MrsSpringsteen
Blue Crack Addict
http://www.cnn.com/2005/HEALTH/11/03/home.aids.test.ap/index.html
"The government panel, the Food and Drug Administration's Blood Products Advisory Committee, heard opinions on whether the test should be made available over the counter.
An FDA scientist said the privacy and convenience of the test is a potential boon in that it could lead to more people seeking treatment earlier during the course of the illness, but the agency needs more information before the kit can be approved for sale directly to the public.
"Anonymous testing potentially leads to more people knowing their HIV status," Elliot P. Cowan, a product review chief at the agency, told the committee.
Still, Cowan raised a number of concerns to the panel, a group of independent experts who can recommend to the FDA whether to approve the product. The panel was not asked to make such a recommendation Thursday but may in a future meeting. The final decision ultimately rests with the FDA.
The possible availability of the test, which relies on a swab on the inside of the mouth, has raised concerns about the potential psychological impact on people who learn they have the virus with no doctors or counselors present.
In that vein, "the biggest issue that has come up repeatedly is suicidal tendencies," Cowan said. "
The test is accurate more than 99 percent of the time, the company says. Still, a few people will get a positive result when they don't have HIV, and anyone who gets a positive result should be confirm it through an additional test by doctors or public health officials, the company said.
"The government panel, the Food and Drug Administration's Blood Products Advisory Committee, heard opinions on whether the test should be made available over the counter.
An FDA scientist said the privacy and convenience of the test is a potential boon in that it could lead to more people seeking treatment earlier during the course of the illness, but the agency needs more information before the kit can be approved for sale directly to the public.
"Anonymous testing potentially leads to more people knowing their HIV status," Elliot P. Cowan, a product review chief at the agency, told the committee.
Still, Cowan raised a number of concerns to the panel, a group of independent experts who can recommend to the FDA whether to approve the product. The panel was not asked to make such a recommendation Thursday but may in a future meeting. The final decision ultimately rests with the FDA.
The possible availability of the test, which relies on a swab on the inside of the mouth, has raised concerns about the potential psychological impact on people who learn they have the virus with no doctors or counselors present.
In that vein, "the biggest issue that has come up repeatedly is suicidal tendencies," Cowan said. "
The test is accurate more than 99 percent of the time, the company says. Still, a few people will get a positive result when they don't have HIV, and anyone who gets a positive result should be confirm it through an additional test by doctors or public health officials, the company said.