San Francisco Chronicle (SF) - SUNDAY, December 18, 1994 Edition: SUNDAY Section: Sunday Chronicle Page: S1/Z1 Word Count: 1,561
Elaine Herscher, Chronicle Staff Writer

The first over-the-counter HIV test kit is making its way through the federal Food and Drug Administration review process and could be on drug store shelves by summer.

If all goes as expected, it will be the first time people will be able to test themselves at home for the beginning signs of a terminal illness. For some, this raises questions about how helpful it is for people to receive potentially devastating news in the privacy of their homes without medical or emotional support.

The kits have also resurrected controversies over privacy and confidentiality that have yet to be resolved. Nothing in the decade since a blood test for the virus was first developed has so divided the AIDS care providers over the appropriate way for people to learn they are HIV-positive.

"The potential mine fields are not as ominous as those in the early '80s, but they do bring back those dialogues about how people are going to be affected," said Charles Nelson, an attorney for the National Minority AIDS Council. Nelson served on an FDA advisory committee, which last summer ruled that the benefits of home HIV tests outweigh the risks.

Two types of tests are making their way toward consumers. The test kit likely to hit the market first, called Confide, involves sending a blood sample to a lab and calling for a result using an ID number. Another test, OraSure, is done by collecting saliva on a cotton swab and could be used by outreach workers on street corners and in bars, although it is far behind the blood test in the approval process. The home test issue has pitted AIDS service providers -- who fear a home test will not provide for adequate counseling and referrals -- against those who argue that the greater the opportunity for testing, the better the chances of preventing the spread of the virus.

In testimony before the FDA, former U.S. Surgeon General C. Everett Koop, a consultant to the manufacturer, called the home kits "the single most important weapon we can use to fight AIDS."

He is joined in that opinion by many notable AIDS experts, including Dr. Donald Francis, who served for 21 years at the federal Centers for Disease Control and Prevention and is now a key researcher in the search for an AIDS vaccine. National organizations such as the NAACP are also calling for the test's approval to extend testing opportunities into minority communities.

Many of the people with the highest risk of contracting HIV are those most alienated from the medical system -- poor people, injection-drug users, teenage runaways. A CDC study revealed that 41 percent of HIV diagnoses last year were made postmortem. Many of the people who died untested may have been unaware of their options to use free county testing services or were afraid to enter a medical facility. Since the FDA hearings, a wide range of AIDS clinics and community-based prevention and education agencies have weighed in against a home test, arguing that phone-in results are no substitute for face-to-face counseling. People who lack a basic knowledge of AIDS -- such as the fact that many HIV-positive people live healthy lives for many years -- may be vulnerable to dangerous behavior, including suicide.

"The decision to break the connection between the diagnosis of disease and the health-care setting must be made with great care," the National Association of People with AIDS wrote in its position paper. "Testing in the absence of education that accurately and clearly conveys the ramifications of both positive and negative test results is unethical and destructive."

Several HIV test kits have been submitted for FDA approval, but the one furthest through the pipeline that insiders say will definitely be approved is Confide, developed by Direct Access Diagnostics, a subsidiary of Johnson & Johnson. The test kits will be priced at between $30 and $40, and consumers will buy them at drugstores, just as they buy home pregnancy tests or kits to measure blood sugar.

The user would prick a finger with a lancet, drip three drops of blood onto a special card and mail it to a lab. After two weeks, the user calls a toll-free number using a code number provided in the kit to protect anonymity. If the test is negative, the caller gets the results by taped message. If it's positive, the call goes through to a counselor who will advise the caller on AIDS services in that person's area.

Although the test's detractors worry about the depersonalized way an HIV-positive person will get the news, those who support home testing point out that personal counseling is in no way guaranteed in a doctor's office or in public health clinics, which are overwhelmed across the country.

Only 14 percent of people tested receive counseling when they get their results, according to CDC data. More than half of all HIV-positive people do not get tested until they are very sick. When queried, 8 percent of those who have not been tested said they would do so using existing options, but more than three times that many people -- 29 percent -- said they would get tested if a home kit were available.

"The current system, according to experts, is not working as well as it should be," said Elliot Millenson, president of Direct Access Diagnostic. "According to the CDC study, 39 million Americans will get tested if the test is available. I think this test has tremendous public health potential."

But many AIDS service providers argue that the home test crosses a boundary that has never been breached before, potentially with disastrous consequences.

"What other test kit for what other disease is being made available to the public with no questions asked? There are none," said Christopher Portelli, executive director of the National Lesbian and Gay Health Association. Consumers can buy home pregnancy test kits and can test their blood sugar, but there has never before been a do-it-yourself test for a condition as serious as HIV infection.

"I've heard this framed as a matter of patients' rights, but the reason we don't have an over-the-counter leukemia or cancer test is there is a sense of ethical responsibility, that the person be equipped emotionally and intellectually," Portelli said. "I don't think it's paternalism. I think it's responsible health care."

Portelli and others question the level of training of the phone counselors, whether counseling will be available in Spanish or other languages, whethercounselors will have up-to-date referral lists and will be qualified to handle distraught people. They question whether people who test negative will understand they are still at risk if they are engaging in unsafe behavior.

And they worry that all the hard-won protocols to guarantee privacy and confidentiality for HIV-positive people could be jeopardized. They say they see potential for abuse -- employees being tested without their knowledge and teenagers coerced by their parents.

"I don't think it's appropriate," said Juanita Quintero, director of AIDS services for the Latino AIDS Project in San Francisco. "There's no guarantee that the blood is being sent by the person. Husbands could be testing wives, wives testing husbands."

Many national organizations representing people of color argued in last summer's hearings that keeping a test off the market is a form of genocide aimed particularly at minorities who are reluctant to go to public health clinics for testing. But minority communities remain split over the home-test issue.

Quintero and others who work with African American and Latino populations warn of the potential for misuse. She recalls that the 1987 federal immigrant amnesty program, which gave immigrants in the United States illegally a chance to become citizens, involved a complete physical exam, including an HIV test.

There were many documented cases of immigrants being informed of their HIV status by Immigration and Naturalization Service employees who knew so little about HIV they were frightened of getting AIDS by being in the same room with a person infected with the virus. Quintero said she worries that a repeat scenario might occur with non-English-speaking people failing to get appropriate advice and counseling.

Direct Access Diagnostics is precluded from commenting during the product review process on any safety or efficacy improvements they may make. However, FDA spokesman Arthur Whitmore said the agency is looking into the product's accuracy and safety and the caliber of counseling and referrals.

As the product makes its way toward drugstore shelves, AIDS vaccine researcher Donald Francis said he is perplexed about why there is even a debate over licensing home HIV tests.

"Why . . . do we continue to ponder stuff when there's an epidemic going on? As long as the quality of the test in the lab is high and the quality of counseling is high, then why not let the market decide if it's a good thing?" Francis said. "You'd think the public would be opening their arms to anything that helps with prevention."

CAPTION: PHOTO C. Everett Koop, called the kits an "important weapon' in the fight against AIDS

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