·   Log in

Trovan vaccine clinical trial victims in Kano to get N26,250,000 for death, injury from Pfizer

Tagged with: , ,
Thursday, January 28, 2010, 20:25 This news item was posted in Clinical Trials, Legal category and has 0 Comments so far.

World’s top drug maker Pfizer will compensate the victims of unethical clinical trial in the African state of Kano using its menigitis vaccine Trovan with not less than N26, 250, 000 (Naira, nigerian currency) per person, reports said.

N26, 250, 000 is 173,944.74 USD per person.

Pfizer has agreed to pay N26, 250, 000 to patients who can prove death or permanent incapacitation following the administration of the Pfizer’s Trovan vaccines in 2006.

Nearly 200 people in Kano state are expected to be compensated by Pfizer.

However, 600 applications were submitted by kano citizens claiming from injury from Trovan vaccine trials 600 applications by Kano citizens, said the Meningitis Trust Fund, a body set up to carry out the compensation exercise on behalf of Pfizer.

Pfizer’s clinical study involved 200 patients with severe cases of cerebro-spinal meningitis (CSM).

In the trial one hundred of patients were treated with ceftriaxone, the gold standard drug in use while 100 others were administered the intravenous Trovan.

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

Kano State initiated series of court cases both civil and criminal challenges Pfizer test on the people.

Following several years of negotiations involving prominent Nigerians, the parties agreed to settle out of court.

Under the terms of the settlement Pfizer and Kano State established a Healthcare/Meningitis Fund from which the study participants can receive financial support.

The agreement has also underwritten several healthcare initiatives chosen by the Kano State government that benefit the people of Kano State, totaling US$30 million over a period of two years.

Pfizer will also reimburse Kano State for US$10 million in legal costs associated with the litigation.

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.

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.

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.

Scroll down to comment on this story
You can leave a response, or trackback from your own site.

Leave a Reply