Pfizer Facing 4 Court Cases in Nigeria
By HEIDI VOGT, AP, Posted: 2007-08-11 00:29:41
KANO, Nigeria (AP) – A security guard in this dusty Nigerian city is living with tragedy – a 14-year-old son whose dazed eyes, slow speech and uneven gait signal brain damage. Mustapha Mohammed says he knows who to blame – Pfizer Inc., the world’s largest drug maker.
New York-based Pfizer is facing four court cases – two filed by the Nigerian government and two by officials in the northern Nigerian state where Mohammed lives – over a decade-old drug study that included Mohammed’s son.
The company, which denies any wrongdoing, is accused of using a 1996 meningitis epidemic to push through a sloppily managed drug study that contributed to death in some and infirmities in others.
The fallout provides a case study of the ethical dilemmas that arise when Western medical priorities run into Third World poverty and ignorance. The communication gap between those handing out medical alms and those receiving has bred mistrust and anger in Kano – with damaging, far-reaching effect.
The Pfizer case was cited as one reason residents of Kano and the state of the same name boycotted a polio vaccine in 2003, fearing it was a plot to make Africans infertile. Polio exploded in Nigeria and eventually spread to 25 previously polio-free countries.
Though the meningitis epidemic is long over and the polio vaccination program is back on track, misinformation and suspicion persist.
Mohammed is sure no one asked his permission to test a drug on his child. But he also wasn’t asking many questions when he rushed his son to the hospital in 1996.
“We were desperate for drugs. We just took it in good faith,” said Mohammed, who lives in a tiny house off a dirt road in one of Kano’s poorer neighborhoods. Mohammed – who can’t read or write – only later found out that the pink paper he kept with Pfizer’s name and treatment dates meant his son had been in the study.
Pfizer says it explained the study to families using practices in line with U.S. and international guidelines, even employing Nigerian nurses and doctors who spoke Hausa, a main Nigerian language. Written permission was obtained when possible, or oral consent if parents were illiterate.
Across town, Abu Abdullahi Madaki can’t be sure if her daughter Firdausi took part in the Pfizer study. Citing privacy concerns, Pfizer has declined to release the names of the 200 children it treated.
All Madaki knows is she took a feverish 8-month-old infant to the hospital in 1996, and now her daughter suffers severe brain damage that left her unable to sit up or talk.
Meningitis – a brain infection – leaves 10 percent to 20 percent of survivors with mental damage, hearing loss, or learning disabilities, according to the World Health Organization.
But Madaki said: “My younger sister had meningitis, but it was nothing like this. My younger sister is now a mother with children.”
Madaki, who is illiterate, said she’d always felt that the hospital did something wrong. She decided when she heard about the charges against Pfizer on the radio that her daughter must have been in the study.
Pfizer says it brought the drug – an antibiotic called Trovan – to Nigeria as a humanitarian effort. Trovan had already been tested on humans in the U.S. It was a tablet, which could be easier to use with children than the standard meningitis treatment – a painful injection.
More than 11,000 children died in Nigeria during the epidemic.
“When this epidemic occurred, the government asked people to come and help them,” said Ngozi Edozien, regional director of the Pfizer branch that covers Nigeria. She said Pfizer wanted to help, but could only offer Trovan through a clinical study because the drug was not yet approved.
Edozien argued that approval to use Trovan to treat epidemic meningitis would not have been a windfall for the company, but for the poor countries that face the disease. She also noted that Pfizer donated medical supplies and equipment to the government to help in the epidemic.
Trovan was approved in the U.S. in 1997 to treat a number of infections, though not for meningitis. It was later pulled from the market because it was shown to cause serious liver damage.
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