Abdullahi v. Pfizer, Inc.

The Kano trovafloxacin trial litigation arose out of a clinical trial conducted by the pharmaceutical company Pfizer in 1996 in Kano, Nigeria, during an epidemic of meningococcal meningitis. To test its new antibiotic, trovafloxacin (Trovan), Pfizer gave 100 children trovafloxacin, while another 100 received the gold-standard anti-meningitis treatment, ceftriaxone, a cephalosporin antibiotic. Pfizer gave the children a substantially reduced dose of the ceftriaxone (specifically, 33mg/kg) relative to that described on the US FDA approved Prescribing Information. The allegation is that this was done to skew the test in favor of its own drug. Pfizer claimed that the dose used was sufficient even though a clinical trial performed by Médecins Sans Frontières recommends a dose of 50 - 100mg/kg. A 2002 report by the World Bank described the military government that ruled Nigeria at the time of these events as "pervasively corrupt". It further cites widespread comments by business managers in Nigeria characterizing the NAFDAC of that period as lacking the capabilities needed to perform its regulatory role and "harassing business and seeking bribes" rather than "protecting businesses and consumers".

Five children given trovafloxacin died, as did six of those given ceftriaxone. The lead investigator, Dr. Abdulhamid Isa Dutse, later provided a letter of approval for human trials that was found to be falsified. The Nigerian government called the trial "an illegal trial of an unregistered drug." It has been alleged that participants and their families were not told that they were part of a trial, and that Médecins Sans Frontières was offering the standard treatment in another part of the same building. Pfizer acknowledged reducing the dose of the standard treatment, but said this was done to minimize injection-site pain, and that the mortality rates in both the trovafloxin and ceftriaxone arms of its trial were lower than among those treated with chloramphenicol by Médecins Sans Frontières.

...
Wikipedia