that does not exist with a vaccine that poses some well-known risks."
The heart of the IOM's critique is that the CDC didn't explain the vaccination program adequately to the people who were called upon to be vaccinated. The national security assessment underlying the plan was not divulged, "and the public health reasoning behind the smallpox vaccination policy and program was never fully explained," the report summary states. One example of this was that the CDC gave only a "vague" explanation of why the official vaccination policy differed from what was recommended by the CDC's Advisory Committee on Immunization Practices.
As a result, "Skepticism among key constituencies was followed by lack of buy-in. Despite their expressed willingness to strengthen preparedness for bioterrorism in general, and their desire to serve their communities, many public health and health care workers were ultimately unwilling to accept the well-known risks of smallpox vaccine in the context of limited information about the risk of smallpox."
Part of the problem, the summary goes on to say, was that "The typically open and transparent communication from CDC . . . seemed constrained by unknown external influences." In a statement he made when introducing the report, Strom said, "It . . . became apparent that security-related constraints were placed on CDC's ability to communicate with key constituencies."
Further, when the program fell short of initial expectations, the CDC didn't clarify or revise the goals, the IOM contends. "For example, if it was important to vaccinate specific numbers rapidly, what was the effect of the low vaccinee numbers on readiness for a release of smallpox virus? This question went unanswered . . .."
"Finally," the report states, "the committee found that the program's outcomes (for example, the status of smallpox preparedness in each jurisdiction and nationally) are unknown because there has been no systematic assessment of smallpox preparedness, no review of administrative lessons learned, and no accounting of what has been done with the opportunities for scientific research."
CDC Director Dr. Julie Gerberding defended her agency in a statement issued last week. "CDC disagrees with the assertion that in any way its valued scientific voice was constrained in the smallpox program," she said. The policy "was based on the best scientific advice of the CDC and other recognized scientific experts," as well as state and local officials, she added.
Asserting that the program succeeded in preparing the nation for smallpox and other public health emergencies, she said, "So far in response to the policy, each state has a smallpox response plan in place and laboratory capabilities to respond have been greatly enhanced. . . . In addition, millions of clinicians have received education packages to help them distinguish between smallpox and other pox viruses." She said the ability to communicate about a threat has also been greatly improved.
Kris Ehresmann, who served as smallpox vaccination officer for the Minnesota Department of Health, agreed that the messages used by the CDC in the program engendered skepticism but said the program did yield important benefits. She is the Minnesota Department of Health section chief for immunizations, tuberculosis, and international health.
She said the CDC failed to provide clear reasons why vaccination was important and simultaneously stressed that the vaccine was a live-virus vaccine that entailed some risk. "Those two things worked together to really reduce the number of people who received vaccine," she told CIDRAP News. "You're not really telling people why you should do it [get the shot], and then you give every reason in the world why you shouldn't do it."
She said it wasn't wrong to provide information about the risk, but in the absence of a clear rationale for vaccination, "the result is going to be fewer people vaccinated."
In Minnesota, about 1,500 health workers received smallpox shots, according to the CDC. Ehresmann said the state is not giving any vaccinations now.
Nonetheless, she said, "There were a number of benefits to Minnesota because of the program. Probably the lowest benefit was vaccinating people. The largest was the partnerships that were established between public health and hospital and healthcare providers, between state and local public health [agencies] working on crisis situations where we needed to accomplish the impossible in a short time."
Ehresmann added, "This smallpox vaccination program was really the beginning of the more formal efforts the department has made for emergency preparedness at an all-hazards level. . . . I think the department is in a much better position that it was in December 2002. Not to say that we're in preparedness nirvana."
CDC spokesman Von Roebuck acknowledged that the CDC has not come up with a set of specific measures to define smallpox preparedness but said the agency is working toward them. He said the next round of agreements with states, whereby states submit preparedness plans and receive CDC funds, will include more specifics on what preparedness means.
"I don't really have measures to give you at this point, but those will be forthcoming in the next cooperative agreements, which will be later this year," he said.
Roebuck also commented that the states are holding smallpox vaccine doses that they ordered but haven't used. The states ordered a total of more than 291,000 doses, he said, which means roughly 250,000 doses haven't been used yet. In the case of an outbreak, having vaccine on hand "could be very beneficial to a particular location prior to when federal relief would come," he said.
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