Forbes also covered the story when it first broke.
"Pfizer's Nigerian Nightmare
What if a drug company experimenting on critically ill children doesn’t get the proper parental consent, 11 of those children die and a whistleblower is fired?
Those are the charges leveled against Pfizer in a legal battle that has dragged on for the past seven years in Manhattan federal court and in Nigeria, where the government is seeking $8.5 billion in restitution and damages–and jail terms for various Pfizer officials, including former chief executive William Steere.
Things may come to a head soon. A federal appeals court is expected to rule on whether the children’s parents can go after Pfizer in New York. Meanwhile, to avoid what’s shaping up to be an ugly court battle, Pfizer is said to have offered to settle with the Nigerian government for $150 million, plus money to modernize and equip a Nigerian infectious disease hospital.
Pfizer says the children died from the disease, not from the drug trial, won’t confirm a possible settlement, and says it’s “proud” of its role during the 1996 epidemic, an ugly trifecta of meningitis, cholera and measles. Twelve thousand Nigerians died from meningitis alone, many of them children.
What really happened at a remote sub-Saharan hospital in Kano, Nigeria may never be known. But interviews with Pfizer employees, parents of some of the victims, Food & Drug Administration officials, court filings and other legal documents provide an unsettling look at the pitfalls of doing hurried drug trials in Third World countries."
excerpt "Pfizer had hired Juan Walterspiel, a pediatric infectious disease specialist at Yale Medical School, in 1994 for Trovan’s pediatric clinical development. Pfizer says it doesn’t know why Dr. Walterspiel wasn’t selected to go to Nigeria. But Dr. Walterspiel, who declined to speak with FORBES, would later write to chief executive Steere that the Nigerian study was “in violation of ethical rules for the conduct of medical experiments in humans.”
excerpt "But parents of the dead children in the Trovan group claim they were never shown–or were read–a consent form and weren’t told about Trovan’s risks or that a proved treatment from Doctors Without Borders was just steps away.
Parents of the dead children in the Rocephin group argue their children would have lived had Pfizer given them the full dose. Dozens of others allege that the trial left their children paralyzed, deaf, mute or blind.
Pfizer says it had bilingual nurses on-site who obtained oral consent from all the parents. The company also says it has all the patient charts with “yes” and “oral” boxes checked as to whether and how their consent was obtained. But Pfizer declined to show these consent forms to a reporter."
excerpt "During a 1997 FDA audit Pfizer produced a letter dated a week before the trial began from a Nigerian hospital granting it ethical clearance. But the letter doesn’t really help Pfizer’s case: It was backdated.
Pfizer concedes the backdating is “unfortunate” but now argues there’s no Nigerian law or regulation requiring ethical committee approval before conducting a clinical trial. “Therefore,” Pfizer argues, “there was no need to obtain what the law did not require.”
Full article here -
http://www.forbes.com/forbes/2008/1208/066.html
Author
