A postcard from India: Don’t ditch DOT, fix it’
WHO-endorsed regimen takes a beating
Tom Frieden, MD, the former czar of TB control in New York City and now a regional head for the World Health Organization based in New Delhi, has a message for the folks back home: When it comes to directly observed therapy (DOT): Don’t throw out the baby with the bath water.
"It is possible to do DOT badly, and that’s not a trivial finding," Frieden says. "There is the risk that DOT can degenerate into something mechanical and authoritarian. In that case, it’s no better — and, in certain subsets of patients, may even be worse — than self-administered therapy. But the correct response isn’t to say that since we can’t do it well, we shouldn’t do it at all."
Frieden is referring specifically to the dust- up that’s been taking place recently in the pages of The Lancet, a British peer-reviewed journal in which a randomized, controlled trial carried out in South Africa pitted the WHO program (which incorporates DOT as one of five principal elements) against self-administered therapy and found the self-administered group did better.
Stateside, DOT also has taken a series of knocks of late. In Chest, a retrospective look at DOT vs. self-administered therapy (also structured as a randomized, controlled trial) found that even though DOT bested the opposition, both methods made a relatively poor showing when measured according to how many patients had completed therapy by the end of 12 months.
Meanwhile, researchers at Johns Hopkins University in Baltimore, a city that has incorporated DOT into its TB control program for the past 15 years, say they also have found that DOT has failed to eliminate ongoing transmission among the homeless population.
"That’s an interesting result, and a little disturbing," Frieden says. He offers a tantalizing prediction: "You’ll soon see some data that says something very different coming out of New York City."
With or without DOT, programs that aren’t getting good results need to figure out where they’re going wrong, Frieden says. "The success or failure of a program is evidence-based," he says. "If a program is getting 85% successful treatment, by whatever means, then more power to them — they should keep doing whatever they’re doing. If not, they should look at what’s happening and improve things."
Though he concedes it’s possible to get good results without DOT, it’s not likely, he adds. "I look at it this way: If you do nothing at all, about 20% of patients get better on their own." Then, according to one recently published meta-analysis, by adding a regular supply of drugs, "you can get about 60% completion. With DOT, you get to about 85% completion." Adding incentives boosts completion to 90% to 95%, he adds. "So how can you possibly justify condemning patients to a method that’s got a 25% less chance of achieving a cure?"
Watch your attitude
As for programs that aren’t getting optimal results with DOT, Frieden offers some simple advice. First, check to see whether programs are operating at inconvenient times or places. Second, make sure your own attitude is correct. If patients experience DOT as authoritarian, which authors of the South African study said they do, it’s the fault of the program leadership, he says. "If you think DOT is an imposition, you can be sure your patients will experience it that way, too," he says. "Blaming staff or patients is no good either; that’s where leadership comes in."
In India, Frieden has found himself up against a variety of hurdles: physicians’ skepticism, bur eaucratic inertia and fatalism, inadequate drug supply, and wide variations in non-approved regimens. Even so, over the next year, he hopes to enroll 100,000 in the WHO program, which incorporates DOT as one of its ingredients.
Plus, he’s managing to overcome widespread skepticism that once threatened to derail his operation, he adds. "The biggest question I get nowadays at medical conferences is why aren’t we covering the whole country with [the WHO-approved regimen, Directly Observed Therapy, Short-Course]?"
(Editor’s note: Next month in TB Monitor International, look for a report of a spirited conversation between Frieden and a TB control expert in South Africa who says DOT isn’t working there.)
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