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Statement of -
Goldbloom Irwin, Deputy Assistant Attorney General, Civil Division, De-
Meyer, Harry M., Jr., M.D., Director, Bureau of Biologics, Food and Drug
Additional material submitted for the record by-Continued
Page General Accounting Office, letter dated December 20, 1977, from Mr. Ahart
to Chairman Rogers re correspondence concerning the scope of study;
28 Health, Education, and Welfare Department: Attachments to Dr. Millar's prepared statement:
Figure 1-Percent of persons with history of receiving influenza
61 Figure III-Guillain-Barre syndrome attack rates in vaccinated and unvaccinated groups by age, United States, October 1976-January 1977.....
62 Figure IV–Guillain-Barre syndrome attack rate for population
>17 years of age, by week of onset after A/New Jersey
63 Figure V-Guillain-Barre syndrome relative risks for population
>17 years of age, by week of onset after A/New Jersey influenza
vaccination, United States, October 1976-January 1977.......... 64 Audit reports ....
350 “Evaluation and control of vaccines for the national influenza immunization program,” report by Barry, et al.
97 Table 1-Tests performed on influenza vaccine loss.
103 Table 2–Summary of test results on commercial influenza vaccines
104 Table 3—Chicken cell agglutination (CCA) test results
105 Ta 4—Hemagglutinin content of A/New Jersey component of
influenza vaccines as determined by immunoelectrophoresis...... 106 Table 5—Amount of vaccine as of December 16, 1976
107 Testing and distribution chart by doses and week ending
108 Letter dated October 4, 1977, from Chairman Rogers to Secretary
Califano re additional written questions with subsequent replies
66 Signing of letter contracts, with attachments pertaining to 1. tax
status of the self insurance retention fund; 2. production of "Shope"
influenza virus vaccine; and 3. waiver of cost accounting standards. 110 Justice Department: Attachments to Mr. Peterson's prepared statement: Claims received at Department of Justice
72 List of suits
74 Correspondence between Chairman Rogers and the Department of
Justice re status of the 28 positions funded by a supplemental
92 Letter dated December 13, 1977, from Irwin Goldbloom, Deputy Assis
tant Attorney General to Chairman Rogers re list of all personnel in
90 Letter dated December 16, 1977, from Barbara Allen Babcock, Assis
tant Attorney General to Chairman Rogers re cost per claim of
82 National Association of County Health Officials (NACHO), attachment to
Dr. Elsea's prepared statement: NACHO survey on selected counties'
392 Statement submitted for the record by
Public Citizen's Health Research Group, Anita Johnson and Sidney Wolfe,
Appendix—"The Swine Flu Program: An Unprecedented Venture in Preven- *Page tive Medicine," report to the Congress by the Comptroller General of the United States—June 27, 1977
Ahart, Gregory J., Director, Human Resources Division.
Oswald, Peter, Supervisory Auditor.
Bradford, Windell, Administrative Assistant to Dr. Millar, Bureau of State
Services, Center for Disease Control, Public Health Service.
Control, Public Health Service.
Goldbloom, Irwin, Deputy Assistant Attorney General, Civil Division.
Peterson, Neil R., Assistant Chief, Torts Section, Civil Division.
Abramson, Clarence A., senior counsel.
Elsea, William R., M.D., vice president.
Gemmell, Mike, legislative representative.
REVIEW AND EVALUATION OF THE SWINE FLU
FRIDAY, SEPTEMBER 16, 1977
HOUSE OF REPRESENTATIVES,
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.
On March 24, 1976, the President announced a national program designed to offer immunization to every American citizen against a newly discovered influenza virus. This initiative came to be known as the swine flu program of 1976.
Congress responded. Under the general immunization authority of the Public Health Service Act, the Appropriations Committee took a bill to the House floor providing appropriations for the swine flu program on April 5, 1976. The funding bill passed the Senate on April 9 with amendments, and the House agreed to the Senate amendments on April 12. H.J. Res. 890 became Public Law 94-268 on April 15, 1976. This committee was advised by HEW that new legislative authority for the program was unnecessary, that HEW could implement the program by contracting with manufacturers. This proved not to be the case.
The subcommittee responded to the President's request and held our first legislative hearings on March 31, 1976. We developed legislation which, although not ultimately enacted, passed the House by voice vote on April 15. Subsequently, we held four additional hearings on the implementation of the program. We were concerned over program operations such as the lag in the production of sufficient quantities of vaccine, changes in instructions to State and local health departments, and the establishment of dosage schedules for children. The major problem which required this subcommittee's attention, however, was that of liability. The liability issue led to Public Law 94-380, the national swine flu immunization program of 1976, which was necessary to the eventual implementation of the program.
Once this major preventive medicine program was underway, however, it was plagued by continued problems, the most unfortunate being the complication of Guillain-Barre, which led to the decision to terminate the campaign on December 16, 1976.