Nigeria sues Pfizer for 1996 clinical trial

January 14, 2008

The 1996 pediatric clinical trial run by Pfizer during a Nigerian meningitis epidemic has caused the world's largest drug company more problems...

The 1996 pediatric clinical trial run by Pfizer during a Nigerian meningitis epidemic has caused the world's largest drug company more problems. The Nigerian government has filed eight charges against Pfizer, as well as a $2 billion civil lawsuit.

The trial was for the broad-spectrum antibiotic trovafloxacin (Trovan). The lawsuit alleges that the trial was conducted in an epidemic camp, that parents did not give informed consent for their children, that the children were isolated from their parents, and that the drug caused blindness, brain damage, deafness, paralysis, and death.

A series of reports from the Washington Post prompted the 12-year delay in filing charges. The Post recently published a suppressed report by the Nigerian government, saying that Pfizer's actions has violated the Declaration of Helsinki and the UN Convention on the Rights of the Child, as well as Nigerian law.

The lawsuit alleges 100 children and infants were given the Pfizer drug, and another 100 were given a comparator. But the Pfizer drug had never been tested in humans before, and the comparator, Roche's Rochephin, was given as harmfully low doses, to influence the trial results. Eleven of the 200 children died, five from the tested drug group and six from the comparator group. The suit claims that the 189 surviving children all have disabilities.