http://www.medpagetoday.com/InOtherWords/36767
Selected paragraphs here, rest at the link.
Patient advocates of the rare disorder chronic fatigue syndrome (CFS) filed up to the podium during the public hearing portion of an FDA advisory committee meeting last month on a drug for the condition.
Here is where all those patient advocates failed: They based their pleas to the FDA on emotion rather than scientific data.
They told stories about how much a treatment was needed for CFS and offered anecdotes on how rintatolimod helped them regain some small amount of normalcy in their life.
Patients spoke about how CFS causes them to sleep their lives away and how the drug offers a sense of hope for a patient community struggling for help.
But the FDA doesn't base its decisions on emotion. It approves drugs whose benefits outweigh the risks, and rintatolimod had questionable evidence for both.
Those 30-some patient advocates didn't seem to care or understand that fact.
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