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Trovan's Troubled History: Early Development

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.

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.

May 15: Walterspiel sues Pfizer, claiming he was fired for raising ethical questions about the Nigeria experiment. Pfizer denies claim; suit later dropped.

July 3: The European Union approves sale of Trovan for adults.

September: FDA approves adding wording to Trovan labels in the United States that note that liver abnormalities and hepatitis have occurred in Trovan patients, and that "liver failure . . . has also been reported rarely."

Dec. 1: FDA receives report of the death of a Trovan patient that the agency says is associated with liver injury.

1999: Call for Ban, New Restrictions

May: Pfizer warns European doctors that 140 Trovan patients have suffered liver damage.

June 3: The non-profit group Public Citizen asks the FDA to ban Trovan, arguing liver problems surfaced in animal and human experiments even before it was approved for sale.

June 9: FDA advises that Trovan's use be restricted to patients with serious diseases in institutional settings. Agency reports more than 100 cases of liver damage among Trovan patients, including six deaths. Pfizer later suspends pediatric experiments.

July 6: Lawsuit filed against Pfizer in South Carolina on behalf of Trovan patient. Other suits follow in Illinois and New York. Cases pending.

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