Dr. David Healy is an internationally renowned psychiatrist, psychopharmacologist, scientist, and author. He was responsible for submitting the key document that led to New York State's successful fraud action against GlaxoSmithKline. [Q.] Youve written at your blog that evidence-based medicine and RCTs [random controlled trials] are ... simply not the answer to determining cause and effect, [because] theyre quite likely to hide rather than reveal a problem like antidepressant induced suicidality. How in fact do RCTs hide such information? [Dr. Healy:] There are ... specific problems like miscoding, where suicidality becomes nausea or emotional lability or even treatment non-responsiveness. There is also the problem of mislocation " patients on placebo end up being given problems they never had " and of nonexistent patients, who dont of course have adverse events. Beyond that, there are more sophisticated tricks that companies can and do play " such as claiming that increased rates of a problem on a drug are not really evidence of an increase in rates if the data are not statistically significant. In this way, companies have hidden many more heart attacks on Vioxx and Avandia or suicidal acts on SSRIs than have been hidden by miscoding or mislocation. When it comes to adverse events, trials almost never get the right answer. The deeper problem ... is the combination of product patents, prescription-only status, and the use of clinical trials as a means of determining efficacy " in particular, when the data from those trials are not made available. This creates a perfect product ... which industry can manipulate to mean whatever they want them to mean.
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