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Health Supplement A Hit Among Lupus Sufferers

August 13, 2001

WEST PALM BEACH, Fla. ( 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. "

Copyright 2001 News Service. All rights reserved