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New Darwinian test method uncovers an antidepressant's hidden toxicity

Stashed in: Mental Health, Darwin

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Many comments here seem to be missing the main point of the study, which is that the researchers are demonstrating the utility of a novel method for drug development. Yes, they do engage in discussion about paroxetine because that is the drug used in the study, but their primary focus is more methodological than clinical.

From the paper’s introduction:

“On average, 73% of pharmaceuticals fail during clinical trials (Lipsky and Sharp, 2001) and 10% of FDA approved pharmaceuticals are recalled after market release (Schuster et al., 2005), despite the 12–15 years of research and $1.4 billion average cost associated with each drug during development (Miller, 2012). One cause of the high pharmaceutical failure rate is the inability of current toxicity assessment methods to detect cryptic, or otherwise undetectable, adversities during preclinical trials, particularly those present at doses near therapeutic levels and/or those occurring at low incidences. . . . We have developed a novel toxicity assessment research method that may be useful during preclinical assessment, known as the organismal performance assay (OPA)” (p.47).

From the paper’s discussion:

“There is currently a great need for additional toxicity assessment assays that evaluate toxic substance exposure on an organismal level. The data presented here suggest OPAs can help fulfill this role and may be useful as during pharmaceutical development and if applied, have potential to increase the detection rate of harmful substances during preclinical trials,” (p.52).

TL;DR: If you are interested in methodological innovations that might help science to progress at a faster rate, this study should be exciting to you (regardless of whether or not you are in favor of antidepressants).

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