Pfizer has dismissed as “preposterous” claims that it ran a “dirty tricks” operation to scuttle a Nigerian federal lawsuit, as the US pharmaceutical group struggles to compensate people affected by a clinical trial it ran in 1996.
A cable from the US embassy in Nigeria last year released on WikiLeaks via the UK’s Guardian newspaper claimed that Pfizer’s country director had hired investigators to uncover corruption allegations concerning the federal attorney-general and feed them to the local media.
The company was pursued by the federal government and the Kano region, where it tested its experimental antibiotic Trovan during a meningitis epidemic, achieving better results than the standard treatment but allegedly failing to meet ethical standards. A Nigerian government commission claimed the company had failed to seek regulatory and research ethics committee approval for the trial in advance, or to obtain participants’ written consent to take part.
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Out of the 190 infected children who took part in the Trovan trial, in which the drug was tested against the existing approved treatment ceftriaxone, 94 per cent survived – compared with an average 60 per cent survival rate for the infection when untreated.
Trovan performed marginally better than its rival, with five deaths among the 93 children who took it, compared with six deaths out of the 97 who received ceftriaxone. No link was clearly demonstrated between the deaths and the drugs.
Pfizer researchers had hoped Trovan would provide a more effective and easier treatment for meningitis, but the procedural problems and subsequent side effects led US and European regulators to forbid its use on children.
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