Pfizer: Nigerian’s Nightmare

Back in November 2008, Pfizer conducted an illegal clinical trial on Nigerian children during a 1996 meningitis outbreak. At the time, the Nigerian government was seeking $8.5 billion in restitution and damages as well as jail terms for various Pfizer officials, including former Pfizer chief executive William Steere.

The Nigerian suit claimed Pfizer drafted children into its clinical trial without their consent, intentionally low-dosed its control drug to boost the profile of its own antibiotic, Trovan, and may be responsible for the deaths of 11 children and injuries to dozens of others.  Now, a Wikileaks’ cable, published by the Guardian,  may provide insight into the discrepancy in settlement amounts.

According to the cable, classified confidential by U.S. economic counselor Robert Tansey, Pfizer hired investigators to uncover corruption links to Nigeria’s Federal Attorney General Michael Aondoakaa and leaked reports of alleged corruption to local Nigerian media outlets in February and March of 2009.

According to the cable, “A series of damaging articles detailing Aondoakaa’s ‘alleged’ corruption ties were published in February and March.” As a result, “Aondoakaa’s cronies were pressuring him to drop the suit for fear of further negative articles,” the cable said.

According to the cable, “Pfizer’s image in Nigeria has been damaged due to this ongoing case. Pfizer’s management considers Nigeria a major growth market for its products and having this case behind it will help in efforts to rebuild its image here.”

Neither Pfizer, Robert Tansey, nor Michael Aondoakaa could be reached for immediate comment.

Pfizer maintains the children documented in the suit died from meningitis, not the drug trial, and describes its trial largely as a humanitarian effort aimed at saving lives during a 1996 epidemic–an ugly trifecta of meningitis, cholera and measles–that killed 12,000 Nigerians, many of them children.

Before Pfizer’s 1996 trial, oral Trovan had never been tested for efficacy in children, in part because of concerns over side effects. Trovan belongs to a powerful class of antibiotics called quinolones, which can have serious side effects, including liver problems and cartilage and tendon abnormalities. Pfizer enrolled 200 children, between 3 months and 18 years old, in its Trovan trial. A month after the trial, five children in the Trovan group and six in the Rocephin group had died. Dozens of others were left paralyzed or with crippling arthritis. Pfizer says the deaths and injuries are tragic. Nevertheless, it maintains the study proved its drug’s efficacy, given that the epidemic killed 10% of all those infected.

“With a survival rate of 94.4%, Trovan helped save lives and was at least as effective as the best treatment available at Kano’s Infectious Disease Hospital. For patients who did not participate in the Trovan investigative study, the survival rate was slightly less than 90%,” Pfizer said in a statement.

Using its trial data, Pfizer initially applied to use Trovan for pediatric meningitis. Pfizer then withdrew that use from its application after a Food and Drug Administration audit found dozens of discrepancies in its trial records. The company says it intended to renew its application following results of a global pediatric trial that was already underway.

But Pfizer never had the opportunity to apply for pediatric use. After approving Trovan for 14 other uses in 1997, the FDA advised the company to pull the drug entirely– two years and over 2.5 million prescriptions later– citing reports of liver damage.