RAPID HIV TEST-DO YOU'll READ THESE WHEN I POST?

I need some feed back from these news reports. Does anyone read them when I post them?
Wednesday, June 14, 2000 | Print this story

FDA Blamed for Holding Up Rapid AIDS
Tests
Health: CDC officials say that the need for getting quick testing
results is critical, allowing for treatment with new drugs almost
immediately.

By MARLENE CIMONS, Times Staff Writer

WASHINGTON--Officials at the federal Centers for Disease
Control and Prevention, in a rare show of discord between two
major health agencies, are complaining that the Food and Drug
Administration is holding off the market new AIDS tests that give
quick results and could reduce new infections.
Fearing the social stigma still attached to AIDS, 25% of those
who get AIDS tests--about 10,000 people each year--never come
back for the results, the Atlanta-based agency estimates. Those
who are infected go untreated, spreading the virus unknowingly.
The new tests, which give results in minutes rather than days or
weeks, could change that, allowing treatment with powerful new
drugs almost immediately.
Several new, so-called rapid HIV tests are moving toward FDA
approval. But officials at the CDC who deal with AIDS testing and
prevention think that they could move even faster.
"I think the FDA is being overcautious, which is wasting time
and costing lives," said Dr. Bernard Branson, one of those officials.
He is a medical epidemiologist at CDC who has studied the effect
that rapid tests would have on the AIDS epidemic.

Problem Exacerbated for Health Officials
Whatever the reason some people fail to return for test
results--denial, fear, inconvenience--the situation poses a vexing
problem for the public health community, which sees early
identification of infection as one of its most effective weapons
against AIDS.
As a result, the FDA is taking heat not just from its sister public
health agency but from others in the AIDS network, including those
who work in clinics, and from state and regional public health
officials. All are impatient to begin using the new tests.
"The waiting period is one of the cruelest elements of HIV
testing," said Lee Klosinski, director of education for AIDS Project
Los Angeles. "It is having to endure two weeks of hell. Because of
it, people get lost. It is the best reason for expediting this
technology."
And Julie M. Scofield, executive director of the National
Alliance of State and Territorial AIDS Directors, wrote in a recent
letter to the FDA: "Early identification of HIV infection is essential. .
. . It is critical that rapid testing be made available in the U.S. as
soon as possible."
But Dr. Jay Epstein, director of the FDA's office of blood
research in its center for biologics evaluation and research,
defended his agency.
"We understand there is an unmet need," he said. "We agree it
would be good to have more on the market. But it's not a simple
thing. The public needs assurance that the [new tests] will meet
standards of accuracy and consistency of manufacturing."
Epstein insisted that the FDA is taking steps to expedite
approval, explaining that rapid test proponents "misunderstand" the
regulatory requirements for licensing of the new tests.
To that end, an FDA advisory committee will take up the matter
Thursday in an attempt to clarify what is expected in the way of
studies--and results.
He added that clinics can apply under special circumstances for
permission to use the new tests before they are licensed. "We are
trying to show flexibility and cooperate with CDC."

Accuracy Is Still a Key Requirement
The FDA has asked its Blood Products Advisory Committee to
recommend that the rapid tests not have to prove that they are as
effective as the test most widely used now in clinics
nationwide--known as the ELISA. But the new tests still will have
to demonstrate a high level of accuracy.
The ELISA test takes a minimum of five hours to work,
sometimes as long as overnight. But since the test often is sent to
labs--where it is run in batches--results often are not available for
days, even weeks.
If rapid tests are approved, several would be needed for the
diagnostic system to work well. Currently, ELISA results must be
confirmed by a different, more sophisticated test, known as the
Western blot.
Once licensed, several rapid tests likely would be used at the
same time to statistically validate accuracy. This would protect
against the possibility of "false positive" or "false negative" results.
There is only one rapid test on the market. Known as SUDS, it
is made by Illinois-based Abbott Laboratories. It works in about
10 minutes, but its accuracy is highly dependent on the level of
training of the person who gives it.

New Tests Seen as Attractive Option
The new tests under development are more user-friendly,
requiring no equipment and little technical expertise. Some work on
whole blood, some work on oral fluids. And they are inexpensive,
costing less than $2, which makes them an attractive option, not
just for clinics but for hospital delivery and emergency rooms and in
developing countries that lack laboratories and other technology,
the CDC's Branson said.
At the Hollywood/Wilshire Health Center and the Gay and
Lesbian Health Center in West Hollywood, a major study
sponsored by the CDC and Los Angeles County has shown that
the rapid tests are accurate.
The first phase of the study involved individuals who already
knew their infection status. It compared the known results with
those of the rapid tests, which proved accurate.
The study is now looking at these tests in actual practice, that is,
conducting them on people who have not been previously
tested--then comparing the results to those obtained using current
technology.

Post Extras: Remind Me!