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CONTENTS

Statement of -

Page
Abramson, Clarence A., senior counsel, Merck & Co. Inc

411
Ahart, Gregory J., Director, Human Resources Division, General Accoun
ing Office

4

Bailey, William O., president, Aetna Life & Casualty

438, 487

Biery, Richard M., M.D., on behalf of the United States Conference of City

Health Officers

397

Bradford, Windell, Administrative Assistant to Dr. Millar, Bureau of State

Services, Center for Disease Control, Public Health Service, Department

of Health, Education, and Welfare

37, 96

Burnett, Michael, Supervisory Auditor, General Accounting Office

4

Elsea, William R., M.D., vice president, National Association of County

Health Officials (NACHO).

384

Flowers, Jesse, Supervisory Auditor, General Accounting Office

4

Gemmell, Mike, legislative representative, National Association of County

Health Officials (NACHO).

384

Goldbloom Irwin, Deputy Assistant Attorney General, Civil Division, De-
partment of Justice

68

Hagan, Charles F., general counsel, American Home Products Corp .411, 418

Harder, Henry U., president, Chubb & Son, Inc

438

Hendrickson, Robert F., vice president, operations, Merck Sharp & Dohme

Division, Merck & Co., Inc.......

411

Jones, T. Lawrence, president, American Insurance Association.

438

Jordan, William, M.D., National Institute of Allergy and Infectious Dis-

eases, Department of Health, Education, and Welfare

37, 96

Lamb, Frederick D., vice president and legal counsel, Merrell-National

Laboratories

.411, 426

Lloyd, Douglas S., M.D., on behalf of the Association of State and Territori-

al Health Officials (ASTHO).

379

Markoe, Frank, Jr., vice chairman, Board of Directors, Warner-Lambert

Co. (Parke-Davis)

411, 418

Meyer, Harry M., Jr., M.D., Director, Bureau of Biologics, Food and Drug
Administration, Department of Health, Education, and Welfare

37, 96

Millar, J. Donald, M.D., Director, Bureau of State Services, Center for

Disease Control, Public Health Service, Department of Health, Educa-

tion, and Welfare...

37, 96

Morris, J. Anthony, Ph. D., Greenbelt, Md

406

Oswald, Peter, Supervisory Auditor, General Accounting Office

4

Peterson, Neil R., Assistant Chief, Torts Section, Civil Division, Depart-

ment of Justice ..

68

Additional material submitted for the record by-

American Insurance Association:

Attachments to Mr. Jones' prepared statement:

Insurance proposals-alternative No. 1, 2, and 3

450

Secretary Mathews' (HEW) telex to insurance companies dated

July 29, 1976

453

Swine flu vaccine program

454

Memorandum dated November 10, 1976, to each subscribing

insurer-special liability insurance and special excess liability

insurance for vaccine manufacturers, national swine flu immu-

nization program of 1976 re claims administration procedures,

proposed implementation .......

464

Servicing carrier agreement for insurers of the manufacturers of

vaccine

469

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;
chronology of events and content of discussions which led to limiting the
scope of evaluation of vaccine manufacturing costs, and for delayed study
of vaccine manufacturing costs and agreement with requesting commit-
tees, with attached letters dated September 21, 1977, to Congressman
Waxman and February 18, 1977, to Chairman John E. Moss, Subcommit-
tee on Oversight and Investigations .........

28 Health, Education, and Welfare Department: Attachments to Dr. Millar's prepared statement:

Figure 1-Percent of persons with history of receiving influenza
vaccine, United States, 1972-77

60
Figure II-Influenza vaccination coverage, percent by State as of
June 23, 1977

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
influenza vaccination, United States, October 1976-January
1977

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
dated October 17, and December 13, 1977...

354
National influenza immunization program vaccine contract and insur-
ance costs .......

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
appropriation made to meet the Department's specific request for
dealing with swine flu program claims

92 Letter dated December 13, 1977, from Irwin Goldbloom, Deputy Assis

tant Attorney General to Chairman Rogers re list of all personnel in
the Civil Division who are presently working on matters arising out
of the swine flu program

90 Letter dated December 16, 1977, from Barbara Allen Babcock, Assis

tant Attorney General to Chairman Rogers re cost per claim of
processing claims by the Justice Department under the swine flu
statute

82 National Association of County Health Officials (NACHO), attachment to

Dr. Elsea's prepared statement: NACHO survey on selected counties'
experience with the national influenza immunization program..

392 Statement submitted for the record by

Public Citizen's Health Research Group, Anita Johnson and Sidney Wolfe,
M.D...

493

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

501
ORGANIZATIONS REPRESENTED AT HEARINGS
Aetna Life & Casualty, William O. Bailey, president.
American Home Products Corp., Charles F. Hagan, general counsel.
American Insurance Association, T. Lawrence Jones, president.
Association of State and Territorial Health Officials (ASTHO), Douglas S. Lloyd, M.D.
Chubb & Son, Inc., Henry U. Harder, president.
General Accounting Office:

Ahart, Gregory J., Director, Human Resources Division.
Burnett, Michael, Supervisory Auditor.
Flowers, Jesse, Supervisory Auditor.

Oswald, Peter, Supervisory Auditor.
Health, Education, and Welfare Department:

Bradford, Windell, Administrative Assistant to Dr. Millar, Bureau of State

Services, Center for Disease Control, Public Health Service.
Jordan, William, M.D., National Institute of Allergy and Infectious Diseases.
Meyer, Harry M., Jr., M.D., Director, Bureau of Biologics, Food and Drug

Administration.
Millar, J. Donald, M.D., Director, Bureau of State Services, Center for Disease

Control, Public Health Service.
Justice Department:

Goldbloom, Irwin, Deputy Assistant Attorney General, Civil Division.

Peterson, Neil R., Assistant Chief, Torts Section, Civil Division.
Merck & Co., Inc.:

Abramson, Clarence A., senior counsel.
Hendrickson, Robert F., vice president, operations, Merck Sharp & Dohme

Division.
Merrell-National Laboratories, Frederick D. Lamb, vice president and legal counsel.
National Association of County Health Officials (NACHO):

Elsea, William R., M.D., vice president.

Gemmell, Mike, legislative representative.
Warner-Lambert Co. (Parke Davis), Frank Markoe, Jr., vice chairman, Board of

Directors.
United States Conference of City Health Officers, Richard M. Biery, M.D.

REVIEW AND EVALUATION OF THE SWINE FLU

IMMUNIZATION PROGRAM

FRIDAY, SEPTEMBER 16, 1977

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HOUSE OF REPRESENTATIVES,
SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT,
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

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.

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.

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