Pfizer Faces Criminal Charges in Nigeria

By Joe Stephens
Washington Post Staff Writer
Wednesday, May 30, 2007

Officials in Nigeria have brought criminal charges against pharmaceutical giant Pfizer 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 from crowds 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 Hoffmann-La Roche. Nigerian 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 that the researchers did not obtain consent from the children's families and that the researchers knew Trovan to be an experimental drug with life-threatening side effects that was "unfit for human use." Parents were banned from the ward where the drug trial occurred, the suit says, and the company left no medical records in Nigeria.

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."

Internal Pfizer records obtained by The Washington Post show that five children died after being treated with the experimental antibiotic, though there is no indication in the documents that the drug was responsible for the deaths. Six children died while taking the comparison drug.

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

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

"It is indeed regrettable that, more than a decade after the meningitis epidemic in Kano, the Nigerian government has taken legal action against Pfizer and others for an effort that provided significant benefit to some of Nigeria's youngest citizens," the statement said.

"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 -- they weren't valid when they were first raised years ago and they're not valid today."

The criminal charges also name Pfizer's Nigerian subsidiary and eight current or former executives and researchers. The charges could result in fines and prison sentences ranging from six months to seven years per count, according to Aliyu Umar, who served as Kano attorney general until earlier this month.

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