The Business Ethics Blog

Panel Faults Pfizer in ’96 Clinical Trial In Nigeria: Unapproved Drug Tested on Children (by The Washington Post’s Joe Stephens)

A panel of Nigerian medical experts has concluded that Pfizer Inc. violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital.

That finding is detailed in a lengthy Nigerian government report that has remained unreleased for five years, despite inquiries from the children’s attorneys and from the media. The Washington Post recently obtained a copy of the confidential report, which is attracting congressional interest. It was provided by a source who asked to remain anonymous because of personal safety concerns.

The report concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants. 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. At the time, Doctors Without Borders was dispensing approved antibiotics at the hospital.

Pfizer’s experiment was “an illegal trial of an unregistered drug,” the Nigerian panel concluded, and a “clear case of exploitation of the ignorant.”

Pfizer says it did nothing wrong. Regarding an apparently falsified letter of approval from a hospital ethics committee, Pfizer states:

“Obviously this should not have occurred and the company very much regrets that it did,” …. “It is important to point out, though, that Pfizer thought proper procedure had been followed at the time of the clinical study.”

This raises important issues about the background conditions and infrastructure in developing nations, the backdrop against which corporate activities are carried out. There are lots of safeguards built into the background, institutions, social conventions, etc. in developed nations, that add several layers of relative safety to clinical trials conducted here. Developed nations, for example, tend to have stable institutions (local and central), educated populations, and a plethora of watchful consumer- and patient-rights groups. Not all places are so fortunate.

Nigeria, for example, scores prett badly on the Fund for Peace’sFailed States Index 2006. The Index ranks Nigeria as #22 (i.e., the 22nd WORST nation-state on earth). This might suggest that companies doing business (or conducting research) in places like Nigeria bear an additional burden, additional responsibilities, and should realize that they cannot simply assume that local safeguards are adequate.