But what happens when the willing participants are helpless infants stricken with Bacterial Meningitis? Who is responsible for giving informed consent for 233 children to be administered drugs that ultimately cause the death of 196 of them? Is it the parents’ liability for giving informed consent or the fault of the pharmaceutical company that conducted the trial?
These questions are soon to be answered as Nigeria has brought their 7 billion dollar lawsuit against Pfizer for clinical trials that they conducted in April of 1996. Of the 233 children that were administered the drug, Trovan, 196 died and 37 children survived only to face conditions such as brain damage, total deafness, the inability to speak, paralysis, and many more life altering issues.
In fact, Trovan has gained approval by the FDA for use in patients in the United States, except it is not to be used in children. Of course all clinical trials have risks and by law these risks are to be made public to those participating in the study. The trouble rests in the fact that the parents of the children who were involved in the study state that they were never warned of adverse reactions that their children could suffer.
Some of the other issues at stake are whether or not the trial was conducted in a legal manner. By law, written consent is to be given by any parent who is allowing their child to participate in a clinical trial. According to Pfizer, the majority of the parents whose children were administered Trovan, were illiterate and therefore couldn’t give written permission.
The case is scheduled to continue on June 26, 2007 and will attract media and global attention. Pfizer states that they had the clearance of the Nigerian government to conduct their trials. Though there are many speculations that the Nigerian government did not authorize or approve the trial making the administration of Trovan illegal, the focus will be on the proceedings to hear the evidence and weigh the facts.
