ju st ou t ▼ June 2 1 , 1 9 0 6 T i l
Cel e b r a t jn_g_ Diver s ity
S ervin g O ur C om m u n ity
w ith P rid e, i n t e g r i t y a n d
P rofession alism
Test anxiety
The FDA has approved an HIV viral load test, but some
experts claim that no one knows what the test results will mean
▼
by Bob Roehr
ood and Drug A dm inistration approval
for the A m plicor test to m easure HIV
viral load has brought as many ques
tions as answ ers for people with AIDS
and their physicians. Beyond the bro
m ide o f “low is good, high is bad,” there
definitive guidelines for using the test in clinical
m anagem ent o f HIV disease.
A m plicor, approved on June 3, is m anufac
tured by a subsidiary o f the pharm aceutical com
pany H offm ann-LaRoche. It uses polym erase
chain reaction (PCR) technology in a laboratory
environm ent and is sensitive enough to measure
as few as 400 copies o f the virus per milliliter.
Roche is offering two free tests to people who
are HIV positive as part o f its initial m arketing
effort. The offer began June 17 and runs for 60
days. Patients and physicians can access the pro
gram by calling 1-888-TEST PCR.
M artin D elaney, executive director o f Project
Inform in San Francisco, calls approval o f the test
“profound. It gives us a tool to m easure a clear-
cut goal in HIV disease for the first tim e.” He
believes it w ould be “crazy” to try to use recently
approved therapies like protease inhibitors and
nevirapine “w ithout the concurrent use o f the
viral load m arker.”
Ernest H opkins, head o f treatm ent advocacy
for the National Association o f People with AIDS,
says his group will initiate a “m ajor alert” to its
m em ber organizations “to encourage people to
take advantage” o f the free offer.
But R ichard Klein, an FDA official in the
O ffice o f AIDS and Special Health Issues, is
skeptical. “Everybody says it [the test] is abso
lutely necessary to m anage your drugs. Based on
w hat? I keep asking people that— as to why it is
necessary and how to interpret it. And nobody has
an answ er.”
“ If you are looking at using the test to manage
drugs,” Klein says, “what number should you use
as your pivot point? How do you know when you
should switch the drug? W hen it goes up? How
much?”
Then there are the test’s apparent anomalies.
U nder standard conditions an effective therapy
should knock dow n viral load and raise CD4
counts. But Klein said a scatter graph presented at
the FD A hearing on the test “had 20 percent o f the
dots [patients] where they both went up or they
both went down. Nobody could interpret what
that m eant.”
are Klein
no is concerned that nobody knows whether
the viral load test will show different results if
taken during different parts o f the day or the week.
Experience has shown that CD 4 levels can vary
substantially during the daily cycle o f body func
tions. Viral load may follow this pattern.
Klein cites testim ony from a National Insti
tutes o f Health researcher on the rigor NIH had to
im plem ent to get continuity from lab to lab with
its viral load testing. “ [He] doesn’t think com m er
cial labs around the country are working together
to m ake sure you are going to get the same results
all the tim e,” Klein said.
“Everybody is assum ing that because [the
test] is out there, and because they hear about it,
that everybody knows the answ ers to those ques
tions,” Klein said. “People agonize over those
num bers without know ing what they mean. But
people agonize over everything— CD4s, antigen
levels. You are looking at this little picture and
d on’t know what the whole picture is.”
K lein believes the m anufacturer made the
A m plicor test more widely available than its
approval for research purposes indicated, in order
to help create a market. And he claims the ploy has
w orked, because treatm ent activists latched onto
it and helped push for full market approval, de
spite there being little data available as to what the
test m eans as a clinical m anagem ent tool.
Spencer Cox o f the Treatm ent Action Group
in New York shares the frustration with Amplicor:
‘T h e re is not much data on using it to m onitor
responses to therapy. A lot o f doctors feel that
they d o n ’t know enough about what it m eans to
use it accurately.”
C ox is also skeptical o f the m anufacturer’s
“m arketing schem e.”
“I don’t want people falling into the trap of
thinking, oh my god, I had one test and it came in at
115,000,1 have to do something right now,” he said.
He urges people with AIDS to think of RNA testing
as “a long-term strategy, it’s not a one-shot deal.”
Socarides replaces Scott as
Clinton’s gay liaison
Log Cabin Republicans spokesm an David
G reer says, “The adm inistration finally gets it.
You can ’t just appoint somebody who doesn’t
know the community intimately. She was caught
extrem ely off guard during the whole same-sex
m arriage th in g .” He believes that “ R ichard
Socarides is much better able to handle the issues
when they get hot.”
C olum nist Richard M ohr is “delighted to see
M arsha Scott gone; the only thing she m anaged to
accom plish was to snooker our weak and grovel
ing national organizations.”
A ctivist Michael Petrelis says, “As far as I
could tell, Scott’s mission was to undercut legiti
mate anger at the president’s betrayal o f gay and
AIDS promises. I wonder why not a single D em o
cratic gay leader lambasted Clinton for appoint
ing a heterosexual to be the gay liaison. Imagine
the uproar if he had appointed a man to be a liaison
to w om en’s groups, or a white person to serve the
needs o f African Am ericans.”
But Petrelis finds little comfort in Socarides’
sexual orientation: “ He is a Democrat who hap
pens to be gay. O ther than working to convince
gay voters to cast ballots for Clinton in N ovem
ber, what is Socarides’ agenda?”
F
M arsha Scott is leaving as liaison to the gay
and lesbian com m unity, exactly one year after
becom ing the First Clinton adm inistration official
to occupy that post. Richard Socarides, a gay
man, will move from the D epartm ent o f Labor to
assume Scott’s responsibilities.
A ccording to The Washington Post, Scott will
“go to C hicago to help handle [Democratic N a
tional] convention VIPs, m eaning everyone from
dignitaries to C abinet m em bers to FOBs [friends
o f Bill] to big contributors.”
Com m unity reaction to the move was predict
able.
Keith B oykin says he is “disappointed she is
leaving, she has done a good jo b .” The executive
director o f the National Black Gay and Lesbian
Leadership Forum was a m em ber o f the W hite
House staff w ho worked with Scott. He “hopes
[Socarides] is able to meet the challenge.”
Helen G onzales is “sad” to see Scott go. “She
played an im portant role in providing access to
our com m unity.” G onzales hopes that Socarides
will have “the sam e type o f access” to the presi
dent that Scott did.
Bob Roehr
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