Pfizer Faces Criminal Charges in Nigeria

Umar said he filed the charges with the backing of federal and state authorities. He said it took 11 years to bring the action because officials only learned details in recent years, through a series of investigative reports in The Post. Three months ago, Umar's office obtained a six-year-old Nigerian government report that concluded Pfizer's actions violated international law.

"We realize we are the Third World and we need assistance," Umar said. "But we frown on people who think they can take advantage of us, especially if it's for profit. That's why we decided we needed to take action against Pfizer.

"Those people responsible should be punished, whether in Nigeria or in the United States, for what they did to our people."

Pfizer's drug trial came to public attention in December 2000, when The Post published the results of a year-long investigation into pharmaceutical testing in the developing world. Nigerians met the news with street demonstrations and demands for reform.

Nigeria's health minister appointed a panel of experts to look into Pfizer's actions, but its final report was suppressed without explanation. Last year, The Post obtained a copy, which revealed that the panel had concluded Pfizer's actions violated Nigerian law, the international Declaration of Helsinki and the U.N. Convention on the Rights of the Child.

The panel said Pfizer administered an oral form of Trovan that apparently had never been given to children with meningitis. It said there were no records documenting that Pfizer told the children or their parents that they were part of a drug trial. And it said an approval letter from a Nigerian ethics committee, which Pfizer used to justify its actions, was a sham concocted long after the trial ended.

"The families of the children who [Pfizer] used as laboratory guinea pigs were led to believe and in fact understood that the Defendants were providing their children with volunteer relief, clearly focused humanitarian medical intervention and nothing more," the lawsuit says.

Parents were not told that alternative treatments were available, it adds.

The suit charges that parents were barred from Pfizer's ward and that the company's own lab tests had shown Trovan's life-threatening side effects. Researchers allegedly administered the comparison drug, Rocephin, in dangerously low doses to make Trovan look more effective.

The lawsuit contends that Pfizer researchers left the area during the epidemic, took all medical records and "obliterated any evidence" of the trial.

"Defendant's illegal conduct was deliberate and solely motivated by financial considerations," it says.

Every surviving child suffered one or more disabilities, the lawsuit says, adding that the state of Kano has incurred major costs caring for the children and otherwise dealing with the drug trial 's repercussions.

In its statement, Pfizer said the drug was in late-stage development and had been tested on 5,000 patients in a number of countries. "Pfizer's doctors had solid scientific evidence that it would provide a safe and effective treatment against the deadly disease," the statement said. The treatment "indisputably helped save the lives of almost 200 children," the company said.

The U.S. Food and Drug Administration never approved Trovan for use in treating American children. After being cleared for adult use in 1997, the drug quickly became one of the most prescribed antibiotics in the United States. But Trovan was later associated with reports of liver damage and deaths, leading the FDA to restrict its use in 1999. It remains available in the United States, but European regulators have banned it.

Research editor Alice Crites contributed to this report.