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Pfizer is sued over Nigerian drug trials
Bill Condie, Evening Standard1 Oct 2007
Drugs giant Pfizer today faces charges in Nigeria that it used children as guinea pigs for a new drug in 1996, killing 11 and causing others permanent damage.
The company is being sued by the Nigerian government and the northern state of Kano for a total of $9.25 billion (£4.4 billion) in damages. They claim that Pfizer rushed doctors into a crisis zone to use an unproven antibiotic.
Nigeria says the company " unlawfully conducted a clinical trial without obtaining a valid clinical trial certificate". But Pfizer says it answered a call for help to save the lives of African children during a meningitis epidemic.
Ngozi Edozien, managing director of the company in West Africa, said the company brought the experimental drug Trovan to Nigeria in response to an international plea for help.
"There was a compelling reason to look at Trovan because it was an oral formulation, it was known to have shown efficacy in meningitis and was a five-day treatment so it was perfect for an epidemic setting," she said.
The meningitis outbreak killed more than 12,000 children in six months near Kano, a predominantly Muslim metropolis with a history of conflict with the West. Meningitis is an infection of the nervous system that can kill in hours.
The test involved 200 children, half of whom received Trovan while the other half received a proven meningitis treatment-Nigeria alleges Pfizer was responsible-for the deaths of 11 children and permanent health problems for many others. It says it failed to obtain all the required approvals for the test and did not get proper consent from the patients.
It claims Trovan saved lives, and the alleged victims were affected by meningitis, not the drug.
"Pfizer strongly disagrees with any suggestion that the company conducted its study in an inappropriate and unethical manner," the company said in a statement.
Trovan was approved for use in the US in 1997 - but for adults, not children. It was withdrawn two years later because several patients died of liver problems.
The Nigerian claim that, as well as deaths, the drug caused brain damage, paralysis and slurred speech - all neurological side-effects of the type of virulent meningococcal disease that then devastated the region.
Little was known of the drug trials, even in Nigerian government circles, until they were revealed by The Washington Post in 2000.
Following that, Kano and national legal authorities said they were duped over the drug trial.
Nigerian representatives of foreign
drug firms last week took out a newspaper advertisement to defend Pfizer, saying it applied high ethical standards in its operations in the country.
The Nigerian Representatives of Overseas Pharmaceutical Manufacturers said that member organisations "including Pfizer are guided by a commitment to patient safety".
