Pfizer, the world’s largest pharmaceutical company, used an antibiotic on Nigerian children and infants suffering from meningitis, but without their parents’ informed written consent. Approximately six children died, and all children given the study drug were left with one or more disabilities, such as blindness, paralysis, or deafness. Pfizer removed themselves and all patient medical records, suggesting that they were covering their tracks, before the study was completed.

The drug had not been FDA-approved for use in children in the United States but was cleared for adults and was already banned in Europe. The Pfizer trial in Nigeria was not regulated nor was it enforced to adhere to the same guidelines set forth by the FDA, hospital, research facility and/or pharmaceutical companies who conduct clinical trials in the United States. There was no regulatory commission, such as the Institutional Review Board (IRB).

An IRB is a committee comprised of physicians, statisticians, researchers and research nurses, patient advocates, and data coordinators, all of whom ensure that the ethics of the clinical trial, and the rights of the participants are protected throughout the study. Every institution that supports a clinical trial involving a human participant must have an IRB at the initiation of the study, and also to periodically review the research data to protect the rights of the participants. This is federal law.

Pfizer has conducted clinical trials in the United States and in other countries. They know the rules. Do no harm is the code in health care. In the United States, during a clinical trial, if a participant experiences any toxicities from the study drug, the research doctor and/or treating doctor is mandated by the protocol guidelines to remove the patient from the study and return the patient to the treatment of standard care. Pfizer had full knowledge of the life threatening effects this particular antibiotic posed to children, and the risks it took administering it to children and infants because this drug had never been used on children with meningitis. Pfizer never told their parents that an alternative treatment was available to the children, nor did they explain to the parents what the side effects were, thereby never obtaining an informed written consent. There is no excuse for what Pfizer did to these innocent children, their parents, and the Nigerian government. Pfizer should be held accountable for its unethical and criminal negligence.

The lawsuit says that the researchers did not obtain consent from the children’s families and that the researchers knew Trovan to be an experimental drug with life-threatening side effects that was unfit for human use. Parents were banned from the ward where the drug trial occurred, the suit says, and the company left no medical records in Nigeria. Pfizer and its doctors agreed to do an illegal act, the criminal charges state, and behaved in a manner so rash and negligent as to endanger human life. Joe Stephens, Washington Post