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Nigeria Trovafloxacin lawsuit
Main article:
Abdullahi v. Pfizer, Inc.
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to
Kano to set up a clinical trial and administer an experimental
antibiotic,
trovafloxacin, to approximately 200 children. Local Kano officials reported that more than 50 children died in the experiment, while many others developed mental and physical deformities. The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa. In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment. According to the news program
Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug." The lawsuits also accuse Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. While the specific facts of the case remain in dispute, both Nigerian medical personnel and at least one Pfizer physician have stated that the trial was conducted without regulatory approval.
Source:
Pfizer - Wikipedia