A recent study in the Journal of Tropical Medicine and International Health estimated that 86 percent of under-strength fakes analyzed in Kenya and Congo came from India and China. Unsurprisingly, this "may be because of the laxity of Indian and Chinese regulatory bodies in checking exported medicines," it said.
Some makers are deliberate counterfeiters, faking the packaging and relabeling aspirin or chalk as a drug. But other culprits are legitimate firms that are simply slack in their operations: with more effort, they might make a perfect copy. Sometimes the entire firm is operating to low standards and at 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 rigors of quality control.
I saw two dozen different unsound anti-malarial drugs in the pharmacies of Lagos and Abuja, the most important cities in Nigeria. One typical pharmacist carried a range of old drugs, plus some of the newer artesunate and artemisinin-combination therapies (ACTs). Only one of these had been tested by a reputable agency so one can assume the rest were useless.
But it's not just the manufacturers who bear the blame. Even some international aid agencies and donors approve drugs that have not been tested for safety or for bioequivalence (therapeutically the same as the original patented drug). 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.
When a Thai government factory badly copied an anti-retroviral, the resulting GPO-Vir failed to help patients but did help the virus evolve defenses--but Medecins Sans Frontieres still distributes it.
One of the heroes of the fight against counterfeits is Dora Akunyili, a 52-year-old pharmacology 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 percent of drugs in Nigeria were fake or substandard: by 2004 that figure had fallen to 48 percent--still a horrifying number.
And it's not just poor countries that suffer. This time last year Canada's first death from counterfeits was caused by drugs bought off the Internet from Eastern Europe, containing contained aluminum and arsenic. In the USA, fake anemia, diabetes and cholesterol products have set off massive product recalls in the last few years.
Until international bodies clean up their act and stop blurring the boundaries between safe medicines and sub-standard copies and until there are harsh local and international penalties for manufacturing and carrying counterfeits, the pirates will continue to get away with murder.
Roger Bate is a resident fellow at AEI. He is the author of a forthcoming AEI Press book on counterfeit drugs.