Fake Drugs Kill the Poor

Resident Fellow
Roger Bate

Most Nigerians administer their own malaria treatment. They know the symptoms and they know the time-tested remedy--chloroquine, purchased from a local pharmacy or street trader. Unfortunately, chloroquine's effectiveness has deteriorated over the years as the malaria parasite has mutated and gained resistance to the drug. Chloroquine now fails most of the time it is administered.

The best new drugs work very well, but complicating malaria treatment is a burgeoning industry of fakes and pseudo-pharmaceuticals with suspicious provenance. A sick patient faces both a social and medical dilemma: a hardy strain of malaria and a corrupt, poor and inconsistent health infrastructure that constantly reinforce each other. The effects are often disastrous for children under five, who make up the vast majority of Africa's malaria victims and require more delicate care than adults.

It is a heartbreaking predicament for parents. While researchers and pharmacologists around the world work on new drugs, their efforts are complicated by the murderous opportunists who fake legitimate products. In this environment, where every sale puts a patient's life in peril, the market--encompassing traditional commerce as well as financial aid and in-kind donations--has broken down in the deadliest of ways. The World Health Organization (WHO) defines a fake or counterfeit drug as a medicine "which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and . . . may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging."

Who makes the bad drugs? Some are deliberate perpetrators, but other culprits are legitimate firms that are simply slack in their operations.

A recent study in the Journal of Tropical Medicine and International Health estimated that 86% of under-strength medicines analysed in Kenya and Congo came from India and China. The reason that "most of the sub-therapeutic dosage drugs were manufactured in India and China may be because of the laxity of Indian and Chinese regulatory bodies in checking exported medicines," the authors write.

Who makes the bad drugs? Some are deliberate perpetrators, faking the packaging and relabeling aspirin or chalk as an anti-malarial. But other culprits are legitimate firms that are simply slack in their operations; with more effort, they might make a perfect copy of a malaria drug. Sometimes the entire firm is operating to unacceptable standards, and other times rogue employees work after hours to increase production and sell the drugs to criminal networks. Either way, such producers cut corners and costs by skipping the rigours of a quality-control process.

Processes like these probably created some--perhaps most--of the two dozen different types of anti-malarial drugs I saw in the pharmacies of Lagos and Abuja, the most important cities in Nigeria. One typical pharmacist carried a range of old, outmoded drugs, plus some of the newer artesunate and artemisinin-combination therapies (ACTs). Only one of these drugs had been tested by a reputable agency. Everything in the store may work, or not. We simply do not know.

But it's not just the manufacturers that bear the blame. Even some international aid agencies and donors sanction drugs that have not been tested for safety or for bioequivalence (that is whether they are therapeutically the same as the patented drug from which they are supposed to be copied). The WHO had to withdraw 18 anti-retrovirals from its HIV treatment campaign in 2004 because it could not be sure the drugs were up to standard. Today the Global Fund may have to withdraw several anti-malarials from its list for the same reason. Well-meaning donors provide an environment in which it is easier to introduce fakes.

One of the heroes of the fight against counterfeits is Dora Akunyili, a 52-year-old pharmacy professor who heads Nigeria's National Agency for Food and Drug Administration and Control. Akunyili has a personal reason for fighting counterfeiters: a friend of hers died from fake anti-diabetes drugs, and since then she has collected volumes of shocking tales. "People have been dying in this country from the effect of fake drugs since the early 1970s," she says.

Transparency International once ranked Nigeria as the most corrupt place on earth, but, recently, in large part due to Akunyili, it has risen from the bottom of the heap. In 2002, the WHO reported that 70% of drugs in Nigeria were fake or substandard; by 2004 that figure had fallen to 48%. But that's still a very disturbing number, and much more needs to be done, notably the prosecution of government officials either directly involved in the fake market or being bribed not to pay any attention to it.

Roger Bate is a resident fellow at AEI.
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