KEY POINTS:
The United States pharmaceutical giant Pfizer has been slapped with criminal charges in Nigeria over a notorious clinical trial it conducted on children during a meningitis epidemic a decade ago.
Patients became unwitting guinea pigs for a new, untested antibiotic and many of them either died or were
left with permanent disabilities. Pfizer and its representatives will be called to account at hearings due to begin next month in the Nigerian state of Kano, where public anger over the clinical trial - and the assurances of any pharmaceutical company - remains so high that the local population won't even trust the Nigerian Government to immunise their children against polio.
The episode, which has already led to one unsuccessful suit in the US courts, was the inspiration for John Le Carre's novel The Constant Gardener.
The Nigerian authorities say Pfizer researchers selected 200 children and infants from a crowded epidemic camp in Kano in 1996 and gave about half of them an untested antibiotic called Trovan. The lawsuit alleges that the researchers did not obtain consent from the children's families even though they knew from their own research that Trovan might have life-threatening side effects and was "unfit for human use". The suit contends that the researchers gave the other half a comparison drug made by Pfizer's competitor Hoffman-La Roche, but deliberately underdosed them to make their own product look better.
Pfizer and its doctors "agreed to do an illegal act in a manner so rash and negligent as to endanger human life".
Once the trial was over, the suit continues, Pfizer left the area, removed all medical records and "obliterated any evidence" of the trial. A Nigerian Government report previously found that Pfizer never told the children or their parents they were participating in a trial.
The report found that of the 11 children who died, five were taking Trovan and six were taking low doses of the comparison drug, ceftriaxone. An unknown number suffered deafness, blindness, paralysis and other disabilities.
The Kano authorities have charged Pfizer on eight counts of criminal conspiracy and voluntarily causing grievous harm. They have also filed a civil suit seeking more than US$2.7 billion in damages.
"Pfizer continues to emphasise - in the strongest terms - that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian Government and in a responsible and ethical way," a company statement said.
- INDEPENDENT
