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FDA Panel Recommends Against 1st Drug for Chronic Fatigue Syndrome
Date:12/21/2012

By Steven Reinberg
HealthDay Reporter

FRIDAY, Dec. 21 (HealthDay News) -- A U.S. Food and Drug Administration advisory committee on Thursday recommended against approval of the first proposed drug to treat chronic fatigue syndrome.

The advisors weighed the risks and benefits associated with the intravenous drug rintatolimod (suggested brand name Ampligen). The drug's maker, Hemispherx Biopharma of Philadelphia, also failed to win FDA approval in 2009 because of concerns about the methodology of clinical trials used to study the drug.

In Thursday's 8-to-5 vote, the advisory panel said the company hadn't provided enough data to support the approval of Ampligen. Although the FDA isn't bound to follow the recommendations of its advisory committees it usually does so.

The central issue Thursday was whether Ampligen works and is safe. The FDA said there wasn't sufficient data in clinical trials to determine the drug's safety. Possible concerns include infections and liver problems, The Wall Street Journal reported.

Several panel members said they struggled with their decisions because it seems the drug works in some patients, the newspaper reported.

Experts have said they would welcome a treatment for chronic fatigue syndrome, a disabling condition that affects as many as 4 million Americans, mostly women. There is no cure, but Ampligen appears to reduce symptoms for some patients.

"It does seem to help at least a subset of patients significantly. For others, there isn't a significant response," said K. Kimberly McCleary, president of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America.

"This drug has been studied in chronic fatigue syndrome since the late 1980s, so it's been around for a while," McCleary added.

Dr. Nancy Klimas, professor of medicine at Nova Southeastern University College of Osteopathic Medicine in Fort Lauderdale, Fla., who is part of a
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