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The Real Trovan Tragedy
Reuters reports that a legal case has been filed against Pfizer in the deaths of 11 children during trials of its meningitis drug, Trovan. Pfizer conducted the trials in 1996 in response to an epidemic then taking place in the Nigerian state of Kano. Two hundred children were part of the trial, half receiving Trovan and half the standard treatment. The $8.5 billion lawsuit alleges that Pfizer failed to get proper approvals and informed consent for the study, charges the company denies. Both the Kano state government and the Nigerian federal government have brought civil and criminal charges. After the Kano trial the U.S. Food and Drug Administration licensed Trovan for use in adults, later imposing strict controls due to evidence of liver damage.
Kano is part of an intensely Islamic region that has previously been in the news for hindering the dissemination of polio vaccine in 2003, which is widely thought to have triggered an epidemic in Nigeria, India and other countries that had been polio-free.
Regardless of the legal outcome, the fallout from the controversy could discourage drug companies that wish to be good citizens in response to future epidemics in the developing world. Merck’s donations of its medication for river blindness in Sub-Saharan Africa are widely credited as a model of corporate responsibility, but clinical trials are inherently complex activities that often raise a host of suspicions wherever they take place, even if the experimental medication in question is not likely to be profitable because of the nature of the potential market. Thus the real tragedy of the Trovan case in Kano is the damage done to international cooperation in the fight against dread diseases.
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