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The Body Hunters

Trovan's Troubled History: Early Development

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Sunday, December 17, 2000

A team led by Pfizer researcher Katherine Brighty synthesizes Trovan (trovafloxacin) for the first time in a laboratory. A broad-spectrum antibiotic, Trovan attacks bacteria responsible for a wide range of illnesses. Pfizer eventually launches the biggest clinical trial program in company history, encom-passing 13,000 patients in 87 studies in 27 countries.

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1996: Tests in Nigeria, Approval Request

April 3 to May 15: Pfizer researchers conduct human experiment in Kano, Nigeria, to compare the drug to another antibiotic in treating 200 children with bacterial meningitis. Researchers say the trial is a success.

Dec. 30: Pfizer files for approval to sell Trovan in the U.S. for a variety of infections.

1997: Inspection, FDA Approval

June: FDA inspects Pfizer's files on the Nigerian Trovan experi-ment, later cites numerous record-keeping deficiencies.

October: Pfizer withdraws FDA application for use of Trovan to fight bacterial meningitis in children in an epidemic.

Dec. 18: Pfizer physician Juan Walterspiel sends letter to Pfizer's chairman, alleging unethical practices in the Nigerian experiment.

Dec. 19: FDA approves Trovan for combating 14 bacterial infections in adults. Human experiments for other possible Trovan uses continue.

1998: Sales Launch, A Death Reported

February: Pfizer sponsors a launch meeting for Trovan in Orlando. The drug quickly becomes one of the most prescribed antibiotic brands in the United States. Pfizer reports sales top $160 million in Trovan's first year; 2.5 million prescriptions are written by mid-1999.

Also that month, Pfizer responds that after an extensive review of the Nigeria experiment, Walterspiel's claims determined unfounded. Walterspiel terminated.


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