Counterfeit Drugs: a Deadly Problem

Counterfeit drugs appear to be all the rage. For some time there have been problems with counterfeit antimalarials, as I learned when I studied in Bangkok at the Asian Tropical Medicine Course in 2006. The practice was common in Asia, causing serious problems with increasing resistance to antimalarials there, as well as in Africa, where counterfeit medications are rife.

Malaria killed 781,000 in 2010. According to the World Health Organization (WHO), there were 216 million cases of malaria in 2010; 81% of these were in the WHO African Region, with 91% of malaria deaths occurring there, primarily in children under 5 years of age (who comprise 86% of the victims) and pregnant women. Because of increasing resistance to the standard antimalarial, chloroquine, WHO had recommended use of artesunate containing products. These are made from Artemisia annua and are far more expensive, as the plant is relatively scarce.

While efforts by both governmental and private sector institutions to eliminate counterfeiting have had some success, the problem is ongoing, and perhaps increasing. News of counterfeiting appears regularly. Last week about $182,000 worth of fake medicines for diabetes, high blood pressure, and cancer were seized in China, and almost 2,000 people were arrested.

Fake drugscurrently known formally as Spurious/falsely-labeled/falsified/counterfeit (SFFC) medicines, can take various forms, as that cumbersome name suggests. These have been deliberately mislabeled, but may well have some sort of active drugbut not necessarily that which it should have. Sometimes toxic chemicals are even substituted for the real medicine. Rather than fraud, other drugs might instead be substandard, lacking in the correct dosage due to factory errors, or from being stored improperly, or being out of date.

Magnitude of the problem

According to the Center for Medicine in the Public Interest, about 30% of brand-name drug sales in developing countries are counterfeit.

Indias Business Standard reports that counterfeits in India comprise about 20% of the total pharma market, and largely involves popular brands of drugs for coughs and colds, vitamins, and symptomatic treatment of acute illnesses. They claim that 8-10% of a drugs production cost goes to efforts to stymie counterfeiting.

In parts of Africa and Asia, estimates are that more than 50% of marketed drugs are fakes. Globally, criminal sales were estimated to total more than US$35,000,000,000 annually (2002-3 data).

In contrast, according to the World Health Organization (WHO) only about 1% of the medicines sold in developed (i.e. Australia, Canada, Japan, New Zealand, the United States of America, and most of the European Union) markets are fake.

Data as to the magnitude of this problem had been scarce. Cockburn et al. realistically suggested that many pharmaceutical companies and governments are reluctant to publicize the problem to health staff and the public, apparently motivated by the belief that the publicity will harm the sales of brand-name products in a fiercely competitive business. For those who like pharma scandals, their paper offers detailed examples, a l The Constant Gardener, of pharmaceutical companies trying to bury their problems quietly.

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Counterfeit Drugs: a Deadly Problem