By Aaron Reiss
By Angelica Leicht
By Dianna Wray
By Aaron Reiss
By Camilo Smith
By Craig Malisow
By Jeff Balke
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But with the state worrying about how to pay for the drugs of indigent people (see "Getting Ugly"), and the various demands being placed on already maxed-out public funds for HIV care, The Center for AIDS' Martinez and others wonder if paying for tests is the best solution to dealing with such a complicated disease.
"I think the problem is, do we make this part of the standard of care without any kind of proof that it has a long-term effect on a person's health?" says Martinez. "Would we be better off providing greater money for ADAP [the AIDS Drug Assistance Program]? Would we be better off providing money for an ultrasensitive viral load test? There are limited resources. There is only so much money that is going to be allowed to us."
Dr. Natalie Vanek's tiny office at the Thomas Street Clinic, the largest freestanding HIV clinic in the country, is a mixture of the personal and professional. A Far Sidecalendar and Glen Campbell CDs are kept not too far from a thick booklet titled "Ninth Conference on Retroviruses and Opportunistic Infections" and a poster of colorful pills labeled "Antiretrovirals at a Glance."
Originally from a tiny north Texas town, Vanek arrived at the clinic in 1989 as a medical student. She liked it so much she never left. Now she has about 350 HIV-positive patients, all of them on public assistance.
"I like public health, and I like working with the indigent," she says brightly. "I'd rather die than work in a wound center."
Thomas Street clients are exclusively HIV-positive people who have no health insurance. John Termine was a patient at the clinic before gaining coverage through his partner. Primarily federally funded through the Ryan White CARE Act, the clinic was able to afford resistance tests only a month ago, even though private insurance companies have been paying for some of these tests for the past few years. But Vanek is not too fired up about Texas Medicaid reimbursing the cost of the tests.
"We learn as we go with HIV, and we have a lot to learn about resistance tests," she says.
Vanek's primary concern centers around the fact that there are no universally accepted standards for these tests, and it is up to the doctors to interpret the results. Unlike the tests that determine whether bacteria are resistant to a certain antibiotic, the results of HIV drug-resistance tests are often foggy.
To make her point, Vanek gives the example of a doctor wanting to know if a certain strain of bacteria is resistant to penicillin.
"If you sent [the bacteria] to the U.S. or Japan or Sweden, if you sent it all over the country, the results would be universally accepted," says Vanek. "If you got this number, there would be no debate -- it would be universally accepted as bacteria that is resistant to penicillin. But all these different companies have different [HIV resistance] tests, and they don't agree -- not even with each other. I think the companies are going to have to sit down and agree on a certain standard, but they don't want to share their proprietary information with each other."
Vanek cites a Centers for Disease Control and Prevention study where five well-known strains of HIV were sent to about 15 companies around the country for resistance testing.
"The CDC knew the strains back and forth," she says. "But there were only three companies that got it right."
While Vanek acknowledges that there are a few large companies in the United States that do trustworthy tests, she worries about what are termed "home brews," tests done by smaller regional labs that might not be as accurate but are often cheaper.
"If Medicaid is going to be paying for this, I know what Medicaid will do," she says. "They will send out bids and go with the lowest bidder, a place that may not have reputable results."
In addition, the results for most of the tests are often nebulous. The strain might be resistant, or the strain is a little resistant. If a doctor who doesn't have a lot of experience with the virus interprets the complicated results incorrectly, he or she might take the wrong course of action.
Before Medicaid agrees to spend state money on these tests, Vanek wants reassurance that the tests are of high standard and are highly reproducible (meaning the same test could be run many times by many people and the results would always be the same). While she admits there are times when running a test is a good idea (for example, on an HIV-positive pregnant woman not taking drugs who needs to start medication again), Vanek thinks the Thomas Street physicians have done "pretty good" without the tests. Instead of resistance tests, they've looked at viral load and T-cell counts, and used their deep understanding of patients' drug and health histories.
Dr. Wayne Shandera, a colleague of Vanek's at Thomas Street who has about 100 indigent HIV-positive patients, agrees with several of Vanek's points. He's especially concerned with the ability of most clinicians to read the results.