4 ms·

The purpose of the FDA is quite different from that of a journal; why would you expect the information needed for each to perform its function to be the same?

• aneth4 14y ago
  Because how can you have peer review of a study if an essential and complicated part of the study is not published. If only the pharmaceutical company and the FDA review placebo technique, then the study has not really been peer reviewed and placebo techniques are a mysterious black box.
  • kvb 14y ago
    Is placebo design actually complicated? Other posts have indicated that you just have the manufacturer of the drug leave the active ingredient out of the normal formulation (so that all fillers, etc. are identical). If this is an important but well-understood aspect of study design (and ultimately vetted by the FDA), then a reviewer's time is better spent looking at the novel or error-prone aspects of the study. Is there any evidence that poor placebo design is a problem in practice, or is this a theoretical concern?
    • aneth4 14y ago
      There is probably not much evidence because that which would constitute evidence is held effectively in secret. There is no way for the scientific community to look for flaws in methodology. Flaws in research methodologies are often found, sometimes years later, so it's to be expected that at least some placebos are making studies inaccurate perhaps dangerously so, and it's also to be expected that we will never know which studies are compromised since the data is not published publicly. Yes, placebo design is extremely complicated and often involves active ingredients intended to simulate side effects and treatment experience without treatment effects. There is quite a bit written in the comments here. For instance, it would be quite easy for a company to fake efficacy accidentally or intentionally by using a placebo that inhibited natural healing or even made the treated condition worse. The control group would fare worse than the treated group, and the drug could advance toward the market. There is a massive economic incentive for this sort of cheating, and I don't think we can presume pharmaceutical companies are above economic incentives.