Monday, May 08, 2006

Pfizer broke law with'96 drug trial, Nigeria finds


Nigerian medical experts have concluded that Pfizer Inc. violated international law during a 1996 epidemic when the company tested an unapproved drug on children with brain infections, The Washington Post reported.

A Nigerian government report on the panel findings that was never released was recently obtained by the Post. The report was provided by a source who asked to remain anonymous because of personal safety concerns, the newspaper reported yesterday.

The Infectious Diseases Hospital in Kano, Nigeria, was treating meningitis patients in 1996 when Pfizer administered the experimental drug Trovan to children.

Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants, the panel's report concludes. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis.

The panel concluded the experiment violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child.

The panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records showing that Pfizer told the children or their parents that they were part of an experiment, the Post reported.

Five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evi dence the drug played a part. Six children died while taking a comparison drug, the newspaper said.

Pfizer pointed to its earlier statements on the matter, while declining to respond to specific points in the panel report. Pfizer said it acted responsibly.

My comment: One of the reasons I do what I do.