San Francisco Chronicle - Wednesday, January 13, 1999
Carl T. Hall, Chronicle Science Writer

Regulators say they are becoming increasingly concerned about the questionable reliability and potential misuse of self-test kits for the AIDS virus.

Only one test for the home-use market, called Home Access, has been approved by the U.S. Food and Drug Administration. But dozens more can readily be found on the Internet, offering quicker results for less money.

No one has a clue as to how many people might actually be relying on such tests. But even if the customers are few, experts view do-it-yourself HIV tests as one of online medicine's more hazardous sub-specialties.

"We don't know much about a lot of these tests," said Dr. Bernard Branson, an HIV-testing specialist at the Centers for Disease Control and Prevention in Atlanta. "Some of them may be OK. Some are not."

Concerns about the growing Web trade in health products came to the forefront last year when several sites began offering the impotence pill Viagra without requiring prescriptions.

In the case of Viagra, customers at least knew what they were getting. That's not necessarily true when you order a self-test for HIV from unknown providers online.

Even if a test gives an accurate result, users may have trouble evaluating what it really means. Someone newly infected, for example, may not realize a negative test means only that antibodies haven't had a chance to develop -- and may go on spreading the virus to others.

Growing access to do-it-yourself HIV tests "raises several concerns," said Dr. Herminia Palacio at the San Francisco Department of Health. "People may be led to assume they can go ahead and have unsafe sex."

Both the FDA and the Federal Trade Commission, which share jurisdiction over health-related marketing practices, are taking a keen interest. However, many of the internet merchants appear to be based overseas, and come and go too fast for regulators to keep pace.

All the kits are designed to pick up antibodies to HIV, which can be found in samples of blood or, less reliably, in saliva.

Kits can be ordered on the Web for about half the price of the FDA- sanctioned kit, a $49.95 "test system" called Home Access Express. A Chronicle reporter was mailed one of the nonapproved HIV test kits after placing an order online and agreeing to a $24.95 credit-card charge, plus $3.95 for shipping and handling.

The test came with an English- language label pasted on top of an original label printed in Russian. The package was shipped from Malta by a European company, Health Diagnostics Ltd., with offices in London, computer equipment in France and a Belgian president, Charles Dupont, who said he was in Monaco when he was interviewed by telephone.

"We're providing a needed service," Dupont said, calling his Web site an electronic evolution of border-town pharmacies in Mexico, which may legally sell drugs to U.S. citizens for personal use.

"There is no law preventing us from responding to an order," he said, "as long we are not importing in bulk or using a distribution center in the U.S."

His Web site promotes the kit as offering "extremely accurate" results almost instantly, "equal to, or better than, FDA-approved laboratory assays."

However, the test kit included no details to back up the reliability claims. Independent experts said that FDA-sanctioned test systems actually provide much more reliable results.

Unlike the other kits, the FDA- approved Home Access product limits what is done at home to collecting the blood sample. The testing is done at the company's lab, using an identifying code to protect anonymity. You call in for results three days later.

You can get counseling or service referrals over the phone should you test positive. That's not the case with the online competitors, which emphasize fast, private results but leave the consequences up to the individual.

Dupont claimed his company's test has been proved reliable after extensive use in several countries, including Russia, where some "pick- up bars" offer customers bowls full of HIV test kits to take along with a potential new partner.

He also said it's legal for him to promote the product on the Internet and to fill orders placed by U.S. residents. The FDA, he said, has no control over such private matters.

Tests for the AIDS virus would seem to be of little use if the customer lacks confidence in the results. Dupont admitted that sales have been minimal so far in the United States -- only about 800 kits in the first few weeks the Web site was up and running.

"If consumers are educated to understand why FDA approval is important and what it means, then it shouldn't be such a hard sell," said Dr. Helga Rippen, director of the Health Information Technology Institute, a Pennsylvania nonprofit research organization.

"The problem," she added, "is that many companies are not comfortable using the Internet and may not know how to effectively use it to market and sell their products while complying with FDA rules on advertisements." The stakes, meanwhile, are growing.

Worldwide, the number of people using the Internet is projected to hit 233 million by next year, up from just 12.6 million in 1995. Find/SVP Inc., a consulting firm, estimates that 36.7 percent of Internet surfers are looking into health matters such as AIDS and HIV.

Not surprisingly, the flourishing online competition is a big concern to Home Access, maker of the FDA- approved test kit. The company claims it spent about $20 million and more than three years to get its product on the market.

"Certainly it's frustrating to us," said Michael Wandell, chief scientific officer. "What concerns me more is that a lot of people are going to get results from unapproved tests that lead them into thinking they are not infected, and go on infecting others, or they will be convinced they have a horrible disease when they really don't."

The FDA has issued detailed warnings to consumers against relying on unapproved do-it-yourself tests to determine something as important as HIV status.

Lenore Gelb, a spokeswoman for the FDA, said that HIV test kits are considered medical devices subject to the agency's jurisdiction.

In September 1997, the FDA advised pharmacies to pull from their shelves two "unapproved, fraudulently marketed" home-use test kits for the AIDS and hepatitis A viruses. The company involved had listed a Bay Area address but quickly disappeared.

"The FDA has a big task trying to control this," Wandell said. "I think they're aware of many of these things that are going on. But it's like a floating crap game. It's a big test to keep up with somebody operating in the Bahamas who's sneaking things into the United States."

CLINIC TESTING

While you can pay nearly $50 to test yourself for the AIDS virus, confidential blood tests for HIV are offered at many health facilities. If you believe you may have been infected, note that it may take a month or more for antibodies to develop. So you may test negative right after exposure but still be infected -- and capable of passing the virus to others.

In San Francisco, the AIDS Health Project provides free testing services at three locations. Call 502-TEST to make an appointment. Results are kept confidential and you need not divulge your name. More details on testing and other HIV-related services are available by calling the California AIDS Hotline, (800) 367-2437.

CHART: TESTING FOR HIV

Do-it-yourself HIV test kits promise instant results at a lower cost than the only FDA-approved kit, but health officials are worried about misleading ad claims and questionable reliability of some tests.

-- FDA-Approved Test

Home Access Health Corp. makes the only home-test system that has been evaluated by the U.S. Food and Drug Administration

-- Kits are widely available in retail outlets and by direct order for about $49.95

-- Users take their own blood sample. Kit includes a prepaid mailer to send sample into lab for testing.

-- Results, along with counseling and service referrals, are available by phone in three days. Access code is used to ensure anonymity.

-- Unapproved Tests

Several Web sites promote HIV test kits that promise instant results.

None are FDA-approved.

-- Promoters assert the tests are reliable, but federal health officials are concerned about the danger of false results.

-- Quality may vary from one kit to the next depending on manufacturing standards. Errors also may occur from shipping or handling conditions.

-- Users are on their own to interpret results and seek appropriate services.

-- A Need For Testing

-- Total number of HIV-positive individuals in U.S.: 700,000

-- Number unaware of HIV-positive status: 300,000

-- Percent of those at highest risk for contracting the AIDS virus who have not yet been tested: 60%

Table 1: Reasons why people got tested(x) Percentages

Unknown or other	19%
Solely to determine HIV status	30%
Hospitalization or surgery	12%
Employment	6%
Military induction	6%
Referral by doctor, health department or sexual partner	7%
Immigration-related reasons	4%
Application for insurance	16%

(x) - Excluding tests given when donating blood Chronicle Graphic, Photos by John O'hara / The Chronicle

Sources: AIDS Action; UCSF Center for AIDS Prevention Studies
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Always watch for outdated information. This article first appeared in 1999. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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