The deadly world of falsified and substandard medicine

FDA/Michael J. Ermarth

An FDA field inspector presents an assortment of illegal imported products marketed as dietary supplements.

Article Highlights

  • Around 10% of all essential drugs in emerging markets fail basic quality tests.

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  • International law is currently inadequate tocombat international fake drugs rings

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  • Until regulators in emerging markets demand better products, tens of thousands will be killed by substandard drugs.

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Everyone knows about the risks narcotics pose and the lethal war waged against them. But there are probably far more deaths caused by dangerous therapeutic medicines. Lazy, cost-cutting manufacturers and criminal counterfeiters make billions of dollars a year peddling products which may kill you and which you might find online or even at your neighbourhood pharmacy.

It is impossible to know the exact size of the illegal medicine trade or its lethal impact.  "I estimate that bad medicines cause at least 100,000 deaths annually. Some markets are barely affected while others are replete with substandard products. Around 10% of all essential drugs in emerging markets fail basic quality tests."-Roger BateI estimate that bad medicines cause at least 100,000 deaths annually. Some markets are barely affected while others are replete with substandard products. Around 10% of all essential drugs in emerging markets fail basic quality tests. The UK is much better served: far less than 1% of all drugs are faulty. Although even if only 0.001% of the hundreds of millions of prescriptions filled in the US every year were compromised, well over one thousand prescriptions could be deadly.

More worryingly, lethal drug incidents are on the rise in the UK. In most cases, no crime is suspected, as the consumers are often quite sick and the evidence is swallowed. If a relative with a heart problem dies from a heart attack, who would think to investigate the medicine? But fake Plavix, one of the most important heart medications, has been found in numerous countries.

Before the civil war in Syria, Damascus was home to a major counterfeit drug operation that made tens of millions of dollars between 2003 and 2009. The ring manufactured over 80 brands of fake medicine very convincingly, only
distinguishable from real drugs by experts. Yet none of them contained the correct ingredients. Fake antibiotics, cancer and heart medications penetrated every major market of the Middle East.

While part of the operation was shut down in 2009, some gang members fled and reassembled in Iraq and Iran. My sources in the Middle East believe that this gang may have begun operations again in Damascus, bribing officials with their vast wealth to turn a blind eye. Most worryingly for us, they may have been the source of the fake cancer-drug Avastin that was traded in UK in March and April of this year.

UK authorities are limited when trying to combat illegal trades outside the UK. International law is currently inadequate to combat international fake drugs rings, and there is a need for a global treaty against such products. I am optimistic that this will change within the next decade; international laws will be strengthened and global efforts against counterfeiters will constrain their activities.

But I am less certain that governments will effectively tackle legal producers who make bad products. These companies pay their taxes, provide jobs and have political clout in numerous emerging markets. Cut-throat competition among chemical and drug manufacturers keeps prices low, but it also encourages corner-cutting. In some emerging markets, there are more than 300 brands of the same class of medicine. Local regulators do not have enough competent staff either to conduct thorough inspections of all production plants or to survey products in the market. Consequently, companies routinely get away with sub-standard production.

Most tragically, these producers undercut better producers on price and sometimes force more responsible players to exit the market. Chinese and Indian producers dominate many drug categories in emerging markets, notably anti-infectives. While many of these companies make good medicines, a substantial subset routinely targets poor
markets with sub-standard versions, as my research team found in two peer-reviewed publications in Research and Reports in Tropical Medicine. Perhaps most worryingly, western health experts and donors spent more time trying to discredit the research than combating the problem it highlights.

Until regulators and customers in emerging markets demand better products, tens of thousands will be killed by substandard drugs, and unfortunately some of these products will make their way to UK markets too.

Roger Bate is a Resident Scholar at the American Enterprise Institute and author of Phake: The Deadly World of Falsified and Substandard Medicines.

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