Mr. AHART. It will be subject to, first of all, all the claims that are filed against the Government and then beyond that whatever portion of those claims the Government feels it could make a case of liability on the part of the manufacturer and go against the manufacturer for reimbursement?

Mr. ROGERS. Yes.

Mr. AHART. Then, if that should absorb the total $2.5 million of each firm's self-insurance fund, then as I understand it the insurance coverage provided by the insurance companies could be reached.

Mr. ROGERS. So, perhaps it is premature to say as yet that there will be no call on that fund; in fact there may be a call up to $220 million?

Mr. AHART. That is correct. I think we put it in our statement this way, and I will repeat it, "may result in profit of nearly the

Mr. ROGERS. I would agree.

Mr. AHART. There is that possibility.

Mr. ROGERS. But also there may be a liability up to as much as $220 million.

Mr. AHART. That is the total coverage, yes sir.

Mr. ROGERS. I would hope that the General Accounting Office would continue to monitor the program, and we will make an official request that this be done. I agree with the gentleman from California, that I think you should discuss the program with all participants. Did you have discussions with insurance companies at all?

Mr. AHART. Mr. Burnett.

Mr. BURNETT. Yes, with representatives of the insurance industry.

Mr. ROGERS. You have made inquiry of them?

Mr. BURNETT. Yes, sir.

Mr. ROGERS. Are there any participants you have not visited with?

Mr. BURNETT. Beyond the manufacturers? No, we have not talked to manufacturers.

Mr. ROGERS. The manufacturers were really the only ones you did not contact?

Mr. AHART. That is correct.

Mr. ROGERS. I would hope that you would do that in the followup audit.

Thank you so much for your presence here. We are grateful. Mr. Walgren, did you have any questions?

Mr. WALGREN. I just wondered, I don't know whether these should be addressed to GAO, how much unused vaccine is presently existent and in whose hands?

Mr. AHART. Let me see if we have that information. Mr. Flowers, do we know how much vaccine is yet unused?

Mr. FLOWERS. They produced 157 million and have administered about 45 million, so out of the total 157 million produced

Mr. BURNETT. About 110 million left, and as we understand it, there is some still with the States and HEW has possession of

some.

Mr. WALGREN. So the States have some, HEW has some, and do the manufacturers still have any?

Mr. BURNETT. That, I couldn't tell you.

Mr. ROGERS. I expect HEW can probably get into this for us. Mr. WALGREN. OK, thank you, I think they would probably know better.

Mr. ROGERS. Thank you for your presence today. You have been most helpful and we will formalize a request for continued investigations.

Thank you.

Our next witnesses will be the Department of Health, Education, and Welfare, Dr. J. Donald Millar, Director of the Bureau of State Services, Center for Disease Control, accompanied by Dr. Harry M. Meyer, Jr., Director of the Bureau of Biologics, Food, and Drug, and also by Dr. William Jordan, National Institute of Allergy and Infectious Diseases. We welcome you gentlemen to the committee. Your statements will be made a part of the record in full. Before you begin, I might say that I wrote to the Secretary reminding him of the requirement for the liability alternative study which was due on August 12. We did get a response yesterday; a first draft of the report outlining some options with no recommended procedures or no formal cost recommendations. It is my understanding, from the letter, that costs studies are to be completed by October 15. Dr. Millar.

STATEMENT OF J. DONALD MILLAR, M.D., DIRECTOR, BUREAU OF STATE SERVICES, CENTER FOR DISEASE CONTROL, PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, ACCOMPANIED BY WINDELL BRADFORD, ADMINISTRATIVE ASSISTANT TO DR. MILLAR; HARRY M. MEYER, JR., M.D., DIRECTOR, BUREAU OF BIOLOGICS, FOOD AND DRUG ADMINISTRATION; AND WILLIAM JORDAN, M.D., NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

Dr. MILLAR. Thank you, Mr. Chairman. I also have with me on my left, Mr. Windell Bradford of my administrative staff. Mr. ROGERS. We welcome you.

Dr. MILLAR. I am grateful for this opportunity to appear before you to review our experiences in trying for the first time in history to prevent the widespread death and disability from a flu pandemic. I hope this review can be constructively used to address the obvious problems which confront any future attempt at a major national effort in preventive medicine.

Mr. Chairman, you have very aptly designated and described these problems and I won't repeat them. I think that our challenge is to address these problems and resolve them in advance, such that national health emergencies in the future can be met head on and in time.

Much attention has been given to the controversial aspects of the swine flu program and I would like at this point to cite some of what I believe to be the undersung positive accomplishments of the program.

The first is the immunity provided. Under the circumstances, a remarkably significant proportion of Americans were immunized. Among those designated as having a high risk of dying from flu, over 40 percent received the vaccine protecting against both swine flu and A-Victoria flu. That is more than twice the coverage level ever previously achieved among this most important group of individuals.

In the general population above the age of 18, 32 percent were immunized. This is several times higher than was accomplished in 1957 and 1968, the only previously attempts at immunization in the face of a pandemic.

You will recall that in both of those instances immunizations had hardly begun when the pandemic stormed across the country and those efforts had very little effect on the outcome.

A second very positive achievement is the remarkable performance of State and local health departments. Almost without exception, they proved capable of a rapid Herculean effort in response to national needs. It has been popular in recent years to impugn the ability of health departments to move rapidly and effectively. However, in spite of delays in the availability of vaccine, complicated immunization schedules, specific shortage of some types of vaccine, and continuous media emphasis on these and other problems, the health departments established programs which immunized more people in 22 months than in any previous immunization program in this country's history.

Third, a major milestone was achieved by requiring the nationwide use of information-consent procedures. There seems now to be widespread acceptance of the notion that individuals presenting themselves or their children for immunization should understand both the risks and the benefits of the procedure.

Other positive aspects of the program include the manufacturers' record production of 150 million doses of flu vaccine. Prior to release of the vaccine, these were subjected to the largest field trials in the history of flu vaccines. A system was established for the first time to monitor illnesses following immunization. There was a five-fold increase in surveillance for influenza disease and the implementation of the program directly involved an impressively wide array of American institutions, public, private, and voluntary.

As the historical evidence emerges, I feel that the national influenza program will prove to have been an appropriate response to the facts at hand at the time the decisions were made, and in the words of the GAO report, "an unprecedented venture in preventive medicine.'

There were numerous well-publicized legal, logistical and administrative problems in implementing the swine flu immunization program requiring special solutions.

Some problems were brought to this committee as they emerged. There are two developments which may be viewed as major negative outcomes of the program. Both have already been referred to. The unexpected discovery of an apparent association between influenza immunization and the Guillain-Barre syndrome. This syndrome is an uncommon condition of unknown cause characterized by transient "ascending paralysis." Although the cause of the

snydrome has never been known, two-thirds of the persons with this condition report an illness or other health event in weeks preceding onset. At least 150 different such antecedent conditions. have been listed.

For the first time we observed a small but finite statistical association between influenza immunization and this syndrome. Following the report of five cases in two States, in November 1976, an intensive investigation was initiated. Neurologists in each of the 50 States were asked to identify all cases of the syndrome that they saw during the period October 1976 through January 1977.

As Dr. Carter has already noted, a total of 1,053 cases of the Guillain-Barre syndrome were found. Of these, 515 were in persons who had received swine flu vaccine and 505 were in persons who had not received flu vaccine.

Analysis revealed that recipients of swine flu vaccines experienced the syndrome at a rate several times higher than ordinarily expected. It appears that one case of the Guillain-Barre syndrom above the expected incidence was observed for each 100,000 flu vaccinations.

Because so little was known previously about the frequency of this syndrome, an interpretation of these findings is very difficult. One thing, however, is clear. Had we not established monitoring systems and had not over 40 million doses of vaccine been given in so short a time, an apparent association of this low order of magnitude would not have been discovered.

Even this appartent association of flu vaccine with the GuillainBarre syndrom, unexpected and undesirable though it is, has opened important avenues of research which may help unravel this mysterious syndrome which has frustrated physicians for over 50 years.

The second major negative outcome of the program is the series of claims already referred to due to illnesses following vaccination. Of these, many relate to the Guillain-Barre syndrome.

Because of the need for swift action in initiating the program, the Federal Government assumed, via Public Law 94-380, unprecedented responsibility for liability for illness following vaccination. Unquestionably, the Federal Government will thereby be involved in the long process of reviewing, litigating, and settling these claims.

It is my understanding that the Justice Department will appear before you today to discuss this current situation.

I would like to turn now to the costs of the program. Congress appropriated the sum of $135 million to carry out the program. Approximately $102.6 million has been obligated. Of the balance, $12 million was reappropriated by Congress for use in other public health programs. The balance available from the original appropriation is due to the amount and the provisional unit cost of the vaccines, both of which are less than originally estimated. While the final cost of vaccine and storage has not been determined, we anticipate that sufficient funds will be available.

Only with respect to the claims that may or may not be allowed in the future is there any possibility of significant cost to the Government beyond what was budgeted.

Please recall that at the outset of the program, serious complications caused by influenza immunization were not known, hence major financial claims were not expected. The combination of the prodigiously rapid output of immunizations plus a system for monitoring illness after vaccination brought to light an apparent low risk of the Guillain-Barre syndrome. This apparent statistical association has been a key factor responsible for many of the claims filed.

There are four aspects of the swine flu program I feel have distinct ramifications for future activities. The first is the decisionmaking process. The GAO has examined the process in 1976 and makes a concrete recommendation that formal points be preestablished at which the basic policy decision is reevaluated in light of new information or lack of it. Such reevaluations in effect were made for the national influenza immunization program through a series of congressional hearings and almost daily they were made by professionals trying to operate the program in the face of seemingly unending problems.

We agree formalizing a system of preplanned periodic policy evaluation deserves serious consideration.

Second are issues of compensation and liability.

The most pressing questions in the wake of the program are those which provoked Public Law 94-380; that is, who is liable if someone is injured by immunization, and what recourse does that person have for compensation for the injury?

Congress made it abundantly clear that Public Law 94-380 was not to be considered as a precedent for the future. Indeed, it directed an examination of alternatives for a careful permanent solution. HEW is preparing a document to be presented by October 15, as you have already heard.

At this point I would like to note the three policy objectives which must be pursued in making the necessary changes.

First of all, we must assure that vaccines are available to protect the citizens who need and want the protection. The refusal of the manufacturers to provide new vaccine without assurances that their liability be limited was the prime impetus for last year's law. Health care professionals, if they are to continue to immunize people, also must be assured that if they administer the vaccines carefully they will not be held liable for injuries resulting from immunization.

Since immunization confers direct benefits to society and not exclusively to the individuals, we must develop means of compensating those rare persons who are injured by the vaccine.

Finally, no medication is free of some inherent risk. We must expand our efforts to define these through more systematic surveillances of illness following vaccination via methods such as those introduced in the swine influenza immunization program.

Effective solutions on a long-term basis to these problems do not lie in time consuming, costly, and often inequitable adversary proceedings in the courts. A societal responsibility exists to provide a fair settlement ot persons injured without the necessity for litigation.

I would like to turn now to the matter of informed consent. Irrespective of the liability and compensation issues, persons re