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REVIEW AND EVALUATION OF THE SWINE

FLU IMMUNIZATION PROGRAM

HEARING

BEFORE THE

1.

SUBCOMMITTEE ON
HEALTH AND THE ENVIRONMENT

OF THE

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE

HOUSE OF REPRESENTATIVES

NINETY-FIFTH CONGRESS

FIRST SESSION

ON

THE EXPERIENCES OF THE PAST 18 MONTHS OF THE

SWINE FLU PROGRAM

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255ST

XL

22/

1 53-005-00

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE

HARLEY O. STAGGERS, West Virginia, Chairman JOHN E. MOSS, California

SAMUEL L. DEVINE, Ohio JOHN D. DINGELL, Michigan

JAMES T. BROYHILL, North Carolina PAUL G. ROGERS, Florida

TIM LEE CARTER, Kentucky LIONEL VAN DEERLIN, California

CLARENCE J. BROWN, Ohio FRED B. ROONEY, Pennsylvania

JOE SKUBITZ, Kansas JOHN M. MURPHY, New York

JAMES M. COLLINS, Texas DAVID E. SATTERFIELD III, Virginia LOUIS FREY, JR., Florida BOB ECKHARDT, Texas

NORMAN F. LENT, New York RICHARDSON PREYER, North Carolina EDWARD R. MADIGAN, Illinois CHARLES J. CARNEY, Ohio

CARLOS J. MOORHEAD, California RALPH H. METCALFE, Illinois

MATTHEW J. RINALDO, New Jersey JAMES H. SCHEUER, New York

W. HENSON MOORE, Louisiana RICHARD L. OTTINGER, New York

DAVE STOCKMAN, Michigan
HENRY A. WAXMAN, California

MARC L. MARKS, Pennsylvania
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

W. E. WILLIAMSON, Chief Clerk and Staff Director
KENNETH J. PAINTER, First Assistant Clerk
ELEANOR A. DINKINS, Assistant Clerk
FRANK W. MAHON, Printing Editor

PROFESSIONAL STAFF
ELIZABETH HARRISON

CHRISTOPHER E. DUNNE
JEFFREY H. SCHWARTZ

WILLIAM M. KITZMILLER
BRIAN R. MOIR

MARK J. RAABE
KAREN F. NELSON

THOMAS M. RYAN
Ross D. AIN

RICHARD D. LINDSAY, M.D.
ROBERT HENLEY LAMB, Associate Minority Counsel
SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT

PAUL G. ROGERS, Florida, Chairman DAVID E. SATTERFIELD III, Virginia

TIM LEE CARTER, Kentucky RICHARDSON PREYER, North Carolina JAMES T. BROYHILL, North Carolina JAMES H. SCHEUER, New York

EDWARD R. MADIGAN, Illinois HENRY A. WAXMAN, California

JOE SKUBITZ, Kansas JAMES J. FLORIO, New Jersey

SAMUEL L. DEVINE, Ohio (Ex Officio)
ANDREW MAGUIRE, New Jersey
EDWARD J. MARKEY, Massachusetts
RICHARD L. OTTINGER, New York
DOUG WALGREN, Pennsylvania
HARLEY O. STAGGERS, West Virginia
(Ex Officio)

STEPHAN E. LAWTON, Counsel
ROBERT W. MAHER, Director of Research and Planning

JO ANNE GLISSON, Senior Staff Associate
DONALD K. DALRYMPLE, Assistant Counsel

WILLIAM V. CORR, Assistant Counsel
STEPHEN J. CONNOLLY, Senior Staff Assistant

BURKE ZIMMERMAN, Research Assistant

(II)

CONTEXTS

%* % * *

Statement

Abcams... Clarence A senior counsel. Merck & Ca Ine
Abar Gregory 1. Director, Human Resources Division General Awun
Bezler. Tusam 0. president, Aetna Life & Casualty
Biery. Pichard MD, on behalf of the United States Conference of City
Bradford, Windel. Administrative Assistant to Dr. Millar, Bureau of State
Services. Ceeter for Disease Control, Public Health Service, Department

of Health Education, and Welfare
Burnett. Michael Supervisory Auditor, General Accounting Office
Elsea, Wisam R., VD, vice president, National Association of County

Health Officials NACHO.
Flowers, Jesse, Supervisory Auditor, General Accounting Office
Gemmell. Mike, legislative representative, National Association of County

Health Officials NACHO).
Goldbloom Irwin, Deputy Assistant Attorney General, Civil Division, De

partment of Justice
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.
Jones, T. Lawrence, president, American Insurance Association

438 Jordan, William, M.D., National Institute of Allergy and Infectious Diseases, 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) 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
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 Peterson, Neil R., Assistant Chief, Torts Section, Civil Division, Department of Justice

68 Additional material submitted for the record byAmerican 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

379

37, 96

(III)

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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 vac-
cines

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

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
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

90

Appendix- The Same Program
tive Medicine 93.2 gras
United States-

OPGAVAS EL
Aetna Life & Cart
American Foce Pro
American Instance : awrens
Association of Seate am 2. Free
Chubb & Son 30 Ser: Sarze res
General Accoon Fee

Ahart. Gregorio recor. 2
Burnett Verze. Suges :
Flowers. Jesse Suge,

Oswald Pets Super Acer
Health, Educatiot an Weržant pense
Bradford moel. Summativ

Services Ceme for Disease or
Jordan. a. M. Vatrona in
Meyer. Farry J. M. Drar Bar

Administration
Millar, J. Donait. N: Threeur: burea.

Control Publr Feater Serie
Justice Department

Goldbloom kw. Deputy ASSEZ: Aro se!

Petes - Nail Asistan Cha :3 --
Merck & Co., Inc:

Abramson, Clarence A. Senior
Hendrickson, Rober. F. vie presies werzon Nereya & A

Division
Merrell-National Laboratories. Fregener 2m 5:37 ar reak.
National Association of County Beari frezas

Elsen, William R. M. vix presider.

Gemmell. Mike legislative represenrave
Warner-Lambert Co Parke avis.. Frane Nanak 2. En daarna buat of

Directors.
United States Conference of Cry Feart. 3er Ferrar. X Brenn:

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