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.
Sources:
"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.
About the author
Christine O'Brien writes the e-letter Health eTips for Dr. Wright's Nutrition and Healing.
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Comments
Hajiahalima
Let me first introduce myself. I am Hajiya Halima Ibrahim from Kano State of Nigeria. I read your article on the 1996 meningitis outbreak and the Trovan trial of Pfizer with interest. As a senior official of a non-governmental organization in the health sector, I have been involved in monitoring the various court cases and the settlement talks. My organization, MENS SANA, is on record as having issued press stating our position that an out-of-court settlement was the best thing in the circumstances because we are not fooled by all the hype of dollar-chasing class action lawyers from the US who wanted a prolonged litigation so that they can lay their hands on some mythical billion dollar settlement.
Your article is quite misinformative (if you would kindly excuse the term). Yes, Pfizer conducted the trial of its Trovan drug during the epidemic, but no, you can’t describe my people who participated in the trial as guinea-pigs. This is because when the court processes started, those of us in the NGO sector called for the facts from the court registries. Pfizer indeed secured the permission of the federal and state governments. In fact some government doctors worked alongside the drug company. The Nigerian version of your FDA is NAFDAC which, contrary to your claim, also gave formal permission to Pfizer. All these can be verified from court papers. We gathered that our government did not have an ethical committee in place at the time they were giving permission for the trials but they set one up eventually. You can’t blame a foreign company for the lapses of our own people.
Indeed we wouldn’t have needed Pfizer’s help if not that our healthcare delivery system is in a shambles. That was why Doctors Without Borders also came here to save our people. Interestingly Pfizer recorded better results (about 94.4 percent survival rate) than Doctors Without Borders. Officially, our government disclosed that 12,000 children died in the epidemic but I can tell you that the final toll was at least 8,000 more. I found very interesting the reference to the claim by the plaintiffs in the suit that “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.” If that was the case, how come Pfizer’s survival rate was higher than that of Doctors Without Borders?
The report of the panel that indicted Pfizer is also available in the public space, although the government has not released it officially. The committee was chaired by a man who had issues with Pfizer and is currently in court against the company. The chairman was a witness at his own panel. Pfizer protested that fact. The drug company also protested that it wasn’t given fair hearing. As it turned out, the chairman was also a judge over a case in which he had served as a witness.
The above were the issues we dispassionately considered and came to the conclusion that the best option was for our people to accept to settle the matter out of court. We appreciate the concern of many people all over the world who have spoken up on the issue but we are no fools. We will still need the help of Pfizer someday. This litigation has given rise to some positive developments as we are going to have a healthcare fund to help rehabilitate our decaying infrastructure. When thousands of our people died again this year from the same meningitis disease the world sadly realized how helpless our people are and how incompetent those who govern us have been. The Governor of Kano State, Alhaji Ibrahim Shekarau, is a shrewd politician; he would never have agreed to the settlement talks if he hadn’t taken a careful look at all the claims and counter-claims. This is not an academic exercise; in fact it is more practical than academic.
The only area where we fear that there could be serious challenges now is in ensuring that the funds achieve the purpose for which they were meant. Our governor has assured us that he will work closely with Pfizer to ensure that politicians don’t see the funds as booty to be shared. We want to monitor all those concerned closely so that from the dark clouds of our present dysfunctional state of healthcare we can look forward to the bright sunshine of a truly responsive healthcare system which would banish curable diseases like meningitis from our borders.
Anonymous
Well said, Hajiahalima. Some of our foreign friends actually mean well, but their support would be even more effective if they check out the facts before making comments. Many of the inaccuracies stem from wire service reports. That itself is curious because any serious reporter can get a copy of papers already filed at the courts. Some foreign 'friends' are even saying the $75 million settlement is too meagre. Such people should gather their own people and queue up for a cocktail of Trovan and chloraphenicol!
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