Ministers at the World Health Assembly in Geneva celebrated unprecedented amounts of money for fighting diseases in Africa. The US Congress has just committed $50 billion over the next five years to combatting HIV/AIDS, TB and malaria, while the Global Fund for these diseases will probably add $25 billion. This is a lot of money and a lot of talking. But what won't be discussed is the fact that many of the drugs that will be bought with this money will end up doing AIDS, TB and malaria patients more harm than good. Part of the problem in poor countries is the alarming amount of fake drugs. In 2007 the WHO reported that 30% of all medicines sold in Africa were counterfeit, "killing thousands. The WHO established the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) in 2006. The problem, however, is not limited to outright fakes. IMPACT needs to turn its gaze towards sub-standard drugs manufactured in Africa and Asia that rarely meet the very high standards of safe and effective medicines. Nor are they tested by independent regulatory authorities. If an AIDS, TB or malaria drug is sub-standard - say with the incorrect level of active ingredient - it allows the virus to mutate and drug resistance to develop. This will eventually make the drug useless for the entire population and even fatal. The outrage is that the Global Fund and WHO have been knowingly promoting sub-standard drugs. When procuring drugs, the Global Fund follows WHO guidelines so the Fund's Option C rule allows the procurement of drugs that have not been reviewed and tested by a credible regulator (such as the US Food & Drug Administration). These are "investigatory drugs, which no doctor in a rich country would ever prescribe because of the risk to patients and of drug resistance. When the WHO and the Global Fund approved Option C, they reasoned it would allow them to buy from mainly Indian companies at a cheaper rate than branded generic (copied, off-patent) and patented drugs - even though properly-tested generic and patented products are frequently available at lower prices. But what they skimped on price, they lost in quality: according to a February 2007 report by the Global Fund, half the drugs purchased under Option C did not comply with the Fund's Quality Assurance Policy. Option C is used to procure drugs for millions of AIDS, TB and malaria patients all over the world. When patients develop drug resistance, their medical costs increase exponentially, often requiring hospitalization and always more specialist care. These extra costs dwarf the original price of the drug and have the potential to bankrupt entire healthcare systems. Drug resistance is already on the rise globally. For AIDS, a World Bank study showed that the increase in drug resistance in the UK was 17 percent for 2001-2003 and 24 percent in the USA between 2001-2002. Lacking data from the developing world, one can estimate that at least 20% of the two million patients (some 400,000 people) under treatment in developing countries are now drug resistant. For tuberculosis, the WHO reported in April that 5 percent of the nine million new cases diagnosed each year are now resistant to many drugs, "the highest rate ever recorded of Multiple-Drug Resistant TB. We can expect the same soon for the newest malaria drugs. In a 2007 study on anti-malarials in Kenya and DR Congo, nine out of 24 samples were sub-standard and two-thirds of dry powder suspensions were either sub-standard or fake. In 2006, Thailand reported that sub-standard malaria drugs had been found in 14 provinces. Research published this month shows that a third of legal malaria drugs sampled in six of the most malarious African cities failed quality tests. Of the African-made samples, half were sub-standard, Bate et al showed in Antimalarial Drug Quality, published in the US medical journal Public Library of Science ONE. All these drugs were legal and registered locally. Because Global Fund recipients keep poor medical records, it is too early to say what portion of drug resistance can be directly attributed to Option C. Nevertheless, it is like playing Russian roulette with the lives of millions of poor patients--with three rounds in the pistol. Damage is already being done but the WHO can help by extending IMPACT beyond counterfeit drugs to sub-standard drugs. As a priority, it must determine the rates of drug resistance caused by sub-standard drugs. The Global Fund's procurement policies can then be altered accordingly. There is no reason why African patients should not receive the same quality medicines as patients in rich donor countries. By failing to abide by this principle, the WHO and the Global Fund are putting the lives of millions at risk. Jeremiah Norris is Director, Center for Science in Public Policy, Hudson Institute, a policy think-tank in Washington DC. He specializes in health and scientific matters.
