If There's A Hell, I Hope It's Spacious
Pfizer has reached a broad agreement to pay millions of dollars to Nigeria's Kano state to settle a criminal case alleging that the drug company illegally tested an experimental drug on gravely ill children during a 1996 meningitis epidemic. ...
Nigerian authorities say Pfizer's infamous trial of the antibiotic Trovan killed 11 children and disabled scores more. The world's largest drug company says the deaths and injuries were the result of meningitis.
The response by Pfizer is a curious one. The children died of meningitis, the very infection their drug was supposed to cure. Something about that logic appears, at the very least, to be quite tortured. That might be because of the backstory:
Details of the drug trial were first made public more than eight years ago in a Post investigative series. The articles reported that the trial did not conform to U.S. patient-protection standards and that the oral form of the drug used in the trial had not been previously tested in children. Pfizer had no signed consent forms for the children, the articles said, and the company relied on a falsified ethics approval letter. Researchers also gave children substandard doses of a comparison antibiotic, the articles added. ...
Trovan was never approved for use by American children. The Food and Drug Administration approved it for adults in 1998 but later severely restricted its use after reports of liver failure. The European Union banned the drug in 1999.
Nice. Pfizer didn't take the standard and required steps for such a trial. It falsified a key document. It even messed with the dosage of the comparison drug, one that might have been less dangerous and more effective than Trovan. What the company did was go to a Third World country where it assumed it wouldn't get busted for such horrendous behavior. I mean, who cares about Nigerian kids?
And the time line is certainly interesting. The drug trial in Nigeria took place in 1996, and was clearly designed to be part of the research which would get the company FDA approval for the drug, which it got in 1998, but only for adults. However, the side effects even for adults were so bad that the FDA placed restrictions on its use and Europe banned it completely.
Twelve years later, Pfizer finally agreed to settle the criminal case by paying a fine, apparently of $75 million. In the general scheme of things, that's peanuts, and Pfizer knows it. The company is getting off cheaply, so cheaply that it no doubt made the whole escapade worth it.
Words fail me.