Nigeria files criminal charges against Pfizer over clinical trial

Joe Stephens, Washington Post

Wednesday, May 30, 2007

(05-30) 04:00 PDT Washington -- Officials in Nigeria have brought criminal charges against pharmaceutical giant Pfizer Inc. for the company's alleged role in the deaths of children who received an unapproved drug during a meningitis epidemic.

Authorities in Kano, the country's largest state, filed eight charges this month related to the 1996 clinical trial, including counts of criminal conspiracy and voluntarily causing grievous harm. They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer, the world's largest drug company.

The move represents a rare -- perhaps unprecedented -- instance in which the developing world's anger at multinational drug companies has boiled over into criminal charges. It also represents the latest in a string of public relations blows stemming from the decade-old clinical trial, in which Pfizer says it acted ethically.

The government alleges that Pfizer researchers selected 200 children and infants at a makeshift epidemic camp in Kano and gave about half of the group an untested antibiotic called Trovan. Researchers gave the other children what the lawsuit describes as a dangerously low dose of a comparison drug made by Hoffman-Laroche. Officials say Pfizer's actions resulted in the deaths of an unspecified number of children and left others deaf, paralyzed, blind or brain-damaged.

The lawsuit says the researchers did not obtain consent from the children's families, and also says the researchers knew Trovan to be an experimental drug with life-threatening side effects that was "unfit for human use."

Pfizer and its doctors "agreed to do an illegal act," the criminal charges state, and behaved "in a manner so rash and negligent as to endanger human life."

Suspicion stirred by news of the drug trial has been so intense in Kano, the lawsuit says, that parents refused to allow their children to be immunized against polio last year, frustrating a program aimed at wiping out one of the disease's last refuges.

In a written statement, Pfizer said the company believes it did nothing wrong and emphasized that children with meningitis have a high fatality rate.

"Pfizer continues to emphasize -- 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 consistent with the company's abiding commitment to patient safety. Any allegations in these lawsuits to the contrary are simply untrue."

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