Thursday, August 30, 2001

Under the Nuremberg Code of 1947 and the World Medical Associations Declaration of Helsinki, those seeking to conduct medical tests on human subjects must explain the purpose, risks and methods of the study and obtain each subject's voluntary consent to participate.



Families Sue Pfizer on Test of Antibiotic
During a meningitis epidemic in 1996, Pfizer treated 100 Nigerian children with the antibiotic Trovan as part of its effort to determine whether the drug, which had never been tested in children, would be an effective treatment for the disease. Pfizer treated 100 other children with ceftriaxone, the gold standard for meningitis treatment, but, the suit says, at a lower-than- recommended dose. Eleven children in the trial died, and others suffered brain damage, were partly paralyzed or became deaf.

Vanessa McGowan, a spokeswoman for Pfizer, said yesterday that the company had not yet seen the suit, which was filed in Federal District Court in Manhattan, and could not comment on the allegations. In the past, Pfizer has said that the number of deaths in the Nigerian Trovan trial was lower than the overall fatality rate for the meningitis epidemic and that the trial had been a philanthropic effort that benefited most of the sick children, not a self-serving effort to obtain quick clinical data, as the suit contends.

In early 1996, within weeks of learning about the meningitis epidemic from an Internet site, Pfizer, the world's largest pharmaceutical company, sent a six-member research team to the Infectious Disease Hospital in Kano, Nigeria, a strife- torn city suffering concurrent epidemics of bacterial meningitis, measles and cholera. The Pfizer team selected children for its test from the long lines of ailing people seeking care at the hospital.
"Pfizer took the opportunity presented by the chaos caused by the civil and medical crises in Kano to accomplish what the company could not do elsewhere — to quickly conduct on young children a test of the potentially dangerous antibiotic Trovan," said the suit, which was filed yesterday by Milberg Weiss Bershad Hynes & Lerach, a New York law firm that specializes in representing groups of plaintiffs against large corporations.

Pfizer conducted the trial at the same hospital where Doctors Without Borders, the Nobel Prize-winning relief organization, was already providing free treatment with chloramphenicol, the cheaper antibiotic that is internationally recommended for treating bacterial meningitis.

"Rather than provide the children with a safe, effective and proven therapy for bacterial meningitis," the suit said, "Pfizer chose to select children to participate in a medical experiment of a new, untested and unproven drug without first obtaining their informed consent, or explaining to the children or their parents that the proposed treatment was experimental and that they were free to refuse it and instead choose the safe, effective treatment for bacterial meningitis offered at the same site, free of charge, by a charitable medical group."
http://www.nytimes.com/2001/08/30/business/30DRUG.html?pagewanted=all

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