The Wall Street Journal - May 15, 1996
Laurie McGinley, Staff Reporter of The Wall Street Journal

The test, called Confide, was developed by a unit of Johnson & Johnson called Direct Access Diagnostics. It will be sold only in Texas and Florida beginning next month at a price of $40 to $50 per kit and will be available nationally in early 1997, according to officials with Direct Access Diagnostics. The test allows a person to take blood at home and send it off to a laboratory, which would deliver the results by phone. Company officials say the test offers a greater degree of privacy and anonymity than a visit to a doctor's office.

Many AIDS activists praised the FDA action. "It might encourage testing among some who might not otherwise get tested," said Brenda Lein, a spokeswoman for Project Inform, a leading AIDS advocacy group in San Francisco.

But others were critical. Christopher Portelli, a spokesman for the National Lesbian and Gay Health Association, which is based in Washington, said his group opposes the test because it precludes the face-to-face counseling that is important when someone learns he or she is infected with HIV. He also said he doesn't believe it will be widely used by some of the highest-risk groups, such as intravenous-drug users.

The FDA, which for years opposed a home-based approach because of the counseling issue, yesterday said the benefits of early detection of HIV infection outweigh any risks posed by the test. "We are confident that this new home system can provide accurate results while assuring patient anonymity and appropriate counseling," said FDA Commissioner David Kessler.

Deputy FDA Commissioner Mary Pendergast said the belief now at the agency is that the public is more prepared to handle test results, especially in the face of some encouraging news on AIDS treatments.

Up to one million Americans may be infected with the human immunodeficiency virus that causes AIDS, and half don't realize they're infected, according to government estimates.

Drug analysts said the test is likely to be a big seller, but not a blockbuster, for Johnson & Johnson. "We would expect several hundred million dollars in annual peak sales four to five years out," said analyst Arvind Desai of Mehta & Isaly.

Indeed, Johnson & Johnson stocks slipped slightly on the news. Shares declined 12.5 cents to $92.50 in composite trading Tuesday on the New York Stock Exchange.

The new test doesn't work like a home pregnancy test, which immediately tells a woman whether she's pregnant. Instead, a person who buys the kit uses an enclosed lancet to prick his or her finger and places three drops of blood on a test card with an identification number. The card is mailed to a laboratory for HIV testing, and samples that test positive are retested to ensure reliability. To get results, the individual calls a week later and punches into the phone his or her identification number.

If the caller's test results are positive or inconclusive, he or she will be connected to a counselor who will explain the results, urge medical treatment and, if necessary, make a referral to a local doctor or health clinic. If the person's results are negative, he or she will be connected to a recording that will note that it's possible to be infected with HIV and still test negative, if the antibodies to HIV haven't yet developed. A counselor will be available for anyone who tests negative and wants to discuss the results.

The FDA said that the kit is as reliable as tests conducted in doctors' offices and clinics.

Nevertheless, Michael Isbell, associate executive director of the Gay Men's Health Crisis, an AIDS-service organization in New York City, said that while his group doesn't oppose the test, it will be "carefully monitoring" its implementation.

"When a person tests positive, he or she needs a real flesh and blood doctor, and we have some skepticism about whether the company is prepared to provide that in every community in the country," he said. He also said his organization is worried that Direct Access Diagnostics, which will be dispensing the results and providing the counseling, might not be adequately prepared "for the small subset of consumers who will experience real emotional distress" upon learning they are HIV positive.

But the FDA's Ms. Pendergast said experience has shown that "you can do suicide prevention and crisis intervention over the phone." In addition, she said, surveys indicate that many patients who go to their doctor don't get in-person counseling with their results, anyway. Some AIDS activists say some doctors have even left bad news on answering machines.

Anita Cunningham, director of marketing for Direct Access Diagnostics, said the company is selling the test kit on a limited basis next month in an effort to ensure that the quality of the counseling is adequate. "We need to find out the level of calls, the length of time it takes to deal with them and the staff that we will need, so that we can answer all calls before two rings are up," she said.

The test will be sold in Texas in drugstores, public-health clinics and on college campuses and through a toll-free telephone line. In Florida, it will be available only through a toll-free telephone number.

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