The world's biggest research-based pharmaceutical company announced on Thursday that it had made payments of $175,000 (£108,000) to each family. More such compensation settlements are expected to follow.
Pfizer was sued after 11 children died in a clinical trial when the northern state of Kano was hit by Africa's worst ever meningitis epidemic in 1996. A hundred children were given an experimental oral antibiotic called Trovan, while a further hundred received ceftriaxone, the "gold-standard" treatment of modern medicine.
Five children died on Trovan and six on ceftriaxone. But later it was claimed that Pfizer did not have proper consent from parents to use an experimental drug on their children and questions were raised over the documentation of the trial.
Legal action filed against the company alleged that some received a dose lower than recommended, leaving many children with brain damage, paralysis or slurred speech.
US-based Pfizer had argued that meningitis and not its antibiotic had led to the deaths of 11 children and harm to dozens of others. But in 2009 it reached a tentative out-of-court settlement with the Kano state government worth $75m.
The families of four of the children each collected cheques for $175,000 from a compensation trust fund, after submitting DNA samples to show that the dead were their offspring.
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.
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.
Abdullahi v. Pfizer, Inc.
From Wikipedia, the free encyclopedia
The Kano trovafloxacin trial litigation arose out of a clinical trial conducted by the pharmaceutical company Pfizer in 1996 in Kano, Nigeria, during an epidemic ofmeningococcal meningitis. To test its new antibiotic, trovafloxacin (Trovan), Pfizer gave 100 children trovafloxacin, while another 100 received the gold-standard anti-meningitis treatment, ceftriaxone, a cephalosporin antibiotic.[1] Pfizer gave the children a substantially reduced dose of the ceftriaxone relative to that described on the US FDA approved Prescribing Information. The allegation is that this was done to skew the test in favor of its own drug.[2] Pfizer claimed that the dose used was sufficient and this claim was later supported by the results of a clinical trial performed by Medicins Sans Frontieres[3] A 2002 report by the World Bank described the military government that ruled Nigeria at the time of these events as "pervasively corrupt". It further cites widespread comments by business managers in Nigeria characterizing the NAFDAC (Nigerian FDA) of that period as lacking the capabilities needed to perform its regulatory role and "harassing business and seeking bribes" rather than "protecting businesses and consumers".[4]
Five children given trovafloxacin died, as did six of those given ceftriaxone. The lead investigator, Dr. Abdulhamid Isa Dutse, later provided a letter of approval for human trials that was found to be falsified.[1] The Nigerian government called the trial "an illegal trial of an unregistered drug."[5] It has been alleged that participants and their families were not told that they were part of a trial, and that Médecins Sans Frontières was offering the standard treatment in another part of the same building.[6] Pfizer acknowledged reducing the dose of the standard treatment, but said this was done to minimize injection-site pain, and that the mortality rates in both the trovafloxin and ceftriaxone arms of its trial were lower than among those treated with chloramphenicol by Médecins Sans Frontières.[7]
The survivors of the trial tried to bring a number of legal actions against Pfizer in the United States. These resulted in four judicial opinions, the first three dismissing the claims onprocedural grounds.[5] According to Ben Goldacre, Pfizer argued that it was not required to obtain informed consent for experimental drug trials in Africa, and that any case should be heard in Nigeria.[6] In May 2006 Representative Tom Lantos of California, the senior Democrat on the House International Relations Committee, described the findings of a report compiled about the case by the Nigerian government as "absolutely appalling," and called for Pfizer to open its records.[5] In January 2009 the United States Court of Appeals for the Second Circuit ruled that the Nigerian victims and their families were entitled to bring suit against Pfizer in the United States under the Alien Tort Statute. Pfizer subsequently settled the case out of court with a $75 million settlement that was subject to a confidentiality clause.[6]
Overall, the 1996 meningitis epidemic in northern Nigeria killed about 12,000 people, during the worst known meningitis outbreak in Sub-Saharan Africa.
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