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Lyme Disease symptoms vary from person to person. (lymes disease lyme's disease lime disease limes disease)
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The Los Angeles Times
Los Angeles CA
December 20, 2004
IN THE LAB
Therapy targets cause of chronic fatigue
By Linda Marsa, Special to The Times
Sufferers of chronic fatigue syndrome are plagued with flu-like
symptoms, joint and muscle aches, a loss of mental acuity and such
profound lethargy that even routine activities can be exhausting.
But the debilitating disorder has no known cause or specific treatment.
An experimental therapy may change this bleak prognosis by lifting the
mental fog and increasing physical stamina. For some patients, this
could mean a return to normal existence.
"I'm hopeful this drug will meaningfully improve people's quality of
life," says Dr. Nancy G. Klimas, an immunologist and chronic fatigue
expert at the University of Miami School of Medicine in Florida. "These
patients are often desperately ill."
Chronic fatigue afflicts an estimated 500,000 to 1 million Americans,
more than half of whom are women. Symptoms can include headaches,
forgetfulness, impaired concentration, dizziness, sore throat, fever,
muscle weakness, night sweats and an inability to achieve restful sleep.
Although experts are unsure what triggers the symptoms, they suspect
that a chronically hyperactive immune system is to blame. The immune
system appears to saturate the body with killer cells and proteins that
normally are dispatched only when repelling a bacterial or viral invasion.
Doctors use a variety of therapies, such as antidepressants and pain
relievers, to relieve symptoms, but the experimental treatment Ampligen
could become the first that targets the illness' underlying cause.
The injectable drug is composed of synthetic genetic material that is
similar to a virus.
"The body interprets this drug as a virus and reacts accordingly," says
Dr. William A. Carter, a co-inventor of Ampligen and chief executive of
Hemispherx Biopharma Inc. in Philadelphia, which makes the drug.
Exposure to the synthetic virus prompts the body's immune system to
produce interferons, which are proteins that combat viruses and dampen
an overactive immune response.
Recent test results were encouraging. In a 40-week study, 234 people
with severe chronic fatigue were given either twice-weekly injections of
Ampligen or a dummy shot. The treated patients experienced a 21%
improvement on a treadmill test (a measure of exercise capacity),
compared with about 5% in the placebo group.
In addition, the Ampligen group reported feeling sharper mentally; about
80% stopped or reduced their use of other medications, and a handful
were able to go back to work.
Although the overall findings show a modest benefit, "these are people
who normally can't do anything strenuous without getting sick, and the
majority of patients experienced an improvement in their most
difficult-to-reverse symptoms," says Dr. Lucinda Bateman, a chronic
fatigue specialist in Salt Lake City who helped test Ampligen.
The company hopes to have Ampligen on the market in 2006.
"I'm excited but cautious," says Klimas. "This drug is quite beneficial
for some patients, and the next step is to figure out how to predict
which ones this can truly help."
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