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Lessons from Swine Flu

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Title: Lessons from Swine Flu


1
Lessons from Swine Flu
  • Harvey V. Fineberg, M.D. Ph.D.
  • Seasonal Pandemic Influenza 2006
  • 1 February 2006

2
US Life Expectancy
3
US Life Expectancy
1918 Flu Epidemic
4
The Great Pandemic of 1918-19
  • gt20 million deaths worldwide
  • gt500,000 deaths in the United States
  • gt200,000 deaths in Great Britain
  • gt5 million deaths in India
  • High mortality among young adults

5
1918
6
1976
  • American Bicentennial Year
  • The most ambitious influenza immunization
    campaign ever mounted in the U.S. in response to
    an outbreak of swine flu in Fort Dix, New Jersey
  • No influenza epidemic appeared

7
(No Transcript)
8
Sequence of Events in the Swine Flu Affair of 1976
  • New flu outbreak Jan
  • CDC decides Feb-Mar
  • HEW endorses, President announces Mar
  • Organization and field trials Apr-Jun
  • Vaccine liability and legislation Jun-Aug
  • Starting and stopping Oct-Dec

9
New Flu OutbreakltJanuarygt
  • Respiratory disease outbreak among army recruits
    at Fort Dix, New Jersey
  • Majority are A Victoria influenza
  • Swine influenza found
  • One death
  • 13 clinical cases
  • up to 500 with serologic evidence of infection
    with A Swine influenza
  • No evidence of infection with A Swine influenza
    at other army camps or elsewhere in New Jersey

10
US Public Health Mindset about Influenza in 1976
  • Relatively severe epidemics tend to occur about
    once every 11 years
  • Antigenic shifts in type A produce severe
    epidemics
  • Predominant H antigens tend to recycle at 60-70
    year intervals
  • Lesson of 1957 and 1968 too little
    immunization, too late
  • Specter of 1918-1919

11
Theory of Antigenic Recycling
12
CDC DecidesltFebruary-Marchgt
  • Consultations and press conference Feb 19
  • ACIP Meetings
  • CDCs Sencer writes action memorandum
  • a strong possibility of widespreadswine
    influenza in 1976-77 population under 50 is
    almost universally susceptible ingredients for a
    pandemic.
  • The situation is one of go or no go A
    decision must be made now.

13
HEW endorses, President announcesltMarchgt
  • Secretary Mathews to Director of Budget
  • There is evidence there will be a major flu
    epidemic this coming fall The projections are
    that this virus will kill one million Americans
    in 1976.
  • President Ford convenes a panel of experts at the
    White House (including Drs. Salk and Sabin) and
    announces a national immunization program, seeks
    135 million appropriation

14
Organization and Field TrialsltApril-Junegt
  • Asst Secy for Health Cooper declares goal of 95
    immunization in testimony to Congress
  • Public opposition surfaces to a pre-committed
    immunization program
  • Chief Epidemiologist Goldfield of New Jersey
  • Editorials in New York Times
  • Sabin advocates active stockpiling
  • Field trial shows poor results in children

15
Where to keep vaccine?
  • It would be better to have an immunization
    program without an epidemic than an epidemic
    without an immunization program. (CDC, 1976)

16
Vaccine Liability and LegislationltJune-Augustgt
  • Casualty insurers decline to offer liability
    coverage to vaccine manufacturers beyond 30 June
    1976
  • Legionnaires disease outbreak in Philadelphia, 1
    August 1976
  • Legislation adopted making the federal government
    the defendant in any suit arising from the swine
    flu program, PL 94-380, 12 August 1976

17
Starting and StoppingltOctober-Decembergt
  • 1 million persons immunized Oct 1-10
  • Three coincident deaths in Pittsburgh Oct 11
    President Ford immunized Oct 14
  • 40 million vaccinated Oct 1 Dec 16
  • Twice as many immunized as in any prior year
  • Highly variable coverage by city and state
  • Guillain-Barré syndrome reported late Nov
  • Program suspended on December 16

18
Seven Critical Features part 1
  • Overconfidence in theory spun from meager
    evidence
  • Conviction fueled by pre-existing agendas
  • Zeal by health professionals to make lay
    superiors do the right thing
  • Premature commitment

19
Seven Critical Features part 2
  • Failure to address uncertainties
  • Insufficient questioning of implementation
    prospects
  • Insensitivity to media relations and to long term
    credibility

20
Overconfidence in theory spun from meager evidence
  • Epidemic appears every 11 years
  • Equating severe epidemics with the appearance of
    new strains
  • Recycling antigens every 60 years

21
Careful historical assessment in the mid-1970s
found
  • The 20 major epidemics between 1729 and 1968
    occurred at irregular intervals of between 3 and
    28 years (W.I.B. Beveridge, 1977)
  • Of the six peak years of excess mortality from
    Influenza A in the US (1936, 1943, 1953, 1957,
    1960, 1963) only one (1957) coincided with an
    antigenic shift in the virus (W. Dowdle, 1976)

22
Pre-existing Agendas
  • Close the immunity gap (Salk)
  • So much to learn (Kilbourne)
  • Value of epidemiology (Stallones)
  • Importance of prevention (Sencer, Cooper)
  • Vital role of the CDC (Sencer)
  • Desire to create public-private partnership
    (Cooper)

23
Zeal by health professionals
  • Concern about political motivation, lack of
    understanding among lay superiors
  • Heroic response to dramatic threat
  • Chance to prepare, to make up for the lack of
    preparedness in Asian Flu epidemic of 1957

24
Premature Commitment
  • Concatenating the decision to begin manufacturing
    the vaccine with the decision to institute a
    universal vaccination campaign
  • General Accounting Office report to Congress,
    June 1977 when decisions must be based on
    very limited scientific data, HEW should
    establish key points at which the program should
    be formally reevaluated.

25
Failure to address uncertainties
  • Failure to estimate risk
  • Scientists reluctant to quantify subjective risk
  • Lay leaders do not elicit quantitative estimates
    of risk
  • Failure to consider threshold conditions during
    the months of preparation for a change in policy
    from an immunization program to stockpiling

26
Insufficient questioning of implementation
prospects
  • Overstated aims
  • Dealing with insurers and manufacturers
    (liability, profit, purchase guarantees)
  • Coping with likely opposition
  • Expected delays (liability, dosage, consent)
  • Experience in different jurisdictions with past
    immunization efforts

27
Insensitivity to media relations and long-term
credibility
  • Media standards and values
  • Controversy
  • Coincident events
  • Side effects
  • Institutional credibility
  • Professional advisory roles and political
    decision making
  • Short-run and long-run considerations

28
Five Lessons from Swine Flu
  • Building a base for program review
  • Thinking about doing
  • Thinking of the media
  • Maintaining credibility
  • Thinking twice about medical knowledge

29
Pitfalls to Avoidin Preparation for Avian Flu
  • Confound likelihood and severity
  • Fail to scrutinize assumptions
  • Overstate goals and objectives
  • Fail to communicate and explain
  • Over-estimate readiness to implement

30
Reflections
  • Decisions in time and under uncertainty
  • Low-likelihood, high consequence events
  • Sequencing, new data, deadlines
  • Science and policy interface
  • Expertise, responsibility, roles
  • Public understanding
  • Complexity of implementation
  • Near and long-term consequences
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