Month: May 2007

Nigerian authorities slapped criminal charges on Pfizer this month, alleging that the company’s infamous 1996 botched antibiotic trial there was “rash and negligent,” and endangered lives.
Some of the subjects in the trial died, others suffered permanent disability, and the prosecutors say it’s Pfizer’s fault for providing a too-low dose of its comparator drug. (Listen to stories on NPR and ABC Australia, which feature a few quotes from me, for details.)
That’s a medical question on which the experts are not unanimous. Kids die from meningitis and are permanently disabled by it, too.
Less debatable is the fact that Pfizer violated international ethics standards and their subjects’ human rights. In a separate class-action suit against the company, the subjects said that they didn’t know they were in an experiment, and the company did not produce signed informed consent forms. The ethics committee “approval” the company produced later turned out to have been backdated.
This is the first time a state has filed criminal charges against a drug company, but I doubt it will be the last. With 80 percent of clinical trials failing to meet recruitment deadlines in the West, major drug companies are today conducting half or more of their trials outside the major markets, often in countries–like Nigeria–with poor human rights records and weak regulatory infrastructures. Pfizer’s Nigeria trial is unusually sensational and high profile, but its bending of the rules may be more the rule than the exception.