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by pleiotrope
4884 days ago
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I think you're correct. The example given in the linked article mentions dry mouth, but it's arguably important in double-blind studies to have both the controls and test groups develop similar side effects, to prevent both the patient and the administering physician from determining which is the placebo group. I don't think it's entirely due to nefarious motives from the drug company. |
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If the physician can effect the trial by knowing to whom they're administering the placebo it seems that the trial lacks in its design. Someone else said that the person administering the drug/control could repeat a test because they felt the result was wrong - why is such a person involved in a drug trial? If they lie about that then it seems they can pervert the trial any number of ways.
How do the patients know how the other members of the study are being affected? If they don't get a dry mouth, but the drug company thinks they should, how does the patient know?
Surely you need the physicians and patients to record exactly what happened, no more and no less.
It seems that you're doomed to fail if you don't know that this is what's happening: suppose you use an active control that dries the mouth (for 95% of patients), if you don't have the side-effect with the drug on test then you know you're part of the active group with a high enough confidence level to alter the results in a qualitatively similar way to using a non-active control (placebo).
So what you need is a placebo that matches exactly the profile of the side-effects of the drug. I'd warrant that's impossible - you don't know the side-effects of the drug that are expected in a wide scale longitudinal study because that's what you're testing isn't it?
What is entirely nefarious is any use of "no significant side-effects beyond that experienced under placebo" when in fact they don't mean placebo but "active-control".
Placebo may be synonymous with active control in Pharma circles but it's not in common usage and so this is still a fraud.