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Pfizer Reportedly Used False Letter to Justify Nigerian Drug Experiment

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From Associated Press

A Nigerian doctor says his office created a backdated letter that the U.S. pharmaceutical company Pfizer Inc. later used to justify its conduct in a controversial drug experiment on ill children in the African nation, the Washington Post reported.

The newspaper, on its Web site Monday, quoted the doctor as saying the document was created when Pfizer officials asked for proof that the earlier tests had been reviewed in advance by a Nigerian ethics committee, as required by U.S. law.

Pfizer spokesman Andy McCormick said last week that he was unaware of possible irregularities in the Nigerian ethics approval document.

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Pfizer, based in New York, gave the letter to the U.S. Food and Drug Administration in 1997 during an audit of records supporting its application to use the drug Trovan for treatment of children during a meningitis epidemic. It is a violation of federal law to knowingly submit false documents.

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