Pfizer will pay an out of court settlement to resolve a long-running case alleging that it carried out an illegal trial of its meningitis drug Trovan (trovafloxacin) in Nigeria that resulted in the death of 11 children.
Prosecutors in the northern Nigerian state of Kano had been seeking $2.75bn (€2bn) in compensation from the US drug giant, accusing it of conducting an unlicensed trial of the drug in 200 children during a meningitis epidemic in 1996.
While details of the settlement are not due to be released until May 25, various media reports suggest Pfizer will pay $35m to the families of patients involved in the trial, $30m to the Kano authorities and around $10m in legal fees.
Pfizer, which has consistently denied the allegations and has yet to comment on the settlement, told Reuters on April 3 that it had reached a “broad and principal fundamental agreement” with the Kano state authorities.
The settlement will be a considerable relief for Pfizer given the negative publicity that the case has generated for the firm over the last few years, particularly given the increasing trend among Big Pharma firms to carry out trials in emerging markets.
However, the UK’s Independent newspaper suggested that the respite for Pfizer may prove to be short lived. In January the US Court of Appeals overturned an earlier ruling and gave a green light to 88 Nigerian families seeking to pursue claims against the firm in the country.
Pfizer accredited for human rights protection during trials
Also on April 3, Pfizer reported that three of its clinical research units (CRUs) in the US, Belgium and Singapore have been accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
The AAHRPP award certifies that Pfizer achieved the highest standards for the ethical treatment of patients in early-stage trials of candidate drugs.
The group audited the three units and deemed that they met its quality and ethical standards, which include the research requirements set by the International Conference on Harmonization (ICH).
Pfizer said that the award places it among the world’s best universities, hospitals, institutional review boards (IRBs) contract research organisations (CROs), and other organisations that are AAHRPP-accredited.