Are Counterfeit Drugs Driving Antibiotic Resistance?

A British couple have been convicted and jailed for running a black market in veterinary drugs that was so large, it earned more money than legal sales of the same drugs — 6 million pounds (almost $10 million) just in the United Kingdom where the case was brought.

(In a detail that seems made for the beleaguered UK tabloids, the wife of the couple moonlighted as a Princess Diana lookalike.)

The business — lucrative enough to pay for an 11-bedroom farmhouse in France — was based on counterfeit and falsely labeled drugs purchased primarily in India, imported covertly, and resold through a network of companies to farmers, stables and kennels, and veterinary practices. The drugs offered included anti-inflammatories, pain medications, sedatives and antibiotics. Which means that the case raises an important questions: How much counterfeit and covertly distributed drugs are contributing to the international epidemic of antibiotic resistance — in this case, not just in human medicine, but in veterinary medicine as well.

The suit against the couple and their collaborators was brought by the UK’s Department for Environment, Food and Rural Affairs (DEFRA). After the conviction, the head of the agency’s Veterinary Medicines Directorate said:

This was a significant commercial enterprise which seriously attacked the principle of safe and effective veterinary medicines. Incorrect use of medication of unknown origin and dubious quality compromises animal health and welfare, increases the risk of harmful residues in the food chain and raises the spectre of unnecessary antibiotic resistance.

Just to define terms: Counterfeit drugs are not necessarily fake, in the sense of being made only of sugar, plaster, gelatin or any other inactive ingredient. By definition, they come from an unidentifiable source and offer no reliable proof of what they contain, but they may contain actual active ingredients — sometimes a small amount, sometimes a significant overdose — and they also may  be actual pharmaceuticals under false labels or being sold through illegal channels.

They also are a massive business. Last fall, Interpol seized $2.6 million in black-market and counterfeit pills in a coordinated bust across European countries. In 2009, the agency seized 10 container-loads of counterfeits in Egypt; in 2008, they busted an Asia-based ring whose revenues were almost as large as those in the UK prosecution and also seized mass quantities of counterfeits in Tanzania and Uganda.

Several of those busts were in cooperation with the World Health Organization, which has been overseeing an International Medical Products Anti-Counterfeiting Task Force (IMPACT) since 2006. The WHO estimates that up to 30 percent of drugs sold in the developing world may be counterfeit or black market, compared to 1 percent in industrialized countries. A 2009 Wellcome Trust report put the global earnings of the counterfeit-drug trade at $75 billion per year.

Does it matter, aside from the scale of the illegal earnings? In 2005,  a journalist, two academic researchers, and representatives of the governmental drug agencies in Nigeria and Ghana  wrote a compelling and largely ignored paper in PLoS Medicine about the underappreciated dangers of fake drugs’ spread. They related these cases:

  • Approximately one-third to one-half of packets of artesunate tablets, the pivotal, life-saving anti-malarial drug, recently bought in Southeast Asia were fakes, containing no active ingredient at all.
  • A nongovernmental organization in a Southeast Asian country bought 100,000 inexpensive “artesunate” tablets only to find that they were counterfeit.
  • 192,000 Chinese patients are reported to have died in 2001 from fake drugs, and in the same year Chinese authorities “closed 1,300 factories while investigating 480,000 cases of counterfeit drugs worth 57 million USD.”
  • In Haiti, Nigeria, Bangladesh, India, and Argentina, more than 500 patients, predominantly children, are known to have died from the use of the toxin diethylene glycol in the manufacture of fake paracetamol syrup.
  • During the 1995 meningitis epidemic in Niger, the authorities received a donation of 88,000 Pasteur Merieux and SmithKline Beecham vaccines from neighboring Nigeria. The drugs were found to be counterfeit, with no traces of active product. Some 60,000 people were inoculated with the fake vaccines.

Wide distribution of counterfeit or adulterated  artesunate, the latest drug in the anti-malarial arsenal, has been held responsible for the spread of artemisin-resistant malaria, especially on the Thai border. (The Lancet 2001; Tropical Medicine and International Health 2004; PLoS Medicine 2006.) A Gates Foundation study in 2009 found that 60 percent of the artesunate that was for sale in the endemic area on the Thai-Cambodian border was fake.

If counterfeit drugs for humans are fueling the spread of resistance, can the same claim be made about drugs given to animals? That’s a harder case to prove, largely because there have been so many roadblocks placed on gathering data on antibiotic use on farms, let alone what results from that use. But it’s a reasonable inference. First, because so many of the drugs used in veterinary medicine are human-use drugs or close analogs. And second, because counterfeiting in veterinary appears just as widespread as among human ones, as the British prosecution — and assessments in China in 2007 and Kenya this past April — continue to show.

(H/t to Pat Gardiner who inspired this post.)

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