Saturday, July 2, 2011

Nobody knows how common these seeding trials. You can guess, but you 'd never get it used to be a libel lawsuit lawyer: it' s only leaks and lawsuits that we can be safe.

None of this is illegal. But it is unethical, with serious implications around informed consent. Patients consented to participate, believing this trial was on the risks and benefits of the drug. In fact it was a study of the marketing benefits of a seeding trial. Does that matter? Well, there is the principle of consent, which is important. But also, this isn't a blemishless drug: out of 2,759 patients, 11 died, 73 had serious adverse events, and 997 had side effects. Gabapentin isn't murderous, but this was more serious than trying a new kind of toilet paper.

And on top of that, finally, while doctors were the true subjects of the experiment, they gave no consent to participating. Though it's harder to feel sympathy, as you imagine their vain, insightless, hollow boasting. "Yeah, we're having some great results with gabapentin actually. Did I tell you I'm an investigator on that trial? It's fascinating work we're doing … "

Ben Goldacre

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