Monday, April 27, 1998
Chronic fatigue syndrome (CFS), an unexplained fatigue not due to
exertion and not relieved by rest, is recognized by the U.S. Centers for Disease Control
and Prevention and treated through a variety of pharmaceutical and psychological means.
Unfortunately, CFS has no validated biochemical markers and is diagnosed by assessing
symptoms and eliminating other possible medical conditions.
The challenge for companies running clinical trials is thus to design
studies with sufficiently rigorous entry criteria and end points to pass regulatory
scrutiny. In the upcoming Phase III trials of its Ampligen nucleic acid-based antiviral
agent in CFS, Hemispherx Biopharma Inc. (HEB, Philadelphia, Penn.) must use end points
that do not directly measure disease state to demonstrate improvement since CFS is a
subjectively diagnosed disorder with possibly multiple underlying causes.