As doctors fought to save lives, Pfizer flew in drug trial team
Amid African meningitis epidemic, 200 children were picked to test a drug. 11 died, and their families began a fight for justice
By Sarah Boseley and David Smith in Kano, Nigeria
guardian.co.uk, Thursday 9 December 2010 21.30 GMT
Africa’s meningitis belt is used to tragedy. Annual epidemics sweep across the continent in the dry season, stopping abruptly when the rains come. In a normal year, maybe 5,000 die, mostly children and young people. But in 1996, the worst-ever African meningitis epidemic hit Nigeria’s northern states. Doctors struggling to bring it under control over a period of three months recorded more than 109,000 cases of meningococcal (cerebrospinal) meningitis and 11,717 deaths.
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.
MSF’s doctors were appalled at an exercise they felt was opportunistic and inappropriate. “It was not a time for a drug trial at all,” says Jean Hervé Bradol, former president of MSF France, to whom the Kano teams were reporting at the time. “They were panicking in the hospital, overrun by cases on the verge of dying. The team were shocked that Pfizer continued the so-called scientific work in the middle of hell.”
MSF had helped set international treatment standards for African meningitis epidemics – a single intra-muscular injection of oil-based chloramphenicol will save a life if a child if treated in time. And tablets, says Bradol, are not the best idea when one of the major symptoms of meningococcal meningitis is vomiting.
MSF’s doctors at the time “were too busy to have a war with Pfizer and their friends”. But they were concerned. Trovan, the brand name given by Pfizer to trovafloxacin, is from the quinolone family of antibiotics. There had not been any previous suggestion, Bradol says, that it could be effective against meningitis.
In the event, Pfizer saved 189 lives of the 200 children treated. Five died on Trovan and six on ceftriaxone. That was a death rate of 6%, which was significantly better than the 20% in some places where the epidemic was raging. In their terms, the trial was a success.
But the drug is not to be found in African pharmacies. It was trialled 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.
The trial did not make headlines until 2001, when doctors from MSF spoke about their concerns to the Washington Post, which was running a series on the ethics of clinical trials in the developing world. But then the accusations began. The fallout has been immense.
At first glance, Kano, in Nigeria’s remote north, is more Afghanistan than Africa. A sign warns visitors, with measured politeness, to please note that sharia law is in force and public indecency and fornication will be dealt with harshly. Notices pronounce “sharia commission” and “purity and praise be to Allah”. Prayers sing from tinny radios and women walk by in headscarves.
On the southern fringes of the Sahara desert, Kano is a frontier town in which poverty is entrenched. Traders operate from flimsy market stalls and the roads are choked with traffic spewing exhaust fumes. Hawkers try to sell masks as a defence against pollution. Rubbish is strewn in gutters and on roadsides. Poles bend under the weight of huge bunches of power cables. There are election posters, adverts for mobile phones, and a sign that says: “Dangote noodles welcomes you to Kanocapital.”
There is also a reminder of the fallout from the 1996 meningitis epidemic: billboards from the Kano state health ministry entreat: “A healthy child is a pride to society. Immunise your child now.”
Kano became famous in recent years as the state that nearly sunk the world’s attempt to end polio. Its Islamic community became suspicious of the vaccine, imported from Christian countries and rumoured at one time to cause sterility. Families refused to have their children immunised. Part of that suspicion is believed to have been fuelled by the Pfizer trial.
Mustapha Maisikeli, wearing a patterned Muslim cap and silk garments, is chairman of the Trovan Victims Forum. He rummages in a storeroom where piles of yellowing newspapers are stacked on plastic chairs. He produces some photographs of children and some documents. One is a pink card labelled “Pfizer meningitis study” that states baldly: “25lb male, 5yo, enrollment date 3 Apr 96, discharge date 6/1/96.”
Maisikeli, 63, who campaigns for families involved in Pfizer’s trovafloxacin trial, lost two daughters, Fatahiyya, then 17, and Surayya, who was six. Both fell ill when meningitis swept through Kano in 1996.
“We were all worried,” said Maisikeli briskly. “I learned they were sick, and people suggested it could be meningitis. Anyone who sees his child with a fever rushes to the infectious diseases hospital. There was a queue and they selected from there – it was, ‘You, follow me’.
“We were gathered in a camp into two groups: MSF and Pfizer. When you see a European, you feel you are safe. It just so happened my children fell within Pfizer.”
He says his daughters stayed for about three days in the hospital “but fell ill again”. Although meningitis usually kills rapidly, he says he holds Pfizer responsible for his daughters’ deaths four months later.
Aliyu Isa, 43, a customer services manager, lost his six-year-old son, Mahmoud. “My child had sickness as a result of meningitis,” he said. “He was administered some drugs, free of charge, by the doctors. Thereafter, he had a sickness full of crying, very severe headaches and very high temperatures. He was taken in for tests and administered drugs. He was discharged. He developed uncontrollable sickness that could not be taken care of.
“He had been treated by Pfizer. It was American experts giving a free drug. It was a very terrible experience.”
Relatives of children treated with Trovan have been trying since 2001 to bring cases against Pfizer in the US, claiming they were damaged by the drug. Three attempts to sue Pfizer in America have been dismissed and one is ongoing.
Pfizer maintains it has done nothing wrong and that nobody was harmed in the trial. In a statement in 2007, lawyers for the drug company said that “all clinical evidence points to the fact that any deaths were the direct result of the meningitis itself.
“The defendants always acted in the best interest of the children involved, using the best medical knowledge available. The defendants believed Trovan could save lives.”
More successful was the action brought by the Kano state government in Nigeria. Two cases in Kano, one civil and one criminal, were settled out of court in April last year for $75m (£48m). Families are to get $35m, while the rest goes to the state government and lawyers. Two boards of trustees have been set up to divide up the money.
Two federal cases, also one civil and one criminal, were dropped by the Nigerian government in October last year. Some of the Nigerian press have demanded to know why, but no explanation has been given. Pfizer says a confidentiality agreement was signed, which is usual in such cases.
A cable from the US embassy in Abuja in April 2009, published by the Guardian today, suggests that Pfizer hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop the case.