Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
The Associated Press - June 21, 1994
Lauran Neergaard, Associated Press Staff Writer
Three companies are seeking FDA approval for drugstore sales of home test kits for HIV, the virus that causes AIDS. People would send spots of dried blood to a lab and call later for the test results.
Supporters say home testing will increase the number of people who know they're infected so they can get treatment and stop spreading the virus. At least 40 percent of the estimated 1 million HIV-infected Americans have never been tested.
But critics fear some people who learn by phone that they're infected would kill themselves, that children would play with the tests and that employers might use them to secretly--and illegally--test workers for AIDS.
The FDA has convened a special advisory committee meeting Wednesday, where about 80 people will argue the issues.
"You have to look at the macro issues of public health and at what's this going to do to human beings," said FDA Deputy Commissioner Mary Pendergast.
The issue also has big financial implications. Companies stand to make substantial profits from sales of the kits, which would sell for an estimated $30.
Currently, Americans can get free AIDS tests at thousands of clinics, but those clinics are overwhelmed. They expect 5 million requests for HIV tests this year, mostly repeats.
The FDA has long maintained that trained health professionals must do HIV tests and in 1990 it rejected the first planned AIDS home test kit.
Now, "lots of things have changed," Pendergast said.
Today people often learn HIV test results over the phone because clinics are too busy to see them in person. There are more drugs that HIV patients can use to try to stave off AIDS.
But the FDA still has questions: Does telephone counseling really work? Still people use home kits properly? Will the labs test accurately? How will home testing affect tracking of the AIDS epidemic?
Manufacturers insist the tests will save lives.
"The enemy is the virus," not private competition to clinic testing, said Elliott Millenson, whose Direct Access Diagnostics created the Confide HIV test.
The bright blue box contains AIDS information written by former Surgeon General C. Everett Koop and detailed, illustrated instructions telling users how to prick a finger and carefully dab three blood spots on the special paper.
Seven days later, people would call the lab, identifying themselves with their kit's unique code. Those who aren't infected would hear the news from a recording that gives information about staying HIV- free. People who are infected would talk to a counselor who would discuss HIV and refer them to a clinic or national AIDS hot line.
Copyright (c) 1994 - Associated Press. Reproduced with Permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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Copyright © 1994 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
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