#NYTimes.com Health RSS

  The New York Times Health

F.D.A. to Weigh At-Home Testing for AIDS Virus

    * E-Mail This
    * Printer-Friendly
    * Reprints
    * Save Article

  By GARDINER HARRIS
http://www.nytimes.com/2005/10/13/health/13aids.html

  Published: October 13, 2005

  Federal drug regulators have agreed to consider
  allowing a Pennsylvania company to sell the first
  rapid, at-home AIDS test that would make testing for
  the virus about as easy and accessible as a pregnancy
  screen. The move could put to rest 18 years of
  controversy.

  Officials at the Food and Drug Administration and
  AIDS advocates long worried that people who got an
  AIDS diagnosis would panic and even consider suicide.
  So for years, the federal drug officials have
  insisted that counseling and professional support
  accompany AIDS tests. This requirement has
  complicated proposals for at-home tests.

  But improved medicines now mean that AIDS is a
  chronic disease that can often be managed for years,
  so the fear that a diagnosis might lead to thoughts
  of suicide have subsided. Just as important, 40,000
  people each year continue to be infected by HIV, the
  virus that causes AIDS. This rate has remained
  stubbornly high for years. Having tried many other
  strategies, federal health officials are now
  increasingly open to the idea that an at-home AIDS
  test could finally lead thousands to change their
  behaviors and stop infecting others.

  "If we're going to win the war against AIDS, we need
  to make HIV testing as easy as pregnancy testing,"
  said Dr. Freya Spielberg, a researcher in the Center
  for AIDS Research at the University of Washington.

  A federal advisory board will discuss the proposal
  for an at-home AIDS test on Nov. 3. After that, the
  test's maker, OraSure Techologies, based in
  Bethlehem, Pa., said that it would likely apply
  formally to sell the device over-the-counter.

  The test, called OraQuick Advance Rapid HIV-?
  Antibody Test, is presently sold only to doctors and
  clinics. It has already proven to be effective, safe
  and easy to use. So the remaining hurdles are
  decisions by the F.D.A. about whether approving such
  a device is a good idea and whether people can
  understand the product's label well enough to
  administer it to themselves.

  A 1987 application for an at-home AIDS test kit led
  to years of controversy. At the time, AIDS advocates
  and public health officials predicted that such a
  test would cause widespread suicides, panic and a
  rush to public health clinics.

  At hearings, AIDS advocates handed out copies of an
  obituary of a San Francisco man who jumped off the
  Golden Gate Bridge after discovering that he was
  infected with HIV. An official for the Centers for
  Disease Control and Prevention told the F.D.A. that
  such tests could lead to "a sudden increase in
  referrals to already overburdened health clinics,"
  according to an F.D.A. document.

  Federal regulators stalled the application for nine
  years, and at-home AIDS testing never caught on.

  Some AIDS advocates are now warily supportive of
  at-home testing.

  "For people who don't have access to a clinic or make
  a decision not to go to a clinic, this is better than
  nothing," said Gregg Gonsalves of Gay Men's Health
  Crisis in New York City, which opposed at-home AIDS
  testing 18 years ago and offers testing and
  counseling itself. "But it's not a magic bullet."

  The switch by advocates is important. Politics have
  long played a crucial role in many F.D.A. decisions,
  according to longtime agency observers and previous
  agency officials. Recently, the agency decided to
  delay a decision on whether to allow over-the-counter
  sales of an emergency contraceptive. The decision was
  seen by some inside and outside of the agency as
  politically driven, and it led a top agency official
  to resign in protest.

  Dr. Spielberg said that about a quarter of the nearly
  million people in the United States who have the HIV
  virus in their blood do not know that they are
  infected. And somewhere between 40 percent and 45
  percent of those who test positive for HIV do so less
  than a year before they are diagnosed with AIDS.

  Since an HIV infection often takes a decade to
  develop into full-blown AIDS, "this suggests that
  people are living with HIV, and spreading HIV for
  many years before they are aware of their infection,"
  she said.

  Many of these people avoid getting tested in clinics
  for a variety of reasons, including fear of discovery
  and convenience, studies show. And many hate having
  to wait more than a week for a lab result, surveys
  show.

  Dr. Spielberg said that she surveyed 240 people
  infected with HIV and found that more than half said
  that they would have preferred to have found out
  about their infection with a rapid at-home test.

  Having a rapid, over-the-counter test widely
  available, Dr. Spielberg said, "is the most powerful
  strategy we have to bring down HIV infections."
  People who find out that they are infected with HIV
  often change their sexual behavior to reduce further
  infections, she said.

  By contrast, OraQuick requires a person to simply
  swab their gums and then place the swab in a holder.
  Twenty minutes later, a strip displays one line for a
  negative result and two lines for a positive one.

  The argument against at-home tests has long been that
  they failed to ensure that patients would get
  adequate counseling. Activists now acknowledge that
  many people who get HIV tests in doctors' offices get
  little or no counseling anyway.

  "The counseling that now occurs is very short or
  abrupt in many settings," said Gene Copello,
  executive director of The AIDS Institute, a
  Washington-based policy group.

  Doug Michels, president and chief executive of
  OraSure, said he plans to include advice about
  counseling on OraQuick's label. "It could be a
  hotline number, a 24-hour manned counseling center,
  Web support or printed material that is included in
  the product," he said.

  The company said it would include whatever the
  advisory committee and the F.D.A. deems is necessary,
  he said. The company now sells the device for between
  $12 and $17, although the price of an
  over-the-counter version has yet to be decided, Mr.
  Michels said.

Related Articles

    * National Briefing | Mid-Atlantic: Pennsylvania:
      Possible AIDS Infection (March 31, 2005)
    * New H.I.V. Test Lets Officials Reach Out to the
      Street (December 16, 2004)
    * New Drug Is Said to Offer Hope For Vaginal Gel to
      Block H.I.V. (October 15, 2004)
    * COMPANY NEWS; CHIRON SETTLES DISPUTE WITH ROCHE
      OVER A PATENT (September 11, 2004)

By Gardiner Harris
http://www.nytimes.com/2005/10/13/health/13aids.html