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Amongst all the talk of pandemic flu and intellectual property at last month’s World Health Assembly in Geneva, there was little mention on what is rapidly becoming one of the most pressing issues in global health: quality and safety of medicines. As a result, multilateral agencies such as the Global Fund are free to continue jeapordising patient safety with their policy of procuring malarial drugs of unknown quality.
Health activists have long claimed that the high cost of patented drugs hinders access to medicines in poor countries, and have pushed for copies to be manufactured and exported at low cost by “generics” companies, mainly in India. As a result of this lobbying the Global Fund to Fight AIDS, Tuberculosis and Malaria now favours these copies when it is financing procurement.
But many of the copy-drugs manufactured in India and Africa are not in fact true generics, rigorously tested by a regulatory agency to ensure they act on the body in exactly the same (bioequivalent) way as the original branded drug: they are copies with no guarantee and can lead to all sorts of health complications, particularly increased drug resistance and clinical failure–also known as death.
The FDA should step in again and rescue the Global Fund as it did the WHO in 2005 and ensure bioequivalence of all the anti-malarials on its list. At the same time, the Global Fund must put patients’ safety above ideology.
The dangers of this strategy were first exposed back in 2004 when 18 anti-HIV copy drugs were withdrawn from the World Health Organization’s list of approved drugs (the “pre-qualification list”) because they could not prove bioequivalence.
Nevertheless, activists and many of the foundations that finance drug procurement, such as Bill Clinton’s, continue to promote these cheaper drugs–but doctors in the field are sceptical. As one told me in South Africa: “Sure they’re cheaper but if the patient fails to respond we don’t know why: is it because the drugs don’t work, or for some other reason?”
The U.S. Food and Drug Administration tried to resolve the problem in 2004 by offering free, fast-track bioequivalence testing to the WHO. Everyone relaxed and it looked as though good quality cheap drugs would reach the poor.
But the WHO actually buys very few drugs: it provides technical expertise and advice to donors.
Far more drugs are purchased by the Global Fund, established in 2002 to finance drug procurement for developing countries: about 30% of its funding comes from the USA and 55% from European Union members. It announced in May that it aims to triple its annual spending to between $6 billion and $8 billion by 2010 and the G8 meeting made the usual promises to support it.
Because the Global Fund has relatively few staff, it was expected that its drug lists would resemble the WHO’s, with its far greater technical expertise. Although the lists are similar for HIV/AIDS and tuberculosis, they are very different for malaria: only 7% of malarial drugs on the Global Fund’s list have undergone bioequivalence testing yet malaria kills more than a million people a year, 90% of them in Africa and most of them children.
Some of the drugs are “monotherapies,” single drugs which have been actively discouraged by WHO because they encourage drug resistance. The list contains further drugs which go against good medical practice, the specific advice of the WHO and even, according to insiders, against the technical advice of competent people at the Global Fund.
This astonishingly low number of bioequivalent malaria drugs is the direct result of the Global Fund’s decision to rely on smaller companies in developing countries–regardless of the quality of their drugs. Insiders tell me the aim is to prevent Western drug companies from profiting from increased demand.
For the time being, the main supplier of anti-malarials remains the Swiss company Novartis, which produces Coartem, one of the most widely-used high quality drugs. But Dr. Willis Akwhale, head of Kenya’s malaria control programme, told me in February of plans to buy untested Indian copies of Coartem. Uganda and Nigeria are likely to do the same. And this is probably just the tip of the iceberg.
What makes this plan most bizarre is that Novartis makes no profit on the drug and assumes all the risk of notoriously weak demand forecasting for malaria.
U.S. Senator Tom Coburn, a great Congressional supporter of malaria control, puts it succinctly: “We cannot allow the world’s poorest, sickest, and most vulnerable populations to be made into guinea pigs through the purchase of medicines that are untested at best and counterfeit or toxic at worst. Why should wealthy nations, through support of the Global Fund, provide drugs to African children that we would never give to our own children?”
The FDA should step in again and rescue the Global Fund as it did the WHO in 2005 and ensure bioequivalence of all the anti-malarials on its list. At the same time, the Global Fund must put patients’ safety above ideology. Africa’s hundreds of millions of malaria sufferers deserve no less.
Roger Bate is a resident fellow at AEI.
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