Pfizer Says Nigeria Gave Approval for 1996 Drug Test

by VR Sreeraman on  July 14, 2007 at 2:54 PM Drug News   - G J E 4
US drug giant Pfizer Thursday said it had got the go-ahead from Nigerian authorities before administering a drug that claimed the lives of 11 children in the northern Kano state in 1996.
Pfizer Says Nigeria Gave Approval for 1996 Drug Test
Pfizer Says Nigeria Gave Approval for 1996 Drug Test

"We have written approvals from NAFDAC (Nigeria's drug agency), the federal ministry of health, Kano government and parents or guardians of the children before the clinical test of the drug was carried out," managing director of Pfizer Specialities Limited Nigeria Ngozi Edozien told reporters.

The Nigerian federal government and Kano state government have filed two separate suits against Pfizer, claiming around some 9.5 billion dollars in damages for victims of the failed drug test.

Both governments accuse Pfizer of administering a test antibiotic called Trovan without authorisation or parental consent among children at a field hospital during an epidemic of meningitis, measles and cholera.

Of the 200 children affected, 11 died while many more -- reportedly 181 -- suffered from deafness, paralysis, brain damage and blindness, according to the allegations. Pfizer denies the charges.

Edozien said Pfizer carried out the test following "an appeal for help" from Nigeria.

She said Trovan as an oral application was the best drug to treat those disease and underlined that Pfizer meant no harm.

The US Food and Drug Administration cleared Trovan for adult use in 1997 and the drug swiftly became established as one of the most prescribed antibiotics in the US market.

She said the company would defend itself against the suits during the next hearing.

The Nigerian federal government filed its suit on June 4 in Abuja for almost seven billion dollars in damages against the US drug firm, while Kano is asking for 2.5 billion dollars.

The federal suit comes up on July 20 while that of Kano government has been fixed for October 3.

Source: AFP

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