Nigerian Committee Criticizes Pfizer's 1996 Study of Trovan

The Washington Post reported on an investigation by a Nigerian committee on a drug trial done by Pfizer Inc. in that country in 1996. The trial was of the drug trovafloxacin (Trovan), an antibiotic whose the US Food and Drug Administration has recommended be restricted to patients with severe infections because of its high risk of liver toxicity.
The issues were:

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.
Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans.
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.'
The panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records documenting that Pfizer told the children or their parents that they were part of an experiment, it said.
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.
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.
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.
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's response was,

Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans. The committee rejected that explanation, pointing out that Pfizer physicians completed their trial and left while 'the epidemic was still raging.'
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.'

Why it took so long for this report to be made public is unclear.

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.
Aspects of the affair remain mysterious, such as why the report remains confidential. The head of the investigative panel, Abdulsalami Nasidi, said in a brief telephone conversation from Nigeria, 'I don't really know myself' why the report was never released.
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.'

It sounds like Pfizer CEO Hank McKinnell (see related post here) has another big issue to deal with, albeit retrospectively. This story sounds another warning that physicians and patients need to be skeptical about how clinical research sponsored by commercial firms was actually implemented.
The Post further reported,

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

Maybe that would help, but problems with implementation of clinical research have obviously also occured in developed countries. (Some recent cases mentioned on Health Care Renewal were those of the US based study of telithromycin [Ketek], and the TGN 1412 calamity in the UK.)