Producers Meet to Hear HIV Testing Procedures Explained

CHATSWORTH, Calif.—This morning, representatives from several major adult production companies including Manwin, Adam & Eve, Hustler, Girlfriends Films, Third Degree and Penthouse gathered at Penthouse Studios for a talk by Dr. Tadd S. Lazarus, Vice-President of Clinical Affairs and Chief Medical Officer for Gen-Probe, the company that makes the Aptima HIV-1 RNA Qualitative Assay test, and his associate Liberty Woods. The meeting was organized by talent agent Shy Love because, she said, there is much misinformation being circulated in the adult community, particularly among performers, regarding the efficacy of the available HIV tests and the testing centers that administer them. Dr. Lazarus began by explaining his background, which includes having treated HIV/AIDS patients for 20 years, as well as having run an HIV treatment program at the former St. Vincent's Medical Center in New York City, which he noted as having one of the largest sex worker outreach programs in the cuntry, before becoming employed by Gen-Probe. He went on to explain how the Aptima test works, noting that it is the only diagnostic test for HIV approved by the federal Food and Drug Administration (FDA), and that it is a "qualitiative" test that looks for the HIV virus itself, rather than the antibodies the human body develops to fight that virus, which are what the so-called "rapid" tests like the ELISA measure. Dr. Lazarus claimed that more than 99 percent of the time, the Aptima test will show positive for an HIV infection occurring at the latest just 4.5 days post-infection, and that a confirmatory test would not be needed thereafter because of the diagnostic nature of the Aptima test. Dr. Lazarus's statement was disputed, however, by the New York State Department of Health AIDS Institute, which has issued a chart showing that the Aptima test may take as long as 14 days to show a positive result—the same period within which a "quantitative viral load assay" test would detect infection. Today's meeting was called in part because some adult industry testing facilities have been using the Abbott Real-Time HIV-1 Amplification test, which unlike the Aptima is a "quantitative" test not FDA-approved for diagnosing HIV, but which instead measures the "viral load" (virus copies per milliliter of blood) of an infected person—which of necessity means the test would have to detect the HIV virus in the first place. Dr. Lazarus stated that the Aptima test can detect a viral load of 15 or lower, depending on circumstances, while the Abbott test can detect a load as low as 30. "There isn't a competitive test on the market that is as sensitive as ours," Dr. Lazarus said, when questioned whether either test was superior for performers who typically test every 28 days, "and being able to find infection early is based on the sensitivity of the assay, and that's why we're the only one that is FDA approved for screening patients with HIV disease, because it's the most sensitive." "[The Abbott test] is utilized in a population that you already know is HIV-infected," he added later. "Those people receive therapy, as all people who are infected do now, and the purpose of that test is to give you an indication of effectiveness of therapy, period. You need a much more sensitive test if you're going to be using it to screen people whose HIV status is unknown, such as your performers... It doesn't matter if you're talking about Abbott's test or if you're talking about Roche's test or if you're talking about Siemens' test; it's the nature of the viral load quantitative technology. It can never go as low as a qualitative test in HIV." Dr. Peter Miao, medical director of the APHSS-approved Cutting Edge Testing facility, disputed whether there is a practical difference for performers whether the test can detect 15 copies/mmL or 30. "There's not a lot of difference between 15, 30, 40, 45," he opined. "If you look at the scientific literature, different machines have different ranges because it doesn't really matter; it's a very low number. I think the important thing is, if it's less than a few thousand copies, the likelihood of being contageous is very low. When it gets up to a few hundred thousand copies or a million copies, infectivity is quite high." "The medical community looks at the quantitative testing and make decisions on when to treat the patient and when to change treatment," he continued, "but for the performers, it also has a great meaning because if we happen to detect the very beginning of the viral viremia, the amount of virus in the bloodstream, if there's 50 copies, 100 copies, 200 copies, less than several  thousand, the likelihood of any infectivity is very, very low, so it really helps to know what is the viral load. If the viral load is 1.6 million, they're very contagious." Dr. Lazarus had showed the group a slide from UC-San Diego which, he said, indicated that HIV-positive patients who had used HIV-suppressing drugs were tested with the Abbott system and found to be undetectable, but were detectable when the same sample was tested with the Aptima system. Ms. Woods also noted that the "false positive" rate with the Aptima was less than one-tenth of one percent. Dr. Miao, however, disputed whether even the Aptima test could detect the virus in a person with well-suppressed HIV, since the suppression itself means that the person's viral load could drop below the threshhold of any test, qualitative or quantitative. "If a person is HIV-positive and is on what so-called 'highly active anti-retrovirus therapy,' we can suppress the viral load to below the detectable range: Less than 15, less than 25, les than 50—different places use a different range of 'detectable'," he said. "Now, the Aptima system is really detecting parts of the viral genome, certain molecules, and then you set a certain amount to be quantitatively positive. I don't know exactly what that amount is, but I think it would be higher than just five copies, so again, it's detecting the virus by the breakdown products of the virus, so if a person is on highly active anti-retroviral treatment, then there is no viremia or no detectable, then the Aptima test really should not be able to detect anything more than the quantitative test. I'm not a molecular scientist, just a practicing therapist, but if you suppress someone's bloodstream to the point where there's no detectable viruses, then whether you're using the Aptima test or a quantitative test, you shouldn't be able to pick up the virus because it's suppressed to the point where it's non-detectable." The undercurrent to today's proceeding, however, was the dispute that's currently going on between the clinics approved for talent testing by the Adult Performer Health and Safety Services (APHSS) organization, which was formed by Free Speech Coalition to replace the now-closed AIM Healthcare Associates, and a clinic, Talent Testing Services (TTS), which at this point does not qualify to be an APHSS provider, in part because the clinic does not have a California-licensed medical doctor overseeing the testing at their in-state facilities. One point in favor of TTS that was brought up by Shy Love was that it has a "clinic in every state," but a look at the company's website indicates that for every location outside of Northridge, California and Miami, Florida, performers must spend at least $25 (up to $46.55 in one case) just to get their blood drawn, and another $35 to have the blood shipped to the testing laboratory—and that's on top of the $110 cost of the test itself. On the other hand, the APHSS-affiliated Advanced Medical Testing Center (AMTC) has more than 4,000 locations, and charges a maximum of $149 per test with no additional charges. Love made it clear that she is a firm supporter of Talent Testing Services. "Talent Testing Service's requirements were requested by [Free Speech executive director] Diane [Duke]," Love stated. "All requirements including doctors—they have a doctor on file. They said it's done. Diane had also requested that if someone came out positive, that there would be counseling done. TTS had agreed that if someone came out positive, with their new HIPAA paperwork that they had, they had the right to have that person converted over to the APHSS system, where they would provide the counseling. They said they had no problem; that was done. The last resource [sic] was, their APHSS system, to enter the data of positives/negatives into the system so APHSS could have it, TTS told them that they were breaking HIPAA laws and against the law because that actually puts the man in charge, so if there's an error, they're liable, but that there is a program that a programmer can put into the back of the system, which at the time Manwin has said that they are willing to pay for the programming and everything else so that that information can be put into the back of the database, and that requirement was met. So all three requirements that Diane had requested..." However, when AVN's Roy Salter brought up the objection that there was no doctor at the TTS facility when the performer's blood was drawn, Love responded, "No, the doctor is available. The doctor's the one that writes the prescriptions. Diane's issue was, she wanted the doctors to be the ones to contact the patient if they came out HIV-positive, and by law, the doctor does not have to do that. They can actually have a licensed HIV specialist who is a counselor contact the patient directly to notify them of the circumstances, and if APHSS was going to be doing the counseling, at that point tell them to come in to retest, go to APHSS for counseling, which we fixed all that in two seconds." Duke made the point, though, that in order to fulfill APHSS's protocols, testing would have to be ordered by a California-licensed physician, which TTS does not currently have. Moreover, TTS has previously stated that it would immediately report any positive HIV performer to the Los Angeles County Department of Public Health even before any confirmatory test had been done, which would likely result in the shutdown of the industry for as long as a month before even a false positive could be sorted out. Of course, all of the debate over testing facilities may be pointless in light of Manwin's announcement this morning that it would require a negative HIV/STD test within two weeks of a performer shooting for the company, and also that Manwin would only accept tests from APHSS-approved clinics—which will be much easier for Cutting Edge since Manwin recently purchased for them a Aptima testing machine, which Dr. Miao stated will be used for all performer testing as soon as the system is fully installed. Before the meeting's end, Love suggested that representatives of both APHSS and Talent Testing Services should schedule a time when they could be present to present their respective "cases" to the industry at large. Keep checking with AVN for more on that situation as it develops.