Nigerians Sue Pfizer in US over Fatal Drug Trials

by Jerome Hule
August 30, 2001

Thirty Nigerian families have filed a lawsuit in New York against drug maker, Pfizer for the unethical conduct of clinical tests of an antibiotic drug on children infected with meningitis in Kano in 1996.

The New York Times reported Thursday that the plaintiffs allege that the American pharmaceutical company carried out the medical experimentation on the children without their consent.

A New York law firm, Milberg Weiss Bershad Hynes & Lerach filed the lawsuit on their behalf.

During a meningitis epidemic in Kano in 1996, Pfizer dispatched a research team to Nigeria that treated 100 Nigerian children with the antibiotic "Trovan," as part of its effort to meet the requirements for the approval of the drug by the US Food and Drug Administration.

A total of 11 children involved in the trial died while others suffered brain damage, were paralyzed, or became deaf.

The Washington Post did an investigation of the trials and published reports on it last year.

The suit alleges that Pfizer never received needed approvals to conduct the research.

When the Food and Drug Administration asked for documents as it began review of the trials, Pfizer produced a letter dated 28 March 1996 from the Infectious Disease Hospital, Kano, saying the study had been approved by the hospital's ethics committee.

The suit, however, contends that the letter was written a year later and backdated and that at the time of the trial, the hospital had neither an ethics committee nor the letterhead on which it was written.

Trovan was introduced in the market in 1998, but it became associated with liver damage. The Food and Drug Administration recommended that it be used only in severely ill patients in institutional settings. The drug was never approved for use in children.

The suit alleges that while carrying out the trials, Pfizer neither informed the families of the children that there was alternative treatment, nor performed tests to ensure that the children had the bacteria meningitis.

Pfizer also failed to modify treatment for children who did not improve after initial trials, the plaintiffs said.

In an indication that the company knew it was doing something wrong, the suit alleges that Pfizer fired its infectious disease specialist, Dr. Juan Walterspiel after he had repeatedly warned management that the company was violating international law, US federal regulations and medical ethics.

The New York Times said a lawyer from the US firm that filed the lawsuit, Elaine Kusel, was in Nigeria in the second quarter of the year to investigate the case.

The suit, brought under the Alien Tort Claims Act, is seeking damages and continuing medical care for those who took part in the trial.

Pfizer spokeswoman, Vanessa McGowan said Wednesday that the company had not seen the lawsuit.

The Times indicated that this is the first suit in the US seeking damages from a US pharmaceutical company for medical experimentation on foreign citizens.

In the wake of reports of unproved drug trials by US companies in foreign countries, the International Relations Committee of the US House of Representatives approved early August a measure that would bar US researchers from shipping experimental medicine abroad without approval by American regulators.

This suit in the US is additional to ones already filed against Pfizer in Nigeria.

Reference:
PanAfrican News Agency