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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (April 16, 2004)
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 f Z **# rO T* A £,ve*tt4 ¡2? P T V en e & ti£ i Coo/icay fan aecu fdcufcnà. S v C U fO rtC Opening Cerem onies April 17th at Panorama 7 to 9 pm Opening Day April 18th Gordon Faber Recreation Complex in Hillsboro Games start at 11:00 am ¿4 oveCcamef for more Information, you can find us at www.rosecltysoftball.org or call 503-552-4769 Screen Printing Tackle Twill Congratulations Newlyweds! 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