| August 13, 2001
WEST PALM BEACH, Fla. (Cox News Service) - Men and women with a
devastating autoimmune disease are finding themselves elbowing athletes at
their local health food stores for an over-the-counter supplement known
for its muscle-building qualities.
DHEA (dehydroepiandrosterone), also being developed as Aslera by
GeneLabs Technologies, has been found to improve the health of people with
lupus, a debilitating, chronic, autoimmune disease that causes
inflammation of various parts of the body, especially the skin, joints and
kidneys.
There is no known cause or cure for lupus, and no drugs to treat the
disease have been developed in more than 40 years.
Currently, steroids and anti-malarials are used to reduce inflammation
and control rashes and fatigue.
But steroids can have very powerful side effects such as mood changes,
depression, muscle weakness, osteoporosis, high blood pressure and
diabetes.
And anti-malarials can affect the eyes. That's what makes the highly
available DHEA such a sought-after alternative.
"Clinical trials have shown this drug has very few minor side
effects," said Ellen Ignatius, vice president of education and
science information for the Lupus Foundation.
"The fact that this can help decrease or eliminate steroids is
very exciting, but it also builds bone mass. We know people with lupus are
taking it, and it makes us nervous because it's not regulated. Nobody's
overseeing this manufacturing operation."
(Over-the-counter supplements, such as DHEA, are not regulated or
controlled by the FDA because they're not considered drugs.)
The Lupus Foundation has been actively supporting approval of Aslera by
the U.S. Food and Drug Administration to assure that it is of
pharmaceutical quality when purchased by patients, most of whom are women.
Ignatius was disappointed when the FDA failed to approve Aslera in
June. She isn't sure why the government didn't take action.
"Experts were confident on the safety and efficacy of this drug.
We wouldn't step out on something we're not sure about," she said.
"We all went into the (FDA) hearing thinking it's a shoo-in."
On its Genelabs Web site, the developer says the FDA raised "various
issues, primarily relating to the interpretation of efficacy and safety
data submitted in the (new drug application.)
"Genelabs is committed to working with the FDA to address the
deficiencies cited and expects to meet with the FDA promptly to clarify
the issues raised and the steps required to be taken before the (drug
application) may be approved."
Meanwhile, Ignatius is mounting a campaign in Congress to get Aslera
approved.
"The Lupus Foundation is getting behind this," she said.
"These things don't get turned around by magic."
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