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At the request of this subcommittee, the General Accounting Office has conducted an extensive review of many aspects of the swine flu program. We are here today to receive that report, and to review with individuals who were involved with the swine flu program, the experiences of the past 18 months.

I would note that our purpose in conducting this hearing is to learn directly of those public policy questions which have arisen or have assumed greater importance as a result of the swine flu program, and to receive whatever constructive suggestions the invited witnesses, and the public at large, may care to offer as possible solutions to those questions.

We shall certainly explore, among other areas, questions related to the Government's decisionmaking process; liability issues-professional liability, product liability, and compensation for citizens who may have been injured as a result of immunization, vaccine production and testing, informed consent, program management, and cost calculations.

Because we have a large number of people wishing to be heard today, we have requested that all witnesses be as brief and concise in their oral testimony as possible. Full copies of prepared statements will, of course, be made a part of the record.

Our first witnesses will be from the General Accounting Office; however, before we hear from GAO, I think other members of the subcommittee may have opening comments. Dr. Carter.

Mr. CARTER. I do, Mr. Chairman, yes sir, I have. I am pleased to join you in holding oversight hearings on the national swine flu immunization program for 1976. It was indeed our Nation's first large-scale venture in preventive medicine and I believe it represents an important step toward a commitment to a preventive philosophy which we have talked about a great deal.

Since the swine flu program was a first step, we know that it had its shortcomings, but I hope today's hearing will not be wasted on trying to find scapegoats. Instead I invite the witnesses today to provide suggestions to help the committee address the many difficult policy and procedural questions which have arisen from the swine flu program.

We need to focus our attention on the future of our Nation's preventive goals and to consider what approach we should take for future immunization programs. Particularly, I hope we can focus on the following issues which should be of concern to all of us,the issue of liability, the issue of public and private roles in future immunization efforts, the issue of provider participation, the issue of Federal-State relations and future immunization efforts, the issue of vaccine research and development, and the issue of informed consent.

I look forward to hearing from the witnesses today on these and other matters.

Thank you, Mr. Chairman.
Mr. ROGERS. Thank you.
Mr. Waxman.
Mr. WAXMAN. Thank you, Mr. Chairman.

There are some in the Federal Government who think we shouldn't be holding these hearings at all. They say this hearing will undermine people's confidence in government health pro

grams. But I feel the American people are so much more intelligent and sensible than they are given credit for. They know the swine flu program was a blunder. That is not the issue. The issue is government credibility and government decisionmaking. The issue is why when a government program gets underway is there so much momentum that dissenting views are not listened to?

I respect the fact that those responsible for the swine flu program acted in good faith. I think they made the best judgments they could. What I am concerned about is that once decisions were made to immunize our population, a public relations campaign got underway which ended up deceiving our people and leaving in its wake public distrust.

The only way to restore public trust is to dig into this program and find out what went wrong. In April, Secretary Califano announced a national immunization program. We must learn from our mistakes in the past before we inaugurate a new immunization drive.

I think the swine flu program was the Federal Government's "Moby Dick." I think it was a great white whale that we pursued so doggedly that commonsense was lost sight of. The program was a terrible waste.

We thought it would cost $135 million, but it looks now like it will cost us well over $1 billion.

We thought a national immunization program would draw us all together in a national effort. This was to be a model for future immunization programs. Instead, we squandered the precious trust the public accords us.

Do you know what could be done with a $1 billion? We could provide all poor children with dental care. We could screen poor children for signs of mental retardation at an age when such a handicap is most easily treated. Can you conceive of how $1 billion could help programs for the handicapped of our Nation. Or how it could be used to modernize our veterans hospitals?

When I think what could be done with the funds we now must devote to cleaning up after the swine flu program I feel frustrated. With all our expertise, why didn't we know better?

I hope we can get answers to some of these questions in this hearing, and I want to thank the chairman for calling these hearings so that we can look into the issue of the swine flu immunization program.

Mr. ROGERS. Mr. Maquire, did you have a statement?
Mr. MAGUIRE. No, Mr. Chairman.

Mr. ROGERS. We are pleased to have as our first witnesses the representatives of the General Accounting Office, who conducted the study requested by the committee. The witnesses are Mr. Gregory J. Ahart, Director of the Human Resources Division, General Accounting Office, who is accompanied by Jesse Flowers, Michael Burnett, and Peter Oswald, supervisory auditors of the General Accounting Office.

We welcome all of you gentlemen here. Your statement will be made a part of the record in full at this point and you may proceed as desired.

STATEMENT OF GREGORY J. AHART, DIRECTOR, HUMAN RE

SOURCES DIVISION, GENERAL ACCOUNTING OFFICE; ACCOMPANIED BY MICHAEL BURNETT, JESSE FLOWERS, AND PETER OSWALD, SUPERVISORY AUDITORS, GAO

Mr. AHART. My statement is quite brief. I will try to make it as brief as possible.

Mr. ROGERS. You may proceed.
Mr. AHART. Thank you.

We are pleased to be here this morning to discuss our report on the swine flu program. This program as you mentioned is an unprecedented venture in preventive medicine. It was the Government's first attempt at immunization of the entire U.S. population.

We monitored program events as they occurred between August 1976 and March 1977 at the Center for Disease Control-CDC-in Atlanta; the Bureau of Biologics, Food and Drug Administration; and the National Institute of Allergy and Infectious Diseases, National Institutes of Health in Bethesda, Md. We also monitored program implementation at 5 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 try to summarize each of these areas and we will be happy to have a copy of the full report in the record.

Mr. ROGERS. We will put the report in the record as an appendix (see p. 501.] Mr. AHART. I will briefly summarize 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: One, Vaccine manufacturers could produce enough acceptable vaccine, and two, 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.

HEW officials said that gambling with money would be better than doing nothing and gambling with lives. In a sense, HEW lost its gamble with money. No swine flu outbreak occurred.

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.

When decisions must be based on very limited scientific data, HEW should establish key points at which the program should be 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 the entire $8.65 million premium paid to vaccine manufacturers for liability insurance;

Leaves unresolved insurance company concerns about nonmeritorious claim risks; and

May result in indeterminable costs to the Government for litigation, awards, and settlements because of potential weaknesses in the form and procedures used to obtain informed consent from persons immunized.

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 national liability policy before another mass immunization 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 n claims experience.

VACCINE TESTING MORE EXTENSIVE THAN IN 1975 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 public. 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, and 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.

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.

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 be. If manufacturers still cannot pro duce 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 anyone 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: Less than full commitment by some project directors; complex, incomplete, and late vaccine recommendations; less than expected participation by private doctors, volunteers, and others; weaknesses in project operations; and lack of State liability insurance.

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 better guidance and assistance from HEW in managing projects and will, in turn, have to make consistent, firm commitments to HEW if any future mass immunization program is to succeed. The Secretary of 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.

The Federal Government could: (1) Assume total liability for the program, (2) assume no liablility for program participants, or (3) assume limited liability similar to that provided under the swine flu program.

Total costs for the swine flu program cannot yet be accurately determined. In some instances, accounting data is too limited to identify precise costs, and, in others, not all costs have been incurred or determined.

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