Preparing for Avian Influenza: Lessons from the "Swine Flu Affair"
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SUPPLEMENT ARTICLE
Preparing for Avian Influenza: Lessons
from the “Swine Flu Affair”
Harvey V. Fineberg
Institute of Medicine, Washington, DC
As a low-likelihood, high-consequence event, the possibility of an influenza pandemic poses a difficult challenge
to policymakers. Drawing from the ill-fated swine influenza immunization program of 1976, this article outlines
7 lessons that apply to preparations for avian influenza: (1) beware of overconfidence in models drawn from
meager evidence, (2) invest in a balanced portfolio of research and contemporary preparedness, (3) clarify
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operational responsibilities in the federal government, (4) refrain from overstatement of objectives and mis-
representation of risk, (5) strengthen local capacity for implementation, (6) communicate strategically, and
(7) lay the basis for program review.
The “swine flu affair” was an unprecedented effort in concerned with the danger that “the lessons of the crash
1976 to immunize the entire US population against a program are learned too well—too literally—producing
possible swine influenza epidemic. The program even- stalemate in the face of the next out-of-routine threat
tually resulted in the immunization of approximately from influenza. Someday there will be one” [2, p. xxvi].
one-fifth of the US population—many more Americans This article summarizes some of the key lessons that
than had ever been inoculated against influenza in 1 we gleaned from the swine flu affair and suggests ways
year. However, no epidemic appeared, and the reported that these lessons may be applied to preparations for
adverse effects of vaccination led to the program’s sus- avian influenza.
pension. The press characterized the program as a fail-
ure and a fiasco. For public health leaders, it was a FEATURES OF THE SWINE FLU AFFAIR
searing experience.
In 1978, at the invitation of Joseph Califano, secre- In drawing lessons from the swine influenza immu-
tary of the Department of Health, Education, and Wel- nization program, Neustadt and I identified 7 leading
fare at that time, my senior colleague Richard E. Neus- features [1, 2].
tadt and I prepared a report on the swine influenza 1. Overconfidence in theory spun from meager
immunization program, which was republished with evidence. Major epidemics of influenza occur infre-
additional case material in 1983 [1, 2]. We intended quently—perhaps 3 or 4 times/century; thus, there are
this analysis to reveal lessons that could be applied to relatively few opportunities for observation during a
subsequent threats from influenza. We were particularly lifetime, compared with the time span available for the-
orizing from the data. In a review published in 1977
[3], Beveridge reported that the 20 major influenza
Potential conflicts of interest: none reported. pandemics between 1729 and 1968 occurred at irregular
Presented in part: Harvard University Asian Flus and Avian Influenza Workshop, intervals of between 3 and 28 years. In contrast, on the
Cambridge, Massachusetts, 8–10 December 2006.
Financial support: supplement sponsorship is detailed in the Acknowledgments.
basis of too few, relatively recent observations, leading
The views expressed are those of the author and do not necessarily represent experts in 1976 expected to encounter major influenza
the views of the Institute of Medicine.
Reprints or correspondence: Dr. Harvey V. Fineberg, Institute of Medicine, 500
pandemics at regular intervals of 11 years [4]. Similarly,
Fifth St. NW, Washington, DC 20001–2721 (fineberg@nas.edu). the idea of antigen recycling at regular intergenerational
The Journal of Infectious Diseases 2008; 197:S14–8 periods of 60 years was not supported by enough data.
2008 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2008/19704S1-0004$15.00
A careful review of annual mortality due to influenza
DOI: 10.1086/524989 in the United States suggests caution regarding the
S14 • JID 2008:197 (Suppl 1) • Finebergbelief that an antigenic shift is necessary for and inevitably expert endorsement, widespread private involvement, adequate
produces a severe influenza season. In 1976, Dowdle [5] re- state operations, 3 months to complete immunization, no use-
ported that, of the 6 peak years of excess mortality due to ful stockpiling, no liability legislation needed, and few (if any)
influenza A virus infection in the United States (1936, 1943, opportunity costs. The problem expressed itself in the failure
1953, 1957, 1960, and 1963), only 1957 coincided with an to take seriously the questions that Russell Alexander posed in
antigenic shift in the virus. The epidemic caused by Hong Kong early discussions at the CDC: What evidence, at what points
influenza virus in 1968 was not included in these 6 peak years in time, and about which things should prompt us to consider
and resulted in a mortality rate only slightly higher than that a change and to what new course?
in 1967. 5. Failure to address uncertainties. Scientists are reluctant
2. Conviction fueled by preexisting agendas. The interests to quantify subjective risk, and lay leaders typically refrain from
and desires of many of the key players in the swine flu affair eliciting quantitative estimates of risk. It is hard for anyone to
shaped their judgments. These were not matters of personal separate the likelihood of an event from its severity, and this
financial interest but deep-seated beliefs and goals. Jonas Salk confusion distorts understanding of the meaning of “risk.” In
had a long-standing interest in closing what he called the “im- the absence of likelihood estimates, it is difficult to be explicit
munity gap,” on the basis of his conviction that prevention of about threshold conditions that might warrant a change in
disease by vaccination was an achievable perfection of the hu- course. Because no lay leader had demanded any estimate of
man condition. Ed Kilbourne, a distinguished influenza expert, probability, Cooper could honestly tell President Ford in the
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felt that active surveillance and wide-scale immunization of- summer that nothing had changed: an epidemic was still “a
fered a unique and valuable learning opportunity. Reuel Stal- possibility,” even though the absence of any cases of swine
lones, an adviser to the Centers for Disease Control and Pre- influenza anywhere in the world meant that, certainly in the
vention (CDC), saw a chance to demonstrate the value of minds of many experts, the possibility had diminished
epidemiology as a fundamental health science. David Sencer, quantitatively.
director of the CDC, and Ted Cooper, assistant secretary for 6. Insufficient questioning of implementation prospects. A
health, both believed in the central role of prevention in public number of the difficulties that hampered the swine influenza
health. Sencer also wished to showcase the vital place of the immunization program were not adequately understood, such
CDC on the national scene, and Cooper saw the program as as the different perspectives of public health experts, vaccine
an opportunity to promote the kind of public-private part- manufacturers, and insurers on the question of vaccine liability.
nership that he saw as key in the advancement of the health Even with early, nearly unanimous agreement in expert opin-
of Americans. ion, opposition over time from some informed experts was to
3. Zeal by health professionals to make lay superiors “do be expected. Delays in the national program arose from issues
the right thing.” The principal public health leaders felt com- of liability, dosage, and consent. However, the most funda-
pelled by their duty to protect the public’s health. They were mental problem of implementation was the varied performance
making a heroic response to a dramatic threat, and they were of different jurisdictions in the immunization program—a pre-
concerned about a lack of understanding among their lay su- dictable problem on the basis of past immunization experi-
periors, who might fail to appreciate the potential catastrophe ences. Cooper had a tendency to feel that he could “doctor his
of a recurrence of the 1918–1919 pandemic. They were deter- way through” any difficulties as they arose, as did many others.
mined to avoid the failure to immunize sufficiently that oc- 7. Insensitivity to media relations and to long-term cred-
curred in 1957, when an outbreak began early during influenza ibility. Early impressions count, and they are hard to undo,
season [6]. They were on a mission to “do the right thing” and which puts a premium on preparation for the early and major
to make certain that their lay superiors acted accordingly. news events that accompany a new national program. NBC and
4. Premature commitment. The fundamental strategic CBS reached different impressions at the outset of the swine
blunder of the swine flu affair was concatenating the decision influenza immunization program, because they had pursued
to institute a universal vaccination campaign with the decision the story in different ways—one through political contacts and
to begin manufacturing the vaccine. This premature commit- the other through local contacts in Atlanta and at the CDC.
ment was coupled with the failure to quantify risk or to be In journalistic terms, each approach had merit. Ironically, the
explicit about other assumptions, such as the likelihood of a political route of inquiry led to the conclusion that the decision
pandemic (of what size, what severity, and what duration), a must be scientific, and the public health line of inquiry led to
sufficiently high yield from eggs used to grow the vaccine virus, the conclusion that the decision must have a strong political
protective immunity from just 1 dose of vaccine per person, component. The authorities did not adequately prepare the
high vaccine efficacy, unparalleled acceptance, favorable pub- media for predictable events, such as coincident deaths and the
licity, sustained congressional support, broad and continuing possibility of previously unrecognized adverse effects (to name
Lessons from Swine Influenza • JID 2008:197 (Suppl 1) • S15just 2), nor did they adequately prepare themselves to deal with ication in the prevention of and response to disease outbreaks,
contradictory views espoused by contrarian experts. This oc- including international collaboration and aid; the preparedness
curred in addition to the fundamental communication problem of hospitals and health care providers for a possible onslaught
that emerges when a policy of immunization continues to be of patients, including the availability of respirators and infec-
followed when the likelihood of an outbreak declines. By not tion-control facilities; the potential disruption of essential ser-
laying the basis for program review and not establishing review vices, economic dislocation, and the maintenance of civil order;
checkpoints, public officials placed their institutions’ long-term and research strategy and timing for new vaccines and field
credibility at risk. They concentrated on the worst case in the trials, for more-efficient vaccine-production methods and in-
short run—namely, a severe pandemic. If they had thought as creased production capacity, and for rapid, accurate, field-based
hard about the most likely case in the long run (adverse effects, diagnostic tests. The US Congress has enacted legislation (Pub-
lawsuits, and no pandemic), the risk of diminished credibility lic Readiness and Emergency Preparedness Act, Public Law 109-
would have loomed large. 148, 30 December 2005) that provides liability protection to
vaccine manufacturers during a declared public health emer-
LESSONS FROM THE SWINE FLU AFFAIR AND gency; thus, one stumbling block from the past has been
AVIAN INFLUENZA PREPAREDNESS removed.
Bearing in mind the similarities and differences between
A number of parallels between the swine flu affair in 1976 and
swine influenza and avian influenza, I suggest 7 lessons for
avian influenza in 2008 are obvious; others are subtle. In the
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avian influenza preparedness.
attempt to identify lessons, dissimilarities are as important as
1. Beware of overconfidence in models drawn from meager
similarities [7]. The specter of the great influenza pandemic of
evidence. Today’s model builders, like the influenza theorists
1918–1919 cast a harsh shadow in 1976 and 2008. The threat
a generation ago, can lead the unwary into overconfident ex-
of a potential pandemic among humans spurred preparations
pectations. Properly interpreted, models play a valuable role.
in both years. Although scientific understanding of influenza
Models can help identify the requirements needed for inter-
has advanced strikingly over the past 3 decades, uncertainties
ventions to succeed, clarify thinking about alternatives and their
regarding likelihood and severity have been a shared reality in
consequences, enable the exploration of particular assumptions
both years. National immunization programs depend pro-
and structural elements without losing sight of the whole, and
foundly on the success of preparation and execution at the local
detect variables in which relatively small changes can strongly
and state levels. Public understanding and support remain crit-
ical to a successful program. Among the more salient distinc- influence results. The model builders can quantify the degree
tions between then and now are the global scope and distri- of uncertainty that should be considered with their predictions,
bution across species of avian influenza and the consequent which can help deter overinterpretation. Models can produce
need for global cooperation; the absence of an available vaccine more-robust conclusions if they include a variety of structural
to protect human populations from avian influenza; the current assumptions and ranges of estimates and if they are supple-
existence of antiviral medication as a potential tool for the mented with information from a variety of sources, such as
prevention of or response to a pandemic; the complexity of historical case studies, laboratory findings, and field investi-
governmental organization and decision making in post–Sep- gations. The most useful models will incorporate sensitivity
tember 11 America; and the novel and diverse forms of public analyses, measures of uncertainty, and changes in assumptions;
media and communication, including e-mail, blogs, Web sites, provide indicators of costs and burdens; and be designed to
cable channels, and cell phones with instant messaging. adapt in real time to new evidence from actual experience.
In the case of swine influenza, the preoccupying policy ques- 2. Invest in a balanced portfolio of research and contem-
tion was whether to embark on a mass immunization campaign, porary preparedness. Dollars spent on key research areas,
which then led to the associated matters of vaccine production, such as the development of a safe and effective vaccine and of
field trials, program implementation, media relations, and sur- rapid diagnostics and understanding the molecular foundation
veillance. In the case of avian influenza, the policy challenges of virus transmission, infectivity, and virulence, are necessary
are more diverse and global: worldwide surveillance and lab- to improve the capacity of the United States and the world to
oratory capacity, including cooperation and transparency across respond to a pandemic threat. These investments are best un-
national boundaries; the management of animal outbreaks, the derstood as a trade-off between present preparedness and stron-
migration of and trade in animals for food and pets, and hu- ger future capacity to prevent and cope with a pandemic. Today,
man-animal interactions; the value and deployment of an array the technology for production of influenza vaccine is essentially
of nonpharmacological infection-control measures, ranging the same as that in the 1970s; this must not be permitted to
from face masks to travel restrictions, quarantine and isolation, be true for another generation. Regardless of whether the cur-
and school closures; the availability and role of antiviral med- rent avian influenza A(H5N1) virus causes the next pandemic
S16 • JID 2008:197 (Suppl 1) • Finebergamong humans, the next worldwide influenza pandemic will level of confidence in our knowledge of the determinants of
occur someday. transmissibility and disease severity, which could improve fu-
3. Clarify operational responsibilities in the federal ture assessments. In the meantime, setting the right balance
government. The post–September 11 dispersal and redefini- regarding what is known about risk will be a challenge, and it
tion of authority over the management of a potential influenza can be expected that, over time, extreme positions of expec-
pandemic is the most striking difference in the national poli- tation (“must occur” or “surely will not occur”) will be es-
cymaking landscape, compared with that in the mid-1970s. It poused. When goals for a program are announced publicly,
is inconceivable today that the CDC should have sole respon- setting achievable results based on honest assessments of ca-
sibility for assessment of the situation and formulation of the pacity will pay dividends in credibility over the long term.
policy response. In 1976, the assistant secretary for health had However, this is not an excuse for settling for an inadequate
line authority over the several health-related agencies in the capability to deliver results.
Department of Health, Education, and Welfare (i.e., the CDC, 5. Strengthen local capacity for implementation. The
the National Institutes of Health, and the Food and Drug Ad- greatest vulnerability to success in 1976 remains present in
ministration). Today, these agency heads report directly to the 2008—namely, the ability of states and communities to imple-
secretary of Health and Human Services, and the assistant sec- ment a program. We will not have a national plan for avian
retary for health serves in a senior staff capacity, along with a influenza until there are 50 state plans and thousands of local
separate senior department official who is responsible for bio- plans for every jurisdiction in the United States. In addition,
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terrorism preparedness. More fundamentally, today’s Depart- plans are not enough. Exhortation of states and cities is not
ment of Homeland Security changes the balance of authority enough. Once we have a vaccine, what will it take in every
among all departments in the federal government, including community to be able to immunize 250 million American res-
the Department of Health and Human Services. Because the idents—that is, five-sixths of the population—in 6–7 weeks?
Department of Homeland Security has jurisdiction over natural What will it take to effectively distribute antiviral medications,
disasters and national emergencies and the Department of make face masks available, or function with closed schools and
Health and Human Services has jurisdiction over health mat- businesses? The speed and scale of the action required may be
ters, there is room for uncertainty and bureaucratic jockeying unprecedented. The seasonal hodgepodge of routine influenza
over responsibility for the response to a health emergency, such vaccination that includes clinics, doctors’ offices, hospitals,
as an influenza pandemic. Is it to be regarded mainly as a work sites, and pharmacies, each available on occasional and
national emergency, with the Department of Homeland Se- uncoordinated days, simply is not up to the task. In what town
curity in the lead, or as a health problem, with the Department or city has every household received a card telling them where
of Health and Human Services in the lead? Recent legislation and when to go to get what they need in the case of an emer-
(Pandemic and All-Hazards Preparedness Act, Public Law 109- gency? If past performance is any guide, variation in local pre-
417, 19 December 2006) directs the secretary of Health and paredness and delivery capacity remains the key shortcoming
Human Services to lead all federal public health and medical in the national readiness to cope with a major pandemic. The
responses to public health emergencies. Although this is an responsibility to upgrade delivery capacity is shared at local,
important clarification, there will be a need for ongoing inter- state, and national levels. Federal-level agencies and officials
departmental dialogue and coordination that involves the De- could help by specifying evidence-based guidelines and stan-
partments of Health and Human Services, Homeland Security, dards in detail, identifying and sharing best practices, providing
State, Defense, Education, and Transportation, among others, technical assistance to achieve acceptable levels of performance,
and that includes the White House Homeland Security Council and ensuring the availability of physical and financial resources
and appropriate state-level authorities and agencies. to each state.
4. Refrain from overstatement of objectives and misrepre- 6. Communicate strategically. Media standards and values
sentation of risk. Communication about risk is difficult, be- differ from those of the scientific and health communities.
cause the public, like many experts, has a hard time separating Public Editor Byron Calame of the New York Times recently
likelihood from severity. Estimation of risk is difficult when the described 7 goals of reporters [8]. To paraphrase, these goals
observable instances are widely separated in time, as with pan- are be first, write stories with impact, win prizes, impress
demic influenza. Explaining the concept of uncertainty as an sources, figure out what is really happening, tell stories in a
estimate of likelihood is challenging. As the scientific capacity compelling way, and get on the front page. These aims do not
for global surveillance improves, distinguishing between when coincide with the health expert’s goal of educating the public
a particular occurrence is happening for the first time and when and gaining public confidence, understanding, and coopera-
it merely is being detected for the first time will be difficult. tion. For example, a newspaper or magazine editor can claim
Eventually, research at a molecular level may lead to a high to have portrayed an issue “accurately” when the publication
Lessons from Swine Influenza • JID 2008:197 (Suppl 1) • S17has quoted correctly an “expert” who espouses a scientifically to incorporate new information in real time and to make de-
absurd position. The media thrive on controversy, and public cisions and act accordingly.
health officials can expect to see those with contrary views Policymaking for avian influenza preparedness is problematic
quoted in the media, even (or especially) if they are in a mi- in part because an influenza pandemic is a low-likelihood, high-
nority. Strategic communication means mapping the message, consequence event. In such cases, steps toward preparedness
the audience, the messenger, and the medium onto one another, are subject to criticism as both unnecessary (in the likely case
to attain the intended effect in the intended audience. The of no event) and inadequate (if a catastrophic event occurs).
advent of new electronic media (Web sites, both official and This politically precarious double bind reinforces the value of
unofficial; e-mail; and blogs), cell phones with instant messag- learning the strategic lessons from past errors of over- and
ing, and the fractionation of the broadcast space by cable and underreaction and applying them to the realities of today.
satellite create an immensely more-varied and challenging com-
munication environment. These developments have created an Acknowledgments
added premium for clear leadership, knowledgeable spokes-
I dedicate this article to the memory of Richard E. Neustadt. The Harvard
persons, and sophisticated outreach through new media as well University Asian Flus and Avian Influenza Workshop was hosted by the
as traditional media. In a pandemic situation, public under- Harvard University Department of Anthropology, Harvard School of Public
standing and cooperation will count for a great deal. Health, and Harvard Asia Center and was supported by the National Sci-
ence Foundation, Harvard Asia Center, and the Michael Crichton Fund.
7. Lay the basis for program review. Decision making in Supplement sponsorship. This article was published as part of a sup-
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advance and during an influenza pandemic will require a se- plement entitled “Avian and Pandemic Influenza: A Biosocial Approach,”
quence of choices that, ideally, will accommodate new and sponsored by the National Science Foundation, Harvard Asia Center, and
the Michael Crichton Fund.
unexpected developments. Many past influenza pandemics in-
troduced unexpected features, such as high mortality among
young adults in 1918–1919 and early outbreaks in 1957 (to References
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