By Walter Armstrong The Atlantic
DECEMBER 27, 2010
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.
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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.
A State Department cable dated April 20, 2009 and released by WikiLeaks, however, suggests that Pfizer’s legal strategy was not simply to delay–it was also to blackmail. Written by an economic counselor at the US embassy in Abuja, Nigeria, the cable reports minutes of meetings during which Pfizer representatives informed the U.S. ambassador that the firm had agreed to settle the Kano State suit for $75 million, mere pocket change for the pharma giant. The ambassador was told that Pfizer “was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years costing Pfizer more than $15 million a year in legal and investigative fees.”
It was how Pfizer deployed these fees that dropped a bombshell:
According to [Pfizer country manager Enrico] 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, XXXXXXXXXXXX. A series of damaging articles detailing Aondoakaa’s ‘alleged’ corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa’s cronies were pressuring him to drop the suit for fear of further negative articles.
Blessed with immense reserves of oil, Nigeria, like many oil-rich developing nations, has in turn been cursed with extravagant corruption. Aondoakaa was among those caught up in it. The cable does not mention Pfizer’s settlement of the $6 billion federal lawsuit, which was signed in secret by lawyers from Pfizer and the Aondoakaa-led Nigerian ministry of justice in October 2009. With the settlement’s terms under wraps, how much Pfizer paid and to whom remains a mystery.
In February 2010, Aondoakaa was booted from the government over charges of corruption. Pfizer denies the version of events reported by the U.S. Department of State official. “Any notion that the company hired investigators in connection to the former attorney general is simply preposterous,” Christopher Loder, a Pfizer spokesman, told The New York Times.
When I emailed Loder asking for comment about the allegations in the WikiLeaks cables, he repeated his statement to the Times verbatim, adding that the cases had been “resolved in 2009 by mutual agreement” and that Pfizer’s conduct was “proper.”
The 1996 Trovan tragedy has cast a long shadow. In 2003, the parents of Kano State boycotted a U.S.-made polio vaccine, threatening to single-handedly short-circuit the global initiative to eradicate the disease. These parents bore the legacy of the Trovan trial and the ensuing years of failed and foiled litigation. Suspicion and cynicism of Western motives ran so deep that they accepted their local clerics’ warnings that the polio vaccine was a plot by Christians to sterilize their daughters, relenting only when health officials switched to a vaccine manufacturer based in Indonesia, a Muslim nation.
Despite all this, Pfizer apparently perceives itself as the real victim. As detailed in the leaked cable, Liggeri portrayed Pfizer to the ambassador as entirely the injured party, dismissing the lawsuits as “wholly political in nature” and asserting that during the meningitis outbreak in 1996, MSF also administered Trovan to children. (When asked for comment by the Guardian, Jean-Hervé Bradol, former president of MSF France, said, “We have never worked with this family of antibiotic. We don’t use it for meningitis. That is the reason why we were shocked to see this trial in the hospital.”) Liggeri warned darkly that the lawsuit against Pfizer had so chilled the entire pharmaceutical industry that “when another outbreak occurs no company will come to Nigeria’s aid.” Whether or not that’s true, it’s not clear that Nigerians would want Pfizer’s help after all.
Photo by Aminu Abubakar/AFP/Getty Images
Walter Armstrong writes about healthcare and gay issues for various magazines and websites. He is the former editor in chief of the HIV magazine, POZ.