By Hauke Goos
Correction notice: The photo and caption that originally accompanied "Nigeria Takes On Pfizer over Controversial Drug Test” incorrectly reported that a child, Anas Mohammed, had been treated with Trovan during a clinical trial conducted by Pfizer in Nigeria in 1996, and now suffers brain damage. Anas was treated with the gold standard for meningitis, Rocephin (active substance Ceftriaxone) by another manufacturer, and does not have brain damage. SPIEGEL ONLINE has also published a letter to the editor from Pfizer, which can be read here.
There are days when Babatunde Irukera feels like nothing can go wrong -- not with the evidence that he has gathered, the letters, reports, protocols and all the witnesses. On days like this he believes that, after 11 long years, justice can finally be served for the children of Kano, for his homeland Nigeria, and for Africa.
On a morning in early October, Irukera was sitting in his hotel eating breakfast when an old man walked in. Irukera knew him -- they met the day before in court. The man was clutching a plastic bag.
He pulled a crumpled pink card from the bag, the torn-off half of a file folder. Irukera read "Pfizer Meningitis Study" in the upper left-hand corner of what was once a white label, and under that he sees a number: "Pf 0001." Patient 0001.
Babatunde Irukera is a lawyer and he is representing the state of Nigeria in a lawsuit filed against the American pharmaceuticals giant Pfizer. In 1996, tens of thousands of Nigerians fell ill during an outbreak of meningitis. Pfizer allegedly used the epidemic to test a new, unapproved drug. Eleven children died as a result, others were left deaf, blind or mentally handicapped. The case is not being tried in the US, but in Kano and the Nigerian capital Abuja.
The old man, a former journalist, had searched for two years to locate the participants in the drug test, and he finally hit pay dirt in the slums of Kano, the capital of the northern Nigerian state of the same name, where the disease took its heavy toll.
At 39, Irukera is a young lawyer. The cases he has handled so far have dealt with immigration rights and workplace discrimination. Pfizer is the largest pharmaceutical company in the world, with 100,000 employees, 32.8 billion in annual sales -- more than half the gross national product of Nigeria.
There are a total of four lawsuits filed against Pfizer, two in Kano and two in Abuja, with a civil lawsuit and criminal lawsuit each. The challenge for Irukera and his team is to match names with the numbers of the Pfizer patients and to give the names faces and real lives. In the statement of claim filed by Irukera, he wrote that Pfizer treated the patients like guinea pigs.
Pfizer responded that the mission in Nigeria was a "humanitarian gesture" -- in other words, an act of compassion.
Perfectly Timed Epidemic
In early 1996, Nigeria was hit by the one of the worst meningitis epidemics in history. Government officials have placed the final death toll at over 11,000.
At the time, Pfizer had just developed a new antibiotic called Trovan to treat a variety of infections.
Such drugs are used primarily in hospitals, mainly to treat blood poisoning. Their severe side effects make these antibiotics unsuitable for children. The risks of causing joint disease, abnormal cartilage growth and liver damage are simply too great.
As a rule, such agents are injected directly into the veins because that is the only way that they can work reliably. Initial tests had raised hopes that Trovan could be effective if swallowed in tablet form. Apparently, Pfizer hoped that this innovation would allow it to outpace market leader Bayer. The company believed that Trovan had the potential to become a "blockbuster" drug.
But Pfizer had a problem: In order to secure certification from the Food and Drug Administration (FDA) in the US, it still needed to conduct a clinical trial. Pfizer evidently hoped that it could use the study in Africa to furnish proof that the new drug was also safe for children. The meningitis epidemic in Nigeria came at just the right moment.
Such tests are extremely difficult to conduct in industrialized countries, where very few parents are willing to allow their children to take part in clinical trials. Consequently, companies often turn to poor countries and regions, such as India and South America, Bangladesh and Thailand -- and Africa. Patients in these parts of the world are so poor they don't care if the drugs they receive have been approved or not. Within just a few years, developing countries have been transformed into an enormous test laboratory.
In the spring of 1996, Pfizer offered to help the Nigerian government deal with the outbreak. In late March, a medical team headed for Africa.
When they arrived in Kano, the Americans revealed that they were not on a humanitarian aid mission, but had been sent to administer medical tests. Physicians selected 200 sick children for the study. They had to be at least three months old and younger than 18, and they could not be HIV-positive or malnourished. It takes an enormous amount of money to pave the way for launching a drug like Trovan on the market -- on average 600 million. Pfizer didn't want to make any mistakes. Half the children were given Trovan, the other half received Rocephin, a competing product from Swiss manufacturer Hoffmann-La Roche.
When word got out about the study five years later, a controversy erupted over fundamental questions, for which the Nigerian lawyer and the US drug company have totally different answers: Is it permissible to test a drug during a deadly epidemic? Is it acceptable to test drugs in the developing world that will benefit the industrialized world, using people who will never be able to afford this treatment?
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