Trovan, Nigerian Children and Pfizer’s Inappropriate Drug Trial

Pfizer is in a long running dispute with the Nigerian government and parents regarding children who died during a meningitis epidemic in 1996.

For background from a 2009 article:

Kano’s infectious diseases hospital, a small collection of concrete buildings inside a sandy compound, was overwhelmed, even after teams from Médecins sans Frontières arrived. They were dealing with not one but three epidemics – measles and cholera had broken out as well. Children were being seen and treated in overcrowded halls and corridors. It was chaos.

And then a chartered DC-9 flew in from the US. On board were doctors from Pfizer, the world’s biggest pharmaceutical company, and better medical equipment than the African town had ever seen. They had come to conduct a trial of an oral antibiotic called Trovan, which they wanted to test in children with meningitis against the “gold-standard” treatment of the western world, ceftriaxone. They took over part of the hospital and dosed 200 children, half with Trovan and half with ceftriaxone. And then they left, leaving behind some surplus drugs and equipment for the hospital.

Using a local facility for the purposes of testing a new unproven drug already raises ethical questions. Arriving and in cold-blooded fashion selecting just 200 patients for participation in the trial and then leaving with the epidemic still raging is at least insensitive and at worst, a damning example of the drug company’s opportunistic quest for profits.

Even worse, the Pfizer never intended the drug for use in Africa, the testing against meningitis there was simply a quick and very dirty way to accrue patients.

But the drug is not to be found in African pharmacies. It was trialed on African children, but never intended for Africa. Pfizer aimed to sell it in the USA and Europe – and yet its licence was withdrawn in Europe because of concern over liver toxicity. It is not licensed anywhere for children.

Pfizer maintained that what they did was “ethical” and that they provided the drug free of charge during an epidemic.

A suit is has been in progress in Nigeria and in the process of being settled.

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.

Also:

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.

And:

The cable reported a meeting between Pfizer’s country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It stated: “According to Liggeri, Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases.”He said Pfizer’s investigators were passing this information to local media.”

Pfizer has subsequently denied the contents of the cable.

Medicynical Note: Pfizer’s insensitivity is quite remarkable. What’s more cynical than delaying resolving this mess for 15 years? What’s more cynical than testing a drug in a place where you never intend to market it–because it will be too expensive? What’s more cynical and opportunistic than flying in a research team in the middle of an epidemic to do drug trials……and then leaving?

It’s enough to give us all, my profession and the formerly “ethical” drug manufacturing companies, a bad name.