ceiving vaccine should receive meaningful information on the benefits and risks of immunization. To do this is not simple. Complex medical information must be presented in language understandable py persons without medical backgrounds. Furthermore, a balanced picture of both risks and benefits, including the risk of not being immunized, is required. At the present time these needs are compounded by a third, the need to provide this information in a way which reduces a litigant's ability to prove in court that he was not adequately warned about the risks of immunization-it goes almost without saying that few people sue if after failing to be immunized they are subsequently ill. Concurrent review of the program as done by the GAO was helpful and their report was carefully considered and generally sound, in our opinion. One of the weaknesses of the report, in my opinion, is that it porceeds almost exclusively from the position that the function of the information consent process is to defend the Government in court. They question the adequacy of our procedures in this respect. However, I believe they have underemphasized the role of the procedure in providing information on which a reasonable person could make a reasonable choice. We must regain a balanced perspective on this, otherwise the construction of statements which are adequate documents for legal defense will fail completely to provide a lucid understanding of the information needed by a person to be immunized or a parent of such a person. Fourth, an outcome of significant ramifications for the future is the fact that an epidemic did not occur. We knew that this outcome was possible and said so repeatedly. In the past, all discoveries of major variations of flu viruses were made in conjunction with pandemics. We now have one example in which a major variant appeared that produced one human epidemic at Fort Dix and did not spread further. Unfortunately, that knowledge doesn't help much. However, we do know that influenza pandemics take a large toll of lives and huge financial outlays for medical care. We also know that another pandemic of some sort is inevitable. It is too early yet to presume that it will not be swine flu. Therefore, we are taking the necessary steps to maintain the existing supplies of swine flu vaccine for future use if needed. In closing, Mr. Chairman, I concur in the importance of pondering our recent experience-which in many ways was arduous and frustrating-especially in the context of previous responses to threats of influenza pandemics. In 1957 and again in 1968 the country moved cautiously but the influenza virus did not. In 1976, the country moved quickly but the influenza virus did not. Some would say that the virus is ahead three touchdowns to none. Nevertheless, faced with a similar challenge again, I hope we will not shirk the necessary prudent decisive action. For if we wait until all questions are answered and all implications are clear, we will always find ourselves too late with too little in the fight against influenza. Thank you, Mr. Chairman. I will be happy to try to respond to any questions. [Testimony resumes on p. 65.] [Dr. Millar's prepared statement and attachments follow:] STATEMENT OF J. DONALD MILLAR, M.I Introduction and Background. Mr. Chairman and members of the Committee before you to review our experience in at emergencies can be met headon and in time. I In Act III, Scene 2, of Shakespeare's Julius eulogizes Caesar saying, "The evil that men ch achieved an unprecedented success. More immunized in 2 1/2 months in the National munization Program than in any previous immuniza in this country's history, and that achievement due to the efforts of State and local health major historic milestone in the practice of eventive medicine was reached by implementing es of informed consent on a nationwide basis. deved by requiring the use of information and procedures for all swine influenza immucept those administered by private physicians ividual private patients. Even in these ysicians frequently elected to use the informed edure, and thereby to be afforded the liability provided by Public Law 94-380. I believe the informed consent will remain an integral against wine Ele and community immunization programs even though ignificance of the documents may change. There among this group of cities ed acceptance of the notion that individuals tective effect of the let chemselves or their children for immunization rstand the risks as well as the benefits of Effective information documents must be promote this growing understanding. This der said than done, as I shall subsequently residents of a nursing home there. Among the total popu lation, above the age of 18, 32 percent were immunized. This is several times higher than was accomplished in 1968, the only previous time when influenza immunizations were provided on a large scale. You will recall that in that instance immunizations had hardly begun when the full force of the Hong Kong influenza epidemic erupted throughout the country in October. 2. Second is the remarkable responsiveness of State and local health departments in implementing the national program. Perhaps the most encouraging aspect of the 1976 program was the performance of State and local health agencies throughout the country. They proved again that they are capable of a rapid, appropriate response, and massive efforts in the face of a clear national need. It has been popular in recent years in some quarters to criticize State and local health departments and to impugn their ability to move rapidly and effectively. However, despite delays in the availability of influenza vaccine, despite the complexity of the vaccine's immunologic behavior and hence the need for various complicated immunization recommendations, despite a shortage of the only vaccine formulation suitable for young people, and despite a continuous media barrage emphasizing these and other problems, the health departments established programs which achieved an unprecedented success. More people were immunized in 2 1/2 months in the National Influenza Immunization Program than in any previous immunization program in this country's history, and that achievement is directly due to the efforts of State and local health departments (Fig. II). 3. Third, a major historic milestone in the practice of community preventive medicine was reached by implementing the principles of informed consent on a nationwide basis. This was achieved by requiring the use of informationconsent forms and procedures for all swine influenza immunizations except those administered by private physicians to their individual private patients. Even in these settings, physicians frequently elected to use the informed consent procedure, and thereby to be afforded the liability protection provided by Public Law 94-380. I believe the principle of informed consent will remain an integral element in community immunization programs even though the legal significance of the documents may change. is widespread acceptance of the notion that individuals presenting themselves or their children for immunization There should understand the risks as well as the benefits of the procedure. Effective information documents must be is much easier said than done, as I shall subsequently discuss. |