Pfizer Faces New Charges Over Nigerian Drug Test

Pharmaceutical giant Pfizer, already fighting state criminal charges in northern Nigeria, also faces a string of criminal counts and $7 billion in civil claims brought by federal Nigerian authorities in the capital of Abuja, newly obtained documents show.

Nigerian prosecutors confirmed this week that the federal attorney general's office has charged Pfizer and some of its medical researchers with forgery, possessing an illegal drug and unauthorized practice of medicine.

All the charges stem from a 1996 Pfizer drug trial in which some children died and others suffered debilitating injuries after being treated during a meningitis epidemic.

The charges and a related lawsuit are independent of similar legal actions initiated by officials in the northern Nigerian state of Kano, where the drug trial took place. The new disclosures bring to four the number of legal actions pending against Pfizer in Nigeria. Combined, the actions seek $9 billion in restitution and damages, and they encompass 31 criminal counts against 10 people, Pfizer itself and its Nigerian subsidiary. The criminal charges carry sentences of up to seven years per charge.

Pfizer spokesman Bryant Haskins said the corporation had not been served in any of the legal actions. "We think all the allegations are inflammatory; we simply don't agree with them," Haskins said. "We believe we conducted the clinical study in an ethical manner that helped save lives."

Defendants in the federal criminal actions include former Pfizer chief executive William C. Steere Jr. and six other people who worked for Pfizer in 1996.

The Nigerian government contends that Pfizer "devised a scheme" under which it offered the nation humanitarian aid in response to the record-setting 1996 epidemic. Instead, prosecutors say, Pfizer secretly imported an untested drug and illegally carried out "an experiment on vulnerable victims."

Pfizer's researchers selected 200 children at an epidemic camp, then gave about half an untested oral version of the antibiotic Trovan, the government contends. The other children allegedly were given dangerously low doses of a comparison drug made by one of Pfizer's competitors. Researchers did not explain to parents that they were administering an experimental drug, the government alleges. Some children died as a result and others suffered a range of disabling injuries, the lawsuits state.

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

Trovan has not been approved for use by American children. It was cleared for adult use in 1997 and quickly became one of the most prescribed antibiotics in the United States. But within two years, it was linked to liver damage and deaths, leading the government to severely restrict its use.

Pfizer did not seek Nigerian government permission to import or administer Trovan and knew the drug would not cure meningitis, the charges say. Seven of the federal charges refer to an approval letter that Pfizer says was issued by a Nigerian ethics committee but that was "forged and backdated," the federal charges state. Pfizer paid a Nigerian physician $20,000 to produce the letter, according to the charges.

Federal prosecutors said that new interest in the decade-old incident arose last year, after The Post published the findings of a confidential Nigerian government report produced in 2001. That report concluded that the trial had violated a series of international laws.

"The people in the federal Justice Ministry had no idea about this," said Babatunde Irukera, a special prosecutor handing the federal prosecution. Initial settlement discussions with Pfizer led nowhere, he said, and necessitated the lawsuits.

Bayo Ojo, whose term as Nigerian attorney general ended Wednesday, called the charges "a groundbreaking legal action."

Two civil lawsuits, filed in the United States by the families of children treated by Pfizer researchers, were dismissed on jurisdictional grounds in 2005. Attorneys for the families are appealing.