NEW YORK-Pharmaceutical giant Pfizer was left defending itself after an article in The Washington Post found the company reportedly did not follow the necessary procedures before beginning their study of the drug Trovan.
Company officials said they were "proud of the way the study was conducted," although there is now a lawsuit filed in the US District Court of New York on behalf of 30 children who participated in the study. They argue the drug, known as trovafloxacin also, was responsible for the deaths and brain damage of children during a 1996 meningitis outbreak in Nigeria. There were more than 200 children who participated in the study, which took place during an epidemic that killed more than 15,000 Africans.
The lawsuit alleges that Pfizer officials rushed important steps to begin the study, therefore violating international law, federal regulations, and medical ethics.
The article, which ran as a series highlighting medical testing abroad by American pharmaceutical companies, showed that the company did not seek approval from an Nigerian medical ethics committee before starting testing.
Trovan, which was approved by the US Food and Drug Administration (FDA) in 1997, was designed to treat many infections, However, after cases of liver failure, its uses was restricted in 1999.
Information from www.washingtonpost.com