Smallpox

1
Smallpox BioterorrismWhat Went WrongWhat To
Do

• William J. Bicknell, MD, MPH
• Boston University School of Public Health
• Former Massachusetts Commissioner of Public
  Health
• Kenneth D. Bloem
• Former CEO Stanford University Hospital
  Georgetown Medical Center

2
Why are we doing this?

• Neither of us work for a federal, state or local
  health agency
• We are not consultants to or employed by any
  firm or group that has a special interest in
  vaccination
• We became involved as, whether coming from a
  public health (WB) or acute medical care (KB)
  perspective, we felt the nation was and is making
  many dangerous missteps.

3
Smallpox Bioterrorism What Went Wrong What
To Do

• I - The threat, the plan the status
• II - Four false premises the real risk of
  vaccinating healthy adults
• III - Why the plan is failing
• IV - Underlying reasons for failure
• V - Our recommendations - Who should do what

4
Six Major Points

• Vaccination Works
• Vaccination is Extremely Safe in Healthy Adults
• Smallpox is the only BT weapon for which there is
  a proven, low cost, preventive approach -
  vaccination - that neutralizes the smallpox
  weapon before it is used
• This means, with just a little bit of effort, we
  can eliminate smallpox as an effective
  bioterrorist weapon - IF WE VACCINATE ENOUGH
  PEOPLE PRE-ATTACK NOW
• So far we have chosen NOT TO DO THIS
• The potential unimaginably high social, economic,
  death human misery consequences to the United
  States require ACTION NOW

5
Caveats

• We will be pointing out various problems we
  perceive with implementing the Presidents plan.
• Our concerns are organizational and systemic not
  personal.
• Further
• we recognize that all parties share a common goal
  - minimizing the nations vulnerability to
  smallpox introduced by bioterrorists.
• Thousands, possibly tens of thousands of
  professionals have been and are continuing to
  work diligently toward this goal.
• Our only objective is to improve the nation's
  effectiveness in minimizing our vulnerability.

6
Are We at Risk?

• Until the national security apparatus says
  otherwise, we continue to believe there is an
  unquantifiable but real risk of a bioterrorist
  attack using smallpox
• with up to 1000s or 10s of thousands of cases
• 30 deaths
• 60 to 80 of survivors disfigured
• The cases and deaths, with advance preparation,
  can be reduced to very small numbers
• The key is preparation now
• If you think there is no risk of smallpox as a BT
  weapon, then no need to stay for the rest of the
  talk

7
Smallpox is a Bad Disease

• It kills 30
• It spreads easily
• It is spreading before you even know it has
  arrived
• And dont think high tech bio-detectors will
  result in early detection sufficient to protect
  the population.
• Although panic is felt to be unlikely in most
  terrorist situations, the reality of a spreading
  deadly disease with an inadequate government
  response could easily lead to persons acting in
  their own best interests - what government likes
  to call panic.

8
A Chilling Scenario

• One person with smallpox arriving in the country
  traveled by train.he was apparently in the
  initial phase of the disease, as nobody noticed a
  rash on his faceAlmost everyone who traveled
  with him in the compartment from Queensborough to
  Manchester contracted smallpox, the ticket
  collector...and those who traveled with him to
  Stalybridge in another train, something like a
  hundred people being infected from one single
  case.
• Not so different from flying in from Europe,
  traveling downtown by public transport and taking
  a train to the next city
• And terrorists are very motivated, so expect them
  to travel even if feeling quite ill

Wanklyn (1913) cited in Dixon p311
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What might this look like in the US?

• Here is a model with one set of assumptions
• Anyone who would like the model need only email
  me ltwbicknel_at_bu.edugt
• You can make you own assumptions
• The next slide assumes a well planned and well
  executed terrorist attack with 12 terrorists
  going to multiple cities.

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The Presidents Plan

• Phase I
• 500,000 civilian first responders by February
  2003 but only 38,436 (9/5/03)
• 500,000 military - essentially done done safely
  (over 490,000 as of 9/9/03)
• Phase II
• Up to 10,000,000 health and emergency workers by
  mid-summer 2003. Actual number ZERO
• Phase III
• Starting mid-2003 permit healthy adults to opt
  for vaccination. Actual number ZERO
• All Phases
• Voluntary Vaccination of Healthy Adults

12
Effective Control of a Bioterrorist Use of
Smallpox Requires Preparation Before an Attack

• The MINIMUM Requirement is
• Vaccine, needles and VIG - We have enough
• A tested system in place for rapid post-attack
  mass vaccination - We dont have this
• Enough vaccinated people pre-attack sufficient to
  
• Staff clinics for mass vaccination - dont have
• Enough people vaccinated pre-attack so that
  vaccinators neither have to be vaccinated first
  nor are they scared to assemble and to get
  vaccinated and then vaccinate others - dont have
• Safely transport smallpox patients to hospitals -
  dont have
• Care for smallpox patients without getting
  infected - dont have
• Doing more than the minimum is even better
• Other hospital workers and emergency workers - no
  longer being discussed
• Healthy adults in the general population who
  choose voluntary vaccination - silence reigns

13
The Current Situation

• If something occurred, we would pull out all the
  stops after the first few cases
• Result
• Excess deaths and disfigurement but
• We would wrap up smallpox fairly quickly
• Probably in 8 to 12 weeks
• With enormous socio-economic disruption excess
  deaths and unnecessary excess leakage to other
  countries
• Plenty of recriminations afterward
• This should not be acceptable, is not necessary
  and certainly is not sufficient.

14
Preparedness Bottom Line

• We are not prepared
• A well done attack could cost many 1000s of
  lives, more sickness and incalculable national
  social and economic disruption.
• We have only to look at the impact of SARS -
  comparatively a very minor event - to put
  smallpox in perspective.
• And Monkeypox to realize that identification can
  easily be slow
• If we choose to prepare, we can
• The cost can be far less than is widely believed
  and with virtually no health risk
• But it appears we may just not care

15
Smallpox Bioterrorism What Went Wrong What
To Do

• I - The threat, the plan the status
• II - Four False premises the real risk of
  vaccinating healthy adults
• III - Why the plan is failing
• IV - Underlying reasons for failure
• V - Our recommendations - Who should do what

16
Why arent we prepared?

• The answer is complex
• More than just errors of fact
• First we will address factual issues
• Then we will turn to the more complex and subtle
  organizational and cultural issues that help to
  explain inertia
• We will suggest that public health organizations
  have cultures that are as difficult to change as
  those in law enforcement, intelligence and
  aerospace
• But first, lets clear up critical
  misunderstandings and present some key facts

17
Four False Premises

• 1 - Control after an attack will not be hard and
  ring vaccination (the technique used to some
  extent in smallpox eradication) will work
• 2 - Pre-attack Vaccination, beyond minimal, is
  just too risky
• 3 - The number of persons vaccinated pre-attack
  is not important
• 4 - Pre-event vaccination is too expensive and
  diverts money and people from other essential
  public health programs
• Each of these premises is seriously flawed

18
1 - Ring Vaccination Ease of Control

• Today we must assume
• Malicious clever dissemination
• We know our population is
• 50 without immunity and 50 with unknown but
  partial and declining immunity from pre-1972
  vaccination
• Highly mobile
• Ring vaccination took years to work when
  population immunity was high and rising,
  populations were far less mobile and there was no
  malicious intent to disseminate disease
• Putting 99 of our eggs in the post-attack, ring
  containment basket is fraught with hazard (see
  Kaplan, Craft Wein)
• The good news - there is movement away from the
  ring approach to mass vaccination post-attack
• Unfortunately, we are not yet prepared to do this

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2 - The Risk of Vaccination in Healthy Adults

• As vaccine risk is at the heart of the problem,
  lets now move to considering the real risk of
  vaccinating healthy adults
• We say healthy adults as thats what the
  President's plan calls for.

20
Risk of Vaccinating Healthy Adults

• CDC has never publicized the risks of the target
  group - healthy adults
• CDC has commingled risk for healthy and sick
  adults and children.
• Sick adults and children have higher, much higher
  risk. We are not vaccinating them. Their risk
  profile is not relevant to the Presidents plan
  and is misleading
• Lets look at risk in healthy adults

21
Adult Risk of Death from Smallpox Vaccination

• Historical US data (details see paper)
• 126,000,000 adults children, healthy and sick
  vaccinated 1959 - 66 68 with 68 deaths
• 1 death/1,800,000
• Eliminate children. 45,000,000 adults
  vaccinated
• Eliminate deaths in sick adults we would screen
  out today 5 deaths (cancers and a connective
  tissue disorder)
• 2 or 3 deaths remain from PVE (post-vaccinal
  encephalitis) or 3 in 45,000,000 or
• 1 per 15,000,000
• Conclusion Very likely that vaccinating
  10,000,000 in Phase II ZERO deaths.

22
Military vs. Civilian

• Military - over 490,000 vaccinated since December
  2002
• Deaths ZERO (attributed to vaccination)
• Major adverse events ZERO
• Minor adverse events, all full recovery 103
• Use of VIG Twice
• Tens of Millions of military vaccinated since
  1945 - ZERO deaths
• These are HEALTHY ADULTS as called for in the
  Presidents plan - 70 younger first time
  vaccinees, 30 older revaccinees
• Our military experience is very relevant,
  includes older and younger, unvaccinated and
  previously vaccinated.
• Civilian about 38,500 and STALLED
• Coronary events Amazing willingness to associate
  temporal association absent biologic plausibility
  with causation
• Myocarditis Real but not long-lasting

23
A Word on Cardiac Complications

• Two types - Cardiovascular Myocarditis
• Cardiovascular events (heart attack and chest
  pain that may precede a heart attack).
• The military rates of heart attack and similar
  events did not change with vaccination. That is,
  older people had neither fewer nor more
  cardiovascular events during the time when
  smallpox vaccinations were being given. These
  cardiovascular events are UNRELATED to smallpox
  vaccination

24
Myocarditis

• Some myocarditis is related to smallpox
  vaccination
• Many immunizations and infections cause
  myocarditis - Finns had 126 cases in recruits 10
  smallpox, 90 other vaccines and common
  infections
• We detect myocarditis now and not in the past
  probably because of better diagnostic techniques
  and better surveillance
• Rate about 1 in 7,500
• Short term varies from trivial to
  hospitalization, mostly minor
• Long-term - no long term complications and death
  very, very rare and has not occurred with either
  the military or civilian program

25
How About Accidental Vaccination of Others?

• I get vaccinated, my wife is on chemotherapy, a
  co-worker is HIV or I have a child with eczema
  at home.
• Considering historical data, the recent US
  military experience, using the semi-permeable
  membrane dressing, long sleeves good counseling
  and some reassignment of clinical workers means
  the risk of an accidental infection resulting in
  death is less than 1 in 10,000,000 if healthy
  adults are vaccinated in Phase II.
• Or, most likely, no one will die or have serious
  long-term side-effects if Phase I Phase II of
  the Presidents plan are fully implemented

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Vaccination Bottom Line

• Vaccination is good for 10 years, possibly more
• Healthy adults, you and I, have a 10 year risk of
  accidental death (falls, MVA, ski accident, etc)
  of 1/333
• Just living 10 years is 42,000 time more
  dangerous than one smallpox vaccination every 10
  years!
• Or, if you dont worry about driving to work or
  dying by accident on vacation and you are a
  healthy adult - dont worry about getting
  vaccinated or accidentally vaccinating someone
  else.
• This is NOT the current impression in the medical
  and public health communities.
• CDC and HHS have an affirmative obligation to
  correct and widely publicize the misperceptions
  about risk to healthy adults
• Why? The Presidents plan calls for vaccinating
  healthy adults and for the nation to be protected
  it is essential this group have accurate,
  understandable information about risk.

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Vaccination Disease Transmission Errors in
Detail

• Risk of vaccine OVERSTATED
• 1/15,000,000 deaths in healthy adults not 1 or
  2/million
• Who can transmit how easily UNDERSTATED
• 4-Day Window MOSTLY MIS-STATED
• Rationale for whom to vaccinate and why specific
  numbers not clearly articulated.

Based on recalculation of published existing
data NEJM Lane et al 1969, NEJM Neff et al
1967, JAMA Lane et al 1970 Bicknell James,
Reviews in Med. Virology, 2003 and Clin. Inf.
Dis. Letter to Editor, August 2003
29
3 - The number of persons vaccinated pre-attack
is not important

• Lets examine this premise and see why it is
  flawed.

30
CDC - Vaccinate the entire country in 10 days

• This is a laudable, ambitious, appropriate and
  very challenging goal.
• What will it take to accomplish this?
• Many disseminated vaccination sites in all urban,
  suburban and rural areas.
• Huge sites with tens to hundreds of thousands
  attending over a short period of time wont work
• Traffic, parking and toilet needs alone preclude
  this
• Massachusetts feels 600 sites for about 6,000,000
  people is about right
• Lets do the numbers

Handout available on request
31
Why do numbers count?

• Massachusetts has moved, appropriately, from a
  few large vaccination centers to planning for 600
  sites (schools)
• We have calculated what we think are high and low
  levels of staffing for 600 sites and extrapolated
  this to the nation
• Our estimate of clinic staffing levels range from
  1,285,538 to 1,681,088 to vaccinate the
  country within 10 days
• If CDC staffing guidelines are applied the number
  RISES to 3,516,000
• And we have about 38,500 people vaccinated
• Numbers MUST count

We are NOT speaking for Massachusetts
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Numbers do Count - Phase I Summarized

• Vaccination teams
• Low estimate 1,286,000
• High estimate 1,681,000
• Transport team 20,400
• Hospital Personnel 696,000
• Total 2,002,000 to 2,397,000
• BUT, if CDC post-event clinic staffing guidelines
  applied to vaccination teams then 1,681,000
  becomes 3,516,000 and the total 4,232,000!
• And we have only 38,500.
• Insufficient vaccinators means delay in
  vaccination with needless death and great social
  and economic disruption
• NUMBERS, SYSTEMS AND OUTPUT DO COUNT

33
4 - The Final False Premise

• Pre-event vaccination is too expensive and
  diverts money and people from other essential
  public health programs

34
Cost Diverting Resources

• Up to more than 700/vaccination has been
  reported as a cost.
• Tiny volumes and high staffing can make anything
  costly
• Decent volumes and more realistic staffing with
  just enough people for screening, jabbing and
  record keeping are all that is needed.
• State budget crunches are very difficult but are
  not caused by smallpox planning.
• Although theoretically money is money, the
  possibility of moving funds from BT to support
  other public health programs is questionable at
  best.

35
Smallpox Bioterrorism What Went Wrong What
To Do

• I - The threat, the plan the status
• II - Four false premises the real risk of
  vaccinating healthy adults
• III - Why the plan is failing
• IV - Underlying reasons for failure
• V - Our recommendations - Who should do what

36
The Weight of the Evidence

• Even though the weight of the evidence supports
  the President's Plan
• When we get to recommendations we will return to
  whether the plan is stalled or is it suspended?
• Lets look at a diagram

37
The Weight of the Evidence

• Unfortunately, a miscalculated and misrepresented
  cost of prevention has prevailed over a
  consideration of the full costs of an attack

38
Why the Plan is Failing

• Rationale neither well framed nor well
  articulated.
• Initial program introduction maladroit and
  delayed
• Liability and compensation risk overstated and
  legislation was delayed
• Lack of understanding of acute health care system
  (links to hospitals and physicians) - surge
  capacity, staff shortages, funding needs
• Post Iraq war perception that risk is much lower
  coupled with increased skepticism about
  intelligence information
• CDC Performance

39
CDC Performance

• Initial CDC approach not accepted by the
  Administration. CDC subsequently charged with
  implementing a program they had opposed
• CDC comingled risk of vaccination in sick adults
  and children with healthy adults, vastly
  overstating risk
• Other Misinformation
• Effectiveness of ring vaccination
• Ease of early diagnosis
• Unimportance of numbers of pre-attack vaccinees
• States hesitant to criticize CDC

40
Smallpox Bioterrorism What Went Wrong What
To Do

• I - The threat, the plan the status
• II - Three false premises the real risk of
  vaccinating healthy adults
• III - Why the plan is failing
• IV - Underlying reasons for failure
• V - Our recommendations - Who should do what

41
Deeper Reasons for Failure

• Organizational resistance
• Ideological dissonance
• Culture of caution
• Lack of a systems orientation

42
Organizational Resistance - 1

• Resistance to change is usual in organizations
  and in professions, especially when
• Organizations are shielded from markets
• Change is paradigmatic
• FBI CIA post September and NASA now
• Original CDC pre-attack smallpox plan rejected by
  Administration. Later CDC charged with
  implementing a plan not of its making
• CDC smallpox veterans have additional reason to
  resist pre-attack vaccination
• De facto admission of potential failure of
  eradication

43
Organizational Resistance - 2

• Within local state health departments
  resistance to new priority of biodefense
• Dont trade off my underfunded program
  (nutrition, TB, AIDS, SARS, etc.) for a
  hypothetical, uncertain event
• Biodefense interpreted by some as
  military/intelligence agencies contaminating
  public health priorities.

44
Ideological Dissonance

• To respond preemptively to biodefense concerns
  requires accepting governments assessment of
  threat
• Bioterrorism threat seen by many in public health
  as a next false chapter after the cold war
• Biodefense investments seen by many as a
  substitute for commitment to known and pressing
  public health priorities
• Acute care sector, driven by market economics,
  sees biodefense as a potential unfunded mandate
• Some in public health and medical community
  skeptical of current administration

45
Public Health A Culture of Caution

• System rewards problem identification, collecting
  information and decision-making with considerable
  certainty - the antithesis of what is likely in a
  BT event
• Culture of professional autonomy Collegial, not
  hierarchical relationships not command and
  control
• Public health largely deals with known,
  observable problems --not with hypothetical
  events
• Public health is shielded from the market place
  funding, programs, and staff are governmental --
  seldom a need for quick change
• Decision usually incremental and barely visible
  draconian actions are rare
• Lingering bitter memories of failed swine flu
  vaccination program

46
Lack of Systems Orientation

• Insufficient recognition of the role of acute
  medical care system in biodefense response
• Insufficient recognition of the strengths,
  resources and lessons represented by the military
• Inability to deal with low probability high
  stakes potential events
• Deficient in ability in ability to make quick
  decision under circumstances of great uncertainty
• Deficient in ability to assess and communicate
  relative risks

47
The Major Factors in Summary

• Confusing successful eradication with what will
  work for terrorism
• The issues and risk of attack and vaccination
  were never clearly and consistently articulated
  by the administration
• White House, HHS and Homeland Security continuing
  commitment seen as weak
• Deficient systems thinking in Public Health
• A risk-averse culture
• Fear of attack
• Fear of preparation
• Uncertainty as to how to balance risks
  consequences of prevention vs. attack
• Our federal-state structure makes command and
  control relevant to bioterrorism very difficult
• Some distrust of government
• If an attack occurs - lousy data uncertainty
• Public Health deals retrospectively, with the
  best possible data
• Terrorism deals with the moment and limited,
  lousy data

48
Smallpox Bioterrorism What Went Wrong What
To Do

• I - The threat, the plan the status
• II - Three false premises the real risk of
  vaccinating healthy adults
• III - Why the plan is failing
• IV - Underlying reasons for failure
• V - Our recommendations - Who should do what

49
Phase I - What CDC Should Do

• Widely disseminate accurate vaccine risk data
  relevant to healthy adults and aggressively
  correct misinformation re
• Vaccine risk
• The ability to vaccinate ands the effectiveness
  of vaccinating within 4 days of exposure.
• The need to plan for mass vaccination, not ring
  containment, post event
• Establish a clear, feasible, testable, post-event
  objective - For example
• Vaccinate 95 of the population in 10 days.
• Propose a vaccinated personnel/population ratio
  based on numerous, disseminated vaccination sites
  for states to either accept or show cause why the
  number should be higher or lower for Phase I
  vaccinees
• Rigorously test the objective and derivative
  state and local plans by careful systems
  analysis, table top exercises and a limited
  number of mock full scale exercises.

50
Our Suggested Phase I Starting Point

• Vaccination Teams
• 6,000 vaccinated team members/1,000,000 or
  nationwide 1,760,000 health and related personnel
  to staff 90 to 100 post-event, vaccination sites
  per million people.
• Teams have practiced and vaccine distribution has
  been tested
• Public know exactly where to go for vaccination
  and how to find out when to go
• Standard Vaccinate 95 of population in every
  state within 10 days
• Transporting Suspected Smallpox Patients
• 1 transport team/million people and no less than
  one per state 20,393 vaccinated transport
  personnel
• Standard - 24/7 coverage by essential vaccinated
  personnel
• Hospital-based care givers for smallpox patients
• 696,000 Hospital personnel vaccinated
• Standard - Emergency unit, isolation room(s) and
  support areas staffed 24/7 with vaccinated
  personnel in 2/3 of the US acute general
  hospitals

Our assumptions and calculations are available on
request after the talk or by email
51
Next Steps - 1

• If true, reassert the threat is real and
  continuing - White House Homeland Security
• Is the plan the plan or is it suspended?
• We urge reaffirmation of a fundamentally sound
  plan
• Aggressively and widely disseminate accurate and
  understandable vaccine risk information relevant
  to healthy adults - HHS and CDC
• Use the semi-permeable membrane dressing for
  everyone - state local health departments
• Pre-position vaccine and related supplies at the
  state level in sufficient quantities to carry out
  48 hours of vaccination - CDC
• Develop nuanced criteria for post-event
  vaccination that probably should vary by
  proximity - in a DC event virtually everyone is
  vaccinated in DC, but northern Idaho may be more
  selective and vice-versa.

52
Next Steps - 2

• Establish performance based post-event planning
  guidelines - CDC
• To pinpoint the actual Phase I numbers needed
• To assure realistic post-event plans
• Note that not only is liability and compensation
  legislation in place, the likelihood of more than
  one or two people needing to access this resource
  is very small - CDC HHS
• The White House, Homeland Security and HHS need
  to enlist the support of the medical, nursing,
  hospital management and public health communities
  and their various professional organizations

53
Phase II Phase III

• Phase II
• Develop standards for vaccine coverage in acute
  general hospitals, ambulatory care and EMS sites
  such as 60 of hospital workers vaccinated. Then,
  derive the numbers
• Develop standards for coverage of fire, police
  and other emergency workers sufficient to assure
  minimal adequate function while post-event
  vaccination takes place, perhaps 10. Then derive
  the numbers
• Add together Phase II number 6 to 10 million
  in addition to Phase I
• Phase III
• Make vaccine available through many normal
  ambulatory care sites for healthy adults

54
Phase III - the Rest of Us

• Citizens just arent smart enough to decide for
  themselves about vaccination.
• This reflects a not uncommon point of view in the
  public health and medical communities.
• Given the misinformation about vaccine safety
  since 9/11 and the absence of an effective pre or
  post event program, it is all the more important
  that citizens have access to a safe and proven
  vaccine that reduces individual risk from a BT
  smallpox attack to ZERO.
• Long ago Mr. Jefferson offered a still timely
  caution.

55
I know of no safe depository of the ultimate
powers of the society but the people themselves
and if we think them not enlightened enough to
exercise their control with a wholesome
discretion, the remedy is not to take it from
them but to inform their discretion. Thomas
Jefferson
Quotation courtesy of Dr. Greg Saathoff
56
Decision Making in Public HealthA Larger Context

• Public health prefers to deal with events once
  full data are available.
• Proactive decision-making when nothing has yet
  happened (smallpox) is an alien notion
• Emergencies with lethal potential may require
  quick, far-reaching decisions with limited data
  of uncertain quality - Risky stuff for a risk
  averse profession
• Contemplating, let alone taking, draconian action
  without the certain knowledge that the action
  will, in hindsight, be correct is largely not in
  the lexicon of public health decision-makers
• This may limit the relevance of public health to
  bioterrorism control

57
What is the Role Place of Public Health in
Bioterrorism

• Recognize that the Public Health System has not
  historically been relevant to the type of
  emergency represented by BT and is unlikely to be
  relevant in the future - The culture and mind
  set of PH is substantially antithetical to the
  mindset needed for BT preparedness and response.
• The public health system may need strengthening.
  However, it may not follow that a stronger public
  health system leads to better preparedness for
  bioterrorism.
• This merits full public debate.

58
Therefore

• Focus on the Acute Care system - Hospitals,
  Emergency Medical Services and larger clinics
• Provide accurate, relevant vaccine risk data
• Emphasize the Public Health role as primarily
  epidemiology and lab support. But the
  epidemiology must be better to be safe
• Establish national response standards that must
  be validated on a state-by-state basis
• How states organize and manage to meet the
  standards can and should vary
• Multi-state, federal-state and within state
  coordination (horizontal and vertical
  coordination) remain problematic and should be a
  priority concern of Homeland Security.

59
Thank You
Email to wbicknel_at_bu.edu KDBloem_at_aol.com