5 ms·

Why do blind studies need the regulation on active placebos to be non rigorous?

• tptacek 14y ago
  Who are you arguing with? Surely not me. But the case you're making isn't the case the blog post made. The blog post suggests, with varying levels of overtness, that there is something shady about active placebos.
  • koide 14y ago
    I'm talking about the quote you used on your comment. That quote by itself does not sound particularly outrageous or ignorant. You should have chosen a different line to illustrate how shady the author thinks active placebos are.
    • tptacek 14y ago
      Outlawing active placebos might be a reasonable course of action?
      • nitrogen 14y ago
        The blog post author may have used the idea of outlawing active placebos as a "door in the face" to make regulating them seem more palatable. At the least, it seems koide is interpreting the second suggestion as having more weight, while you are focusing on the first.
      • koide 14y ago
        I take the sentence to mean "If there are no rigorous controls in place on active placebos, they should be outlawed" which doesn't sound unreasonable.
        • tptacek 14y ago
          It's totally unreasonable; it would be saying "because we don't trust the FDA, we should unblind drug trials".
          • derefr 14y ago
            People threaten people with things that they themselves would find horrible, in order to incentivize the other party, all the time. The US budget sequestration, for example: a bunch of spending cuts none of us wanted, created with the intention of making us pick spending cuts we did want instead so that it wouldn't happen. The idea behind this statement is similar: if the FDA actually pre-commits to a policy saying "either we're going to figure out a huge set of requirements for publishing placebo composition data [huge hassle for us, honestly] or, if we haven't done that by January 2015, no more active placebos"--well, suddenly the drug companies are breathing down the FDA's neck to get those requirements drafted so they can comply with them before it's too late.
      • bigfudge2 14y ago
        Outlawing active placebos would actually be very foolish. Up to 90% of patients and 100% of physicians have been found to have broken blinds in trials of tricyclics, almost certainly because of the side effects. The original article is extremely weak in failing to address this... in fact, drug companies really should be adding ingredients with side effects to their placebos, but won't because it increases the complexity and reduces the statistical power of the trials they run.
        • einhverfr 14y ago
          Agreed, so change advertising requirements. Instead of "compared to a placebo" (which is highly misleading in this case), make the drug companies disclose side effects differently. "In clinical trials, this drug had the following incidents of side effects... An active placebo intended to cause anticipated side effects had the following incidents...." This preserves all of what you can currently get, but it frames the issue so that the average individual does not assume that an on-par comparison means all side effects are placebo effect.
      • einhverfr 14y ago
        I don't think it would be a reasonable course of action. However, I do think that as long as they are relatively unregulated, a much better approach would be to limit inserts and advertising descriptions on the incidents of side effects to absolute proportions, not comparing side effect proportions to those on active placebos intended to mimic expected side effects.