Lessons Learned from the Smallpox Vaccination Program
As the committee observed in its first report, the smallpox vaccination program is not a typical public health program, but rather a biopreparedness program predicated on national security considerations (IOM, 2003a). Bioterrorism preparedness is a recent addition to the scope of work of public health agencies, and it presents opportunities and challenges (such as new types of information restrictions and new domains of uncertainty) as public health agencies learn to work with national security and defense entities on matters of shared concern.
The smallpox vaccination program is a case study in blending public health and national security interests to prepare for an event of low likelihood and high consequence—bioterrorism in the form of a smallpox virus release. The program will not be the last of its kind as long as terrorism, specifically bioterrorism, continues to be a threat. Therefore, discerning broad lessons to be learned from the smallpox vaccination program is important for ensuring the success of similar future programs. The present chapter highlights the committee’s major findings about the program and provides a conclusion and a recommendation based on those findings.
ABSENCE OF EXPLICIT SCIENTIFIC AND PUBLIC HEALTH RATIONALE FOR THE PROGRAM
In 2002, most public health officials and health care workers who participated in surveys or in several forums discussing smallpox vaccination expressed support for a limited pre-event smallpox vaccination effort and
willingness to be vaccinated if they were designated as members of smallpox response teams (Banks and Hannan, 2002; Everett et al., 2002; IOM, 2002; Yih et al., 2003). Yet the high degree of support for limited smallpox vaccination to prepare the nation to respond to attack did not generate a substantial turnout of volunteer vaccinees; by the end of 2004, fewer than 40,000 people had been vaccinated, far short of original estimates of turnout. The committee found several possible and related reasons for that incongruity.
First, the scientific and public health rationale that led to the smallpox vaccination policy was never fully explained to key constituencies—traditional partners in the development and implementation of public health strategies, including state and local public health agencies—that provided input to the process but whose advice and perspectives were not reflected in the final policy. Although the committee recognizes that the terrorist attacks of 2001 were a dramatic and persuasive reminder of the importance of biopreparedness, it was never made clear to the public health and health care communities why smallpox was selected as a primary target for biopreparedness, how pre-event smallpox vaccination was identified as a core strategy, and why vaccination was urgent.
Second, the scientific and public health rationale that led to the structure of the smallpox vaccination program (in its final form, characterized by the phases and numbers discussed elsewhere in this report) was never fully explained. The ultimate policy called for a much higher number of vaccinees than the original, cautious estimate provided to the government by the Advisory Committee on Immunization Practices (ACIP), and the rationale for offering the vaccine to 500,000 initially, then to up to 10 million, and finally to insistent members of the public was not made clear to important constituencies. Instead, confusing and contradictory information was presented to the public and the public health community about the policy and program.
Third, the limited amount of information that was provided to explain the rationale for the policy and for the structure of the program was neither updated nor reiterated during the course of the program despite strong signals that updating or reiteration was needed.
Fourth, program implementation was characterized by a lack of review of the program’s course and reassessment of starting assumptions. Despite calls for a pause to assess program progress and safety, the program continued. As its pace waned, there was no apparent attempt to reassess or review program implementation and its trajectory.
Finally, and most centrally, the ability of the Centers for Disease Control and Prevention (CDC) to speak authoritatively as the nation’s public health leader, on the basis of the best available scientific reasoning, was severely constrained, presumably by the top levels of the executive branch.
Because the smallpox vaccination program involved both public health and national security considerations, it is understood that the latter could involve classified information and thus limit what could be made available to the public. However, the apparent, unexplained constraints on CDC led to an environment in which the public health and health care communities and their leaders did not receive all the information needed to make institutional and individual decisions regarding smallpox vaccination (Selecky, 2003; Smith, 2003). There is little to suggest that the scientific and public health reasoning that typically characterizes the development of public health policies was a priority in this case. The expert input of public health leaders and other relevant constituencies was not reflected in the final structure of the smallpox vaccination policy. Agencies and organizations expected to be important partners in implementing the program expressed concerns and questions about it, and those concerns ultimately affected the program’s outcomes. Key constituencies remained skeptical about the need for the program, and their lack of buy-in led to poor participation in the vaccination program. At the institutional level, this is illustrated by the request of the Association of State and Territorial Health Officials (ASTHO) for an explanation of the rationale for the program (Selecky, 2003) several months after the beginning of vaccination. Among individual public health and health care workers, receiving what they perceived as insufficient information left them unable to accept smallpox vaccination.
Lack of Scientific and Public Health Rationale for the Existence of the Vaccination Program
In 2003, in Health Affairs, Kuhles and Ackman wrote:
The key message we received from potential vaccinees was that civilians are unlikely to voluntarily assume personal risk without good reason. Before performing an invasive procedure, physicians are required to undertake an informed-consent process with the patient, which spells out the indications, alternatives, and risks. The government owes its health care, public health, and first-responder communities the same consideration, particularly as it relates to the indications for vaccination, which thus far has been lacking.
Surveys of public health and health care workers (ASTHO, 2003; Everett et al., 2002; Yih et al., 2003), interviews (Kuhles and Ackman, 2003; Markowitz and Rosner, 2004), and newspaper articles (Associated Press, 2003; Bavley and Dvorak, 2003; Connolly, 2003a; Denogean, 2003; McCullough, 2003; McNeil, 2003; Ornstein and Bonilla, 2003; Wheeler, 2003) have shown that personal decision-making about smallpox vaccination was shaped by perceptions about known and considerable vaccine risk and unknown vaccine benefit in the absence of disease. The question of
vaccine benefit was linked with the rationale for the vaccination program. On the basis of mass media coverage of program progress and a variety of additional sources, including presentations to the present Institute of Medicine (IOM) committee, it appears that despite the expressed sense of personal commitment (May et al., 2003) to protecting the public’s health, both individuals and institutions found the information available for decision-making inadequate in quantity and quality and ultimately not sufficiently conducive to an affirmative decision regarding vaccination.
Communication about the smallpox vaccination policy and the decisions that led to it was incomplete and vague, particularly information quantifying or explaining the available evidence about the threat of smallpox and information about the epidemiologic and public health reasoning regarding whom and when to vaccinate. Although sensitive, classified information may have been involved, it does not appear that the complete facts needed for decision-making and buy-in at the state and local levels were shared with constituencies, and failure to do that had a detrimental effect on the program’s progress and, more important, may have compromised the relationship of trust between CDC and the public health community.
The president’s announcement stated multiple times that the government had no information that a smallpox virus release was imminent (White House, 2002). Information provided by the Department of Health and Human Services (DHHS) and CDC largely reiterated the president’s statements and shed no additional light on the evidence that led to the decision to begin pre-event smallpox vaccination (U.S. Department of State, 2002). At least some of the information appeared to be many years old, dating back to the fall of the Soviet Union (Gellman, 2002), and it was never made clear to the public what accumulation of evidence made smallpox vaccination an urgent priority. The president’s announcement that the threat was not imminent, although not zero, restated what had been the case for at least a decade. Undoubtedly, the events of September and October 2001 were important in shaping how old information was being viewed (White House, 2002).
A complete risk-benefit analysis in the face of extreme ambiguity seemed impossible, and both institutional and personal decisions regarding vaccination were complicated by the lack of information. The factual information available to institutions and individuals considering participation in the voluntary vaccination program consisted primarily of the following:
The president’s statement about the threat assessment.
The statements of other federal officials (including the director of CDC) about the threat assessment.
The recent occurrence of domestic terrorism and bioterrorism.
The immediacy of war with a nation that the administration asserted had weapons of mass destruction, including biologic weapons.
Historical evidence about the vaccine.
Historical evidence about the disease.
The provisions of Section 304 of the Homeland Security Act.
The resulting sense of uncertainty proved to be problematic. As one clinician stated, the perceived lack of evidence regarding a possible smallpox virus release was a deterrent to vaccination. “It is not enough for someone—whether it is the president or the secretary of state—to say, ‘I’m worried about this; trust me’…. We need more than that today as a profession and as a society,” he observed (Connolly, 2003a). In a presentation to this committee, the president of a large health and hospital system stated (Anderson, 2003) that he did not believe he had the evidence to support the vaccination of “even the core 100 [vaccinees]. It was our concern that there was evidence that we didn’t have, that we weren’t being given, or it wasn’t being shared, that something was more serious here than we thought. Maybe there was a weaponized product, that somebody had broken through, and that we weren’t being told about.” The hospital epidemiologist of a university health system stated (Edmond, 2003) that “we didn’t want the decision to vaccinate to be one that was ideological. We wanted it to be an evidence-based decision.” On the basis of the information available to it, the leadership of that university health system developed an institutional policy to undertake only planning for postevent vaccination and to implement smallpox vaccination only in any of three scenarios: if a smallpox case occurred anywhere in the world, if information were provided by the federal or state government about a serious smallpox risk, or if smallpox stocks were found outside the two approved repositories. Representatives of a large health plan also listed among problems with the program the perception that the case for smallpox vaccination was “never sufficiently compelling” and that the uncertainty surrounding the policy and program created distress and skepticism among staff (Skivington and Witt, 2003). Finally, interviews conducted with health officials and other public health experts in the early months of the program’s implementation indicated that some did not believe that a convincing case had been made to justify the pre-event vaccination program (Kuhles and Ackman, 2003; Markowitz and Rosner, 2004).
The Input of Key Constituencies
The committee’s knowledge of the circumstances surrounding the development of the policy is derived primarily from official CDC and DHHS transcripts of press conferences, testimony before Congress, presentations
at IOM committee meetings, and, to a lesser extent, mass media reports (when multiple reports corroborating an event were available). During the development of the smallpox vaccination policy, there was communication among CDC, DHHS, the Office (later the Department) of Homeland Security, and the White House (Cohen and Enserink, 2002). Multiple constituencies (including various entities in the health care, public health, and first responder communities) provided written and oral input to CDC and to Congress (for example, at CDC-organized forums across the nation) in the months before the policy was developed and during its implementation. For example, during summer 2002, CDC engaged its state and local partners (such as representatives of ASTHO and the Council of State and Territorial Epidemiologists) in numerous discussions and provided multiple opportunities for comment about the policy options being considered (ASTHO, 2002; CDC, 2002a; IOM, 2002). In June 2002, ASTHO held a conference call and then conducted a survey to determine its members’ views on strategies for smallpox preparedness. The survey found that a majority of state health officials were opposed to pre-event vaccination of the general public, but most supported pre-event vaccination of designated response teams (Banks and Hannan, 2002). Consensus reached at the June 2002 ACIP meeting reflected a similar opposition to pre-event vaccination of the general public and support for vaccination of specific groups of responders (CDC, 2002b). The ultimate policy decision on vaccinating members of the general public and on vaccinating health care workers differed from the consensus of key constituencies, and it is unclear to what extent their expertise and input were considered.
The collaborative nature of public health in the United States, described in the IOM report The Future of the Public’s Health in the 21st Century, makes partnership and communication essential to any program’s success. Within that process, the credibility of information and decisions from the national level sets the stage for all later decisions and actions by state and local health departments and their partners. Not knowing what evidence was considered and not receiving information about it from CDC—as evidenced by the fact that key partners, such as ASTHO, requested clarification (to the committee’s knowledge never provided) of the rationale behind the policy and the structure of the program—may have affected the public health community’s trust in CDC, as is evident in the expressed perceptions and concerns of many in the public health and health care communities (ASTHO, 2003; Pendley, 2003; Markowitz and Rosner, 2004). A recent CDC analysis of the swine influenza vaccination program of 1976 noted the importance of ensuring the credibility of decisions made by CDC (DHHS, 2004). The Neustadt and Fineberg analysis (1983) of the swine flu program also concluded that the program demonstrated an “insensitivity to the long-term credibility of institutions.”
The final vaccination policy differed considerably from the recommendations of public health leaders and other important constituencies, and those groups were left with questions about the rationale for the vaccination program. That contrasts with the implementation of more typical public health programs and with the principles of public health practice. First, the ethos of public health attaches great importance to the empower-ment and participation of a broad constituency in decision-making; a high degree of openness and collaboration also is consistent with the democratic principle of public accountability (Gostin, 1995). Second, effective policy-making requires identifying potential obstacles, and those are likely to be known or anticipated by key constituencies. The implementation of the vaccination program reveals missed opportunities at the level of policy-making to identify or adequately address potential obstacles to implementation (discussed in Chapter 3). For example, in addition to unease about compensation and liability issues, state and local public health agencies expressed concern that implementing a vaccination program of massive proportions, beyond the initial 500,000 vaccinees, would have safety implications and enormous resource requirements (Connolly, 2002; Hardy 2002; Libbey, 2003a, 2003b; Rosado, 2003).
That the policy was not consistent with the recommendations of key constituencies and its rationale was not clearly and adequately explained to them may also have led to difficulties in balancing competing priorities. For example, the vaccination program’s single-agent focus and great resource requirements burdened the public health system to the detriment of other public health activities, including the routine activities of public health and preparedness for other kinds of emergencies. Smallpox efforts were all-consuming for many local public health agencies, especially smaller health departments. Despite the bioterrorism grants that had been made available to states, state and local public health officials expressed frustration at the program’s vast underestimation of its direct and opportunity costs and argued that the vaccination program necessitated a diversion from bioterrorism plans that they had already developed in anticipation of funding (ASTHO, 2003; Cook, 2003; GAO, 2003; Kuhles and Ackman, 2003; Markowitz and Rosner, 2004; NACCHO, 2003a, 2003b; Staiti et al., 2003; U.S. House of Representatives, 2004). Of local public health agencies surveyed by the National Association of County and City Health Officials (NACCHO) in March 2003, 79 percent reported that smallpox activities adversely affected their other bioterrorism preparedness efforts (NACCHO, 2003a). County health officials also reported on opportunity costs of diverting staff to smallpox activities and on delaying or deferring other public health programs (Kuhles and Ackman, 2003; Madlock, 2003; Nikolai, 2003; NACCHO, 2003b; Markowitz and Rosner, 2004; U.S. House of Representatives, 2004). As one county public health agency struggled with
a tuberculosis outbreak, its efforts were complicated by the fact that its resources were greatly strained by a combination of budget cuts and the demands of the smallpox vaccination program. Other local health departments reported diverting staff from their regular activities, delays in childhood immunizations, cancelled family planning clinics, cuts in tobacco control and maternal and child health services, and other changes or cuts in services routinely provided by public health agencies (Connolly, 2003b; Cook, 2003; Hughes, 2003; Staiti et al., 2003).
Planning for the smallpox vaccination program appears not to have included sufficient analysis of the potential effect of vaccination activities on the provision of essential public health services and on other preparedness efforts or analysis of the added costs of implementing such a large vaccination program (GAO, 2003; IOM, 2003b, 2003c). It remains unclear to what extent the supplementary funding provided by DHHS in May 2003 ameliorated the fiscal challenges experienced by some jurisdictions.
Lack of Scientific and Public Health Rationale for the Structure of the Vaccination Program
The rationale for the program’s structure also was not fully explained. As discussed in Chapter 3, ACIP’s June 2002 recommendation to CDC and DHHS called for the vaccination of up to 20,000 people: public health personnel who would serve on smallpox public health investigation teams and health care personnel staffing designated “smallpox hospitals” (CDC, 2002b). John Modlin, ACIP chair, acknowledged the group’s unease with the unknown risk of smallpox virus release, but he believed that its recommendation to DHHS and CDC was made carefully. “The committee has been told that the risk is low but not zero. We obviously can’t put a number on that but we … assume that it’s low, and I think the decision that we made … balanced that low or very low risk with … the known risk from the vaccine” (CDC, 2002c). In October 2002, after the mass media had reported on the various figures being considered by the administration, one of which was 500,000 vaccinees, ACIP revised its recommendation in recognition that hospitals would probably resist being designated as smallpox hospitals and, more important, that smallpox-stricken persons would go to the nearest emergency department rather than to a designated location (Altman, 2002; Brown, 2002; CDC, 2002b; Cohen and Enserink, 2002). ACIP’s revised vaccination target was 500,000. The ACIP chair acknowledged that that was a “back-of-the-envelope” calculation based on the assumption that if the nation’s roughly 5,100 acute-care hospitals each vaccinated roughly 100 people, the total would be about a half-million vaccinated health care workers. That may explain in part how the target for the first phase of the program was derived, although to some the 500,000
figure seemed oddly coincidental with the estimate first suggested by White House officials, and there was some initial concern that ACIP was pressured to modify its earlier recommendation (Brown, 2002; Cohen and Enserink, 2002) (see also discussion in Chapter 2).
The rationale for the second and third phases of the program, vaccinating 10 million responders and insistent members of the general public, respectively, which surpassed and even diverged from ACIP recommendations and from the advice of constituencies such as the American Public Health Association, the American Academy of Family Physicians, the Emergency Nurses Association, and others that called for limited vaccination (AAFP, 2002; APHA, 2002; ENA, 2002; IDSA, 2002; May et al., 2003), was never shared with those who would implement the program or who would volunteer to be vaccinated. There was no apparent public health reasoning behind the decision to offer vaccine to the public. In fact, the present committee stated in its fourth report to CDC that “offering vaccination to members of the general public is contrary to the basic precepts of public health ethics, which focus on a fair and reasonable balance of risks and benefits among individuals and for the population as a whole” (IOM, 2003b; see Appendix E). The nation’s public health and health care communities expected an explanation of the public health reasoning behind the policy that would include an epidemiologic justification for offering vaccination to the three types of vaccinees identified, evidence that vaccinating response teams before a smallpox virus release would ensure a better and faster response to an attack, evidence that vaccinating other types of responders (such as firefighters and police) would substantially improve response effectiveness, and evidence that implementing specific pre-event vaccination activities would be an optimal use of resources as part of bioterrorism preparedness efforts. The committee is unaware of evidence showing whether and how the advantages and disadvantages of various pre-event vaccination options were carefully weighed and compared or evidence that decisions were made accordingly.
Confusing and Contradictory Information About the Policy and the Program
The contradictory and confusing information provided during the implementation of the smallpox vaccination program may have constituted another barrier to implementation of the program and may have undermined CDC’s credibility further. For example, the announcement of the policy and later explanations assured Americans that there was no imminent risk of smallpox virus release (U.S. Department of State, 2002; White House, 2002). Nevertheless, the federal government repeatedly called for rapid implementation of the vaccination program. CDC’s initial guidance
to the states called for implementing vaccination within 30 days (CDC, 2002d). After the program began, representatives of the public health community remarked on the challenging timeline and called for slower implementation (Hardy, 2002; Libbey, 2003a, 2003b). Although the initial 30-day timeline was later changed and CDC acknowledged that flexibility would be needed because of administrative difficulties and variation among states, CDC continued to call for rapid implementation without specifying the reason (CDC, 2003a, 2003c; Ornstein and Bonilla, 2003; Russell, 2003). CDC’s emphasis on safety and speed seemed contradictory and generated confusion and an atmosphere of near-crisis in which public health agencies at all levels felt compelled to undertake smallpox vaccination activities about which they had doubts (ASTHO, 2003; Connolly, 2003b; Cook, 2003; McKenna, 2003; NACCHO, 2003a; Pezzino, 2003). In addition, owing to the remarkable speed with which the program was implemented, a number of administrative and procedural components were not ready for implementation, as discussed in greater detail in Chapter 3. Although impending crisis would have justified a rapid response, that was not the case that was made. Instead, the rush to vaccinate as many personnel as possible as rapidly as possible gave rise to concerns about the wisdom of exposing people to an unsafe vaccine in the absence of a known threat of disease.
As described in Chapter 3, the present IOM committee and ASTHO urged CDC to pause after the first phase of vaccination to assess program safety and to plan for the next phase, and ACIP recommended terminating the program because of the occurrence of cardiac adverse events and their unknown long-term safety ramifications (CDC, 2003d; IOM, 2003d; Meckler, 2003a). The present committee repeated its call for a pause in the vaccination program in another report in which that was the primary recommendation (IOM, 2003b); however, despite its acknowledgment of the importance of safety, CDC stated that it expected the program to progress seamlessly from one phase to the next, at least in part to maintain momentum (Henderson, 2003; McGlinchey, 2003a). It is not clear whether CDC discussed the merits and costs of a pause in the vaccination program with its state and local counterparts. In the end, multiple state and local programs paused or stalled simply for lack of volunteer vaccinees.
Lack of Updating or Reiteration of the Rationale
The juxtaposition of impending war with the uncertainty surrounding the rationale for the vaccination policy and the lack of information pertaining to the smallpox threat assessment may have contributed to the program’s slow progress. In January and February 2003, simultaneously with the implementation of smallpox vaccination, the administration was demonstrating to the nation and international allies that a war in Iraq was neces-
sary to prevent the use of weapons of mass destruction. That clearly contentious matter was debated in Congress, in the mass media, and elsewhere. An attack on Iraq was argued on security, economic, foreign relations, military, and other grounds.
Although the federal government did not explicitly link the war with Iraq and the vaccination program and at times even denied that the rationale for the program was related to the rationale for the war, several officials (DHHS Secretary Thompson, CDC Director Gerberding, and CDC National Immunization Program Director Walt Orenstein) and legislators (Senators Bill Frist and Judd Gregg) made statements that could be interpreted as suggesting that the war was a factor in the decisions made about the smallpox vaccination policy and program or as asserting the importance of vaccination in view of developments related to the war and the possibility of a bioterrorrist attack (Frist, 2002; Gregg, 2002; Hallow, 2002; Manning and Sternberg, 2002; Pear, 2003; Rath and Turcotte, 2003; Tanner, 2003; Washington Post, 2002). Whether formally linked with the war or not, by its timing the smallpox vaccination policy was caught up in the larger debate with its emotional and polarizing consequences. Similarly, there was debate in some quarters about the efficacy and necessity of the vaccination program. According to the April 2003 General Accounting Office (GAO, now the Government Accountability Office) report, and to local health officials, hospital administrators, and others who were interviewed by the media or who addressed this committee, many people concluded that the risk of a smallpox attack was associated with the contentious war with Iraq (Anderson, 2003; Judson, 2003; Kuhles and Ackman, 2003; Krupnick, 2003; Manning, 2003; McKenna, 2003; McNeil, 2003). As the weeks passed, major combat in Iraq ended; the homeland security threat level, which had been increased before the war, was lowered; and the smallpox threat did not materialize. In September 2003, the U.S.-led Iraq Survey Group reported that it did not find weapons of mass destruction in Iraq; in particular, the group found no evidence of smallpox (Linzer, 2003; CIA, 2004; UN Security Council, 2004). Unfortunately, the smallpox threat assessment was neither updated nor reiterated, and that left many prospective volunteers in the public health and health care communities to draw their own conclusions about the threat status and may have further eroded their trust, given what they were (or were not) hearing from their federal-level partners. Those factors may have contributed to a waning sense of urgency; combined with concerns about cardiac adverse events, they go far to explain the declining rate of vaccination.
At the May 2003 meeting of the present IOM committee, ASTHO summarized what the nation’s health officials considered requirements for advancing smallpox preparedness, including a definition of the full scope of smallpox preparedness, a national consensus on who should be asked to
consider voluntary vaccination (before an event) and why, a clear articulation of the best available intelligence information regarding the nation’s potential risk of smallpox, and a clear statement of all known benefits and risks associated with smallpox vaccination (Selecky, 2003). Even months into the vaccination program, public health officials were actively seeking more information about the threat of smallpox virus release and the rationale for smallpox vaccination.
The Senate Select Committee on Intelligence Report on the U.S. Intelligence Community’s Prewar Intelligence Assessments on Iraq (2004) and the report of the special adviser to the director of central intelligence on Iraq’s weapons of mass destruction found much of the evidence on the existence of weapons of mass destruction in Iraq to be weak, including the evidence on smallpox (CIA, 2004). The significance of those reports is not that the evidence that may have been used to make the vaccination policy had been brought into question but rather that the evidence and the extent of uncertainty about it were not communicated to relevant constituencies as part of a discussion of the scientific and public health rationale for the vaccination program. Policies and programs are sometimes found to have been based on flawed information and are accordingly changed or terminated. Public health decisions are sometimes made in the face of great uncertainty, but the uncertainty is generally openly discussed. The Senate and Central Intelligence Agency reports give rise to questions about why a sense of uncertainty about the probability of smallpox virus release was not more openly conveyed, with more information about the rationale for the policy, and why the threat assessment was not clarified, changed, or confirmed as the sense of urgency in the program diminished and the rate of vaccination dropped. Although DHHS and CDC officials expressed concern about the loss of momentum in the pre-event smallpox vaccination program and the apparent complacency among health care and public health workers, there was neither a formal reiteration of the threat assessment nor a formal reassessment of whether and how the program should continue (Fiorill, 2003; Meckler, 2003b). If the decision to vaccinate was based on some type of evidence, how could the decision remain unchanged when the evidence apparently changed? Again, the absence of a science-based and public health-based public explanation to either continue or end the program may have constituted a threat to trust.
Lack of Review of the Program’s Course and Lack of Reassessment of Starting Assumptions
In its report on another controversial vaccination program, the swine influenza program of 1976, GAO (1977) recommended that “when decisions must be based on very limited scientific data, HEW [the Department
of Health, Education, and Welfare, predecessor of DHHS] should establish key points at which the program should be formally evaluated.” Another analysis of the swine influenza program (Neustadt and Fineberg, 1978) recommended “a comprehensive definition and review of assumptions everyone can see and weigh before decision and remember after. The review thus should be public.” The multiple assumptions and decisions involved in the swine influenza vaccination policy were never clarified before or during the program, and the program lacked designated points for stopping to assess program progress and safety and to plan for the future.
In the case of the smallpox vaccination program, the transition between the first and second phases of the vaccination campaign seemed to offer an appropriate point for stopping to evaluate assumptions, assess safety, and plan for what would be needed for a new population of vaccinees. The executive director of the American Public Health Association underscored the need to reassess assumptions before progressing to a new population of vaccinees (McKenna, 2003). As noted, in May 2003, the present committee called for a pause in the vaccination program before the second phase (IOM, 2003d). In June 2003, ACIP recommended that CDC not proceed with smallpox vaccination beyond the initial group of health care and public health response team members (CDC, 2003d). ACIP cited the cardiac adverse events: the fatal myocardial infarctions that prompted the development of cardiac exclusion criteria and the military and probable civilian cases of heart inflammation (myo/pericarditis) that came to be considered serious adverse events related to vaccination. Subsequent to ACIP’s or IOM’s calls to stop or pause, CDC Director Gerberding reiterated the agency’s commitment to proceeding with smallpox vaccination (CDC, 2003e). Although CDC’s rapid and appropriate response to the cardiac adverse events may provide partial evidence of the effectiveness of the adverse event active surveillance system and demonstrate the emphasis on safety, this IOM committee remained concerned that without a programmatic pause, states would have no opportunity to benefit from a national-level evaluation and perspective on the smallpox vaccination program. Given the much higher numbers of vaccinees expected in the second phase of vaccination, the potential for complications and other challenges seemed greater and therefore justified careful evaluation of phase I and planning for phase II, especially the communication, training, and education needs.
CDC’s Role in Providing Scientific and Public Health Reasoning for Policy
Even in ordinary circumstances, policy-making in the federal government is a complex and somewhat amorphous process. Conflicting values
and priorities and multiple sources of evidence and data are involved (Gostin, 1995). The process that led to the smallpox vaccination policy may have been similar to the development of other public health policies, except for its unusual marriage of public health and national security. Although many principles that guide other public health programs appeared to apply, the nature of the problem to be addressed by the policy made it likely that most decisions would, in time, be scrutinized and criticized. The decision to take preventive action in circumstances in which preparation itself poses a risk or cost (as in the case of smallpox vaccine) would be criticized if the threatened event did not occur. Without a doubt, a decision to do nothing would be criticized if the threat did materialize. The smallpox vaccination program occurred in an environment of great uncertainty, so it required a clear explanation of its scientific and public health rationale and required every reasonable effort to ensure transparency and effective, regular communication among public health agencies at the federal, state, and local levels.
The presentations of multiple public health and health care leaders at the committee’s meetings, substantial coverage by the mass media, surveys and briefs from ASTHO and NACCHO, findings of the 2003 GAO report, a summary of interviews with public health workers (Markowitz and Rosner, 2004), and ultimately the slow and halting progress of the vaccination program itself provided the committee with ample evidence that many in the public health and health care communities were skeptical or confused about the rationale for the program. The committee asserts that the reaction of the public health community in particular to the program (for example, deferring or refusing participation) indicates that the trust of public health agencies, officials, and workers in CDC as the nation’s public health leader was compromised. As National Institute of Allergy and Infectious Diseases Director Anthony Fauci stated (2002),
because people of good intentions disagree on government policy regarding smallpox vaccination in the context of a bioterrorist threat, the general public must understand the decision-making process as well as the rationale behind decisions that may affect their health and their lives. The need to be forthcoming is of particular importance, given the terrible trauma caused by the unforeseen events of September 11, 2001, as well as the anxiety associated with the continued threat of bioterrorist attacks. Because the population feels powerless, it must rely heavily on the deliberations and decisions of government leaders.
Explaining the decision-making process behind the smallpox vaccination policy to the public was important for both ethical and practical reasons (to inform and to reassure). Yet the federal government provided little public communication during program implementation. For the people expected to implement and participate in the program, explaining
the decision-making process seemed crucial for the preparedness program’s very existence, to safeguard the trust between CDC and its public health partners, and to secure the agreement and participation of public health agencies, health care organizations, professional associations, and other constituencies.
CDC has long been a leader in protecting the public’s health by playing many roles, including supporting state and local health departments, supporting and evaluating the nation’s immunizations programs, and performing the epidemiology and laboratory functions of communicable disease control. CDC’s leadership role and the centrality of scientific evidence to its mission (CDC, 2004) are apparent in the agency’s relationships with public health agencies and in CDC’s performance in response to major crises, such as the SARS outbreak of 2003. The committee asserts that CDC’s leadership role depends in part on the agency’s ability to function as the definitive voice of science-based public health; its decisions and recommendations must always be seen as emerging logically from the best available scientific and public health reasoning. Many in the public health community did not perceive that to be the case during the smallpox vaccination program. Indeed, the national security context may have complicated CDC’s ability to provide and communicate scientific and public health reasoning in the development of smallpox vaccination policy; CDC leadership may have been unable to disclose some of the underlying data, or such information may not have been made available to CDC itself.
The committee recognizes that public health policy decisions are not made solely on the basis of conclusive scientific data although science is accorded an extremely high value. The circumstances surrounding the smallpox vaccination policy at the interface between public health and national security interests were conducive to decision-making with little or no attention to public health and scientific imperatives. Those circumstances made CDC’s role as the voice of science-based public health even more critical, yet CDC appeared unable to communicate in its typically transparent and clear manner. Furthermore, the implementation of the smallpox vaccination program was characterized by targets that were established and changed, phases that were established and eliminated, and recommendations that were sought—from ACIP and from the present IOM committee—and then not followed (Brown, 2002; CDC, 2002b, 2003b; McGlinchey, 2003a). Although it is not surprising that the program changed and its goals shifted, little or no explanation was given of the reasoning behind the decisions. In the short term of the program’s implementation, the unanswered questions and concerns that overshadowed the program contributed to problems and delays. In the long term, those issues may have created barriers to strengthening preparedness and may have impaired reliance on CDC as the nation’s definitive public health
leader and one of the best sources of science-based, timely, and accurate public health information.
Based on the lessons learned from the smallpox vaccination program, the committee concludes that a policy strategy and a mechanism are needed to balance the need for scientific evidence and public health analysis with the imperatives of national security, ensuring in the process that the authoritative voice of CDC, the nation’s public health leader, will be preserved.
OUTCOME UNKNOWN: HAS SMALLPOX PREPAREDNESS BEEN ENHANCED?
The smallpox vaccination program did not progress according to expectations, and its overall contribution to smallpox and public health preparedness is unclear (GAO, 2003; Gursky, 2003; U.S. House of Representatives Select Committee, 2004). The perception that the vaccination program’s focus was on numbers of vaccinees rather than on smallpox preparedness was apparently created and perpetuated by a failure to communicate effectively about goals and objectives and about program progress and challenges.
Focus on Numbers Rather than Preparedness
The initial distinction between pre-event vaccination plans and postevent plans may have caused some confusion because vaccination of response teams is an activity that could be simply included among smallpox post-event plans as the only type of vaccination activity that occurs in advance of a smallpox virus release. The CDC director’s statement in November 2003 that the agency never had a vaccination program but had a preparedness program (a comment described by the mass media as a denial of the program’s existence) amounted to a distinction that had not been adequately communicated to the public or to the media (McGlinchey, 2003b; National Press Club, 2003). The vaccination effort was officially titled “the National Smallpox Vaccination Program” (CDC, 2002d), and it was meant to be one component of preparedness: vaccination of workers who would help to shorten the response time in the event of a smallpox virus release. However, the way in which the program was portrayed made its focal point “How do we get to these numbers?” rather than “What do we have to do to protect the country from this potential threat?” Ideally, vaccination would have been described as one activity in a comprehensive smallpox preparedness program. The ineffective communication on that important point might have misrepresented the program’s goals, adversely
shaped the opinion of many in the public health and health care communities, and created confusion in the mass media.
Within several weeks of the beginning of the vaccination program across the nation, the mass media reported a halting start (slow in comparison with the pace suggested by the initial 30-day timeline) as prospective vaccinees weighed substantial unknowns against what they knew about potential vaccine complications and in the absence of an adequate compensation plan (Bavley and Dvorak, 2003; GAO, 2003; Kemper, 2003; McCullough, 2003; Ornstein and Bonilla, 2003). The vaccination rate dropped steeply in April and May 2003 in the wake of cardiac adverse events and the announced end of major combat in Iraq. As DHHS and CDC officials were questioned about the number of vaccinees necessary for preparedness, the figure of 50,000 was offered although no additional guidance was made available to advise states on the numbers they would need to “effectively investigate an outbreak, care for patients, and vaccinate members of the public”, especially given the variation among states and the difference between the number achieved and initial estimates (GAO, 2003). The value and legitimacy of the vaccination program were further questioned in news reports that documented shifting goals and CDC’s often uneasy communication on the matter, for example, a change in the DHHS-CDC position on the numbers of vaccinees, denial that there had been a change in the program’s focus, and the claim that preparedness, not numbers of vaccinees, had been the focus all along (Roos, 2003; Shockman, 2003). Public health officials even expressed some concern that they might have inadvertently created an exaggerated perception of the risk posed by the vaccine by being exceedingly cautious in informing prospective vaccinees about possible complications (Connolly, 2003a).
In a program already beset by ambiguity and unanswered questions, numbers seemed to constitute one concrete element, but the lack of an explanation of the scientific evidence and public health reasoning that went into shaping the smallpox vaccination program left the numbers—and the expectations of key actors, the mass media, and the public—ungrounded in factual information. Because preparedness was not defined from the beginning and the concept of broad preparedness was not reiterated and reinforced during the course of the program, numbers, however inexact, became a proxy for preparedness. The lack of clarification of the relationship between vaccination and preparedness allowed vaccination to obscure and even supersede comprehensive preparedness in rhetoric and in practice. Little or no explanation or evidence was provided to explain whether preparedness was related to vaccination; whether vaccination was required for preparedness and, if so, what number of vaccinees; and what constitutes preparedness. In fact, some of the early communication from CDC implied that preparedness required vaccination and that rapid vacci-
nation was essential for preparedness (CDC, 2003a). Not until several weeks into the program did CDC state that “preparedness is not numbers,” echoing statements made by ASTHO and by the present IOM committee (Cook, 2003; IOM, 2003d; Kuhles and Ackman, 2003; NACCHO, 2003a; Selecky, 2003). Months into the program, when CDC attempted to reorient program focus toward the full scope of preparedness, the efforts were perceived as an attempt to divert attention from a troubled program (McGlinchey, 2003b). The pattern of confusing vaccination numbers with preparedness continued. In 2004, the DHHS secretary responded to a question about the status of smallpox vaccination, stating that “we would like to be able to keep increasing that vaccination number, so that every state is ready” and perhaps reinforcing the perception that numbers were a correlate of readiness (DHS, 2004).
Despite the late effort to differentiate preparedness and vaccination, the committee has determined that many people and institutions were able to distinguish between the two. For example, public health agencies worked on training staff, developing communication plans, and other preparedness activities while hospital administrators who decided not to receive or implement vaccination at the time continued to work on planning, training, education, and other elements of preparedness (Edmond, 2003; Selecky, 2003; Toomey, 2003).
There are other challenges to the claim that preparedness was the program goal from the beginning. If preparedness, not numbers, was the program’s focus, the frenetic pace of vaccination imposed at the beginning of the program was not needed. If the program had all along been about preparedness and not about numbers of vaccinees, CDC could have decided to delay the program because of concerns about compensation, the states could have been encouraged to proceed with their planning, training and education, and related preparedness efforts while deferring vaccination until compensation and other issues were resolved. The federal government’s single-minded and intense focus on vaccination and vaccination targets also imposed great burdens on public health agencies that may have affected not just the routine work of the agencies (the Ten Essential Public Health Services) but their ability to develop comprehensive smallpox preparedness in the context of bioterrorism preparedness.
Is the Nation More Prepared Against Smallpox?
It is unclear whether smallpox preparedness has been strengthened. Government officials have said that preparedness has been improved, but the committee is not aware of the evidence that such readiness has been reached. That type of evidence, properly communicated, is critical to reassure the public that local, state, and federal public health agencies have the
equipment, staff, and other resources to mount an effective response to an attack that uses smallpox virus. Smallpox preparedness also has broader implications for other types of preparedness. For example, the capacity to implement mass vaccination requires many of the plans and resources that are needed to implement mass distribution of other types of countermeasures, from iodine tablets to anthrax prophylaxis.
At the committee’s November 2003 meeting, the director of CDC’s Office of Terrorism Preparedness and Emergency Response (OTPER), Joseph Henderson, presented the agency’s efforts to define and measure public health preparedness, including smallpox preparedness. CDC had developed 4 preparedness goals, 22 objectives, and 127 indicators, 10 of which specifically addressed smallpox preparedness. CDC intended the indicators to serve as a way to “scorecard” preparedness nationally and state by state and as a way to evaluate compliance with grant guidance (Henderson, 2003). This IOM committee was asked to review the smallpox preparedness indicators (in the context of the larger bioterrorism indicators project) and to advise CDC on their appropriateness and on ways to determine when an indicator had been met. The committee devoted its fifth report, included here as Appendix F, to a review of the indicators and included an assessment of relevant constituencies (state and local public health agencies, health care professionals, health care institutions, and first responders), whose input was solicited at the November 2003 meeting. In that report, the committee stated that preparedness for public health emergencies (including a potential smallpox event) should be part of overall continuous quality improvement of the public health system (IOM, 2003e).
CDC appears to have continued its work on the performance indicators; but at the time the present report was being written, no indicators or other assessment tool had been implemented. In May 2004, at the meeting of the DHHS secretary’s Council on Public Health Preparedness, a CDC official stated that efforts to develop assessment tools were continuing and summarized CDC’s Evidence-Based Performance Goals for Public Health Disaster Preparedness—42 performance goals and 47 measures (Knutson, 2004). In July 2004, at the CDC–American Medical Association First National Congress on Public Health Readiness, the director of CDC’s OTPER noted that CDC’s Evidence-Based Performance Goals for Public Health Disaster Preparedness—more recently, consisting of 35 performance goals and 45 measures—would be available for review on August 31, 2004 (Schable, 2004).
The committee is unaware of the current status of the performance goals and measures. On the basis of available information, the committee has concluded that the nation’s smallpox preparedness has not yet been formally, systematically, and comprehensively evaluated. Therefore, if the smallpox vaccination effort was in fact part of a larger preparedness pro-
gram, it is unclear whether the effort succeeded in strengthening preparedness. An early program objective was to build the capacity of every state to vaccinate its entire population within 10 days of a smallpox virus release. Although an ASTHO survey has found that most states believe they are prepared to complete mass vaccination within 10 days and the DHHS secretary has stated that most states “could vaccinate every person … within 10 days, and that’s our goal” (DHS, 2004), there are no data to confirm that states and the nation as a whole would be able to accomplish that. Furthermore, defining preparedness is still a necessity because it is unclear what information has been used to determine that 10 days was an appropriate target. The window of opportunity for smallpox prophylaxis is believed to be 3-4 days after exposure (CIDRAP and IDSA, 2004). If so, aiming to vaccinate all within 10 rather than 3 days would probably be insufficient for the prevention of next-generation cases if exposure were widespread—and certainly insufficient to avert public concern about whether everyone can obtain protection if needed.
After nearly 2 years of great effort, considerable expenditures, and the smallpox vaccination of nearly 40,000 people, the nation remains with insufficient evidence that it is prepared to respond to a smallpox virus release. In fact, the delay evidenced in the response to the monkeypox outbreak (CDC was informed of the outbreak 13 days after its start), which could be considered a proxy for a bioterrorist attack, indicates that considerable gaps in preparedness remain (Mitchell, 2003).
The committee recommends that, in collaboration with its state and local partners and in the context of broad bioterrorism preparedness, CDC define smallpox preparedness; set goals that reflect the best available scientific and public health reasoning; conduct regular, comprehensive assessments of preparedness at the national level and by state; and communicate to the public about the status of preparedness efforts.
This will inform and reassure Americans about the public health system’s ability to protect their health and will help jurisdictions continuously improve and learn from the process of preparing for public health emergencies, including smallpox virus release.
Trust is a unifying theme among the committee’s findings. The committee asserts that a relationship of trust between CDC and the public health and health care communities is a critical requirement in the implementation of biopreparedness programs. When a policy has the potential to greatly affect the public’s health, an explanation of the evidence base and rationale that led to the policy becomes necessary to justify and mobilize public
health action. The rationale of the smallpox vaccination program was never adequately explained to key constituencies and communication with CDC was constrained by unknown factors. As a result, the public health and health care communities seemed unable to trust the government and CDC fully when they called for smallpox vaccination in large numbers and at a rapid pace. The pace of vaccination ultimately declined, and the number of vaccinees reached fell far short of initial expectations. CDC’s credibility has been recognized to be an important asset.
The role of CDC as the nation’s public health leader—providing scientific and public health reasoning to inform the process of policy-making and to explain the rationale for policy to key constituencies—must be safeguarded. The reality and perception of CDC’s independence to communicate openly and transparently came into question during the implementation of the smallpox vaccination program. It is essential to preserve the public health and health care communities’ trust in CDC’s leadership; therefore, when reasons of national security limit CDC’s ability to perform its role, that fact should be made explicit and public.
The trust of the general public in government and government’s ability to protect the public’s health also is a critical requirement for responding to bioterrorism (and other public health threats). Communication experts (Covello and Sandman, 2001; Sandman, 2002) and a recent survey (Lasker, 2004) have shown that people’s trust in the government must be handled with great care, but it is an essential requirement for effective communication; people are less likely to panic and more likely to participate constructively during an emergency if they believe they can trust government agencies to provide accurate and timely information.
The public’s confidence in the public health system’s capacity to protect people in a bioterrorism event efficiently and effectively depends on evidence and reassurance that CDC and the nation’s public health agencies are prepared. Although considerable resources and effort have been invested in the smallpox vaccination program, it remains unclear whether the nation is more prepared than it was before to respond to an attack with smallpox virus; preparedness has not been defined, clear goals have not been set, and there has been no comprehensive and systematic assessment of smallpox preparedness. Such an assessment is necessary to demonstrate that the nation is prepared and to communicate that to the public.
Since the eighteenth century, American governments at all levels have determined that public health is an appropriate concern. The history of the agencies established shows regular debates about the array of activities to be expected and the degree to which decision makers and the public agree with the rationale that prompts action. Decisions about regulation of drinking water, protection of the food chain, immunization of children, and many other matters reflect those concerns. Without a regular exchange of
trustworthy information and clarity of rationale, the ability of the public health community to act decisively when needed is compromised. The committee believes that it is crucial for the highest level of the executive branch of the federal government to examine the consequences of the unclear rationale for the smallpox vaccination policy and for CDC itself to undertake a careful and transparent analysis of the problems encountered by the smallpox vaccination program, from problems with implementation to the lack of known outcomes. Only such an effort, in collaboration with public health partners at the state and local levels, can lay the foundation for a preparedness program that can build on the trust so central to a public health community and can reassure the public that the nation’s public health system is prepared to protect their health.
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