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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
An agreement has been reached between Pfizer and Nigeria's Kano State government following the long-running Trovan trial, which stems from the accusation that Pfizer illegally tested the antibiotic Trovan (trovafloxacin) on children in 1996 during a meningitis outbreak.
An agreement has been reached between Pfizer and Nigeria's Kano State government following the long-running Trovan trial, which stems from the accusation that Pfizer illegally tested the antibiotic Trovan (trovafloxacin) on children in 1996 during a meningitis outbreak. According to various third party reports (Africa news, Thompson, RTT News, Bloomberg), 11 children died and others were left with serious disabilities including blindness, deafness and brain damage.
Under the terms of the agreement outlined in a joint statement, Kano State will drop the Trovan cases and Pfizer will pay more than $70 million, which includes the reimbursement of Kano State's legal fees.
"We have been a partner with the people and governments of Nigeria for more than 50 years," Brad Lerman, Pfizer's Senior Vice President and Associate General Counsel, explained in the statement. "The company believe that a mutually agreeable resolution is the best way to continue that relationship and allow Pfizer and the Nigerian governments to focus on what matters improving healthcare for all Nigerians."
Trovan, once touted as blockbuster broad-spectrum antibiotic, became available in the US and Europe in 1998. Shortly afterwards, however, both agencies became concerned about severe liver injuries that were occurring as a result of treatment. According to a report by The New York Times, one of Pfizer's scientists claimed that data showed that Trovan "hurt one patient in every 50000". In 1999, the use of Trovan in the US was severely restricted by the FDA and marketing authorization was withdrawn completely in Europe.
With regards to the Trovan cases in Nigeria, Pfizer has denied any wrongdoing or liability in connection with the clinical study conducted in 1996. In a Trovan fact sheet published on Pfizer's website, the company claims it: "obtained all necessary approvals from relevant federal and state government agencies in Nigeria".
Despite this, the company has pledged financial support (a maximum of $35 million) to those who participated in the clinical study in the form of a Healthcare/Meningitis Fund. The company will also reimburse Kanto State for its legal costs and will commit $30 million over 2 years to support healthcare initiatives chosen by the Kano State government. In the statement, Pfizer's Lerman said: "With the procedures in place for the Healthcare/Meningitis Fund, the people of Nigeria will have confidence that the parties have taken strong steps to ensure that the funds reach only those for whom they are intended."
In the statement, Pfizer also claimed that the results of a clinical study showed that Trovan helped save lives and "was at least as effective as the best treatment available at Kano's Infectious Disease Hospital".