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Pfizer Facing 4 Court Cases in Nigeria
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.
  Anas Mustapha foreground who was one of the children tested with the meningitis epidemic experimental drug and now suffering brain damage stands near the entrance of their house in Kano, Nigeria Thursday, July 19, 2007 New York-based Pfizer is facing four court cases two filed by the federal government , two by the state in Nigeria over a decade-old drug trial in the northern Muslim city of Kano. It is accused of using a 1996 meningitis epidemic to push through a sloppily managed study without the full understanding of the parents or the proper regulatory approval. AP Photo/George Osodi) (George Osodi - AP) |
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.
Death rates were similar among the 100 children taking Trovan and the 100 Pfizer gave the standard meningitis treatment. Five of the Trovan subjects died, compared with six in the control group -- rates comparable to those of Western hospitals, according to Pfizer.
Still, families and the government argue that Pfizer kept some children on Trovan even though their condition was worsening, that the doses of the standard treatment should have been higher and that dubious procedures used in pushing the experiment through mean Pfizer should be held accountable for any future health problems in those it treated.
It's hard to know if truly "informed consent" is possible during a health care crisis among a widely uneducated, isolated population.
"If you're sick and trying to get health care and somebody says to you, 'Do you want to be in a research study?' If somebody is not familiar with the idea of a research study, it becomes more difficult for them to evaluate," says Benjamin Wilfond, head of Seattle's Treuman Katz Center For Pediatric Bioethics.
But if the people of Kano were uninformed, it's not just a U.S. drug company that's to blame. Lawyers for the study families say the government failed to guard its citizens.
