On Day 12 of WikiLeaks's release of U.S. State Department cables, the daily drip, drip, drip of diplomatic secrets implicated the pharmaceutical industry. The company was Pfizer, the country was Nigeria, and the context was the long-simmering, still-bitter aftermath of the drug giant's quick-and-dirty 1996 trials of an experimental antibiotic for children during a devastating meningitis outbreak. A truly chilling cautionary tale of industry-funded clinical trials in the developing world, this event is recalled in the West mainly as the inspiration for John le Carré's evil-pharma thriller The Constant Gardener.
The cables suggest that the world's largest drugmaker may have blackmailed the head of Nigeria's Ministry of Justice into dropping a $6 billion criminal lawsuit.
The 1996 meningitis emergency in northern Nigeria presented Pfizer with a golden opportunity: to test its then-promising broad-spectrum antibiotic, Trovan, in children. Pediatric approval is key to maximizing sales of antibiotics, but parents in the developed world are leery of offering up their offspring as guinea pigs. Time was running out if Pfizer wanted its trial as the epidemic was already past its peak. The company managed to design a clinical trial of this experimental compound, which had never been tested either in children or against meningitis, in six weeks, though the risks and complications of such a trail would typically require a year to adequately assess.
The Trovan team chartered a jet, flew to Kano, an ancient Nigerian city of 2 million on the edge of the Sahara, commandeered the overcrowded compound of crumbling cinder-block bunkers that passed for a hospital, ran the test, and flew out two weeks later with their data. When all but five of the 100-child Trovan cohort survived (six on the control drug died)--the death rate of untreated meningitis in Kano had been 20 percent--Pfizer trumpeted to Wall Street that the drug's success spelled blockbuster. That Trovan could be portrayed as having saved African children might even lend a priceless "halo" effect to the drug's launch.
The company's predictions turned out to be inflated, to say the least. Though U.S. guidelines say that meningitis experiments should include long-term follow-ups, Pfizer called for no such checks. When less than half of the tested children returned to the clinic, Pfizer said that this minority was sufficient to prove the experiment showed no side effects.
The trial data were so sloppy that the FDA refused to even consider approval of Trovan for children or for meningitis. Although the antibiotic hit the market in 1998, it quickly resulted in a rash of complications due to liver toxicity, including six deaths. Less than two years after its launch, the drug itself was finished.
A Pfizer infectious-disease specialist who later analyzed the test procedures was fired after protesting to Pfizer executives that the study was a violation not only of medical ethics but of federal and international laws.
In Kano, a groundbreaking Washington Post investigative series found that parents had not knows that their children were part of an experiment, nor were they informed that an adjacent clinic administered by Medicines San Frontieres could have given their children a proven antibiotic. As an injectable, unlike the oral Trovan, that faster-acting antibiotic offered a critical advantage against meningitis, which can kill in hours.
In 2000, following the Post revelations, a cry for justice in the Nigerian media triggered street protests and an investigation by Nigeria's health ministry, whose report on the incident went missing until 2006, when a leaked version revealed that the health officials had reached more or less the same verdict as the fired Pfizer expert: The experiment was "an illegal trial of an unregistered drug," a "clear case of exploitation of the ignorant," and a violation of Nigerian and international law.
These disclosures prompted a raft of civil and criminal lawsuits in Kano State Court on behalf of the families and in Federal High Court on behalf of the nation itself, as it were. But Pfizer kept the suits tangled up in proceedings to postpone any settlement.