Pfizer has expressed its disappointment in response to media reports that the Kano state government in Nigeria has taken legal action against the company over a clinical study carried out in 1996 for its antibiotic Trovan.
Press reports from Africa claim that authorities in Kano have filed a lawsuit claiming that Pfizer secretly used 200 children as “guinea pigs to test a drug under the guise of humanitarian gesture" when the then-unapproved quinolone antibiotic Trovan (trovafloxacin) was administered following an outbreak of a particularly virulent form of meningitis which ultimately killed 15,000 people.
The lawsuit allegedly claims that Trovan, which was withdrawn from the market in 1999 after being linked to liver damage, was given without any authorisation. Five of the 200 children died after being treated with the experimental antibiotic, although there was no direct evidence Trovan caused their deaths, while six others died while taking a comparison drug. It has been reported that the Kano authorities are seeking compensation from the New York-based behemoth of around $2.75 billion.
Trial was responsible and ethical
Pfizer, which has not received a copy of the reported lawsuit, sent a statement to PharmaTimes WorldNews saying that "it would be regrettable if more than 11 years after the Trovan clinical study, the Nigerian government took legal action against Pfizer and others for introducing a new meningitis treatment, which indisputably saved lives, to the region". It points out – “in the strongest terms - that the 1996 clinical study was undertaken with the full knowledge of the Nigerian government in a responsible and ethical way consistent with the company’s abiding commitment to patient safety”.
Pfizer goes on to argue that “the study helped save the lives of almost 200 children stricken with meningococcal meningitis, a disease that if left untreated, kills four out of every 10 people who contract it. Pfizer always acted in the best interests of the children involved, using the best medical knowledge available.” The company concluded by noting that it has "a more than 50-year history of cooperation with the government and people of Nigeria that has included support of programmes to improve the level of health and the accessibility of medical treatment in that country”.
Nevertheless the Kano case continues to dog Pfizer and in May last year, scrutiny of the trial was reopened after the conclusions of a government advisory panel were obtained and published by the Washington Post. The November before, a US federal judge dismissed a lawsuit that accused the drugmaker of not properly warning patients about the risks of Trovan and said the case should be heard in a Nigerian court.