NIGERIA:The US pharmaceutical giant Pfizer has asked a Nigerian court to throw out a $2 billion lawsuit, saying its researchers did no harm, and in fact saved lives, when they gave children an experimental drug during a 1996 meningitis epidemic.
In a brief filed in the northern Nigerian state of Kano, Pfizer said the clinical trial of an antibiotic known as Trovan was legal and ethical. The filing provides the company's most complete defence since Nigerian authorities charged it and its representatives with 31 criminal charges and $8.5 billion in civil claims.
Nigerian authorities allege that the Trovan trial led to the deaths of 11 children and injured 189 others. Prosecutors also say the company did not tell families their children were participating in a drug experiment. Pfizer's response addresses only allegations made in the civil case in Kano state court.
Pfizer's lawyers assert that "all clinical evidence points to the fact that any deaths were the direct result of the meningitis itself. The defendants always acted in the best interest of the children involved, using the best medical knowledge available."
Pfizer said the survival rate was 94.4 per cent for children given Trovan and 93.8 for a comparison drug. The survival rate for the rest of the hospital, where the aid organisation Doctors Without Borders was treating victims of the epidemic, was about 90 per cent, the company said.
Pfizer argued that prosecutors should have brought their case within three years of learning of the drug trial in a December 2000 Washington Post series and a subsequent government investigation.
It said said it explained the trial to parents and obtained their consent orally before it enrolled their children in the study.
Trovan was never approved for marketing to children but was approved for adult use in the US. It briefly became a best-selling antibiotic but was soon associated with reports of liver damage and deaths. In 1999, the US Food and Drug Administration severely restricted its use and the EU banned it.In May 2006, the Post published a health ministry report, which said Pfizer had violated Nigerian law. ( LA Times-Washington Post service)