FDA Panel Reopens Debate on Home AIDS Test Kits : Medicine: Advocates say the home testing could save or prolong lives. Opponents fear abuses and even suicides without counseling given by clinics.

The Food and Drug Administration Wednesday reopened the controversial debate over whether to approve home AIDS test kits, an idea that was rejected four years ago.

During a daylong hearing before the agency’s blood products advisory committee, advocates predicted that the availability of a home test kit would encourage more people to be tested--thus prolonging or saving additional lives--while opponents argued that the kits hold the potential for abuses, possibly even dire consequences, particularly in the absence of face-to-face counseling.

The tests do not work like home pregnancy tests, in that results are not immediately available. They are, in fact, home collection kits, meaning that an individual takes a blood sample at home, mails it to a lab and then calls a week later for the results.

“Testing is all we have, testing is what we must do,” said former Surgeon General C. Everett Koop, a consultant to Direct Access Diagnostics, a subsidiary of Johnson & Johnson, developer of the leading test kit. “We cannot only triple the volume of people who are tested, but we can do it without government budgets and without government bureaucracies.”

But Marion Brown, director of HIV counseling and testing for the Whitman Walker Clinic, a gay and lesbian health services center in Washington, warned: “I shiver when I think of people getting tested for HIV without the benefit of face-to-face pretest counseling and then receiving their test results over the phone.”

The panel is not expected to make a recommendation immediately. Although the FDA is not bound by the committee’s advice, it typically wields considerable influence in the agency’s final decision-making.

The FDA acknowledges that the climate toward the idea has begun to change. Many who initially had opposed the concept of AIDS home testing have said they now believe that the potential benefits are greater than the risks and that the availability of testing kits could fill critical gaps that now exist.

Many clinics, backed by federal funding, offer free or inexpensive tests to those who cannot otherwise afford them. But the wait for an appointment often can be as long as six weeks, with another several weeks before results are available. Approval of home testing would not affect the existing system.

Proponents of the kits said that they offer an opportunity for privacy that the clinics--or personal physicians--do not provide, especially for those who live in small towns or rural areas. Also, the kits would make testing easier for individuals who cannot obtain transportation, child care or even time to get to a clinic, they said.

Furthermore, they cited statistics from the Centers for Disease Control and Prevention that show 24% of those who thus far have failed to be tested would use such a kit.

CDC figures also indicate that a significant percentage of people who undergo testing fail to receive the appropriate counseling under the current system, the proponents said.

Mary Fisher, the prominent Republican who heads the Family AIDS Network, was infected by her late husband, whom, she said, never took the test. She said that knowledge of his infection might have prevented her from becoming infected.

“I wonder whether such an option (the home kit) might have saved my life,” she told the panel. “Two out of three people at risk have never been tested. I can put a name on one of them. His name was Brian. We shared a marriage and two sons and eventually one virus.”

Despite these arguments, critics of the kits said they were worried that the impersonal nature of the process would result in an increased risk of suicide among HIV-positive individuals, or that children or teen-agers would use the test without understanding its implications.