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The United States Smallpox Bioterrorism Preparedness Plan: Rational Response or Potemkin Planning?

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Abstract

Smallpox was a major bogeyman after the terrorist attacks on September 11, 2001. The Bush administration launched a major smallpox vaccination campaign, and the Centers for Disease Control and Prevention (CDC) was directed to develop a national response plan for a smallpox bioterrorism attack. This paper grows out of an article written in 2004 on the failure of that smallpox vaccination campaign in the civilian population and implications for the CDC’s smallpox response plan. Since the 2004 article, public health systems across the United States have lost key personnel and resources due to budget cuts, Hurricane Katrina showed the danger of relying on local emergency response, and the H1N1 vaccination campaign illustrated how hard it is to implement a new vaccination program.The thesis of this paper is that these events further undermine what was already a questionable smallpox response plan. But one more ineffective government response plan would hardly be news. Since the Duck and Cover films of the 1950s, the federal government has attempted to mollify the public with patently inadequate response plans for events that experts understand cannot be mitigated. The official United States nuclear war strategy was called Mutually Assured Destruction because it was assumed that there would be few survivors — making duck and cover little more than a cruel joke to frighten a generation of children.The smallpox response plan is useful to study because the plan itself — unlike duck and cover — is based on good science and experience. It fails because the necessary public health infrastructure has been undermined, and because more than 30 years of politically expedient public health decisionmaking has made it impossible to deal with large scale threats when dealing with those threats has significant political costs. It is a Potemkin plan, which, like the villages in Potemkin’s story, exist only to fool the eye. This paper will show ways to recognize Potemkin planning, which is the first step to realistically facing risk.
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5179
THE UNITED STATES SMALLPOX BIOTERRORISM
PREPAREDNESS PLAN: RATIONAL RESPONSE OR
POTEMKIN PLANNING?
Edward P. Richards, III
I. INTRODUCTION .................................................................... 5180
II. BASELINE ASSUMPTIONS ON BIOTERRORISM ....................... 5181
III. THE COURSE OF SMALLPOX INFECTION .............................. 5182
IV. SMALLPOX TRANSMISSION ................................................... 5184
V. ERADICATION ....................................................................... 5185
VI. ENABLING SMALLPOX BIOTERRORISM ................................. 5186
VII. THE POTENTIAL IMPACT OF SMALLPOX BIOTERRORISM...... 5187
VIII. IS SMALLPOX PREPAREDNESS REALLY NECESSARY? .............. 5190
IX. CONTROLLING A SMALLPOX OUTBREAK .............................. 5192
X. SMALLPOX VACCINATIONS ................................................... 5193
XI. VACCINE COMPLICATIONS ................................................... 5196
XII. RISKS OF A MASS IMMUNIZATION PROGRAM ........................ 5199
XIII. THE CDC PLAN .................................................................... 5202
XIV. HOW LONG TO GET STARTED? ............................................ 5204
XV. CHASING CONTACTS ............................................................ 5205
XVI. WILL WE NEED MASS IMMUNIZATION? ................................ 5207
XVII. POTEMKIN PLANNING .......................................................... 5208
XVIII. THE HURRICANE KATRINA EFFECT ...................................... 5209
XIX. FROM POTEMKIN PLAN TO WORKABLE PLAN ....................... 5212
XX. A HARD LOOK AT RING IMMUNIZATION .............................. 5213
XXI. IS RING IMMUNIZATION REALISTIC? .................................... 5215
XXII. WHAT IS THE ALTERNATIVE? ................................................ 5216
XXIII. BUILDING INFRASTRUCTURE BEFORE THE OUTBREAK ........ 5218
XXIV. CONCLUSION ....................................................................... 5220
Harvey A. Peltier Professor of Law and Director, Program in Law, Science,
and Public Health at the Paul M. Herbert Law Center, Louisiana State University.
Address correspondence to Professor Richards at LSU, Baton Rouge, LA 70803-
1000, or via e-mail at Richards@lsu.edu. He maintains a Web site at
http://biotech.law.lsu.edu. This article is supplemented with online resources at
http://biotech.law.lsu.edu/blaw/bt/smallpox.htm.
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5180 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
I. INTRODUCTION
Smallpox is perhaps the most frightening bioterrorism agent
because we do not need to imagine its effects. Smallpox killed and
disfigured hundreds of thousands of people within living memory,
even with the availability of effective vaccines. Before the vaccine
age, smallpox was one of the great plagues, evolving with human
civilization because it affects no other species. While malaria and
tuberculosis are also great killers, they kill by stealth. Smallpox
strikes terror because it kills quickly and horribly.
Smallpox was a major bogeyman after the terrorist attacks on
September 11, 2001. The Bush administration launched a major
smallpox vaccination campaign, and the Centers for Disease
Control and Prevention (CDC) was directed to develop a national
response plan for a smallpox bioterrorism attack. This article
grows out of an article written in 2004 on the failure of that
smallpox vaccination campaign in the civilian population and
implications for the CDCs smallpox response plan.1
The thesis of this article is that these events further undermine
what was already a questionable smallpox response plan. But one
more ineffective government response plan would hardly be news.
Since the Duck and Cover films of the 1950s,
Since the
2004 article, public health systems across the United States have
lost key personnel and resources due to budget cuts, Hurricane
Katrina showed the danger of relying on local emergency response,
and the H1N1 vaccination campaign illustrated how hard it is to
implement a new vaccination program.
2
The smallpox response plan is useful to study because the plan
itselfunlike duck and coveris based on good science and
the federal
Government has attempted to mollify the public with patently
inadequate response plans for events that experts understand
cannot be mitigated. The official U.S. nuclear war strategy was
called Mutually Assured Destruction because it was assumed that
there would be few survivorsmaking duck and cover little more
than a cruel joke to frighten a generation of children.
1. See generally Edward P. Richards et al., The Smallpox Vaccination Campaign of
2003: Why Did It Fail and What Are the Lessons for Bioterrorism Preparedness?, 64 LA. L.
REV. 851 (2004) (discussing the failures of the CDCs civilian smallpox vaccination
campaign).
2. DUCK & COVER (Archer Productions 1952).
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experience. It fails because the necessary public health
infrastructure has been undermined, and because more than thirty
years of politically expedient public health decisionmaking has
made it impossible to deal with large scale threats when dealing
with those threats has significant political costs.3 It is a Potemkin
plan, which, like the villages in Potemkins story, exists only to fool
the eye.4
II. BASELINE ASSUMPTIONS ON BIOTERRORISM
This article will show ways to recognize Potemkin
planning, which is the first step to realistically facing risk.
If you study disasters, a natural part of that study is working on
worst case scenarios. For natural disasters, these are somewhat
constrained by laws of physics and the history of such events. For
example, while Hurricane Katrina was a large storm, it was well
within known parameters and was not as large as other known
storms in the same area. Assume an analysis based on Hurricane
Katrina hitting the Louisiana coast about one hundred miles
farther west than its actual landfall. This would shift the major
forces of the storm to New Orleans, rather than the Mississippi
coast, which would overwhelm all existing and proposed
protections and utterly destroy most of the city. This is a worst case,
but one that arises from known and highly probable events.
We use the same sort of bounded assumptions about
bioterrorism by basing our analysis on the known properties of
existing bacterial and viral agents. The analysis in this article
follows this principle for smallpox. This can lead to a pretty
frightening worst case. However, if you are free to speculate about
unproven bioengineering modifications of bioterrorism agents, all
bounds are lost. Assume a disease is untreatable and without a
vaccine, fast to develop, very contagious, and that people are
infectious for a few days before they are obviously ill, and you have
a disease that will kill the world pretty quickly. Such a disease can
be used to justify whatever draconian powers the proponent would
3. Cf. House of Cards (CNBC television broadcast June 3, 2009) (discussing
the government policies that enabled the housing bubble that contributed to the
financial crisis of 2008).
4. The term Potemkin village is taken from a Russian story that Potemkin
once had impressive fake villages built along a route that Catherine the Great was
to travel, and is defined as an imposing or pretentious facade or display designed
to obscure or shield an unimposing or undesirable fact or condition. Forest
Guardians v. Thomas, 967 F. Supp. 1536, 1561 n.22 (D. Ariz. 1997).
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5182 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
like to justify, even if such powers would be meaningless in actually
controlling the disease. For the purpose of this article, it is clear
that garden-variety smallpox is quite sufficient to challenge our best
defenses. In this authors view, policy makers should not worry
about fantasy bugs until they have solved the problems with known
agents.
III. THE COURSE OF SMALLPOX INFECTION5
Smallpox is caused by a virus. It has a characteristic course,
with the different stages varying in duration and severity in
different individuals.
6 When a person becomes infected, the virus
grows silently for seven to seventeen days, without symptoms, and
without posing a risk of infection to others. The variability of the
length of this period means that when the first case of smallpox is
identified, it will be at least a week before it is known with any
certainty how many persons were infected by the attack.7 If a case
of smallpox is detected, every person in contact with the case must
be quarantined at least twenty-one days to assure that they are not
infected.8
This is followed by the prodrome, two to four days of flu-like
symptoms, usually with a high fever.
As discussed below, an individual exposed to smallpox
who is vaccinated within a few days of exposure may escape
infection, but will still have to be helped for the full quarantine
period.
9 The disease becomes
contagious during the prodrome.10
5. Parts of this section are adapted from Richards et al., supra note
While not as contagious as later
in the infection, this period is very dangerous from a disease-
control perspective because the disease is easily confused with
other flu-like illnesses. If the health care providers are not
specifically looking for smallpoxwhich would only be the case
after an outbreak has been declaredit is unlikely that the disease
would be identified until the characteristic rash develops in the
next phase of the illness. The disease is likely to bring the person
into an emergency room or urgent care center, potentially
1.
6. See DEPT OF HEALTH & HUMAN SERVS., CTRS. FOR DISEASE CONTROL AND
PREVENTION, SMALLPOX FACT SHEET 2 (2004) [hereinafter CDC SMALLPOX SHEET]
(describing different stages of smallpox infections).
7. Id. This, of course, assumes there is only a single introduction of the
virus.
8. Id.
9. Id.
10. Id.
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exposing others in the facility, including the health care workers,
before the disease is identified. The risk is minimized to the extent
that the disease keeps the infected person from carrying on normal
activities.
The end of prodrome is defined by the emergence of a
characteristic rash, starting as small red spots on the tongue and in
the mouth.11 These spots become sores which break down and
shed virus.12 When this begins, the person is the most infectious,
and remains infectious as long as the unhealed sores remain.13
Over the next ten days, the rash spreads over the body, developing
into pustules, which then begin to rupture.14
When the rash becomes pustular and widespread, it is easy to
identify as smallpox, and in severe cases, it is impossible to confuse
with any other disease. While the current literature on smallpox
focuses on these very characteristic manifestations of the disease,
the historical record provides ample evidence of persons with
much milderand thus more difficult to diagnosecases. During
a known outbreak, every rash will be assumed to be smallpox until
proven otherwise. Mild cases could complicate the initial
identification of the disease, and during an outbreak, would not
incapacitate an infected individual, allowing that individual to
evade detection. This is a real problem, because control strategies
that depend on identifying and controlling infected individuals
assume that individuals are too sick to evade detection.
The severity of this
pustular rash is related to the fatality of the disease. In the most
severe cases, the pustules merge into a uniform pavement and large
sections of the patients skin sloughs off.
Once the rash develops, the infected person will either die or
begin to recover over the next two weeks. Recovery begins when
the pustules began to scab over. The recovery may be prolonged,
and the person remains contagious until all of the scabs have fallen
off.15 In previous outbreaks, between 6.3% and 35.5% of infected
persons died, depending upon the type of infection and whether
the individual had been vaccinated.16
11. Id.
Those who survive are often
12. Id.
13. Id.
14. Id.
15. Id.
16. FRANK FENNER ET AL., SMALLPOX AND ITS ERADICATIO N 5 (1988). This is the
definitive work on smallpox, compiled to preserve for posterity the story of the
control of smallpox. See also WILLIAM H. MCNEILL, PLAGUES AND PEOPLES 20609
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terribly disfigured by the smallpox scars and many were blinded by
the disease.17 Persons who recover from a smallpox infection have
a long-lasting immunity.18
IV. SMALLPOX TRANSMISSION
Antiviral drugs and intensive-care
support for vital life functions both postdate the last smallpox
outbreaks. This means that we have no data on whether smallpox
would be as lethal with full access to modern treatments. We do
know that it would be difficult to provide such treatments on a
widespread basis during an epidemic.
Smallpox is spread through close contact when infected
persons cough out particles of the virus (variola major) from sores
in their mouths and lungs.19 These particles can be inhaled, but
are more commonly picked up as tiny dried droplets in the
environment and inadvertently ingested or rubbed into the eyes.20
The infectious period can begin during the prodrome of the
disease and extends until the scabs fall off, a period of about three
weeks.21 It is estimated that about half of those exposed to the
virus, who are not immune to smallpox, develop the infection.
This varies, based on the nature of the contacts and the
contagiousness of the infected person.22
Smallpox infects only human beings. It has no animal
reservoirs and persists in the environment for only a short period,
except when properly preserved in a laboratory.
23
(1976) (detailing how disease really subdued the Aztecs, not the Spanish).
Smallpox
infections lead to no chronic carrier statesno individual is
infectious for more than a few weeks, and there are no latent
17. FENNER ET AL., supra note 16, at 4950.
18. Id. at 5152.
19. See, e.g., Joel G. Breman & Donald A. Henderson, Diagnosis and
Management of Smallpox, 346 NEW ENG. J. MED. 1300, 1302 (2002) (describing how
one patient at a hospital managed to infect seventeen others patients on three
different floors of the hospital simply by coughing).
20. Id. (noting that smallpox is spread primarily through respiratory-droplet
nuclei).
21. Id. at 1300. The typical period is about ten days, but stretches out to
three weeks if the rash is slow to heal. Id.; see also CDC SMALLPOX SHEET, supra
note 6, at 2 (explaining that the infectious period begins during the prodrome
phase and continues until the scabs fall off).
22. Id. The rate of secondary attacks among unvaccinated contacts is thirty-
seven to eighty-eight percent. Id. at 1302. As previously noted, figuring how many
people will be exposed is controversial.
23. Therefore, there is no risk that an ancient smallpox-infected blanket will
turn up in a museum and trigger an outbreak.
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infections to blossom later. Smallpox must spread from human to
human in an unbroken chain or it dies out. Smallpox could not
exist until the human population reached a high enough density
that there were enough communities to allow the disease to
circulate from community to community, often not returning until
there was a new generation of children or young adults who were
susceptible to the disease.24
The lack of a chronic infected state and an animal host is
fundamental to the control of a smallpox outbreak and, ultimately,
to the eradication of smallpox.
25 Outbreaks are controlled by
limiting the ability of an infected person to come into contact with
persons who are susceptible to smallpox, i.e., persons who have not
been previously infected or have not had a recent vaccination. This
is done by a combination of isolating contagious individuals to limit
their contacts, and quickly immunizing all identified contacts or
potential contacts to limit the development of new cases.26
V. ERADICATION
It is like
starving a fire of fuel. Once the fire runs out of fuel (susceptible
persons), the fire burns out. The more effectively you can isolate
every case from contacting susceptible individuals, the quicker the
outbreak will be controlled. Outbreaks are ended when it has been
three weeks from the last infection.
The difficulties in storing and transporting vaccines made
worldwide eradication of smallpox a distant hope until 1951, when
Collier developed a freeze-dried smallpox vaccine that could be
stored at room temperature and thus easily transported to remote
locations.27 A Western Hemisphere smallpox eradication program
was started by the Pan American Sanitary Organization in 1950.28
At the suggestion of the Soviet Union, the World Health
Organization (WHO) began a worldwide eradication program in
1967.29
The best description of the worldwide eradication program is
24. JONATHAN B. TUCKER, SCOURGE: THE ONCE AND FUTURE THREAT OF
SMALLPOX 6 (2001).
25. While HIV does not have an animal host, infected persons remain
infected for decades because there is no cure, making eradication impossible.
26. As discussed infra Parts XIIXIII, the trade-off between isolation and
vaccination is the core controversy in smallpox control.
27. FENNER ET AL., supra note 16, at 287.
28. Id. at 38889.
29. Id. at 387.
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in the book, Smallpox, The Death of a Disease,30
As all honest public health experts recognize, eradication
demanded the ruthless suppression of the disease. Rewards were
paid for finding cases, and individuals had no right to refuse
isolation and vaccination. This is significant, because, as discussed
later, the smallpox vaccine has real risks. The eradication
campaign was carried out mostly in the developing world, and it is
easy to assume that it was only for that reason that such single-
minded methods were tolerated. It is impossible to say for certain
that such methods would have been allowed in Europe or the
United States in the 1970s, but they had clearly been accepted
when smallpox was still in those countries.
by Dr. D.A.
Henderson, the U.S. scientist who was the administrative genius
who kept the program on track. Putting the enormous
administrative and political complications aside, the fundamental
approach was the same as controlling a local outbreak: combine
intensive case finding and contact tracinglooking for persons
infected with or exposed to smallpoxwith mandatory vaccinations
and isolation for all exposed persons. While Dr. Henderson does
not dwell on the individual rights issues, he does not attempt to
rewrite history and claim that eradication was accomplished
through full information and informed consent.
On October 26, 1977, the last known naturally occurring
smallpox case was recorded in Somalia. In 1980, the WHO
declared that smallpox had been eradicated. The United States
ended routine smallpox vaccinations in 1972, and they were not
routinely given anywhere after 1983.
VI. ENABLING SMALLPOX BIOTERRORISM
The irony of smallpox bioterrorism is that it would have been
impossible in 1970. By 1970, most of the developed world had
been vaccinated, and much of the developing world was either
vaccinated or had natural immunity from exposure to the disease.
Introducing smallpox into a community could cause new infections
and even deaths, but the public health community could and did
bring new outbreaks under control very quickly. This was because
a large part of the population was not at risk or was only at low risk
of contracting the disease. Thus, if the tracking of contacts was not
perfect, the probability was that a missed contact would not
30. D.A. HENDERSON, SMALLPOX: THE DEATH OF A DISEASE (2009).
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become infected. While individuals were at risk of death, and an
outbreak would be disruptive, it did not threaten the
destabilization of the state.
It took many years after eradication and ending of routine
smallpox vaccinations for the world to become immunologically
susceptible to smallpox bioterrorism. Unlike the life-long
immunity that accompanies surviving smallpox, immunity from the
vaccine wears off, with the assumption that after thirty or more
years, there is little residual immunity. In the developing world,
with its faster population growth, most of the population was born
after the last immunizations, and even in the developed world, the
majority of the population has never been vaccinated. With the
exception of a small number of individuals who survived a smallpox
infection, the whole world is immunologically naïve for smallpox.
An immunologically naïve population poses special risks
beyond the obvious one that there are a lot of people who can get
infected. If the disease is fast moving, it means that a lot of people
can get sick at the same time, which will cause social disorder and
the breakdown of basic societal services. For example, measles
alone does not kill a very high percentage of infected individuals.
But when measles enters a naïve population, as it did when
European explorers brought it to the new world, it has a high
fatality rate. The disease is the same, but when everyone in a
culture is infected at once, no one can care for the sick, find food
and water, and carry out the necessary tasks of daily life.31
VII. THE POTENTIAL IMPACT OF SMALLPOX BIOTERRORISM
The
social disorder potentiates the disease.
It is the potential impact of a smallpox bioterrorism event
31. See generally MCNEILL, supra note 16 (describing the impact of plagues on
societies); J.V. Neel et al., Notes on the Effect of Measles and Measles Vaccine in a Virgin-
Soil Population of South American Indians, 91 AM. J. EPIDEMIOLOGY 418, 418 (1970)
(The impact of measles on a primitive population is well-known. It seems to have
been generally assumed that this is a result of a greater constitutional
susceptibility. However, in 1877, Squire (1), describing the collapse of village life
during an epidemic of measles in Fiji, clearly presented a contrary view: Excessive
mortality resulted from terror at the mysterious seizure, and the want of
commonest aids during illness; there were none to offer drink during the fever
nor food on it subsidence. Thousands were carried off for want of nourishment
and care as well as by dysentery and congestion of the lungs. We need to invoke
no special susceptibility of race of peculiarity of constitution to explain great
mortality.’”).
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where the facts are few and the controversies large that is of
particular concern. The heart of the controversy is how fast the
epidemic would spread, both temporally and geographically. The
most basic data is the number of persons who will be infected by a
given contact. Our only information on this is basic because it was
derived from populations with significant immunity.32
For example, Fenners comprehensive history of the
eradication of smallpox gives a revealing illustration of the
problem.
The limited
data we do have suggests the vulnerability of unprotected societies
could be both quite severe and difficult to predict or control.
33 In 1970, a German hospital in Meschede admitted an
electrician into its isolation ward ten days after his return from
Pakistan with a feverish illness . . . suspected to be typhoid fever.34
Three days later, he developed a rash, confirmed, using an electron
microscope, to the smallpox two days later.35 At that time, after five
days in the general hospital in full isolation, the patient was
transferred to a specialized smallpox hospital.36 Despite the
rigorous isolation of the patient and the vaccination of all of the
patients and nurses in the general hospital, nineteen additional
cases of smallpox resulted from the electricians admission.37
Several aspects of this event are quite chilling. The electrician was
only on the first floor, yet persons on all three floors of the hospital
developed smallpox. One person, case 8, visited the ground floor
of the hospital only once, fourteen days after the electrician was
admitted, for no more than fifteen minutes.38 Smoke tests
performed by investigators of the outbreak revealed that eleven
cases were in rooms outside of the smokes flow pattern; two cases
upwind of the smoke pattern.39
Perhaps the most sobering aspect of the Meschede outbreak is
Case 17 developed twenty-one days
after the electricians admission and case 19 developed fourteen
days after a visit to case 17.
32. See generally Martin I. Meltzer et al., Modeling Potential Responses to Smallpox
as a Bioterrorist Weapon, 7 EMERGING INFECTIOUS DISEASES J. 959 (2001) (discussing
the probable durations of each disease stage). The base rate information used by
Meltzer was from Fenners study, which included populations with significant
immunities. See generally FENNER ET AL., supra note 16.
33. See generally FENNER ET AL., supra note 16.
34. Id. at 192.
35. Id.
36. Id.
37. Id.
38. Id.
39. Id. at 193.
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the contrast between the results of a fleeting exposure in an
unprotected population with the results of prolonged exposure in a
protected population. Fenner observed: Especially in India, long-
distance movements by train or bus of patients suffering from
smallpox, with an overt rash, used to occur frequently, yet infection
of casual fellow-travellers [sic] was rare indeedso rare that
instances of it were deemed unworthy of special report.40 Here,
while contained in a controlled, isolated hospital room, one sick
person infected nineteen more with smallpox, more than six times
the 3:1 infection ratio assumed in the Meltzer model,41
Beyond the critical variable of how many people will be
infected by a given carrier is the question of how far contacts can
spread the disease if they are not identified and quarantined. For
almost all of human history, the natural spread of human disease
was essentially limited by how far a person could walk before he
became too sick to travel. In an age when an infectious person can
reach any spot on Earth in twenty-four hours, the geographic
spread of a disease might also be much faster.
which was
developed by a CDC team and reflects the CDC assumptions about
transmission.
42 If individual
carriers can spread the disease to more than two or three people,
and if some of those people can travel before being identified and
quarantined, this could be sufficient to seed a global pandemic that
would disrupt modern society.43
The greatest fear with smallpox bioterrorism is that it would
escape control and infect so many people that basic social order
would break down. Modern society is very complex but not
necessarily very robust. Grocery stores run out of food, and few
people keep more than a day or two of food on hand at home.
Water and power systems can fail. A failing police presence,
combined with a desperate population, leads to the worse
nightmare of smallpox response planners: an out-of-control
40. Id. at 191.
41. See Meltzer et al., supra note 32, at 961.
42. See FENNER ET AL., supra note 16, at 202, 107779 (describing how the
modern transportation infrastructure has contributed enabled the rapid spread of
smallpox and providing case studies of the diseases importation into Europe).
43. See Tara OToole et al., Shining Light on Dark Winter, 34 CLINICAL
INFECTIOUS DISEASES 972, 975 (2002) (describing how a war-game simulation of a
smallpox outbreak in the United States used a transmission rate of 1:10, which the
authors characterized as conservative estimate in part due to the globalization of
trade and travel, urban crowding, and deteriorating public health infrastructure).
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population would make disease control impossible, assuring the
maximum spread and lethality of the disease. This would rapidly
destabilize global markets and lead to a worldwide financial
collapse.
Thus smallpox has the ultimate blowbackthe risk of
destruction of the party that started the pandemic. While
blowback, in the form of mutually assured destruction (MAD), was
the cornerstone of nuclear deterrence against the Soviet Union
and China, it was based on each countrys refusal to commit suicide
to punish the others. In a world dominated by the NGO terrorist
groups who use suicide as a tool and, at least for some of them,
believe the rebirth of the earth can only come through destruction,
biological MAD is not a reassuring concept.
VIII. IS SMALLPOX PREPAREDNESS REALLY NECESSARY?
There is no smallpox in the wild, nor do we need to worry
about some dusty old museum exhibit or tomb reseeding the
world. Unless carefully preserved, it is not a stable virus.44 When
smallpox was still an active disease threat, laboratories around the
world maintained stocks of the virus for research purposes. After
eradication, a laboratory accident that led to a smallpox death
reminded the world that these laboratory stocks of virus had the
potential to reintroduce smallpox into the world.45
Many scientists believed that the smallpox virus retained by the
CDC and the Soviet laboratory should be destroyed as a sign of
good faith and to eliminate the possibility of an accident reseeding
Political
pressure finally persuaded all the labs to transfer their collections
of smallpox virus subtypes to the CDC, or to destroy them. The
CDC and the Soviet Union were designated the only labs that could
retain the smallpox virus.
44. If this were not so, we would never have been able to eradicate it. Infected
persons shed a huge amount of virus into their environment, but once the active
cases are healed, you do not see subsequent cases.
45. See FENNER ET AL., supra note 16, at 1097. The victim, a forty-year-old
woman, was a medical photographer in the Anatomy Department of the Medical
School of the University of Birmingham . . . [who] became ill with fever, headache
and muscular pains on 11 August [1978]. Id. She had last been vaccinated in
1966. Id. A rash developed on August 15, vesicles developed on August 24 (which
led to a suspicion of smallpox), and she was placed in an isolation hospital later
that day. Id. However, her health deteriorated rapidly and she died on 11
September [1978]. Id. The specifics of this outbreak are in Chapter 23,
Smallpox in Non-endemic Countries. Id. at 10691101.
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the virus into the world. There was further unease about the
retained stocks when it was found that the Soviet Union moved its
stocks without informing the world community. While this debate
was going on, a defector who ran the Soviet Unions biological
warfare operations claimed that the Soviet Union had produced
thousands of pounds of smallpox virus in derogation of the
Biological Warfare Treaty.46
This defector, Ken Alibek, had been a high official at
Biopreparat, the Soviet bioweapons research center. His specific
claims have been impossible to verify, and there have been
questions about whether his story was really about increasing his
perceived value to the West. Unfortunately, with the breakup in
the Soviet Union and the lack of cooperation of Russian
authorities, it has been impossible to either verify or refute this
claim. It is clear that the Soviets were violating the Biological
Warfare Treaty, so it is credible that smallpox was made at the
facility.
47
Thus we have to assume that smallpox is available as a
bioterrorism weapon. But, because there is no way to determine a
probability for a smallpox attack, the level of threat is an arbitrary
determination subject to political manipulation. On the legislative
side, Congress is easily frightened into passing bioterrorism
response laws that provide immunity for the Government and
private companies for vaccines and other bioterrorism response
agents and practice. The arbitrariness of the risk makes the public
suspicious of the Governments motives, and ties into the current
anti-vaccination paranoia. Rather than confront these fears, the
federal Government has avoided them in its response plan. In the
view of this author, ignoring public fears and the public role in
smallpox preparedness will greatly complicate response to a
smallpox bioterrorism event and exacerbate the damages.
46. See Terrorist & Intelligence Operations: Potential Impact on the U.S. Economy:
Hearing Before the J. Economic Comm., 105th Cong. (1998) (statement of Dr. Kenneth
Alibeck, Program manager, Battelle Memorial Institute) (describing the role of
smallpox in the Soviet Unions development of biological weapons).
47. See generally KEN ALIBEK, BIOHAZARD (1999) (telling the story of the Soviet
bioterrorism enterprise). Dr. Henderson indicates that he believes enough of the
story is true to paint a picture of a very dangerous Soviet bioterrorism program.
HENDERSON, supra note 30, at 275.
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5192 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
IX. CONTROLLING A SMALLPOX OUTBREAK
The basic strategy for controlling all short-duration infectious
diseases is the same: prevent infected persons from coming in
contact with persons who are susceptible to the disease, and doing
it until everyone who is infected either recovers or dies.48
If you apply the one-percent doctrine, as espoused by Vice
President Cheney and others in the Bush administration,
In the
1960s, the solution was universal smallpox vaccinations in the
United States. While no universal system is 100% effective, it
assured that most people who encountered a person infected with
smallpox were immune. This limited the spread, which gave the
public health authorities plenty of time to find and isolate contacts,
and immunize anyone whose immunization was out of date. After
9/11, Vice President Cheney advocated beginning universal
vaccination of the U.S. population.
49
universal vaccination makes sense. The Dark Winter simulation
showed that it was possible for a smallpox outbreak to burn
through a large part of the population, destroying the U.S.
economy, and perhaps even leading to civil disorder and the
breakdown of the state. While this is a low probability event, a pure
national security analysis would argue that it would be worth
avoiding at almost any cost, and the cost of universal immunization
would be low compared to many other security measures that were
taken post-9/11.50
This was strongly opposed by public health experts,
If it could be carried out, it would absolutely
end the threat of smallpox bioterrorism in the United States,
reducing it to an annoyance that might kill a few people and cost
some time and money for eradication, but nothing that could not
be handled by local public health.
48. This cannot work for long-term infectious diseases such as HIV because
individuals remain infectious for decades. For large outbreaks, it is only realistic
for diseases with a short incubation period and a short infectious period, otherwise
the logistics become impossible. For example, drug-resistant tuberculosis carriers
may need to be isolated for long periods of time, but it is a hard disease to spread,
so there are never more than a handful of cases at any one time.
49. See generally RON SUSKIND, THE ONE PERCENT DOCTRINE: DEEP INSIDE
AMERICAS PURSUIT OF ITS ENEMIES SINCE 9/11 (2006) (describing the Bush
administrations decision to treat the likelihood of a catastrophic event or terrorist
attack as a certainty even though in reality it is closer to one percent).
50. The war in Iraq, for example, has cost more than $1 trillion and was also a
response to a low probability threat.
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particularly Dr. D.A. Henderson.51 Risk analysis in public health is
always about balancing risks, benefits, costs, and probabilities.
Unlike national security, public health officials are always acutely
aware of their limited political and financial support.52
X. SMALLPOX VACCINATIONS
The critical
issue, medically and politically, is that the smallpox vaccine is
dangerous to persons with impaired immune systems.
Understanding these risks is critical to evaluating whether the
opposition of Dr. Henderson and others is well-founded.
Vaccination for smallpox was one of the first effective public
treatments. Drawing on folk traditions, the English physician
Edward Jenner documented that dairymaids who had been
infected with cowpox, a mild pustular infection, thereafter were
immune to smallpox.53 In 1796, Jenner intentionally infected a
young man with cowpox, and the boy developed smallpox
immunity.54 The technique for inoculating individuals with cowpox
spread quickly and became a standard public health intervention.
This is a live virus vaccine, which works because the person
develops a mild case of the disease, triggering the development of
antibodies. Dead virus vaccine has been tried, but it does not
work.55
At the same time, it was a controversial intervention because
the vaccination process was dangerous. This was long before the
germ theory and notions of sanitation. The vaccine either came
from a scab on the vaccination site of another person, or from the
scabs on the belly of a calf who had been vaccinated by abrading its
abdomen and rubbing in vaccine material. In both cases, there was
a high probability of bacterial contamination of the vaccine, as well
51. See HENDERSON, supra note 30, at 293.
52. Cf. M. J. Rosenau, The Uses of Fear in Preventive Medicine, 162 BOSTON MED.
& SURGICAL J. 305, 30507 (1910), available at
http://biotech.law.lsu.edu/cphl/history/articles/Rosenau_fear.htm (suggesting
that the amount of public funding dedicated to a particular public health initiative
corresponds with the level of fear a society has toward a particular disease).
53. See EDWARD JENNER, THE THREE ORIGINAL PUBLICATIONS ON VACCINATION
AGAINST SMALLPOX (1798).
54. Id. at 258.
55. See E.R. Freed et al., Vaccinia Necrosum and Its Relationship to Impaired
Immunologic Responsiveness, 52 AM. J. MED. 411 (1972). This article discusses the use
of killed virus to screen for antibody response because it cannot cause infection.
There is no other discussion of the use of killed virus in the modern literature.
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5194 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
as the transmission of blood-borne illness such as hepatitis or
syphilis. A vaccination involved inserting a bit of scab or an elixir
made from scabs into the skin of the individual being vaccinated,
assuring that whatever accompanying infections would also be
effectively introduced into the persons system. Add in that
physicians and vaccine agents did not clean their instruments
between patients, and it is clear that fears of complications from
smallpox vaccination were well-founded.
When genetic analysis was developed, it was found that the
virus used for inoculation was not really cowpox at all. It was a virus
called vaccinia, which is not cowpox nor any other known pox
virus.56 It may be the now extinct horsepox or a hybrid of horsepox
and cowpox. Vaccinia is so closely related to smallpox that a
person who is infected with vaccinia develops immunity to
smallpox. Because this vaccinia is not identical to smallpox, this
immunity is not as long lasting. Persons who are vaccinated with
vaccinia have to be revaccinated every five to ten years to keep up
full immunity and need to be vaccinated again when exposed to
smallpox.57
The modern vaccine is called Dryvax, manufactured by
Wyeth.
58 It was developed during World War II, and some of the
current stockpile has been in storage for more than thirty years.59
It is produced in a sanitary matter and is then freeze dried, which
allows it to be stored for long periods. It is still a live virus vaccine
containing vaccinia,60 but it does not pose the risk of any other
infections. There is a new way of manufacturing the vaccine using
cell culture that produces a vaccine with less contamination than
the process used for making Dryvax, but it poses the same risks
because it uses the same live virus.61
56. TUCKER, supra note
24, at 37.
57. FENNER ET AL., supra note 16, at 175.
58. Press Release, Am. Home Prods. Corp., American Home Products
Submits Plan to Produce Smallpox Vaccine (Oct. 26, 2001).
59. Wyeth-Ayerst Laboratories, a division of American Home Products
Corporation, began manufacturing a vaccinia (smallpox) vaccine, Dryvax, in 1944.
Id.
60. See Wyeth Laboratories, Inc., Package Insert Dryvax [hereinafter Dryvax
Package Insert], available at
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPro
ducts/UCM142613.pdf (listing vaccinia as one of the ingredients). The current
label reflects the risk of myocarditis. Id. The original label is available at
http://biotech.law.lsu.edu/blaw/bt/smallpox/DRYVAX_label.htm.
61. See Sharon E. Frey et al., Dose-Related Effects of Smallpox Vaccine, 346 NEW
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To be effective, a smallpox vaccination must result in a small
infected sore on the patients arm. A drop of the vaccine is put
between the prongs of a very small two-pronged needle, which is
then punched into the patients arm multiple times.62 Patients with
normal immune system function will have a small sore at the
vaccination site, which will form a scab, and then the scab will fall
off as the sore heals. That sore and scab contain live vaccinia virus.
The sore will not spread unless the person scratches it or it is
spread by some other trauma.63 If a person scratches the sore and
then scratches his or her eye or nose, or an insect bite or scratch,
the virus will form sores at the scratched location. As many as one-
third of vaccinated persons suffer fever and malaise sufficient to
interfere with work or recreation, but most recover quickly without
permanent sequelae.64
The recommendation for bandaging the sore and wearing
long sleeves until the sore heals is to prevent the spread of the
vaccinia to other sites on the vaccinated person and to others. The
recommended bandage is a combination of gauze to absorb the
ENG. J. MED. 1275 (2002); Steven R. Rosenthal et al., Developing New Smallpox
Vaccines, 7 EMERGING INFECTIOUS DISEASES 920, 922 (2001) (describing a new cell
culture used to manufacture the vaccine, which still contains vaccinia).
62. See Dryvax Package Insert, supra note 60 (describing the administration of
the vaccine). It was found during the smallpox eradication program that it was
better to use fifteen jabs with the needle rather than package insert specified three
jabs for a primary immunization. HENDERSON, supra note 30, at 294. This
increased the chance that the vaccine would really get through the skin and had a
much higher rate of successful vaccinations. Id. When the CDC was preparing
recommendations for smallpox vaccinations for the 2002 vaccine campaign, the
FDA prevented them from using the fifteen poke standard because it had never
been approved by the FDA, even though it had been shown to be much more
effective. Id.
63. Ctrs. for Disease Control and Prevention, Smallpox Vaccination and Adverse
Reactions: Guidance for Clinicians, MORBIDITY & MORTALITY WKL Y. REP., Jan. 24, 2003,
available at
http://biotech.law.lsu.edu/blaw/bt/smallpox/di52cha1/di52cha1.htm. This
document was originally published as a Dispatch from the Centers for Disease
Control and Preventions (CDC) Morbidity and Mortality Weekly Report
(MMWR). However, the CDC no longer maintains the original document. An
updated version was published by the CDC as an MMWR Recommendations and
Reports on February 21, 2003. Ctrs. for Disease Control and Prevention, Smallpox
Vaccination and Adverse Reactions: Guidance for Clinicians, MORBIDITY & MORTALITY
WKLY. REP. RECOMMENDATIONS AND REP. RR-04, Feb. 21, 2003, at 1, 128
[hereinafter CDC, Guidance II], available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5204a1.htm.
64. See CDC, Guidance II, supra note 63 (describing the side effects resulting
from the vaccine).
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5196 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
fluids from the vaccination sore and a covering that will keep these
fluids and the virus they contain from getting out of the bandage.65
Changing the bandage to keep the sore dry and healing increases
the risk of spread to others. There was documented secondary
spread among the military vaccinees.66 This could be a more
serious problem for recently vaccinated health care workers, since
patient contact is a much more conducive environment for
transmission.67
XI. VACCINE COMPLICATIONS
All modern vaccines are very safe, yet the general public is still
frightened of them.68 Despite massive efforts by the CDC and state
public health programs, it is estimated that only about twenty-five
percent of the target population was willing to be vaccinated for
H1N1.69 Unfortunately, the smallpox vaccine is dangerous. A small
number of persons suffer neurologic sequelae, which can be
permanent or even fatal in a small percentage of cases.70 Persons
with eczema and related skin conditions are at risk for the
spreading of the vaccination sore, leading to the development of
sores on other parts of the body.71
65. Dryvax Package Insert, supra note
While not usually life-
threatening, this is a painful, difficult-to-treat complication that can
leave the individual permanently scarred. When the virus spreads
from the original vaccination sore, the risk of infecting others with
60.
66. Ctrs. for Disease Control and Prevention, Secondary and Tertiary Transfer of
Vaccinia Virus Among U.S. Military PersonnelUnited States and Worldwide, 20022004,
53 MORBIDITY & MORTALITY WKLY. REP. 97, 103 (2004).
67. Id.
68. There are many reasons for this fear, including long-term efforts by
plaintiffs attorneys to undermine confidence in vaccines to benefit their products
liability cases. The best example are the autism cases, which were subject to
comprehensive rejection in a recent series of cases: Snyder ex rel. Snyder v. Secy of
Dept of Health and Human Servs., No. 01-162V, 2009 WL 332044 (Fed. Cl. Feb
12, 2009), appeal denied, Snyder ex rel. Snyder v. Secy of Health and Human Servs.,
88 Fed. Cl. 706 (Fed. Cl. 2009); Cedillo v. Secy of Health and Human Servs., No.
98-916V, 2009 WL 331968 (Fed. Cl. Feb 12, 2009), affd, Cedillo v. Secy of Health
and Human Servs., 89 Fed. Cl. 158 (Fed. Cl. 2009); Hazlehurst v. Secy of Dept of
Health and Human Servs., No. 03-654V, 2009 WL 332306 (Fed.Cl. Feb 12, 2009),
affd, Hazlehurst ex rel. Hazlehurst v. Secy Dept of Health & Human Servs., 88
Fed. Cl. 473 (Fed. Cl. 2009).
69. Only 1 in 4 Americans Got H1N1 Vaccine, MEDLINE PLUS, Apr. 1, 2010,
http://www.nlm.nih.gov/medlineplus/news/fullstory_97126.html.
70. Donald A. Henderson et al., Smallpox as a Biological Weapon: Medical and
Public Health Management, 281 JAMA 2127, 2134 (1999).
71. Id. at 2134.
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vaccinia through secondary spread is dramatically increased.72
There is little reason to expect that the eczema and neurologic
complications would occur at higher rates than they did in the
1960s when smallpox vaccinations were routine. The major change
in risk factors since the 1960s is for immunosuppressed persons.
Vaccinia creates a small sore because the vaccinated individuals
immune system keeps the infection in check. If the individuals
immune system does not function properly, the vaccinia virus grows
unchecked and the sores spread over the entire body. This is
called disseminated vaccinia.
73 The virus spreads as a whole body
illness, creating sores that look very much like smallpox.
Disseminated vaccinia is often fatal. It was very rare in the 1960s
and early 1970s when the last smallpox vaccinations were done in
the United States, accounting for about one death per million
immunizations.74
Studies at the time found that such cases could usually be
traced to persons with defective immune systems. More
importantly, the leading study determined that persons with
defective cellular immunity were usually killed by the vaccine.
75
The only specific treatment for disseminated vaccinia is human
vaccine immunoglobulin (VIG) which is made from the serum of
persons recently vaccinated with smallpox vaccine.76 There was
very little VIG available when the smallpox vaccination campaign
was announced in 2002, and it is unlikely that there is nearly
enough VIG to treat the expected complications from vaccinating
millions of persons over a few months.77
When smallpox vaccinations were routinely given in the
United States, there were very few persons with chronic immune
The amount of available
VIG has never been revealed to the general public. While there are
no antiviral drugs that are known to treat vaccinia, there are drugs
that are effective against other pox viruses, and it is hoped these
will help cure vaccinia reactions.
72. Such persons must be managed much as a smallpox case is managed so
they do not spread vaccinia to unvaccinated persons or persons at risk of vaccine
complications.
73. There is some confusion about the nomenclature. Disseminated vaccinia
in this review means the generalized spread of vaccinia throughout the body.
74. Steven M. Gordon, Pre-Event Smallpox Vaccination: Unresolved Issues, 70
CLEVELAND CLINIC J. MED. 80, 81 (2003).
75. Freed et al., supra note 55.
76. Henderson et al., supra note 70, at 2132.
77. Id.
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5198 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
system defects. Children with genetic defects in their immune
systems usually died shortly after birth because they could not fight
off any infections. There were some persons with cancer, and some
whose cancer was not yet diagnosed, who were inadvertently
vaccinated. Immunosuppression was so rare that it was a major
clinical research triumph when scientists were able to keep a
completely immune suppressed baby alive in a germ-free
environment.78 Since 1972, the use of powerful cancer drugs,
arthritis drugs, and transplant drugs, plus the emergence of
HIV/AIDS, has increased the number of immunosuppressed
persons. There are at least one hundred times as many
immunosuppressed people in the United States today as in 1972
and perhaps one thousand times as many.79
Since routine smallpox immunizations were stopped before
immunosuppression secondary to drug treatment or HIV was a risk,
the consequences of immunizing such persons have to be
extrapolated from limited data and from the susceptibility of
immunosuppressed persons to other viral illnesses. There is one
case reported in the literature where a person with HIV was
immunized with smallpox vaccine.
80 The victim was a healthy
nineteen-year-old soldier who had been tested and found to have
normal blood work before immunization.81 This was before all
military personnel were routinely screened for HIV, which began
after this case. Within three weeks of vaccination, the soldier
developed disseminated vaccinia.82 Despite intensive treatment,
including many injections with VIG, he died after a prolonged
illness, although his vaccinia appeared to resolve before this
death.83 The vaccinia virus triggered a rapidly progressive case of
AIDS.84
78. Probably the best-known case of Severe Combined Immunity Deficiency
Syndrome was David Vetter, the bubble boy, who died in 1984 at the age of
thirteen. See Steve McVicker, Bursting the Bubble, HOUSTON PRESS, Apr. 10, 1997, at
1020.
Given the lack of knowledge about AIDS and HIV at the
time, and the unavailability of modern anti-HIV drugs, it is
unknown whether he would have had the same course with
modern aggressive treatment.
79. Gordon, supra note 74, at 8182.
80. R.R. Redfield et al., Disseminated Vaccinia in a Military Recruit With Human
Immunodeficiency Virus (HIV) Disease, 316 NEW ENG. J. MED. 673, 673 (1987).
81. Id.
82. Id. at 674.
83. Id.
84. Id.
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In the 2002 vaccination campaign, it was discovered that
several vaccinees suffered symptoms of cardiac disease, and three
died.85 This unexpected complication, occurring in a relatively
small population of civilian vaccinees, marked the end of the
Governments active support of the vaccination of civilian
volunteers. Subsequent studies confirmed an excess occurrence of
myopericarditis in military vaccinees, at a rate of about 140 cases
per million vaccinations.86 While a retrospective study of cardiac
deaths in New York City during the last mass vaccination program
for smallpox in 1947 showed no excess cardiac deaths,87
XII. RISKS OF A MASS IMMUNIZATION PROGRAM
myopericarditis does appear to be a risk of smallpox vaccinations in
contemporary populations.
The CDC estimated that about 1.1 million persons were
infected with HIV in 2006, with about twenty-one percent
undiagnosed.88 It is estimated that that are more than 50,000 new
cases each year.89 About 12,000 people die each year from HIV-
related illness,90 so there is a new increase of about 38,000 cases a
year.91
85. Ctrs. for Disease Control and Prevention, Update: Cardiac and Other Adverse
Events Following Civilian Smallpox VaccinationUnited States, 2003, 52 MORBIDITY &
MORTALITY WKLY. REP. 629, 639 (2003).
The CDC estimates are very likely on the low side so these
will be minimum estimates of HIV prevalence, so a working
estimate in 2010 would be at least 1.2 million cases. There are
probably more than 300,000 solid organ transplant patients living
and on long-term immunosuppressive therapy. There is no good
data on patients on immunosuppressive chemotherapy for cancer,
arthritis, and other diseases, or persons on short-term and long-
86. Mark K. Arness et al., Myopericarditis Following Smallpox Vaccination, 160
AM. J. OF EPIDEMIOLOGY 642, 642 (2004).
87. Ctrs. for Disease Control and Prevention, Cardiac Deaths After a Mass
Smallpox Vaccination CampaignNew York City, 1947, 52 MORBIDITY & MORTALITY
WKLY. REP. 933, 933 (2003) [hereinafter CDC, Cardiac Deaths].
88. Ctrs. for Disease Control and Prevention, HIV Prevalence EstimatesUnited
States, 2006, 57 MORBIDITY & MORTALITY WKLY. REP. 1069, 1073 (2008).
89. H. Irene Hall et al., Estimation of HIV Incidence in the United States, 300
JAMA 520, 520 (2008).
90. CTRS. FOR DISEASE CONTROL AND PREVENTION, HIV/AIDS SURVEILLANCE
REPORT 2007, at 19 (2009).
91. Whether the low death rate will continue depends on the race between
scientists developing new anti-HIV drugs and the ability of the virus to mutate to
forms that are resistant to the drugs. In the early 1990s, the death rate was about
50,000 per year.
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5200 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
term steroid therapy, which is immunosuppressive. A rational
working number might be that one percent of the population is at
significant risk of serious or fatal complications from a smallpox
vaccination. This is orders of magnitude higher than the baseline
in 1970.92
These numbers mean that a mass immunization program that
indiscriminately vaccinated individuals without regard to risk status
could lead to thousands of serious reactions and hundreds of
deaths per million persons vaccinated. HIV is also
disproportionately concentrated in the minority populations, with
blacks having seven times the risk for HIV infection as whites, and
risk factors for Hispanics falling somewhere between the two ethnic
groups. This would make vaccine complications strongly race-
related. The complications would overload local health care
resources, further raising the death rate. People would need to be
carefully screened for immunological status, which would need to
include an HIV test. There would also be the question of providing
economic support for treating the patients and for compensating
injured persons.
While Dr. Henderson and others were successful in persuading
the Bush administration to not roll out a national smallpox
vaccination campaign, the Bush administration did start a more
limited campaign in the fall of 2002 to vaccinate military personnel
(before the Iraq war) and civilian health care providers and first
responders.93 The results of this campaign were detailed in a
previous paper, and will only be summarized here.94
92. More generally, we have many more persons at medical risk in the
population today than in 1970. Advances in treatment have dramatically increased
the life expectancy for diseases such as Type I diabetes, chronic pulmonary
disease, and cystic fibrosis, among many others. These individuals are medically
fragile, so that any medical risk will affect them much more severely than it will the
general population.
Approximately 500,000 vaccinations were given to military
93. In previous smallpox epidemic, hospital-based spread was very important.
Mathematical modeling of smallpox control strategies first published at the time
of the roll out of the smallpox vaccine campaign showed that the most efficient
control strategy was a combination of vaccinating hospital workers before an
outbreak, and then aggressively vaccinating contacts after an outbreak. This
would quench the epidemic more quickly with the smallest number of
vaccinations, and thus the least risk of vaccine complications. Joshua M. Epstein et
al., Toward a Containment Strategy for Smallpox Bioterror: An Individual-Based
Computational Approach 15 (Ctr. on Soc. and Econ. Dynamics, Working Paper No.
31, Dec. 2002).
94. Richards et al., supra note 1.
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personnel, and another 500,000 have been given to military
personnel since then, with relatively few complications, other than
the cardiac complications noted above. This is not surprising
military personnel are screened for HIV on a regular basis and are
separated from the service if infected. They are also separated for
most other conditions that would put them at risk for
immunosuppression. As importantly, every soldiers medical
history is known by the military and there are no privacy issues
involved in screening them for risk factors.
The civilian side of the campaign was less successful, but
provides useful insights into the problems that would be posed by a
more widespread civilian immunization campaign. The goal was to
vaccinate 500,000 volunteer health care workers and first
responders who would be available to manage smallpox cases if
there was an outbreak. When the program was cancelled due to
cardiac complications, only 39,213 were vaccinated, fewer than ten
percent of the goal.95 Fears of complications were a factor in
reducing volunteers, but as big a problem was that the federal
Government never had an adequate answer to questions about who
would pay for workers compensation claims, medical care costs,
and long-term injuries and death from the vaccine. This was
further complicated by the comprehensive immunity that the
Government, its agents, and manufacturers enjoy for all
bioterrorism-related claims. Subsequent to the immunization
campaign, a smallpox vaccine injury compensation act was passed,
but it is limited and dependent on the discretion of the authority
with no judicial review.96
95. Ctrs. for Disease Control and Prevention, Update: Adverse Events Following
Civilian Smallpox VaccinationUnited States, 2003, 53 MORBIDITY & MORTALITY WKLY.
REP. 97, 106 (2004). This number may include personnel who were vaccinated
through the military reserves, further reducing the number of civilian volunteers.
It is unlikely to provide reassurance to
individuals and employers worried about who would pay for vaccine
complications.
96. The consent for smallpox vaccinations for persons at risk of potential
complications states that the CDC will provide the vaccine immune globulin, but
that [t]he other costs of hospital and medical care will not be covered by CDC
and will need to be paid by your insurer, Medicare, Medicaid or you. CTRS. FOR
DISEASE CONTROL AND PREVENTION, GUIDELINES FOR LARGE SCALE SMALLPOX
VACCINATION CLINI CS ANNEX 3, at 30 (2002) (emphasis in original).
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5202 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
XIII. THE CDC PLAN
The CDC plan97
Although smallpox vaccine is considered a safe vaccine,
postvaccination adverse events can occur. These adverse
events and their rates as determined in a 1968 10-state
survey include: 1) inadvertent inoculation (529.2/million
primary vaccinations), 2) generalized vaccinia
(241.5/million primary vaccinations), 3) eczema
vaccinatum (38.5/million vaccinations), 4) progressive
vaccinia (1.5/million primary vaccinations), and 5)
postvaccinial encephalitis (12.3/million primary
vaccinations). Death also occurred in about one per
million primary vaccinations, usually as a result of
progressive vaccinia, postvaccinial encephalitis, or severe
eczema vaccinatum.
for controlling a smallpox outbreak is
essentially unchanged since 2002. In some ways it is unchanged
from 1968the page describing the vaccine relies on data since
1968:
98
While the next paragraph of the plan does indicate that
persons with HIV should only be vaccinated if they have been
exposed to smallpox,
99
97. While this plan is put forward by the CDC, the CDC follows the direction
of the Department of Homeland Security, and it is assumed that this is the
Homeland Security as much as the CDCs plan. There is no official publication
for the CDC smallpox response plan. It is currently available at:
http://www.bt.cdc.gov/agent/smallpox/response-plan/index.asp. However, the
federal Government in general, and the CDC in particular, do not assure that
URLs for their documents are stable over time, and the CDC does not make
previous versions of documents available. To assure access to these documents for
readers of this article and scholars in general, the CDC smallpox response
documents as of February 28, 2010, have been archived at:
http://biotech.law.lsu.edu/blaw/bt/smallpox/CDC-28feb2010/index.htm.
These documents appear to be the same, with some formatting changes, from the
version of September 25, 2002, archived here:
http://biotech.law.lsu.edu/blaw/bt/smallpox/CDC_25sept02/index.htm.
there is no indication that the risks of the
98. Executive Summary, Smallpox Response Plan (Mar. 20, 2003), at 2,
available at http://biotech.law.lsu.edu/blaw/bt/smallpox/CDC-28feb2010/exec-
sections-i-vi.pdf.
99. Several groups have been identified as having a higher risk for
developing postvaccination complications. These persons are advised not to
receive smallpox vaccination unless they have been exposed or are at high risk of
exposure to smallpox virus. These include 1) persons with atopic dermatitis or
eczema (including a history of atopic dermatitis or eczema), 2) persons with acute,
active, or exfoliative skin conditions, 3) persons with altered immune states (e.g.,
HIV, AIDS, leukemia, lymphoma, immunosuppressive drugs, etc.), 4) pregnant
and breast-feeding women, 5) children younger than age 1 year, 6) persons who
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vaccine in 1968 have little relevance to the risks in 2010. Even the
characterization of the vaccine as considered safe is hardly
justified. It would be more accurate to say that the smallpox
vaccine is a dangerous vaccine, but one whose risks are justified in
the face of a smallpox outbreak.
There are other parts of the plan that are out of touch with the
best science, such as the one detailed by Dr. Henderson about the
insistence on an outdated vaccination technique because no one
had bothered to update the FDA approval from decades earlier.100
This insistence on legalistic detail in situations where it will make it
very difficult to rapidly vaccinate a large number of persons is most
evident in the informed-consent requirements. These anticipate
that in a mass vaccination situation each individual would get
screened and watch a video, approximately twenty percent would
get personal counseling, and all would fill out a packet of consent
forms based on the smallpox vaccine being available as
Investigational New Drug, i.e., as if smallpox vaccine was a new
experimental drug.101
The plan itself is basically the same proven plan that was used
during eradication: identify infected cases and their contacts, and
use isolation,
102 quarantine,103 and vaccination104
have a serious allergy to any component of the vaccine. Id. (emphasis in
original).
to limit the spread
100. See HENDERSON, supra note 30, at 294.
101. Annex 3, Guidelines for Large Scale Smallpox Vaccination Clinics,
Logistical Considerations and Guidance for State and Local Planning for Emergency, Large-
Scale, Voluntary Administration of Smallpox Vaccine in Response to a Smallpox Outbreak,
at 3, available at http://biotech.law.lsu.edu/blaw/bt/smallpox/CDC-
28feb2010/annex-3.pdf.
102. Isolation is the restriction of persons who are known to be infectious. For
smallpox, isolation is severe, requiring respiratory precautions for all persons
coming in contact with the patient, handling all linens and wastes as hazardous
waste, and, ideally, holding the person in a negative pressure room, with the air
drawn into a HEPA filter before exhausting it outdoors, away from any occupied
areas. Since the consequences of violating isolation could be catastrophic, the
patient would need to be locked in and guarded, unless very ill. Isolation for
smallpox lasts until the last scabs have healed.
103. Quarantine is the restriction of persons thought to have been exposed to
a communicable disease but who have not developed the symptoms of the disease.
Quarantine lasts for a few days beyond the longest known incubation period of the
disease, or until the person develops symptomatic disease and is transferred to
isolation.
104. Vaccination for smallpox can abort or mitigate the disease even if done
up to four days after exposure. Persons who are contacts must still be
quarantined, even if they are vaccinated.
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5204 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
of the disease until it has been eradicated.105
XIV. HOW LONG TO GET STARTED?
(There are additional
sections for setting up mass immunization clinics if necessary.)
This strategy is called ring immunization because it seeks to create
a ring of immunized persons around every infected person. There
is no question that this worked to eradicate smallpox, but have the
assumptions it is based on changed sufficiently that it will not be
effective in a contemporary outbreak? There are three key
assumptions for ring immunization. First, each contagious person
can be identified and isolated before exposing a large number of
contacts. Second, the contacts can be identified, quarantined, and
vaccinated. Third, there is a single, geographically limited
outbreak.
Analyzing these assumptions in turn, the identification and
isolation of the first cases in an outbreak depends on those persons
getting to a health care provider who makes the diagnosis of
possible smallpox and triggers the public health response. As
described previously, during the incubation period, there is no
evidence of disease, and the person is not contagious.
Infectiousness starts during the prodrome, which looks like a
generic flu-like illness with fever. Ideally, the infected person
would stay home and in bed, until going to the hospital when the
pustules appear, and the pustules would alert the ever vigilant
emergency room or clinic staff to the presence of a potential case
of smallpox.
In the real world, the H1N1 epidemic reminded us that many
people go to work sick unless specifically told not to. Even then,
those without benefits will still try to work because without working,
they do not get paid. This is especially true for people in the black
economy. Off the books illegal workers have little incentive to stay
home if they can possibly work. Street criminals, such as drug
dealers, do not figure in any bioterrorism or pandemic
preparedness plans, but they may also be infected and are unlikely
to stay at home, if they have a home.106
105. See supra text accompanying note 18.
106. In one of the best public health movies, there is a plague case spread by a
criminal who comes into New Orleans by sneaking off a ship. Tracing the cases is
complicated because the persons he exposed are criminals, who are avoiding the
public health officials and law enforcement. PANIC IN THE STREETS (Twentieth
Century Fox Film Corp. 1950). For more information, see
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Even if a person in the prodrome seeks medical care, there is
little chance that a health care provider would think about
smallpox unless the outbreak was already known. The likely
scenario would be the infected person spending a long time in a
crowded emergency room waiting room, exposing others nearby,
then being seen by a physician who prescribes over the counter
medication for fever and recommends that the person stay home
and rest until the illness was over. In the process, the physician and
ancillary staff would also be exposed.
Once pustules begin to develop, the person becomes much
more infectious, but also much easier to diagnose. If the person
returns for medical care or seeks first-time medical care once the
pustules are obvious, the case will likely be flagged and public
health authorities will be notified of a suspicious looking disease.107
However, an atypical or milder case might go undiagnosed, further
delaying the beginning of contact tracing. Meltzer estimated a
minimum of twenty-five days from first exposure to full
implementation of the plan.108
XV. CHASING CONTACTS
Once a case is identified, the process of identifying and tracing
contacts can begin. The difficulty of tracing contacts will be
determined by how many people the infected person came in
contact with, and whether the nature of the contact lends itself to
investigation. If the case is in a small town, it will be much easier
than in a big city. If the person goes to work on the subway in New
York City, visited a busy emergency room, and worked until too sick
to stand, it is going to be harder to identify contacts. In practical
terms, the more potential contacts, the more personnel will be
necessary to carry out the investigations. Health departments have
lost a lot of expert disease control personnel over the past decade,
and even with full staffing, would still have to bring in others such
as police officers to do a widespread search for contacts.
http://www.imdb.com/title/tt0042832/.
107. It is likely, but not absolutely certain. In less urbanized areas, it is possible
that the person would get a prescription for soothing lotion, a shot of steroids, and
be told to stay away from poison ivy.
108. Twenty-five days assumes 15 days for the first signs of overt symptoms
(Figure 2), 2 days for initial clinical diagnosis, 1 day for specimen transport, 3 days
for laboratory confirmation, and 4 days to mobilize and begin appropriate large-
scale interventions. Meltzer et al., supra note 32, at 962.
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5206 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
In the Internet world, it will be impossible to keep a smallpox
outbreak secret. More problematically, everyone will quickly know
that any contacts of a case will be quarantined and will be very
strongly encouraged to be vaccinated.109
If persons exposed to the disease leave the area, they will not
be identified until they develop symptomatic disease. By the time
their disease is diagnosed, they will have exposed others in new
areas. This will defeat the ring immunization strategy. It was not
an issue during eradication because few people had the resources
to flee. Smallpox was well-known and was seen as less of a threat
than it will be seen in the United States. Stopping this flight could
require quarantining a major urban center, which is difficult to
imagine being done successfully.
This will make contact
tracing much more complicated. While the quarantine will worry
them, most would be expected to want the vaccine and would not
evade authorities. It would not be surprising, however, if some
persons who were potential contacts would flee the area. More
generally, it would be expected that large numbers of persons
would attempt to flee the area to avoid contact with the disease.
Closing roads and subways and stopping people from driving
their SUVs across fields to avoid blockades would require massive
personnel. The quarantine would have to continue for the
duration of the outbreak, which could be for many weeks, since it is
assumed that some contacts of the first cases will slip through.
Supplying food would be difficult and economic activity would halt
since most urban centers depend on a large number of commuters.
Yet, given the publics suspicion of the Government and of
vaccinations, not quarantining the area would assure that some
infected persons would escape to other areas, something that
would not be known until they were sick and had already exposed
new contacts in those areas. Beyond outlining what quarantine
would mean for a smallpox epidemic, the CDC documents are
silent on how this could actually be done, just indicating that
quarantine is a state matter110
109. The federal Government maintains that it will never force anyone to be
vaccinated. It is impossible to tell if this is just a political ploy because of the
firestorm of criticism the CDC would get over mandatory vaccinations. There is
certainly constitutional authority to require vaccinations.
and that the feds have the power to
110. Guide C, Part 2: Quarantine Guidelines, at 2, available at
http://biotech.law.lsu.edu/blaw/bt/smallpox/CDC-28feb2010/guide-c-part-
2.pdf.
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promulgate quarantine regulations.111
XVI. WILL WE NEED MASS IMMUNIZATION?
While the CDC documents do not provide guidance on when
the response would shift to mass immunizations, a multi-focal
outbreak spread over several communities would make it
impossible to rely on ring immunizations.112 This would be
immediately obvious if cases were detected in several communities
at the same time, as would happen with a simultaneous release.
But even if the outbreak were only detected in one community,
would it be reasonable to assume that it would only stay in that
community? That citizen cooperation with ring vaccination and
quarantine would be sufficient to confine the spread? As Meltzer
points out, it will take nearly two months to contain an outbreak of
one hundred localized cases, as a best case scenario, and it will
likely take longer.113
Even if one were willing to make the assumption that
quarantine and ring vaccination could successfully contain the
outbreak to one community, one is still left with the problem that
the only source of a smallpox outbreak is a bioterrorist attack. As
Richard Danzig, former Secretary of the Navy and noted
bioterrorism consultant argues, bioterrorism preparedness must
assume reload, that unlike conventional attacks such as 9/11, a
bioterrorism attack will leave the terrorists undetected and with the
capability to attack again.
This is a long time for a population to see new
cases and deaths on every news cast and website.
114
111. Id. at 5.
Once smallpox is out of the freezer
and in the hands of terrorists, it would be very dangerous to assume
that they would not do follow-up attacks while the United States was
reeling from the primary attack.
112. E-mail from Dr. D.A. Henderson, Professor of Public Health and
Medicine, University of Pittsburgh, to Edward P. Richards, Harvey A. Peltier
Professor of Law and Director, Program in Law, Science, and Public Health at the
Paul M. Herbert Law Center, Louisiana State University (Jan. 14, 2010) (on file
with author).
113. Meltzer et al., supra note 32, at 966 tbl. 3.
114. See Richard Danzig, Catastrophic BioterrorismWhat is to be done?, CENTER
FOR TECH. & NATL SECURITY POLY, Aug. 2003, available at
http://biotech.law.lsu.edu/blaw/general/danzig01.pdf.
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5208 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
XVII. POTEMKIN PLANNING
In the spring of 2005, I had the privilege of presenting part of
a smallpox bioterrorism exercise to a group of sophisticated federal
government employees and military officers. I raised the question
that is at the heart of this article: is the CDC plan workable, and
how do we decide when to make the transition to mass
immunizations? What is plan B, and when do we go to it? The
response of the group was illuminating: the notion that plans do
not work was not part of their analysis. Their world was premised
on the plans working and everyone carrying out their designated
functions. Perhaps military plans work like that, but my experience
with state and local programs is very different.
The CDC plan is dependent on state and local public health
and law enforcement for the detection of cases, maintaining
quarantine, and, generally, setting up the infrastructure for the
response. In itself, this is not unreasonablepublic health is a very
local enterprise, requiring local knowledge, and the feds do not
have the personnel to mount a massive response on their own.
This national response is driven by an elaborate top down federal
planning effort, with the CDC plan being part of a general national
response plan.
The problem is that the federal planning effort has no
auditing function to assure that the states are really prepared to
carry out the plan. All those assurances come from the same
people who are doing the plans. From the perspective of state and
local government employees, they have to do these plans or the
feds will cut funding to programs they depend on, or otherwise
harass them. Their state and local funding has been dramatically
reduced over the past twenty years through a combination of
budget cuts and expansion of the mission.115
The result is that most plans for large scale emergency
State and local
politicians who set these budgets do not want to hear that cuts have
consequences for public health and safety, so that it is not an
option to respond to the CDC or other federal agency that it is
impossible to staff or carry out the requested plan with the existing
levels of staff, expertise, and material.
115. For just one example, as obesity has become a fashionable topic, health
departments have been tasked with various programs to track obesity in children,
set up education programs, and otherwise tackle the obesity epidemic. These new
duties come with no money, at the same time that budgets are being cut, and they
require different expertise than core communicable disease control activities.
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response, including bioterrorism, are Potemkin plans, based on
representations about expertise, personnel, and material that are
not realistic. Such plans also indicate that the state and local
officials will follow the federal lead and carry out actions as
described in the plan. Yet everyone who has worked with state and
local government knows that no elected official takes orders from
other elected officials. When the time for emergency response
comes, local issues will determine the shape of that response
without regard to federal plans, mandates, or orders. Elected
officials do what they think is best for their constituencies at the
moment, with an eye on their constituencies that they will see the
politicians actions at reelection time.
XVIII. THE HURRICANE KATRINA EFFECT
A few months after I was assured that response plans work and
that all levels of Government carry out their roles, Hurricane
Katrina threatened the Gulf Coast.116 While the roots of the
Katrina disaster were 200 years of bad land use planning by the
New Orleans and Louisiana governments, the most critical mistake
was the failure to call for a timely evacuation of New Orleans and to
provide the support for such an evacuation. Ironically, Louisiana
state and local officials had completed a major federal planning
exercise just the year before for a theoretical storm that would have
done much more damage than Katrina. As with all good planning
exercises, everyone went home assured they were ready.117
All cats are black in the dark and all plans work before the
disaster. Disaster response plans have financial and political costs,
which must be balanced against their benefits. Before the disaster,
the benefits are only theoretical, but some of the costs are real.
Balancing those real costs against the net present day cost of being
prepared in the future is difficult and made much more difficult
when the future event is difficult to predict, and thus can be seen as
of low probability in the short run. The Hurricane Pam exercise
and all the federal hurricane planning efforts for New Orleans
ignored the most important political reality: state and local officials
116. This article is not meant to be an in-depth analysis of the governmental
failures surrounding Hurricane Katrina. That has been the subject of endless
post-hoc analyses, most of which are not well-informed about the actual events and
their cause, but addressing these is beyond the scope of this article.
117. FEMA, Hurricane Pam Exercise Concludes (July 23, 2004), available at
http://biotech.law.lsu.edu/blaw/FEMA/FEMA_Hurricane_Pam.pdf.
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5210 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
could not admit that New Orleans might flood.
The history of New Orleans is a history of attempting to
expand the original core of the city which was built on the narrow
stretch of high land along the river, into the swamps and eventually
into the surrounding bays themselves.118 Combined with the
subsidence of the crustal plate under South Louisiana, this leaves a
significant part of New Orleans below sea level. New Orleans has
flooded on a regular basis during its history, the most recent pre-
Katrina flood being Hurricane Betsy in 1965, in which the levees
broke and flooded most of the same areas flooded by Katrina.119
But that was forty years ago, and a mythology had grown up that
the levees were now fine and would prevent any future flooding.120
There had been several evacuations of New Orleans since
Hurricane Betsy and all were pronounced great successes. As we
learned with Hurricane Katrina, you do not really know how many
people do not evacuate until you have the flood, so there was no
reason to doubt the success of these evacuations. At no time did
the politicians say that New Orleans could flood, because that
would undermine property values, and the strategy had worked for
forty years because all the hurricanes had missed New Orleans at
the last minute. The assumption was that Katrina would be no
different, so it was treated no differently. The evacuation was
called at the last minute, because if evacuations were called two
days before landfall, there would be a lot of false alarms because of
the difficulty of predicting the course of hurricanes. There were
shelters of last resort opened in the city, which further reinforced
the message that New Orleans could not flood because no one
would have shelters that would flood. The area hospitals were not
evacuated, again reinforcing the message that the city could not
flood. Had Katrina missed the city, as all the storms had since
1965, the Hurricane Katrina evacuation would have been logged as
a success and an example of the effective state-federal disaster
This was crucial to land values in New Orleans, as well as the
retention of businesses in what was a declining city.
118. See generally CRAIG E. COLTEN, AN UNNATURAL METROPOLIS: WRESTING NEW
ORLEANS FROM NATURE (Louisiana State Univ. Press 2004).
119. THOMAS R. FORREST, HURRICANE BETSY, 1965; A SELECTIVE ANALYSIS OF
ORGANIZATIONAL RESPONSE IN THE NEW ORL EANS AREA (U. Del., Disaster Res.
Center 1979), available at http://biotech.law.lsu.edu/katrina/betsy/HC-205.pdf.
120. This may have been the longest interval between New Orleans major
floods. The 1970s through the 1990s was a historical low period for hurricanes in
the United States, which helped fuel a mass exodus to the Gulf and Atlantic coasts.
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response.
Hurricanes are frequent events on the Gulf Coast, at least as
compared to potential smallpox bioterrorism. The 2004 hurricane
season was the worst on record, until the 2005 season. It was
assumed that state and local officials would take the risks of a storm
in 2005 very seriously after the 2004 season, yet they did not. A
smallpox bioterrorism event is an event with an undeterminably
low probability. It would be surprising if state and local
governments, and, frankly, the federal Government (who did not
do very well after Katrina itself), are as prepared as their plans
indicate. It is also possible that the local response to a smallpox
outbreak might not be very effective, and that the officials in
charge might not realize that, or might have reasons to downplay
their failure.
The first reason would be the economic consequences of a
massive quarantine on the city and regional economies. The cost
of the involved governmental resources would be huge, and the
loss of a large fraction of the business income for weeks would be
catastrophic, especially if the attack were to occur during an
economic downturn that such state and local governments faced
between 2008 and 2010. The second reason is that a mass
immunization program would cause a large number of injuries,
some deaths, huge health care costs, and potentially ruinous
political consequences. A real political fear would be to go to mass
immunizations very quickly and effectively stop the outbreak, but
end up with more vaccine injuries than smallpox deaths. In
political terms, it would be better to have a lot of bodies to justify
the possible consequences of mass immunizations.
In the Hurricane Katrina disaster, the error in not supporting
a timely and massive evacuation only became apparent when the
water started filling the city and the emergency phone system was
overwhelmed with calls for help. At that point, it was too late to
save many of the people trapped in their flooding houses or in
flooded hospitals and nursing homes, or in city shelters of last
resort. In a smallpox outbreak, the failure of the primary ring
immunization approach would only be evident as new generations
of unanticipated infections appeared, especially if they appeared in
new communities. This would either be evidence of reloada
second attackor the escape of infected persons from the original
target community. This would (hopefully) shift the response to
mass immunizations as well as ring immunizations, but with a loss
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5212 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
of at least a couple of weeks. Under the conditions of the Dark
Winter simulation, that would be enough for the smallpox to
become a full-blown epidemic which would be very hard to contain,
and which would gravely disrupt the U.S. economy.
XIX. FROM POTEMKIN PLAN TO WORKABLE PLAN
The CDC has trained epidemiologists who understand the
science of communicable disease control in general and smallpox
in particular. But the CDC is also a political organization and its
political leadership has to be attentive to politically unpopular
endeavors, regardless of their scientific merit. After the political
fallout from the 1976 Swine Flu immunization campaign, the CDC
has avoided controversial disease control measures.121
Mandatory vaccinations are controversial, so controversial that
many states have even altered their routine childhood
immunization law to allow parents to opt their children out of
immunizations based solely on parental moral objections. There is
no need to be a Christian Scientist anymore. Mass vaccination with
smallpox vaccine, a live virus vaccine that can prove deadly to
persons with immune system diseases, would require identifying
everyone at higher risk of vaccine injury. This would, in turn,
require knowing peoples HIV status, which could include
controversial mandatory HIV testing. More generally, plans that
anticipate that state and local efforts may be inadequate, and that
indicate that niceties such as an elaborate consent process for
vaccinations may have to be abandoned, are also controversial.
This is
especially true of plans that are unlikely to be implementedWhy
put controversial components in a plan that has little chance of
being endorsed?
This section will take a hard look at both contact tracing and
the ring immunization strategies to indicate that it is an adequate
plan for a smallpox bioterrorism event. It will conclude with an
alternative plan that will better meet the specific needs of a
smallpox outbreak and will improve public health preparedness in
general.122
121. For a detailed analysis of the swine flu vaccination program and its
political dimensions, see RICHARD E. NEUSTADT & HARVEY V. FINEBERG, THE SWINE
FLU AFFAIR: DECISION-MAKING ON A SLIPPERY DISEASE (1978).
122. The basic library for smallpox information has been collected at
http://www.nlm.nih.gov/nichsr/esmallpox/esmallpox.html.
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XX. A HARD LOOK AT RING IMMUNIZATION
The ring immunization approach to a smallpox outbreak
makes good public health sense. It worked for eradication and is a
good balance between the risks of smallpox vaccination and the
risks of an unconstrained smallpox outbreak. Ring immunization
starts with careful epidemiology. The index casesthe persons
first infected with the introduction of the smallpox into the
communitymust be diagnosed and reported to public health
authorities. As discussed earlier, this may take more time than
plans anticipate because health care providers are likely to be
unfamiliar with the disease and because of limited access to health
care. Once the state or local health department is notified of a
potential case, the department will decide whether to immediately
call the CDC or to verify the case first. This decision will turn on
how much the case looks like smallpox. A person covered with
typical sores will trigger an immediate national response. However,
a case with a less obvious presentation might be dismissed as
measles or some other common disease, which could delay
identification. During the early contagious period, before the sores
are obvious, it is very unlikely that the disease would be identified,
but would instead be dismissed as flu.123
Everyone who comes into contact with the patient during the
interval between when the patient becomes contagious and when
the patient is diagnosed with smallpox and put into isolation must
be assumed to be potentially infected with smallpox. Every contact
must be identified, vaccinated, and quarantined for at least
fourteen days to assure that if they develop smallpox, they do not
pose a risk to more people. The process of contact tracing begins
with an in-depth interview with the infected person to reconstruct
the patients movements and all contacts from before the earliest
point at which the patient could have been infectious. Depending
on how long the diagnosis was delayed, this might be for the
previous four to seven days. If the patient is too sick to provide
information, to properly remember the information, or if the
patient is unwilling to cooperate,
124
123. See Meltzer et al., supra note
the history must be
32, at 96061; see also A.R. RAO, SMALLPOX 41
42 (The Kothari Book Depot 1972).
124. In the classic film noir, Panic in the Streets (Twentieth Century Fox Film
Corp. 1950), a criminal smuggled off a ship was infected with plague. The heroic
health officer and New Orleans officials had to track his contacts in the
underworld, encountering resistance at all turns. For more information, see
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5214 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
reconstructed from family members, co-workers, or other persons
who might know of the patients behavior.
The clock is ticking during this investigation because every
contact that becomes contagious before being identified and
isolated will start another chain of investigation. Once a case of
smallpox has been identified anywhere in the United States (or
probably anywhere in the world), the index of suspicion will be very
high, and anyone with a flu-like illness or a rash will seek medical
care at once, and health care providers will treat every remotely
suspicious case as smallpox.125
Meltzer analyzes the effect of various levels of efficiency in
quarantining and vaccinating contacts in the time necessary to end
the outbreak and the total number of cases of smallpox that would
occur.
This will create noise, i.e., the large
number of cases that are assumed to be positive (false positives) will
consume valuable epidemiologic resources to evaluate and
quarantine cases until they are positively excluded as smallpox
cases. The false positives and the difficulty of identifying all
contacts of the initial cases guarantee that some contacts will not be
identified until they develop smallpox, triggering the need for new
chains of contact tracing.
126 Meltzer uses a conservative (low) estimate that each
person with smallpox will infect three others if there is no
intervention.127 The model assumes an initial seed of one hundred
cases.128
http://www.imdb.com/title/tt0042832/.
The paper is silent on the nature of the geographical
distribution of the cases, but since it does not mention overlap in
the contact networkswhich increases efficiency in contact
identificationit appears that the model assumes that the contacts
are spread over a fairly wide area. Meltzer did not model a mass
vaccination program because of potential complications and
125. While this will shorten the time to diagnose the secondary cases, it will
challenge the health care system and especially emergency rooms where most
people will seek care. At the same time that there is a massive influx of people
worried that they have smallpox, the emergency rooms and other clinic facilities
will be implementing infection control procedures to prevent the spread of
disease in the waiting and triage areas. This will require controlling access to
hospitals, perhaps closing emergency rooms to walk-in patients, and other
measures. The provision of care to infected persons and the protection of the
health care system from shutdown due to contamination are critical issues, but
they are beyond the scope of this article.
126. See Meltzer et al., supra note 32, at 96167.
127. Id. at 961.
128. Id.
Richards_formatted_final.doc 7/20/2010 7:56 AM
2010] SMALLPOX BIOTERRORISM 5215
because it was assumed at the time of publication that there were
only 40,000,000 doses of vaccine available. Meltzer shows that
contact tracing and quarantine, combined with ring immunization,
is more effective than either strategy alone. But Meltzer also shows
that its assumptions on the effectiveness of contact identification
and vaccination, which seem realistic, and even perhaps a bit
conservative, result in an outbreak lasting several months or even
up to a year long, with 3,200 to 12,400 cases, depending on
whether the interventions were fully in place by the twenty-fifth day
or the forty-fifth day.129
XXI. IS RING IMMUNIZATION REALISTIC?
Meltzers analysis raises three critical issues. First, the long
delay needed to control an outbreak seems politically
unsustainable. The public, the media, and politicians will fixate on
each new case, and each death, likely paralyzing government in the
affected areas and creating demands for complete travel
restrictions to prevent the spread of smallpox to unaffected areas.
The economic consequences of the disruptions and uncertainty
will be very serious.
Second, Meltzer provides very powerful evidence that the start
time of the interventions is the most critical variable. The start
time for the outbreak is the initial exposure of the index cases, and
Meltzer assumed that it would take twenty-five days to have full
scale interventions working.130
Third, the Meltzer model recognizes that delays in
implementing the strategies or not being able to carry them out
effectively can make control impossible.
As the delay for starting
interventions increases, the time to control the outbreak and the
number of expected cases before control is achieved increases
dramatically.
131
129. Id. at 963.
Ring immunization
depends on a functioning public health system, a compliant public,
and politicians willing to make unpopular decisions to support the
quarantine and vaccination efforts. In these regards, the average
U.S. city is likely less well-prepared to properly support ring
130. Twenty-five days assumes 15 days for the first signs of overt symptoms
(Figure 2), 2 days for initial clinical diagnosis, 1 day for specimen transport, 3 days
for laboratory confirmation, and 4 days to mobilize and begin appropriate large-
scale interventions. Id. at 962.
131. Id. at 965 fig.6.
Richards_formatted_final.doc 7/20/2010 7:56 AM
5216 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
immunization than an African village in 1970.
We have lost public health infrastructure, in particular the
expert epidemiologists that are necessary for doing effective
contact tracing. Studies have shown a consistent decline in the
number of epidemiologists at both state and local health
departments, except for a brief respite after 9/11 which augmented
health department budgetsan increase that is now history.132
These studies underestimate the loss of infectious disease control
expertise because they do not differentiate between chronic disease
epidemiologists, who are primarily mathematicians, and infectious
disease epidemiologists who deal with disease investigations and
interventions.133
XXII. WHAT IS THE ALTERNATIVE?
Part of this loss is due to politicians who are
unwilling to face the problems in the system, and a public that does
not support, or is unwilling to cooperate with, public health
activities such as immunization programs. Together, the loss of
expert personnel and public and political support make it unlikely
that a massive contact tracing and ring immunization program
could be carried out effectively and quickly.
Meltzer clearly identifies the key variable in a successful
response to a smallpox outbreak: time. The number of cases
increases dramatically with each new generation. Even using the
conservative number of three infections per case, an initial seed of
100 cases yields 300 at 15 days, 900 at 30 days, and 2,700 at 45 days,
with future growth dependant on the success of control measures.
132. The beginning of the problem was noted in the early 1990s. See Michael
T. Osterholm, Guthrie S. Birkhead & Rebecca A. Meriwether, Impediments to Public
Health Surveillance in the 1990s: The Lack of Resources and the Need for Priorities, J. OF
PUB. HEALTH MGMT. & PRAC., Fall 1996, at 1115; Lyn Finelli et al., Epidemiologic
Support to State and Local Sexually Transmitted Disease Control Programs: Perceived Need
and Availability, SEXUALLY TRANSMITTED DISEASES, Mar. 1998, at 132; Ctrs. for
Disease Control and Prevention, Assessment of the Epidemiologic Capacity in State and
Territorial Health DepartmentsUnited States, 2001, 52 MORBIDITY & MORTALITY WKLY.
REP. 1049 (2003); Ctrs. for Disease Control and Prevention, Assessment of the
Epidemiologic Capacity in State and Territorial Health DepartmentsUnited States, 2004,
54 MORBIDITY & MORTALITY WKLY. REP. 457 (2005); Ctrs. for Disease Control and
Prevention, Assessment of the Epidemiologic Capacity in State and Territorial Health
DepartmentsUnited States, 2009, 58 MORBIDITY & MORTALITY WKLY. REP. 1373
(2009).
133. See John J. Potterat, Disease Intervention Specialists as a Corps, Not Corpse,
SEXUALLY TRANSMITTED DISEASES, July 2008, at 703, available at
http://biotech.law.lsu.edu/cases/STDs/Disease_Intervention_Specialists_as_a_Co
rps.12.pdf.
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2010] SMALLPOX BIOTERRORISM 5217
If the initial seed is larger, or the number of new cases per index
case is higher, the numbers grow faster. Under the assumptions in
the Meltzer paper, effective control measures would not be in place
until day twenty-five, which is after the second generation of cases
has been infected, so there would already be a tripling before there
could be any effect of the program. If the contract tracing was not
as effective as expected, or there were more cases per index case
than predicted, this would not be detected until the fourth and
fifth generations, by which time the disease would likely have
escaped control. The only alternative at that point would be mass
immunizations, but with a high rate of smallpox in the community
disrupting the immunization program and potentially leading to
social disorder.
The CDC plan is based on a bet that the system will work, but
this bet is undermined by the impossibility of including the
substantial probability that state, local, and federal resources will
fail: the Katrina problem. Yet if these resources fail, then the
chance to control a smallpox outbreak without massive social and
economic disruption and loss of life is lost. This is the risk that
must be balanced against the risks of vaccine-related illness and
death secondary to a mass immunization program, rather than the
balance of the risks of mass immunizations against a successful ring
immunization program. Plan B would be to start mass
immunizations when the first case of smallpox is confirmed, with
an emphasis on making vaccine available to health care workers
and first responders, and their families, as fast as possible.134
134. If you do not include families, people will likely not come to work because
they are afraid of carrying infection home to their families.
This
would satisfy the public demand for vaccine and the accompanying
disorder when that demand is not met. It would also start to fill the
population with immune persons, making the ring immunization
program more effective as the consequences of missing contacts
diminish, because the chance that those contacts are already
vaccinated increases. At two weeks past the first cases of smallpox,
it would be clear whether ring immunization was workingif there
were new cases among persons not previously identified by
contacts, especially in new communities, this would either be
evidence of additional attacks or break-down of the ring
immunization program. If there are no unexpected new cases,
then mass immunizations could be curtailed.
Richards_formatted_final.doc 7/20/2010 7:56 AM
5218 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
XXIII. BUILDING INFRASTRUCTURE BEFORE THE OUTBREAK
Plan B requires more than just flipping the switch on the
existing CDC mass immunization clinic guidelines.135
Building an effective response infrastructure for a smallpox
bioterrorism event, or any other wide-spread public health
emergency such as pandemic flu must be done in real time. It
must be part of the routine public health infrastructure, supported
and accepted by the public. The best way to accomplish this would
be to put money and political will behind making our current
public health system function properly. This would prepare us for
future challenges and would provide immediate benefits. It would
also allow effective quality control auditing because there would be
real data on the effectiveness.
As Hurricane
Katrina demonstrates, plans on the shelf backed up by table-top
exercises do not assure that the real system would work in an
emergencythe time when it is most difficult to make anything
work. The United States cannot effectively immunize the
population against seasonal flu or H1N1, many states allow parents
who do not like vaccinations to opt their children out of
vaccinations for school attendance, and there are no provisions
that address the problems that undermined the 2002 smallpox
vaccination campaign, such as payment for vaccine-induced
damage.
136
135. While the CDC does not provide much information on how the smallpox
vaccine is stored, other information available about the Strategic National
Stockpile indicates that it takes times to deploy all the way out of the final clinic
settings. The CDC mass vaccination plan also assumes the use of a relatively small
number of high volume clinics, so that each clinic can vaccinate about 10,000
persons per day. This creates logistic problems in people getting to the clinic, and
crowd control at the clinic. As an alternative, vaccine could be widely distributed
to health care workers and vaccinations could be done in the community, as was
done during the 1947 outbreak. But this would require giving up the highly
structured, legalistic control of the vaccination.
Problems would be detected
quickly and the system refined to work better and gain more public
support. This is impossible with academic exercises that have no
real world implementation.
136. While it is beyond the scope of this article, all modern methods of
statistical quality control and continuous quality improvement depend on
analyzing a running program, detecting problems, and correcting those problems
before they affect the quality of the end product or service. Programs that are
only called into existence for a one-shot emergency can never be evaluated or
refined, and are prone to unanticipated system failures. For quality control
theory, see W. EDWARD DEMING, OUT OF THE CRISIS (2000).
Richards_formatted_final.doc 7/20/2010 7:56 AM
2010] SMALLPOX BIOTERRORISM 5219
As examples, there are two public health programs that would
significantly improve public health and would also build
professional and political infrastructure to improve bioterrorism-
response capability. The first would be a program for seasonal flu
immunizations that would quickly immunize ninety percent of the
at-risk population. Since there is a flu pandemic each winter, with
the occasional bonus of an additional epidemic such as H1N1, this
would be an ongoing program that would pay for itself by saving
thousands of lives each year, improving productivity by reducing
workplace illness, and by saving flu-related medical costs. Making
this program work would require educating the public about the
value of vaccinations, eliminating legal barriers to vaccination
programs, and developing an effective system of vaccine
distribution and administration. All of these would improve the
ability to respond to a bioterrorism event as well as improve
vaccination rates for both childhood and adult diseases.
The best way to improve infectious disease epidemiology
staffing would be to develop a proper HIV control program that
could identify every person infected with the disease, help them get
better treatment, and more effectively limit the spread of HIV.137
Such public health epidemiology and disease management
programs would improve the health of the public, reduce health
care costs, and support the necessary expertise and infrastructure
for a proper response to smallpox and other pandemic and
bioterrorism threats.
This would also put persons with HIV on notice of their status,
which would help them avoid smallpox vaccine complications.
There are presently about one million persons living with HIV in
the United States, augmented by 40,000 newly infected persons
annually, with 15,000 dying annually. The economic and human
cost is tremendous, making it easy for an effective HIV control
program to pay for itself, while developing invaluable contact
tracing and identification infrastructure for a future smallpox
outbreak.
138
137. John J. Potterat, Partner Notification for HIV: Running Out of Excuses,
SEXUALLY TRANSMITTED DISEASES, Jan. 2003, at 8990, available at
http://biotech.law.lsu.edu/cases/STDs/Partner_Notification_for_HIV.pdf.
If such programs could be made to work
and were used to build acceptance for disease control by the
138. For an example of such an all-hazards plan, see Edward P. Richards et al.,
U.S. Dept of Justice, The Role of Law Enforcement in Public Health Emergencies: Special
Considerations for an All-Hazards Approach (2006), available at http://www.dr-
kate.com/docs/214333.pdf.
Richards_formatted_final.doc 7/20/2010 7:56 AM
5220 WILLIAM MITCHELL LAW REVIEW [Vol. 36:5
public, we might not need a Plan B for smallpox because we could
have more confidence that Plan A could be successfully
implemented.
XXIV. CONCLUSION
The CDC smallpox bioterrorism response plan is founded on
good science, empirically proven during the smallpox eradication
program of the 1960s and 1970s. Its weakness is that it is based on
assumptions about the public health infrastructure, political
leadership, and public cooperation that are at odds with observed
realities. More fundamentally, it is a victim of the larger federally-
driven emergency response system. This is based on cram-down
planning exercises that blindly assume that state and local
government agencies have the resources they claim and that they
can and will do what they promise in the plan when there is an
emergency.
The result is a theoretical plan-based system that cannot be
audited or refined and whose failure modes will only be detected
when it is too late to prevent the consequences of those failures. In
contrast, rebuilding public health infrastructure to address real
public health threats would provide both real benefits in the short-
term and a verifiable response system for bioterrorism events,
pandemics, and emerging infectious diseases.
ResearchGate has not been able to resolve any citations for this publication.
Article
Full-text available
On December 13, 2002, the White House announced a plan to vaccinate active duty military personnel and certain civilian hospital, health care, and emergency services workers against smallpox. This announcement was accompanied by a Smallpox Vaccination FAQ. The goal was to vaccinate 500,000 military personnel as soon as possible, and then to vaccinate 500,000 civilians within a few weeks. There were no specific plans to vaccinate the general population, but there was discussion about making the smallpox vaccine available to the general public in 2004. President Bush was immunized first, with no reported ill effects.By January 2004, 578,286 military personnel were vaccinated. During the same period, only 39,213 civilian health-care and public health workers were vaccinated, less than ten percent of the original goal. This article analyzes why the civilian smallpox vaccination campaign failed, the impact of this failure, and what it should teach us about future vaccination campaigns for smallpox and other bioterrorism agents. Some of the reasons for failure could have been averted with better planning and legislation, but others are intrinsic to the United States’s medical and legal systems. Addressing these intrinsic problems demands fundamental modifications in the plans for bioterrorism preparedness.This article does not discuss the control of a smallpox outbreak, beyond the use of smallpox vaccinations. Control measures would include stopping all transportation in and out of the affected area, identifying all cases, persons in contact with those cases or in contact with contacts of those cases, vaccinating and isolating the contacts, and trying to preserve social order and infrastructure in the affected region. Such measures would require military intervention as discussed in other papers in this symposium issue. It is possible that we would see the breakdown of civil order and imposition of martial law. The authors believe that such measures will be nearly impossible to carry out because they pose difficult moral and ethical dilemmas such as whether to shoot the soccer mom with the minivan full of kids trying to get out of the city. As a result, the authors stress the importance of a workable vaccination program which can stop the epidemic even if draconian control measures fail.This article originated in the Smallpox Vaccine Injury and Legal Guide, an online analysis of the medical and legal issues posed by the smallpox vaccine campaign that was updated as the campaign progressed. Through the guide and discussions with health care institutions, unions, health departments, and reporters, Professor Richards and Dr. Rathbun helped many health care organizations tailor their response to the smallpox vaccine campaign.
Article
Sexually transmitted diseases (STDs) comprise the majority of national infectious disease morbidity reported, yet the number of epidemiologists working in state and local STD programs is estimated to be small. Even less is known about the training and activities of those epidemiologists. To determine the number, training, and affiliation of epidemiologists working with STD programs and the level of satisfaction with epidemiologic support available. Survey of 65 program managers in state and local health departments. Program managers named 146 people working on epidemiologic activities, and 84 of those people were classified as "epidemiologist" by the criteria we applied. The median number of full-time equivalent (FTE) epidemiologists working in or with STD programs was 0.5; one quarter of all STD program had no epidemiologists. There was a significant association between number of FTE epidemiologist and population, with most programs with more than 0.5 epidemiologists located in areas with at least 1,000,000 population. State Epidemiologists do not provide technical support to most state STD programs. Almost half (45%) of all program managers indicated that they have inadequate epidemiologic support for routine program activities. The current level of epidemiologic support available to most STD programs is inadequate to perform surveillance and data analyses, interpret data to develop program objectives, and perform program evaluation. An essential next step is the delineation of a set of critical, analytic STD field epidemiology functions to define appropriate standards against which epidemiologic capacity can be more precisely measured.
Article
With the increased demand for public health surveillance data comes the development of new surveillance systems and the expansion of existing systems. A corresponding increase in financial and personnel resources to support data collection, particularly at the local public health department level, has been documented. Adequate and timely surveillance data are critical to both overall public health program design and evaluation and to meet emerging surveillance needs. Without an emphasis placed on priorities and resources for public health surveillance, the foundation upon which public health decisions are based is threatened.
Disease Control and Prevention, Assessment of the Epidemiologic Capacity in State and Territorial Health Departments-United States
  • Ctrs
  • For
Ctrs. for Disease Control and Prevention, Assessment of the Epidemiologic Capacity in State and Territorial Health Departments-United States, 2004, 54 MORBIDITY & MORTALITY WKLY. REP. 457 (2005);
aff'd, Cedillo v. Sec'y of Health and Human Servs
  • Cedillo V Sec'y Of Health
  • Human Servs
Cedillo v. Sec'y of Health and Human Servs., No. 98-916V, 2009 WL 331968 (Fed. Cl. Feb 12, 2009), aff'd, Cedillo v. Sec'y of Health and Human Servs., 89 Fed. Cl. 158 (Fed. Cl. 2009);
aff'd, Hazlehurst ex rel. Hazlehurst v. Sec'y Dep't of Health & Human Servs
Hazlehurst v. Sec'y of Dep't of Health and Human Servs., No. 03-654V, 2009 WL 332306 (Fed.Cl. Feb 12, 2009), aff'd, Hazlehurst ex rel. Hazlehurst v. Sec'y Dep't of Health & Human Servs., 88 Fed. Cl. 473 (Fed. Cl. 2009).