FDA OKs West Nile Trial Therapy
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WASHINGTON (AP) _ The Food and Drug Administration has approved the first national trial of a drug to treat West Nile virus, which is quickly spreading west and has infected more than 250 people in a dozen states.
The agency cleared the way Monday for James Rahal of the New York Hospital Queens to see whether interferon can lessen the symptoms and duration of the illness in infected patients. Transmitted to humans by mosquito bites, West Nile virus can cause fever, body aches, brain swelling, coma, paralysis or death.
Rahal said the trial studies 40 hospitalized people, aged 50 and over, chosen at random. Younger patients would be enrolled only if they are diagnosed with encephalitis, or swelling of the brain. Outpatients are not eligible.
In a randomized and controlled trial, half the patients will receive the drug and the other half will receive basic care without it. Patients must agree in advance to allow that decision to be made for them.
Sold by Schering-Plough as Intron A, the drug has been shown by lab tests to be effective against West Nile virus.
West Nile first appeared in the United States in 1999, when seven people infected with it in New York died. Nationwide, the CDC has reported 12 U.S. deaths this year from West Nile, eight of them in Louisiana. As of Tuesday, 253 human cases of the virus had been reported to the CDC this year in 11 states and the District of Columbia.
It first appeared this year on the East Coast, but quickly spread west. This week, officials in Missouri, Kentucky and Texas said they were investigating three deaths suspected of being caused by the virus.
On the Net: Centers for Disease Control: http://www.cdc.gov
Food and Drug Administration: http://www.fda.gov