In what is reportedly the first such legal action in the United States, 30 families from Nigeria are suing the US based drug manufacturer Pfizer Pharmaceuticals in a federal court in New York for allegedly carrying out medical experiments on the children of foreign citizens without consent.
The move marks the latest development in a long saga about whether Pfizer used a new drug without official approval during a meningitis epidemic in Nigeria five years ago. An inquiry was set up by the Nigerian health minister, Tim Menakaya, in January this year into the allegations (BMJ 2001;322:194).
According to the suit, during a meningitis epidemic in 1996 Pfizer treated 100 children at the Infectious Diseases Hospital in Kano, Nigeria, with its antibiotic trovafloxacin (Trovan) as part of an effort to determine if the drug would be effective against bacterial meningitis.
Members of the company's research team gave another 100 children ceftriaxone—an accepted drug for meningitis—but in lower than recommended doses. Eleven of the children died, and others developed brain damage, partial paralysis, or deafness, the suit said.
The suit alleges that “Pfizer took the opportunity presented by the chaos … 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.”
It continues: “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.”
The relief organisation, Médecins Sans Frontières, was already providing free treatment at the hospital with the antibiotic chloramphenicol, an internationally accepted treatment for bacterial meningitis, the suit pointed out.
The Nuremberg Code of 1947 and the World Medical Association's Declaration of Helsinki stipulate that researchers seeking to conduct medical tests on humans must explain the purpose of the tests, the methods to be used, and the risks involved and must obtain their subjects' voluntary consent.
The suit notes that Dr Juan Walterspeil, an specialist in infectious diseases who was assigned to the test, repeatedly warned Pfizer that it was violating international laws, federal regulations, and medical ethics. Dr Walterspeil was subsequently fired.
A spokesman for Pfizer Limited said: “The Trovan study in Kano, Nigeria, was an important clinical investigation, and Pfizer is proud of the way the study was conducted, in the midst of a deadly meningococcal meningitis epidemic in Nigeria. The study was well conceived, well executed and saved lives.
“The study was conducted with approval of the Nigeria federal and state governments and with consent from the families of treated patients.
“The study was part of a broad series of studies of Trovan for the treatment of many serious infections. Results showed that Trovan was as effective as ceftriaxone, proven to be a highly effective treatment for meningococcal meningitis.
“Fatality rates in the Kano study, approximately 6% for both Trovan and ceftriaxone, were lower than published results for other forms of treatment in this epidemic.”