Pfizer settles with victims of Nigerian drug trial

The drug company Pfizer has paid out $175 000 (£107 000; €120 000) to each of four families whose children died during a study of an experimental antibiotic in Kano, Nigeria. But the settlement has been strongly criticised by the families involved and by a leading ethicist in the United States, where Pfizer has its headquarters.

The study was conducted during a deadly outbreak of meningitis in 1996, when some 200 children were enrolled in the study. Half were given Pfizer’s experimental antibiotic, trovafloxacin (which it markets as Trovan), and half were given ceftriaxone. Five children died in the trovafloxacin arm and six in the ceftriaxone arm. Pfizer has not reported on the outcomes of 10 of the children.

The families said that Pfizer failed to tell them that their children were being enrolled in an experimental drug trial and that free, effective treatment was available from the charity Médecins Sans Frontières at the same hospital.

The settlements come from a $35m fund to compensate the families of children in the study. Pfizer has agreed to pay another $30m to support healthcare initiatives in Kano and $10m in legal costs.

In 2007 Pfizer acknowledged that it had given some of the children just one third of the recommended dose of the comparator antibiotic (ceftriaxone) because, the company said, the shots were “too painful” and made it too hard for the children to walk (BMJ 2007;334:1181, doi:10.1136/bmj.39237.658171.DB).

Trovafloxacin was later banned in Europe, and in 1999 the US drug regulator the Food and Drug Administration severely restricted its use, issuing a warning that the drug could lead to serious liver damage and death.

The study and the settlement have angered many Kano families, who say that Pfizer has delayed action for many years. Harriet Washington, a former ethics fellow at Harvard Medical School and a writer on ethics issues, told the BMJ that the agreement is “very troubling on several levels.” She said that families were told after the agreement was reached that they would have to undergo DNA testing—a demand that Pfizer argued was necessary as more than 500 people sought restitution even though only 200 children were in the study.

Ms Washington branded this request “draconian” and said that it violated the families’ human rights, as the identities of individuals could have been confirmed in a more conventional, less intrusive manner. DNA testing created yet another obstacle for the families, because many Nigerians are already distrustful of Western drug companies, and for DNA samples to be obtained a large device needed to be inserted into their mouths at the behest of the same company that had already victimised them, said Ms Washington. Some families subsequently dropped their lawsuits, fearful that the company might be subjecting them to yet another secret test.

A spokesperson for Pfizer told the BMJ: “DNA testing is an internationally recognised method of verifying an individual’s identity. The collection and testing of DNA is a safeguard—included in the settlement agreement—to ensure as much as possible that the funds reach only those for whom they are intended.

“Under the settlement agreement the trust funds’ board—not Pfizer or the Kano state government—will make the final determinations on eligibility of claimants and, if, applicable, the level of financial support they will receive. Pfizer will provide the board with the funds to compensate approved claimants, as specified in the settlement agreement.”

Ms Washington said, “Probably the biggest difference between Kano and other non-consensual studies around the world is that Kano was well publicised.”