By Joe Stephens
Washington Post Staff Writer
Friday, July 31, 2009
Pfizer signed a $75 million agreement Thursday with Nigerian authorities to settle criminal and civil charges that the pharmaceutical company illegally tested an experimental drug on children during a 1996 meningitis epidemic.
Nigerian authorities say Pfizer's test of the antibiotic Trovan killed 11 children and disabled scores more. Pfizer says the deaths and injuries were the result of meningitis.
An attorney for the state of Kano, where the charges were lodged, said the settlement was a long time in coming but welcome because it set the record straight about Pfizer's culpability. "People and entities can and must be held accountable for the consequences of their conduct," the attorney, Babatunde Irukera, said. "People around the world are no different and must be accorded the same levels of protections, always."
Charges filed against Pfizer by Nigeria's federal government, which is seeking about $6 billion in damages, are unaffected by the settlement, Irukera said. Two lawsuits related to the Trovan experiment also remain pending in New York.
In a news release, Pfizer said that it "specifically denies" any wrongdoing or liability. The company said its researchers conducted the clinical trial of the antibiotic Trovan legally, with the approval of the Nigerian government and the consent of guardians of the children. The company said the settlement was the best way to "allow Pfizer and the Nigerian governments to focus on what matters -- improving healthcare for all Nigerians."
Under the agreement, the world's largest drug company agreed to pay $30 million over two years toward health-care initiatives chosen by the Kano state government. It will reimburse the state for $10 million in legal costs. And Pfizer agreed to create a fund that will pay up to $35 million toward "valid claims" for financial support submitted by patients who took part in the clinical trial. A panel appointed by Pfizer and Kano state will determine eligibility and levels of support.
In return, Kano officials agreed to drop civil and criminal actions against the company. Kano and the Nigerian federal government originally filed legal actions naming as defendants Pfizer and 10 individuals, including former Pfizer chief executive William C. Steere Jr. The actions sought $9 billion in restitution and damages and included 31 criminal counts, including homicide.
Details of the drug trial were first made public in December 2000 in a Washington Post investigative series. The articles reported that the trial did not conform to U.S. patient-protection standards and that the oral form of the drug used in the trial had not been previously tested in children. Pfizer had no signed consent forms for the children, the articles said, and the company relied on a falsified ethics approval letter.
Five years later, in May 2006, The Post obtained and published a confidential report that concluded that Pfizer violated Nigerian and international law in the experiment. That set in motion the criminal charges.
Trovan was never approved for use by children in the United States. The Food and Drug Administration approved it for adults in 1998 but later severely restricted its use after reports of liver failure. The European Union banned it in 1999.