The Global Fund to Fight AIDS, Tuberculosis and Malaria is under intense scrutiny from malaria researchers, who say that its limited resources are being wasted on useless malaria drugs.
The controversy was sparked by the latest figures on the fund's spending on malaria treatment in Africa. More is being spent on chloroquine, which costs just $0.10 (£0.06; €0.08) for each dose but which is largely ineffective in Africa, than on combination treatments based on artemisinin, which are highly effective but cost at least 10 times as much. The result, say the researchers, is that lives are being lost needlessly.
“It is terrible to waste lives and money deploying a useless drug,” said Professor Nick White, director of the Wellcome Trust's South-East Asia Overseas Unit.
Dr Amir Attaran, associate fellow at the Royal Institute of International Affairs in London, believes that the fund's reputation is at stake. “In Africa extensive resistance means that chloroquine therapy is almost everywhere a contradiction in terms, such that financing chloroquine is both a waste of the fund's very limited money and is tantamount to medical malpractice.”
The fund argues that its critics have misunderstood the way it operates and the way in which the chloroquine it has bought is being used in each country.
Individual countries send proposals to the fund asking it to finance specific projects to control malaria. The World Health Organization, which launched the Roll Back Malaria campaign in 1998 to halve the number of deaths from malaria by 2010, advises countries on which drugs they should ask the fund to buy. In addition, the fund has a technical review panel that decides which proposals should be funded.
“Do we naively believe that every country has the right proposal?” said Professor Richard Feachem, the fund's executive director. “No. That's why an independent review panel looks at the choice of drug.”
When the fund buys chloroquine it is because a country itself has asked for it, with WHO's advice, explained Dr Vinand Nantulya, Professor Feachem's senior adviser.
“We would like artemisinin based combination therapies to be made available to all countries,” he said. “That is the best treatment. But we don't tell countries what to use. We leave it to WHO to guide the process in terms of technical support. We're a financing mechanism.”
Figure 1.
WHO is planning to shift policy towards cheap prevention efforts such as bed nets, a change that has been called “catastrophic”
Credit: ANDY CRUMP/TDR
Dr Nantulya agrees that the fund should not support the use of chloroquine as monotherapy. But he has broken down the figures on a country by country basis, and in the four countries that account for 82% of the fund's spending on chloroquine—Uganda, Nigeria, Ethiopia, and Sudan—the drug is being used with a second antimalarial, usually sulfadoxine-pyrimethamine. This combination, he said, is more effective than chloroquine alone.
But this is just combining two failing drugs, argued Professor Bob Snow of the Kenya Medical Research Institute. “There is almost no evidence that this strategy has ever succeeded or is actually of any biological or scientific sense.”
Professor Snow said that Uganda asked the fund for help to buy this combination at a time when the combination was associated with a clinical failure rate of 33% or more by day 28. One site in Uganda reported a failure rate of about 80% on day 14. So the fund is doing a poor job at peer reviewing proposals, he said, while “WHO is not providing the technical leadership countries deserve.”
He gave Kenya's malaria proposal as another example of poor peer review. In the first round of the fund's financing Kenya asked for $102m for malaria control that would have paid for artemisinin based combination therapies. The proposal was rejected. In the second round Kenya, realising that this treatment was too costly for the fund, asked for $32m to buy a cheaper alternative, sulfadoxine-pyrimethamine. The fund agreed, said Professor Snow, even though this treatment “is on its last legs” in Kenya.
“The global fund would of course argue that if this is what countries want, then who are they to disagree? If countries asked for paracetamol as their first line treatment, would they [the fund] also provide support?”
At the heart of the controversy, says the aid charity Médecins Sans Frontières, is the widespread confusion about which drugs WHO is recommending to African countries. Nathan Ford, head of the group's medical unit, said that in 2001 WHO clearly recommended artemisinin based combination treatments as the first line treatment for malaria in Africa. But now, he says, WHO is back pedalling.
WHO's new policy is laid out in a draft strategy document for the Roll Back Malaria campaign for 2004-8, which is out for consultation until the end of November. The draft document is “catastrophic,” said Mr Ford. “Artemisinin based combination therapies are now seen as future possibilities, not promoted for use immediately. Instead, interim policies are advised using combination therapies with drugs which are known to be less effective.”
Even worse, said Mr Ford, is that the document signals a shift in policy towards an emphasis on cheap prevention efforts, such as bed nets, rather than treatment with effective but expensive drugs. “All the evidence to date suggests that ramping up prevention efforts won't stop people dying of malaria,” he said. And as with antiretroviral drugs, the way to lower the price of artemisinin based combination treatments is by increasing their use across Africa, he added.
Dr Allan Schapira, Roll Back Malaria's coordinator of strategy and operations, said it was appropriate that “most countries are going for scale up of prevention efforts.” While it would be better, he said, if more countries asked the fund to back artemisinin based treatments, in the meantime cheaper alternative combinations of drugs are available that work better than chloroquine alone.
And if all countries asked the fund to pay for artemisinin based combinations, on top of their requests for funding for bed nets and for control of HIV and tuberculosis, “the fund would be in trouble.”
“It doesn't have the resources,” he said. “This is where the outrage is.”
Professor White agrees that it comes down to money. He lays the blame largely at the hands of the donors, who he says are unwilling to pay for expensive malaria treatments, preferring to see their money spent on cheaper bed nets.
“Artemisinin based combination therapies are safe and effective everywhere, but they currently cost more than the donors are willing to pay,” Professor White said. “The global fund takes its advice from Roll Back Malaria. Roll Back Malaria is controlled by the donors. Pushing bed nets without adequate case management is not going to roll back malaria.”