| As the price of the HIV
test rises, some lower-income individuals who are at greater risk for
HIV infection will not be able to afford it. The FDA has been criticized
because it bases its decisions on small studies performed in
non-representative populations.
"When approving new technologies, the FDA should focus
less on the general population and more on the people who will actually
use these technologies," said co-author A. David Paltiel, PhD, of the
Yale School of Medicine. "The disconnect between approved indication and
actual use is stark."
The test in question is the OraQuick ADVANCE 1/2, a
rapid, point-of-care test that can detect antibodies to both HIV-1 and
HIV-2 in 20 minutes using a simple cheek swab. The test is already FDA-approved
for use in health care settings such as hospitals, drug treatment
facilities, state and local health departments, clinics, community-based
organizations, and university health centers throughout the United
States.
The FDA has asked the manufacturer to collect data on
the ability of the test to correctly detect both the presence and
absence of HIV infection when employed by untrained users. However, it
has not requested any further information on how the manufacturer's
retail price will influence the demand for home testing in populations
with high-rates of undetected HIV infection. Using a mathematical
analysis, the authors demonstrate that many of the highest-risk
individuals will be unable to afford home testing at the price the
manufacturer is likely to propose. By failing to take into account the
relationship between retail pricing, consumer purchasing behavior, and
HIV risk, the FDA may overestimate the test's ability to identify
previously undetected cases of HIV infection.
"The information currently sought by the FDA is not
sufficient to address the true benefit of the HIV test for home use,"
write Paltiel and co-author Harold A. Pollack, PhD of the University of
Chicago School of Social Service Administration. "Our analysis suggests
that a cheaper test may do a better job of finding HIV infection. The
home HIV test product might actually work better at a lower price."
###
"Price, Performance, and the FDA Approval Process: The
Example of Home HIV Testing" in Medical Decision Making is now
online and freely available for a limited time at
http://mdm.sagepub.com/cgi/rapidpdf/0272989X09334420v1.
|
