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COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE

HARLEY O. STAGGERS, West Virginia, Chairman

JOHN E. MOSS, California JOHN D. DINGELL, Michigan

PAUL G. ROGERS, Florida

LIONEL VAN DEERLIN, California
FRED B. ROONEY, Pennsylvania
JOHN M. MURPHY, New York
DAVID E. SATTERFIELD III, Virginia
BOB ECKHARDT, Texas

RICHARDSON PREYER, North Carolina
CHARLES J. CARNEY, Ohio
RALPH H. METCALFE, Illinois
JAMES H. SCHEUER, New York
RICHARD L. OTTINGER, New York
HENRY A. WAXMAN, California
ROBERT (BOB) KRUEGER, Texas
TIMOTHY E. WIRTH, Colorado
PHILIP R. SHARP, Indiana

JAMES J. FLORIO, New Jersey

ANTHONY TOBY MOFFETT, Connecticut JIM SANTINI, Nevada

ANDREW MAGUIRE, New Jersey

MARTY RUSSO, Illinois

EDWARD J. MARKEY, Massachusetts

THOMAS A. LUKEN, Ohio

DOUG WALGREN, Pennsylvania

BOB GAMMAGE, Texas

ALBERT GORE, JR., Tennessee

BARBARA A. MIKULSKI, Maryland

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W. E. WILLIAMSON, Chief Clerk and Staff Director
KENNETH J. PAINTER, First Assistant Clerk

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CONTENTS

Statement of—

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411

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

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

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Additional material submitted for the record by-Continued

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 committees, with attached letters dated September 21, 1977, to Congressman Waxman and February 18, 1977, to Chairman John E. Moss, Subcommittee on Oversight and Investigations.

Health, Education, and Welfare Department:

Attachments to Dr. Millar's prepared statement:

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

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

Figure III—Guillain-Barre syndrome attack rates in vaccinated
and unvaccinated groups by age, United States, October
1976-January 1977.

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

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.
Audit reports

"Evaluation and control of vaccines for the national influenza immuni-
zation program," report by Barry, et al.

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Table 1-Tests performed on influenza vaccine loss........
Table 2-Summary of test results on commercial influenza vac-
cines

103

104

Table 3-Chicken cell agglutination (CCA) test results

105

Table 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 Testing and distribution chart by doses and week ending 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...

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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. Justice Department:

110

Attachments to Mr. Peterson's prepared statement:

Claims received at Department of Justice
List of suits

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

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

statute

Letter dated December 16, 1977, from Barbara Allen Babcock, Assistant Attorney General to Chairman Rogers re cost per claim of processing claims by the Justice Department under the swine flu 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..

Statement submitted for the record by

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

493

Appendix-"The Swine Flu Program: An Unprecedented Venture in Preventive Medicine," report to the Congress by the Comptroller General of the United States-June 27, 1977

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.

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501

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.

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