Smallpox Bioterorrism What Went Wrong What To Do

1. Smallpox & BioterorrismWhat Went Wrong&What 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 President�s 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 1000�s or 10�s 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 don�t 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 face�Almost 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

9. 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 <wbicknel@bu.edu> 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.

11. The President�s 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 don�t have this Enough vaccinated people pre-attack sufficient to Staff clinics for mass vaccination - don�t 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 - don�t have Safely transport smallpox patients to hospitals - don�t have Care for smallpox patients without getting infected - don�t 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 aren�t 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, let�s 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

19. 2 - The Risk of Vaccination in Healthy Adults As vaccine risk is at the heart of the problem, let�s now move to considering the real risk of vaccinating healthy adults We say healthy adults as that�s 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 President�s plan and is misleading Let�s 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 President�s 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 President�s plan are fully implemented

27. 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 don�t worry about driving to work or dying by accident on vacation and you are a healthy adult - don�t 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 President�s plan calls for vaccinating healthy adults and for the nation to be protected it is essential this group have accurate, understandable information about risk.

28. 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.

29. 3 - The number of persons vaccinated pre-attack is not important Let�s 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 won�t work Traffic, parking and toilet needs alone preclude this Massachusetts feels 600 sites for about 6,000,000 people is about right Let�s do the numbers*

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

32. 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? Let�s 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 �Don�t 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

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 aren�t 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.

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.