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A Nigerian judge has ordered the arrests of three Pfizer officials for failing to attend court to respond to criminal charges against Pfizer for treating children with an experimental drug during a deadly meningitis outbreak in Kano, Nigeria, in 1996.
Judge Shehu Atiku in Kano ordered arrest warrants for the head of Pfizer in Nigeria, Ngozi Edozien, and the senior officials Lare Baale and Segun Donguro, after they failed to attend court on 6 November.
Government prosecutors in Nigeria say that Pfizer used critically ill children as “guinea pigs” to study Pfizer’s experimental drug trovafloxacin. Four separate legal actions have been filed in Nigeria against Pfizer, including 31 criminal counts against 10 people.
Plaintiffs seek a total of $9bn (£4.5bn; €6bn) in civil suits. Pfizer says that it will “vigorously defend itself against the ‘untrue allegations’ in the government’s lawsuits,” and it says that the children died from meningitis and not from the drugs. In response to the judge’s most recent order, the company issued a statement on 26 December saying that the arrest orders are “improper and violate due process” because the summonses were “not properly served on the defendants.”
According to Reuters, Pfizer obtained an injunction in Lagos last month preventing police from serving the summonses. Pfizer argues that the Kano court lacks jurisdiction to hear the case.
The company successfully quashed three previous attempts to sue the company in US courts on the grounds that the US courts lacked jurisdiction.
A committee commissioned by the Nigerian Federal Ministry of Health to investigate the conduct of the study, concluded in a March 2001 report that Pfizer conducted an illegal study of an unregistered drug. The findings were kept secret until May 2006 when the report was leaked by an anonymous source to the Washington Post (BMJ 2006;332:1233, doi: 10.1136/bmj.332.7552.1233-a). Pfizer argues that the report is “illegal, inaccurate, and biased.”
Trovafloxacin was not approved for use in the United States when it was tested on the children in Nigeria. Subsequent reports of liver failure caused the drug to be banned in Europe and severely restricted in the US.
The 2001 government report, which is contested by Pfizer, found that “although the protocol mentioned the possibility of elevated liver enzymes . . . it did not consider carrying out any liver function test either before or after the treatment.”
Five of 93 children in the trovafloxacin arm died, and six of 97 in the ceftriaxone arm died, according to Pfizer. Patients’ outcomes are not verifiable, according to the committee, because “no patient record given to the committee by Pfizer was complete with patient names and addresses,” making independent verification impossible.
The study, which was only published as an abstract, shows that 10 of the children enrolled in the study were excluded from the analysis. Pfizer did not respond to queries by the BMJ about the outcomes of those 10 children.