Methodological Miasma not mental dystrophy plagues drug trials

by Arthur Caplan, Ph.D. and Bruce Levin, Ph.D. The Wall Street Journal and many other media outlets chose to beat on the FDA for its recent decision to deny approval of eteplirsen, a treatment for Duchenne muscular dystrophy being developed by Sarepta Therapeutics. Actually it was the FDA’s scientific advisors not the FDA who concluded that there wasn’t sufficient evidence the drug was effective. Still the WSJ sneered that “Here’s the gist of FDA’s objection: 12 patients are too few, and thus we don’t know if the drug helps boys walk longer or if the results are skewed.…
Source: blog.bioethics.net - Category: Medical Ethics Authors: Tags: Clinical Trials & Studies Featured Posts Media eteplirsen Sarepta Wall Street Journal Source Type: blogs