Panel Faults Pfizer in '96 Clinical Trial In Nigeria

A New York City attorney for the families of the children, Elaine Kusel of Milberg Weiss Bershad & Schulman, said her firm had spent years looking for the report, of which they believed there were only three copies. They tracked one to a Nigerian government safe, but it was reported stolen, she said. Another copy was reported to have been held by an official who died.

"It sounds like a mystery novel here, like John le Carré," Kusel said.

The current Nigerian health minister, Eyitayo Lambo, did not respond to calls and e-mail messages from a reporter. Dora Akunyili, director of the Nigerian drug control agency, said she did not know why the report remained confidential but added that her agency had independently concluded that "these people did not have authority to conduct the trial."

Executives at Pfizer, the world's biggest drug company, said they had not seen the report. After reviewing a copy, they responded in a two-page statement:

"The Nigerian government has neither contacted Pfizer about any of the committee's findings nor are we aware that the committee has approved a final report. Therefore it would be inappropriate for the company to respond to specific points in the document.

"However, as we have stated repeatedly over the past several years, Pfizer conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigerian law and Pfizer's abiding commitment to patient safety."

Pfizer said it had previously tested the drug in thousands of patients and found it effective. Local nurses explained the experiment to Nigerian parents, it added, and obtained their "verbal" consent. The company said that Trovan demonstrated the highest survival rate of any treatment at the hospital.

"Trovan unquestionably saved lives, and Pfizer strongly disagrees with any suggestion that the company conducted its study in an unethical manner," the statement said.

At the time of the Nigerian experiment, Pfizer was developing Trovan for release in the United States, where it was expected to gross up to $1 billion a year.

The FDA never approved Trovan for use in treating American children. After being cleared for adult use in 1997, the drug quickly became one of the most prescribed antibiotics in the United States. But Trovan was later associated with reports of liver damage and deaths, leading the FDA to severely restrict its use in 1999. European regulators banned the drug.

After The Post published its report, Nigeria's health minister at the time, Tim Menakaya, appointed a blue-ribbon panel of medical experts to look into Pfizer's actions, saying, "Let me assure you that my ministry will take all necessary steps to obtain details of this incident and make them known to the general public." The committee collected hundreds of documents and interviewed at least 26 people.

Pfizer had told authorities that a Nigerian doctor directed the experiment. The committee, however, found that researchers from Pfizer's U.S. office controlled the trial, and the inexperienced Kano doctor, Abdulhamid Isa Dutse, was the principal investigator "only by name."