In August 2011, four families in northern Nigeria received $175,000 each, 15 years after their children died during the experimental testing of an antibiotic. The money came from a $75 million fund set up by Pfizer, the company that ran a trial of its antibiotic Trovan during a massive outbreak of meningitis.
According to the Nigerian Health Journal (November 2011) about 200 children treated with Trovan were negatively affected; 11 died and many others were left severely disabled with blindness, deafness, brain damage, and paralysis. Pfizer says the fatalities were due to meningitis; the Nigerian outbreak in 1996 took 12,000 lives.
Meningitis in Nigeria
Kano State in northern Nigeria is a hot, dry, and dusty place that is home to about nine million people. In 1996, the worst meningitis outbreak in Nigeria’s history hit the area and aid agencies such as Médecin sans Frontières (MSF) rushed in to help.
Also quickly on the scene was a research team from the world’s biggest pharmaceutical company, Pfizer. The drug giant had a new antibiotic called Trovan that it wanted to study for its efficacy in treating meningitis. In a later investigation (December 2000), Washington Post reporter Joe Stephens wrote that, “Pfizer researchers prepared the study over six weeks, instead of the year or longer common in the United States.”
In a statement (January 2011) MSF recalled the events by noting it had set up a field hospital at the Kano State Hospital and “was treating children using a preferred and clinically approved antibiotic regimen for bacterial meningitis.” Meanwhile, elsewhere in the same facility, “Pfizer carried out the trial of the oral antibiotic trovafloxacin, branded Trovan, even though there had not been any previous medical evidence that it could be effective against meningitis.”
Controversy Surrounds Drug Trial
The Washington Post wrote that while Trovan was being administered in Nigeria, the drug had “not yet [been] approved in the United States.”
And Joe Stephens writes in a later article (May 2006) that, “A panel of Nigerian medical experts has concluded that Pfizer Inc. violated international law” during its Trovan trials.
The panel could find no evidence that the children treated or their parents had given consent to use the experimental therapy. In addition, “An approval letter from a Nigerian ethics committee, which Pfizer used to justify its actions had been concocted and backdated by the company’s lead researcher in Kano, the report said.” Pfizer later acknowledged the approval was “incorrect” and added “Obviously this should not have occurred and the company very much regrets that it did.”
The former president of MSF France Jean Hervé Bradol, who was overseeing the Kano outbreak, said in a statement: “It was not a time for a drug trial. They were panicking in the hospital, overrun by critically ill patients. The team were shocked that Pfizer continued the so-called scientific work in the middle of hell.”
Nigeria Sues for Compensation
When the story came to light as a result of the Washington Post investigation in 2000 there was a huge public outcry in Nigeria and elsewhere. The Nigerian government sued Pfizer $8.5 billion and said the company’s officials could face criminal and civil charges.
After years of legal arguments, Pfizer agreed to pay $75 million to the State of Kano. In a statement Pfizer noted that, “Under the terms of the settlement, Kano State will dismiss both the civil and criminal Trovan-related cases it filed against the company and various individuals, and Pfizer specifically denies any wrongdoing or liability in connection with the 1996 study.”
The Fate of Trovan
Trovan was approved for use in the United States and went on the market in February 1998. Industry analysts said Pfizer had a winner on its hands and predicted annual sales would rise to $1 billion.
Then, as reported by Melody Peterson in the New York Times (August 2000), “serious possible side effects that were never apparent in clinical trials surfaced quickly when the drug was prescribed widely. Patients began experiencing liver toxicity just months after the drug first became available.” Several people died.
By the middle of 1999, the Food and Drug Administration advised doctors to use Trovan “only in rare cases and only in hospitals.” Europe went further and outright banned Trovan. And, several law firms in the United States are putting together class-action suits for people who have suffered ill effects from taking the drug.
Sources
- “Still no Compensation for Trovan Victims.” Olaolu Olusina, Nigerian Health Journal, November 1, 2011.
- “Where Profits and Lives Hang in the Balance.” Joe Stephens, Washington Post, December 17, 2000.
- "Statement: Pfizer Promoted Misleading and False Accusations of MSF’s Involvement in Unethical Drug Trials the Company Conducted in Nigeria in 1996.” Médecin sans Frontières Statement, January 5, 2011.
- “Panel Faults Pfizer in ‘96 Clinical Trial in Nigeria.” Joe Stephens, Washington Post, May 7, 2006.
- “Pfizer, Kano State Reach Settlement Of Trovan Cases.” Chris Loder, Pfizer, July 30, 2009.
- “Unforeseen Side Effects Ruined One Blockbuster.” Melody Peterson, New York Times, August 27, 2000.
Rupert Taylor - Rupert Taylor is the editor of a magazine that provides background to current events.
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