ORGANIZATIONS REPRESENTED AT THE HEARINGS Aetna Life & Casualty, William O. Bailey, president. American Home/National Union of the American International Group: Jarman, Brian, senior vice president. American Home Products Corp.: Bogash, Richard, Dr., president, Wyeth Laboratories. Finney, Thomas, counsel, Wyeth Laboratories. Gray, Burton J., vice president for administration, Wyeth Laboratories. Hagan, Charles F., general counsel. Ross, Charles N., counsel, Wyeth Laboratories. Shaw, Daniel L., Jr., M.D., vice president for medical affairs, Wyeth Laboratories. American Hospital Association, Leo J. Gehrig, M.D., senior vice president. Cheek, Leslie, vice president, Federal Affairs. Reiss, Robert C., senior vice president and manager, Commercial Casualty Department, Chubb & Son, Inc. American Public Health Association, George Pickett, M.D., director, San Mateo County, Calif., Public Health and Welfare Department. American Reinsurance Co.: Koehnen, James, president. Patton, Mark R., vice president. Association of State and Territorial Health Officials, Edward Coates, M.D., first deputy commissioner of health, New York State Health Department. Center for Law and Social Policy: Greenberger, Marcia, attorney, Women's Rights Project. Marks, Susan, law student intern, Women's Rights Project. Chubb & Son, Inc.: Alford, Newell, general counsel. Baldwin, Edwin, vice president and counsel. Harder, Henry U., president. Reiss, Robert C., senior vice president and manager, Commercial Casualty Department. Continental Insurance Cos.: Keyes, George. Murphy, Joseph F., executive vice president. Crum & Forster Insurance Co., B. P. Russell, chairman and chief executive officer. Cooper, Theodore, M.D., Assistant Secretary for Health. Haislip, Gene R., Deputy Assistant Secretary for Legislation (Health). Krause, Richard M., M.D., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Meriwether, W. Delano, M.D., Director, National Influenza Immunization Program. Meyer, Harry M., Jr., M.D., Director, Bureau of Biologics, Food and Drug Administration. Seal, John R., M.D., Deputy Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Sencer, David J., M.D., Director, Center for Disease Control. Taft, William H., IV, General Counsel. Home Insurance Co.: Katz, Henry, general counsel. Lenz, Henry P., executive vice president. Johnson & Higgins, Kenneth A. Greiner, vice president. Liberty Mutual Insurance Co.: Carleton, John W. Farwell, Frank L., chairman of the board and chief executive officer. Merck & Co., Inc.: Abramson, Clarence A., counsel, Merck Sharp & Dohme. Banse, Robert L., general counsel. Hendrickson, Robert F., vice president, operations, Merck Sharp & Dohme. Kingham, Richard F., counsel. ORGANIZATIONS REPRESENTED AT HEARINGS-Continued Merrell-National Laboratories, Division of Richardson-Merrell, Inc.: Clark, Roger, counsel. Husovsky, Ivan, president. Lamb, Frederic D., vice president and general counsel. Rogers, William P., counsel. National Association of County Health Officials, David Rogers, M.D., health officer, Calvert County, Maryland Health Department. Nationwide Insurance Cos., Robert Culp, vice president for business insurance. Northbrook Insurance Co.: Clements, Bruce, counsel, Casualty Insurance. Foss, Richard, vice president, Casualty Insurance. Parke, Davis & Co (See Warner-Lambert Co.) Prudential Insurance Co.: Cowan, Ross, vice president, Prudential Reinsurance. Simon Leroy, senior vice president, Prudential Reinsurance. Public Citizen's Health Research Group: Johnson, Anita. Wolfe, Sidney, M.D., director. U.S. Conference of City Health Officers, Albert G. Randall, M.D., M.P.H., director, Houston, Tex., City Health Department, Warner-Lambert Co.: Finney, Thomas D., Jr., Washington counsel in behalf of Parke, Davis & Co. Markoe, Frank, Jr., executive vice president and general counsel, also in behalf of Parke, Davis & Co. Timm, Dr. Eugene, in behalf of Parke, Davis & Co. Warneke, Paul, counsel. Wyeth Laboratories. (See American Home Products Corp.) SWINE FLU IMMUNIZATION PROGRAM MONDAY, JUNE 28, 1976 HOUSE OF REPRESENTATIVES, COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE, SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT, Washington, D.C. The subcommittee met at 10 a.m., pursuant to notice, in room 2123, Rayburn House Office Building, Hon. Paul G. Rogers, chairman, presiding. Mr. ROGERS. The subcommittee will come to order, please. Today we are holding supplemental hearings on the President's national swine flu immunization program. As many of you know, in April this subcommittee considered the proposal and, despite unresolved questions respecting the liability of manufacturers for their participation in the program and other issues, approved the initiation of the vaccination campaign. Since that time, the manufacturers have grown the virus in quantities sufficient to produce vaccine, extensive clinical trials have been held in various communities around the country, funds have been appropriated for the program and the Department of Health, Education, and Welfare has made initial arrangements with the States for the conduct of the program. While this progress has been made, there has been some criticism heard from the Health Research Group, the New York Times, and a few members of the scientific community. In addition, as should have been expected, some problems have been encountered in resolving the liability problem for the manufacturers of the vaccine, establishing doses for use in children, and in other areas. For these reasons, we have concluded that it is appropriate at this time to hold hearings on the full scope of the program and to explore in detail on the public record the progress and problems to date. We have invited a wide array of witnesses representing a variety of different interests involved in the program and hope to hear from them a full description of their efforts and problems. We will also explore in detail the legislation which the Department of Health, Education, and Welfare has now proposed which would give it authority for indemnification of the manufacturers against claims resulting from the use of the vaccine in situations in which they have exercised due care in its manufacture and handling. If the hearings show there to be reasonable need for this legislation, we will then proceed expeditiously to its consideration by the subcommittee in markup in hopes of its early enactment. 1 See also "Proposed National Swine Flu Vaccination Program," hearings held before the Subcommittee on Health and the Environment, Interstate and Foreign Commerce Committee, Mar. 31, 1976, serial No. 94-79. Our first witness this morning is Hon. Theodore Cooper, Assistant Secretary for Health, and he is accompanied by Dr. James F. Dickson, Deputy Assistant Secretary for Health, Dr. David J. Sencer, Director, Center for Disease Control, and William Taft IV, General Counsel. Mr. Secretary, we welcome you and your colleagues to the committee, and we will be glad to have you proceed. Your statement will be made part of the record and you may proceed as you see fit. STATEMENT OF THEODORE COOPER, M.D., ASSISTANT SECRETARY FOR HEALTH, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, ACCOMPANIED BY WILLIAM H. TAFT IV, GENERAL COUNSEL; JAMES F. DICKSON III, M.D., DEPUTY ASSISTANT SECRETARY FOR HEALTH; GENE R. HAISLIP, DEPUTY ASSISTANT SECRETARY FOR LEGISLATION (HEALTH); W. DELANO MERIWETHER, M.D., DIRECTOR, NATIONAL INFLUENZA IMMUNIZATION PROGRAM; DAVID J. SENCER, M.D., DIRECTOR, CENTER FOR DISEASE CONTROL; HARRY M. MEYER, JR., M.D., DIRECTOR, BUREAU OF BIOLOGICS, FOOD AND DRUG ADMINISTRATION; AND JOHN R. SEAL, M.D., DEPUTY DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH Dr. COOPER. Thank you, Mr. Chairman, members of the committee. In addition to the members that you have mentioned, we have Mr. Gene Haislip, our Deputy Assistant Secretary for Health Legislation, Dr. W. Delano Meriwether, Program Director for the national influenza immunization program, Dr. Harry Meyer, Director of the Bureau of Biologics of the Food and Drug Administration, and Dr. John R. Seal, Deputy Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, available for any information that you may need. Mr. ROGERS. We welcome all of you gentlemen to the committee. Dr. COOPER. It is a pleasure to appear before you today to report on the status of the national influenza immunization program and on one of the most pressing problems which confronts the program-the need to relieve vaccine manufacturers of concern that they may be held liable for damages, not by reason of any negligence or error of their own, but by reason of the conduct of others participating in the program-more particularly the conduct of the Federal Government. H.R. 14409, introduced by Congressmen Carter and Madigan on June 16, 1976, on behalf of the administration, would permit the United States to provide indemnification against claims for injury related to inoculation with vaccine under a comprehensive nationwide influenza. immunization program. I will discuss that issue later. STATUS OF INFLUENZA IMMUNIZATION PROGRAM First, let me bring you up to date on the implementation of the program. Since we last appeared before you on March 31, an appropriation bill has been enacted, initial vaccine trials have been completed, and project grants have been awarded to assist in the implementation of the program in every State and territory of the United States. Virtually every agency of the Federal Government has begun the task of identifying its own role in the program, and of working with us in the Department to insure optimum cooperation and coordination. The same spirit of involvement and cooperation is being seen among a wide range of voluntary organizations, the private medical sector, labor organizations, and many of the Nation's largest and smallest employers. At the State level, the organization framework for getting the vaccine to people is well advanced. Voluntary help is being identified and organized. Training of volunteers and of health department personnel is beginning. The private medical community is deeply involved in the planning of the program in many States, and through State and local medical societies, is endorsing and pledging support for the program. Influenza surveillance both here and abroad, particularly in the Southern Hemisphere where the normal influenza season is occurring, is being stepped up. We have not as yet identified any additional outbreaks of A/New Jersey influenza, or swine flu, as it is commonly known. Despite the problems which we face, and to which I will turn in a minute, the public health community is well prepared to meet the unprecedented challenge which we outlined less than 3 months ago, and it has done so with unprecedented cooperation from virtually every sector of American society. The problems we face are very difficult ones, but in my view they are solvable. The first issue which must be addressed is the likelihood of a pandemic in view of the fact that we have identified no more outbreaks of swine flu (A New Jersey influenza) since Fort Dix. Unfortunately, we know no more about the probability of a pandemic this fall and winter than we did 3 months ago. Was the Fort Dix outbreak a forewarning of a pandemic or a chance isolated incident? The answer to this question cannot be given. However, we have never identified a major antigenic shift in the influenza virus which did not lead to a pandemic. Let me reiterate my conviction that the mobilization of American resources to take preventive steps in the face of a possible influenza pandemic, is still the proper step to take. We have watched influenza take an enormous toll in human and economic resources in previous pandemics, and for the most part we have been helpless to do much more than watch. Even in nonpandemic years, influenza has often been a major cause of illness and death. CLINICAL TRIALS Public Health Service-sponsored clinical trials with the new swine influenza vaccine began on April 21. 1976 at the National Institutes of Health. Results from studies employing 33 separate experimental prenarations of influenza vaccine in over 5,000 volunteers are now available. Additional studies are still in progress and others will be initiated during the coming months to supplement the information already obtained. The experimental vaccines were provided by the four United States manufacturers currently engaged in vaccine production. The purpose of the trials is to evaluate the effectivenessprotective antibodies-and safety-side reactions-of different dosage |