Was African Trovan Study Ethical?
May 14, 2001
Pfizer Pharmaceutical's 1996 drug experiment investigating the effectiveness of its new antibiotic Trovan on sick Nigerian children may not have received appropriate approvals by Nigerian medical officials. A Nigerian doctor in charge of the Trovan drug trial recently admitted that he backdated government approvals in order to help Pfizer satisfy American regulators.
Before any experimental drugs may be administered in Nigeria, the Nigerian government requires that research procedures meet certain ethical standards. Apparently Pfizer did not receive the Nigerian government's approval prior to beginning its experiment on Nigerian children suffering from meningitis. When American drug regulators sought proof of the Nigerian government's approval of the Trovan project, Dr. Abdulhamid Isa Dutse agreed to backdate such approval, perhaps up to a year after it was due. Pfizer spokesman Andy McCormick said that he was unaware of any irregularities in the Nigerian study, but that the company would look into it.
In 1996 Pfizer researchers realized that the Nigerian meningitis outbreak was the perfect testing ground for the company's experimental antibiotic Trovan. Dr. Dutse's backdated letter was submitted to the FDA after the agency conducted an audit of Pfizer's Trovan experiment. Sadiq S. Wali, medical director of the Nigerian hospital where the Trovan study took place, confirmed that the approval letter was indeed fabricated. According to Wali, the hospital did not even have an ethics oversight board as of the date of the letter.
According to Dr. Dutse, he signed and backdated the approval letter because he felt that it reflected the tacit approval he assumed was given by Nigerian officials at the time the experiment took place. One of the doctors that Dr. Dutse claims gave such tacit approval was Dr. Idris Mohammed. However, Dr. Mohammed says that no approval, explicit, tacit, or otherwise, was ever given by Nigerian officials. In fact, Dr. Mohammed said that he was concerned with the conduct of the Trovan experiment from the start. "You shouldn't try an experiment in an epidemic," said Mohammed, "You needed to give these patients something that was proven." Dr. Mohammed's comments echo those of other health officials familiar with the Trovan study. While Pfizer certainly may have gained valuable information from using Trovan on young meningitis victims, it may have placed many lives needlessly at risk. Experts say that many tried and true medications could have been used to treat these victims.
Pfizer tries to portray the Nigerian Trovan study as a humanitarian medical mission. Other charitable groups assembled to fight the epidemic challenge Pfizer's stance. These groups, including the international organization Doctors Without Walls, used proven medical techniques to treat the victims. Many observers criticize Pfizer for giving sick children an oral dose of Trovan rather than the faster acting intravenous version. The Nigerian government vows to investigate the controversy further.
-- Article Courtesy of InjuryBoard.com
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