Pfizer to settle Trovan unethical trial case in Kano for $75 m out of court

The unethical Kano trial killed 11 children, and disabled dozens. Trovan is banned in Europe and recalled in US.

World’s largest drug maker Pfizer Inc has reportedly agreed for an out-of-court settlement in a multi-billion-dollar lawsuit over a 1996 Trovan  with Nigeria’s Kano state.

Structure of Trovafloxacin

The meningitis drug Trovan (trovafloxacin) killed 11 children and left dozens disabled said authorities in Kano, a north African state which sued Pfizer in May 2007 for $2 billion in damages.

Nigeria’s federal government also sued Pfizer for $7 billion in 2007, but this case could be dropped as a result of the new settlement, reports said.

Pfizer has apparently agreed to pay tens of millions of dollars to settle a lawsuit over a drug trial it ran in Nigeria.

That the settlement would come to near $75 million, with $30 million going to Kano state, $35 million to victims and $10 million going on legal fees.

Nigeria’s federal government also sued Pfizer for $7 billion in 2007 over the Trovan trial, although it is expected to withdraw the suit if the Kano case is settled.

Pfizer had proposed to pay $10 million in compensation, rehabilitate the hospital where the Trovan study took place, and upgrade Kano’s state-owned drug manufacturing company, sources said.

The “unethical’’ Trovan trial in Kano

It was 1996 that Pfizer turned up in Nigeria for a human trial for what it hoped would be a pharmaceutical “blockbuster”, a broad spectrum antibiotic that could be taken in tablet form. Pfizer sent a team of its doctors into the Nigerian slum city of Kano in the midst of an appalling meningitis break-out. Ultimately, it turned out that Pfizer was conducting an unlicensed medical trial on critically-ill children under the guise of  a “humanitarian mission”.

Pfizer’s team of doctors reached the Nigerian camp as soon as the outbreak, which killed at least 11,000 people, starting taking lives. They settled near a medical station run by the aid group Médecins Sans Frontières, which was dispensing proven treatments to ease the epidemic.

Pfizer picked 200 sick children from the crowd that had gathered at the Kano Infectious Diseases Hospital. Half of them were given doses of the experimental drug Trovan and the others were treated with a proven antibiotic from a rival company.

As soon as Trovan was administered eleven of the children died and many more later suffered serious side-effects ranging from organ failure to brain damage, it is alleged.

According to reports, the Pfizer team packed up after two weeks and left. Meanwhile, meningitis, cholera and measles were still raging and crowds still queueing at the fence of the camp.

However, after 18 months of the trial a Pfizer employee, Juan Walterspiel wrote a letter to the then chief executive of the company, William Steere, saying that the trial had “violated ethical rules”. Mr Walterspiel was instantly fired a day later for reasons “unrelated” to the letter, according toPfizer.

Pfizer claimed only five children died after taking Trovan and six died after receiving injections of the certified drug Rocephin. The pharmaceutical giant says it was the meningitis that harmed the children and not their drug trial.

At stake at one point last year was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff.

Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.