A recent article about home HIV testing
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11/21 Seeking Assurance From a $40 Kit
- Sales of Home H.I.V. Tests Are Brisk, But Concern Persists Over Propriety
Publication Date: November 21, 1996
Section D, Page 1, Column 3
By DANA CANEDY
At a Rite Aid drugstore in Manhattan recently, a man handed the pharmacist a
slip of paper he had torn from a pad hanging next to the condoms. After the
pharmacy section cleared out, she gave him a bag with a home H.I.V. test
inside.
''I wouldn't do it with all these people in there,'' said the pharmacist,
Linda Lee. Many customers, she realizes, do not want to be seen taking kits
off the counter, where they are displayed between nicotine patches and reading
glasses.
At a Walgreen in Chicago, many customers are unsure how to use the kits.
The pharmacist, Barbara Donoval, spends a fair amount of time walking them
through the procedure.
In Queens, girls as young as 15 have been coming to a Rite Aid for weeks to
buy the tests in groups, and heterosexual and gay couples have been purchasing
two so they can test themselves together.
''The biggest thing people say is they have such peace of mind now,'' said
Leonard Humel, pharmacist at the Queens store, where the kits are selling out
as fast as he can replace them.
After a decade of being rebuffed by the Food and Drug Administration, two
companies got approval last summer to sell the tests, entering the marketplace
just as promising new drugs are prompting more people than ever to be tested
for the virus that causes AIDS. But the birth of this market has been anything
but smooth.
The manufacturers, Home Access Health, a fledgling one-product operation,
and Direct Access Diagnostics, a unit of Johnson & Johnson, are still
grappling with just how to navigate the sexual and interest group politics of
selling a product that many customers must work up the courage to buy and
could easily be pitched to people's worst fears.
With, say, home pregnancy tests, the market is well defined, but the makers
of home H.I.V. tests are simultaneously selling to gay men, teen-agers and
heterosexual adults, who each bring different attitudes about AIDS to the drug
counter and are likely to respond to different marketing.
The challenge is evident in ads for the kits, some of which are sexually
provocative by design and have drawn fire from AIDS advocacy groups for being
simplistic or for trivializing concerns about disclosing H.I.V. status to
sexual partners. The kits are being advertised in youth-oriented publications
like Rolling Stone, gay-oriented magazines like Poz and The Advocate,
magazines like Essence and Jet that are read predominantly by blacks and
Spanish-language magazines, as well.
As great a sales challege is the fact that the tests are costly, more than
some visits to a doctor or clinic. A kit called Confide, from Direct Access,
costs $35 to $40 in stores, and $49.95 mail order. Home Access kits costs
$39.95 in stores and $49.95 for the model that is shipped.
But for many people, a desire for secrecy outweighs price.
''Gay men have probably been exposed to testing before,'' said Dave Mulryan
of the Mulryan Nash agency in New York, which created ads aimed at gay men for
Home Access. ''For them, convenience, time and price may be an issue, whereas
the teen market may be afraid to go to the doctor or that their parents may
find out. Anonymity may be an issue for heterosexual men.''
Home H.I.V. tests were developed in the mid-80's, but faced fierce
opposition from the F.D.A. and some AIDS organizations and health care
agencies. The agency cited a host of concerns, including the issue of whether
there should be phone counseling for those who test positive. Other concerns
involved the accuracy of the tests and confidentiality.
This year -- after intensive lobbying by manufacturers and mounting
evidence that the tests' benefits outweigh the risks -- the F.D.A reversed its
position, persuaded that the tests' benefits outweighed the risks.
With the approval, the companies are facing renewed opposition from critics
of home testing -- especially about marketing and counseling. There is also
great uncertainty about how big the market is.
''There is absolutely no accurate model to predict sales of a service like
this,'' said Arisa Cunningham, director of marketing for Direct Access. ''We
need a few more months of experience under our belt.''
At Home Access, which has much more riding on the test than its giant
competitor, ''We are making up the rules as we go along,'' Richard
Quattrocchi, the president, said. ''It is a very intimate and personal
purchase, and a service like this has never been offered before, so there is
an acceptance curve.''
Yet with analysts estimating that home H.I.V. tests will grow into a $100
million to $200 million market within five years, both companies are racing to
grab market share, particularly with two other companies awaiting F.D.A.
approval of their kits, including one that tests saliva instead of blood. The
tests now on the market require lancing a finger and placing blood droplets on
a test card that is shipped to a laboratory. The tests now have a 99.9 percent
accuracy rate.
Johnson & Johnson began selling its test in June, and Home Access in July.
Each says it has already sold tens of thousands of kits. They are available in
almost all states and will be available in every state by the end of the year.
They are sold in chains like Eckerd, Walgreen and Rite Aid and are sold by
mail order.
Home Access said that about 70 percent of buyers are men -- half
homosexual, half heterosexual. In large urban markets, store sales are
outnumbering mail orders roughly 2 to 1, while in rural areas, where the
cashier is likely to be a neighbor, mail orders have a 3-to-1 edge.
The manufacturers say that slightly more than 1 percent of the tests are
registering positive for H.I.V.
Health care agencies that conduct their own testing and some AIDS advocacy
groups say they think the companies' revenue estimates are a bit high and the
consumer demographics are inaccurate, particularly in light of the cost of the
kits and the limited sales so far.
The companies brush this off. ''Demand is exceeding our expectations in a
big way,'' Mr. Quattrocchi said. ''There might have been pent-up demand''
among those who did not want employers, insurance companies or friends and
family to know they feared testing positive.
Perhaps. What is certain, though, is that each company is navigating around
its own unique obstacles. Home Access has come under fire for a salacious
national magazine advertisement that suggests that women will be reassured by
a small prick of the finger.
A leading AIDS organization, the Gay Men's Health Crisis, called the ad
inappropriate and misleading, showing the company's naivete. The ad presumes
an H.I.V.-negative result, the group says, and ignores the complexities of
testing and trivializes issues of disclosure.
Mr. Quattrocchi defended the ad, which ran in Rolling Stone. ''It was
designed to be provocative and to get heterosexual men who think they are not
at risk for H.I.V. to start thinking about it,'' he said. Similarly, another
of the company's ads portrays an amorous couple in a close embrace. The ad
copy reads: ''Once women waited to hear three little words. Now it's just two.
I'm negative.''
Johnson & Johnson, hardly a neophyte in introducing new products, faces
different problems. It is bogged down in a legal battle with the creator of
its test and will likely have to give up all rights to it, and analysts say it
is thus reluctant to take on a big marketing budget.
In July, an arbitrator ordered Johnson & Johnson to turn over the business
to Elliott Millenson, an entrepreneur who had created the test and
subsequently headed Direct Access. Mr. Millenson was dismissed last year after
the company accused him of making unapproved political contributions to help
win F.D.A. approval of its test, an accusation he has denied. Last month, the
company lost an appeal of the arbitrator's ruling in New Jersey Superior Court
and is considering its options, including seeking another appeal. Johnson &
Johnson denies that it has backed off marketing Confide pending the outcome
but will not say how much it is spending.
For both companies, price is an issue. ''Opponents have said this basically
is only going to be used by the worried well or rich gay men,'' said Dr.
Bernard Branson, an epidemiologist specializing in AIDS and H.I.V. at the
Centers for Disease Control and Prevention. ''They are in the market to make
money. The manufacturers of home collection devices may try to find people at
risk, but they also want to find people who can afford this test.''
In fact, while numerous consumers in Manhattan drugstores said they thought
the tests were needed, some said the price would discourage them. ''I'd
probably go to my doctor; it's cheaper,'' said Michael Spier at a Rite Aid in
Manhattan.
The manufacturers are also being criticized by health care and counseling
agencies that say the process for learning results is flawed and the phone
counseling the companies offer is risky. ''The efficiency of phone counseling
when it comes to finding out whether you have a life-threatening illness is
just something we don't know anything about,'' said Christopher Portelli,
spokesman for the National Lesbian and Gay Health Association. ''There is no
follow-up.''
Not everyone takes issue with phone counseling. ''People have this
impression that the whole country has got it as good as in San Francisco and
New York, where you go to a clinic and are offered counseling when you get
results,'' Peter Staley, a board member of the American Foundation for AIDS
Reseach, said. ''That's not the case nationwide.''
Mr. Quattrocchi of Home Access said there was no proof that phone
counseling was ineffective. What's more, ''If people don't want phone
counseling, guess what: they can can go to a clinic or their doctor's
office.''
Mr. Portelli also faults both companies for using a recorded message to
deliver test results that are negative while using counselors to give results
to those who test positive. He said, ''If you are given a live operator, you
know your status, and you'll hang up, that's our fear.''
Mr. Quattrocchi countered by saying that his company randomly chooses
consumers who test negative to receive results from counselors, too. Ms.
Cunningham pointed out, meanwhile, that Direct Access customers who test
positive are staying on the phone for counseling an average of 45 minutes.
Counselors advise customers who test negative how to avoid risk, and those who
test positive are told where to seek treatment or face-to-face counseling.
She added that there were several reasons someone calling for results might
receive a live operator, including to be told the kit was damaged in shipping
or that not enough blood was collected to make a diagnosis. ''No one should
ever assume hearing a live voice means they are H.I.V. positive,'' she said.
Illustration: Photos: Analysts estimate that H.I.V. home tests will grow
into a $100 million market within five years. Two kits, Confide and Home
Access, are competing for that market. (Naum Kazhdan/The New York Times) (pg.
D1); Home H.I.V. test kits like Confide, produced by a unit of Johnson &
Johnson, are sold in drugstores nationwide. While the kits may cost more than
a visit to a clinic, secrecy outweighs prices for many people. (Naum
Kazhdan/The New York Times) (pg. D8) |
