Nigerian Court Seeks Arrests of Three Over Pfizer's Trovan Trial
Pfizer is under fire again because of its Nigerian experiment. This time, a Nigerian court has leveled criminal charges against three researchers who conducted a clinical trial on the effectiveness of the antibiotic Trovan on children in 1996. Nigerian authorities say the research killed 11 children and left others disabled. The trial took place in the northern state of Kano during a meningitis epidemic that killed 12,000 children in six months. The Nigerian government has also filed a civil suit against Pfizer seeking 6.5 billion dollars.
Pfizer was testing its then unapproved drug on children with brain infections at a field hospital. Nigeria has alleged Pfizer never had approval to conduct the trial either from the government or from the parents of the 100 children drafted as subjects into the trial. At the same time Pfizer was conducting its research, Doctors Without Borders was dispensing approved antibiotics at the hospital.
A Medical Panel in Nigeria had previously concluded that an oral form of Trovan had never been given to children with meningitis. Pfizer could produce no records documenting that the researchers had told the children or their parents that they were part of an experiment, In addition, an approval letter from a Nigerian ethics committee Pfizer used to justify its actions apparently had been created then backdated by the company's lead researcher.
The FDA never approved Trovan for use in children. After the drug was approved for adults in 1997, it became one of the most prescribed antibiotics in the United States earning Pfizer millions. But the FDA severely limited Trovan's use in 1999 after reports of liver damage and deaths surfaced. European regulators flat out banned the drug.
Bioethicists have long contended Pfizer conducted the trial in Africa because the Protocol never would have been approved in this country.
Alan Milstein
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