Panel Faults Pfizer in '96 Clinical Trial In Nigeria

Publications listed Dutse as the lead author of articles on Trovan, but the committee found that depiction "did not sufficiently reflect his role." Dutse indicated he was kept in the dark about the experiment's results and said he did not see at least one publication until the committee showed it to him.

"He was shocked that Pfizer could publish such data without showing him or intimating him with details," the report said, concluding that Dutse was "naive and exploited."

The report quoted Dutse as saying that Pfizer's motive was far from philanthropic.

"I have trusted people and am disappointed," Dutse told the committee. "I regret this whole exercise, I wonder why on earth I did this."

Dutse admitted that he created a letter after the experiment purporting to show that the test had been approved in advance by a Nigerian hospital's ethics committee. He then backdated the letter to March 28, 1996 -- a week before Pfizer's experiment began.

Pfizer used the letter as a key justification for the trial in discussions with reporters and submitted it to the FDA. U.S. regulations require the sponsors of foreign medical research seeking FDA approval to show that the tests have been reviewed in advance by an ethics committee.

The Post previously reported that the hospital had no ethics committee in March 1996 and that the letterhead stationery used was not created until months after the experiment's conclusion.

In a statement last week, Pfizer said that after that article appeared, the company investigated and found that the letter was "incorrect."

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

The former director of Nigeria's version of the FDA said the agency had been unaware of the experiment. He told the panel that he "viewed the conduct of the trial by Pfizer as an act of deception and misuse of privilege."

The report said the treatment of two children during the experiment represented unspecified "serious deviations" from the trial's protocol and concluded that those deviations compromised their care. One was a 10-year-old girl identified only as Patient No. 0069, who was given the experimental antibiotic for three days as her condition deteriorated. She died without receiving any other antibiotic.

Last week, Rep. Tom Lantos of California, the senior Democrat on the International Relations Committee, described the report's findings as "absolutely appalling" and called on Pfizer to open its records.

"I think it borders on the criminal that the large pharmaceutical companies, both here and in Europe, are using these poor, illiterate and uninformed people as guinea pigs," Lantos said.

Lantos said he expected to introduce a bill requiring U.S. researchers to give regulators details of tests they plan in developing countries.

"It's the only ethical thing to do," Lantos said. The bill is similar to one his committee approved in 2001 that did not make it out of the House. "There should be a lot of bipartisan support for it. This outrages people."

The report's findings also breathe new life into a lawsuit against Pfizer, according to Kusel, who represents 30 Nigerian families. "It's great news, I'm very excited," she said when told of the committee's conclusions.

The families sued Pfizer in federal court in New York in 2001, alleging that the company had exposed the children to "cruel, inhuman and degrading treatment."

A U.S. judge dismissed the suit last summer, saying U.S. courts lacked jurisdiction. Kusel is appealing.

"A report like this does not get suppressed without someone high up being involved," she said.