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Thursday, 30 August, 2001, 22:49 GMT 23:49 UK
Nigerians sue Pfizer over test deaths
Nigerian market place
Pfizer tested Trovan in Nigeria in 1996
A group of Nigerian families has sued the drugs giant Pfizer following the deaths of 11 children and injury to others who are said to have taken part in tests of a drug to treat meningitis.

The group argues that the tests of Trovan, an antibiotic, were the cause of the deaths and injuries.

Pfizer denied the accusation.

In a statement, the drugs company said it was "proud of the way the study was conducted".

The lawsuit, filed in a US District Court on Wednesday, seeks unspecified damages on behalf of 30 children who took part in trials in Kano, in northern Nigeria.

The suit alleges that the drug company did not obtain consent and did not explain that the proposed treatment was experimental.

Pfizer said in a statement that it had received the approval of both the Nigerian government and the families of the treated patients.

It is further alleged that Pfizer representatives travelled to Kano to test the experimental drug in the impoverished region of Nigeria.

"But rather than making the trip to provide humanitarian relief, as charitable organisations were doing, Pfizer hurried to Kano to exploit the misfortune there for its own benefit," the suit alleges.

Pfizer, which already faces two class-action lawsuits and a government investigation in Nigeria over the Trovan trials, said it would not comment on the substance of the suit because it had not seen the document.

When the allegations first surfaced, Pfizer had said that the number of deaths in the trial was lower than the overall fatality rate for the meningitis epidemic.

The company stressed the trial was not an attempt to gather clinical data, but an effort to help sick children in a poor region of Nigeria.

Trial trail

At issue are tests which were carried out during the 1996 epidemics of bacterial meningitis, measles and cholera in Nigeria.

More than 15,000 people died during the epidemics.

In December last year, Pfizer issued a press release saying the results from the study "benefited the majority of the children" who participated.

But in March, a Kano federal high court ruled that parents of children treated with Trovan could sue Pfizer for administering the vaccine without their prior consent.

Trovan, also known as Trovafloxacin, was approved by the US Food and Drug Administration (FDA) in 1997 to treat a broad range of infections, but its use was severely restricted in 1999 after being linked to several cases of liver failure.

Test results

The 30 families represent just some of the 200 children who to part in the tests.

The suit alleges the drug was given in a form never before tested on humans and which was known to have life-threatening side effects.

Other children in the test group were given low doses of a control drug known to be an effective meningitis treatment and approved by the FDA. The suit alleges that the low dosages resulted in six deaths among the control group.

The families say the results from the control group allowed Pfizer to claim Trovan was effective, possibly more so than other drugs on the market.

It further alleges that Pfizer did not tell parents they were free to refuse the drug and instead choose an internationally approved treatment for meningitis being offered at the same site free of charge by a charitable medical group.

Kate Robbins, Pfizer
"Every drug comes with its risks"
Jean-Michel Piedagnel, Medecins Sans Frontieres
"As far as meningitis was concerned there was an existing way to cure people"
See also:

14 Mar 01 | Africa
Nigeria's drug trial fears
07 Feb 00 | Business
Drugs giants merge
23 Mar 01 | Business
Health brings wealth
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