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Pfizer denies Nigerian trial wrongdoing
Pfizer has denied any wrongdoing during a 1996 trial in Nigeria for the antibiotic Trovan. The Washington Post has reported that Pfizer tested Trovan on children with brain infections when the drug was unapproved for use, according to a Nigerian government document that was never released officially.
The trial involved selecting patients with a severe strain of meningitis from a hospital in the city of Kano. Of the 100 children and infants in the trial, five died and others developed arthritis, although there is no suggestion that the Trovan caused this as six died when using a comparison drug. The report allegedly describes the trial as “an illegal trial of an unregistered drug”.
Pfizer has categorically denied any wrongdoing and said that Trovan has saved many lives. It added that it had not been contacted by the Nigerian government about the report and stated that it conducted the trials with the government’s full knowledge.
A statement read: “Pfizer is confident that no one associated with the Trovan clinical study – conducted in Kano, Nigeria during a meningitis epidemic in 1996 – ever put a patient?s health at risk and that the company acted in the best interests of the children involved in the study, using the best medical knowledge available.”
“Pfizer was guided at all times by the laws of Nigeria, advice from that country?s Ministry of Health, and the company?s commitment to patient safety,” the company added.
Trovan has been used for a wide range of infections, although in 1999 the FDA published guidelines for the drug’s use after liver damage was reported as a side-effect in some cases where the drug had been administered for long periods.
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