This Day (Lagos)
8 October 2007
A federal court in Abuja, is scheduled to convene today, in a case brought by
Pfizer, charging that a report on which the Nigerian government has based many
of its claims in litigation against the company is illegal, inaccurate, and
should be quashed.
The lawsuit states that in 2001, the Nigerian Ministry of Health constituted an investigative committee to look into Pfizer's 1996 Trovan clinical study. The resulting report was never made public until a prominent U.S. newspaper reported excerpts from it in 2006.
The complaint points out that to date, "the Federal Government of Nigeria has not accepted the Report, considered the Report in the Federal Executive Council, or issued a white paper on the basis of the said Report."
The lawsuit also states that the committee "acted in excess of its powers," as its job was mere fact-finding and it lacked authority to impose any punishment.
Moreover, the complaint alleges that proceedings of the committee and the Report were in utter violation of and total disregard of the Applicants rights to Fair Hearing.
"In its Statement of Defence in the Kano State civil case - filed on July 16, 2007 - Pfizer maintains that before conducting the Trovan study, the company sought and obtained all necessary approvals from relevant federal and state government agencies in Nigeria."
"In that regard, Pfizer has at least 12 letters between the company and the U.S. FDA, as well as Nigeria's NAFDAC among other Ministry of Health and Ministry of Finance, discussing and approving the study. Pfizer also states that the results of the study plainly proved that Trovan helped save lives. With a survival rate of 94.4 per cent, Trovan was at least as effective as the best treatment available at Kano's IDH. The overall survival rate in Nigeria was less than 90 per cent.Pfizer's Statement of Defense also asserts that at Kano's IDH, parents or guardians of potential study participants were explained the details of the trial, including that participation was voluntary; that local Nigerian nurses explained orally to patients' parents and/or guardians in Hausa the details of the study; that oral consent (as indicated in the approved study protocol) was obtained before any patient was admitted into the study; and that at no point were the parents or guardians separated from the children.
Pfizer also contends that patients in the Trovan study were confirmed to have symptoms of meningitis before they were treated and that advanced meningitis could lead to brain damage, hearing loss, mental retardation, paralysis, seizures, coma and death. All clinical evidence points to the fact that any deaths occurring during the Trovan study were the direct result of the illness and not the treatment provided to patients. The company highlights the fact that survivors of meningitis could suffer these long-term complications and that these complications have been unjustly and erroneously attributed to the Trovan clinical trial and the associated medications.
http://allafrica.com/stories/200710080570.html