aprii 16. 2004 • Just
rTîTTTïïTTîTI news
Peter Engelhard, a Miami Beach
physician specializing in HIV,
pproves apid
est
received training in administering
New-Fill in Paris and later organized
he Food and Drug Administration announced
a compassionate use, 100-patient,
March 26 that the first oral rapid HIV test, which can
open-label trial of the product in
deliver results in 20 minutes, has been approved for use.
Florida. HIV physician Douglas Mest
About 40,000 people are infected each year with HIV,
organized a parallel trial for patients
and approximately 300,000 men, women and children are
in the Los Angeles area. Both found
unknowingly infected, according to the Centers for Dis
similar patterns of ease of administra
ease Control and Prevention. The Human Rights Cam
tion, safety and patient satisfaction as
paign called The newly approved rapid HIV test is a leap
were seen in the European trials.
forward for prevention efforts.
Engelhard said about half of his
“This is a vital new tool tor preventing new HIV infec
patients require a “touch up treat
tions and getting life-prolonging treatment to those
ment” within a year, though some
already infected,” president Cheryl Jacques said. “Every
have gone two to three years without
one should know their status to protect their own health
additional treatment. He believes
and the health of their loved ones.
patients who need the touch up are
“HIV testing should he rapid, accurate and confiden
continuing to experience fat redistri
tial,” Jacques continued. “By offering a pain-free testing
bution as they show continued signs
mechanism and reducing wait time for results, this new
of lipodystrophy in other parts of
test could increase testing rates.
their body. Many patients who go the
“In addition to testing advances, it is critical that Con
longest without needing additional
gress and the administration fund strategic prevention pro
injections have switched HIV regi
grams at the C D C ,” Jacques added. “Infection rates of gay
mens, and their lipodystrophy has
and bisexual men are rising, and we need well-funded sci
either stopped or reversed.
ence-based approaches to halt this alanning trend."
The FDA panel was concerned by
—Jim Radosta |H
formation of what were described as
micro-nodules or irregularities where the injec ment Activists Coalition pressed for “the
tions were made. But the doctors said these forma strongest possible labeling language, indicat
tions seldom were visible or even noticed by the
ing the reconstructive/corrective nature” of
patients; only a trained physician could tell they the product, as most insurers do not pay for
were there by gently massaging the skin. The prob cosmetic procedures. The FDA agreed with
lem was most noticeable around the eyes, where
the stronger labeling.
the skin is thinnest and directly over bone.
Conant said his Conant Foundation, which
Mest said the nodules tend to occur within
conducted a trial of Sculptra, would push private
the first two months of treatment
insurers and MediCal in California
and slowly abate over time; he
to cover the prcKedure. The foun
assumes they are excess product.
dation will take administrative and
The way to minimize their forma
legal action as necessary to see that
tion is to inject less of the product
people have access to it.
and add more later, if needed.
Whether financially hard-
While the FDA panelists were
pressed state AIDS Drug Assis
frustrated with limitations of the
tance Programs agree to add
data presented to them, there was
Sculptra to their formulary is
little doubt that the product is
unclear. But given the FDA label
safe. The committee unanimously
indication and the often severe
recommended approval of Sculp-
psychological burdens that can
tra, but with several caveats.
accompany facial lipoatrophy, a
Among them is a training and
strong case for inclusion can be
certification program for doctors
made.
who administer it; trials in
Dermik Laboratories, the U.S.
— Marcus Conanf dermatology arm of the inter
women and people of color to
make sure the effects are no dif
national pharmaceutical company
ferent (most trial participants have been white
Aventis, recently acquired rights to Sculptra and
men); and longer-term safety data. The FDA is submitted it to the FDA. It has begun discussing
expected to follow the panel’s advice and
creation of a patient assistance program with AIDS
approve Sculptra within the next month or so.
ad vi Kates. i n
The next hurdle for people with A ID S who
want the benefits of Sculptra is getting insur Be tb RoEHR is a free-lance reporter based in
ers to pay for it. That is why the A ID S Treat-
W ashington, D .C .
FDA A
R
HIV T
I
out 21
yo t to y e t to 'í¥¿C£oéo>iof
T
"Facial lipoatrophy
has become the
scarlet letter of
AIDS. It is the thing
that is bothering
our patients the
most... even
doctors wait to start
their medication.
5
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