Author George Annas, chair of the department of health law, bioethics and human rights at the Boston University School of Public Health in the US, says that concerns about informed consent as well as wider fears over the ethics of clinical trials conducted in developing countries have been growing for several decades.
He suggests that the Food and Drug Administration’s (FDA) 2008 decision that trials must follow its guidelines for good clinical practice rather than the Declaration of Helsinki, which updated guidelines set out by the Nuremberg Code in 1946, has done little to improve matters.
Pfizer and Trovan
The study cites the ongoing controversy over Pfizer’s trial of its meningitis drug Trovan (trovafloxacin) in Nigeria in 1996 as an example of why some form of international ethical trial code is needed.
Annas explains that Pfizer had successfully argued that since no international requirement for its physicians to gain informed consent exists it was not liable to lawsuits brought by the families of children who were allegedly injured by the drug during the trial.
While this argument was defeated in 2006 when Nigerian authorities ruled the trial had breached the country’s laws and more recently when the US Court of Appeals decided that Pfizer can be tried in the US, the authors argue that international legal clarification is needed.
Pfizer maintains its innocence and suits brought against the firm in the US since the Appeals court decision have not yet been heard.
Annas goes on to pose the following open question: “What is the legal status of the Nuremberg Code and the Declaration of Helsinki? Are they outdated ethical rules that researchers can ignore with impunity? Or have they arrived at the status of international human rights law that must be followed?”
The full NEMJ article can be found here.