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April 17, 2000

CDC/ATSDR
Attn: FOI Office, MS-D54
1600 Clifton Road, N.E.
Atlanta, GA 30333
[Fax number: 404-639-7395
Phone number: 404-639-7270]

Re: Freedom of Information Act Request

Dear Sir or Madam:

This letter constitutes a request under the Freedom of Information Act (�FOIA�), 5 U.S.C. § 552, for information concerning the recommendation by the Advisory Council on Immunization Practices (ACIP) for use of hepatitis B vaccine in infants and children.

We hereby request all government documents in the possession of the CDC or the Advisory Committee on Immunization Practices (�ACIP�) relating to the use of this vaccine in infants and children, including but not limited to:

(a) The Dr. Palmer Beasely study on hepatitis B vaccine given to newborn infants in Taiwan, used by the ACIP in 1991 to determine that at-birth hepatitis B vaccination in the US was safe, with all underlying data, including but not limited to:

(1) Number of newborns in study;

(2) Ethnicity of every newborn in the study;

(3) Age in hours of newborns in the study;

(4) Hepatitis B infected state of mother;

(5) Length of observation for adverse reactions after vaccination;

(6) All adverse reactions reported in study, including but not limited to: convulsions, screaming syndrome (high-pitched, inconsolable screaming), encephalitis, death, neuropathy, and hemorrhage or bleeding diathesis;

(7) The exact formal process by which the Palmer Beasley study was peer reviewed, including but not limited to: the names and scientific credentials of those who reviewed it, all medical journals to which it was submitted for publication, all responses from all experts who reviewed it, the reason it was not published in a peer-reviewed medical journal, and any rejection notices the study received from peer- reviewed medical journals to which it was submitted for publication; and

(8) All material relating to the funding of the Palmer Beasley study, including but not limited to: the names of vaccine manufacturers that provided funding, the dollar amount of funding, any consulting agreements Dr. Beasley has with the manufacturers of the hepatitis B vaccine;

(b) other studies or reports used by the CDC and ACIP concerning the safety and efficacy of the hepatitis B vaccine in infants and children;

(c) CDC and ACIP internal memoranda concerning their recommendation in 1991 for universal use of the hepatitis B vaccine in infants and children;

(d) CDC and ACIP minutes of meetings concerning their recommendation in 1991 of universal use of the hepatitis B vaccine in infants and children;

(e) internal memoranda and minutes of meetings of the CDC and ACIP that refer to reports of possible adverse reactions to hepatitis B vaccine submitted to the Vaccine Adverse Event Reporting System.

If the estimated costs for complying with this FOIA request exceed $750, then we request a cost estimate prior to incurring the charges.

We request a waiver of fees because this information is in the public interest and will greatly contribute to the public understanding of the risks and safety of the hepatitis B vaccine. We are a non-profit organization and have no commercial interest in this information.

We request that you expedite this request so that we may respond promptly to urgent medical care issues raised by our members. Thank you.

Sincerely,

Jane Orient, M.D.