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.
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
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.
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