Lessons from Swine Flu

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Lessons from Swine Flu

• Harvey V. Fineberg, M.D. Ph.D.
• Seasonal Pandemic Influenza 2006
• 1 February 2006

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US Life Expectancy
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US Life Expectancy
1918 Flu Epidemic
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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

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1918
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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

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(No Transcript)
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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

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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

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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

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Theory of Antigenic Recycling
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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.

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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

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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

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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)

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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

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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

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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

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Seven Critical Features part 2

• Failure to address uncertainties
• Insufficient questioning of implementation
  prospects
• Insensitivity to media relations and to long term
  credibility

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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

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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)

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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)

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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

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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.

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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

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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

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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

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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

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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

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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