Pfizer to answer for testing unapproved drug on Nigerian children
After using unsuspecting children as guinea pigs, Pfizer will end a decade-long legal struggle out of court.
Thirteen years after a drug trial that left 11 children dead and dozens disabled, Big Pharma king Pfizer and Nigeria’s Kano state have agreed to settle a lawsuit out of court.
Justice may finally be served…sort of. While the details have yet to be worked out, lawyers on both sides are reporting that a broad agreement has been reached. One thing’s pretty certain—you can bet the settlement will be on Pfizer’s terms.
The nightmare started with an outbreak of meningitis, one that killed over 12,000 in just six months. Researchers from Pfizer swept in, eager to test Trovan, an antibiotic that could make them billions if it was approved.
Their efforts to prove their drug ended in tragedy. A tragedy for which they’ve spent over ten years denying responsibility.
Eleven children dead. Dozens more disabled. After a trial that involved only 200 children. And only half were given Trovan.
The original lawsuit, demanding billions in damages, was blunt in its accusation. Pfizer had used the children as “guinea pigs” for its experimental drug.
Pfizer, of course, denied the charges, claiming that Trovan had saved lives and that they had acted ethically, within the confines of the law. But their claims quickly started to unravel…
The former director of Nigeria’s version of the FDA said the agency had been unaware of the experiment.
Pfizer responded by producing an approval letter from the Nigerian Ethics Committee. A letter they couldn’t provide when they first arrived in Kano. A letter that was later proven to be a fake.
In 2006, a Nigerian government report that had been unreleased for five years finally saw light of day. In it, a panel of medical experts concluded that Pfizer violated international law. The panel concluded that Pfizer did not have the authority to conduct the trial, described as a “clear case of exploitation of the ignorant.”
Because, after interviewing at least 26 people and reviewing hundreds of documents, it was determined that Pfizer acted without the consent of the families involved.
And that might not even be the worst part. The lawsuit alleges that Trovan was given in a form never before tested on humans and was part of a class of antibiotics known to have life-threatening side effects. Children in the control group were given low doses of a drug known to be effective against meningitis (doses perhaps too low to have effect). The families involved in the suit say the results from the control group allowed Pfizer to claim Trovan was a superior treatment.
Pfizer continues to deny the charges, saying they are “proud of the way the study was conducted,” and that meningitis killed the children, not Trovan. And they’re, of course, committed to bringing “the Trovan matter to a fair and final resolution.”
At the time of the Nigerian experiment, Pfizer was developing Trovan for release in the United States, where it was expected to gross up to $1 billion a year. There was a snag, however. The FDA hadn’t approved Trovan for children.
So, as cynical as it may sound, the epidemic had perfect timing for Pfizer.
Tomorrow I’ll tell you more about Trovan, its life- threatening side effects, and why Pfizer’s actions, by most accounts, amount to a sickening abuse of trust and power.
“Pfizer near $75 mln settlement with Nigeria.” Reuters (www.reuters.com), 4/1/09.
“Deal in Pfizer-Nigeria drugs suit.” BBC News (news.bbc.co.uk), 4/9/09.
“Nigeria Takes on Pfizer over controversial drug test.” Spiegel (www.spiegel.de), 11/16/07.
“Panel Faults Pfizer in ’96 Clinical Trial In Nigeria.” Washington Post (www.washingtonpost.com), 5/7/06.