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Nigerian Report Finds Violations in 1996 Pfizer Trial

An unreleased report by a panel of Nigerian experts says that the U.S. drug manufacturer, Pfizer, violated international and Nigerian law when it conducted a study of an experimental drug to treat meningitis in children a decade ago in Nigeria.

The report sharply criticizes how Pfizer went about testing, in 1996, a drug that was at that time unapproved. The drug, Trovan, was tested on children suffering from a deadly strain of meningitis in the northern Nigerian state of Kano.

The confidential report, recently obtained by The Washington Post, was written by a panel of medical experts appointed by Nigerian government to investigate the circumstances of the tests conducted by Pfizer. However, though the tests took place in 1996, the panel was not created until more than four years later, after The Washington Post newspaper published a series of articles on pharmaceutical trials conducted abroad.

Staff reporter Joe Stephens wrote the original series for the Post in 2000 and the recent story about the unreleased report by the Nigerian medical experts.

"They said that the drug trial was not properly approved by Nigerian authorities, that there was no paperwork that could prove that the children or their families were told that they were part of a medical experiment," said Stephens. "And they said that the doctor who ran the experiment admitted that an ethics committee approval letter had been concocted and back dated long after the trial was over and it made to look as though an ethics committee had approved the trial ahead of time."

Out of nearly 100 children and infants who were treated with Trovan during the trial, five died and several others suffered complications after taking the antibiotic. But it is not clear that Trovan was directly responsible for the deaths of the five children. Six others died after taking a comparison drug.

Pfizer told Nigerian authorities investigating the 1996 tests that a Nigerian doctor, Abdulhamid Dutse, ran the Trovan experiment in Kano, but the report says otherwise.

"The committee determined he was not in charge. That actually it was Pfizer physicians who flew in from the United States who were in charge," said Joe Stephens of The Washington Post. "And that, in fact, Dr. Dutse had not kept the results, did not know the results for a long time to the experiment, had nothing to do with putting together the plan or the protocol. Dr. Dutse also acknowledged under questioning by the committee that he had personally falsified this medical ethics committee document when he had been asked for it much later by Pfizer."

Dr. Dutse spoke with VOA's Hausa service. He said during the experiment, he did the work he was assigned to do. Dr. Dutse also told VOA he was not in charge of the 1996 Trovan study. He said, initially, he believed that Trovan was a good drug that would help Nigerian children who had become sick during the meningitis epidemic based on evidence he says Pfizer officials showed him regarding what they claimed were previously successful trials of Trovan on children.

Pfizer Incorporated has denied repeatedly any wrongdoing in the 1996 clinical trial, although recently it has admitted the Nigerian ethics committee approval letter was written after the trial began and back dated.

Pfizer would not agree to several requests for an interview with VOA. It has released a written statement, saying the company "conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigeria law and Pfizer's abiding commitment to patient safety."

The company statement goes on to say that, without question, Trovan saved lives and that it showed the highest survival rate of any other treatment given at the Kano hospital.

Though the drug remains available in the United States, it use is strictly limited. Washington Post reporter Joe Stephens points out that Trovan was never approved for use by children in the United States or anywhere else.

"But it was approved for adults in the U.S. and in Europe and it quickly became a major seller. But then was associated with liver damage and some deaths. It has now been severely restricted in the U.S. and it has been banned entirely in the EU [European Union]. "

Families of several Nigerian children who took part in the 1996 clinical trial who died or were disabled have filed suit in the United States accusing Pfizer of not fully informing them of the risks associated with the drug. The case has been dismissed on grounds that only Nigeria has jurisdiction over the matter. Lawyers representing the families are appealing the 2005 ruling.

Meanwhile, the controversy around the trial and the now public contents of the Nigerian panel's report have gotten the attention of U.S. lawmakers, including California Congressman Tom Lantos. He is planning to introduce legislation tightening regulations on companies that conduct clinical drug trials in developing nations.