TB Monitor International-Gates' latest TB grant stokes longtime dispute
Poor countries to get help
Whether he knew it or not, when Bill Gates announced this summer that he'd give $45 million to finding ways to treat multidrug-resistant TB (MDR-TB) in poor countries, he stepped into the midst of the biggest slugfest in recent public health history.
On one side of the dispute is the World Health Organization (WHO), which has long maintained that poor countries simply can't afford an individualized approach to treatment for drug-resistant TB.
Besides that, with a committed approach to the TB control strategy promulgated by WHO, resistant disease eventually would subside on its own.
In the other corner, playing David to WHO's Goliath is a group of impassioned social-justice advocates ensconced at the Harvard Medical School's program in infectious disease and social change.
The Harvard group's clinical arm, Partners in Health (PIH), argues the WHO approach has done little but add rich-world insult to poor-world injury — first by assuming that patients who fail the standardized regimens are probably noncompliant and, second, by replacing the initial four-drug regimen with a five-drug re-treatment scheme in violation of the near-sacred dictum that a single drug must never be added to a failing regimen.
The Gates grant may not resolve the dispute, but it certainly assures that PIH (where dedicated employees recently voted themselves a pay cut in the face of dwindling funds) won't have to hold any bake sales, at least not for the immediate future.
Bill Foege, MD, the public health expert who once headed the Centers for Disease Control and Prevention and now serves as a trusted adviser to the Gates Foundation, is said to have been instrumental in persuading Gates to throw his considerable weight behind the Harvard contingent.
The grant will go to fund research over the next five years at PIH's pilot project for treating impoverished victims of MDR-TB, a program set in a slum on the northern outskirts of Lima, Peru.
Few sour grapes
Considering the size of the Gates gift, resentment at WHO and elsewhere seems remarkably low. Still, the news of the giant grant caused some international TB experts to behave as if they heard a giant sucking sound that signaled the disappearance of every last donor dollar on earth into Peru. "If I could talk to Bill Gates, I would tell him, 'Fantastic! Very visionary!'" says Mario Raviglione, MD, head of epidemiology and operational research at WHO's infectious diseases unit. "Then I would say, 'Now, please, give us 10 times more for the global TB problem.'"
The head of Medecins Sans Frontieres International echoes Raviglione's concerns. "The PIH program in Peru is very important, but there are other programs that are equally important," says James Orbinski, MD. "And if [standardized] TB programs aren't also strengthened, even with the finest MDR-TB treatment program in the world, you'll never get rid of TB."
Treatment could be at risk
Strengthening basic TB control in developing countries is exactly what Gates' largesse will accomplish, retorts Paul Farmer, MD, PhD, the intense and charismatic physician/ anthropologist who founded PIH and serves as co-chair of the Harvard program. As Farmer sees it, the re-treatment scheme puts the entire standardized-treatment apparatus into the gravest jeopardy, first by generating treatment failures and, second, by creating drug resistance.
"We've claimed for years that the re-treatment regimen will always backfire, and that it should never be used," Farmer says. Now, he adds, new data — one article he cites appeared in this past January's issue of The Journal of the American Medical Association — are emerging that show even single-drug resistance can result in widespread treatment failures. "They accuse us of being ideological," he says, referring to PIH's critics. "But the rationale for the retreatment scheme is based entirely on ideology, and economic ideology at that. It would never, never pass muster here in the U.S."
Along with Jim Yong Kim, MD, PhD — Farmer's best friend, the principal investigator named in the Gates grant, and co-chair of the Harvard program — Farmer says he intends to use the Gates money for two purposes: to find better ways to treat "chronic" patients, the ones who've failed standardized treatment repeatedly, and to tackle the whole retreatment problem by figuring out how best to manage patients who don't respond and still have positive smears well into treatment.
Finding a better way to carry out retreatment need not be prohibitively expensive, either, he adds. "Do you know how much a basic sensitivity [test] costs? About $2," he says. "Isn't that a lot cheaper than giving a course of drugs that are, at best, useless?" He's also eager to try a new diagnostic gizmo dubbed "the Bronx box," devised by researcher Bill Jacobs, PhD, an investigator at the Howard Hughes Medical Institute in the Bronx, New York.
"It'll cost less than $3, and you'll get results within a day!" Farmer says. "Why haven't we been allowed to try out these kinds of things in poor countries before? Because," he adds derisively, "the economists wouldn't let us!"
Finally, time to do research
The Gates money also will go to polishing the rough edges off the Peruvian MDR-TB pilot. With enough money now to do all the tweaking they like, researchers finally have the capacity to sort out a long list of important operational questions, says Kim, Farmer's colleague.
Kim happily ticks off some of the questions he wants to settle. For starters, given that the MDR-TB regimens will last an arduous 18 months, must every dose of medication be directly observed? Can family members be trained to observe dosing? Can community health workers be trained to observe treatment?
And how about administration of the second-line drugs, many of which must be injected? Must injections be done on a daily basis, or might every other day work? Could health workers be trained to give them?
Money spread thin
And what about the optimum dose levels and combinations of drugs? When it comes to the drugs' harsh side effects, what's the minimum pharmacopoeia to be kept on hand to manage them? What agents will work best to manage which side effects?
"We know a lot about some of this already," Kim adds. "But by being able to do it on a large scale, we'll learn a lot more."
The grant, though it sounds like a lot, will be used eventually to mop up all MDR-TB in the country, and it must stretch to cover not only the cost of drugs, but the infrastructure and research budgets as well, adds Kim. "You know, I really hope people don't get the idea that we're rich now," he says, sounding for a moment like his pinchpenny colleagues at WHO. "Because if they do, we're in big trouble. There's still an awful lot more work to be done."
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