Fear of AIDS Means Big Bucks for Makers of Home HIV Test Kits

by Nicolas Sheon

Home HIV test kits have been around for over a year in the US. The two major brands are Confide (Johnson and Johnson) and Home Access Kit (Home Access Diagnostics). Confide was pulled off the store shelves in June 1997 for lack of sales. Home Access is now in a position to monopolize the market.

Home test kits are very expensive. If you and your partner want to get tested, this could mean up to $100! The alternative is to call the local AIDS hotline in your area and get a referral to a free test site. Many test sites offer drop-in hours, and some offer "women only" clinics.

Some advertisements for HIV testing companies offer test results in just a few days, but often at a high price. Be warry of these places because you cannot be sure of the level of quality control in such a rushed labratory environment. For home test kits, the turn around time is very tight since they have to get the sample in the mail.

Only one home test kit is approved by the FDA, the Home Access Kit. The FDA has written a helpful guide to help consumers interested in home HIV testing make the right choice.

Accurate HIV antibody testing takes time because positive tests must be confirmed using several different testing methods. The first test performed on your blood sample, the ELISA, has a slight tendency to produce false positives. Therefore, positive ELISA results must be confirmed by a Western Blot Test which requires time and expertise to perform correctly. Never rely on preliminary test results that have not been confirmed by a Western Blot test. Test kits offering results in a few days may not do all the confirmatory tests needed. Here is more information on HIV testing methods and accuracy.

Home testing industry is not prevention oriented, it is profit oriented. They offer almost no information on the window period, safer sex, or how their counseling service works. For a critical perspective on the type of counseling offered by these companies see the article, "HIV Home Tests and Youth: For a Testing Controversy, Press 1" that appeared in Bridges Newsletter (HIFY).

Their advertizements target mostly low risk heterosexuals, not the high risk groups they claim to serve. When I called to get information about the Confide test, all I got was a recorded voice asking for my credit card number. How anonymous can that be?

By contrast "free" test sites are either anonymous or confidential. They are offered at many family planning clinics and sexually transmitted disease (STD) clinics. They are usually funded by the Center for Disease Control by way of your local health department. They are staffed by experienced test counselors who can answer your questions and provide ideas and referrals on a lot of issues besides the test. These include issues like birth control, STD's, the relative risks of different kinds of sex, safer sex techniques, and under what conditions it's okay not to use condoms with your partner.

Most publicly funded test sites provide results in 2 weeks, but some take only one week, as does the Berkeley Free Clinic. Knowing that the tests will be performed accurately by a reputable laboratory is well worth waiting a few extra days.

Home testing also rases a number of ethical concerns. One of the most important functions of a test counselor is to determine that the person requesting the test is doing so voluntarily. With home testing, there is no way to know whether the person sending in the sample is the source of the blood. This means that there is no way to determine over the phone that the person whose results are being disclosed ever consented to be tested. Imagine the possibilities for coercion and pressure between groups of friends, lovers or spouses.

Giving results over the phone is also problematic since anyone with the access code from the test kit can get the results. However, with a face-to-face test result disclosure, the person getting the result can be visually matched with the demographic information of the person who tested, yet still remain anonymous.

Granted, counseling over the phone can be just as good as face-to-face counseling. But getting a positive result over the phone is very risky. Without eye-to-eye contact, there is no way to know that the person is listening or what counseling messages should be prioritized for that particular test client.

A person receiving a positive result can hang up on a phone counselor, but not one right in front of you. A test site counselor can give you not just emotional support but also a packet of information with the best medical and counseling referrals in your area. A phone counselor can only recommend places over the phone, hoping you are in a state of mind to write them down.

 

Here are some news clips about Home HIV test kits collected by the Centers for Disease Control AIDS Daily Summaries.

"FDA Warns Consumers Against Internet HIV Kits"

Newsbytes Online (08/11/97)

The Food and Drug Administration has cautioned consumers about the risks of buying HIV home testing kits online. The agency's Center for Biologics Evaluation and Research has posted information about which tests are approved on the World Wide Web at http://www.fda.gov /cber. Information is also available via the FDA's Office of Special Issues at (301) 827-4460. Home Access Health Corp. claims to sell the only approved home test kit for HIV infection. In an interview with Newsbytes, Rich Quattrocchi, president of Home Access Health, noted: "There is a lot of fraud on the Internet that preys on people's fears of HIV and AIDS by selling illegal testing kits."

 

"Rapid Self Testing for HIV Infection"

Lancet (02/01/97) Vol. 349, No. 9048, P. 352; Merson, Michael H.;

Feldman, Eric A.; Bayer, Ronald; et al.

The advent of HIV home test kits raised many complex issues recently, but the concept of a true self test for HIV raises even more. The implications of HIV self-testing at home (independent of an outside laboratory) for both individuals and public health must be considered before it is introduced, contend Dr. Michael H. Merson, of Yale University's medical school, and colleagues, in a Lancet commentary. A rapid self-test could largely increase access to HIV testing, the authors say, noting that survey results show that 30 percent of people would choose a home test, including 60 percent who have not been tested. Because such tests would be conducted separate from counseling services, which the Food and Drug Administration required for current home HIV tests, their benefits must be balanced against concerns about quality, use, and impact. The tests would have to be accurate, easy to administer, safe, and easy to read. The psychological responses to both positive and negative test results would also have to be better understood before a self-test is made available. The potential for misuse of rapid self tests--such as for forced testing or discrimination--must also be considered, as should the ethical concerns of cost and access to HIV treatment, the authors conclude.

 

"HIV Home Test Kits Catching on But Still Criticized"

USA Today (05/12/97); Painter, Kim

For several months, two HIV home test kits have been available to consumers who can take their own blood sample, send it to a lab, and learn by telephone whether or not they've tested positive for HIV. The kits now available are the Home Access Kit from Home Access Health Corp., and Confide from Johnson & Johnson's Direct Access Diagnosis. According to the companies, 99 percent of their customers test negative. Evidence thus far shows the kits offer users convenient, accurate results, but some AIDS service experts who have tested the services criticize aspects of the telephone counseling. Testing J&J's Confide kit, Health Services for Youth worker Stephan Milenkovic, who is HIV-positive, cited his counselor's failure "to make any attempt at all to ascertain my mental state," as well as her referral to an alternative health clinic which proved to lack basic HIV care. Author Robert Penn, who is also HIV-positive and tried out the Home Access kit, said his counselor was caring, knowledgeable, and able to suggest good local services. Penn noted, however, that his counselor provided the wrong extension at the crisis center to which he was referred, connecting him to an administrative line rather then the expected 24-hour hotline. "That's a big problem," Penn said. The companies note that such examples are atypical, and they say they have received positive reports from many customers. Others also give good marks to the companies' efforts. "I think it's tremendous because it increases public awareness of HIV and gets people tested," says Howard Brown Health Center's Scott McCallister.

 

"Home-Use HIV Test Kits in Turkey"

Lancet (05/10/97) Vol. 349, No. 9062, P. 1401; Doganci, Levent

In a letter to the editors of the Lancet, a British medical journal, Levent Doganci of the Gulhane Military Medical Academy in Turkey reports the use of HIV home test kits in his country. Turkey was introduced to home HIV testing in early March, when Turkish television aired a semi-advertisement program featuring a medical academic carrying out the tests on a popular news reporter. The kits, sold by the U.S. company Bartels State, cost about $20 and take only a minute to process results after one drop of blood has been collected. However, Doganci notes that in the United States, these testing products have only been sold in partial form in Texas and Florida. Moreover, the U.S. version requires the subject to collect the samples and then mail them in to a professional laboratory. The results are disclosed from a center where counseling and referral can be done anonymously. The author notes that even in the United States, testing for HIV cannot be done without the assistance of a medical professional, and he points out that the tests' limited availability is an attempt to avoid "the possibility of increasing false confidence in the sexual partners of infected individuals." In conclusion, Doganci claims that the Turkish Ministry of Health should concentrate on HIV prevention and education, limit medical professionals' involvement in television programs that imitate commercials, and take measures to address the program's negative public health impact.

 

"Seeking Assurance From a $40 Kit"

New York Times (11/21/96) P. D1; Canedy, Dana

Home HIV test kits, made by Home Access Health and Johnson &Johnson, are being marketed with distinct campaigns aimed at gay men, teenagers, and heterosexual adults in publications targeting each of these populations. Despite the relatively high cost of the tests, the anonymity they offer is attractive to many consumers, said Dave Mulryan of the Mulryan Nash advertising agency in New York. The Home Access kit costs $39.95 in stores and $49.95 by mail, while the Johnson and Johnson test costs $35 to $40 in stores and $49.95 by mail. After years of opposition from the Food and Drug Administration, the tests gained approval last summer, but critics are now attacking the companies' marketing tactics and question the reliability of telephone counseling for customers who test positive.

 

"HIV Kits Target Untested Market"

Marketing News (01/20/97) Vol. 31, No. 2, P. 1; Miller, Cyndee

Although the home HIV test kits offered by Direct Access Diagnostics and Home Access Health are similar, the two companiestook different approaches to marketing the new products. Direct Access Diagnostic's test, called Confide, is promoted in a serious tone, featuring health care professionals in white lab coats, while Home Access' ads include more controversial themes. Kevin Johnson, of Home Access, said the company is planning to use more targeted marketing strategies in upcoming campaigns. One Home Access ad, geared toward young heterosexual males, was criticized by the Gay Men's Health Crisis for trivializing the implications of a positive HIV test. These ads reportedly emphasize that the tests offer a convenient, anonymous alternative to traditional HIV testing, while those aimed at a teenage audience focus more on the importance of getting tested. Arisa Cunningham, director of marketing at Direct Access, meanwhile, says the company is promoting its test to a general audience. "We wanted to express an understanding of what it feels like for a person to have been exposed to the virus and to feel like they may be infected," she said. "Since the virus doesn't care if you're gay or straight, male or female, the message of understanding is universal."

 

"Rapid Self Testing for HIV Infection"

Lancet (02/01/97) Vol. 349, No. 9048, P. 352; Merson, Michael H.;

Feldman, Eric A.; Bayer, Ronald; et al.

The advent of HIV home test kits raised many complex issues recently, but the concept of a true self test for HIV raises even more. The implications of HIV self-testing at home (independent of an outside laboratory) for both individuals and public health must be considered before it is introduced, contend Dr. Michael H. Merson, of Yale University's medical school, and colleagues, in a Lancet commentary. A rapid self-test could largely increase access to HIV testing, the authors say, noting that survey results show that 30 percent of people would choose a home test, including 60 percent who have not been tested. Because such tests would be conducted separate from counseling services, which the Food and Drug Administration required for current home HIV tests, their benefits must be balanced against concerns about quality, use, and impact. The tests would have to be accurate, easy to administer, safe, and easy to read. The psychological responses to both positive and negative test results would also have to be better understood before a self-test is made available. The potential for misuse of rapid self tests--such as for forced testing or discrimination--must also be considered, as should the ethical concerns of cost and access to HIV treatment, the authors conclude.

 

"A Two-Minute Test for the AIDS Virus"

Maclean's (02/17/97) Vol. 110, No. 7, P. 70

An HIV blood-testing kit developed by Octopus DiagnosticsResearch of Hantsport, Nova Scotia, reportedly can detect thevirus that causes AIDS in a drop of blood in two minutes, whilestandard tests can take up to five days. Clinical studies of thetest show that its rate of false positives--less than 2percent--is similar to other tests, but that it fails to detectHIV up to 5 percent of the time. Octopus has already contractedto provide half a million test kits to a Hong Kong distributor,and it is negotiating similar deals with other countries. Thetest is being considered for approval in Canada.

 

"It Pays to Be Upfront About HIV"

American Druggist (03/97) Vol. 214, No. 3, P. 46; Slezak, Michael

Home HIV tests may sell better if customers can pick them upfrom a display rather than having to ask for them, a survey of 62 pharmacies suggests. Interviews with pharmacists in several major U.S. cities revealed that sales of home HIV test kits, introduced last summer, have been lagging. Only 15 pharmacists reported brisk sales, compared to seven who said sales were modest, 26 who reported sluggish sales or no sales, and 14 who said they did not stock the tests. Seven of the 14 pharmacies that displayed the tests at the pharmacy counter or in the diagnostics aisle reported strong sales, and an additional three reported moderate sales. Mukesh Patel, a pharmacist at a Walgreen store in Chicago, says stocking the products both in the pharmacy and in the diagnostics area is helpful. Richard Quattrocchi, president of Home Access Health, the maker of the Home Access test, says the company's sales figures also reflect better sales in stores where the kit is easily accessible to customers. The price tag on the tests, around $40, is also cited as a possible reason for the slow sales, along with the proliferation of clinics where HIV tests are offered for free.

 

"Johnson & Johnson Pulls Its Home Test For HIV Off Market"

New York Times (06/27/97) P. B9

Due to lack of demand, Johnson & Johnson's Direct Access Diagnostics unit is taking its Confide home HIV test off the market. The company, which noted that it expected greater demand, said that after a year on the market, about 90,000 tests had been sold. The only other competitor in the home HIV blood testing market is Home Access Health Corp., which reports sales of around 150,000 units thus far in 1997. Direct Access stopped shipping Confide on Thursday and will ask retailers to pull them from the shelves and return inventories. The company will continue to process results until Aug. 8, after which time anyonesending in tests will be informed about how to obtain a refund. Direct Access' result center, which provides counseling and referrals, will remain open until August 29. After that date, callers will be referred to the CDC National AIDS Hotline.

 

"F.D.A. Warnings Preceded Withdrawal of H.I.V. Test"

New York Times (07/03/97) P. D4; Canedy, Dana

Prior to Johnson & Johnson's removal of its Confide home HIV test kit from drugstore shelves last week, the Food and Drug Administration had apparently been warning the company about changes in its quality control procedures. Confide, which was reportedly discontinued because of slow sales, has long been a difficult product for J&J, which spent 10 years and millions of dollars to develop the product. In the last several months, the FDA had warned J&J's Direct Access Diagnostics unit, which made Confide, that, in some cases, envelopes used by consumers to send in blood samples to Direct Access had been inadvertently provided to users of Home Access Health's home HIV test. Another problem that the FDA brought up was that the test used blood that had been frozen and thawed instead of fresh blood. Johnson & Johnson maintained that the practice was effective, yet agreed to change. The FDA also noted that Direct Access had not submitted mandatory reports to the agency following the receipt of complaints that it might have given the wrong test results to some individuals.

"FDA Sent Warnings to J&J on HIV Test; Firm Decided to Pull Kit on Slow Sales"

Wall Street Journal (07/07/97) P. B5; Tanouye, Elyse

Johnson & Johnson says its decision to withdraw its Confide home HIV test from the market last month was motivated by low demand and was "absolutely not" the result of two Food and Drug Administration warning letters. The company said that FDA concerns raised in the warning letters regarding the improper distribution of envelopes meant for Confide customers and problems with J&J's quality-control test on the test filter paper had largely been addressed before the company decided to pull its product.


[ Home Page ][ Site Map ][ Links ][ Feedback ][ Submit ][ HIV Prevention Services ]
[ Berkeley Free Clinic ][ Confession Box ][ Counselor Resources ][ Relationships ][ Theorizing Desire ]