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The manufacture and distribution of medicines is a global industry, tainted by fake and substandard products. Not only might these drugs not work as expected, but some are even contributing to antimicrobial resistance. So, what’s in your medicine cabinet.
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In late 2012, 60 people died in two cities in Pakistan after drinking cough syrup to get high. Syrups from two separate manufacturers were involved. It was found that both were using an active ingredient – dextromethorphan, a synthetic morphine-like compound – imported from the same manufacturer in India. Indian drug authorities put a halt to production while they investigated.
Tests in Pakistan revealed that the medicines seemed to contain the correct amount of active ingredient. But further tests revealed something that was not supposed to be there. Levomethorphan, a chemical five times stronger than morphine, was the contaminant that had caused the deaths.
In September 2013, 44 children in Paraguay were admitted to hospital with breathing difficulties. It turned out the children had all been given a locally made cough medicine. Investigators went to the factory and found import records for the dextromethorphan it contained. When they checked the World Health Organization’s database of substandard and falsified medical products, they found that this came from the same batch that had caused the deaths in Pakistan.
Doctors in Paraguay were able to administer an antidote and save the children. A WHO alert went out listing the batches from the Indian factory that might be contaminated. By then the ingredient had been transported to multiple countries in Europe, north Africa, the Middle East and Latin America. It had already been made into cough medicines in Colombia and Peru, but these were recalled before they could reach patients. The batch that went to the Middle East could not be traced.
In this case, a blatantly poor-quality medicine was detected because its effects were conspicuous. A more discreet kind of substandard medicine – say, an antibiotic without enough active ingredient – probably stands a strong chance of reaching patients across the world without getting discovered.
This is a story of how the manufacture and distribution of medicines today is such a complex, globalised affair that it is often hard to track where fake or substandard medicines come from and where they go. This is a story of how these medicines could make you ill or even kill you, even if you don’t take them.
The term “poor-quality medicines” is something of a catch-all. It includes “substandards”, medicines that have had inadequate quality control or that have degraded from improper storage or the passage of time. And it includes falsified medicines – fakes – that claim to be what they are not. These may not be made by the manufacturer whose name is on the package, and they may not contain the stated ingredients in the stated quantities.
Poor-quality medicines might not work. Like those peddled by Peter Gillespie, who was jailed for introducing 72,000 packets of falsified medicines into the UK’s distribution system from 2006 to 2007. 25,000 packets reached pharmacies and were given to patients. These knock-off tablets were used to treat heart disease, pancreatic cancer and mental illnesses, and had none or only part of the active ingredient they were supposed to contain. This meant that those people’s illnesses were left to take their course.
Poor-quality medicines can kill you if you take them. As happened with Thomas Rybinski, a 56-year-old autoworker from Tennessee, USA, who got an injection for his back pain in 2012. He fell ill and died because the medicine had contaminants that caused fungal meningitis. The batch of medicine, originating in a New England pharmacy with close to no quality control, ended up causing severe infections in nearly 800 people across the USA, killing 64 of them.
Poor-quality medicines can kill you even if you don’t take them. Antimicrobial drugs (including antibiotics and antivirals) that have too little active ingredient are generally accepted to help disease-causing bugs evolve so that they develop resistance to treatment even with good-quality antimicrobials. And then these bugs spread.
Ramanan Laxminarayan is the director of the Center for Disease Dynamics, Economics and Policy in Washington, DC. He says that with some drugs, like statins or arthritis drugs, the effects of poor quality are confined to those taking them. But with antimicrobials, inappropriate use reduces their effectiveness for everyone else. “If there’s misuse in South Asia then everyone is affected. It’s a problem that comes up when people act in ways that don’t take into account the effects of what they are doing on everyone else,” he says.
“It’s really no different from climate change,” says Laxminarayan. “Either in terms of potential global impact, or in the fact that everyone needs to be working together to solve the problem.”
The factors that speed up the development of antimicrobial resistance – high rates of infections, the overuse and misuse of antimicrobials, poor sanitation, poor-quality medicines – are more common in low- and middle-income countries, which means that so is resistance. But microbes know no boundaries, and they travel easily across the world, in foodstuffs being exported and in the bodies of humans. And often, resistant microbes can transfer genetic material to each other to become even more dangerous to humans.
The result: infections that were simple to cure, gonorrhoea for example, are back with a vengeance. Conditions like tuberculosis and HIV are getting harder to treat. In the future, routine surgery or cancer treatment could become risky. There is a real danger of returning to a time where any one of us, anywhere in the world, could pick up such an infection and find that medicine is powerless to save us from dying