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Haitian program demonstrates Small-scale success
As the debate rages over whether or not developing countries engulfed by an AIDS epidemic get generic or discounted antiretroviral therapy, public health experts are struggling to resolve what may prove a more pressing question.
Assuming that triple-therapy regimens do become widely available, how will nations that are poor in health care infrastructure cope with issues such as compliance and side effects?
An idea that’s been kicking around in the AIDS community for years is to borrow directly observed therapy (DOT) from the world of TB and use it to boost compliance. Recently, in fact, a presidential committee assessing high rates of noncompliance among young AIDS patients in the United States strongly recommended using DOT on a broad scale here at home.
When TB experts look abroad, noncompliance — with its consequent development of drug resistance — is a big concern. "We’ve learned from TB that making drugs available without controls is a grave mistake," says Barry Bloom, dean of the Harvard School of Public Health in Cambridge, MA. "If you just make antiretrovirals available, it will lead to resistance and to the growth of a black market." Growth of a black market, in turn, will give rise to a situation where only the rich and powerful have access to drugs, Bloom says.
AIDS might prove trickier than TB
The experts also worry about how low-income countries will manage the considerable array of side effects from triple-combination AIDS therapy. "There’s great skepticism that with AIDS drugs, the adverse effects and the need to change drugs and so on will be so formidable that the drugs can only be given by medical personnel," Bloom says. "If that’s so, it simply won’t be possible to give these drugs in poor countries. We may decide that this is a much trickier disease than TB and that this won’t work."
To see whether community workers with only minimal medical training will be able to manage side effects, Bloom and others at Harvard (including economist Jeffrey Sachs) are calling for the establishment of multi-country, large-scale pilot programs.
But some international TB experts say they worry that DOTS (as the international treatment approach using DOT is termed) is too cumbersome. After all, they argue, even though 200 countries have adopted DOTS, in practice only one-quarter of TB patients in those countries have access to DOTS. Perhaps, they argue, it’s time to start over and try to find something that’s just as effective but more streamlined.
"Let’s face it: DOTS is not a perfect strategy," says James Orbinsky, former president of Medecins Sans Frontieres (MSF) and president of the Global TB Alliance’s Stakeholders Association. "I think we have to be careful not to develop a MacMedicine’ model of health care delivery.’
In practice, DOTS has proven to be too expensive, others add. "For the majority of TB patients who are poor to begin with, DOTS isn’t cheap," says Ian Small, director of MSF’s Aral Sea Area Program in Uzbekistan. Small notes that DOTS works best when patients get supplements for transportation, food, and loss of salary — but adds that that’s asking a lot of "governments with health budgets that are already stretched thin."
That may be true, says Bloom, but isn’t that all the more reason for TB and AIDS to join forces and perhaps produce a bit of synergy? By piggybacking AIDS treatment on top of an existing DOTS infrastructure, both AIDS patients and TB victims stand to benefit, he suggests. "Everyone’s very eager to bring in these AIDS drugs; the hope is that DOTS is something to build on," he says.
Others agree. "The point is to avoid developing two side-by-side vertical systems and instead integrate the two," says Giorgio Roscigno, MD, acting chief executive officer of the Global Alliance for TB Drug Development.
Even if a synergistic approach works well, there’s still the problem of who gets AIDS drugs, Bloom adds. "I doubt anyone is going to pay for treatment for 36 million AIDS patients from now until forever," he says. Even if the money could be found, there probably aren’t enough drugs in the world to do such a thing, he adds. That means developing countries will have to make some hard decisions about who gets treated — the richest patients? The sickest?
Bloom proposes targeting three groups that contribute most to the continued spread of HIV: Pregnant women, commercial sex workers, and truck drivers (who carry HIV from town to town as they travel). In the rush to bridge disparities of access, transmission prevention is still of utmost importance and risks getting lost in the current impassioned debate, he adds. "In a country like Botswana, where 37% of pregnant women are HIV-positive, you simply can’t afford to ignore prevention," he says.
So far, evidence exists — slight, but encouraging — that a DOTS-style framework could work well in poor countries. In Haiti, Partners in Health (a Cambridge, MA-based health care organization with close ties to Harvard) has been using DOTS successfully for many years to treat TB patients. Recently, the group added to its treatment roster two AIDS patients. Both are doing well, with good compliance and only negligible side effects, says Bloom.
"They’re seeing fewer adverse effects than we’d see in Brigham and Women’s Hospital here in Boston," Bloom says. "Often in developing countries, there seems to be an inverse correlation between severity of the illness and the number of complaints about side effects you get — as if the sicker you are, the more grateful you are for anything that makes you feel better."
Two-thirds of the Haitian DOTS supervisors are illiterate, Blooms adds. "But they can count," he adds, "and they can fill out a form to indicate that a patient has taken his drugs."
DOTS simply doesn’t work all that well’
Even though Orbinsky and others are skeptical, they still add that DOTS is a good starting point. MSF uses DOTS all the time and seeks to expand its DOTS programs, notes MSF spokesperson Kris Torgeson. "DOTS simply doesn’t work all that well for TB patients," adds Torgeson. "We need to look at lots of different models, not just impose DOTS onto AIDS treatment as the de facto way to go." In that spirit, MSF is starting its own pilot studies to see what works for delivering antiretroviral therapy to AIDS patients in poor countries and what doesn’t, says Orbinsky.
"DOTS is a starting place," Bloom agrees. "What I’m saying is that we shouldn’t run out and make a huge investment in drugs for everyone — not until we’ve figured out how to make a positive impact on health and prevention and at the same time prevent resistance and the growth of a black market."