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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (June 21, 1996)
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 tfuging or Selling gour home is an important choice . . . Let me guide gou through the process ------------C e 1 i a J . L y o n ----------- Sales A ssociate ▼ O U T ON B R O A D W A Y ▼ ----------------------- Mulitmillion $ Producer ------------------------ pag er 9 2 0 -8 4 0 3 cellular 260-6231 Equitg Qroup Realtors Snc. 2 8 7 -8 9 8 9 ext. 147 _______________ 7 8 6 -4959 res. 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