oversight

The Swine Flu Program

Published by the Government Accountability Office on 1977-09-16.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                         DCCUMENT RESUME
03503 -   1263866]
The Swine Flu Program. September 16, 1977. 10 pp.
Testimony before the House Ccmmittee on Interstate and Foreign
Commerce: Health and the Environment Subcommittee; by Gregory J.
Ahart, Director, Human Resources Div.
Issue Area: Health Programs: Surveillance, Control and Screening
    Activities to Reduce the Incidence of Disease   1211).
Contact: Human Resources Div.
Budget Function: Health: Prevention and Control of Health
    Problems (553).
Organization Concerned: Center for Disease Control; Food and
    rrug Administration; National Institutes of Health: National
    Inst. of llergy and Infectious Diseases.
Congressional Relevance: House Ccmmittee on Interstate and
    Foreign Commerce: Health and the Environment Subcommittee.

          The Swine Flu Program was the Government's first
attempt at immunization of the entire U.S. population and was
based primarily on scientific judgments that a pandemic could
occur at any time. o swine flu outbreak occurred during the
1976-77 xlu season. If recent experience shows that considerable
money can be saved and if the Department of ealth, Education,
and welfare (BEW) intends to continue rigorously testing and
approving e ry vaccine lot, then total Federal assumption of
the liability coverage for vaccine production should be
considered. Congress should establish a national liability
policy efore another immunization program is needed. HEW should
continue its own potency tests on all lots of flu vaccine until
manufacturers' test results can be relied on and should test
vaccine interded for trial use as it would be tested for public
use. The duration of protection provided by the vaccine is
uncertain. In any future programs, State and local agencies will
need better guidance and assistance from HEW in managing
projects and will, in turn, have to make firm commitments to
BEW. Expenditures for the Swine Flu Program reported by the
Center for Disease Control were about $103 million. Total costs
have not yet teen accurately determined but may far exceed the
$135 million appropriated. (SW)
            UNITED STATES GENERAL ACCOUNTING OFFICE
                    WASHINGTON, D.C. 20548



                                          FOR RELEASE ON DELIVERY
                                          EXPECTED AT 10:00 EDT
                                          SEPTEMBER 16, 1977
                                          RAYBURN BUILDING



                         STATEMENT OF
                  GREGORY J. AHART, DIRECTOR
                   HUMAN RESOURCES DIVISION
                            BEFORE
                    SUBCOMMITTEE ON HEALTH
                     AND THE ENVIRONMENT
                   COMMITTEE ON INTERSTATE
                    AND FOREIGN COMMERCE
                             ON
                    THE SWINE FLU PROGRAM



     Mr. Chairman and Members of the Subcommittee, I am pleased

to appear here today to discuss our report to the Congress

(HRD-77-115, dated June 27, 1977) on our review of the swine

flu program.

     This program was an unprecedented venture in preventive

medicine.   It was the Government's first attempt at immunization

of the entire U.S. population. Faced with the possibility

of an epidemic that could cost many lives and billions

of dollars and offered a chance to prevent it, the Department
of Health, Education, and Welfare (EW)   planned, and

the Congress approved, the $135 million swine flu program.

     We monitored program events as they occurred between

August 1976 and March 1977 at the Center for Disease
Control (CDC) in Atlaata; the Bureau of Biologics, Food

and Drug Administration; and the National Institute of

Allergy and Infectious Diseases, National Institutes

of Health in Bethesda, Maryland. We also monitored

program implementation at five immunization projects,

and visited 26 mass immunization clinics within these

project areas.

     Our report discusses considerations for future programs

with respect to program justification and cost, Federal

liability implications, vaccine production and testing,

and program planning and implementation.     I will briefly
summarize each of these areas.

PROGRAM JUSTIFICATION

     The decision to vaccinate everyone in the United States

was based primarily on scientific judgments that a swine

flu pandemic could occur at any time, regardless of whether

outbreaks, in addition to the one at Fort Dix, were

detected in the interim.   Underlying this decision were
several assumptions, including (1) vaccine manufacturers

could produce enough acceptable vaccine and (2) the public

and private health care system could deliver the vaccine

promptly to the entire population.     Criticism of this
decision was also based on judgments and assumptions.

      Many of the limited facts available were used to both

support and condemn the program.     The validity of either


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position could be tested only over time.    Even though the

decision was a gamble, HEW officials said that gambling with

money would be better than doing nothing and gambling with lives.

In a snse, HEW lost its gamble with money.      No swine flu

outbreak occurred during the 1976-77 flu season.
     For any future immunization effort as large or concentrated

as the swine flu program, the many preventive health care questions
that arose would likely have to be broadly considered again by
all parties involved.   The solutions devised for the swine flu

program were not intended as a pattern for future efforts.
     In any event, when decisions must be based on very limited

scientific data, HEW should establish key points at which the
┬Ěprogram should b   formally reevaluated.

LIABILITY CONTINUES
TO BE A PROBLEM
     Although effective in getting the swine flu program

started, we found that the legislation designed to solve

program liability problems
     -- may result in profit to the insurance companies
        of nearly tne entire $8.65 million premium paid
        by vaccine manufacturers for liability insurance;

      -- leaves unresolved insurance company concerns

        about nonmeritorious claim risks; and
      -- may result in indeterminable costs to the Govern-

        ment for litigation, awards, and settlements
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       because of potential weaknesses in the form and

       procedures used to obtain "informed consent"

       from persons immunized.

     In regard to future mass immunization programs, insurance

executives stated that the Government should be responsible

for both the liability and the costs of litigation, since

the Government controls all key program aspects.

HEW's Assistant Secretary for Health stated that a national

policy concerning compensation will have to be developed

for any future mass immunization program. So that resolution
of the liability issue does not delay or adversely affect
public acceptance of future programs, we recommend that
the Congress establish a naticnal liability policy before
another mass inuunization program is needed.
     We believe two alternatives should be considered in
developing the most efficient and effective way to deal with
vaccine liability. First, if experience gained from the
swine flu program shows that considerable money can be
saved and if HEW intends to continue rigorously testing
and approving every vaccine lot, then total Federal assumption
of the liability coverage for vaccine production should
be considered.   Second, the insurance industry could
make manufacturers' premiums adjustable retrospectively
based on claims experience.

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     The swine flu program was the first time that the

Federal Government assumed responsibility and liability

for informed consent.   To evaluate the effect of its role
will take years.   HEW should monitor this process as it
occurs for possible future program applications.

VACCINE TESTING MORE EXTENSIVE
THAN IN 175

     All vaccine which was released for use in the

swine flu program that we reviewed ultimately met Food and

Drug Administration potency and safety standards. Almost

30 percent of the vaccine was considered subpotent, and

the agency did not permit its release to the public until
the minimum potency requirement was met.
     Tests showed that some of the trial vaccine did not meet
specified potency levels, and trial participants were not given
the same protection as the general publi:.   The potency test does
not accurately indicate the protection provided by the vaccine.
     Because of the deficient potency test and the continual
differences in manufacturer and Food and Drug Administration
test results, we believe that the agency should continue
its own potency tests on all lots of flu vaccine until
manufacturers' test results can be relied on. In addition,
the agency should speed up its work to
     -- identify and resolve potency test variances with
       the manufacturers   nd
     -- develop and Put into practice an improved method

       to measure potency and relate it to the level of

       protection provided by the vaccine.

     To improve the accuracy of trial data and the protection

of trial participants, the agency should test flu vaccine

intended for trial use as it would be tested for public use.

POTENTIAL PROTECTION PROVIDED
BY SWINE FLU VACCINE

     HEW officials estimated, based on past experience and

trials, that the swine flu vaccine would adequately protect

70 to 90 percent of those vaccinated.   However, protection
is difficult to estimate based solely on previous experience.

     Further, estimating protection based on trial results

was complicated by problems in getting adequate antibody

responses in younger people and by the inactivity of one
vaccine component.

       The duration of protection provided by the vaccine is
uncertain.

NOT ENOUGH VACCINE PRODUCED
OR PRODUCED IN TIME

     HEW estimated in late March 1976 that manufacturers

could produce and deliver 200 million doses of vaccine by

the end of November.   Primarily because of unresolved
liability questions, the first delivery was delayed--from

July to October.


                                6
     Vaccine available then could immunize only about

12 percent of the population.     Although three of the four
manufacturers said they continued to produce at full

capacity during the delay and the fourth had met its

original estimate, vaccine production fell short of the

original estimates by about 43 million doses and required over

2 months longer to produce.

     To assure that vaccine is delivered on schedule in any

future programs, HEW must determine in a timely fashion how the

vaccine will be formulated and packaged and what the delivery

specifications will De.    f manufacturers still cannot produce

enough vaccine in time to meet the needs, alternative methods

should be sought.

STATE READINESS AND IMPLEMENTATION

     Each swine flu grant project offered immunization to

aiyone medically able to take the vaccine.     However, because
the epidemic never materialized and demand for vaccine was

less than expected, the Nation's system for mass immunization

was not fully tested.    Some problems in planning
and implementing swine flu immunizations at the local

level should be considered for any future mass

immunization programs.

     State and local immunization projects were not

ready to begin the program in July as planned.       They were
limited by

                              7
     -- less than full commitment by some project

       directors,

     -- complex, incomplete, and late vaccine recommendations,

     -- limited quantities and delayed delivery of vaccine,

     -- less-than-expected participation by private doctors,

       volunteers, and others,

     -- weaknesses in project operations, and

     -- lack of State liability insurance.

     Project readiness and implementation were limited by

biological and liability problems beyond the projects' control.

Consequently, we could not determine whether State or

local projects could be ready for future mass immunization

programs.

     In addition, State and local agencies will need     etter
guidance and assistance from HEW in managinj projects and

will in turn have to make consistent firm commitments to HEW

if any future mass immunization program is to succeed.    The
Secretary, HEW, should request the Department of Defense to

revise its policy so that both military personnel and

equipment can be quickly mobilized and effectively

used in civilian immunization projects.

     We also recommend that the Congress consider the effect

which inadequate liability protection might have on State

participation in future immunization programs.   The Federal


                           8
Government could (1) assume total liability for the
program, (2) assume no liability for program participants,

or (3) assume limited liability similar to that provided

under the swine flu program.

PROGRAM COSTS

     Total costs for the swine flu program cannot yet be

accurately determined.   In sow- instances, accounting data

is too limited to identify precise costs; and,    in others,
not all costs have been incurred or determined.

     Total program costs include:

     -- Expenditures from funds appropriated for the program.

     -- Expenditures from other Federal funding sources.

     -- Expenditures from State and local funds to supplement

       the Federal grants.
     -- Lost opportunity costs to other health programs.

     -- Costs incurred for health care and lost earnings

       by individuals who have adverse reactions to the vaccine.

     Expenditures from the $135 million appropriated for the

swine flu program were reported by CDC to be about $103 million

through September 9, 1977. Costs yet to be determined include:

    -- The final cost of the vaccine and vaccine storage.

       Contracts for purchasing vaccine were not signed until

       last month.   One is still unsigned. Final vaccine costs
      will not be known until HEW Audit Agency completes its

       evaluation of costs included in each final contract.

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     -- Department of Justice costs of litigation and Federal

       funds for settlements and awards for claims over

       $2,500 which are not recoverable from third parties.
       (HEW will pay settlements of $2,500 or less from

       the $135 million appropriated.)     The total dollar amount
       of claims and suits filed as of September 8, 1977,

       exceeded $1.5 billion.

     The Center for Disease Control is estimating costs for
which limited accounting data is available. Not all of

the estimates are complete. These costs include:

     -- Personnel costs of full-time HEW employees detailed

       from other programs.     (Estimated at $0.5 million.)
     -- State and local program costs in addition to those

       funded by the Federal grants.     (Estimated at $24 million.)
     -- Lost opportunity costs to other programs.    (No
       estimate yet.)

     -- Costs incurred for health care and lost earnings by

       individuals because of immunization reactions.      (No
       estimate yet.)

     Although precise costs cannot yet be determined, total
costs of the program may far exceed the $135 million

appropriated.

     Mr. Chairman, this concludes our statement. We shall
be happy to answer any questions that you or other Members

of the Subcommittee might have.

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