The Associated Press reports that lawyers working on a multi-billion dollar lawsuit against Pfizer are close to reaching a settlement.
Nigerian authorities allege that Pfizer conducted deadly drug experiments in Nigeria's northern Kano state during devastating meningitis outbreak. They claim that the pharmaceutical giant used children there for an unlicensed trial of what it hoped would be a new "blockbuster" drug - a broad spectrum antibiotic that could be taken in tablet form. Pfizer disagrees, insisting that it acted with approval from the Nigerian government and with the consent of the children's guardians.
In 1996, a group of Pfizer employees arrived in Kano under the pretext of a humanitarian mission, just as the meningitis epidemic was peaking. Setting up metres from a MÃ©decins Sans FrontiÃ¨res medical centre, the doctors selected 200 children and administered half with the experimental drug Trovan. The control group received ceftriaxone, a proven antibiotic from a rival company, allegedly in sub-optimal doses. Eleven of the children involved in the trial died, and many more are said to have suffered from complications such as brain damage and organ failure. Pfizer contests that these injuries were in line with typical effects of meningitis and that survival rates of those in the trial were higher than average.
The Independent reports that Pfizer fabricated a letter of permission from a Kano ethics committee. The committee was formed a year after the original trial, and the letter backdated.
At one point during the proceedings over $8 billion in damages was being sought, as well as jail terms for several Pfizer staff. However it looks likely now that the parties have settled on a figure close to Â£50 million.
Trovan is banned in the EU and has been withdrawn from the US market. It is no longer in production.
This is good news, and it will hopefully serve as a warning to others who wish to cut regulatory corners.
As it happens I think that Pfizer is almost certainly right that the deaths and injuries associated with the trial were due to the disease rather than the treatment, and that the treatment helped the trial participants, but that doesn't absolve them from their responsibility for running an unethical trial.
The liver problems that lead to the withdrawel of Trovan, uncommon (less than 1 in 1,000 of patients?) cases of liver problems and several deaths due to those idiosyncratic reactions, are unikely to have been a factor in the Kano trial.
We'd like to think that clinical research associates for big pharma are inherently moral people, so I'm not sure how the CRAs in this case can possibly justify the use of sub-optimal antibiotics in their control samples. It's sick. I'm sure some of them were convinced they were doing something for the greater good.
I recall Mark Thomas (the political comedian) doing a nice expose of pharmaceutical immorality, where some companies were dumping expired or about to expire medicines on developing countries, which they wrote off as charitable donations and therefore tax deductible.
It also means that they could avoid the rather expensive incineration fees, which are mere pennies to big pharam, but which the developing world countries have to fork out to bury or incinerate the unusable medicines.
Mark Thomas pulled a stunt where he dumped Â£10,000 in one penny coins at the entrance to the car park of a pharma co. Seems they didn't want it; he pointed out how disappointed he was that after giving them such a wonderful gift of Â£10,000 they told him to take it away. They said they had no way to deal with it.
I have been a close observer of the Trovan trial case and have really not seen any sense in the allegation of Trovan been responsible for 5 or 11 death and deformities in 189 as bandied around.
There have been reports in recent past of an alarming death toll as a result of the meningitis scourge. I want to believe that some of meningitis victims died regardless of the drug administered on them. Who will then be held responsible for these death or paralysis as the case may be.
I f Pfizer out of being magnanimous seeks to reach out to the Trovan patient and the rehabilitation of the Infectious Disease Hospital on account of the Trovan study, they should be commended and not been seen as paying for its crime.
Yeah, aren't people frustrated with how long it takes to get drugs from the lab and through the approval process and into patients? If those kids had died from liver disease, this would be a different story.
I'm sorry, but I trust Big Pharma over the Nigerian government any day. And I really doubt that settlement will go to the aggrieved parties. Something tells me that some minister or another just got a sweet new palace.